Martin IP Pty Ltd v Meridian Medical Technologies, Inc - [2019] APO 54

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Martin IP Pty Ltd v Meridian Medical Technologies, Inc. [2019] APO 54
Patent Application: 2010201665

Title:Automatic injector with kickback attenuation

Patentee:Meridian Medical Technologies, Inc.

Opponent:Martin IP Pty Ltd

Delegate:Xavier Gisz

Decision Date: 29 November 2019

Hearing Date: Written submissions filed on 21 August 2019, 4 September 2019 and 11 September 2019

Catchwords: PATENTS - opposition to the allowance of amendments under subsections 102(1) and 102(2)(b) of the Patents Act 1990 – Amendments allowable – costs awarded against the opponent.

Representation: Patent attorney for the patentee: Phillips Ormonde Fitzpatrick
Patent attorney for the opponent: Martin IP Pty Ltd

IP AUSTRALIA
AUSTRALIAN PATENT OFFICE

Patent Application: 2010201665

Title:Automatic injector with kickback attenuation

Patentee:Meridian Medical Technologies, Inc.
Date of Decision: 29 November 2019
DECISION

The opposition fails on all grounds relied on. The proposed amendments satisfy the requirements of subsections 102(1) and 102(2)(b) of the Patent Act 1990.
I allow the amendments.
Costs are awarded according to Schedule 8 against the Opponent.
REASONS FOR DECISION

