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 .
Election/Restrictions
Applicant's election with traverse of Species A, CC, claims 1-5, 7-9, 11-16, 18-24 in the reply filed on 12/15/2025 is acknowledged. The traversal is on the ground(s) that “although the inventions cited may be patentably distinct, examination of the entire application should not require a serious burden due to the limited number of potentially patentably distant inventions and the limited number of claims directed thereto”. This is not found persuasive because although there are a limited number of distinct inventions and claims, the examination of each species and corresponding claims requires a serious burden. The different species and/or subspecies are not obvious variants and requires specific search and consideration. For instance, the groove having a polymer based substance is distinct and requires a distinct examination rather than including shoulders within the groove. Further there are 5 different species and 9 different subspecies which would result in 40 different species/subspecies combinations. The examiner maintains that examination of 40 different combinations requires the serious burden based on the amount of consideration for each different use of combination. The election/restriction is maintained.
The requirement is still deemed proper and is therefore made FINAL.
Of note: the elected species A, subspecies CC is directed to figures 1a-c, 8a-e, paragraph 66-67, 73 which support a rectangular, device, with a flat underside, curved topside, two grooves on opposite sides of the central aperture and a polymer that is in the groove, affixed to the device. The groove does not engage the suture by compression and has a diameter that is equal to or wider than all gauges of suture. The suture is submerged into the polymer in the groove where the cumulative tension along the groove prevents the suture from pulling out.
Claim 2 is directed to a device having open-ended slots proximate to the at least one groove. The slots seem to be supported by 122a-d in figures 14-15, species E. The elected clip species A is directed to a rectangle clip with the polymer two grooves and there does not seem to be support for the additional slots of claim 2. Therefore claim 2 is considered to be not a part of the elected species subspecies combination.
Claim 16 is directed to a device having a groove with a shoulder. The shoulders are supported by figure 7a-c, 10a-b, 11a,b, 12a,b, subspecies BB, EE, FF. The elected groove subspecies CC is directed to a groove with a polymer and there does not seem to be support for the groove to have the polymer and shoulders. Therefore claim 16 is considered to be not a part of the species subspecies combination.
Claim 21 (and dependent claims 22-25) are directed to a device having a groove with a shoulder. The shoulders are supported by figure 7a-c, 10a-b, 11a,b, 12a,b, subspecies BB, EE, FF. The elected groove subspecies CC is directed to a groove with a polymer and there does not seem to be support for the groove to have the polymer and shoulders. Therefore claim 21 and dependent claims 22-25 are considered to be not a part of the species subspecies combination.
Claims 2, 6, 10, 16, 17, 21-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species subspecies combination, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/15/2025.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “groove narrows across a width thereof from the aperture to an edge of the device or narrows across the width from the edge of the device to the aperture” must be shown or the feature(s) canceled from the claim(s). The narrowing of the groove, with respect to the species subspecies subcombination should be shown. It would seem the elected subspecies with the polymer uses the cumulative tension to prevent the suture from pulling out. Therefore a groove with different widths may allow for different suture engagement. Therefore how the groove narrows with the polymer filled groove should be shown, or the claim be withdrawn/canceled. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 states “at least one aperture” in line 3 and “the aperture” in lines 4-5. For clarity purposes, “the aperture” of lines 4-5 should be “the at least one aperture”. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: claim 1 states “at least one aperture” in line 3 and claim 7 states “the aperture” in line 1. For clarity purposes, “the aperture” of claim 7 should be “the at least one aperture”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: claim 1 states “at least one aperture” in line 3 and claim 8 states “the aperture” in line 1. For clarity purposes, “the aperture” of claim 7 should be “the at least one aperture”. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: claim 1 states “at least one groove” in line 4 and claim 12 states “the groove” in line 1. For clarity purposes, “the groove” of claim 12 should be “the at least one groove”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: claim 1 states “at least one groove” in line 4 and claim 13 states “the groove” in line 1. For clarity purposes, “the groove” of claim 13 should be “the at least one groove”. Appropriate correction is required.
