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 .
Response to Amendment
This Office Action is a response to applicant’s arguments and amendment filed 11/06/2025. Claim 39 is amended. Claims 15-35 and 38 are cancelled. Claims 41-61 are new. Claims 1-14, 36-37 and 39-61 are currently pending, with claims 1-14, 36-37 and 40 withdrawn from consideration.
The objection of claim 39 has been withdrawn due to applicant’s amendment.
Response to Arguments
Applicant’s arguments, see Remarks, filed 03/11/2025, with respect to the rejection(s) of claim(s) 39 under 35 U.S.C. 102(a)(1) as being anticipated by Sander, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendments to the claims.
Applicant argues Sander does not disclose a curved portion comprising at least one flexible section and at least one non-flexible section. Applicant further argues Sander does not disclose a suture thread as claimed (Remarks, pg. 10).
In response to applicant’s argument, it is respectfully submitted the arguments are narrower than the claim limitations. The curved portion as claimed includes at least one flexible section (flexible material 16) and at least one non-flexible section (anchoring members 14, which Sander explicitly discloses as being less flexible than flexible material 16, therefore meeting the claimed limitation of a non-flexible section relative to a flexible section, para. [0052]). There is no further structure claimed regarding the curved portion, such that the claimed limitation is met, because flexible material 16 is depicted as curved in figs. 1-2, and also imparts a curve to anchoring members 14. Anchoring members 14 themselves also have curved portions at least at barbs 18. Further, Sander discloses flexible material 16 being formed of multiple filaments or fibers of suture, such that at least one fiber of the flexible material 16 meets the limitation of a suture thread as claimed. Accordingly, the rejection is maintained.
Applicant’s arguments with respect to claims 41-60 have been fully considered, and new claims 41-60 have been rejected as discussed below.
Claim Rejections - 35 USC § 112
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 41-42 and 44-59 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.
Regarding claim 41, the claim recites “the suture thread is attached to a non-flexible section of the curved portion”. It is unclear whether the phrase is referring to the at least one non-flexible section previously introduced, or introducing a new, separate non-flexible section. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the at least one non-flexible section previously introduced.
Regarding claim 42, the claim recites “the suture thread is attached to a flexible section of the curved portion”. It is unclear whether the phrase is referring to the flexible section previously introduced, or introducing a new, separate flexible section. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the flexible section previously introduced.
Regarding claim 44, the claim recites “a non-flexible section of the needle body”. It is unclear whether the phrase is referring to the at least one non-flexible section previously introduced, or introducing a new, separate non-flexible section. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the at least one non-flexible section previously introduced.
Regarding claim 45, the claim recites “a flexible section of the needle body”. It is unclear whether the phrase is referring to the flexible section previously introduced, or introducing a new, separate flexible section. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the flexible section previously introduced.
Regarding claim 46, the claim recites “two adjacent non-flexible sections”. It is unclear whether the phrase is referring to the at least one non-flexible section previously introduced, or introducing a new, separate non-flexible sections. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to include the at least one non-flexible section previously introduced.
Regarding claim 53, the claim recites “two adjacent flexible sections”. It is unclear whether the phrase is referring to the flexible section previously introduced, or introducing new, separate flexible sections. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to include the at least one flexible section previously introduced.
Claims 47-52 and 54-59 are indefinite due to their dependencies on indefinite base claims 46 and 53.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 39, 41-49 and 60-61 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sander (US 2006/0161160 A1) (previously of record).
Regarding claim 39, Sander discloses (see abstract; paras. [0036]-[0082]; figs. 1-16) a suturing needle (fig. 2) comprising:
a needle tip portion (needle 32, annotated fig. 2) having a needle tip (tip of needle 32) at a proximal end of the needle tip portion for piercing tissue (sharp tip 13 for penetration into tissue, considered to be at proximal end of needle 32, para. [0036]);
a needle body (remainder of repair device 10, including anchoring members 14, at least one fiber/filament of flexible material 16, and second needle 32, para. [0037]; fig. 2) comprising a curved portion (includes anchoring members 14 and the at least one fiber/filament of flexible material 16, depicted as curved in fig. 2, see also curved portions of barbs of anchoring members 14) having a proximal end connected to a distal end of the needle tip portion (annotated fig. 2) and a distal end opposite the proximal end (annotated fig. 2), wherein the curved portion comprises at least one flexible section (the at least one fiber or filament of flexible material 16, paras. [0037] and [0061]-[0062]) and at least one non-flexible section (anchoring members 14, which have less flexibility compared to 16 and therefore encompass a non-flexible section relative to 16, para. [0052]); and
a suture thread (at least a second fiber or filament of flexible material 16, which is formed of braided suture and therefore encompasses multiple suture filaments, paras. [0037] and [0061]-[0062]) attached to either (a) a portion of the needle body between the at least one flexible section and the at least one non-flexible section (considered to be attached to remainder of device 10 between portions of flexible material 16 and anchoring members 14, fig. 2), or (b) the distal end of the curved portion (considered to be at least indirectly attached to distal end of curved portion via anchoring members 14, fig. 2).
