AFT Pharmaceuticals Limited
[2024] APO 41
•8 October 2024
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
AFT Pharmaceuticals Limited [2024] APO 41
Patent Applications: 2022201576 and 2023222825
Title:Medication
Patent Applicant: AFT Pharmaceuticals Limited
Delegate:C. Mitchell
Decision Date: 8 October 2024
Hearing Date: Written submissions filed on 6 December 2023
Catchwords: PATENTS – section 45 – Examiner’s objection – use of paracetamol, ibuprofen and xylometazoline to treat cold and flu during a day – inventive step – common general knowledge – claims lack an inventive step – applications are refused
Representation: Patent attorney for the applicant: A J Pietras IP Ltd
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Patent Applications: 2022201576 and 2023222825
Title:Medication
Patent Applicant: AFT Pharmaceuticals Limited
Date of Decision: 8 October 2024
DECISION
Claims 1-22 of both applications are not inventive.
I refuse the parent application and divisional application.
REASONS FOR DECISION
Background
Patent application number 2022201576 (the parent application) was filed on 8 March 2022 by AFT Pharmaceuticals Limited (the applicant). A further application 2023222825 (the divisional) was filed on 28 August 2023 and claims divisional status from the parent application. The earliest priority date for both applications is 8 March 2022.
The request for examination of the parent application was also filed on 8 March 2022. The first examination report was issued on 29 August 2022. Subsequent reports were issued on 31 October 2022, 14 December 2022 and 10 March 2023 following responses from the applicant. A fifth examination report was issued on 24 August 2023, maintaining an objection for a lack of inventive step. The applicant requested a hearing on 28 August 2023.
The request for examination of the divisional was also filed on 28 August 2023. The first examination report was issued on 25 September 2023, raising an objection for a lack of inventive step. Further, the examiner noted the divisional would also be referred to a Hearing Officer so that the hearing requested by the applicant can be in relation to both the parent application and the divisional. On 7 December 2023 the applicant submitted that a hearing on the divisional should not be a part of the hearing proceeding. On 11 December 2023 the Commissioner upheld that both the parent and divisional application will proceed to hearing together as previously indicated. The claims of the divisional are identical to the claims as proposed to be amended in the parent.
Applicable Law
On 15 April 2013, the Intellectual Property Laws Amendment (Raising the Bar) Act 2012 (the Raising the Bar Act) commenced which resulted in significant amendments to the Patents Act 1990 (the Act) and Patents Regulations 1991 (the Regulations). The amended provisions of the Act and Regulations apply to the examination of the instant applications and to these proceedings.
This means that I must accept the instant applications if I am satisfied, on the balance of probabilities, that the instant applications comply with the Act. If I am not so satisfied, I may refuse the instant applications or remit it back to examination for further consideration. I will only refuse the applications if I am also satisfied that providing the applicant with an opportunity to amend will serve no useful purpose.
This decision is in respect to the outstanding inventive step objection maintained in the fifth examination report for the parent application and the same objection in the divisional.
Allowability of the amendments
On the parent application, the amendments up to and including amendment item 2 as detailed in the statement of proposed amendments filed 4 August 2023 add an additional limitation to the independent claims and add two new dependent claims. The features added by these amendments are supported by the discussion on page 3 in the second last paragraph, the discussion about the effect xylometazoline has on ibuprofen in the first paragraph on page 9 and the discussion on dosage events at the beginning of page 7.
Consequently, the proposed amendments do not appear to extend beyond the scope of the specification as filed. The proposed amendments therefore comply with s102(1) and are allowable. Accordingly, this decision is being made on the basis of the amendments filed up to and including those made on 4 August 2023 on the parent application.
The specifications
The specification of the divisional is identical to the parent application as proposed to be amended on 4 August 2023. Therefore, I will discuss the specifications for both together.
The invention described in the specifications
The field and background of the invention are discussed under the relevant titles on page 1. The described invention concerns medications to treat cold or flu. The specification briefly mentions that “[c]old and flu in humans are associated with body aches, pain and congestion of the nasal passages.”[1] The specification then states that it is desirable to overcome or remediate these symptoms as the affected person recovers.
[1] Parent specification at page 1 paragraph 1.
A set of consistory statements are provided as three aspects of the invention: use in manufacture, method of treatment, and product for use in treatment.[2] The first and the second aspects of the invention are largely identical to claims 1 and 11 as set out below. A short summary of the invention is provided as “a medication comprising the active agents paracetamol, ibuprofen and xylometazoline, and the use of the medication, for treating cold and/or flu in a human.”[3]
[2] Parent specification at pages 1-6.
