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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/2/2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/3/2025, 11/6/2025, 11/19/2029 and 2/5/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Claim Objections
Applicant’s arguments, see “Remarks”, filed 3/2/2026, with respect to the objection to claim 1 for reciting “insertion of an extend of suture threads” which contained a grammatical error have been fully considered and are persuasive in light of Applicant’s amendment to the claim language to cancel the cited erroneous language. The objection of claim 1 has been withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/138,200, to Locke, in view of Clark (US 2011/0196417 A1)(previously of record).
Regarding claim 1, Locke claims:
A vessel clamping pressure device (see Claim 1, Line 1), comprising:
a pressure applying surface including a first slit there through, wherein the first slit extends through a thickness of the pressure applying surface and extends from a lateral edge of the pressure applying surface toward a central portion of the pressure applying surface, the pressure applying surface being configured to be applied facing the skin of a patient at a site of a wound closure (see Claim 1, Lines 2-6);
a support structure coupled to the pressure applying surface, the support structure comprising a hollow portion and a second slit there through (see Claim 1, Lines 7-8), wherein the second slit is aligned with the first slit (see Claim 1, Lines 24-25), wherein the second slit extends through the support structure from a first end of the support structure coupled to the pressure applying surface to a second end of the support structure opposed to the first end, and wherein the second slit is open along a lateral side thereof that extends between the first end and the second end (see Claim 1, Lines 7-13); and
a spindle positioned within the hollow portion of the support structure (see Claim 1, Lines 20-21), wherein the spindle is configured to rotate within the hollow portion about a longitudinal axis of the spindle and includes a third slit there through (see Claim 1, Lines 20-26), wherein the third slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Claim 10);
wherein the third slit is selectively alignable with the first and second slits by rotation to a first rotation angle of the spindle to allow insertion of suture threads into the first, second, and third slits and misalignable by rotation to a second rotation angle of the spindle to bind the suture threads between the support structure and the spindle to maintain tension on the suture threads (see Claim 1, Lines 20-26).
However, Locke does not expressly claim a cushioning material secured to the pressure applying surface on one side and having an opposed side configured to be applied to the skin of the patient.
In the same field of endeavor, namely wound closure devices, Clark teaches wherein a wound closure device (see Figs. 6) comprising tissue-contacting surfaces (footplate 22, see Fig. 6), wherein the tissue-contacting surface comprises one or more adhesive pads (pads 32, see Fig. 6) which adhere to the surface of the skin during use of the device to prevent the device from shifting position on the skin while in use (see Para. [0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pressure applying surface of Locke to comprise one or more adhesive pads thereon as taught and suggested by Clark to, in this case, adhere to the surface of the tissue to prevent the device of Locke from shifting position while in use (see Clark Para. [0037]).
Claim 1 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of copending Application No. 18/079,457, to Locke (hereinafter, Locke2), in view of Clark (US 2011/0196417 A1)(previously of record).
Regarding claim 1, Locke2 claims:
A vessel clamping pressure device (see Claim 1, Line 1), comprising:
a pressure applying surface including a first slit there through (see Claim 1, Line 1), wherein the first slit extends through a thickness of the pressure applying surface and extends from a lateral edge of the pressure applying surface toward a central portion of the pressure applying surface (see Claim 1, Lines 2-5), the pressure applying surface being configured to be applied facing the skin of a patient at a site of a wound closure (see Claim 1, Lines 5-6);
a support structure coupled to the pressure applying surface (see Claim 1, Line 7), the support structure comprising a hollow portion and a second slit there through (see Claim 1, Lines 7-8), wherein the second slit is aligned with the first slit (see Claim 1, Lines 21-22 mentioning wherein the support structure slit and pressure applying surface slit are aligned with one-another), wherein the second slit extends through the support structure from a first end of the support structure coupled to the pressure applying surface to a second end of the support structure opposed to the first end (see Claim 1, Lines 9-12), and wherein the second slit is open along a lateral side thereof that extends between the first end and the second end (see Claim 1, Lines 12-13); and
a spindle positioned within the hollow portion of the support structure (see Claim 1, Line 17), wherein the spindle is configured to rotate within the hollow portion about a longitudinal axis of the spindle and includes a third slit there through, wherein the third slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Claim 1, Lines 17-20);
wherein the third slit is selectively alignable with the first and second slits by rotation to a first rotation angle of the spindle to allow insertion of suture threads into the first, second, and third slits and misalignable by rotation to a second rotation angle of the spindle to bind the suture threads between the support structure and the spindle to maintain tension on the suture threads (see Claim 1, Lines 21-25).
However, Locke does not expressly claim a cushioning material secured to the pressure applying surface on one side and having an opposed side configured to be applied to the skin of the patient.
