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 .
Withdrawn Rejections
Any objection\rejections from the previous office action filed 5/2/2025 not addressed below has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1,4-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 9,788,844) in view of Callegaro et al. (US 2001/0008937, cited previously). This new rejection was necessitated by amendment.
Miller teaches suture anchors featuring a tapered end with a smaller cross-section then the other end with an aperture throughout the anchor with a suture tread entering one end of the aperture and out the other. See entire disclosure, especially abstract, Fig 1, col 4 lin 58-col 5 line 26 and claims.
Miller is silent with respect to the specific suture claimed which requires a bioresorbable hyaluronan based polymer (benzyl ester of hyaluronic acid in claim 15) and a second non-resorbable polymer (specific example in claim 13) and a third resorbable fiber in claim 14.
Callegaro teaches benzyl esters of hyaluronic acid HA, including Hyaff-11 fully benzyl esterfied (100%) and 75% esterfied, and their use in threads including sutures, the threads could be multifilament containing other polymers including polylactic acid (meeting claim 14) and polytetrafluoroethylene (meeting claim 13). See entire disclosure, especially abstract, figures, [0002]-[0014],[0031],[0075], examples and claims 10-20 and 26. Regarding claims 10-11, the process to make the suture does not impart a patentable difference since there is nothing in the claims to physically distinguish the suture from Callegaro. The products are still sutures, thus the method to make them does not impart a patentable distinction. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Regarding claim 9, the diameter of the threads of Callegaro were 75-800 microns, within the claimed range. See [0031]. Regarding claims 7-8, the sutures shown in the drawings and described as having a diameter are considered to read on having a circular and oval cross section. Callegaro is silent with respect to the amount of non-degradable polymer in claim 12. However generally, differences in the amount of polymer fiber used in the multifilament thread will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such an amount is critical. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426. The treads could be tailor made based on the polymer types used to have a rapid or prolonged degradation time and by could act as bacteriostats by use of hyaluronic acid, clear advantages for a suture. See [0031]-[0038].
Since the primary reference clearly suggest that the disclosed suture anchors are used in combination with a suture one of ordinary skill in the art would have a very high expectation of success in adding/substituting the sutures of Callegaro. Reason to make such a modification stems from the noted advantages of the suture fibers of Callegaro, which include tailer made degradation coupled with antibacterial properties conferred by hyaluronic acid. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Claim(s) 1 and 4-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Miller (US 9,788,844) in view of Callegaro et al. (US 2001/0008937) in view of Arora et al. “Drug eluting sutures: A recent update” Review Article | Volume: 9, Issue: 7, July, 2019. This new rejection was necessitated by amendment.
The combination of Miller and Callegaro is cited above. The combination is silent with respect to homogeneously embedding active agents within the suture fibers as recited in claims 16-19.
Arora reviews different methods to add drug to suture fibers, several techniques to mix the drug and polymer would produce a homogenous distribution of embedded active within the suture, including coextrusion as claimed, as well as other techniques including spinning and electrospinning from solutions of polymer and active. See entire disclosure, especially abstract, table 2, page 116 lft col-pag 117 rt col 2nd ¶.
Since it was well known that in the art before the time of the claimed invention that suture fibers could be embedded with active as taught by Arora one of ordinary skill in the art would have a high expectation of success in embedding active into one or multiple fibers of Callegaro by extrusion. Reason to make such a modification would be to provide healing, infection prevention or pain relief to the wound treated by the suture. Thus the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Response to Arguments
Applicant's arguments filed 11/3/2025 have been fully considered but they are not persuasive. Applicants assert the claims which require an anchor with two end cross sections in which the second is smaller than the first distinguishes the claims from the previously cited art.
The previous rejection over Bounutti has been withdrawn, however the claims are considered obvious over the combination of Miller and Callegaro as noted in the new rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/ Primary Examiner, Art Unit 1618