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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/30/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 12/17/2025. As directed by the amendment: claims 1 have been amended and claims 6 and 9-20 have been cancelled. Thus, claims 1-5 and 7-8 are presently pending in this application.
Response to Arguments
Applicant's arguments, see page 4, filed 12/17/2025, with respect to the drawing objections have been fully considered but they are not persuasive. The applicant asserts that their Fig. 3 illustrates apertures 31, 33 extending along longitudinal axis 12a and in a plane parallel to axis 12a.
The drawings were previously objected for not showing the newly added claim language of "wherein the first aperture and the second aperture extend in a plane about parallel to the longitudinal axis of the flexible body". The applicant argues that Fig. 3 of their drawings show the claimed language. The examiner respectfully disagrees. The definition of parallel according to the online Merriam-Webster dictionary is "extending in the same direction, everywhere equidistant, and not meeting or everywhere equally distant". In both cases, the definition is not met. As clearly shown in Fig. 3, the planes of the apertures, are not parallel as they intersect, hence touch, with the longitudinal axis 12a. Furthermore, there is not adequate support for the language in the applicant's written specification. Hence, this claim language is new matter without support.
Applicant's arguments, see pages 4-6, filed 12/17/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Gaynor et al (US 20110092985 A1), herein referenced to as “Gaynor” have been fully considered but they are not persuasive.
The applicant asserts that Gaynor is silent to wherein at least one aperture is “configured to rest on a ventral surface of a finger” and “engage a handle of an insertion tool and to retain a flexible strand on the insertion tool”.
The applicant additionally argues that Gaynor is silent about the apertures extending in a plane parallel to the longitudinal axis of the device. Specifically, they state that the first and second apertures extend in planes perpendicular to the longitudinal axis and not parallel to it.
The examiner respectfully disagrees.
Firstly, the language, " configured to rest on a ventral surface of a finger" and “engage a handle of an insertion tool and to retain a flexible strand on the insertion tool” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Gaynor meets the structural limitations of the claim, and is capable of resting on a ventral surface of a finger when a finger is inserted through the apertures and engaging a handle of an insertion tool by means of element 396 that can slide onto an insertion tool and threading a flexible strand through the apertures, which can be tied around an aperture to retain the flexible strand on the insertion tool.
Secondly, the claimed language “wherein the first aperture and the second aperture extend in a plane about parallel to the longitudinal axis of the flexible body”. There is no requirement in the language for the entire aperture to extend in the plane. Hence the first and second apertures of Gaynor extend in a plane that cuts through both of them, as these apertures extend parallel to the longitudinal axis by virtue of being coincidental openings.
Applicant's arguments, see pages 6-7, filed 12/17/2025, with regards to rejection of claim 2 under 35 U.S.C. 103 as being unpatentable over Gaynor in view of Brackett et al (US 20080275499 A1), herein referenced to as “Brackett” have been fully considered but they are not persuasive.
The applicant argues that there is no motivation to modify to include an O-ring as it already has a “car 170” secured to the introducer. They additionally assert that Gaynor does not give any indication that its suture fixation system is inadequate for use.
The examiner respectfully disagrees.
Gaynor need not show the need in order for there motivation to be motivation to combine. The applicant does not specifically show any teaching against said motivation of adding an O-ring to allow the user to individual stretch each aperture and furthermore, stretch them apart when the device is stretched open to be removed from a finger or digit (see [0065] of Brackett).
As such the rejection of the claims will be maintained.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “wherein the first aperture and the second aperture extend in a plane about parallel to the longitudinal axis of the flexible body” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-5 and 7-8 are 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.
The claimed language “wherein the first aperture and the second aperture extend in a plane about parallel to the longitudinal axis of the flexible body”.
The definition of parallel according to the online Merriam-Webster dictionary is "extending in the same direction, everywhere equidistant, and not meeting or everywhere equally distant". In both cases, the definition is not met. As clearly shown in Fig. 3 (see annotated Fig. 3 of applicant’s patent application publication below, marked for clarity), the planes of the apertures, are not parallel as they intersect, hence touch, with the longitudinal axis 12a. Furthermore, there is not adequate support for the language in the applicant's written specification. Appropriate correction is required.
