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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/5/2026 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 11/3/2025, 11/5/2025, 11/19/2025 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.
Claim Objections
Claim 13 is objected to because of the following informalities:
Claim 13 recites, “The vessel clamping pressure device of claim 12, wherein the pressure applying surface is wider than the support structure body” and this appears to be a duplicate limitation as claim 12 has been recently amended to include the limitations of “wherein the pressure applying surface is wider than the support structure body such that an outer portion of the pressure applying surface extends beyond the support structure body”. The Examiner suggests the limitations of claim 13 be removed or further amended since the presently-recited language therein is already present in claim 12.
Appropriate correction is required.
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.
Claims 1-2, 4 and 12-13 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/138,200 (reference application) to Locke. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claim 1, Locke claims:
A vessel clamping pressure device (see Claim 1, Line 1), comprising:
a pressure applying surface including a surface slit therein on a peripheral edge thereof (see Claim 1, Line 2), wherein the surface 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 2-4), 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 4-6);
a support structure coupled to the pressure applying surface (see Claim 1, Line 7) , the support structure comprising a support structure slit and a hollow portion (see Claim 1, Lines 8-10), wherein the support structure slit extends completely through a portion of the support structure (see Claim 1, Lines 8-10; the support structure slit of the co-pending application extends from a first end to the opposing second end of said support structure);
wherein the support structure 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 8-11), and wherein the support structure slit is open along a lateral side thereof that extends between the first end and the second end (see Claim 1, Lines 9-13), wherein the pressure applying surface is wider than the support structure such that an outer portion of the surface slit extends laterally beyond the support structure (see Claim 2), and wherein the inner portion of the surface slit aligns with the support structure slit (see Claim 1, Lines 24-28 reciting wherein the slits of the pressure applying surface and support structure are alignable); and
a spindle positioned within the hollow portion of the support structure (see Claim 1, Line 20), wherein the spindle is configured to rotate within the hollow portion about a longitudinal axis of the spindle and includes a spindle slit, wherein the spindle slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Claim 1, Lines 20-23 and 24-28; as the spindle may be rotated within the support structure to align and misalign with the pressure applying surface slit and support structure slit, the spindle slit therefore is understood to extend through the spindle laterally relative to the longitudinal axis so this selective alignment can occur);
wherein the spindle slit is selectively alignable with the surface slit and the support structure slit by rotation to a first rotation angle of the spindle to allow insertion of suture threads into the surface slit, the support structure slit, and the spindle slit, 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 24-28).
Regarding claim 2, Locke claims the invention of claim 1, Locke further claims wherein the pressure applying surface is transparent (see Claim 1, Lines 17-19) .
Regarding claim 4, Locke claims the invention of claim 1, Locke further claims wherein the spindle comprises a handle configured to rotate the spindle within the hollow portion of the support structure (see Claim 1, Lines 20-22; as the spindle of the co-pending application is “configured to rotate”, said spindle is understood to have a “handle” that can be used to perform the rotating action).
Regarding claim 12, Locke claims:
A vessel clamping pressure device (see Claim 1, Line 1), comprising:
a support structure (see Claim 1, Line 7) comprising:
a support structure body that includes a support structure slit (see Claim 1, Lines 8-10), wherein the support structure slit extends through the support structure body from a first end of the support structure body to a second end of the support structure body opposed to the first end (see Claim 1, Lines 8-10; the support structure slit of the co-pending application extends from a first end to the opposing second end of said support structure), and wherein the support structure slit is open along a lateral side thereof that extends between the first end and the second end (see Claim 1, Lines 9-13);
a pressure applying surface at the first end of the support structure body (see Claim 1, Lines 2-4), wherein the pressure applying surface includes a surface slit that 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 2-4), wherein the surface slit is at least partially aligned with the support structure slit (see Claim 1, Lines 24-28 reciting wherein the slits of the pressure applying surface and support structure are alignable), wherein the pressure applying surface is wider than the support structure body such that an outer portion of the pressure applying surface extends beyond the support structure body (see Claim 2), and wherein at least the outer portion of the pressure applying surface is transparent (see Claim 1, Lines 17-19); and
a hollow portion extending through a side of the support structure other than a first side on which the pressure applying surface is connected thereto or a second side that is opposed to the first side (see Claim 1, Lines 7-8); and
a spindle positioned within the hollow portion of the support structure (see Claim 1, Line 20), wherein the spindle is configured to rotate within the hollow portion about a longitudinal axis of the spindle between at least a first rotational position and a second rotational position (see Claim 1, Lines 20-23 and 24-28) and includes a spindle slit therein (see Claim 1, Lines 20-23), wherein the spindle slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Claim 1, Lines 20-23 and 24-28; as the spindle may be rotated within the support structure to align and misalign with the pressure applying surface slit and support structure slit, the spindle slit therefore is understood to extend through the spindle laterally relative to the longitudinal axis so this selective alignment can occur), 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 (see Claim 1, Lines 20-23 and 24-28).
