New Tec Pty Ltd
[2011] APO 27
•4 May 2011
IP AUSTRALIA
AUSTRALIAN PATENT OFFICE
Covidien AG v New Tec Pty Ltd [2011] APO 27
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 May 2011
Hearing Date: 7 February 2011 in Canberra
Catchwords: PATENTS - opposition to the grant of a patent under s 59 – submissions that claims lack of novelty – claims 1, 2, 3, 5, 10, 13, 19 and 34 are not novel – opposition successful on the ground of lack of novelty
Representation: Patent applicant: Matthew Sulman & Associates
Opponent:Spruson & Ferguson
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 May 2011
DECISION
The opposition is successful. Claims 1, 2, 3, 5, 10, 13, 19 and 34 are not novel in light of US 2,528,843 (Poor).
Subject to an appeal to the Federal Court, the applicant is given 60 days to propose amendments that address the lack of novelty.
Costs are awarded in accordance with Schedule 8 against the Applicant, New Tec Pty Ltd.
REASONS FOR DECISION
Background
Patent application 2006294397 (the Application) was filed on 11 August 2006 by New Tec Pty Ltd (the Applicant) as PCT/AU2006/001156 under the Patent Cooperation Treaty. The Application proceeded to acceptance and was advertised accepted on 8 January 2009.
The Application was opposed under section 59 on 8 April 2009 by Covidien AG (the Opponent). A Statement of Grounds and Particulars was served on 8 July 2009. The Statement of Grounds and Particulars was amended on 21 September 2009. Evidence in Support was served on 8 January 2010. Evidence in Answer was served on 21 June 2010. Evidence in Reply was not served.
The matter was heard in Canberra on 7 February 2011. At the hearing the Applicant was represented by Demetrias Illiades of counsel assisted by Matthew Sulman of Matthew Sulman & Associates, while the Opponent was represented by Greg Turner of Spruson & Ferguson.
Evidence
Evidence in Support is a statutory declaration by John Brydon of 21 December 2009 with exhibits JB-1 to JB-5, and a statutory declaration by Malcolm Bock of 6 January 2010 with Exhibits MB-1 to MB-7.
Evidence in Answer is a statutory declaration by Ross Crawford of 11 June 2010 with exhibits RWC1 to RWC4, a statutory declaration by Matthew Sulman of 17 June 2010 with exhibits MJS1 to MJS5, and a statutory declaration of Gregory Wren of 17 June 2010 with exhibits GAW1 to GAW7.
Statement of Grounds and Particulars
The grounds of opposition listed in the Statement of Grounds and Particulars are: novelty, inventive step, manner of manufacture, clarity, succinctness, fair basis and full description.
Submissions
At the hearing the opponent made submissions on the ground of novelty. No other grounds were pressed at the hearing or in the submissions. The opponent argued that the Application lacks novelty in light of the following five documents:
US 2,528,843 Poor
US 3,862,629 Rotta
US 4,624,244 Taheri
US 5,014,681 Neeman et al
US 6,478,757 Barak
The opponent also submitted that the Application lacks novelty in light of a disclosure of the invention made by the Applicant before the priority date.
Law
The relevant portion of section 59 of the Patents Act 1990 states:
The Minister or any other person may, in accordance with the regulations, oppose the grant of a standard patent on one or more of the following grounds, but on no other ground:
(b) that the invention is not a patentable invention;
10. The relevant portion of subsection 18(1)(b)(i) of the Act states:
(1) … an invention is a patentable invention for the purposes of a standard patent if the invention, so far as claimed in any claim:
(b) when compared with the prior art base as it existed before the priority date of that claim:
(i) is novel;
11. The relevant portion of subsection 7(1)(a) states:
(1) For the purposes of this Act, an invention is to be taken to be novel when compared with the prior art base unless it is not novel in the light of any one of the following kinds of information, each of which must be considered separately:
(a) prior art information … made publicly available in a single document or through doing a single act;
12. The test for novelty is the reverse infringement test. The formulation of this test is that presented by Aickin J in Meyers Taylor Pty Ltd v Vicarr Industries Ltd [1977] HCA 19; (1977) 137 CLR 228, at page 235:
"The basic test for anticipation or want of novelty is the same as that for infringement and generally one can properly ask oneself whether the alleged anticipation would, if the patent were valid, constitute an infringement".