Background

Patent application 2010201665 in the name of Meridian Medical Technologies, Inc. (the Patentee) was advertised as accepted on 30 May 2013 and granted on 12 September 2013. Re‑examination was requested on 5 March 2018 by Eager & Martin Pty Ltd.
An adverse re-examination report was issued on 25 May 2018.
On 24 July 2018 the Patentee proposed amendments to overcome the objections raised in the re‑examination report.
On 16 November 2018 the Patentee was informed that, once the amendments are allowed, the objections raised in the re-examination report would be overcome.
The amendments were advertised for opposition on 29 November 2018.
On 29 January 2019 Martin IP Pty Ltd (the Opponent) filed a Notice of Opposition to the amendments. A Statement of Grounds and Particulars was filed on 27 February 2019.
The Opponent did not file evidence in support.
On 27 March 2019 the Commissioner made the following direction:
“the Patentee has two months from the date a direction is issued to file evidence in answer to the Statement of Grounds and Particulars; and
the Opponent has one month from the date the Commissioner gives it a copy of the evidence in answer and notifies it that all the evidence in answer has been filed to file any evidence in reply.”
On 29 March 2019 the Patentee filed evidence in answer comprising a declaration by Neil Sheehan and Exhibits NS-1 to NS-3. The Opponent did not file evidence in reply.
The Commissioner advised that the hearing would be on the basis of written submissions. The Opponent’s submissions were filed on 21 August 2019. The Patentee’s submissions were filed on 4 September 2019. The Opponent’s submissions in reply were filed on 11 September 2019.
Regulation 5.23
On 3 October 2019 the Applicant informed the Commissioner that they believed that part of the Opponent’s submissions in reply were not relevant to the issue in dispute. The Applicant also included another declaration of Neil Sheehan dated 30 September 2019 which responded to an alleged misunderstanding in the Opponent’s submissions in reply.
On 16 October 2019 the Delegate proposed the following direction:
That the following material from the Opponent’s reply evidence filed 11 September 2019 not be available in determining the s104 opposition:
·appendices A to C;
·paragraph 17, from the sentence beginning “In this regard…” onwards, i.e. the second sentence of paragraph 17 onwards; and
·paragraphs 23 to 26
On 22 October 2019 the Opponent provided arguments as to why the information in the reply submissions was relevant to the opposition. The Opponent further suggested that, to the extent that the information could be considered evidence rather than submissions, that information could be introduced into the opposition under Regulation 5.23.
On 23 October 2019 the Applicant generally agreed with the proposed direction but also suggested some amendments to the proposed direction.
On 5 November 2019 the Delegate informed the parties that the proposed direction of 16 October 2019 was now made. The Delegate also informed the parties that the hearing officer would consider the disallowed information and the additional declaration of Mr Sheehan. The hearing officer would then decide whether to rely on the information under Regulation 5.23.
I have reviewed the Opponent’s disallowed information and the additional declaration of Mr Sheehan. The information that is directly relevant to the allowability of the amendments addresses the same issues as the evidence already on file. I am not satisfied that the information is likely to be determinative of the opposition. Consequently, I will not rely upon the Opponent’s disallowed information or the additional declaration of Mr Sheehan under Regulation 5.23.
Grounds of Oppositions
The Statement of Grounds and Particulars opposes the amendments under subsection 102(1) and paragraph 102(2)(b) of the Patents Act. Under paragraph 102(2)(b), it is asserted that the proposed amendments would not comply with subsections 40(2) or 40(3).
The law
As the request for examination of the patent application was filed before 15 April 2013, substantive amendments of the Patents Act brought about by the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 do not apply to the present patent application.
The relevant sections of the Patents Act in the current case are sections 102(1) and (2) as they existed prior to the introduction of the Raising the Bar Act. These are set out below:
(1) An amendment of a complete specification is not allowable if, as a result of the amendment, the specification would claim matter not in substance disclosed in the specification as filed.
(2) An amendment of a complete specification is not allowable after the relevant time if, as a result of the amendment:
(a) a claim of the specification would not in substance fall within the scope of the claims of the specification before amendment; or
(b) the specification would not comply with subsection 40(2) or (3).
(2A) For the purposes of subsection (2), relevant time means:
(a) in relation to an amendment proposed to a complete specification relating to a standard patent--after the specification has been accepted
The applicable parts of section 40 of the Patents Act 1990 as they apply to the present case are set out below:
(2) A complete specification must:
(a) describe the invention fully, including the best method known to the applicant of performing the invention; and
(b) where it relates to an application for a standard patent – end with a claim or claims defining the invention.
(3) The claim or claims must be clear and succinct and fairy based on the matter described in the specification.
It is plain from the wording of section 102 that the test provided by this section of the Patents Act is confined to matters which arise as a result of amendment (see Kornelis’ Kunsthars Producten Industrie BV v WR Grace & Co-Conn [1994] FCA 969). Consequently any pre-existing deficiencies in the specification which are unaffected by amendment are not relevant to the present action.
Construction
The proper approach to the construction of claims was discussed by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd [2009] FCAFC 70, 81 IPR 228 at [118] – [120]:
“the words in a claim should be read through the eyes of the skilled addressee in the context in which they appear ... while the claims define the monopoly claimed in the words of the patentee's choosing, the specification should be read as a whole ... it is not permissible to read into a claim an additional integer or limitation to vary or qualify the claim by reference to the body of the specification ... terms in the claim which are unclear may be defined or clarified by reference to the body of the specification.”
The claims also need to be construed in a purposive common sense manner. As Middleton J noted in Eli Lilly and Company Limited v Apotex Pty Ltd [2013] FCA 214, 100 IPR 451 at [139]:
“It is well settled that the Court should, from the outset, approach the task of patent construction with a generous measure of common sense. The Court must place itself in the position of a person skilled in the relevant art, being the subject matter of the patent. From this perspective, the patent is to be read as a whole, in the context of the specification and in light of the prevailing common general knowledge and state of the relevant art at the priority date.”
Subsection 102(1): In-substance disclosed in the specification as filed
When determining whether a matter is in substance disclosed in the specification as filed, the courts have basically applied the test for fair basis. Thus for an amended claim to claim matter in substance disclosed in the specification as filed, the amended claim must be fairly based on the specification as filed (see United-Carr Incorporated's Application [1971] RPC 23, RGC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd [1998] FCA 1358; (1998) 42 IPR 353).
Under Section 40(3), fair basis is “concerned purely with the relationship between the body and claims of the one specification.” (Lockwood Security v Doric Products [2004] HCA 58; 217 CLR 274; 212 ALR 1; 79 ALJR 260). As was noted in Kimberly-Clark Australia Pty Ltd v Arico Trading International Pty Ltd [2001] HCA 8; 207 CLR 1; 177 ALR 460; 75 ALJR 518 the test requires “a comparison between the matter described in the specification and the claim which defines the scope of the monopoly”, following the reasoning of Barwick CJ in Olin Corporation v Super Cartridge Co Pty Ltd [1977] HCA 23; (1994) 180 CLR 236 when he said:
“The question whether the claim is fairly based is not to be resolved ... by considering whether a monopoly in the product would be an undue reward for the disclosure. Rather, the question is a narrow one, namely whether the claim to the product being new, useful, and inventive, that is to say, the claim as expressed, travels beyond the matter disclosed in the specification.”
As was noted in Lockwood (supra):
“the statutory test as expounded by Barwick CJ does not call for any evaluation of whether the breadth of the claims exceeds "the technical contribution to the art embodied in the invention", merely for an evaluation of whether the claims travel beyond the matter described in the specification”
I also note that it was said in Rehm Pty Ltd v Websters Security Systems (International) Pty Ltd [1988] FCA 162 at [54]:
“The circumstance that something is a requirement for the best method of performing an invention does not make it necessarily a requirement for all claims; likewise, the circumstance that material is part of the description of the invention does not mean that it must be included as an integer of each claim. Rather, the question is whether there is a real and reasonably clear disclosure in the body of the specification of what is then claimed, so that the alleged invention as claimed is broadly, that is to say in a general sense, described in the body of the specification”