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Claims 2-4 and 7-8 are rejected as being dependent on claim 1.
Claim Rejections - 35 USC § 102
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) 1, 4-5, and 7-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gaynor et al (US 20110092985 A1), herein referenced to as “Gaynor”.
Claim 1
Gaynor discloses: A surgical construct for suture retention and finger protection 352 (see Figs. 11-13, [0062], attachable to finger, which would cover hence protect a portion of the finger and suture assembly), comprising: a flexible body the body of 352 (see Figs. 11-13, [0062] and [0072], 352 is molded from plastic, a form of plastic is disclosed as silicone, and according to the applicant, see [0018] of applicant’s patent application publication, silicone is a flexible material) with an elongated configuration has a generally elongate configuration (see Fig. 13), a longitudinal axis the longitudinal axis that runs through the openings of the ring of 352 (see annotated Fig. 13 below), a proximal end the proximal end of 352 at one end defined by 390 and 392 (see Fig. 13), and a distal end the distal end of 352 defined at an end opposite to the proximal end defined by 390 and 392 (see Fig. 13); and a first aperture a first aperture of 352 located at the proximal end (see annotated Fig. 13 below) located at the proximal end, and a second aperture a second aperture of 352 located at the proximal end (see annotated Fig. 13 below) located at the distal end, wherein the first aperture a first aperture of 352 located at the proximal end (see annotated Fig. 13 below) and the second aperture a second aperture of 352 located at the proximal end (see annotated Fig. 13 below) extend in a plane about parallel (see annotated Fig. 13 below) to the longitudinal axis the longitudinal axis that runs through the openings of the ring of 352 (see annotated Fig. 13 below) of the flexible body the flexible body 352, and wherein a portion the portion of 352 between the two apertures (see Fig. 13) of the flexible body the body of 352 extending between the first aperture a first aperture of 352 located at the proximal end (see annotated Fig. 13 below) and the second aperture a second aperture of 352 located at the proximal end (see annotated Fig. 13 below) is configured to rest on a ventral surface of a finger, and wherein at least one of the first aperture a first aperture of 352 located at the proximal end (see annotated Fig. 13 below and see Figs. 11-12C, the proximal aperture can have the shaft 360 + delivery head 364 run through it, which can act as an handle which a surgeon can grab when maneuvering the insertion tool 354) and the second aperture a second aperture of 352 located at the proximal end (see annotated Fig. 13 below and see Figs. 11-12C, the distal aperture can have the shaft 360 + delivery head 364 run through it, which can act as an handle which a surgeon can grab when maneuvering the insertion tool 354) is configured to engage a handle of an insertion tool and to retain a flexible strand 380 (see Figs. 11-12C, [0064], a suture line is a flexible strand) on the insertion tool.
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The language, "wherein a portion of the flexible body extending between the first aperture and the second aperture is configured to rest on a ventral surface of a finger, and wherein at least one of the first aperture and the second aperture is configured to engage a handle of an insertion tool and to retain a flexible strand on the insertion tool," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The Office submits that the device of Gaynor meets the structural limitations of the claim, and is capable of having a portion of the flexible body between the first and second apertures to rest on a ventral surface of a finger when slid over the finger, similar to as shown in Fig. 14. Furthermore, an aperture could engage a handle of an insertion tool as it is an opening that can fit a finger as well and threading a flexible strand through the apertures, which can be tied around an aperture to retain the flexible strand on the insertion tool.
Claim 4
Gaynor discloses: The surgical construct of claim 1, see 102 rejection above. Gaynor further discloses: wherein the flexible body 352 consists essentially of silicone (see [0072], 352 is molded from plastic, a form of plastic is disclosed as silicone).
Claim 5
Gaynor discloses: The surgical construct of claim 1, see 102 rejection above. Gaynor further discloses: wherein the surgical construct 352 is disposable (see [0037], sterile disposable surgical instruments).
