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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 6/25/2025 and 8/21/2025 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
Applicant's arguments filed 9/24/2025 with regards to the amended limitations of “wherein the third slit is selectively alignable with the first and second slits by rotation of to a first rotation angle of the spindle to allow insertion of an extend of suture threads laterally into the first, second and third slit” have been considered but are not persuasive.
In regards to wherein the suture threads of Ashland are configured to be “inserted into the first, second and third slits laterally”, the Examiner notes that Applicant has not defined a relative focal point for the term “laterally” (i.e., laterally relative to “X”). As Bonutti discloses wherein the plunger of Ashland may be rotatable (as previously cited), Ashland’s “first rotation angle” has been defined to be the configuration shown in Ashland Fig. 4 in which the opening 34, well 68 and opening 64 are all aligned and configured to receive the suture therein (see also Ashland Para. [0027]-[0028]). Looking to Fig. 4, the suture is inserted laterally (i.e., sideways) through each of the three openings. Further, as modified by Bonutti, the plunger is configured to be rotate to misalign opening 64 relative to opening 34 and well 68, resulting in a binding of the suture thread to produce tension therein, as previously discussed. Therefore, the combination of Ashland and Bonutti are understood to read on the current claim language, as amended, until further limitations are incorporated into the claims to prevent such an interpretation.
Claim Objections
Applicant has filed arguments, see “Remarks”, filed 9/24/2025, with respect to:
The objection to claim 2 for reciting, “cushion application of the pressure applying surface the patient” which included a typographical error in the indicated phrase.
The objection to claim 4 for reciting, “wherein the cushioning material covers has a thickness” which included a typographical error in the indicated phrase.
The objection to claim 5 for reciting, “wherein the cushioning material covers has a thickness” which included a typographical error in the indicated phrase.
The objection to claim 10 for reciting, “wherein the cushioning material comprises a silicon material” while the specification only discloses the use of silicone as a material for the cushioning”
Applicant’s arguments have been fully considered and are persuasive in light of Applicant’s amendment to correct all of the above typographical errors. The objections to claims 2, 4, 5 and 10 have been withdrawn.
Claim Objections
Claim 1 is objected to the for the follow informalities:
Claim 1 recites, “ …insertion of an extend of suture threads…” which contains a grammatical error in the recitation of “extend of suture threads”.
Appropriate correction is required.
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.
Claim(s) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ashland (US 2011/0152889 A1)(previously of record) in view of Bonutti (US 2018/0368826 A1)(previously of record), further in view of Clark (US 2011/0196417 A1)(previously of record).
Regarding claim 1, Ashland 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 (opening 34, see Fig. 1) there through, the pressure applying surface being configured to be applied facing the skin of a patient at a site of a wound closure (see Figs. 4-5 and 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 (suture channel 32, see Figs. 1-5) and a second slit (well 68, see Figs. 4-5) there through, wherein the second slit is aligned with the first slit (see Fig. 3 and Para. [0027]-[0031]);
a spindle (plunger 44, see Fig. 1) positioned within the hollow portion of the support structure (see Figs. 4-5 and Para. [0027]-[0030]) and includes a third slit there through (opening 64, see Figs. 1-5).
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; and
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 an extend of suture threads laterally 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.
However, in the same field of endeavor, namely suturing devices configured to repair an incision or wound in a patient, Bonutti 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.
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 tissue-contacting face (16) 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]).
Regarding claim 2, the combination of Ashland, Bonutti and Clark disclose the invention of claim 1, Ashland, as modified by Clark, further discloses wherein the cushioning material includes a third slit therethrough that is aligned with the first and second slits (once incorporated onto the face 16 of Ashland, the adhesive pads would comprise a “third slit” therethrough allowing passage of a suture through the opening 34 and well 68 so as not to occlude the suture-passing channel. The resulting “third slit” would be aligned with opening 34 and the portion of well 68 that extends along the same longitudinal axis as opening 34).
Regarding claim 3, the combination of Ashland, Bonutti and Clark disclose the invention of claim 1, Ashland, as modified by Clark, further discloses wherein the cushioning material covers substantially all of patient-facing side of the pressure applying surface (see Clark Fig. 6 showing wherein the adhesive pad covers the entirety of each foot plate (22), seen to keep this configuration when incorporated into the device of Ashland. Further, Clark discloses wherein the size of the adhesive pad may be altered or changed to best accommodate the wound site and/or part of the body to which the device is being applied, allowing a user to easily modify the size of the pad as a matter of obviousness based on the needs and/or intended use area).
