DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/30/2026 has been entered.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(a-d) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/AU2020/050848, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Certified copies, filed 02/15/2022, does not provide support for the claimed subject matter of the “texture to grip” disposed on the inner surface of the cover body, as required in claim 1; and “texture” on the outer surface of the cover body, as required in claim 14. Therefore, the foreign priority date claimed is not given for those specific structures.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-4, 6, 8, 14, 20-22, 24, 27, 32, 37, 39 and 45 are rejected under 35 U.S.C. 103 as being unpatentable over Campsen (US 2015/0289940) in view of Torai (US 2022/0202207).
Claims 1
Campsen discloses a medical device (1) for thermally insulating a graft to be transplanted, the medical device comprising a cover body (15) made of biocompatible thermally insulating material (see [0025] and [0084]) including an inner surface defining a cavity (25) within which, in use, the graft is adapted to be received, the cover body having an outer edge (defined by edge where joint 18 is provided) defining an opening (see figure 5) through which the graft is received into the cavity (see [0083]), wherein the medical device is configured to keep the graft received therein sufficiently cool in the body of a subject during surgery to substantially prevent warm ischaemic injury to the graft (see [0084]). Campsen does not disclose the inner surface of the cover body textured to grip an outer surface of the graft to prevent egress of the graft from the cavity. However, Torai discloses an organ container (1) comprising texture/projections (41) to grip an outer surface of the graft (see figure 3). Torai discloses when the organ is fitted within the container, the projections come in intimate contact with the outer surface of the organ, preventing movement of the organ within the container, and reducing damage of the organ (see [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Campsen including the texture/projections as taught by Torai to prevent movement of the graft/organ within the medical device, and reducing damage of the graft/organ when disposed within the medical device. After Campsen is modified, then the texture/projections will provide a texture to the inner surface of the cover body which will prevent egress of the graft/organ from the cavity.
Claim 2
Campsen further discloses an external surface of the cover body is biocompatible (see [0025]).
Claims 3 and 4
Campsen further discloses a shape of the inner surface of the cover body could be similar to a shape of the graft, such as a human kidney (see [0074]).
Claim 6
Campsen further discloses the cover body could extend over substantially all of an external surface area of the graft, in use, and/or the cover body is capable to closely cover the graft, in use. Campsen discloses the cover body is sized and shaped to receive organs (see [0074]).
Claim 8
Campsen further discloses the cover body is capable to conform to an outer shape of the graft, in use. Campsen discloses the main body is formed from flexible material capable to conform to an outer shape of an organ (see [0032] and [0093]).
Claim 14
Campsen does not disclose texture on an outer surface of the cover body. However, Torai discloses texture/projections (51) on an outer surface of the container (see figure 3). Torai discloses the projections facilitates surgeon’s handling of the organ container when the surgeon stretches opening (21) to store the organ in the container (see [0044]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the medical device including projections on the outer surface for better gripping of the medical device to the surgeon
when handling the organ/graft.
Claim 20
Campsen further discloses the medical device includes a gripping portion (4) extending from the cover body to allow the user to comfortably grip and manipulate the cover body when the graft is located within the cover body, in use (see figure 3).
Claim 21
Campsen further discloses at least one fastener (12) located on the cover body, adjacent the opening, configured to provide a barrier across the opening of the cover body to prevent egress of the graft from the cavity, in use (see [0079], figures 3 and 5).
Claim 22
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Campsen further discloses the at least one fastener includes a first portion attached adjacent a first portion of the edge, and a second portion adjacent an opposing second portion of the edge located across the mouth (see figure above).
Claim 24
Campsen further discloses the medical device is of unitary/one piece construction (see figure 5).
Claim 27
Campsen further discloses the cover body further comprising a cooling pocket (40) for receiving a cooling insert (see [0091]).
Claim 32
Campsen discloses a medical device (1) for thermally insulating a graft kidney to be transplanted comprising a curved cover body (15) having a substantially U-shaped cross-section having an inner surface (see figure 3), the U-shaped cross-section defining a cavity (25) within which, in use the kidney graft is adapted to be received (see [0074] and figure 5); wherein the curved cover body comprises a biocompatible thermally insulating material (see [0025] and [0084]) and is configured to keep the graft kidney sufficiently cool in the body of the subject to substantially prevent warm ischaemic injury to the graft kidney, in use (see [0084]). Campsen does not disclose the inner surface of the curved cover body is textured to grip an outer surface of the graft kidney to prevent egress of the graft kidney from the cavity. However, Torai discloses an organ container (1) comprising texture/projections (41) to grip an outer surface of the graft (see figure 3). Torai discloses when the organ is fitted within the container, the projections come in intimate contact with the outer surface of the organ, preventing movement of the organ within the container, and reducing damage of the organ (see [0045]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Campsen including the texture/projections as taught by Torai to prevent movement of the graft/organ within the medical device, and reducing damage of the graft/organ when disposed within the medical device. After Campsen is modified, then the texture/projections will provide a texture to the inner surface of the cover body which will prevent egress of the graft/organ from the cavity.
Claim 37
Campsen further discloses the cover body is curved in an arc, thereby defining a recess (30) such that, in use, blood vessels and ureter of the kidney are capable to be positioned within the recess to enable a user to easily access to blood vessels and ureter of the kidney during transplantation (see [0063]).
Claim 39
Campsen discloses a medical device (1) for thermally insulating a graft to be transplanted, as explained in the rejection of claim 1 above; and an active cooling apparatus (50) capable to provide cooling to the cover and the graft received therein (see [0069]).
Claim 45
Campsen discloses a system for cooling a graft before transplant comprising a medical device (1) for thermally insulating a graft kidney to be transplanted, as explained in the rejection of claim 32 above; and an active cooling apparatus (50) capable to provide cooling to the cover and the graft received therein (see [0069]).
Allowable Subject Matter
Claims 47 and 48 are allowed. No prior art discloses a medical device comprising a biocompatible thermally insulated cover comprising a texture surface comprising a pattern with interconnected cooling channels which fluid can travel to cool an outer surface of a graft as required in the claim.
Claims 17, 49 and 50 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments with respect to claims 1-4, 6, 8, 14, 17, 20-22, 24, 27, 32, 37, 39, 45 and 47-50 have been considered but are moot in view of a new ground of rejection.
Regarding applicant’s argument of the affidavit filed 04/30/2026, the examiner points out that the statements from the affidavit were considered, however a new ground of rejection has been applied to the claims, therefore the statements in the affidavit does not apply to the ground of rejection used for the claims.
Conclusion
Examiner has cited particular paragraphs and/or columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested of the applicant, in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or prior art(s) disclosed by the Examiner (in the attached PTO-892 form).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAFAEL A. ORTIZ whose telephone number is (571)270-5240. The examiner can normally be reached Monday - Friday 9am - 6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Orlando E. Aviles can be reached at 571-270-5531. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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RAFAEL A. ORTIZ
Primary Examiner
Art Unit 3736
/RAFAEL A ORTIZ/Primary Examiner, Art Unit 3736
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