13. This requires the alleged anticipation to disclose all the essential features of the invention as claimed (Nicaro Holdings Pty Ltd v Martin Engineering Co (1990) 16 IPR 545 at page 549).
The specification
14. The specification of the Application relates to an apparatus for enhancing blood flow through a person’s limb by applying a peristaltic sequence of compressions to the limb. The specification ends with 34 claims with the two broadest claims being independent claims 1 and 34. The claims are reproduced below:
1. An apparatus for enhancing 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 sequence to move blood within the limb from one end of the sleeve to the other, 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.
2. The apparatus of claim 1, wherein the sleeve further includes a firm backing sleeve for ensuring that the compressive force of the compressors is largely exerted on the limb.
3. The apparatus of claim 2, wherein the backing sleeve extends adjacent to an outer surface of the compressors and around the limb.
4. The apparatus of claim 2, wherein the backing sleeve is made from a hard material.
5. The apparatus of claim 2, wherein the backing sleeve is made from a flexible material.
6. The apparatus of claim 1, wherein the sleeve further includes a casing which encloses at least the compressors.
7. The apparatus of claim 6, wherein the sleeve further includes a protective layer situated between the casing and the limb.
8. The apparatus of claim 7, wherein the protective layer is detachably connected to the casing.
9. The apparatus of claim 6, wherein the protective layer consists of a plastic- backed absorbent sheet.
10. The apparatus of claim 1, wherein the compressors are inflatable chambers.
11. The apparatus of claim 10, wherein a respective chamber is located adjacent to each end of the sleeve, and at least one chamber is located between the chambers which are located adjacent the ends of the sleeve, wherein the chambers located adjacent the ends of the sleeve are narrower and have a smaller volume than the other chambers.
12. The apparatus of claim 10, wherein each chamber has a pressure relief valve for preventing over inflation of the chamber.
13. The apparatus of claim 10, wherein the apparatus also includes a fluid delivery system for delivering fluid to each of the chambers.
14. The apparatus of claim 13, wherein the pressure that the chambers are inflated to by the fluid delivery system may be adjusted.
15. The apparatus of claim 13, wherein the period of time that each chamber is inflated for by the fluid delivery system may be adjusted.
16. The apparatus of claims 13, wherein the chambers are inflated in a pulsatile manner by the fluid delivery system.
17. The apparatus of claim 13, wherein the fluid delivery system includes a pump, and a manifold extending between the pump and the chambers.
18. The apparatus of claim 17, wherein the pump is a pulsating pump.
19. The apparatus of claim 13, wherein the fluid delivery system includes a valve assembly for inflating and deflating each chamber in sequence.
20. The apparatus of claim 19, wherein the valve assembly includes a rotary valve.
21. The apparatus of claim 19, wherein the valve assembly includes a plurality of three-way valves for inflating and deflating the chambers.
22. The apparatus of claim 17, wherein the pump is mounted on the sleeve.
23. The apparatus of claim 1, wherein the compressors are tourniquets.
24. The apparatus of claim 23, wherein the apparatus also includes a chain drive and lever assembly for tightening and relaxing the tourniquets.
25. The apparatus of claim 24, wherein the chain drive and lever assembly includes a pair of sprockets, a chain extending around the sprockets, and a motor for driving the chain around the sprockets.
26. The apparatus of claim 25, wherein the chain includes a plurality of links, and wherein select links of the chain include lateral extensions for moving the levers to a tourniquet tightened position and for holding the levers in the tourniquet tightened position.
27. The apparatus of claim 23, wherein the apparatus includes a gear system for tightening and relaxing the tourniquets.
28. The apparatus of claim 27, wherein the gear system includes a gear train, wherein each gear of the train is separately connected to an end of a respective tourniquet, and wherein the other end of each tourniquet is fixed relative to a casing, and wherein each gear is able to be rotated between a tourniquet tightened position and a tourniquet relaxed position.
29. The apparatus of claim 23, wherein the tourniquets are electrical conductors which are adapted to tighten and compress the limb when an electrical current is passed through the tourniquets.