This was cited with approval in Lockwood (supra).
Paragraph 102(2)(b): Compliance with subsection 40(3), clarity and fair basis
I have already identified the relevant law with respect to fair basis. In relation to clarity, I note that the requirement that the claims are clear is understood to be satisfied if a person could ascertain "whether or not what he proposes to do falls within the ambit of the claim" (Monsanto Co v Commissioner of Patents (1974) 48 ALJR 59).
The Amendments
A marked-up version of the amendments is provided below:
1.An automatic injector comprising:
a housing; having a retention step formed on an inner surface of the housing;
a cartridge having an opening therein and containing a medicament, the medicament rearwardly confined by a plunger received through the opening, the cartridge including a needle assembly operative to dispense the medicament there through during a medicament dispensing operation, the needle assembly including a needle;
a cartridge container disposed within the housing and operative to receive the cartridge therein, the cartridge container having a ledge that abuts the retention step of the housing to limit movement of the cartridge container within the housing, the cartridge container having a closed front end except for an opening therein sized to receive the needle there through during the medicament dispensing operation, the closed front end operative to engage the cartridge and oppose continued movement of the cartridge after the needle passes through the front end opening;
an actuation assembly providing a stored energy source capable of driving the plunger within the cartridge to dispense the medicament through the needle assembly, the actuation assembly secured to the housing; and
a needle cover at least partially received within the housing and operative to receive therein at least the front end of the cartridge container, such that the needle cover is operative to contact a front end of the cartridge container, moving the cartridge container rearwardly into the housing during a loading operation, the needle cover extending beyond the housing and having an end surface operative to contact an injection site prior to a medicament dispensing operation, the end surface having an opening sized to receive the needle there through during a medicament dispensing operation; wherein:
residual force from the energy source after activation of the automatic dispensing operation is contained within the cartridge container, the cartridge, the housing, and the actuation assembly to prevent kickback of the automatic injector from the injection site during a medicament dispensing operation.
2.The automatic injector of claim 1 wherein the cartridge further comprises a needle sheath disposed about the needle, the needle sheath being compressed between the cartridge container and the cartridge during a medicament dispensing operation.
3.The automatic injector of claim 1 or 2 wherein the actuation assembly is secured to the housing via projections formed on an outer surface of the actuation assembly that are snap fit into respective openings in the housing.
4.The automatic injector of any of claims 1 to 3 wherein the stored energy source is a spring in the actuation assembly.
5.The automatic injector of any of claims 1 to 4 further comprising a needle cover spring positioned inside the needle cover between the end surface of the needle cover and the front end of the cartridge container.
6.The automatic injector of any of claims 1 to 5 wherein the ledge of the cartridge container is located on an end opposite the closed front end.
7.The automatic injector comprising:
a housing;
a cartridge having an opening therein and containing a medicament, the medicament rearwardly confined by a plunger received through the opening, the cartridge including a needle assembly operative to dispense the medicament there through during a medicament dispensing operation, the needle assembly including a needle;
a cartridge container disposed within the housing and operative to receive the cartridge therein, the cartridge container having an annular structure that engages an inner surface of the housing to limit movement of the cartridge container within the housing, the cartridge container having a closed front end except for an opening therein sized to receive the needle there through during the medicament dispensing operation, the closed front end operative to engage the cartridge and oppose continued movement of the cartridge after the needle passes through the front end opening;
an actuation assembly providing a stored energy source capable of driving the plunger within the cartridge to dispense the medicament through the needle assembly, the actuation assembly secured to the housing; and
a needle cover at least partially received within the housing and positioned between the housing and the cartridge container, such that the needle cover is operative to contact a front end of the cartridge container, moving the cartridge container rearwardly into the housing during a loading operation, the needle cover having an opening formed therein sized to receive the needle there through during the medicament dispensing operation, the needle cover extending beyond the housing and operative to contact an injection site prior to a medicament dispensing operation; wherein:
energy released from the stored energy source to drive the needle and cartridge during the medicament dispensing operation is not transmitted to the needle cover.
8.The automatic injector of claim 7 wherein the annular structure of the cartridge container is a ledge located on an end opposite the closed front end.
9.The automatic injector of claim 7 or 8 wherein the actuation assembly is secured to the housing such that the actuation assembly is not movable with respect to the housing.
10.The automatic injector of any of claims 7 to 9 wherein the front end of the cartridge container is tapered, the cartridge container comprising a plurality of ribs formed on the outer surface of the tapered front end, the automatic injector further comprising a needle cover spring positioned inside the needle cover and disposed about the plurality of ribs.
11.The automatic injector of claim 10 wherein the needle cover spring has a force that is less than an activation force required to activate the automatic injector.
12.The automatic injector of any of claims 7 to 11 wherein the cartridge further comprises a needle sheath disposed about the needle, the needle sheath being compressed between the cartridge container and the cartridge during a medicament dispensing operation.
13.The automatic injector of any of claims 7 to 12 wherein the stored energy source is a spring.
14.A method of assembling an automatic injector to attenuate kickback of the automatic injector, the automatic injector comprising a housing, a cartridge, a cartridge container, an actuation assembly, and a needle cover, the cartridge having a rearward opening confined by a plunger received through the opening, the cartridge including a needle assembly that includes a needle, the cartridge container having a closed front end except for an opening sized to receive the needle there through, the actuation assembly providing a stored energy source, the needle cover operative to receive the front end of the cartridge container, the needle cover extending beyond the housing prior to a medicament dispensing operation and having an end surface that has an opening sized to receive the needle there through, the end surface operative to contact an injection site prior to a medicament dispensing operation, the method comprising:
securing the actuation assembly to the housing;
receiving the cartridge within the cartridge container;
receiving the cartridge container within the housing;
slidably receiving the needle cover within the housing;
opposing continued movement of the cartridge within the cartridge container by engaging the cartridge container during a medicament dispensing operation; and
limiting movement of the cartridge container within the housing by engaging the housing during a medicament dispensing operation wherein:
residual force from the energy source after activating the automatic injector is contained within the cartridge container, the cartridge, the housing, and the actuation assembly to prevent transferring the residual force to the needle cover.; and
the needle cover contacts a front end of the cartridge container, moving the cartridge container rearwardly into the housing during a loading operation.
15.The method of claim 14 further comprising compressing a needle sheath between the cartridge and the cartridge container during a medicament dispensing operation to prevent transferring force to the needle cover.
16.The method of claim 14 or 15 wherein the step of limiting movement comprises engaging a retention step formed on an inner surface of the housing with a ledge formed on the cartridge container.
17.The method of any of claims 14 to 16 wherein the step of opposing continued movement comprises opposing continued movement of the cartridge within the cartridge container by engaging the closed front end of the cartridge container after the needle passes through the front end opening.
18.The method of any of claims 14 to 17 further comprising applying a force against the end surface of the needle cover to activate the automatic injector.
19.The method of any of claims 14 to 18 further comprising extending the needle cover outward from the housing with a needle cover spring.
20.The method of any of claims 14 to 19 wherein the step of securing comprises securing the actuation assembly to the housing via projections formed on an outer surface of the actuation assembly that are snap fit into respective openings in the housing.
The invention

