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 have been fully considered but they are not persuasive.
Specifically, Applicant contends that none of either Ashland or Bonutti expressly disclose the amended limitations of “a pressure applying surface including a surface slit thereon on a peripheral edge thereof, wherein the pressure applying surface is coupled to the support structure and its wider than the support structure and the surface slit aligns with the support structure slit”. The Examiner respectfully disagrees. As provided in the rejection below, Ashland discloses a pressure applying surface (face 16, see Fig. 1 and 5, see also Para. [0021] and [0030]) that includes a surface slit (opening 34, see Fig. 1) on a peripheral edge thereof (see Figs. 1 and 5 showing wherein opening 34 is located on an exterior periphery of the face). Therefore, Ashland is seen to disclose the amended limitations recited above until further amendments are incorporated into the claim to overcome the current interpretation.
Additionally, Applicant contends that none of either Ashland or Bonutti expressly disclose the amended limitations of “inserting the lateral side of the suture threads includes inserting the lateral side through a first of the slits in a portion of the pressure applying surface that is wider than the support structure and a second of the slits in the support structure”. The examiner respectfully disagrees. Firstly, Ashland appears to expressly disclose a second slit in the support structure (suture channel 32, see Figs. 3-5) that is configured to receive a suture thread therethrough (see Figs. 3-5 and Ashland Para. [0027]-[0028]). Regarding wherein a “lateral side” of the suture thread is inserted through the second slit, the Examiner notes that an entire longitudinal length of suture thread is inserted through all three slits (i.e., 34, 64 and 32/36) as shown in Figs. 3-5 and Para. [0027]-[0028] of Ashland. Inserting a length of suture through the three slits includes inserting a lateral side of the thread, since a thread exists in three-dimensions and thus comprises a lateral side along all portions of the length thereof.
Lastly, regarding the limitation of “wherein the pressure applying surface is wider than the support body”, while Ashland does not expressly disclose the cited limitation, Ashland does provide a teaching of wherein each face of the body may define various shapes and comprise a width of between 5mm to 50mm (see Para. [0020]).
The examiner therefore contends that 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 width of the body faces of Ashland to have the tissue- contacting face (face 16) comprise a width within the disclosed range that is greater than the width of the other faces along the body as Applicant appears to have placed no criticality on the claimed relative dimensions and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the Examiner is not able to find a mentioning within the disclosed specification pertaining to the relative width dimensions as claimed, instead appearing to rely solely on the disclosed drawings to show this claimed feature, indicating a lack of criticality to the functioning or problem-solving ability of the claimed width limitation.
Claim Objections
Applicant’s arguments, see “Remarks”, filed 9/24/2025, with respect to the objection to claim 6 for reciting, “extending the suture threads an entrance incision in the patient” which contained a typographical error have been fully considered and are persuasive in light of Applicant’s recent amendment to correct the previously-mentioned typographical error. The objection of claim 6 has been withdrawn.
Claim Rejections - 35 USC § 112
Applicant’s arguments, see “Remarks”, filed 9/24/2025, with respect to the 112(a) rejection of claim 4 for reciting “the support structure and spindle are configured so that the spindle can be rotated only through approximately 180 degrees” which lacked written support within the specification as to a mechanism that would prevent a user from rotating said spindle beyond 180 degrees have been fully considered and are persuasive in light of Applicant’s recent amendment to remove the previously-recited limitations. The 112(a) rejection of claim 4 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 9/24/2025, with respect to the 112(a) rejection of claim 5 for reciting “the support structure and spindle are configured so that the spindle can be rotated only through approximately 90 degrees” which lacked written support within the specification as to a mechanism that would prevent a user from rotating said spindle beyond 90 degrees have been fully considered and are persuasive in light of Applicant’s recent amendment to remove the previously-recited limitations. The 112(a) rejection of claim 4 has been withdrawn.
Applicant’s arguments, see “Remarks”, filed 9/24/2025, with respect to the 112(b) rejection of claim 6 for reciting, “after a sufficient period of time” without providing any context for what timeframe this would correspond to have been fully considered and are persuasive in light of Applicant’s recent amendment to remove this limitation from the claim. The 112(b) rejection of claim 6, and all claims dependent therefrom, has been withdrawn.
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, 4-5 and 18-19 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).