Regarding claim 4, the combination of Ashland, Bonutti and Clark disclose all of the limitations of the invention of claim 3.
However, while Clark discloses wherein the size of the pads, as incorporated into the device of Ashland, may change size and/or shape depending on the desired tissue and/or the size and shape of the wound size as a matter of obviousness, none of either Ashland or Clark expressly disclose wherein the cushioning material has a thickness in a range between 1 and 5 millimeters.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the pads of Clark, as incorporated into the device of Ashland, to have a thickness ranging from 1 millimeter and 5 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the pads of Clark, as incorporated into the device of Ashland, would not operate differently with the claimed thickness range and since both devices are intended to be used to heal a wound site, coupled with the disclosure of Clark indicating it to be obvious to “optimize” the dimensions and size of the pads to best suit the needs of the intended target area and/or the size of the closure device, closure device of Ashland would function appropriately with the pads of Clark having the claimed thickness parameters. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “may” be within the claimed ranges (see Specification Para. [0090]-[0091]).
Regarding claim 5, the combination of Ashland, Bonutti and Clark disclose all of the limitations of the invention of claim 3.
However, while Clark discloses wherein the size of the pads, as incorporated into the device of Ashland, may change size and/or shape depending on the desired tissue and/or the size and shape of the wound size as a matter of obviousness, none of either Ashland or Clark expressly disclose wherein the cushioning material has a thickness in a range between 2 and 3 millimeters.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the pads of Clark, as incorporated into the device of Ashland, to have a thickness ranging from 2 millimeter and 3 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the pads of Clark, as incorporated into the device of Ashland, would not operate differently with the claimed thickness range and since both devices are intended to be used to heal a wound site, coupled with the disclosure of Clark indicating it to be obvious to “optimize” the dimensions and size of the pads to best suit the needs of the intended target area and/or the size of the closure device, closure device of Ashland would function appropriately with the pads of Clark having the claimed thickness parameters. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “may” be within the claimed ranges (see Specification Para. [0090]-[0091]).
Regarding claim 6, the combination of Ashland, Bonutti and Clark disclose the invention of claim 1, Ashland, as modified by Clark, further discloses wherein the pressure applying surface includes a ribbon or strip of cushioning material positioned adjacent to an outer perimeter portion of the pressure applying surface that is configured to cushion application of the pressure applying surface the patient (adhesive pads of Clark, as incorporated into the device of Ashland, are positioned adjacent a tissue-contacting surface of the device, see Clark Fig. 6 – the pads covering the surface of the tissue-contacting surface constituting a “strip” of material unless otherwise further defined or limited).
Regarding claim 7, the combination of Ashland, Bonutti and Clark disclose all of the limitations of the invention of claim 6.
However, while Clark discloses wherein the size of the pads, as incorporated into the device of Ashland, may change size and/or shape depending on the desired tissue and/or the size and shape of the wound size as a matter of obviousness, none of either Ashland or Clark expressly wherein the ribbon or strip of cushioning material positioned adjacent to the outer perimeter portion of the pressure applying surface has a radial width between 2 and 5 millimeters and a thickness between 2 and 6 millimeters.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the pads of Clark, as incorporated into the device of Ashland, to have a radial width between 2 and 5 millimeters and thickness ranging from 2 to 6 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the pads of Clark, as incorporated into the device of Ashland, would not operate differently with the claimed radial width and thickness ranges since both devices are intended to be used to heal a wound site, coupled with the disclosure of Clark indicating it to be obvious to “optimize” the dimensions and size of the pads to best suit the needs of the intended target area and/or the size of the closure device, closure device of Ashland would function appropriately with the pads of Clark having the claimed thickness parameters. This is additional supported by the disclosure of Clark indicating the pads, no matter the resulting sizing, would achieve the result of preventing movement of the closure device since the pads are coated in an adhesive. Therefore, so long as the pads are present in some form, the disclosed benefits would remain applicable unless otherwise limited by the disclosure of Clark. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “may” be within the claimed ranges (see Specification Para. [0090]-[0091]).
Regarding claim 8, the combination of Ashland, Bonutti and Clark disclose all of the limitations of the invention of claim 6.
However, while Clark discloses wherein the size of the pads, as incorporated into the device of Ashland, may change size and/or shape depending on the desired tissue and/or the size and shape of the wound size as a matter of obviousness, none of either Ashland or Clark expressly wherein the ribbon or strip of cushioning material positioned adjacent to the outer perimeter portion of the pressure applying surface has a radial width of approximately 3 millimeters and a thickness between 2 and 3 millimeters.
However, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to cause the pads of Clark, as incorporated into the device of Ashland, to have a radial width of approximately 3 millimeters and thickness ranging from 2 to 3 millimeters since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the pads of Clark, as incorporated into the device of Ashland, would not operate differently with the claimed radial width and thickness ranges since both devices are intended to be used to heal a wound site, coupled with the disclosure of Clark indicating it to be obvious to “optimize” the dimensions and size of the pads to best suit the needs of the intended target area and/or the size of the closure device, closure device of Ashland would function appropriately with the pads of Clark having the claimed thickness parameters. This is additional supported by the disclosure of Clark indicating the pads, no matter the resulting sizing, would achieve the result of preventing movement of the closure device since the pads are coated in an adhesive. Therefore, so long as the pads are present in some form, the disclosed benefits would remain applicable unless otherwise limited by the disclosure of Clark. Further, applicant places no criticality on the range claimed, indicating simply that the thickness “may” be within the claimed ranges (see Specification Para. [0090]-[0091]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ashland (US 2011/0152889 A1) in view of Bonutti (US 2018/0368826 A1), further in view of Clark (US 2011/0196417 A1), further in view of Beto (US 2006/0095073 A1).
Regarding claim 9, the combination of Ashland, Bonutti and Clark disclose all of the limitations of the invention of claim 1.
However, Clark does not expressly disclose a material used to form the pads, as incorporated into the device of Ashland and thus does not expressly disclose wherein the cushioning material is transparent.
However, in the related field of endeavor of arterial pressure-applying devices, Beto teaches wherein using a transparent material for pressure-applicator pads allows a user to more easily and precisely place the device over the wound site (see Para. [0029]).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the pad of Clark, as incorporated into the device of Ashland, to be formed from a transparent material as taught and suggested by Beto to, in this case, allow a user to more easily and precisely place the device over the wound site (see Beto Para. [0029]).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ashland (US 2011/0152889 A1) in view of Bonutti (US 2018/0368826 A1), further in view of Clark (US 2011/0196417 A1), further in view of Evard (US 5425705 A).
Regarding claim 10, the combination of Ashland, Bonutti and Clark disclose all of the limitations of the invention of claim 1.
However, Clark does not expressly disclose a material used to form the pads, as incorporated into the device of Ashland and thus does not expressly disclose wherein the cushioning material comprises a silicone material.
In a similar field of endeavor, namely arterial compression devices, Evard teaches wherein tissue-contacting surfaces (jaws 82, 84) comprise pads thereon (see Col. 7, Lines 40-48 and Col. 8, Lines 50-55) that are formed from silicone which reduces trauma to the contact portions of tissue (see Col. 7, Lines 40-48 and Col. 8, Lines 50-55).
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 pads of Clark, as incorporated into the device of Ashland, to be formed from silicone as taught and suggested by Evard to, in this case, reduce trauma cause to the tissue contacted by the pads (see Evard Col. 7, Lines 40-48 and Col. 8, Lines 50-55).
Regarding claim 11, the combination of Ashland, Bonutti and Clark disclose all of the limitations of the invention of claim 1.
However, Clark does not expressly disclose a material used to form the pads, as incorporated into the device of Ashland and thus does not expressly disclose wherein the cushioning material is selected from the group comprising rubber, foam, silk, viscose rayon, polyester, nylon, polyvinyl chloride, paper, and sheep skin.
In a similar field of endeavor, namely arterial compression devices, Evard teaches wherein tissue-contacting surfaces (jaws 82, 84) comprise pads thereon (see Col. 7, Lines 40-48 and Col. 8, Lines 50-55) that are formed from silicone which reduces trauma to the contact portions of tissue (see Col. 7, Lines 40-48 and Col. 8, Lines 50-55 – Silicone is a type of rubber (i.e., an elastomer)).
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 pads of Clark, as incorporated into the device of Ashland, to be formed from silicone as taught and suggested by Evard to, in this case, reduce trauma cause to the tissue contacted by the pads (see Evard Col. 7, Lines 40-48 and Col. 8, Lines 50-55).
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 2003/0229361 A1 to Jackson, US 7867253 B2 to McMichael, US 9636106 B2 to Meier and US 20050096699 A1 to Wixey all disclose wound closure devices comprising a pressure-applying surface having either a transparent or silicone material.
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 MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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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