Regarding claim 13, Locke claims the invention of claim 12, Locke further claims wherein the pressure applying surface is wider than the support body structure (see Claim 2).
Claim 3 and 14-15 and 18-19 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of copending Application No. 18/138,200 (reference application) to Locke in view of Ashland (US 2011/0152889 A1)(previously of record).
Regarding claim 3, Locke claims all of the limitations of claim 1.
However, Locke does not expressly recite or suggest wherein the pressure applying surface is flat.
In the same field of endeavor, namely surgical vessel pressure applicator devices, Ashland teaches:
a vessel clamping pressure device (see Fig. 6) comprising:
a pressure applying surface (face 16, see Figs. 1 and 5 and Para. [0021] and [0028]-[0030]) including a slit opening therethrough (opening 34, see Fig. 1), the pressure applying surface configured to be applied facing the skin of a patient at the site of a wound closure (see Figs. 4-5 and Para. [0021] and [0028]-[0030]);
wherein the pressure applying surface is flat (see Para. [0019]-[0020] mentioning wherein any of the face of the device may be made flat).
Since Locke does not claim an expressly-recited shape for the pressure-applying surface, it would have therefore been obvious to one of ordinary skill in the art, to have looked to analogous prior art devices to provide a known shape for the pressure-applying face of the pressure applicator device. Since Ashland further discloses wherein any of the surface “may” be made flat, Ashland indicates that the shape of the pressure applying surfaces is not a critical feature to the function of the device as the disclosed flat 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 14, Locke claims all of the limitations of claim 12.
However, Locke does not expressly claim wherein the surface slit includes a tapered cross-section.
In the same field of endeavor, namely surgical vessel pressure applicator devices, Ashland teaches:
a vessel clamping pressure device (see Fig. 6) comprising:
a pressure applying surface (face 16, see Figs. 1 and 5 and Para. [0021] and [0028]-[0030]) including a slit opening therethrough (opening 34, see Fig. 1), the pressure applying surface configured to be applied facing the skin of a patient at the site of a wound closure (see Figs. 4-5 and Para. [0021] and [0028]-[0030]);
wherein the slit of the pressure applying surface includes a tapered cross-section (see Fig. 1 showing wherein 34 comprises a tapered cross-section that tapers radially-inwardly from the surface of face 16).
Since Locke does not claim an expressly-recited shape for the slit of the pressure applying surface, it would have therefore been obvious to one of ordinary skill in the art, to have looked to analogous prior art devices to provide a known shape for the slit of the pressure applicator device. Since Ashland discloses wherein the pressure applying face slit comprises a tapered profile but does not indicate any criticality pertaining to this shape, one of ordinary skill would have expected the device of Locke to function equally well with a tapered pressure applying face slit since the shape appears to have no critical function in the operation of the device.
Regarding claim 15, Locke claims all of the limitations of claim 12.
However, Locke does not expressly claim wherein the support structure slit includes a tapered cross-section.
In the same field of endeavor, namely surgical vessel pressure applicator devices, Ashland teaches:
a vessel clamping pressure device (see Fig. 6) comprising:
a pressure applying surface (face 16, see Figs. 1 and 5 and Para. [0021] and [0028]-[0030]) including a slit opening therethrough (opening 34, see Fig. 1), the pressure applying surface configured to be applied facing the skin of a patient at the site of a wound closure (see Figs. 4-5 and Para. [0021] and [0028]-[0030]);
a support structure (body 14, see Fig. 1) including a support structure slit (suture channel 32, see Figs. 1-5) including a tapered cross-section (see Fig. 2 showing wherein opening 36 (of the suture channel) comprises a tapered cross-section that tapers radially-inwardly from the surface of face 18).
Since Locke does not claim an expressly-recited shape for the slit of the support structure, it would have therefore been obvious to one of ordinary skill in the art, to have looked to analogous prior art devices to provide a known shape for the support structure slit of the pressure applicator device. Since Ashland discloses wherein the support structure slit comprises a tapered profile at one end but does not indicate any criticality pertaining to this shape, one of ordinary skill would have expected the device of Locke to function equally well with the support structure slit having a tapered shape since the shape appears to have no critical function in the operation of the device.