The invention is summarised at paragraph 2:
“The invention relates to an automatic injector or auto-injector for delivering medicament to an injection site. In particular, the invention is directed to an auto-injector having a needle cover mechanism to prevent a user from coming into contact with the needle of the auto-injector after use. The needle cover mechanism is held in a locked position prior to activation of the auto-injector. After injection, the needle cover mechanism is held in a locked deployed position such that the user cannot access the needle.”
The invention is most easily understood when viewed as a sequence of steps as shown in figures 2, 4, 7 and 9:
Figure 2 shows the auto-injector in an inactivate state having the release pin in place. Figure 4 shows the autoinjector having the release pin (120) removed for activation. Figure 7 shows the autoinjector in an actuated state with the needle in a drug delivery position. Figure 9 shows the auto-injector following delivery of the drug wherein the needle cover is in an extended protective state.
The steps of using the auto-injector are: 1) remove the release pin, 2) press needle cover against the injection site of the patient’s body, 3) needle is automatically forced into the patient’s body by the spring (530), 4) the needle cover is automatically forced forward by the spring (153).
Section 102(1) and Section 102(2)(b) (fair basis)
Is there an “Intermediate generalisation”?
The Opponent states in their submissions at paragraphs 8-13:
“Amended claim 1 specifies an unallowable “intermediate generalization”.
Section 2.23.8.2 of the Manual, Section 102(1) Examination Practice, sets out that an amendment of a claim to an "intermediate generalisation" that falls between a general disclosure, and the specific examples described, is only allowable in restricted circumstances.
Claim 1 as amended recites “such that the needle cover is operative to contact a front end of the cartridge container, moving the cartridge container rearwardly into the housing during a loading operation”. This feature is allegedly based on paragraph [0109] of the specification as originally filed:
“[0109] As shown in Figures 5 and 6, the user presses the end surface 152 of the needle cover 150 against the injection site. This causes the pre-compressed spring 153 to be slightly further compressed until the needle cover 150 moves and contacts the front end 145a of the cartridge container 140 (see Fig. 51), thus moving the ledge 142 of the cartridge container 140 rearwardly. The force of spring 153 is less that the force of spring 530. The needle cover 150, the cartridge container 140 and the cartridge 160 are then moved rearwardly into the outer body 110. The cartridge container 140 moves upward into the outer body 110 until the ledge 142 thereof contacts the ledge 335 of the power pack inner body 330. The power pack inner body 330, and the collet 430 and the spring assembly 530 are then pushed rearwardly into the auto-injector 100 into the power pack outer body 230. The collet 430 moves upwardly until it contacts the collet activation structure 239, shown in Figure 28. The arrowheads 434a and 434b contact the sloped activation surface 239a. The arrowheads 434a and 434b are compressed together by the sloped surface 239 as the collet 430 moves rearwardly, such that the arrowheads 434a and 434b are released from the collet retention surface 332b. During this loading operation, the needle cover 150 is rearwardly pushed a small amount into outer body 110. When this occurs, the preload on the locking teeth 340 provided by the spring 153 is temporarily removed. As such, the v-shaped notch 347 temporarily disengages projection 156 formed on the needle cover 150. During this operation, the projection 156 no longer contacts either surface 347a or 347b, but remains in a space provided between the surfaces. As such, when pressure from the needle cover 150 is removed, the projection 156 will return into contact with the surfaces 347a or 347b. The locking teeth 340 will completely release the needle cover 150 only in response to movement of the cartridge 160 as it travels forwardly within the cartridge container 140. Accordingly, the needle cover 150 cannot deploy until the cartridge 160 moves”.
According to the original disclosure, the loading operation includes at least all of the following features: movement of the ledge of the cartridge container rearwardly, movement of the needle cover, the cartridge container and the cartridge rearwardly, the ledge of the cartridge container contacts the ledge of the power pack, the collet moves upwardly until it contacts the collet activation structure such that the arrowheads are released from the collet retention surface.
The essence of the loading operation, according to the original disclosure, is release of the pre-loaded spring by rearward movement of the cartridge container and compression of the collet.
Considering the above (paragraphs 10 – 12), I submit that amended claim 1 is significantly broader than the specific disclosure in only claiming rearwardly movement of the cartridge container by operation of the needle cover. The exclusion of other essential features, including release of the spring by compression of the collet, etc., impermissibly generalizes the original disclosure. Accordingly, amended claim 1 defines an unallowable intermediate generalization. That is, there is no basis in the application as originally filed for the broad definition of a loading operation as claimed.”
The Patentee states in their submissions at paragraphs 3-8:
“The phrase that has been added to claim 1 by amendment describes the movement of the needle cover and cartridge container. Both the needle cover and cartridge container were features of claim 1 prior to amendment.
Mr Martin argues that the amendment to claim 1 amounts to an intermediate generalisation of the type referred to in section 2.23.8.2 of the Examiner's Manual. We disagree that the amendment can be characterised in this way.
Paragraph 109 of the specification as filed clearly discloses the needle cover moving to contact the front end of the cartridge container and moving the cartridge container rearwardly. Whilst the movement is described with reference to the specific components described in the figures, we assert that the skill addressee would understand that the movement sequence is not specific to these particular components shown in the figures but is a disclosure of the movement of a needle cover generally and of a cartridge container generally.
The appropriate test for determining whether, as a result of amendment, the specification could claim a matter that is 'in substance disclosed' in the specification as filed, is the fair basis test. That is, is there in the specification as filed a 'real and reasonably clear disclosure' of the subject matter of the claim as amended (RJC Mineral Sands Pty Ltd v Wimmera Industrial Minerals Pty Ltd 42 IPR 353).