[3] Parent specification at page 6 paragraph 2.
The specification describes how the actives can be made into formulations containing varied amounts of the actives depending upon the number of tablets or capsules taken at each dosage event. Paracetamol and ibuprofen are presented as tablets or capsules for oral administration and xylometazoline is administered as a nasal spray from a liquid.[4]
[4] Parent specification at page 6 paragraphs 3-4.
The specifications detail the amount of paracetamol, ibuprofen and xylometazoline taken with preferable amounts of 1000 mg or 975 mg paracetamol, 300 mg ibuprofen, and 0.12 mg xylometazoline base, per nostril.[5]
[5] Parent specification at page 6 paragraphs 5-6.
The specifications discuss how the number of dosage events differ for each active and dosage events can coincide or happen at different times of day. Paracetamol and ibuprofen are taken four times daily and xylometazoline is taken two to three times daily.[6]
[6] Parent specification at page 6 paragraph 7.
The clinical trial and the trial results to evaluate the pharmacokinetic parameters are presented.[7] The participants were given oral paracetamol + ibuprofen, nasal xylometazoline hydrochloride alone or the triple combination where oral paracetamol + ibuprofen was administered immediately after the nasal xylometazoline hydrochloride. Blood samples were collected and tested for the maximum concentration of active ingredients (Cmax) and the time it took to get to the maximum concentration in the blood (Tmax). Over a 720-minute observation period after administration, the results showed that the Cmax of ibuprofen was 10% lower and Tmax was 33% greater in the triple combination in comparison to when taken as paracetamol + ibuprofen.[8]
The invention as claimed
[7] Parent specification at pages 7-9.
[8] Parent specification at page 9 paragraph 1.
Claims of the parent and divisional are identical so I will only set them out once. The total number of claims is 22, with two independent claims.
The first independent claim, claim 1, is reproduced below:
“Use of paracetamol, ibuprofen and xylometazoline (or a pharmaceutically acceptable salt thereof) in the production of a medication for use in treating cold and/or flu in a human, by administering or taking during the same day:
a)1,000 mg (±5%) paracetamol, orally;
b)300 mg (±5%) ibuprofen orally; and
c)0.12 mg (±5%) xylometazoline (or an equivalent amount of the pharmaceutically acceptable salt) sprayed, or applied as one or more droplets, into each nostril.”
The other independent claim, claim 11, reads as follows:
“A method of treating cold and/or flu in a human, comprising administering or taking during a day:
a)1,000 mg (±5%) paracetamol orally;
b)300 mg (±5%) ibuprofen orally; and
c)0.12 mg (±5%) xylometazoline (or an equivalent amount of a pharmaceutically acceptable salt thereof) sprayed, or applied as one or more droplets, into each nostril.”
Dependent claims 2-5, 10, 12-15 and 20 define additional limitations on amounts of actives administered, features relating to dosage events or features relating to how often the actives are taken during the same day. Dependent claims 6-8 and 16-19 are directed to specific formulations of the actives. Claim 21 is the sole dependent claim that refers to the result achieved by administering the triple combination of actives. Claim 22 further specifies the dosage event to achieve that result.
Construction
The principles to be applied in construing the claims are well settled in law and were summarised by Bennett J in H Lundbeck A/S v Alphapharm Pty Ltd[9]:
“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.”
Swiss claim vs method claim
[9][2009] FCAFC 70, 81 IPR 228 [118]-[120].
Claim 1 is limited to defining the manufacture of a medication wherein the medication is intended for a specific treatment, making it a Swiss-type claim.[10] Use of paracetamol, ibuprofen and xylometazoline is essential to the preparation of the medication, qualified by the amounts and formulations of the three actives in the dosage regimen:
a)1,000 mg (±5%) paracetamol, orally;
b)300 mg (±5%) ibuprofen orally; and
c)0.12 mg (±5%) xylometazoline (or an equivalent amount of the pharmaceutically acceptable salt) sprayed, or applied as one or more droplets, into each nostril.
[10] Apotex Pty Ltd v Sanofi-Aventis Australia Pty Limited [2013] HCA 50; (2013) 304 ALR 1 and Otsuka Pharmaceutical Co., Ltd v Generic Health Pty Ltd (No 4) [2015] FCA 634.