Regarding claim 1, Ashland discloses:
A vessel clamping pressure device (see Fig. 1), comprising:
a pressure applying surface (face 16, see Fig. 1 and 5, see also Para. [0021] and [0030]) including a surface slit (opening 34, see Fig. 1) on a peripheral edge thereof (see Figs. 1 and 5 showing wherein opening 34 is located on an exterior periphery of the face);
a support structure (body 14, see Fig. 1) comprising a support structure slit (suture channel 32, see Figs. 3-5) and a hollow portion (well 68, see Figs. 3-5), wherein the support structure slit extends completely through a portion of the support structure (see Figs. 3-5);
wherein the pressure applying surface is coupled to the support structure (see Fig. 1) and the surface slit aligns with the support structure slit (see Fig. 4 and Para. [0027]-[0028]);
a spindle (plunger 44, see Fig. 6) positioned within the hollow portion of the support structure (see Figs. 4-5 and Para. [0027]-[0031]), wherein the spindle includes a spindle slit (opening 64, see Fig. 6) through which suture threads can be passed (see Para. [0027]).
However, while Ashland discloses wherein the sutures may be maintained under tension (see Para. [0010]) and wherein each face of the body may define various shapes and comprise a width of between 5mm to 50mm (see Para. [0020]), Ashland does not expressly disclose:
wherein the spindle is configured to rotate within the through-hole; and
wherein the pressure applying surface is wider than the support structure
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, 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]). 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.
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 width of the body faces of Ashland to have the tissue-
contacting face (face 16) comprise a width within the disclosed range that is greater than the width of
the other faces along the body as Applicant appears to have placed no criticality on the claimed relative
dimensions and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside
ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the Examiner is not able to find a mentioning within the disclosed specification pertaining
to the relative width dimensions as claimed, instead appearing to rely solely on the disclosed drawings
to show this claimed feature, indicating a lack of criticality to the functioning or problem-solving ability
of the claimed width limitation.
Regarding claim 4, the combination of Ashland and Bonutti disclose the invention of claim 1, Ashland, as modified by Bonutti, further discloses wherein:
the spindle comprises a handle (lever 40, see Fig. 6) configured to rotate the spindle within the hollow portion of the support structure (a user would utilize the lever of Ashland to rotate the plunger, as incorporated from the teachings of Bonutti)
Regarding claim 5, the combination of Ashland and Bonutti disclose the invention of claim 1, Ashland, as modified by Bonutti, further discloses wherein:
the spindle comprises a handle (lever 40, see Fig. 6) on an opposite side of the spindle relative to the spindle slit (see Fig. 6 showing wherein the opening 64 is located at the distal end of the plunger while the lever 40 is located at a proximal end thereof).
Regarding claim 18, the combination of Ashland and Bonutti disclose the invention of claim 1, Ashland further discloses wherein the surface slit includes a tapered cross-section (see Fig. 1 showing wherein opening 34 comprises a tapered cross-section that tapers radially-inwardly from the surface of face 16).
Regarding claim 19, the combination of Ashland and Bonutti disclose the invention of claim 1, Ashland further discloses wherein the support structure slit includes a tapered cross-section (see Fig. 2 showing wherein opening 36 comprises a tapered cross-section that tapers radially-inwardly from the surface of face 18).
Claim(s) 2-3, 12-15 and 17 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 Pandya (US 2018/0055497 A1)(previously of record).
Regarding claim 2, the combination of Ashland and Bonutti disclose all of the limitations of the invention of claim 1.
However, while Ashland discloses wherein the body (14) may be made from “ABS or polypropylene or other material that can be conveniently and economically injection molded in large quantities (see Para. [0020]), Ashland does not expressly disclose wherein the ABS or polypropylene is transparent, resulting in a transparent pressure applying surface.
In the same field of endeavor, namely vasculature would closure devices, Pandya teaches wherein forming surgical equipment from either ABS or polypropylene allows the device to be transparent (see Para. [0035]).
It would have therefore been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of forming the ABS or polypropylene body from the device of Ashland from a transparent variety thereof as disclosed by Pandya. Since both materials are identical between the disclosed devices, one of ordinary skill in the art would have expected the device of Ashland to operate equally well with either an opaque or transparent variety of ABS or polypropylene since both varieties maintain the same structural characteristics and are thus seen to be interchangeable.
Regarding claim 3, the combination of Ashland, Bonutti and Pandya disclose the invention of claim 2, Ashland further discloses wherein the pressure applying surface is flat (see Para. [0019]-[0020] mentioning wherein any of the faces of the body may be made flat).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)), to have obtained the predictable result of having the body (including the tissue contacting surface thereof) be in the form of a shape having a flat tissue-contacting surface since Ashland expressly discloses wherein this shape may be used interchangeably with any of the other disclosed shapes depending on the size and nature of the wound to be operated on (see Para. [0019]-[0021]).