30. The apparatus of claim 29, wherein the tourniquets include wires which are threaded through ceramic beads.
31. The apparatus of claim 29, wherein the apparatus also includes a master control module and slave microcontrollers for regulating electrical current in the tourniquets.
32. The apparatus of claim 31, wherein the apparatus includes sensors for sensing the tautness of the tourniquets and for providing feedback to the microcontrollers.
33. The apparatus of claim 32, wherein the sensor is a strain gauge sensor.
34. A method for enhancing 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 sequentially to move blood within the limb from one end of the sleeve to the other, 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.
Claim Construction
15. Before considering novelty it is necessary to construe the claims. The legal principles which are relevant to the task of construction are well established (see Décor Corp v Dart Industries 13 IPR 385 at 400).
16. The two independent claims – claims 1 and 34 – define the invention as an apparatus and as a method respectively. Claims 1 and 34 each contain six features as follows:
a) Enhancing blood flow through a limb of a subject
b) A compression sleeve extendable around the subject’s limb
c) A plurality of compressors situated next to one another along the sleeve
d) The compressors substantially encircle the limb
e) The compressors compress the limb in a sequence to move blood within the limb from one end of the sleeve to the other
f) The first compressor begins to compress the limb, a 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 third compressor which precedes the second compressor in sequence ceases to compress the limb.
Persons skilled in the art
17. In determining the scope of the claims and the disclosure of the prior art, the opinion of persons with skill in the art must be considered. The evidence includes the opinion of four people whom I consider to have skill in the art of medial treatment methods and devices: John Brydon, Malcolm Bock, Ross Crawford and Gregory Wren.
Enhancing blood flow
18. The phrase “enhancing blood flow” in the claim should be construed in conjunction with the portion of the claim which defines how the blood is moved; specifically “…to move blood within the limb from one end of the sleeve to the other”. Thus I construe the phrase “enhancing blood flow” to mean moving blood in the limb from one end of the sleeve to the other in a medically beneficial manner.
Compression sequence
19. The Applicant argued that the claims define a cyclical type compression sequence, wherein when the last compressor on the sleeve is reached, the compression sequence continues back at the first compressor in the sequence (see paragraphs 132 and 163 and page 38 at “Novelty (b)” of Applicant’s submissions). However, I can see no reason that the elements of the description referring to the cyclical compression sequence should be read into the claims. Indeed it is generally impermissible to reduce or enlarge the meaning of words of a claim by glosses derived from other parts of the specification: Welch Perrin & Co. Pty. Limited v Worrell [1961] HCA 91; (1961) 106 CLR 588 per Dixon C.J., Kitto and Windeyer JJ. at 610. Consequently the claims are construed such that there is a plurality of compressors, but the sequence is only defined for three adjacent compressors and is not necessarily cyclical.
Diagrammatic representation of the compression sequence
20. I have drawn the following diagram to help construe the compression sequence:
21. The diagram shows the pressure in the 1st, 2nd and 3rd compressors as a function of time. The solid lines represent parts of the compression sequence defined in the claims, while the dotted lines are not explicitly defined in the claims but help to show the compression sequence disclosed in the specification of the opposed application.
22. There are four points in time defined in the claims which I have designated with lower case Roman numerals from i to iv. The claims are drafted from the point of view of the present moment in time which I have designated ii in the drawing. Other parts of the sequence are defined in terms of words such as ‘already’, ‘begins’, ‘continues’ and ‘ceases’ to describe the past, present and future moments in the sequence. The processes that take place at various points in time is as follows:
i“second compressor preceding the first compressor already compresses the limb”
ii“first compressor begins to compress the limb”, “third compressor which precedes the second compressor in sequence ceases to compress the limb”
iii“first compressor compresses the limb to substantially the same extent as the second compressor”
iv“second compressor preceding the first compressor in sequence … continues to compress the limb until at least the first compressor compresses the limb to substantially the same extent as the second compressor”
23. A notable feature of the compression sequence is shown at point ii of the diagram where first compressor begins to compress the limb at the same time that the third compressor ceases to compress the limb. In other words, the first and third compressors are not activated at the same time. Thus only two adjacent compressors are activated at any time during the compression sequence.