This infers that the medication cannot be a single formulation or composition, like a single tablet, given its not possible for a nasal spray to be within the same medicament. Therefore “production of a medication” means that it can be all three drugs provided separately into a box or that both paracetamol and ibuprofen are a single tablet provided separately with the nasal spray in a box.
The medication is purpose-limited “for use in treating cold and/or flu in a human”. The claim further defines the treatment “by administering or taking [the medication] during the same day”.
Similarly, claim 11 is directed to a method of treating cold and/or flu in a human, comprising administering or taking during a day:
a)1,000 mg (±5%) paracetamol, orally;
b)300 mg (±5%) ibuprofen orally; and
c)0.12 mg (±5%) xylometazoline (or an equivalent amount of the pharmaceutically acceptable salt) sprayed, or applied as one or more droplets, into each nostril.
As guided by the definition for “day” in the specification, this means administration over a 24-hour period. Within the 24-hour period, oral paracetamol, oral ibuprofen and sprayable xylometazoline are to be taken at specific doses via different and separate routes of administration.
In both instances, it is plain that the three actives are formulated at specific doses for different and separate routes of administration. This is consistent with the current specification where it says that “The dosage events for taking paracetamol + ibuprofen may or may not coincide with the dosage events for taking the xylometazoline.”[11]
The same day/during the day
[11] The parent specification at last paragraph on page 6 onto page 7.
A definitions section on page 1 sets out the relevant definition for the term “day” as meaning a 24-hour period. That is, the provided definition seeks to align the meaning of the term “day” to include a day and a night in plain terms. Claim 1 uses “during the same day” and claim 11 uses “during a day”. There is a slight distinction between these phrases when read in context with the treatment steps. For claim 1, “during the same day” the prepared medication is taken throughout the course or duration of the same 24-hour period. For claim 11, the administration of the three actives occurs over any 24-hour period.
Inventive Step
The statutory basis for inventive step is set out at subsection 7(2) and subsection 7(3) of the Act as it stood after commencement of the Raising the Bar Act, and is reproduced below:
(2)For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed (whether in or out of the patent area) before the priority date of the relevant claim, whether that knowledge is considered separately or together with the information mentioned in subsection (3).
(3)The information for the purposes of subsection (2) is:
(a)any single piece of prior art information; or
(b)a combination of any 2 or more pieces of prior art information that the skilled person mentioned in subsection (2) could, before the priority date of the relevant claim, be reasonably expected to have combined.
The question of obviousness has been extensively considered by the courts. In particular, Aickin J stated in Wellcome Foundation Ltd. v VR Laboratories (Aust) Pty. Ltd.[12]:
“The test is whether the hypothetical addressee faced with the same problem would have taken as a matter of routine whatever steps might have led from the prior art to the invention, whether they be the steps of the inventor or not.” (emphasis added)
[12] [1981] HCA 12 at [45]; (1981) 148 CLR 262 at [286].
The High Court in Aktiebolaget Hassle v Alphapharm Pty Ltd[13] approved this approach. The High Court accepted the approach taken in Olin Mathieson Chemical Corporation v Biorex Laboratories Ltd[14] where Graham J posed the reformulated Cripp’s question:
“Would the notional research group at the relevant date, in all the circumstances, .... directly be led as a matter of course to try [the claimed combination] in the expectation that it might well produce a [useful or better result]?” (emphasis in original)
[13] [2002] HCA 59, 212 CLR 411.
[14] [1970] RPC 157 at [187].
Where the invention is a combination of integers, as in the present case, inventive step is to be determined by reference to the combination as a whole and not each integer individually. As stated by Gleeson CJ in Aktiebolaget vAlphapharm Pty Ltd[15] :
“The claim is for a combination, the interaction between the integers of which is the essential requirement for the presence of an inventive step. It is the selection of the integers out of ‘perhaps many possibilities’ which must be shown by Alphapharm to be obvious, bearing in mind that the selection of the integers in which the invention lies can be expected to be a process necessarily involving rejection of other possible integers.”
[15] [2002] HCA59212 CLR 411 at [41].
It is useful to bear in mind that when the claimed invention is directed to a particular combination of common general knowledge features then it is “the selection of the integers out of, perhaps many possibilities, which must be shown to be obvious.”[16]
[16] Minnesota Mining and Manufacturing Co. v Beiersdorf (Australia) Limited [1980] HCA 9; (1980) 144 CLR at [116].
