Covidien AG v New Tec Pty Ltd

[2012] APO 59

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Covidien AG v New Tec Pty Ltd [2012] APO 59

Patent Application:                   2006294397

Title:An apparatus for preventing deep vein thrombosis

Patent Applicant:  New Tec Pty Ltd

Opponent:  Covidien AG

Delegate:  Xavier Gisz

Decision Date:  4 June 2012

Hearing Date:  2 May 2012

Catchwords:  PATENTS – final determination of an opposition – opponent argued that the amendments do not overcome the deficiencies identified in the decision and raise new grounds of invalidity – amendments are considered to overcome the deficiencies identified in the earlier decision and do not raise any new grounds of invalidity.

Representation:  Patent applicant:  Matthew Sulman, Matthew Sulman & Associates, Brisbane

Opponent:Greg Turner, Spruson & Ferguson, Sydney

IP AUSTRALIA

AUSTRALIAN PATENT OFFICE

Patent Application:                   2006294397

Title:An apparatus for preventing deep vein thrombosis

Patent Applicant:  New Tec Pty Ltd

Date of Decision:  4 June 2012

DECISION

The amendments are considered to overcome the deficiencies identified in the earlier decision (Covidien v New Tec Pty Ltd [2011] APO 27) and do not raise any new grounds of invalidity.

Subject to appeal, I direct that the application proceed to sealing.

I award costs according to Schedule 8 against the opponent, Covidien AG.

REASONS FOR DECISION

1. Patent application 2006294397 in the name of New Tec Pty Ltd was opposed by Covidien AG. Following a hearing on 7 February 2011, a decision was issued on 4 May 2011 finding that some of the claims lacked novelty. That decision (which will hereinafter be referred to as the earlier decision) is reported as Covidien v New Tec Pty Ltd [2011] APO 27, and the background to the matter is fully listed there. The applicant amended the specification to overcome the deficiencies identified in the earlier decision. The opponent requested to be heard on the final determination of the opposition. The opponent made submissions that the amendments: a) do not overcome the deficiencies identified in the decision and b) raise new grounds of invalidity. The opponent and applicant attended the hearing in Canberra on 2 May 2012.

The amendments

1. The amendments to the two broadest claims (claims 1 and 34) following the earlier decision are as reproduced below in ‘marked-up’ form (with strike through indicating words deleted from the claim and underline indicating words added to the claim):

1. An apparatus for enhancing venous blood flow through a limb of a subject, said apparatus including a compression sleeve extendable around the subject's limb and having a plurality of compressors situated next to one another along the sleeve, wherein in use the compressors substantially encircle the limb and compress the limb in a continuous cyclical compression sequence to move blood within the limb from one the distal end of the sleeve to the other proximal end to replicate venous blood flow and to prevent backflow, and as a said first compressor begins to compress the limb, a said second compressor preceding the first compressor in sequence already compresses the limb and continues to compress the limb at least until the first compressor compresses the limb to substantially the same extent as the second compressor, and a said third compressor which precedes the second compressor in sequence ceases to compress the limb.

34. A method for enhancing venous blood flow through a limb of a subject using an apparatus having a compression sleeve, said method including the steps of:

(1) extending the compression sleeve around the subject's limb, wherein said sleeve has a plurality of compressors which substantially encircle the limb which the compression sleeve extends around, and which are situated next to one another along the sleeve; and

(2) allowing the compressors to compress the limb in a continuous cyclical compression sequencetially to move blood within the limb from one the distal end of the sleeve to the proximal end other to replicate venous blood flow and to prevent backflow, wherein as a said first compressor begins to compress the limb, a said second compressor preceding the first compressor in sequence already compresses the limb and continues to compress the limb at least until the first compressor compresses the limb to substantially the same extent as the second compressor, and a said third compressor which precedes the second compressor in sequence ceases to compress the limb.

Submissions by the parties

1. The opponent submitted that the amended claims did not overcome the lack of novelty found in the earlier decision, and additionally introduced the new grounds of invalidity on the basis that the claims are not clear, fairly based and that the invention is not fully described. The applicant submitted the amended claims overcome the deficiencies identified in the earlier decision and did not raise any new grounds of invalidity.

Clarity

1. The opponent submitted that the amended claims lack clarity for the following reason:

“I cannot determine from claim 1 what is “the” distal end and what is “the” proximal end, as there is no antecedent provided in the claim. I therefore cannot determine the direction of blood flow. As this feature added to claim 1 is important, the failure in clarity is no light matter.”