Novelty
24. The novelty of the claims with respect to the five prior art documents is now considered.
US 2,528,843 Poor
25. US 2,528,843 (hereinafter referred to as Poor) discloses an apparatus for the treatment of intermittent claudication. Poor discloses three embodiments of the invention. Specifically, figures 4 to 9 show three different types of valves for delivering compressed air to the apparatus in figure 1.
Enhancing blood flow and moving blood within the limb from one end to the other
26. Poor discloses at column 1 lines 1 to 9:
“This invention relates generally to means for the treatment of certain vascular diseases in which there exists deficient or impaired circulation, and particularly by increasing the immediate flow by forcing blood flow through established vessels and by stimulating collateral circulation in certain areas.”
27. Mr Brydon states at page 4 of his declaration that:
“The progressive compression of the compressors moves the blood from one end of the limb to the other: Col 1 lines 14-16, 20-22, Col 3 lines 42-47.”
28. Mr Wren states at paragraphs 288 and 290 of his declaration:
“I should be noted here that [Poor] is for “THE TREATMENT OF INTERMITTENT CLAUDICATION” and therefore the device disclosed necessarily enhances distal or arterial flow. This is opposite to the enhanced blood flow that is affected by the device of the Patent in Suit which is specifically venous flow.
First paragraph – The actual words, despite what Mr Brydon says, are “increasing the intermediate flow by forcing blood flow through established vessels by stimulating collateral circulation” NOT “enhancing blood flow”. There is an inherent practical difference between the teaching of “forcing” and “enhancing” flow.
[reference to various articles about collateral circulation]
The above articles explain that collateral circulation relates to arterial circulation which supplies blood DOWN to the leg rather than enhancing blood flow UP the leg and generally positively to the heart which is what our device was designed to do. The teaching here is quite different.”
29. I am not persuaded by Mr Wren’s evidence that Poor does not disclose an apparatus for enhancing blood flow as defined in the claims for the following two reasons. Firstly, Poor discloses a medically beneficial treatment for a patient. Although the Poor device may not be suitable for affecting venous blood flow, this limitation is not present in the claims of the Application. Secondly, the claims do not specify which direction the blood flow is enhanced, merely that the blood is moved from one end of the sleeve to the other. Consequently I find that Poor discloses a device for enhancing blood flow and moving blood within the limb from one end of the sleeve to the other.
Compression sleeve and plurality of compressors
30. Mr Wren states at paragraph 295 of his declaration:
“Fourth Paragraph – Column 2 [of Poor] describes a “limb enveloping applicator”, it does not say “substantially encircles the limb” which is not the same. The term “enveloping” gives the impression of complete or total covering or encapsulation of the limb, whereas “substantial encirclement” connotes an idea of a more narrow focus upon the limb and a more purposeful approach.”
31. Mr Wren has taken the term “enveloping” from the Poor disclosure, and attempted to draw a distinction between this and the claimed feature of “encircling”. However, the disclosure must be read as a whole. Figure 1 of Poor clearly shows a flexible base (14) which acts as a sleeve encircling the limb but is not totally covering or encapsulating the limb. Consequently, the feature of a compression sleeve is disclosed in Poor.
Compressors substantially encircle the limb
32. The inflatable sections (11) act as compressors. The compressors substantially encircle the limb as can be seen in Figure 2.
The compression/decompression sequence
33. Poor discloses several different methods of producing a compression sequence comprising different types of valves. The opponent argues that the translating piston valve embodiment anticipates the claimed invention.
34. The translating piston valve embodiment discloses a chamber formed between the pistons (30) and (31). When the chamber is connected to the tubes (12) the inflatable portions (15) are inflated. The gas from the inflatable portions (15) vents to the atmosphere through vents (21) and (22) when the tubes are not fluidly coupled to the chamber.
35. The citation discloses the chamber formed between pistons (30) and (31) to be fluidly connected to three tubes (see figure 4 and column 3 lines 13 to 16). I have already determined that the claims of the opposed patent define that only two compressors are inflated at any time during the compression sequence. Thus the invention disclosed in Poor with particular reference to figure 4 does not anticipate the claims of the Application.
36. The opponent notes that the pistons (30) and (31) are adjustably mounted on the tube (24). The opponent argues that the pistons could be adjusted such that the compression sequence as claimed is achieved. I agree that the pistons could be adjusted in this manner, however this hypothetical adjustment is not a clear and unmistakable direction of only two compressors being inflated at any time during the compression sequence. Thus figure 4 still does not anticipate the claims of the Application.