Regarding claim 12, Ashland discloses:
A vessel clamping pressure device (see Fig. 1), comprising:
a support structure (body 14, see Fig. 1) comprising:
a pressure applying surface at one end thereof (face 16, see Figs. 1 and 5, see also Para. [0021] and [0029]-[0030]), wherein the pressure applying surface includes a surface slit (hole 34, see Fig. 1);
a support structure body (body 14, see Fig. 1) that includes a support structure slit (opening 36, see Fig. 2) aligned with the surface slit (see Figs. 3-5 and Para. [0027]-[0028]), wherein the support structure body extends away from the one end of the pressure applying surface to an opposed end (see Fig. 1); and
a hollow portion (well 68, see Figs. 3-5) extending through a side of the support structure other than the pressure applying surface or the opposed end (see Figs. 3-5); and
a spindle positioned within the hollow portion of the support structure (see Figs. 3-5 and Para. [0023] and [0027]), the spindle including a spindle slit therein (opening 64, see Figs. 1 and 6).
However, while Ashland discloses wherein the body (14) may be made from “ABS or polypropylene or other material that can be conveniently and economically injection molded in large quantities (see Para. [0020]), Ashland does not expressly disclose:
Wherein the pressure applying surface is transparent;
wherein the spindle is configured to rotate within the hollow portion between at least a first rotational position and a second rotational position;
wherein in the first rotational position the support structure slit and spindle slit are aligned to receive lateral insertion of a portion of suture thread; and
wherein in the second rotational position the spindle slit is not aligned with the support structure slit such that rotating the spindle from the first rotational position to the second rotational position will bind the portion of the suture thread that is inserted in the spindle slit between the spindle and the support structure.
In the same field of endeavor, namely vasculature would closure devices, Pandya teaches wherein forming surgical equipment from either ABS or polypropylene allows the device to be transparent (see Para. [0035]).
It would have therefore been obvious to one or ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of forming the ABS or polypropylene body from the device of Ashland from a transparent variety thereof as disclosed by Pandya. Since both materials are identical between the disclosed devices, one of ordinary skill in the art would have expected the device of Ashland to operate equally well with either an opaque or transparent variety of ABS or polypropylene since both varieties maintain the same structural characteristics and are thus seen to be interchangeable.
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 within and 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 (see Ashland Para. [0027]-[0028]) 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 (see Ashland Fig. 5 and Para. [0027]-[0028]), as taught and suggested by Bonutti. 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.
Regarding claim 13, the combination of Ashland, Bonutti and Pandya disclose the invention of claim 12.
However, while Ashland discloses wherein each face of the body may define various shapes and comprise a width of between 5mm to 50mm (see Para. [0020]), Ashland does not expressly disclose wherein the pressure applying surface is wider than the support structure body.
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 width of the body faces of Ashland to have the tissue-
contacting face (face 16) comprise a width within the disclosed range that is greater than the width of
the other faces along the body as Applicant appears to have placed no criticality on the claimed relative
dimensions and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside
ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the Examiner is not able to find a mentioning within the disclosed specification pertaining
to the relative width dimensions as claimed, instead appearing to rely solely on the disclosed drawings
to show this claimed feature, indicating a lack of criticality to the functioning or problem-solving ability
of the claimed width limitation.
Regarding claim 14, the combination of Ashland, Bonutti and Pandya disclose the invention of claim 12, Ashland further discloses wherein the surface slit includes a tapered cross-section (see Fig. 1 showing wherein opening 34 comprises a tapered cross-section that tapers radially-inwardly from the surface of face 16).
Regarding claim 15, the combination of Ashland, Bonutti and Pandya disclose the invention of claim 12, Ashland further discloses wherein the support structure slit includes a tapered cross-section (see Fig. 2 showing wherein opening 36 comprises a tapered cross-section that tapers radially-inwardly from the surface of face 18).
Regarding claim 17, the combination of Ashland, Bonutti and Pandya disclose the invention of claim 13, Ashland further discloses wherein the spindle comprises a handle (lever 40, see Fig. 1) extending from the hollow portion (see Figs. 1-2) to facilitate rotation of the spindle between the first rotational position and the second rotational position (a user would rotate lever 40 to cause rotation of the plunger, as modified by Bonutti).
Claim(s) 6 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), further in view of Hathaway (US 5304184 A)(previously of record).