We assert that the specification as filed discloses that the broadest embodiment of the invention is an automatic injector having a combination of parts that is set out in paragraph 0008B and claim 1 of the specification. Included within those parts is a needle cover, cartridge container and housing amongst others. The parts are not limited to any particular configuration. The passage at paragraph 109 describes the movement of the needle cover and cartridge container. We submit that a skilled addressee would understand that paragraph 109 describes the movement of the needle cover and cartridge container that is described in the broad embodiment of the invention. It is a real disclosure of the movement of these parts. The amendment to claim 1 goes no further than to add that disclosure.
Mr Martin refers to other features described in paragraph 109 such as the spring and collet. However, these are clearly preferred and not essential features of the automatic injector. They are not recited in the broadest statement of the invention in the specification as filed and requiring the patentee to include these additional preferred features in claim 1 would be to require the patentee to limit the claim down to the preferred embodiment.”
I consider that the Opponent’s argument regarding the “intermediate generalisation” is unrelated to the amendments. Whether the claims contained an “intermediate generalisation” in the accepted claims (and prior to the amendment) is not relevant to the present consideration.
I consider the amendments to claim 1 to limit the claim in how the cartridge container moves during the loading operation. This claimed movement of the cartridge container is consistent with the description at paragraph 109. I consider this aspect of the amendments is in substance disclosed in the specification as filed, and thus complies with s 102(1).
Is there redundancy between claims 14 and 18?
The Opponent states in their submissions at paragraphs 3-7:
According to the rule against redundancy, there is a presumption that “each claim is of differing scope, and where possible claims should be construed accordingly” (Patent Examiner’s Manual (“the Manual”), Section 2.11.2.3.2.).
Dependent claim 18 modifies the subject matter of claim 14 by the addition of a force to move the needle cover and activate the injector.
The amendment to claim 14 adds a force that (implicitly) moves the needle cover to move the cartridge during a loading operation.
Applying the rule against redundancy, the moving force being newly added to independent claim 14 must be different to the moving force being added by dependent claim 18, resulting in two different moving forces. However, there appears to be only one force responsible for moving the cartridge and activating the injector according to the description, not two different forces (see, the specification of patent number 2010201665 (“the specification”), paragraph [0109], lines 5-17.
Accordingly, as a result of the amendment to independent claim 14, the specification would claim matter that extends beyond that disclosed in the complete specification as filed.
The Patentee states:
Claim 14 has been amended to provide further details of the interaction of the needle cover and the cartridge container during the loading operation. This further detail does not require the reader to understand that there are two forces in operation. Rather, the amendment is providing further detail on what occurs inside the housing when the force is applied to the needle cover. The foundation for Mr Martin's submission, that there is a redundancy, does not exist.
Claim 18 specifies that applying a force against the end surface of the needle cover activates the automatic injector. This force is applied by the surface of the injection site. Claim 14 defines that the other end of the needle cover contacts a front end of the cartridge container. Because the needle cover is rigid, the force on one end of the needle cover is transferred to the other end. The Opponent’s argument is that it is redundant to define the force at each end of the needle cover.
Claim 14 is not limited to any particular force activating the injector using the needle cover, whereas claim 18 specifies a particular position at which the exterior force is applied which must also be sufficient to activate the injector. Consequently, I do not consider that defining the forces acting at each end of the needle cover is redundant. Thus claim 18 provides a further limitation in the claim set. The Opponent’s argument that the alleged redundancy leads to the claim defining the two different unrelated forces is thus obviated. Consequently this aspect of the amendment complies with s 102(1).
Is the needle cover an “all means” claim?
The Opponent states at paragraphs 32-34:
“According to the Manual at Section 2.11.7.6, “…[a] claim may define a product by reference to its resulting properties rather than its structure.” With respect to amended claim 14, the amendment further defines the needle cover in terms of what it does (i.e., being operative to contact a front end; and moving the cartridge container). Therefore, the amendment is phrased in such a way that it is essentially claiming by result.
The Manual at Section 2.11.7.6 further goes on to state that “…where (on a true construction of the specification), the result is a known or desired goal, then the invention will not lie in the result itself, but in the means of achieving that result. Claims to ‘all means’ in these cases travel beyond the subject matter of the invention and will not be fairly based.
With respect to amended claims 1, 7, and 14, the result (a needle cover moving the cartridge container rearwardly) is known as shown in FIG. 25 and column 10, lines 3 to 20 of US 5,295,965 (Appendix A) and FIGS. 10 and 11 of US 5,271,744 (Appendix B) and column 5, line 49 to column 6, line 18. As such, the patent is not entitled to claim all means of achieving that result. In attempting to do so, the amendment is not fairly based.”
The Patentee states in their submissions at paragraphs 19-20:
“Mr Martin argues that the feature added by amendment to claims 1, 7 and 14 is known as shown in two prior art documents. As such, the patentee is not entitled to claim all means of achieving a known result and the claims lack fair basis.
The submission is misconceived. Assuming that the proposition at section 2.11.7.6 is correct (and we deal with this further below), it does not apply for various reasons:
(a) Claims 1, 7 and 14 do not define a product by result. Claims 1 and 14 define an automatic injector having a combination of features. The automatic injector is defined by reference to its features, not by what it achieves. The amendment simply goes to describing the movement of two components of the injector. Similarly, claim 14 defines a method of assembly of the automatic injector, having the features of the product claims rather than a product by result.