37. Another embodiment of the invention disclosed in figure 6 and column 4 lines 42 to 71 of Poor comprises one gas supply and venting valve for each inflatable portion. The compression sequence is defined at column 4 lines 67 to 71 as follows:
“In the form illustrated a single rotative cam can successively close peripherally arranged switches, the length of the cam portion determining whether 1, 2 or 3 sections are simultaneously being inflated and repetitiously.” [emphasis added]
38. A rotative cam is a mechanism that actuates elements, such as switches, as it rotates. Poor discloses a rotative cam that actuates two switches simultaneously thus inflating two adjacent elements at one time. As the cam rotates, the two valves it actuates moves progressively from the first and second valves, to the second and third valves, and so on. Thus the compression sequence claimed in the opposed application is thus disclosed in Poor.
Novelty of claims 1 and 34 in light of Poor
39. I have determined that Poor discloses each of the six features in claims 1 and 34 of the opposed application. Consequently claims 1 and 34 lack novelty in light of Poor.
Novelty of appended claims in light of Poor
40. The Opponent asserted that claims 2, 3, 5, 6, 10, 13, 14, 15, 19 and 20 which are appended to claim 1 also lack novelty in light of Poor. I will now assess the novelty of these appended claims.
41. Claim 2: Mr Brydon states at page 4 of his declaration:
“The base element 14 that is part of compressors 11 is typically composed of relatively inextensible 4 oz. canvas: Col 2 lines 17-20”.
42. Mr Wren states at paragraph 233 of his declaration:
There is no mention of using a “firm backing sleeve” and certainly no mention of ANY sleeve being specifically described to ensure the compressive force is largely exerted on the limb. This would be coincidental in [Poor], and is unlikely with a backing, being not “firm” as in a canvas backing.”
43. The purpose of the word ‘firm’ in claim 2 is defining a characteristic of the backing sleeve in terms of its function which is to ensure that the compressive force from the compressors is largely exerted on the limb. In my opinion terms such as ‘not stretchable’, ‘inelastic’ or ‘inextensible’ equally define this characteristic. Mr Brydon states that the 4 oz. canvas base disclosed in Poor is relatively inextensible. Although Poor does not explicitly describe the reason for using an inextensible material as a backing sleeve, it is implicit that the use of an inextensible material would ensure “that the compressive force of the compressors is largely exerted on the limb” as defined in claim 2. Thus Poor discloses a firm backing and consequently claim 2 lacks novelty in light of Poor.
44. Claim 3: Poor discloses a base element (14) that extends adjacent to an outer surface and around the limb (see figure 2). Therefore claim 3 lacks novelty in light of Poor.
45. Claim 5: Poor discloses a base element (14) that to be made of canvas which is considered flexible. Therefore claim 5 lacks novelty in light of Poor.
46. Claim 6: Poor discloses a base element (14) but I do not consider this to be a casing since this is already considered part of the sleeve. The feature of the casing must be in addition to the sleeve. Therefore claim 6 is novel in light of Poor.
47. Claim 10: Poor discloses inflatable chambers (15) which act as compressors. Therefore claim 10 lacks novelty in light of Poor.
48. Claim 13: The valves and pressure supply disclosed in column 4 lines 42 to 71 in Poor are considered a fluid delivery system. Therefore claim 13 lacks novelty in light of Poor.
49. Claim 14: Although Poor appears to disclose a pressure regulating valve (unnumbered item at the bottom of figure 6), there is no clear and unmistakable disclosure that this valve is used for adjusting the pressure of the chambers. The pressure regulating valve could, for example, be only used to turn the device on and off. Therefore claim 14 is novel in light of Poor.
50. Claim 15: Poor does not explicitly disclose, in the embodiment shown in figure 6, adjusting the time period that each chamber is inflated. Therefore claim 15 is novel in light of Poor.
51. Claim 19: Poor discloses a valve assembly for inflating and deflating each chamber in sequence at figure 6 and column 4 lines 49 to 65. Therefore claim 19 lacks novelty in light of Poor.