Regarding claim 6, Ashland discloses:
A method of closing an incision in a vascular vessel in a patient, comprising:
closing the incision in the vascular vessel using suture threads (see Para. [0009] and [0029]-[0031]), and extending the suture threads from an entrance incision in the patient (see Para. [0009] and [0029]-[0031] - To suture a wound, the sutures need to enter the tissue at the site of the wound);
inserting a lateral side of the suture threads extending from an entrance incision through slits (opening 34, see Fig. 1; lateral sides of sutures inserted therethrough) in a vessel clamping pressure device (see Fig. 1) comprising:
a pressure applying surface (face 16, see Fig. 1, see also Para. [0009], [0021], [0027] and [0029]-[0030]);
a spindle (plunger 44, see Fig. 1, see also Para. [0027] and [0029]-[0030]); and
a support structure (body 14, see Fig. 1, see also Para. [0027] and [0029]-[0030]);
wherein inserting the lateral side of a suture thread includes inserting the lateral side through a first (opening 34, see Fig. 1) of the slits (see Figs. 3-5 and Para. [0027]-[0028]) in a portion of the pressure applying surface (see Fig. 1) and a second of the slits in the support structure (well 68, see Figs. 3-5);
tensioning the suture threads between the vessel clamping pressure device and the patient (Para. [0009] and [0029]-[0031]);
leaving the vessel clamping pressure device on the entrance incision for a clotting period (see Para. [0009] and [0029]-[0031]); and
after the clotting period, releasing tension on the suture threads and removing the sutures threads below the vessel clamping pressure device (see Abstract, Para. [0009] and [0029]-[0031]).
However, while Ashland discloses wherein the sutures may be maintained under tension between the plunger and the body of the device (see Para. [0010] and Figs. 4-5) and wherein each face of the body may define various shapes and comprise a width of between 5mm to 50mm (see Para. [0020]), in addition to wherein the suture threads are removed from below the vessel clamping device, Ashland does not expressly disclose:
wherein the tension on the suture threads is established by turning the spindle to bind the suture threads between the spindle and the support structure of the vessel clamping pressure device;
releasing the tension on the suture threads by turning the spindle, and wherein the sutures are removed via cutting; and
wherein the pressure applying surface is wider than the support structure.
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, 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]). 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 suturing devices for closing a wound within a patient, Hathaway teaches wherein when removing a repair device from a patient, the length of sutures are cut and removed, leaving lengths of suture closing the wound in-place (see Col. 6, Lines 45-60).
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 incorporated the method of removing sutures from a bodily space by cutting them, as taught and disclosed to be a well-known method in the art by Hathaway.
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 width of the body faces of Ashland to have the tissue-
contacting face (face 16) comprise a width within the disclosed range that is greater than the width of
the other faces along the body as Applicant appears to have placed no criticality on the claimed relative
dimensions and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside
ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). In the instant case, the Examiner is not able to find a mentioning within the disclosed specification pertaining
to the relative width dimensions as claimed, instead appearing to rely solely on the disclosed drawings
to show this claimed feature, indicating a lack of criticality to the functioning or problem-solving ability
of the claimed width limitation.
Claim(s) 7 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 Hathaway (US 5304184 A)(previously of record), further in view of Stopek (US 2011/0125185 A1)(previously of record).
Regarding claim 7, the combination of Ashland, Bonutti and Hathaway disclose all of the limitations of the method of claim 6.
However, none of the combination expressly discloses the step of applying a bandage to the patient over the vessel clamping pressure device.
However, in the same field of endeavor, namely wound closure devices, Stopek teaches wherein bandages, films, gauzes, etc. may be applied over a wound closure device as a method of better securing a wound closure device to the tissue (see Para. [0088]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have incorporated a step of applying a bandage over the wound closure device of Ashland, as taught and suggested by Stopek, to better secure the wound closure device to the tissue (see Stopek Para. [0088]).
Claim(s) 8-9 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 Hathaway (US 5304184 A)(previously of record), further in view of Pandya (US 2018/0055497 A1).
Regarding claim 8, the combination of Ashland, Bonutti and Hathaway disclose all of the limitations of the method of claim 6, Ashland further discloses wherein, prior to releasing tension on the suture threads, performing a visual inspection (a user would maintain eye contact with the surgical site throughout the procedure).
However, while Ashland discloses wherein the body (14) may be made from “ABS or
polypropylene or other material that can be conveniently and economically injection molded in large
quantities (see Para. [0020]), none of the combination expressly discloses wherein performing said visual inspection is performed through the wider portion of the pressure applying surface that is transparent to assess a healing state near the incision.