Claim 14 is objected to because of the following informalities: claim 1 states “at least one groove” in line 4 and claim 14 states “the groove” in line 1 and “said groove” in line 2. For clarity purposes, each of the “the/said groove” of claim 14 should be “the at least one groove” and “the at least one groove” respectively. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: claim 1 states “at least one groove” in line 4 and claim 15 states “the groove” in line 1. For clarity purposes, “the groove” of claim 15 should be “the at least one groove”. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: claim 1 states “at least one aperture” in line 3 and claim 15 states “the aperture” in lines 2, 3 . For clarity purposes, each of “the aperture” of claim 15 should be “the at least one aperture”. Appropriate correction is required
Claim 20 is objected to because of the following informalities: claim 1 states “at least one groove” in line 4 and claim 20 states “the groove” in line 3. For clarity purposes, “the groove” of claim 20 should be “the at least one groove”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13, the phrase "soft" renders the claim indefinite because the scope of “soft” is unclear. Paragraph 73 supports the groove contains “a softer or similarly absorbable polymer” but does not state what material the polymer is made of or what form the “soft” polymer is made of (sponge, liquid, solid…). Therefore it is unclear how the polymer can be soft or what would be considered not a soft polymer. See interpretations in the rejections below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-5, 7, 9, 11, 12, 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 4,275,736 to Chodorow.
As to claim 1, Chodorow discloses a device for locking a suture on a wound (col. 2 ll. 44-48), comprising: a body (1/11) with a substantially geometrical shape (figure 1, the device 1, and/or at least the bridge 11 can be in the shape of a rectangle); at least one aperture (30,31 / or 5, the turret 30 is central and has a tunnel 31 which goes through the device for the suture to extend therethrough, see figure 2, and/or the device has apertures 5, figure 1, 2, col. 5 ll. 28-39) disposed throughout the device; and at least one groove (29, figure 1, 2, 4, col. 5 ll. 55-67) disposed across a top side of the body on either side of the aperture. The “groove” 29 is on top of the device and can be on opposite sides of the tunnel 31 and/or apertures 5.
As to claim 3, Chodorow discloses the body comprises a substantially rectangular shape or a circle shape (figure 1). The bridge 11 and/or the entire device 1 can have a substantially rectangular shape.
As to claim 4, Chodorow discloses the body comprises rounded edges at a perimeter of a circumference thereon (figure 4).
As to claim 5, Chodorow discloses the body comprise a convex top side and a flat underside (figure 3). Without further distinctions of the top side and underside, the top strap 17 can read on a convex shape and be on a top side of the device and the bottom of the feet 13, opposite the strap can have a flat underside.
As to claim 7, Chodorow discloses the aperture is disposed through a center of the device (figure 1, 2, the turret 30 / tunnel 31 is shown to be at the center).
As to claim 9, Chodorow discloses the device comprise one groove (figure 1). The device has one axial groove 29.
As to claim 11, Chodorow discloses the device comprise a plurality of grooves radially disposed on either side of the aperture (figure 1). The axial groove to either side of the turret 30 can be considered two different grooves which can read on the plurality of grooves radially disposed on either side of the aperture.
As to claim 12, Chodorow discloses the groove has a diameter sufficient to secure therein a suture (3) of a specific size (col. 3 ll. 68-col. col. 4 ll. 1). The suture 3 is sewn and tied to the bridge, therefore the diameter of the groove of which the suture is sits in has a sufficient diameter to accept and secure the suture.
As to claim 14, Chodorow discloses the groove has a rectangular shape, has a U-Shape, or has a V-Shape (figure 4, the groove seems to have a rectangular shape).
Claims 1, 3, 4, 8, 9, 11-13, 15, 18, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2013/0110164 to Milazzo.
As to claim 1, Milazzo discloses a device capable for locking a suture on a wound (paragraph 11), comprising: a body (400) with a substantially geometrical shape (figure 4); at least one aperture (402) disposed through the device; and at least one groove (116, figure 4, paragraph 43) disposed across a top side of the body on either side of the aperture (paragraph 43, the slot extends on opposite sides of 402, and the view of figure 4 can be a topside view).
As to claim 3, Milazzo discloses the body comprises a substantially rectangular shape or a circle shape (figure 4). The bridge 11 and/or the entire device 1 can have a substantially circular shape.
As to claim 4, Milazzo discloses the body comprises rounded edges at a perimeter of a circumference thereon (figure 4). The clip is a circle, so can have rounded edges that create the perimeter.
As to claim 8, Milazzo discloses the aperture is curved at a circumference thereof (figure 4), the aperture is a circle, so can have a curve to define the circumference of the aperture.
As to claim 9, Milazzo discloses the device comprise one groove (paragraph 43, there is one slot 116).
As to claim 11, Milazzo discloses the device comprise a plurality of grooves radially disposed on either side of the aperture (figure 4, the slot can define two grooves on opposite dies of 402).