52. Claim 20: Poor discloses in one embodiment of the invention a rotary valve (see figure 7). However, the embodiment of the invention that discloses the compression sequence of claim 1 (shown in figure 6) is a rotative cam not a rotary valve. If the combination of features do not reside in a single embodiment of the invention but rather the features reside in different embodiments, the same principle applies as when considering novelty under s 7(1)(b) (see chapter 2.4.4.4 of the Examiners manual). That is, it must be determined whether a person skilled in the art would treat the embodiments as a single source of information. There is no evidence that a person skilled in the art would treat the embodiments as a single source of information and consequently I am not satisfied that this is the case. Therefore claim 20 is novel in light of Poor.
53. In summary, the appended claims 2, 3, 5, 10, 13 and 19 lack novelty in light of Poor.
US 3,862,629 Rotta
54. US 3,862,629 (hereinafter referred to as Rotta) discloses a device for lowering the incidence of thromboembolism and generally improving venous and secondary blood flow.
The compression/decompression sequence
55. Column 4 lines 29 to 42 of Rotta states:
“As explained more fully in the above generalized description of the present invention the pressurized fluid is directed to and exhausted from the individual toroidal chambers n-2 et seq. in a predetermined repetitive sequence such as to provide continuous stressing and unstressing of the tissues in the regions surrounding the blood vessels of a patient in a continuous pattern of pressure pulses which are propagated wave-like along the series of toroidal chambers.
At any given moment several of the toroidal chambers will be at or near maximum fluid pressure while others are at or near minimum fluid pressure and the remaining toroidal chambers which lie between those at high or low pressure will be under rapidly increasing or decreasing pressure.” [emphasis added]
56. Although Rotta clearly discloses a peristaltic compression sequence, the compression sequence disclosed in Rotta is two or more compressors activated at any one time. Rotta does not explicitly disclose exactly two adjacent elements are inflated at any one time. Thus Rottta does not disclose a compression sequence where a first compressor begins to compress the limb at the same time the third compressor ceases to compress the limb. Therefore Rotta does not disclose the claimed invention.
US 4,624,244 Taheri
57. US 4,624,244 (hereinafter referred to as Taheri) discloses a device for aiding venous flow from the foot and leg of a patient.
Compressors substantially encircling the limb and compress the limb
58. The document discloses inflatable bladders A, B, C and D. These bladders are enclosed in the sleeve. The bladders are relatively small and do not extend around the limb.
59. The opponent argues that although the bladders themselves do not extend around the limb, the sleeve to which they are attached does extend around the limb and thus the sleeve acts as a compressor.
60. Taheri states at column 2 line 63 to column 3 line 3:
Bladders A, B, C and D do not extend more than about one-half the width of their respective cuffs so as to confine them substantially to the area of the soft tissue proximate the deep veins which they are to press against. When the bladders are inflated, there are spaces 48 outside of the outer side edges of the bladders where the cuffs do not press against the flesh, as schematically shown in FIG. 3A, thus never cutting off circulation completely in rings around the leg or arch.
61. In the Taheri disclosure, the pressure directly applied by the bladders is confined to the soft tissue proximate the deep veins on one side of the leg (see figure 3A). Although some of the force from the inflatable bladders would be indirectly distributed to the other side of the limb via the sleeve, this is merely incidental to the sleeve’s purpose rather than its intended function and thus does not properly constitute a compressor. Therefore Taheri does not disclose all the features of the claimed invention.
US 5,014,681 Neeman et al
62. US 5,014,681 (hereinafter referred to as Neeman) discloses a method and apparatus for stimulating blood flow.
A plurality of compressors situated next to one another along the sleeve
63. Neeman discloses inflatable chambers A-K which are next to one another along the sleeve (see figures 1 and 2).
The compression/decompression sequence
64. The compression sequence of Neeman. is disclosed at column 5 lines 1 to 5:
“As seen in FIG 3d of the drawings, the cells 12’’ and 10’’’ are inflated whilst the immediately preceding cell 10’’ is partially deflated whilst the immediately succeeding cell 12’’’ is partially inflated.”
