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 .
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 26 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
It is not evident that the disclosure provides a discussion of obtaining autologous fibrin during surgery. Pre-surgical preparation of the claimed blood product is specifically discussed for collecting patient blood to make the product for later use and the importance of maintaining its sterility (see page 8 lines 15-29). Thus the artisan of ordinary skill would not have deemed the applicant to be in possession of the invention as claimed at the time of filing.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 22 and 25-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “increased” in claim 22 is a relative term which renders the claim indefinite. The term “increased” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Here there is no basis of comparison provided and a variety of other fibrin structures exist with varying properties that could serve as the comparison. For the sake of application of prior art, compressing the single layered blood product into a thinner single layer sheet will be deemed sufficient to meet this limitation. Clarification is still required.
Claims not explicitly expounded upon are also indefinite because they require the limitations of an indefinite claim and do not add clarity.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22, 26-27, and 30 are rejected under 35 U.S.C. 103 as obvious over Beretta et al. (US Patent No 6,368,298) in view of Delmotte et al. (WO 96/22115 – henceforth Delmotte C) as evidenced by Serhan et al. (WO 2014/126545) and Sheetrit et al. (previously cited).
Beretta et al. teach an autologous solid fibrin web that is made by drawing a patient’s blood, centrifuging to separate the plasma, loading the plasma into a flat bottom container, adding a polymerization activator, and then conducting the polymerization/coagulation while centrifuging concurrently (see abstract and examples 1, 3, and 5). Tranexamic acid may be included in the plasma (see example 1). Although called a glue, the web/membrane is recovered from (compressed at) the bottom of the container and employed during a surgical procedure as a separating structure that holds tissues (see example 5). Serhan et al. teach that centrifugation yields the separation of mixtures based upon sedimentation (see page 4 lines 6-7). A mixture in a tube subjected to centrifugation has its heavier components collect at the bottom and the lighter components move toward the top due to centrifugal force (see page 4 lines 8-11). Since the web of fibrin is centrifuged as it is polymerizing, the increasingly larger polymerized product would concentrate at the bottom of the structure and yield a higher concentration than at the top (see instant claim 1). Beretta et al. further teach blood drawn from a patient, converted into a fibrin structure, and then employed within 2-3 from preparation into a surgical space (see example 3). Beretta et al. do not explicitly teach the fibrin web as anti-adhesive.
Delmotte C teach of the utility of a crosslinked fibrin membrane glue material as an anti-adhesive barrier to be employed on adjacent tissues during surgery to separate them from one another and inhibit their adhesion (see page 1 lines 16-21 3 line 22-page 4 line 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the fibrin web of Beretta et al. in a surgical setting where it is inserted between two tissues that are desired to be separated. This modification would have been obvious in light of Delmotte C who teach the utility of such webs in this capacity. The inclusion of tranexamic acid also would have been obvious in light of the suggestion by Beretta to do so. Sheetrit et al. include tranexamic acid in the fibrin layer of a post-surgical adhesion barrier and see that it had a lower post-inoculation bacterial count than an uncoated comparison and a commercial hernia mesh (see example 7 and example 9, and figures 9-10). Thus tranexamic acid acts as a preserving component in fibrin (see instant claim 27). The short time between blood draw and use of the preparation fibrin material contemplated by Beretta et al. implies a single surgical session could encompass the collection of blood and use (see instant claim 26). Therefore claims 22, 26-27, and 30 are obvious over Beretta et al in view of Delmotte C as evidenced by Serhan et al. and Sheetrit et al.
Claims 22, 25-27, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Beretta et al in view of Delmotte C as evidenced by Serhan et al. and Sheetrit et al. as applied to claims 22, 26-27, and 30 above, and further in view of Shanbrom (US PGPub No. 2005/0196393).
Beretta et al. in view of Delmotte C as evidenced by Serhan et al. and Sheetrit et al. render obvious the limitations of instant claims 22, 26-27, and 30. The modified teachings detail a membrane made from the blood component fibrin, but a reinforcing net is not detailed.
Shanbrom teach a fibrin membrane product from purified blood components that solidifies into a solid for surgery and for treating wounds (see paragraphs 16 and 50-51). They go on to teach embedding a mesh in the material to reinforce the fibrin membrane (see paragraph 52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a mesh (net) in the autologous solid fibrin of Beretta et al. in view of Delmotte C as evidenced by Serhan et al. and Sheetrit et al. in light of Shanbrom. This modification would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 22, 25-27, and 30 are obvious over Beretta et al in view of Delmotte C and Shanbrom as evidenced by Serhan et al. and Sheetrit et al.
Claims 22 and 25-30 are rejected under 35 U.S.C. 103 as being unpatentable over Beretta et al. in view of Delmotte C and Shanbrom as evidenced by Serhan et al. and Sheetrit et al. as applied to claims 22, 25-27, and 30 above, and further in view of Sheetrit et al.
Beretta et al in view of Delmotte C as evidenced by Serhan et al. and Sheetrit et al. render obvious the limitations of instant claims 22, 25-27, and 30 where a compound (tranexamic acid) is present that acts as a preservative is present (see instant claim 29). Beretta et al. detail that their fibrin membrane could also be stored for several days indicating the contemplation of the option for several hours to pass between preparation and use (see example 6).
Sheetrit et al. teach a method of inhibiting post-surgical adhesions, where a location between tissues is identified and a mesh (net) coated on one side with a fibrin hydrogel film (single layer) is inserted between the tissues (see example 2 and paragraphs 154-157; instant claims 22-23 and 25). This mesh with a single layer of fibrin had fewer adhesions than uncoated mesh (see table 3). They detail that drying stabilizes the fibrin coating and increases adherence to the mesh (see paragraph 125; instant claim 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to dry the mesh reinforced fibrin membrane of Beretta et al. in view of Delmotte C and Shanbrom as evidenced by Serhan et al. and Sheetrit et al. in light of Sheetrit et al. This modification would have been obvious so as to stabilize the fibrin as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 22 and 25-30 are obvious over Beretta et al. in view of Delmotte C Shanbrom and Sheetrit et al. as evidenced by Serhan et al. and Sheetrit et al.
Response to Arguments
Applicant's arguments filed September 17, 2025 have been fully considered. In light of the amendment to the claims, the previous grounds of rejection under 35 USC 103 and the objection are withdrawn. The applicant’s arguments concerning the maintained rejection under 35 USC 112(a) are not persuasive.
The applicant acknowledges that the specification does not state that the claimed fibrin is obtained during the surgery. While the applicant discusses several details of how the blood is to be treated, and that it is autologous, none of this discussion suggests obtaining the material during surgery. The applicant’s suggestion that obtaining the blood product during the surgery is implicit from other discussions in the specification does not conform to the stated intent and discussion of the claimed invention. The specification makes a point of teaching away from obtaining the blood product during surgery via the discussion of pre-surgical extraction and processing that is stated to “avoid the need for staff and equipment for preparation of the blood product during the surgical procedure” (see page 8 lines 20-23). Thus the specification positions the invention as specifically obtaining the fibrin of the method outside of the surgical procedure.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615
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