As to claim 12, Milazzo discloses the groove has a diameter sufficient to secure therein a suture of a specific size (paragraph 43). The slot can have feature to prevent a suture from entering the opening, therefore can have a diameter that can engage a sized suture.
As to claim 13, Milazzo discloses the groove ha a diameter greater than a diameter of a suture (paragraph 43, the slot can have a diameter at least in the open configuration that can be greater than a suture), the groove containing a soft, absorbable polymer (paragraph 46, 49, 50, 52). The device can be made of multilayers of a bioabsorbable polymer and can be coated. Further the device can flex in order to movement between the open/closed configuration. Therefore the groove can comprise a polymer which is absorbable, and the device flexes so the materials need to be non-rigid to flex. There is no distinct of where/how/why the groove contains the polymer or where the polymer is located. Further, as argued above, the scope of “soft” is indefinite. Since Milazzo does disclose the device can be made of an absorbable polymer, have multiple layers, and coatings, and the device can flex, Milazzo can read on the “soft, absorbable polymer” that the groove contains.
As to claim 15, Milazzo discloses the groove narrows across a width thereof from the aperture to an edge of the device or narrows across the width from the edge of the device to the aperture (figure 4). The groove has the narrowing in the closed configuration.
As to claim 18, Milazzo discloses the body is made of an absorbable or non-absorbable polymer (paragraph 46).
As to claim 20, Milazzo discloses a stich locking system, comprising: the device of claim 1; and a suture (500) attached by an end thereof to a distal end of the groove (paragraph 44-45). The end of the barb can engage the top edge of the inner side wall, which can define the distal end of the groove. There is no distinction or spatial orientation of the distal end of the groove. The specification states the distal end of the suture is farthest from the needle (paragraph 44) but does not define the distal end of the groove.
Claims 1, 3-5, 7-9, 11, 12, 14, 18, 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Publication 2019/0336121 to Lear.
As to claim 1, Lear discloses a device capable for locking a suture on a wound (paragraph 32), comprising: a body (100) with a substantially geometrical shape (figure 2a); at least one aperture (121) disposed through the device; and at least one groove (121, at least figure 2a,b, paragraph 49-50) disposed across a top side of the body on either side of the aperture (figure 2a, the slot at least extending from the aperture can read on the groove being on the top side of the body on either side of the aperture).
As to claim 3, Lear discloses the body comprises a substantially rectangular shape or a circle shape (figure 2a). The device can be substantially rectangular in that it has two longitudinal parallel sides and two lateral sides. The lateral sides are curved, but similarly to curved to figure 1a of the application. Therefore the device can be “substantially rectangular”.
As to claim 4, Lear discloses the body comprises rounded edges at a perimeter of a circumference thereon (figure 2a).
As to claim 5, Lear discloses the body comprises a convex top side and a flat underside (figure 5b). The device has a curve on the top side and have parts on the bottom side which are flat.
As to claim 7, Lear discloses the aperture is disposed through a center of the device (figure 2a, paragraph 5b).
As to claim 8, Lear discloses the aperture is curved at a circumference thereof (figure 2a). The aperture is a circle, so can have a curve to define the circumference of the aperture.
As to claim 9, Lear discloses the device comprise one groove (paragraph 49, the slot 120 of each leg can be considered “one groove”).
As to claim 11, Lear discloses the device comprise a plurality of grooves radially disposed on either side of the aperture (figure 4, the slot 120 of each leg can be considered to first and second slots which are radially disposed on either side of the aperture).
As to claim 12, Lear discloses the groove has a diameter sufficient to secure therein a suture of a specific size (paragraph 49).
As to claim 14, Lear discloses the groove has a rectangular shape, has a U-shape, or has a V-shape (figure 4).
As to claim 18, Lear discloses the body is made of an absorbable or non-absorbable polymer (paragraph 57).
As to claim 20, Lear discloses a stich locking system, comprising: the device of claim 1; and a suture (“suture”, paragraph 49, as also seen as suture S2, figure 9b, paragraph 71 and/or 1305, in figure 13d, paragraph 79) attached by an end thereof to a distal end of the groove (paragraph 49, 71, 79). The suture can engage the end of the slot, and therefore have the end of the suture attached to the distal end of the groove.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2019/0336121 to Lear in view of U.S. Patent Publication 2012/0150202 to Chen and/or U.S. Patent 11,172,926 to Moliver.