(b) Even if these were claims to a definition of an invention by result, for the proposition to apply it would be necessary for the entire 'result' to be known. In other words, if an invention is to a product that is a combination of features and that combination is new, how does this offend against the principles set out in section 2.11.7.6 if only one of the features is defined by result? It does not. As noted, claims 1 and 7 define a combination of integers and claim 14 defines a combination of method steps. The combination of integers and steps are not 'known' in light of the disclosure of either US5295965 or US5271744.”
It is well established that claims can define both physical elements and how those elements function. In this case the physical element (the needle cover) is defined in terms of how it functions in relation to adjacent elements (i.e. the needle cover contacts the front of the cartridge container). This aspect of the amended claims is not considered speculative nor is it so broad as to be considered an “all means” claim. I consider this feature fairly based on the description. The Opponent’s argument that a needle cover moving the cartridge container rearwardly is allegedly known in the prior art is not relevant to the consideration of fair basis. Consequently this aspect of the amendment complies with s 102(1).
Section 102(2)(b) (Clarity)
Does the term “loading operation” lack clarity?
The Opponent states in their submissions at paragraphs 18-28:
“I submit that the amendment set out in paragraph 17 above does not comply with subsection 40(3) of the Patents Act 1990 (Cth) because it lacks clarity with regard to the phrases “a loading operation”, “cover is operative”, and “moving the cartridge”.
The phrase “a loading operation” is introduced for the first time by the claim amendment (see paragraph 17 above).
The phrase “loading operation” has several reasonable meanings. For example, it may refer to loading a spring, or loading of the cartridge. It is not possible to tell what is referred to just looking at the claim itself.
Under Australian law, the entire specification is taken into consideration. When referring to paragraph [0109] of the specification, the “loading operation” appears to be just compressing arrowheads 434a and 434b as collet 430 moves rearwardly. (specification, paragraph [0109], lines 12-14; and Fig. 23.)
Fig. 23 (see below) shows collet 430 positioned within power pack spring assembly 530. (The specification, paragraph [0089], line 1.) Collet 430 includes a projection 437, which is configured to receive a plunger (specification, paragraph [0089], line 13.).
Amended claim 1 recites an “actuation assembly” in the clause immediately before the needle cover. The actuation assembly, per claim 1, provides “a stored energy source capable of driving the plunger within the cartridge to dispense the medicament through the needle assembly.”
Based on claim 1, paragraph [0089], and Fig. 23, it is clear that collet 430 and arrowheads 434a and 434b are part of the actuation assembly. Accordingly, the “loading operation” discussed in relation to these elements in paragraph [0109] is in relation to the actuation assembly, not the needle cover. The introduction of the “loading operation” with the needle cover conflates elements of the needle cover and the actuation assembly, thereby causing a lack of clarity.
I submit, moreover, that the phrase “loading operation” does not even relate to loading a spring since the spring is pre-loaded, and merely released by the actuation. No mention is made in the description of the specification (“the description”) of loading the cartridge. Consequently, not only does the phrase “loading operation” as recited in claim 1 lack clarity, but a person skilled in the art, when reading the description in an attempt to decipher the phrase “loading operation”, would not be helped since the phrase as used in the description is contrary to what a skilled person in the art would have expected.
I submit, furthermore, that the term “loading operation” lacks clarity in combination with the previously recited medicament dispensing operation.
In addition to a loading operation, claim 1 recites “activation of the automatic dispensing operation”. This activation occurs by applying a force against the end surface of the needle cover to activate the automatic injector according to claim 18.
Accordingly, claim 1 encompasses rearward movement of the needle cover initiating both the loading operation and the medicament dispensing operation. The terms “loading operation” and “medicament dispensing operation” thus lack clarity as it is not clear whether they are referring to the same operations and how the terms are to be differentiated from each other, if at all.”
The Patentee states at paragraphs 10-14:
Mr Martin asserts at paragraph 20 that 'loading operation' has several meanings and it is not possible to tell what is referred to by just looking at the claim itself. He then notes at paragraph 21 that the phrase appears at paragraph 109 of the specification, but he interprets it to refer to the movement of arrowheads 434(a) and 434(b) alone.
The patentee has put on evidence of Mr Neil Sheehan who has expertise in the field of medication delivery systems and components. Mr Sheehan has made a declaration dated 24 May 2019. Mr Sheehan has read the specification and claims as amended and provided comments on the meaning to him of the phrase 'loading operation' at paragraphs 19-26 of his declaration. As set out in these paragraphs, Mr Sheehan has had no difficulty understanding the meaning of the phrase 'loading operation' in the context of claim 1. He is able to say that the phrase describes the steps that take place to prepare the automatic injector to fire and occur from the commencement of use up to the firing step (see in particular paragraphs 19 and 25 of his declaration).
Mr Sheehan's understanding is confirmed when he reads claim 1 as amended in light of the specification as a whole including paragraph 109. Mr Sheehan does not understand the reference to 'during the loading operation' in this paragraph to mean only movement of the arrowheads. We assert that Mr Todd's interpretation of paragraph 109 in this regard is strained and unnatural.
The opponent has not put on any evidence going to the meaning of 'loading operation' or any difficulty arising from the use of the phrase in claim 1. To the best of our knowledge, Mr Martin is not an expert in the field of this technology.
Mr Martin attempts to support a lack of clarity assertion by identifying the collet 430 and arrowheads 434(a) and 434(b) as part of the actuation assembly. The phrase 'loading operation' refers to a sequence of events rather than integers of the automatic injector. Furthermore, various integers of the automatic injector can and do take part in different series of movements during the whole operation of the injector. This does not cause the phrase 'loading operation' to be unclear. Mr Sheehan has directly addressed this point at paragraph 28 of his declaration and has given evidence that the movement of the collet 430 and arrowheads 434(a) and 434(b) (being part of the preferred embodiment) do not cause any confusion for him with regard to the understanding of the phrase 'loading operation'.