Claim 7
Gaynor discloses: The surgical construct of claim 1, see 102 rejection above. Gaynor further discloses: wherein the insertion tool 354 is an inserter for a tensionable suture anchor (see Figs. 12A-12C, [0065]-[0068] and [0071], the capsule is a suture anchor, and the suture can be pulled which tensions it through tissue).
Claim 8
Gaynor discloses: The surgical construct of claim 1, see 102 rejection above. Gaynor further discloses: wherein the flexible strand 380 is high-strength suture (see Figs. 11-12C, [0064], suture, per applicant’s definition of “high-strength suture”, see applicant’s patent application publication [0030], is “any elongated flexible member”, which a suture meets the definition of).
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.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaynor in view of Brackett et al (US 20080275499 A1), herein referenced to as “Brackett”.
Claim 2
Gaynor discloses: The surgical construct of claim 1, see 102 rejection above. Gaynor does not explicitly disclose: wherein at least one of the first aperture and the second aperture is an O-ring configured to attach to the handle of the insertion tool.
However, Brackett in a similar field of invention teaches a surgical construct 10 for finger protection (see Fig. 7, can be put onto a finger, hence covers a portion of a finger and would protect said portion of covered finger) with a first and second aperture (see Figs. 1-6, the apertures on both side of the device for a finger to fit through defined by the first and second layers, see [0067]). Brackett further teaches: wherein at least one of the first aperture and the second aperture the first and second apertures defined by the first and second layers (see [0067]) is an O-ring (see [0067], the first and second layers that define the apertures, are O-rings).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gaynor to incorporate the teachings of Brackett and teach a surgical construct with at least one of the first aperture and the second aperture is an O-ring. Motivation for such can be found in Brackett as this allows the user to individual stretch each aperture and furthermore, stretch them apart when the device is stretched open to be removed from a finger or digit (see [0065]).
The language, " configured to attach to the handle of the insertion tool," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combination device of Gaynor and Brackett meets the structural limitations of the claim, and is capable of the O-rings attaching to a handle of an insertion tool, as the flexible O-rings could fit a handle roughly the size of a finger of an insertion tool, of which, suture tensioning device typically have elongate handles roughly the thickness, or thinner, of a finger (see Fig. 6C of Gaynor as an example of the comparative width of a finger to a general suture insertion tool).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gaynor in view of Pfotenhauer et al (US 20200069298 A1), herein referenced to as “Pfotenhauer”.
Claim 3
Gaynor discloses: The surgical construct of claim 1, see 102 rejection above. Gaynor does not explicitly disclose: wherein the first aperture has a diameter larger than the diameter of the second aperture, to accommodate the finger.
However, Pfotenhauer in a similar field of invention teaches a surgical construct 100 (see Figs. 1A-2J) for attachment to a surgical device (see Fig. 1A) with a first aperture 124a (see Figs. 2A-2J) and a second aperture 122a (see Figs. 2A-2J). Pfotenhauer further teaches: wherein the first aperture 124a has a diameter the diameter of 124a (see Figs. 2A-2B, [0050], the opening 124a is larger than 122a, and since they are both circular, the diameter of 124a is larger than that of 122a) larger than the diameter the diameter of 122a (see Figs. 2A-2B, [0050]) of the second aperture 122a.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Gaynor to incorporate the teachings of Pfotenhauer and teach a surgical construct with the first aperture has a diameter larger than the diameter of the second aperture. Motivation for such can be found in Pfotenhauer as this can allow a bushing for a locking mechanism to be accommodated within the surgical construct (see [0050] and [0053]), which would assist in securing the surgical construct to a surgical tool.
The language, "to accommodate the finger," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the combined device of Gaynor and Pfotenhauer meets the structural limitations of the claim, and is capable of the aperture accommodating a finger (see [0009], the first recessed portion 150a, includes aperture 124a, is configured to at least partially conform to a finger of a user).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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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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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771