In the same field of endeavor, namely vascular wound closure devices, Pandya traches wherein
forming surgical equipment from either ABS or polypropylene allows the device to be transparent (see Para. [0035]) (i.e., using a form of transparent ABS or polypropylene in related devices).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of forming the ABS or polypropylene body of the device of Ashland from a transparent variety thereof as disclosed by Pandya. Since both materials are identical between the disclosed devices, one of ordinary skill in the art would have expected the device of Ashland to operate equally well with either an opaque or transparent variety of ABS or polypropylene since both varieties maintain the same structural characteristics and are thus seen to be interchangeable. As the body of the device of Ashland is transparent, as modified by Pandya, during a procedure while maintaining eye contact with the surgical site, a user would be able to visually inspect the site to assess both the procedure and healing during the surgical procedure.
Regarding claim 9, the combination of Ashland, Bonutti, Hathaway and Pandya disclose all of the limitations of the method of claim 8, Ashland, as modified by Pandya, further discloses wherein the pressure applying surface is transparent (as modified from the teachings of Pandya), and wherein performing the visual inspection comprises observing the entrance incision through the flat transparent pressure applying surface to assess wound healing progress (during the procedure, a user maintains eye contact with the device at the surgical site and would thus be observing the entrance incision through the pressure applying surface).
Further, Ashland discloses wherein the pressure applying surface is flat (see Para. [0019]-[0020] mentioning wherein any of the faces of the body may be made flat).
It would have therefore been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known element for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)), to have obtained the predictable result of having the body (including the tissue contacting surface thereof) be in the form of a shape having a flat tissue-contacting surface since Ashland expressly discloses wherein this shape may be used interchangeably with any of the other disclosed shapes depending on the size and nature of the wound to be operated on (see Para. [0019]-[0021]).
Claim(s) 10-11 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 Hathaway (US 5304184 A)(previously of record), further in view of Jackson (US 2003/0229361 A1).
Regarding claim 10, the combination of Ashland, Bonutti and Hathaway disclose the method of claim 6, Ashland further discloses wherein the spindle comprises a handle (lever 40, see Fig. 6).
However, while a user may rotate the lever of Ashland any degree to impart tension onto the suture, as taught and suggested by Bonutti, Bonutti does not provide an express teaching of rotating the spindle 90 degrees to cause said binding.
In the same field of endeavor, namely suture locking devices, Jackson teaches wherein a suture locking device (see Fig. 1) comprises a rotatable spindle (rotatable element 14, see Fig. 1) that is insertable within a housing device (see Fig. 2) and is configured to receive a suture within an opening therein (holes 15, see Fig. 1), wherein in order to impart tension and lock said suture at a desired length/amount of tension, the spindle is rotated 90 degrees (see Fig. 4A and Para. [0034]) to tightly hold the sutures in place (see Para. [0034]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to impart a desired amount of tension onto the suture thread of Ashland by turning the plunger (as modified by the teachings of Bonutti) 90 degrees as taught by Jackson to, in this case, impart a desired amount of tension onto said suture thread via winding of the plunger 90 degrees so as to lock and tightly hold the suture in tension (see Jackson Para. [0034]).
Regarding claim 11, the combination of Ashland, Bonutti and Hathaway disclose the method of claim 6, Ashland further discloses wherein the spindle comprises a handle (lever 40, see Fig. 6).
However, while a user may rotate the lever of Ashland any degree to impart tension onto the suture, as taught and suggested by Bonutti, Bonutti does not provide an express teaching of rotating the spindle 180 degrees to cause said binding.
In the same field of endeavor, namely suture locking devices, Jackson teaches wherein a suture locking device (see Fig. 1) comprises a rotatable spindle (rotatable element 14, see Fig. 1) that is insertable within a housing device (see Fig. 2) and is configured to receive a suture within an opening therein (holes 15, see Fig. 1), wherein in order to impart tension and lock said suture at a desired length/amount of tension, the spindle is rotated several revolutions so as to wrap the suture around the spindle several times to lock and tightly hold the suture in-place under a specific tension (see Fig. 4A, 4C and Para. [0034]) to tightly hold the sutures in place (see Para. [0034]). The disclosure of the spindle wrapping the suture around “several times” indicates that several revolutions are made, encompassing the 180 degree rotation.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to impart a desired amount of tension onto the suture thread of Ashland by turning the plunger (as modified by the teachings of Bonutti) 180 degrees (during more or more revolutions) as taught by Jackson to, in this case, impart a desired amount of tension onto said suture thread via winding of the plunger at least 180 degrees so as to lock and tightly hold the suture in tension (see Jackson Para. [0034]).