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Annotated Figure 2 of Sander
Regarding claim 41, Sander discloses the suturing needle of claim 39. Sander further discloses wherein when the suture thread is attached to the distal end of the curved portion, the suture thread is attached to a non-flexible section of the curved portion (considered to be attached to anchoring members 14, fig. 2).
Regarding claim 42, Sander discloses the suturing needle of claim 39. Sander further discloses wherein when the suture thread is attached to the distal end of the curved portion, the suture thread is attached to a flexible section of the curved portion (considered to be attached to other fibers/filaments of flexible material 16, fig. 2).
Regarding claim 43, Sander discloses the suturing needle of claim 39. Sander further discloses wherein when the suture thread is attached to the distal end of the curved portion, the suture thread is attached to a tapered suture attachment section at the distal end of the curved portion (second fiber/filament of flexible material 16 attached to barbs 18 via anchoring members 14, which are considered to be tapered and located at a distal end of curved portion, fig. 2).
Regarding claim 44, Sander discloses the suturing needle of claim 39. Sander further discloses wherein the distal end of the needle tip portion connects to a non-flexible section of the needle body (connects to at least one anchoring member 14, fig. 2).
Regarding claim 45, Sander discloses the suturing needle of claim 39. Sander further discloses wherein the distal end of the needle tip portion connects to a flexible section of the needle body (distal end of needle 32 considered to at least be indirectly connected to flexible material 16 via anchoring members 14, fig. 2).
Regarding claim 46, Sander discloses the suturing needle of claim 39. Sander further discloses wherein the at least one flexible section is located between and is separated by two adjacent non-flexible sections (flexible material 16 located between and separated by two anchoring members 14, fig. 2).
Regarding claim 47, Sander discloses the suturing needle of claim 46. Sander further discloses wherein the at least one flexible section has a diameter that is the same as a diameter of at least one of the two adjacent non-flexible sections (fiber/filament of flexible material 16 considered to have a diameter that is the same as portion of anchoring members 14 without barbs 18, see fig. 2 depicting a continuous diameter at portions opposite of barbs 18).
Regarding claim 48, Sander discloses the suturing needle of claim 46. Sander further discloses wherein the at least one flexible section has a diameter that is different than a diameter of each of the two adjacent non-flexible sections (fiber/filament of flexible material 16 considered to have a different diameter relative to barbs 18 of anchoring members 14, fig. 2).
Regarding claim 49, Sander discloses the suturing needle of claim 46. Sander further discloses wherein the at least one flexible section has opposing ends (proximal and distal ends of the at least one fiber/filament of flexible material 16), and wherein each of the opposing ends attaches to a different non-flexible section of the two adjacent non-flexible sections (fig. 2), via on-center attachment (depicted as having on-center attachment, fig. 2).
Regarding claim 60, Sander discloses the suturing needle of claim 39. Sander further discloses wherein the needle body has a substantially circular cross section (needles depicted as circular in shape, figs. 1-2).
Regarding claim 61, Sander discloses (see abstract; paras. [0036]-[0082]; figs. 1-16) a suturing needle (fig. 2) comprising:
a first needle tip portion (first needle 32, annotated fig. 2 below) having a first needle tip (tip of first needle 32) at a proximal end of the first needle tip portion for piercing tissue (sharp tip 13 for penetration into tissue, considered to be at proximal end of needle 32, para. [0036]);
a second needle tip portion (second needle 32, annotated fig. 2 below) having a second needle tip (tip of second needle 32) at a distal end of the second needle tip portion for piercing tissue (sharp tip 13 for penetration into tissue, considered to be at distal end of needle 32, para. [0036]);
a needle body (includes anchoring members 14 and at least one fiber/filament of flexible material 16, paras. [0037] and [0061]-[0062]; fig. 2) comprising a curved portion (flexible material 16 depicted as curved in fig. 2, see also curved portions of barbs of anchoring members 14) having a proximal end connected to a distal end of the first needle tip portion (annotated fig. 2 below) and a distal end opposite the proximal end connected to the proximal end of the second needle tip portion (annotated fig. 2 below), wherein the curved portion comprises at least one flexible section (the at least one fiber or filament of flexible material 16, paras. [0037] and [0061]-[0062]) and at least one non-flexible section (anchoring members 14, which have less flexibility compared to 16 and therefore encompass a non-flexible section relative to 16, para. [0052]);
a suture thread (at least a second fiber or filament of flexible material 16, which is formed of braided suture and therefore encompasses multiple suture filaments, paras. [0037] and [0061]-[0062]) attached to a portion of the needle body between the at least one flexible section and the at least one non-flexible section (considered to be attached between portions of flexible material 16 and anchoring members 14, fig. 2).