Regarding claim 18, Locke claims all of the limitations of claim 1.
However, Locke does not expressly claim wherein the surface slit includes a tapered cross-section.
In the same field of endeavor, namely surgical vessel pressure applicator devices, Ashland teaches:
a vessel clamping pressure device (see Fig. 6) comprising:
a pressure applying surface (face 16, see Figs. 1 and 5 and Para. [0021] and [0028]-[0030]) including a slit opening therethrough (opening 34, see Fig. 1), the pressure applying surface configured to be applied facing the skin of a patient at the site of a wound closure (see Figs. 4-5 and Para. [0021] and [0028]-[0030]);
wherein the slit of the pressure applying surface includes a tapered cross-section (see Fig. 1 showing wherein 34 comprises a tapered cross-section that tapers radially-inwardly from the surface of face 16).
Since Locke does not claim an expressly-recited shape for the slit of the pressure applying surface, it would have therefore been obvious to one of ordinary skill in the art, to have looked to analogous prior art devices to provide a known shape for the slit of the pressure applicator device. Since Ashland discloses wherein the pressure applying face slit comprises a tapered profile but does not indicate any criticality pertaining to this shape, one of ordinary skill would have expected the device of Locke to function equally well with a tapered pressure applying face slit since the shape appears to have no critical function in the operation of the device.
Regarding claim 19, Locke claims all of the limitations of claim 1.
However, Locke does not expressly claim wherein the support structure slit includes a tapered cross-section.
In the same field of endeavor, namely surgical vessel pressure applicator devices, Ashland teaches:
a vessel clamping pressure device (see Fig. 6) comprising:
a pressure applying surface (face 16, see Figs. 1 and 5 and Para. [0021] and [0028]-[0030]) including a slit opening therethrough (opening 34, see Fig. 1), the pressure applying surface configured to be applied facing the skin of a patient at the site of a wound closure (see Figs. 4-5 and Para. [0021] and [0028]-[0030]);
a support structure (body 14, see Fig. 1) including a support structure slit (suture channel 32, see Figs. 1-5) including a tapered cross-section (see Fig. 2 showing wherein opening 36 (of the suture channel) comprises a tapered cross-section that tapers radially-inwardly from the surface of face 18).
Since Locke does not claim an expressly-recited shape for the slit of the support structure, it would have therefore been obvious to one of ordinary skill in the art, to have looked to analogous prior art devices to provide a known shape for the support structure slit of the pressure applicator device. Since Ashland discloses wherein the support structure slit comprises a tapered profile at one end but does not indicate any criticality pertaining to this shape, one of ordinary skill would have expected the device of Locke to function equally well with the support structure slit having a tapered shape since the shape appears to have no critical function in the operation of the device.
This is a provisional nonstatutory double patenting rejection.
Allowable Subject Matter
Claims 6-11 are allowed.
Regarding claim 6, the closest prior art of record, namely Ashland (US 2011/0152889 A1)(previously of record) 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 the pressure applying surface includes a surface slit (opening 34, see Fig. 1) that 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. 1-5);
wherein the support structure includes a support slit (suture channel 32, see Figs. 1 and 4-5) that 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. 4-5); and
wherein an inner portion of the surface slit aligns with the support structure slit (see Figs. 4-5); and
wherein inserting the lateral side of the suture threads includes inserting the lateral side through the surface slit and the support structure slit (see Fig. 1 showing wherein the suture threads are inserted through the opening 34 and suture channel 32);
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]);
wherein the spindle includes a spindle slit that extends through the spindle laterally relative to the longitudinal axis of the spindle; and
wherein turning the spindle rotates the spindle slit from a first rotation angle at which the spindle slit is aligned with the surface slit and the support structure slid to a second rotation angle at which the spindle slit is misaligned with the support structure slit to bind the suture threads.
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 such that an outer portion of the surface slit extends laterally beyond the support structure; and
wherein the support structure 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 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, 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 (US 5304184 A)(previously of record) 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.
However, none of the prior art of record, including Ashland, expressly discloses the amended limitations of “wherein the support 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 7-11 are seen to be allowable due to their dependency from and further modification of claim 6.
Claims 1-4, 12-15 and 18-19 are conditionally allowable over the prior art of record, pending resolution to the above-cited non-statutory double patenting rejections.