“Signposts” or “secondary indicia” of inventive step can have a role to play in cases concerning an inventive step. Firstly, the question of whether or not the claimed invention is obvious still needs to be addressed[17]. The High Court also cautioned that Australian courts “should be slow to ignore secondary evidence”, noting that “its weight will vary from case to case”.[18]
Person skilled in the art
[17] Elconnex Pty Ltd v Gerard Industries (1992) AIPC 90-984 at [31].
[18] Lockwood Security Products Pty Ltd v Doric Products Pty Ltd (No 2) [2007] HCA 21; 235 CLR 173 at [116].
In KD Kanopy Australasia Pty Ltd v Insta Image Pty Ltd[19] Kiefel J identified the person skilled in the art (“PSA”) as:
“...a person acquainted with the surrounding circumstances of the state of the art and manufacture at the relevant time...They are likely to have a practical interest in the subject matter of the invention...and may often work in the art with which the invention is connected.”
[19] [2007] FCA 481; 71 IPR 615 at [16].
In Root Quality Pty Ltd v Root Control Technologies Pty Ltd[20], Finkelstein J stated:
“He is the person to whom the patent is addressed and who must construe it. He is the person whose knowledge will determine whether a patent is novel. He is the person who will judge whether a patent is obvious.”
[20] [2000] FCA 980; 9 IPR 225 at [70].
In Aktiebolaget Hässle v Alphapharm Pty Ltd[21], Gleeson CJ discussed the relevant field:
“The identification of the relevant field will, in its turn, determine the characteristics of the notional worker skilled in the art who must provide the answer to the question of whether the invention was obvious. Such characteristics will include the qualifications of the notional worker, the setting in which he or she operates and the practices and techniques that he or she will regard as commonplace and known.”
[21] [2002] HCA 59; [2002] HCA 59; (2002) 212 CLR 411 at [153].
In the present case the invention is directed to the treatment of cold and/or flu symptoms in a human by administering a combination of paracetamol, ibuprofen and xylometazoline within a specific range of amounts. Details are provided about formulating the actives, adjusting the amounts and administering the actives to humans at each dosage event. The specification also details the uptake of the drugs into the bloodstream and their basic pharmacological effects, good or otherwise.
The applicant’s submissions at various points describe the PSA as the unimaginative addressee/person/thinker a pharmaceutical scientist or a drug developer[22]. The examiner has not identified the PSA in their inventive step objection.
[22] Applicant’s submissions at [33], [40], [44] and [66].
The PSA is likely to be a pharmaceutical scientist who is skilled in formulating a variety of drug formulations. An equally legitimate representation of the PSA is the pharmaceutical scientist working in a team of skilled workers that includes:
a) Pharmacists/pharmacologists who are responsible for formulations to optimise bioavailability and dose selection; and
b) Clinicians with a knowledge of the relevant therapeutic area and who are responsible for the design of clinical trials and actual care of the trial patients.
I consider a pharmaceutical scientist is a reasonable representation of the person skilled in the art for the present invention.
The examiner’s objections
The objection to the divisional application refers to the inventive step objection raised in the parent so I will set the objection out once.
The following citations are referred to in the examination reports of the parent application:
D1 InformedHealth.org, Institute for Quality and Efficiency in Health Care (IQWiG) 2020, Common colds: Relief for a stuffy nose, cough and sore throat, accessed 17 August 2022, Otrivin 2019, How to relieve cold & flu symptoms, < retrieved from WayBackMachine 17 August 2022
D3 NPS MedicineWise 2019, Paracetamol/ibuprofen combinations for acute pain, < Retrieved from WayBack Machine 17 Aug 2022
D4 WO 2006/016126 A1
D5 WO 92/17171 A1
D6 Ghelani R. 2019, Otrivine adult nasal spray (xylometazoline), NetDoctor, < retrieved from WayBack Machine 17 Aug 2022
D7 WO 2007/122580 A3
D8 WO 00/000272 A1
D9 Advil Congestion [retrieved from internet on 23 August 2023] URL: < last reviewed 15 December 2021
D10 Eccles,‘R. 'Over the counter medicines for colds', in Eccles, R. and Weber, O. (ed.) Common Cold, Germany: Birkhauser, pages 249-273
At objection 8 of the fifth report on the parent application, the examiner maintains that the invention defined in claims 1-22 lacks an inventive step in light of the disclosure of D1 or common general knowledge. Objection 1 of the first report on the divisional application dated 25 September 2023 raises the same inventive step objection. The examiner is of the view that the current invention is a combination of known products simply indicated to be used for their known functions. The treatment aspect of the claims was addressed in more detail in earlier reports of the parent application.