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Annotated Figure 2 of Sander
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) 50 is rejected under 35 U.S.C. 103 as being unpatentable over Sander in view of Green (US 6190401 B1).
Regarding claim 50, Sander discloses the suturing needle of claim 46.
Sander further discloses wherein the at least one flexible section has opposing ends (proximal and distal ends of the at least one fiber/filament of flexible material 16), and wherein each of the opposing ends attaches to a different non-flexible section of the two adjacent non-flexible sections (fig. 2).
However, Sander fails to disclose wherein each of the opposing ends attaches to a different non- flexible section of the two adjacent non-flexible sections, via off-center attachment.
Green teaches (col. 8 line 53-col. 9 line 19 and claims 1 and 7-8; fig. 10), in the same field of endeavor, a needle (fig. 10) comprising a flexible section (306) attached to a different non-flexible section (304) via off-center attachment (claims 1 and 7-8; fig. 10), for the purpose of providing an unobstructed tool engaging surface at the proximal end of each of the anchoring members (claim 1).
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 ends of the at least one fiber/filament of flexible material 16 of Sander to attach to anchoring members 14 via off-center attachment, in order to provide an unobstructed tool engaging surface at the end of each of the anchoring members 14 when desired, based on the teachings of Green (claims 1 and 7-8).
Claim(s) 51-52 are rejected under 35 U.S.C. 103 as being unpatentable over Sander in view of Shave (US 5358498).
Regarding claim 51, Sander discloses the suturing needle of claim 46.
Sander further discloses wherein the at least one flexible section has opposing ends (proximal and distal ends of the at least one fiber/filament of flexible material 16), wherein each of the opposing ends attaches to a different non-flexible section of the two adjacent non-flexible sections (fig. 2).
However, Sander fails to disclose wherein at least one of the opposing ends has a tapered transition that attaches to one of the two adjacent non-flexible sections.
Shave teaches (col. 4 line 34-col. 8 line 8; figs. 1-13), in the same field of endeavor, a suturing needle (figs. 1 and 6) comprising a tapered transition (via sleeve 22, depicted as tapered, see annotated fig. 6) that attaches an end of a flexible section (suture 15) to a non-flexible section (12), for the purpose of providing a suture coupling structure that allows the suture to be coupled to structures of greater diameters (col. 6 lines 10-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify at least one end of flexible material 16 to further include heat shrink sleeve 22 which has a tapered transition, in order to provide the capability of coupling the flexible material with anchoring members of different diameters when desired, based on the suggestions and teachings of Shave (col. 6 lines 10-26).
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Annotated Figure 6 of Shave
Regarding claim 52, Sander discloses the suturing needle of claim 46.
Sander further discloses wherein the at least one flexible section has opposing ends (proximal and distal ends of the at least one fiber/filament of flexible material 16), wherein each of the opposing ends attaches to a different non-flexible section of the two adjacent non-flexible sections (fig. 2).
However, Sander fails to disclose wherein each of the opposing ends has a tapered transition that attaches to a different non-flexible section of the two adjacent non-flexible sections.
Shave teaches (col. 4 line 34-col. 8 line 8; figs. 1-13), in the same field of endeavor, a suturing needle (figs. 1 and 6) comprising a tapered transition (via sleeve 22, depicted as tapered, see annotated fig. 6) that attaches ends of a flexible section (suture 15) to other structures (includes 12 and 26), for the purpose of providing a suture coupling structure that allows the suture to be coupled to structures of greater diameters (col. 6 lines 10-26).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify each end of flexible material 16 to further include heat shrink sleeve 22 which has a tapered transition, in order to provide the capability of coupling the flexible material with anchoring members of different diameters when desired, based on the suggestions and teachings of Shave (col. 6 lines 10-26).
Claim(s) 53-56 and 58-59 are rejected under 35 U.S.C. 103 as being unpatentable over Sander in view of Jones (US 2008/0027486 A1).
Regarding claim 53, Sander discloses the suturing needle of claim 39.
However, Sander fails to disclose wherein the at least one non-flexible section is located between and is separated by two adjacent flexible sections.
Jones teaches (paras. [0028]-[0030] and [0038]; fig. 1), in the same field of endeavor, a suturing needle (fig. 1) comprising a non-flexible section (section including barbs 104 which are generally rigid, para. [0029]) located between and separated by two adjacent flexible sections (separated by unbarbed sections 129, 130 and 127, paras. [0029]-[0030]; fig. 1), for the purpose of providing portions of the suture that are stronger and easier to handle during the procedure by providing additional, unbarbed lengths of suture allowing insertion and withdrawal of the needles during suture deployment that do not remain implanted in the patient (paras. [0028] and [0038]).