Claim(s) 16 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 Pandya (US 2018/0055497 A1)(previously of record), further in view of Garvin (US 2019/0343633 A1).
Regarding claim 16, the combination of Ashland, Bonutti and Pandya disclose all of the limitations of the invention of claim 12.
However, while Ashland does not provide an express written disclosure as to the length of channel 52 (containing well 68), Ashland appears to show wherein the channel does not extend “completely” through the length of body 14 (as shown in Figs. 3-5) and therefore does not expressly disclose wherein the hollow portion comprises a through-hole completely through the support structure.
In the same field of endeavor, namely surgical suturing devices comprising mechanisms for adjusting suture length, Garvin teaches wherein a suture length adjusting device (see Fig. 1J) comprising a suture adjustment device (200, see Figs. 3A-3B and Para. [0025]) having a support body (actuation tube 202, see Fig. 3A) having a channel extending therethrough (see Fig. 3B) configured to receive a spindle (bars 204, see Fig. 3B) for wrapping the suture around to adjust the length said suture passing therethrough (see Para. [0025]-[0027]), wherein the spindle-receiving channel extends completely through the width of the support body (see Figs. 3A-3B).
Since Ashland is silent as to the length at which channel 52 pass through body 14, instead relying on the disclosed drawings to show said feature, the longitudinal length of said channel is not seen to be a critical feature and thus it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known arrangement for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the channel 52 (receiving the plunger therein) extend completely through the length of the body of Ashland (as opposed to extending through only a majority of the length thereof) as disclosed as an alternative configuration by Garvin. Since none of either the claimed invention of the disclosure of Ashland provide an express disclosure pertaining to the length of the plunger-receiving channel, instead relying on the disclosed drawings to show said feature, the claimed limitation is not understood to be critical to the functionality of the device. Further, since the length of the plunger itself is responsible for receiving the length of suture therethrough (see Ashland Para. [0027]-[0028]), the depth of the receiving channel is determined not to impact the plunger’s ability to pass therethrough to align opening 64 with openings 34 and 36.
Claim(s) 20 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 XX
Regarding claim 20, the combination of Ashland and Bonutti disclose all of the limitations of the invention of claim 1.
However, while Ashland does not provide an express written disclosure as to the length of channel 52 (containing well 68), Ashland appears to show wherein the channel does not extend “completely” through the length of body 14 (as shown in Figs. 3-5) and therefore does not expressly disclose wherein the hollow portion comprises a through-hole completely through the support structure.
In the same field of endeavor, namely surgical suturing devices comprising mechanisms for adjusting suture length, Garvin teaches wherein a suture length adjusting device (see Fig. 1J) comprising a suture adjustment device (200, see Figs. 3A-3B and Para. [0025]) having a support body (actuation tube 202, see Fig. 3A) having a channel extending therethrough (see Fig. 3B) configured to receive a spindle (bars 204, see Fig. 3B) for wrapping the suture around to adjust the length said suture passing therethrough (see Para. [0025]-[0027]), wherein the spindle-receiving channel extends completely through the width of the support body (see Figs. 3A-3B).
Since Ashland is silent as to the length at which channel 52 pass through body 14, instead relying on the disclosed drawings to show said feature, the longitudinal length of said channel is not seen to be a critical feature and thus it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, as a matter of simple substitution of one known arrangement for another (see KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 82 USPQ2d 1385, 1396 (2007)) to have obtained the predictable result of having the channel 52 (receiving the plunger therein) extend completely through the length of the body of Ashland (as opposed to extending through only a majority of the length thereof) as disclosed as an alternative configuration by Garvin. Since none of either the claimed invention of the disclosure of Ashland provide an express disclosure pertaining to the length of the plunger-receiving channel, instead relying on the disclosed drawings to show said feature, the claimed limitation is not understood to be critical to the functionality of the device. Further, since the length of the plunger itself is responsible for receiving the length of suture therethrough (see Ashland Para. [0027]-[0028]), the depth of the receiving channel is determined not to impact the plunger’s ability to pass therethrough to align opening 64 with openings 34 and 36.
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 8916077 B1 to Goraltchouk, US 8721664 B2 to Ruff and US 11672524 B2 to Sampson all disclose suturing devices configured to seal or close a wound in a patient comprising a suture-locking mechanism.
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.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771