In objection 8 of the fifth report on the parent application and objection 1 of the first report of the divisional application, when starting from common general knowledge and referencing previous reports, the examiner stated that analgesics, such as paracetamol and ibuprofen are commonly used in combination with nasal decongestants to relieve cold and flu symptoms. In support of the objection the examiner referenced two common general knowledge information sources including D9 and D10[23]. Previous reports reference D1-D8 as common general knowledge information as well.
[23] Analgesics, bridging pages 250-251, Pharmacology, page 254 and Multi-symptom treatments page 267.
Specifically, when starting from D1, the examiner notes D1 discusses the available methods for relieving cold and flu symptoms and how there are advantages to using analgesics and nasal spray over the others listed because they are the only methods with demonstrated efficacy in symptom relief.
On a review of the reasoning provided, the apparent difference identified by the examiner from either specific representations of common general knowledge[24] or D1 and the claimed invention is the addition of xylometazoline to the treatment regimen. In the examiner’s view it would be obvious for the person skilled in the art to do so.
[24] Eccles, R. (2009). “Over the counter medicines for colds” In: Eccles, R., Weber, O. (eds) Common Cold.
It is noted that in their assessment of lack of inventive step the examiner has sought to utilise the problem-solution approach, of interest are the following passages:
“The problem addressed in the instant application is to overcome or remediate the symptoms of cold and flu to at least some extent (page 1 paragraph 2). The target symptoms are body aches, pain and congestion of the nasal passages.
That is, the claimed subject matter appears to reside in the collocation of known products that are simply indicated to be used for their known function.
…analgesics, such as paracetamol and ibuprofen are commonly combined with nasal decongestants, for instance see D10: Analgesics, bridging pages 250-251. Where paracetamol and ibuprofen provide anti-inflammatory and antipyretic activity in both the brain and peripheral tissues (D10: Pharmacology), relieving muscle ache, headache, and fever symptoms. While actives such as xylometazoline, are administered to the nasal cavity as a decongestant (D10: page 254). Further, D10 recognises that the complex of multiple symptoms which constitutes a cold, supports the development of multi-symptom treatments medicines, including up to four separate actives, for convenient treatment (Multi-symptom treatments, page 267).
However, it is apparent from the CGK, particularly that evidenced by D10, that multi-symptom combinations are routine. The skilled person need only follow the directions of use for each active, at least once a day, and arrive at the claimed subject matter.
Therefore, on balance, I consider that a person skilled in the art would combine oral paracetamol and ibuprofen at their standard doses, together with nasal xylometazoline at its standard dosing, to overcome or remediate the symptoms of cold and flu, to at least some extent in light of D1 or the common general knowledge.”
In the remaining paragraphs of the inventive step objection the examiner sets out why the secondary arguments for inventive step put forward by the applicant do not contribute to providing inventiveness to the claimed combination of the parent application.
The applicant’s submissions
The applicant provided written submissions addressing the outstanding objections on 6 December 2023. At [1]-[12] of the written submissions, the applicant sets out the context leading to the present proceedings, noting that they only address the parent application. I have dealt with these matters above.
At [14]-[79] of their submissions, the applicant presents argument in rebuttal of the inventive step objection. Addressing the starting point from D1, the applicant sets several features that, in their view, are not disclosed or taught in D1:[25]
·…does not suggest combining ibuprofen and paracetamol, and does not suggest combining any one of them with a nasal decongestant;
·…raises serious concerns about nasal decongestants, including that they are associated with adverse side effects and may cause the very nasal congestion they are intended to relieve;
·…does not even mention a single nasal decongestant. It makes no reference of xylometazoline at all; and
·…makes no dosage recommendations for individual drugs, let alone for a combination of them.
[25] Applicant submissions at [35]-[39].
Addressing the starting point from common general knowledge, the applicant identifies a number of features that, in their view, are not taught or known to the person skilled in the art from common general knowledge as evidenced by D10:[26].