In the same field of endeavor, namely wound closure devices, Clark teaches wherein a wound closure device (see Figs. 6) comprising tissue-contacting surfaces (footplate 22, see Fig. 6), wherein the tissue-contacting surface comprises one or more adhesive pads (pads 32, see Fig. 6) which adhere to the surface of the skin during use of the device to prevent the device from shifting position on the skin while in use (see Para. [0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pressure applying surface of Locke to comprise one or more adhesive pads thereon as taught and suggested by Clark to, in this case, adhere to the surface of the tissue to prevent the device of Locke from shifting position while in use (see Clark Para. [0037]).
Claims 1 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 32 of copending Application No. 17/867,205, to Locke (hereinafter, Locke3), in view of Clark (US 2011/0196417 A1)(previously of record).
Regarding claim 1, Locke3 claims:
A vessel clamping pressure device (see Claim 32, Line 1), comprising:
a pressure applying surface including a first slit there through, wherein the first slit extends through a thickness of the pressure applying surface and extends from a lateral edge of the pressure applying surface toward a central portion of the pressure applying surface (see Claim 32, Lines 2-9), the pressure applying surface being configured to be applied facing the skin of a patient at a site of a wound closure (see Claim 32, Lines 2-3);
a support structure coupled to the pressure applying surface (see Claim 32, Line 10) the support structure comprising a hollow portion and a second slit there through (see Claim 32, Lines 10-15 and 17-18 mentioning wherein a spindle is received within the central shaft, understood to be within a “hollow portion” thereof), wherein the second slit is aligned with the first slit (see Claim 32, Lines 20-23), wherein the second slit extends through the support structure from a first end of the support structure coupled to the pressure applying surface to a second end of the support structure opposed to the first end (see Claim 32, Lines 13-15), and wherein the second slit is open along a lateral side thereof that extends between the first end and the second end (see Claim 32, Lines 13-15); and
a spindle positioned within the hollow portion of the support structure (see Claim 32, Line 17), wherein the spindle is configured to rotate within the hollow portion about a longitudinal axis of the spindle and includes a third slit there through, wherein the third slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Claim 32, Lines 17-25);
wherein the third slit is selectively alignable with the first and second slits by rotation to a first rotation angle of the spindle to allow insertion of suture threads into the first, second, and third slits and misalignable by rotation to a second rotation angle of the spindle to bind the suture threads between the support structure and the spindle to maintain tension on the suture threads (see Claim 32, Lines 17-25).
However, Locke does not expressly claim a cushioning material secured to the pressure applying surface on one side and having an opposed side configured to be applied to the skin of the patient.
In the same field of endeavor, namely wound closure devices, Clark teaches wherein a wound closure device (see Figs. 6) comprising tissue-contacting surfaces (footplate 22, see Fig. 6), wherein the tissue-contacting surface comprises one or more adhesive pads (pads 32, see Fig. 6) which adhere to the surface of the skin during use of the device to prevent the device from shifting position on the skin while in use (see Para. [0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pressure applying surface of Locke to comprise one or more adhesive pads thereon as taught and suggested by Clark to, in this case, adhere to the surface of the tissue to prevent the device of Locke from shifting position while in use (see Clark Para. [0037]).
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claim 1 is conditionally allowable over the prior art of record pending resolution to the above non-statutory double patent rejections for the same reasons as co-pending applications 18/079,457, 17/867,205 and 18/138,200.
Regarding claim 1, the closest prior art of record, namely Ashland (US 2011/0152889 A1)(previously of record) discloses:
A vessel clamping pressure device (see Fig. 6), comprising:
a pressure applying surface (face 16, see Fig. 1 and 5, see also Para. [0021] and [0028]-[0030]) including a first slit there through (opening 34, see Fig. 1), wherein the first slit extends through a thickness of the pressure applying surface and extends from a lateral edge of the pressure applying surface toward a central portion of the pressure applying surface (see Figs. 1-6), the pressure applying surface being configured to be applied facing the skin of a patient at a site of a wound closure (see Para. [0021] and [0028]-[0030]);
a support structure (body 14, see Fig. 1) coupled to the pressure applying surface (see Fig. 1) the support structure comprising a hollow portion and a second slit there through (suture channel 32, see Figs. 3-5), wherein the second slit is aligned with the first slit (see Figs. 3-5), wherein the second slit extends through the support structure from a first end of the support structure coupled to the pressure applying surface to a second end of the support structure opposed to the first end (see Figs. 3-5 showing wherein the suture channel extends between faces 16 and 18 on opposing sides of the body);
a spindle (plunger 44, see Fig. 1) positioned within the hollow portion of the support structure (see Figs. 1-6), the spindle includes a third slit there through (opening 64, see Figs. 1-6), wherein the third slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Figs. 1-6).