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 suturing needle of Sander to include additional unbarbed sections of suture between needles 32 and anchoring members 14, in order to provide portions of the suture that are stronger and easier to handle during the procedure by providing additional, unbarbed lengths of suture allowing insertion and withdrawal of the needles during suture deployment that do not remain implanted in the patient, based on the teachings of Jones (paras. [0028] and [0038]).
Sander (as modified) further teaches wherein the at least one non-flexible section is located between and is separated by two adjacent flexible sections (combination considered to further teach additional flexible material 16 separating anchoring members 14 from needles 32, such that anchoring members 14 are located between portions of flexible material 16).
Regarding claim 54, Sander (as modified) teaches the suturing needle of claim 53. Sander further discloses wherein the at least one non-flexible section has a diameter that is the same as a diameter of at least one of the two adjacent flexible sections (portion of anchoring members 14 without barbs 18 considered to have a diameter that is the same as the at least one fiber/filament of flexible material 16, see fig. 2 depicting a continuous diameter at portions opposite of barbs 18).
Regarding claim 55, Sander (as modified) teaches the suturing needle of claim 53. Sander (as modified) further teaches wherein the at least one non-flexible section has a diameter that is different than a diameter of each of the two adjacent flexible sections (diameter of anchoring members 14 including barbs 18 considered to be different than diameter of each of the flexible material 16, fig. 2 of Sander).
Regarding claim 56, Sander (as modified) teaches the suturing needle of claim 53. Sander (as modified) further teaches wherein the at least one non-flexible section has opposing ends (proximal and distal ends of at least one anchoring member 14 of Sander), and wherein each of the opposing ends attaches to a different flexible section of the two adjacent flexible sections (combination considered to further teach each end of the at least one anchoring member 14 attached to a different flexible material 16), via on-center attachment (combination considered to further teach similar on-center attachment to additional flexible material as that depicted in figs. 1-2 of Sander).
Regarding claim 58, Sander (as modified) teaches the suturing needle of claim 53. Sander (as modified) further teaches wherein the at least one non-flexible section has opposing ends (proximal and distal ends of at least one anchoring member 14 of Sander), wherein each of the opposing ends attaches to a different flexible section of the two adjacent flexible sections (combination considered to further teach each end of anchoring members 14 attached to additional flexible material 16), and wherein at least one of the opposing ends has a tapered transition (barb 18) that attaches to one of the two adjacent flexible sections (considered to be attached to flexible material 16, since barbs 18 extend to ends of anchoring member 14 and are tapered, fig. 2 of Sander).
Regarding claim 59, Sander (as modified) teaches the suturing needle of claim 53. Sander (as modified) further teaches wherein the at least one non-flexible section has opposing ends (proximal and distal ends of at least one anchoring member 14 of Sander), wherein each of the opposing ends attaches to a different flexible section of the two adjacent flexible sections (combination considered to further teach each end of anchoring members 14 attached to additional flexible material 16), and wherein each of the opposing ends has a tapered transition (barb 18) that attaches to a different flexible section of the two adjacent flexible sections (each end considered to be attached to flexible material 16, since barbs 18 extend to ends of anchoring member 14 and are tapered, fig. 2 of Sander).
Claim(s) 57 is rejected under 35 U.S.C. 103 as being unpatentable over Sander in view of Jones as applied to claim 53 above, and further in view of Green.
Regarding claim 57, Sander (as modified) teaches the suturing needle of claim 53.
Sander further discloses wherein the at least one non-flexible section has opposing ends (proximal and distal ends of at least one anchoring member 14), and wherein each of the opposing ends attaches to a different flexible section of the two adjacent flexible sections (combination considered to further teach each end of anchoring members 14 attached to additional flexible material 16).
However, Sander (as modified) fails to teach wherein each of the opposing ends attaches to a different flexible section of the two adjacent flexible sections, via off-center attachment.
Green teaches (col. 8 line 53-col. 9 line 19 and claims 1 and 7-8; fig. 10), in the same field of endeavor, a needle (fig. 10) comprising a flexible section (306) attached to a non-flexible section (304) via off-center attachment (claims 1 and 7-8), for the purpose of providing an unobstructed tool engaging surface at the end of each of the anchoring members (claims 1 and 7-8).
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 ends of the anchoring members 14 formed between flexible material 16 of Sander (as modified) to attach via off-center attachment, in order to provide an unobstructed tool engaging surface at the end of each of the anchoring members 14 when desired, based on the suggestions and teachings of Green (claims 1 and 7-8).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2005/0267532 A1 to Wu, disclosing a surgical thread.
US 2009/0312791 A1 to Lindh, Sr., disclosing a collapsible barbed suture.
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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571)-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRIGID K BYRD/Examiner, Art Unit 3771