·…refers to analgesics, it refers to them as a genre. The three drugs noted in the passage are only given as illustrative of the broader group that the statement is directed to. And notably they are not recommended for any particular combination;
·…refers to nasal decongestants, it too refers to them as a genre. Again, the particular decongestant drugs noted are also only given as illustrative of the genre and no recommendations are made for any of them; and
·…the passage refers not only to decongestant drugs but also to multiple administration routes. (applicant emphasis)
[26] Applicant submissions at [44]-[48].
Expanding on these points, the applicant notes that the examiner has not provided any evidence why the combination of the three drugs as claimed in claims 1 and 11 is obvious in light of D1 or common general knowledge. Further at [40]-[41] and [68]-[69] the applicant points out that “the objection essentially boils down to a series of arguments as to what a clever person “could” do after reading D1, not what the unimaginative person “would” do”.[27]
[27] Applicant’s submissions at [40]-[41].
Throughout the examination of the parent application the applicant has raised a number of secondary indicia for inventive step. The applicant addresses the examiner’s objection in the fifth report to these secondary indicia.[28] They are broadly related to what is commonly known in the art about analgesics and decongestants, their side effects, their pharmacology, the disease symptoms they treat and what they are combined with. The applicant asserts that overall the examiner has not made out a fair and non-speculative prima facie case to rebut the secondary arguments.
[28] Applicant’s submissions at [53]-[79].
I note that the applicant has not provided any new evidence or new arguments as to why the claimed invention is inventive. In general, the submissions focus on refuting the examiner’s objections and that the examiner has not provided any specific evidence.
The problem
I agree with the examiner that the problem to be addressed is to overcome or remediate the symptoms of cold and flu to at least some extent. The applicant did not provide any submissions on their interpretation of the problem to be solved. Therefore, I will proceed on the basis that the problem is not in contention.
Common general knowledge (CGK)
Common general knowledge was considered by Emmett J in ICI Chemicals & Polymers Ltd v Lubrizol Corporation Inc[29]:
“The common general knowledge is the technical background to the hypothetical skilled worker in the relevant art. It is not limited to material which might be memorised and retained at the front of the skilled workers mind but also includes material in the field in which he is working which he knows exists and to which he would refer as a matter of course. It might, for example, include:
·standard texts and handbooks;
·standard English dictionaries;
·technical dictionaries relevant to the field;
·magazines and other publications specific to the field.”
[29] [1999] FCA 345; 45 IPR 577 at [112].
In the present proceedings no new evidence of CGK in the art at the priority date has been provided by the applicant. It is also noted that the specification provides limited information about the state of the CGK at the priority date. As no new evidence of CGK in the art was provided in the applicant’s submissions the additional information on common general knowledge presented below was gathered to provide more detail on underlying activity and safety of the actives.
Analgesics
There has been widespread acceptance over a long period of time that analgesics can relieve some cold/flu symptoms by inhibiting the activity of cyclooxygenase enzymes responsible for the biosynthesis of inflammatory mediators like prostaglandins that inflame the effects of cold and flu symptoms. Further, the preferred analgesic typically depends on the age group being treated and individual patient’s need to avoid known side effects. This information was not presented in the current specifications or in applicant’s submissions. When looking at paracetamol and ibuprofen pharmacology, the primary difference is the known peripheral anti-inflammatory activity of ibuprofen. In conclusion, both paracetamol and ibuprofen are generally recognised as being safe and effective for cold and flu treatment at the priority date[30].
Decongestants
[30] Eccles, R. (2009). “Over the counter medicines for colds” In: Eccles, R., Weber, O. (eds) Common Cold.
It has been known since the 1980s that patients can experience different side effects from use of topical decongestants like nasal irritation and rebound congestion, depending on individual health factors and duration of use[31]. It is commonly understood in the art that using topical decongestants for more than one week can cause these side effects. In conclusion, nasal administration and efficacy of topical decongestants in cold and flu treatment is well-established at the priority date, tempered by well-accepted advice of its safety for long-term use.
Development of Multi-ingredient combinations of cold-flu drugs
[31] Chodirker W. B., “Rhinitis medicamentosa”, Can. Med. Assoc. J. Feb 1981, vol. 124, No. 4, pages 370–372.
Its noteworthy that there is insufficient information on multi-ingredient combinations of cold-flu drugs in the specification and in the applicant’s submissions[32] given this appears to be the inventive concept. The following information I found myself[33] is supplementary to the common general knowledge already considered by the examiner and the applicant[34].
[32] Applicant’s submissions at [68]-[69].
