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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/14/ 2026 has been entered.
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 24 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. In particular the functional limitation or property that the suture maintains a knot pull strength above 34.5 N for at least 135 days is considered new matter. This measurement was obtained for a very specific example and does not include the broader claimed range of polymers. The claimed functional properties are achieved from a specific suture featuring specific polymers and amounts, thus the specific type of polymers and amounts that make up the suture must be positively specified in order to place one of ordinary skill in the art in possession of the claimed suture with the desired properties. While applicants have shown possession of a specific suture as having the claimed knot strength, they have failed to show possession of the claimed knot strength for all sutures recited in the generic claims. The examiner suggests simply deleting this functional limitation to overcome this rejection.
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) 1,4-12,14,21-22,24 and 25 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), in view of Grafton et al. (EP 1,293,218).
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 (ultra-high molecular weight polyethylene UHMWPE) and a third resorbable fiber in claim 14.
Callegaro teaches benzyl esters of hyaluronic acid HA, including 75% esterified, in addition and in combination with fully benzyl esterified (100%) Hyaff-11, and their use in threads including sutures, the threads could be multifilament containing other polymers including polylactic acid (meeting claim 14) and polytetrafluoroethylene fibers (non-bioresorbable). 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 claims 12, 22 and 25. 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]. Regarding claim 21, Callegro teaches that the extent of esterification with aliphatic alcohol is from 1-50 and benzyl alcohol is from 50-75%, these ranges include esterification percentage of 80 and 100. A prima facie case of obviousness typically exists when the range of a claimed composition lies inside the range disclosed in the prior art, such as in the instant rejection. Therefor, based on the described overlap above, the instant claims would have been obvious to one of ordinary skill in the art. MPEP § 2144.05. Additionally, selection of ranges such as 80% esterification is not patentable on its own absent a showing of unexpected results.
Grafton is used for its disclosure that UHMWPE fibers were a well-known non-degradable suture material. See entire disclosure, especially abstract and claims. The suture featuring UHMWPE fibers had high strength with improved tie down characteristics. See [0003].
Since the primary reference clearly suggests 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 suture fibers of Callegaro and Grafton. 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 and the advantages of UHMWPE fibers noted in Grafton, which include improved strength and tie down ability. 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) 1,4-12,14,16-19 and 21-25 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 Grafton et al. (EP 1,293,218) 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, Callegaro and Grafton is cited above. The combination is silent with respect to homogeneously embedding active agents within the suture fibers as recited in claims 16-19 and 23.
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 and Callegaro teaches extrusion of HA, See [0030] and examples 10-12, one of ordinary skill in the art would have a high expectation of success in embedding active into one or multiple fibers of Callegaro and/or Grafton 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. Additionally, selection of ranges such as 80% esterification is not patentable on its own absent a showing of unexpected results. 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.
Response to Arguments
Applicant's arguments filed 9/14/2026 have been fully considered but they are not persuasive.
Applicants assert Callegaro teaches its HA is a mixed ester and contains benzyl alcohol lower than 75%.
The relevance of this assertion is unclear as applicants claims do not preclude HA that is esterified with other esters besides benzyl ester since the limitation uses the open transitional phrase “comprising”. Only claim 21 requires a certain percent of esterification. However, even claim 21 does not specify it is only benzyl ester, therefore other esters could contribute to the number and Callegara teaches amounts that incorporate the two data points, rendering them obvious.
Applicants assert claim 16 also distinguishes from the prior art including the relied upon Aura reference which fails to teach coextrusion of HA with active agent. Applicants assert Callegaro’s examples use specific solvent exchange HA chemistry different from that of Aura. Applicants assert such a change would require significant adaptation and experimentation.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Auro was not used for teaching the specific esterified HA polymers claimed but for its general teaching of adding drug to polymer by melt extrusion. Making this modification to Callegaro would be obvious for the reasons of record, especially the fact that Callegaro exemplifies extrusion of HA. See [0030] and examples 10-12. Simply because some experimentation and adaptation may be necessary would not dissuade one of ordinary skill from trying to produce drug infused HA by extrusion. Obviousness does not require absolute predictability of success. In re 0 'Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988).
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
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