65. From this passage and from figure 10 it is clear that during the compression sequence, four of the cells are inflated to some extent at any one time. Neeman does not disclose only two cells inflated at any one time. Nor does Neeman disclose a compression sequence where a first compressor begins to compress the limb at the same time the third compressor ceases to compress the limb. Therefore Neeman does not disclose the claimed invention.
US 6,478,757 Barak
66. US 6,478,757 (hereinafter referred to as Barak) discloses a device for pressurizing limbs.
Enhancing blood flow and moving blood within the limb from one end to the other
67. Column 3 lines 56 to 57 of Barak discloses the device to be used to enhance the flow of venous blood of the limb:
“…a regime which generates peristaltic contractions of the sleeve so as to force fluids inside the limb towards the proximal end of the limb, or a regime which enhances the flow of venous blood in the limb”
68. Barak also discloses the movement of fluids in the limb towards the trunk at column 1 lines 40 to 43:
“The inflation-deflation cycles of the different cells in the sleeve are typically staggered so as to generate peristaltic contractions of the sleeve, thus moving fluids inside the limb towards the trunk. In addition to being of benefit in cases of edema, these devices are also useful in the treatment of c.v.i. [chronic venous insufficiency], v.v [varicose veins]., v.u. [varicose ulcer] and the prevention of deep vein thrombosis.”
69. Mr Wren states at paragraph 447 of his declaration:
“The device in JB5 [Barak] is for the purpose of “massaging the limbs to promote blood flow”. The concepts of “promoting” and enhancing” are different. If someone massages muscles [of] a limb, one can massage in any direction, and move blood in any direction, and by massaging, would squeeze blood out of the muscles and then when relaxed, blood would necessarily move back into the previously emptied muscle. At this point blood could come from either direction. The application in suit teaches uni-directional enhancement of blood flow.”
70. In light of Mr Wren’s analysis I find that Barak moves fluid from one end of the limb to the other, but does not disclose the movement of blood from one end of the limb to the other. Blood flow is also affected by Barak but blood is not necessarily moved within the limb from one end of the sleeve to the other. Consequently the feature of moving blood within the limb from one end of the sleeve to the other is not clearly disclosed. Therefore Barak does not disclose the claimed invention.
Prior Publication of the invention by the applicant
71. The Opponent asserted in their submission that the invention was disclosed to Mr Crawford before the priority date and this constitutes prior publication.
72. Mr Crawford states at paragraph 34:
“Wren and Bennett came to me in 2002-2003 as they had heard that I was interested in mechanical compression devices and that I had been using and talking about them. They had heard that I might be interested in their device, so they came and showed it to me.”
73. The Opponent argued that the device shown to Mr Crawford in 2002-2003 had all the features of the invention claimed. However there is no evidence of the combination of features possessed by the device. It is quite plausible that the device shown to Mr Crawford was a prototype of the invention which did not have all of the features in the claimed invention. Without evidence to show that the device shown to Mr Crawford had all the features of the claimed invention, I am not satisfied that this is a disclosure of the claimed invention.
Inventive Step
74. Although the Opponent did not make submissions regarding inventive step at the hearing, the ground of inventive step was included in the Statement of Grounds and Particulars and thus it is appropriate to consider this ground pursuant to s 60(3).
75. Claims 1, 2, 3, 5, 10, 13, 19 and 34 lack novelty in light of Poor. If it were assumed that the Poor document could be reasonably expected to have been ascertained, understood and regarded as relevant by a person skilled in the art at the priority date, the same claims that were found to lack novelty would also lack inventive step. However, this will merely provide two coterminous reasons (novelty and inventive step) that the claims are invalid rather than one (novelty only), and thus is considered a moot point.
Summary
76. Claims 1, 2, 3, 5, 10, 13, 19 and 34 lack novelty in light of US 2,528,843 Poor.
77. In my opinion these novelty deficiencies can be overcome by amendment. I allow the applicant 60 days from the date of this decision in which to propose suitable amendments to overcome the above findings.
Costs
78. The award of costs is a discretionary matter. It is a general principle in matters such as these that costs follow the event, and I see no reason to depart from this practice. I have found that Opponent has successfully opposed the Application on the basis that it lacks novelty. I therefore award costs in accordance with Schedule 8 against the Applicant, New Tec Pty Ltd.
Xavier Gisz
Delegate of the Commissioner of Patents
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