[33] Eccles, R. et al. “Rationale for treatment of common cold and flu with multi-ingredient combination products for multi-symptom relief in adults”, Open Journal of Respiratory Diseases, 2014, vol. 4, pages 73-82.
[34] Eccles, R. (2009). “Over the counter medicines for colds” In: Eccles, R., Weber, O. (eds) Common Cold.
The specification does not refer to any common known cold and flu combination medicaments currently available on the market, such as the combination between paracetamol and pseudoephedrine, sold under many brand names. These over the counter multi-active combination medicaments have been used for over sixty years for the treatment of colds and flu. Some known clinical benefits of multi-active combination medicaments include convenience for patients and simplified treatment regime[35]. Thus, I consider that multi-active combination medicaments for cold and flu treatment are well-accepted and well-established at the priority date. This evidence is merely additional to that raised by the examiner in the parent and the divisional and my conclusions are the same as the conclusions of the examiner regarding common general knowledge.
Summary of common general knowledge
[35] Eccles, R. et al. “Rationale for treatment of common cold and flu with multi-ingredient combination products for multi-symptom relief in adults”, Open Journal of Respiratory Diseases, 2014, vol. 4, pages 73-82.
In summary I consider that the following information was CGK at the priority date:
·Cold and flu viruses cause a variety of well-known symptoms.
·Paracetamol and ibuprofen are widely used and accepted oral medications to treat some cold and flu symptoms.
·It is known that the different modes of administering decongestants to treat some cold and flu symptoms balances efficacy and known side effects.
·The use of analgesics and decongestants at the same time for cold and flu treatment is common.
·Multi-combination products for cold and flu treatment are an established practice in the art.
Consideration of Inventive step
Consideration of inventive step in light of CGK
When considered individually, the claimed actives are defined in commonly known dosage formulations. This fact poses the question of whether the person skilled in the art would, as a matter of course, prepare a medication by combining such known actives in their known dosage formulations that are intended for treating cold and flu in humans. The claimed analgesics are commonly used together and its clear from the common general knowledge that they are intentionally used together to treat cold and flu in humans. Consequently, the choice of paracetamol and ibuprofen in known dosage formulations is obvious. The material[36],[37] in front of me suggests that the PSA would routinely recommend that nasal decongestants are used together with analgesics when treating cold and flu in humans.
[36] Eccles, R. et al. “Rationale for treatment of common cold and flu with multi-ingredient combination products for multi-symptom relief in adults”, Open Journal of Respiratory Diseases, 2014, vol. 4, pages 73-82.
[37] D10.
The applicant’s understanding of D10 as a representation of common knowledge is that no recommendations are made for any of the particular decongestant drugs mentioned. However, I note that during the discussion of the efficacy of topical decongestants like xylometazoline D10 clearly states that “[t]he efficacy of topical decongestants oxymetazoline and xylometazoline is not in doubt.”[38] Given this well-known recommendation to use xylometazoline for treating cold and flu in humans, I consider that the PSA would be directly led, as a matter of course, to select standard dosage xylometazoline as the decongestant to be provided with standard oral paracetamol and ibuprofen to produce a medication intended for treating cold and flu in humans.
[38] D10 at page 255.
I am also not persuaded that administration of the medication on the same day or during a day to treat cold and flu in humans adds anything inventive to claims 1 and 11. The person skilled in the art would as a matter of course use the three specific pharmaceutical actives during a day when treating cold and/or flu symptoms with the understanding that each active remedies different symptoms. On the balance of probabilities, the PSA would be aware of the well-known side effects of xylometazoline, but I see no reason why these would act as a deterrent when the skilled addressee is making the obvious choice in the first instance of treating cold and flu symptoms.
The information before me describes no particular problem to be overcome that would act as a barrier. I also consider that the common general knowledge does not teach away from bringing the known dosage formulations together to independently relieve cold and flu symptoms via their normal action. A person skilled in the art or even an unskilled person having a cold would know that the claimed actives treat cold and flu symptoms in their standard dosages. Hence they would readily seek to try the specific pharmaceutical actives together to maximise the benefit of relief from cold and flu symptoms.
I am therefore not satisfied, given the information before me, that the invention as defined in claims 1-22 of the parent involves an inventive step in view of common general knowledge alone. The same conclusion applies to claims 1-22 of the divisional application.