However, while Ashland discloses wherein the sutures may be maintained under tension (see
Para. [0010]), Ashland does not expressly disclose:
a cushioning material secured to the pressure applying surface on one side and having an opposed side configured to be applied to the skin of the patient;
wherein the spindle is configured to rotate within the hollow portion about a longitudinal axis of the spindle;
wherein the third slit is selectively alignable with the first and second slits by rotation to a first rotation angle of the spindle to allow insertion of suture threads into the first, second, and third slits and misalignable by rotation to a second rotation angle of the spindle to bind the suture threads between the support structure and the spindle to maintain tension on the suture threads (see Claim 32, Lines 17-25); and
wherein the second slit is open along a lateral side thereof that extends between the first end and the second end.
In the same field of endeavor, namely wound closure devices, Clark (US 2011/0196417 A1)(previously of record) teaches wherein a wound closure device (see Figs. 6) comprising tissue-contacting surfaces (footplate 22, see Fig. 6), wherein the tissue-contacting surface comprises one or more adhesive pads (pads 32, see Fig. 6) which adhere to the surface of the skin during use of the device to prevent the device from shifting position on the skin while in use (see Para. [0037]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pressure applying surface of Ashland to comprise one or more adhesive pads thereon as taught and suggested by Clark to, in this case, adhere to the surface of the tissue to prevent the device of Ashland from shifting position while in use (see Clark Para. [0037]).
in the same field of endeavor, namely suturing devices configured to repair an incision or wound in a patient, Bonutti (US 2018/0368826 A1)(previously of record) teaches a mechanism for placing a suture under desired tension comprising a rotatable spindle (member 14, see Fig. 1) comprising a pair of apertures configured to receive a suture therethrough (see Figs. 1-2 and Para. [0049]-[0050]), wherein the spindle is configured to rotate from a first rotational position to a second rotational position, causing the suture disposed through the respective apertures to wind around the spindle and place the suture under a desired amount of tension (see Para. [0050]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the plunger of Ashland to be rotatable relative to the body of the device as taught and suggested by Bonutti to, in this case, provide a known method of placing the sutures under a desired amount of tension before locking the suture at said desired amount of tension (see Bonutti Para. [0050]). The “first rotational position” in defined to be an initial, suture receiving position (see Ashland Fig. 4) to allow the suture to be received by the plunger while the “second rotational position” is defined to be a rotational position in which the opening 64 of the plunger is rotational offset from the hole 34 of the body during a tensioning/winding of the suture, as taught and suggested by Bonutti). Wherein, in the “first rotational position” (see Ashland Fig. 4), the suture threads are insertable through all of the opening 34, well 68, opening 64 (see Ashland Figs. 4 and Para. [0027]-[0028]), wherein in the “second rotational position (see Ashland Fig. 5), the opening 64 becomes misaligned with the opening 34 and well 68 (see Ashland Fig. 5). Since Ashland discloses wherein the suture are “maintained” at a desired tension but does not provide description as to how this tension is placed on the suture, one of ordinary skill would have looked at similar device and structure within the same field of endeavor for methods of placing the suture under tension before locking the suture in place, as said tension.
However, none of the prior art of record, including Ashland, expressly discloses the amended
limitations of “wherein the second structure slit is open along a lateral side thereof that extends
between the first end and the second end”.
The slit of the support structure of Ashland (suture channel 32), while extending through the
support structure (body 14) from the pressure applying surface (face 16) to a second surface opposite
the pressure applying surface (face 18), the slit of the support structure of Ashland is not “open along a
lateral side of the support structure that extends between the first side to the second side thereof” since
the suture channel of Ashland is enclosed within the body. It would not have been obvious to one of ordinary skill in the art to have modified the suture channel of Ashland to be open along a lateral side of
the body without an express teaching from the prior art as such a modification would require a
substantial alteration to the structure of the device without and express benefit or purpose.
Additionally, making the suture channel of Ashland “open” along a side of the body would likely require
substantial testing to ensure the suture pinching mechanism performed by the spindle (plunger 44)
remained functional without allowing the suture to slip out from the body of the device along the
opening within the lateral surface thereof.
Claims 2-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
While the combination of Locke (Appl. 18/138,200, 17/867,205 and 18/079,457), in combination with Clark claim and teach the limitations of claims 1 and 2, none of the combination expressly discloses or suggests the limitations of claims 3-11 which further modify the structure, size, shape and location of the cushioning material. While it is known in the art to modify the location, size and shape of cushioning materials for a pressure applicator device (see for example Beto (US 2006/0095073) and Ebard (US 5425705 A), previously cited in the Final Office Action, dated 11/5/2025), it would not have been obvious to have modified the teaching reference of Clark, before incorporation into the co-pending applications without impermissible hindsight as none of either the co-pending applications, or Clark suggest the additional modifying limitations without additional modifying references to achieve the resulting claimed invention.
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 20070288040 A1 to Ferree, US 2016/0000554 A1 to Woo and US 20080167519 A1 to St-Germain all disclose pressure applicator devices utilizing sutures.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached on 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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