1. I consider that the words ‘proximal’ and ‘distal’ are commonly understood in the medical field as meaning respectively as ‘close to’ and ‘distant from’ a reference point. In this case it is inherent that the reference point is the centre of the body of the patient and this is consistent with conventional use of the terms in the field of medical devices. Consequently, I consider the claims to be clear as a result of the amendments.

Fair basis

1. The opponent had the opportunity but chose not to oppose the amendments under section 104(4). Section 102(1), which is a consideration of a section 104(4) opposition, is essentially a determination on the fair basis of the amendments to the claims. It is lamentable that instead of raising the issue of fair basis by opposing the amendments, the opponent has allowed the amendments to be made unopposed, only to raise this issue at the final determination of the matter. Nonetheless, the issue of fair basis will now be considered.

1. The opponent submitted the amended claims lack fair basis for the following reason:

“There is no basis for the phrase “to replicate venous blood flow” nor is there anything in the specification as lodged, as originally accepted or as amended which can give any reasonable meaning to this phrase.”

1. The opponent has raised this ground on the basis that the word “replicate” does not appear in the specification as filed. Whether the specification as filed discloses a device to affect the movement of venous blood flow is not contested; indeed, this has ample descriptive support, for example at page 16 lines 10 to 12 and page 19 lines 25 to 27:

   “The apparatus 40, 70 does not rely on intact, healthy directional valves of the veins to work as the wave-like motion of the sleeve 41 pushes blood continuously upwards.”

   “The master control module 154, by way of the slave microcontrollers 153, is used to apply electrical current to each tourniquet 151 in sequence such that venous blood is moved through the limb towards the heart.”

1. The opponent argued that the movement of blood in the specification is achieved through a peristaltic wave, whereas the venous blood flow moves in a sharp and rhythmic manner and thus the opponent argues that the device does not ‘replicate’ the venous blood flow.

10.  In my opinion, the opponent’s construction of the phrase “to replicate venous blood flow” is inconsistent with the approach taken by the courts. It is established that in considering fair basis the specification should be read as a whole (see, for example, Kimberly-Clark v Arico [2001] HCA 8 at [16]). Reading the description as a whole it is clear that the disclosure of affecting the movement of blood flow in a venous direction in the description is equivalent to the claimed replicating of venous blood. Consequently I consider the claims to be fairly based.

Full description

11.  Having established that the phrase “to replicate venous blood flow” is equivalent to “affecting the movement of blood in a venous direction” for which there is ample descriptive support, the proposition that the description lacks full description is untenable. Consequently I consider the invention to be fully described.

Novelty

12.  The opponent argued that the claims lack novelty in light of prior art document US patent US 2,528,843 which is hereinafter referred to as Poor. The amended claims limit the scope of the claims to moving blood within the limb from the distal end of the sleeve to the proximal end.

13.  The opponent argued that although the Poor disclosure did not explicitly state a direction in which the compression cycle would move blood, it was implicit that the device could be used in either direction. However the test for novelty is not whether a device disclosed in the prior art could be used to anticipate the claims but whether there were clear and unmistakable directions to do so. As noted in Canadian General Electric Co v Fada Radio Limited [1930] AC 97:

“...it is not enough to prove that an apparatus described in an earlier specification could have been used to produce this or that result. It must also be shown that the specification contains clear and unmistakeable directions to use it.”

14.  Furthermore, evidence was provided in the original opposition (see paragraph 28 of the previous decision) that the Poor device would be used only to move blood in an arterial flow direction and not in a venous flow direction. Consequently the claims are considered novel in light of Poor.

15.  The opponent’s argument that the device of poor could be used to move blood in a venous direction is better suited to an objection on the basis of inventive step. However, since the ground of inventive step was not raised, and no evidence in support of this ground was provided, there is no basis for a lack of inventive step to be found.

Conclusion

16.  The amendments overcome the deficiencies identified in the decision and do not raise any new grounds of invalidity.

17.  Subject to appeal, I direct that the application proceed to sealing.

Costs

18.  In view of my decision, it is appropriate to award costs against the unsuccessful party.  I award costs according to Schedule 8 against the opponent, Covidien AG.

Xavier Gisz
Delegate of the Commissioner of Patents