Mr Sheehan states in his declaration at paragraph 12:
“Before commenting on the meaning of the phrases that form part of the amendments to claim of the Patent, I set out below my understanding of the coverage of the claim prior to amendment. For the purposes of this exercise, I have divided the claim into various features.
(a)An automatic injector comprising
I understand the claim is directed to a medical injection device that is automated.
(b)a housing having a retention step formed on an inner surface of the housing
The injector has a housing, which is something that contains another part or parts of the device. There is a feature that acts as a stop on the inside wall of the housing.
(c)a cartridge having an opening therein and containing a medicament, the medicament rearwardly confined by a plunger received through the opening, the cartridge including a needle assembly operative to dispense the medicament there through during a medicament dispensing operation, the needle assembly including a needle
I understand that what is being defined here is a syringe. At one end there is a plunger to push the medicament out of the syringe in a medicament-dispensing operation. The cartridge or syringe has a needle assembly with a needle.
(d)a cartridge container disposed within the housing and operative to receive the cartridge therein, the cartridge container having a ledge that abuts the retention step of the housing to limit movement of the cartridge container within the housing, the cartridge container having a closed front end except for an opening therein sized to receive the needle there through during the medicament dispensing operation, the closed front end operative to engage the cartridge and oppose continued movement of the cartridge after the needle passes through the front end opening
The cartridge container is located within the housing. The cartridge container is a part that can operate to receive the cartridge. The cartridge container has a ledge that I understand to be a projecting surface such as a flange that can contact the retention step to stop the movement of the cartridge within the housing. At the front of the cartridge container there is an opening that can receive the needle during the medicament-dispensing operation. The closed front end can operate to stop the movement of the cartridge but allow the needle to emerge from the cartridge container.
(e)an actuation assembly providing a stored energy source capable of driving the plunger within the cartridge to dispense the medicament through the needle assembly, the actuation assembly secured to the housing I understand the term 'assembly' to describe a collection of related parts.
This feature informs me that the assembly provides a stored energy source. For example, it includes a spring or a gas storage as the energy source. The assembly drives the plunger within the cartridge.
(f)a needle cover at least partially received within the housing and operative to receive therein at least the front end of the cartridge container, such that the needle cover is operative to contact a front end of the cartridge container, moving the cartridge container rearwardly into the housing during a loading operation, the needle cover extending beyond the housing and having an end surface operative to contact an injection site prior to a medicament dispensing operation, the end surface having an opening sized to receive the needle there through during a medicament dispensing operation; wherein
The feature tells me that there is a cover for the needle and it is positioned so that it is partially within the housing and part of it extends outside the housing. The needle cover can perform a number of actions. It can receive a front end of the cartridge container. Further, the end surface can contact the injection site, which is the site on the patient where the user wishes to make the injection. I further understand the end surface of the needle cover has an opening of sufficient size so that the needle can extend through the cover during the medicament-dispensing operation.
(g)residual force from the energy source after activation of the automatic dispensing operation is contained within the cartridge container, the cartridge, the housing, and the actuation assembly to prevent kickback of the automatic injector from the injection site during a medicament dispensing operation
This feature tells me that the residual force from the energy source after activation is contained within the four features specified: the cartridge container, the cartridge, the housing and the actuation assembly. Thus, the residual force is isolated from the needle cover. Kick-back or bouncing of the injector away from injection site during the injection operation is thereby prevented. Kick-back, which is any force that makes an automatic injector back off from the injection site during administration of the medicament, is a concern with such devices. It can result in insufficient or no medicament being administered.”
Mr Sheehan states at paragraphs 19-26:
“In the context of the claim, it is clear to me that the 'loading operation' describes all the steps that take place to prepare the automatic injector to fire - that is all the steps from placement of the device against the injection site and up to the firing of the device.
In claim 1 as amended, there is reference to the 'medicament dispensing operation' and the 'loading operation.' I understand that each refers to a different operation.
The claim recites that the cartridge dispenses the medicament through the needle assembly during the medicament dispensing operation (step (c)) and the cartridge container receives the needle and opposes continued movement of the cartridge during the medicament dispensing operation (step (d)).
I also understand that the stored energy in the actuation assembly drives the plunger within the cartridge to dispense the medicament through the needle assembly.