As to claim 13, Lear discloses the device above including the groove has a diameter greater than a diameter of a suture (paragraph 49-50, figure 13d, figure 14d, based on the figures of slots being usable with a suture, the slot 120 can have a diameter greater than a diameter of a suture) but is silent about the groove containing a soft, absorbable, polymer.
Chen teaches a similar device (suture device, abstract) having a groove containing a polymer (paragraph 31, the suture grooves are coated). Moliver teaches a similar device (suture, abstract) having a soft, bioabsorbable coating (col. 10 ll. 31-60, col. 11 ll. 17-34). The scope of “soft” is indefinite as argued above since the application does not specific what determines if the polymer is soft. The coating of Moliver is applied to a suture so will be flexible since the suture is also flexible. Further Moliver teaches conventional coatings can be bioabsorbable. Moliver also teaches the suture can have the bioabsorbable coating to improve lubricity, durability, and therapeutic functionality. The groove coating of Chen can be the similar conventional coating. Alternatively the suture which is contained in the groove can have the coating which would read on a “soft, absorbable, polymer” and also be contained in the groove. The groove of Lear can have a coating, which can be a soft, absorbable polymer, which can improve lubricity, durability, and therapeutic functionality of the device with respect to the suture being within the groove. It would have been obvious to one of ordinary skill in the art before the effective filing to have the groove of Lear contain a soft, absorbable polymer in order to improve lubricity, durability, and therapeutic functionality of the groove.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 4,275,736 to Chodorow in view of U.S. Patent Publication 2016/0053784 to Mohika.
As to claim 19, Chodorow discloses the device above but is silent about the body is color-coded or numbered to correlate to a suture size or suture type or a combination thereof.
Mohika teaches a similar device (suture device) having a body which is color-coded or numbered to correlate to a suture size or suture type or a combination thereof (paragraph 66-68). The clamps are color coded to indicated to the clamp applicable to a wire type or size. The color-coded indicator can be used in the body of Chodorow in order for indicating the applicable suture type and/or size best used with the device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the body of the Chodorow be color-coded or numbered to correlate to a suture size or suture type or a combination thereof in order for indicating the applicable suture type and/or size best used with the device.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2013/0110164 to Milazzo in view of U.S. Patent Publication 2016/0053784 to Mohika.
As to claim 19, Milazzo discloses the device above but is silent about the body is color-coded or numbered to correlate to a suture size or suture type or a combination thereof.
Mohika teaches a similar device (suture device) having a body which is color-coded or numbered to correlate to a suture size or suture type or a combination thereof (paragraph 66-68). The clamps are color coded to indicated to the clamp applicable to a wire type or size. The color-coded indicator can be used in the body of Milazzo in order for indicating the applicable suture type and/or size best used with the device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the body of the Milazzo be color-coded or numbered to correlate to a suture size or suture type or a combination thereof in order for indicating the applicable suture type and/or size best used with the device.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication 2019/0336121 to Lear in view of U.S. Patent Publication 2016/0053784 to Mohika.
As to claim 19, Lear discloses the device above but is silent about the body is color-coded or numbered to correlate to a suture size or suture type or a combination thereof.
Mohika teaches a similar device (suture device) having a body which is color-coded or numbered to correlate to a suture size or suture type or a combination thereof (paragraph 66-68). The clamps are color coded to indicated to the clamp applicable to a wire type or size. The color-coded indicator can be used in the body of Lear in order for indicating the applicable suture type and/or size best used with the device. It would have been obvious to one of ordinary skill in the art before the effective filing date to have the body of the Lear be color-coded or numbered to correlate to a suture size or suture type or a combination thereof in order for indicating the applicable suture type and/or size best used with the device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent 3,993,076 to Fogarty, U.S. Patent Publication 2003/0125767, U.S. Patent Publication 2004/0049207 to Goldfarb, U.S. Patent Publication 2006/0190041 to Fallin, U.S. Patent Publication 2007/0123860 to Francis, U.S. Patent Publication 2016/0113755 to Senior, U.S. Patent Publication 2016/0270776 to Miraki, U.S. Patent Publication 2017/0027617 to Strnad, and U.S. Patent Publication 2020/0029957 to O’Donnell, all disclose similar devices capable of disclosing, rendering obvious, or providing evidence on the claims of record.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER J ORKIN whose telephone number is (571)270-7412. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/ALEXANDER J ORKIN/Primary Examiner, Art Unit 3771