Consideration of inventive step in light of D1
I note that the examiner’s inventive step objection said “in light of D1 or common general knowledge”. I have taken this to mean the claimed invention lacked inventive step when compared to the disclosure of D1 in light of common general knowledge because clearly D1 does not describe all the claimed features as discussed below.
D1 provides general information on analgesics, nasal sprays, vitamin supplements, antibiotics and increased fluid intake and their usefulness for providing relief from cold and flu symptoms. Ibuprofen and paracetamol are mentioned briefly in the fourth paragraph of D1, while decongestants are discussed in general. Adverse side effects for decongestants are briefly discussed. The first paragraph states “nasal sprays and painkillers like ibuprofen and paracetamol can provide some relief from cold symptoms”.
As I have noted above, the applicant states in their written submissions that D1 fails to disclose or teach “combining ibuprofen and paracetamol, and does not suggest combining any one of them with a nasal decongestant” and “does not even mention a single nasal decongestant. It makes no reference of xylometazoline at all”[39]. I agree that these are the main points to consider when assessing if the disclosure of D1 would, rather than could, lead to do what is claimed as a matter of course with the understanding that obviousness is to be determined by reference to the combination as a whole and not each integer individually.
[39] Applicant’s submissions at [38].
Firstly, there is no specific mention in D1 of specific decongestants, let alone xylometazoline. D1 does not direct the PSA to pick any specific decongestant. There is a strong emphasis on the adverse side effects of nasal sprays in D1 but this teaching is not relevant as neither claims 1 nor 11 are directed to a treatment lasting longer than a week.
As I have already noted above, combining analgesics for the treatment of cold and flu symptoms were well known at the priority date. It is also apparent from D10, as a representation of common general knowledge, that xylometazoline is an often-recommended decongestant for cold and flu treatment[40]. I am persuaded by common general knowledge that the PSA would specifically provide sprayable xylometazoline with oral ibuprofen and paracetamol as a medication intended for cold and flu treatment. I would add that the PSA would use standard xylometazoline as the decongestant with standard oral paracetamol and ibuprofen when looking to treat different cold and flu symptoms during the same day or during a day. The choice is clearly taught by D1 in light of common general knowledge.
[40] D10 at page 255.
I am therefore not satisfied that the invention as defined in claim 1-22 involves an inventive step in view of the disclosure of D1 when considered together with the CGK. The same conclusion applies to claims 1-22 of the divisional application.
Secondary evidence
Throughout the prosecution of these applications there were numerous points raised about secondary indicators of inventive step. None of these factors or features were present in the claims or discussed in the specifications, and I am not sufficiently persuaded to shift the balance in the applicant’s favour. I will comment on the two key questions raised by the secondary arguments:
·Is the additional feature of dependent claim 21 that “said administering or taking is such that the xylometazoline lowers the Cmax and increase the Tmax for the ibuprofen” indicative of inventiveness?
·Is the 3-day problem well known in the art for decongestants and would a patient take a decongestant longer than 3 days? [41]
[41] Applicant’s submissions [57]-[59].
When considering the first point and following the obvious path outlined in the inventive step consideration above, I also consider that this additional feature would have been inevitably achieved (or a bonus effect) as the person skilled in the art would have inevitably arrived at taking the three known actives together to independently relieve cold and flu symptoms via their normal function.
With regard to the second point, the fact that the claimed invention does not specify a duration of treatment leads me to give the 3-day problem little weight. Nor is the 3-day rebound mentioned in the specifications.
I am not persuaded that any of these secondary indicators sway the balance of probabilities in favour of the claimed invention being inventive.
Can an allowable amendment overcome the negative finding?
The specification is very short and does not mention any information of more substance than that discussed above. I am unable to identify any material that could form the basis for a claim that defines a patentable invention. The disclosure is essentially putting three known actives together “in a box” so to speak, for administration on the same day. While there may be “bonus” effect in bringing these elements together, I consider that the prior art teaches the combination.
In the circumstances where I can see no clear way to overcome my negative finding with respect to inventive step, and in view of the public interest in certainty as to the status of the applications, I consider that providing the applicant with a further opportunity to amend and continuing the examination would serve no useful purpose.
Conclusion
I have found that claims 1-22 of both applications lack inventive step. Furthermore, I have formed the view that no allowable amendment could result in the claims having an inventive step.
I am not satisfied that the applications, in their present form, should be accepted. I therefore refuse both the parent and divisional applications.
C. Mitchell
Delegate of the Commissioner of Patents
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