From all these statements, it is clear to me that the 'medicament dispensing operation' being described in the claim starts from the 'firing' of the actuation assembly to release the stored energy to cause the cartridge and plunger to move, resulting in the medicament being dispensed.
During the loading operation, the needle cover contacts the front end of the cartridge container to move the cartridge container rearwardly into the housing (step (f)). This series of movements commences with the front of the needle cover contacting the injection site. The needle cover can be moved by for example pushing it against the skin of the patient.
I therefore understand that the 'loading operation' refers to steps that occur from the commencement of use (when the front of the needle cover is placed on the injection site) up to the firing step. The term 'loading' is descriptive of these steps as they are the steps that take place prior to a 'firing' action.
My understanding of 'loading operation' is confirmed by the description of the invention earlier in the patent document. Paragraph 109 describes a preferred automatic injector and a preferred way of operating such an injector. The paragraph commences with the step of the user pressing the end surface 152 of the needle cover 150 against the injection site. There then follows a series of actions described from line 1 to line 14 of the paragraph. The sentence mid-way through line 14 commences 'During this loading operation,….' That is, the steps that precede this sentence, commencing with pressing the end surface of the needle cover against the injection site, are part of a preferred loading operation.”
The Opponent asserts that the “loading operation” is unclear and could be referring to the action of compressing arrowheads 434a and 434b as collet 430 moves rearwardly. However, I disagree with the Opponent’s assessment and accept the evidence provided by Mr Sheehan – the “loading operation” defines the steps that take place to prepare the automatic injector to fire and occur from the step of applying force to the cartridge via the needle cover to the firing step. This aspect of the amendment is clear.
Does the term “cover is operative” lack clarity?
The Opponent states in their submissions at paragraphs 28 and 29:
“The phrase that the cover is operative to contact a front end of the cartridge container implies that the cover itself performs some function to contact the front end. In reality, it takes a human to cause the action, not a cover operating itself to do the action. Therefore, the phrase “cover is operative” lacks clarity.
Similar to the covering being operative, the amendment to claim 1 implies that the cover (itself) moves the cartridge. Again, in reality, it takes a human to cause the movement. Therefore, the phrase “moving the cartridge” lacks clarity.”
The Patentee states in their submissions at paragraph 18:
“Applying a practical and common sense approach to the interpretation of amended claim 1, the expert Mr Sheehan does not have difficulty understanding the phrases 'cover is operative' and 'moving the cartridge' and he rejects the interpretation that somehow, the phrases imply that movement occurs by itself (see the Sheehan declaration at paragraphs 15-18).”
Mr Sheehan states at paragraphs 15-16:
“I understand that this means that the cover can function or operate to do the step specified.
POF has asked me whether the phrase implies that the cover itself moves the cartridge without human intervention. These words do not imply this meaning to me. The words are describing a part of an automatic injector. Of course an automatic injector is operated by a person and I understand the words 'cover is operative' in this context. That is, I understand that the user of the device takes steps to put the device into operation and in the course of the operation of the device, the needle cover can function as recited in the claim.”
I consider the Opponent’s construction of the term “cover is operative” (that cover itself performs some function to contact the front end) to be unconvincing.
I consider the phrase “cover is operative” defines that, during activation, the needle cover contacts the front of the cartridge container. I see no reason to consider that there is some aspect of mechanical self-functioning, and instead the feature simply refers to operation under human action. This aspect of the amendment is clear.
Does the term “moving the cartridge” lack clarity?
The Opponent states at paragraph 29:
“Similar to the covering being operative, the amendment to claim 1 implies that the cover (itself) moves the cartridge. Again, in reality, it takes a human to cause the movement. Therefore, the phrase “moving the cartridge” lacks clarity.”
Mr Sheehan states at paragraphs 17 and 18:
“I understand that this phrase, in the context of the claim, is reciting that the needle cover contacts the front end of the cartridge container and moves the cartridge container rearwardly. I do not have any difficulty understanding the meaning of the phrase.
POF has asked me whether the phrase implies that the cover itself moves the cartridge without human intervention. This is a similar to the question that was raised above with respect to the phrase 'cover is operative.' As I have noted above, I of course understand that a person operates the automatic injector of claim 1 and takes steps that puts the device into operation. I do not understand that the device functions autonomously.”
The Patentee states in their submissions at paragraph 18:
“Applying a practical and common sense approach to the interpretation of amended claim 1, the expert Mr Sheehan does not have difficulty understanding the phrases 'cover is operative' and 'moving the cartridge' and he rejects the interpretation that somehow, the phrases imply that movement occurs by itself (see the Sheehan declaration at paragraphs 15-18).”
Similarly as above in the discussion of the phrase “cover is operative”, I consider the Opponent’s construction of “moving the cartridge” to be unconvincing. I consider that the phrase “moving the cartridge” defines that the needle cover contacts the front end of the cartridge container and moves the cartridge container rearwardly. This aspect of the amendment is clear.
Is the relationship between the cartridge and the cartridge container adequately defined?
The Opponent states at paragraph 35:
“Further, claim 1 recites “the cartridge container having a ledge that abuts the retention step of the housing to limit movement of the cartridge container within the housing” and has been amended to define “moving the cartridge rearwardly into the housing”. The interrelationship of these features, however, has not been defined, specifically rearward movement of the cartridge container moving the ledge rearwardly and the role of the ledge in releasing the power pack as described in paragraph [0109]. Accordingly, the amendment is not fairly based on the specification.”
The Patentee states at paragraph 24:
“The feature of 'the cartridge container having a ledge that abuts the retention step of the housing to limit movement of the cartridge container within the housing' was present in claim 1 prior to amendment. It is unclear why the addition of the further feature of the cartridge moving rearwardly into the housing in the loading operation gives rise to any lack of fair basis. The question is, is there a real and reasonably clear disclosure in the specification of the cartridge moving rearwardly into the housing? We submit that there is at paragraph 109 of the specification.”
I agree with the Patentee. This does not appear to be an objection to the amendments, and instead is addressing the claims as accepted (prior to amendment). The relationship between the cartridge and cartridge container defined in the claims as amended is consistent with the description and is thus considered clear and fairly based.
Conclusion
The opposition fails on all grounds relied on. The proposed amendments satisfy the requirements of subsections 102(1) and 102(2)(b) of the Patent Act 1990.
Costs
Costs typically follow the event. Neither party made submissions on costs, which I will take as acquiescence to the usual practice. I award costs according to Schedule 8 against the Opponent, Martin IP Pty Ltd.
Xavier Gisz
Delegate of the Commissioner of Patents