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. 1), comprising:
a pressure applying surface (face 16, see Figs. 1 and 5 and Para. [0021] and [0028]-[0030]) including a surface slit therein on a peripheral edge thereof (hole 34, see Fig. 1), wherein the surface 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 and 3-5), the pressure applying surface 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 Figs. 1 and 3-5), the support structure comprising a support structure slit (suture channel 32, see Figs. 1-5) and a hollow portion (see Figs. 3-5), wherein the support structure slit extends completely through a portion of the support structure (see Figs. 3-5);
wherein the support structure 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. 1-5 showing wherein suture channel 32 extends completely through the body 14 from face 16 to face 18), and wherein the inner portion of the surface slit aligns with the support structure slit (see Figs. 1-5); and
a spindle positioned within the hollow portion of the support structure (plunger 44, see Figs. 1-5), wherein the spindle includes a spindle slit (opening 64, see Fig. 6) wherein the spindle slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Fig. 6).
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 hollow portion about a longitudinal axis of the spindle;
wherein the spindle slit is selectively alignable with the surface slit and the support structure slit by rotation to a first rotation angle of the spindle to allow insertion of suture threads into the surface slit, the support structure slit, and the spindle slit, 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;
wherein the pressure applying surface is wider than the support structure such that an outer portion of the surface slit extends laterally beyond the support structure; and
wherein the support structure slit is open along a lateral side thereof that extends between the first end and the second end.
However, 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, 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 (US 5304184 A)(previously of record) 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.
However, none of the prior art of record, including Ashland, expressly discloses the amended limitations of “wherein the support 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 3-4 and 18-19 are conditionally viewed to be allowable pending resolution to the above non-statutory double patenting rejections in light of the dependency from and further modification of independent claim 1.
Regarding claim 12, the closest prior art of record, namely Ashland (US 2011/0152889 A1)(previously of record) discloses:
A vessel clamping pressure device (see Fig. 1), comprising:
a support structure (body 14, see Fig. 1) comprising:
a support structure body (body of 14, see Fig. 1) that includes a support structure slit (suture channel 32, see Figs. 1-5), wherein the support structure slit extends through the support structure body from a first end of the support structure body to a second end of the support structure body opposed to the first end (see Figs. 1-5 showing wherein the suture channel extends through the body from one end to the other);
a pressure applying surface at the first end of the support structure body (face 16, see Figs. 1 and 5 and Para. [0021] and [0028]-[0030]), wherein the pressure applying surface includes a surface slit (hole 34, see Fig. 1) that 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. 1-5), wherein the surface slit is at least partially aligned with the support structure slit (see Figs. 1-5);
a hollow portion extending through a side of the support structure other than a first side on which the pressure applying surface is connected thereto or a second side that is opposed to the first side (see Figs. 3-5 showing wherein the body is hollow); and
a spindle (plunger 44, see Figs. 1 and 6) positioned within the hollow portion of the support structure (see Figs. 1 and 6);
wherein the spindle includes a spindle slit (opening 64, see Fig. 6) therein, wherein the spindle slit extends through the spindle laterally relative to the longitudinal axis of the spindle (see Figs. 1-6);
wherein the support structure slit and spindle slit are configured to receive a suture thread therein (see Figs. 1-5).
However, while Ashland discloses wherein the sutures may be maintained under tension (see Para. [0010]), wherein each face of the body may define various shapes and comprise a width of between 5mm to 50mm (see Para. [0020]), and 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 spindle is configured to rotate within the hollow portion about a longitudinal axis of the spindle 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; and
wherein the pressure applying surface is wider than the support structure body such that an outer portion of the pressure applying surface extends beyond the support structure body, and wherein at least the outer portion of the pressure applying surface is transparent; and
wherein the support structure 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 vasculature would closure devices, Pandya (US 2018/0055497 A1)(previously of record) 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 (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, 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 (US 5304184 A)(previously of record) 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.
However, none of the prior art of record, including Ashland or any other references cited on the attached PTO-892 expressly disclose or suggest the amended limitations of “wherein the support 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 13-15 are conditionally viewed to be allowable pending resolution to the above non-statutory double patenting rejections in light of the dependency from and further modification of independent claim 12.
Claims 5, 16-17 and 20 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.
Co-pending application 18/138,200 provides no mention of the limitations present in claims 5, 16-17 or 20 and thus does not overlap in scope with the limitations present in the cited claims. Claims 5, 16-17 and 20 are thereby objected to as being allowable should they be incorporated into the limitations of the respective base claim(s).
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 20160000554 A1 to Woo and US 20080167519 A1 to St-Germain all disclose suturing devices configured to seal or close a wound in a patient comprising a suture-locking mechanism.
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 at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771