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 without traverse of Species VI in the reply filed on 1/5/26 is acknowledged.
Claims 5, 6, 17 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/5/26.
The Examiner has removed also claims 5 and 17 because these claims are directed to a non-elected species. For example, the Applicant’s representative elected Species VI, referring to Fig. 9. Claim 5 is directed to the step of making a hole in the index metacarpal and inserting an anchor mechanism into the hole of the index metacarpal. The elected Species VI does not disclose a hole or an anchor in the index metacarpal (see Fig. 9). The step of anchoring the strand is by creating a loop around the index metacarpal. Additionally claim 17 is referring to a different embodiment since, the embodiment of Fig. 9 does not show a cannulated spacer.
Claim Rejections - 35 USC § 102
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 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, 4, 7-12, 14-16 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bruker et al US Patent Pub. 2015/0127047A1.
Regarding claims 1 and 11, Bruker et al discloses a method of treating thumb arthritis, the method comprising: anchoring (see Fig. 5) a first part (80) of a strand (45) to an index metacarpal (25), disposing a spacer (90 (knot, see knot in figure below)) along the strand (45) and anchoring (see Fig. 5) a second part (85) of the strand (45) to a thumb metacarpal (15). Wherein the spacer (90) is disposed between the thumb metacarpal and the index metacarpal (see figure below) to prevent impingement between the thumb metacarpal and the index metacarpal (if the knot is between the two metacarpal bones then it will prevent impingement).
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Regarding claim 3, the anchoring of the first and second parts of the strand are attached by two anchoring mechanisms (35 and 40).
Regarding claims 4, 9 and 19, see paragraph 45 disclosing the first end (80) attached as a knot (90) to secure the suture (45) to the index metacarpal anchor (35). Also, see figure above showing the knot between the two metacarpal bones.
Regarding claims 7 and 16, see paragraph 47 disclosing a sling (45) made of polymeric material or biological material.
Regarding claims 8 and 15, see paragraph 47 disclosing that the sling (45) can be a tape.
Regarding claim 10, it is inherent to create a surgeon knot to create a strong attachment between element 45 and element 35.
Regarding claim 12, the Examiner interpreted the “suture anchor” broadly, therefore, elements 35 and 40 have been interpreted as suture anchors, since, they are attached to the end of element 45.
Regarding claim 14, see paragraph 47 disclosing a suture.
Claims 1, 3, 7, 11, 12, 14 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by DelSignore US Patent Pub. 2010/0106254A1.
NOTE: as disclosed in Figure 4A and 4B part of element 102 is in contact with anchor 106, therefore, it is inherent that part of element 102 will be disposed between the two metacarpal bones preventing impingement in that area between the thumb metacarpal and the index metacarpal.
DelSignore discloses a method of treating thumb arthritis (see abstract), the method comprising anchoring (106, see Fig. 4A and 4B) a first part (part attached to 106) of a strand (101) to an index metacarpal (307, see Fig. 4B), disposing a spacer (102, see Fig. 4A) along the strand and anchoring (400) a second part (part attached to 400) of the strand (101) to a thumb metacarpal (306). Wherein the spacer is disposed between the thumb metacarpal and the index metacarpal (see note below) to prevent impingement between the thumb metacarpal and the index metacarpal.
Regarding claim 3, the anchoring of the first part is done with one anchoring mechanism ((106).
Regarding claim 7, see paragraph 30 and 71 disclosing a sling (spacer) made of woven fabric.
Regarding claim 11, a surgical kit system for treating thumb arthritis, the surgical kit system comprising a spacer (102, see Fig. 4A) configured to be disposed between a thumb metacarpal (306) and an index metacarpal (307) a strand (102) having a first part (end attached to anchor 106) configured to be anchored to the index metacarpal (307) and a second part (end attached to anchor 400) configured to be anchored to the thumb metacarpal (306). A first anchoring mechanism (106) configured to anchor the first part of the strand to the index metacarpal; and a second anchoring mechanism (400) configured to anchor the second part of the strand to the thumb metacarpal.
Regarding claim 12, the Examiner interpreted the “suture anchor” broadly, therefore elements 106 and 400 can be interpreted as the suture anchor, since, both anchors are attached to element 102 by a suture.
Regarding claim 14, see suture 101 in Fig. 101.
Regarding claim 16, see paragraph 30 and 71 disclosing a sling (spacer) made of woven fabric.
Claims 11-14, 16 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Murray et al US Patent Pub. 2019/0134269A1.
NOTE: the Examiner is giving patentable weight to all the limitations of the claims. However, regarding the surgical kit system, the Examiner is just looking for a system capable of being inserted between the metacarpal bones. Additionally, the Examiner believes the Murray et al reference is capable of being inserted to the targeted area, since, the application discloses in paragraph 32 that the length of the spacers can be between 1mm to about 10mm and the Murray et al reference discloses that the scaffolds can have a length from 0.1mm to 100 mm (see paragraph 37), therefore, the device is capable of being inserted in the targeted area.
Murray et al discloses a surgical kit system capable of treating thumb arthritis, the surgical kit system comprising, a spacer (18 or 20) capable of being disposed between a thumb metacarpal and an index metacarpal, a strand (12) having a first part configured to be anchored to a bone (4) and a second part configured to be anchored to a second bone (6). A first anchoring mechanism (14) configured to anchor the first part of the strand to the first bone (4) and a second anchoring mechanism (14) configured to anchor the second part of the strand (12) to the second bone (6).
Regarding claim 12, as shown in Figs. 3A-3D, the Examiner interpreted the “suture anchor” broadly, therefore elements (14) can be interpreted as the suture anchor, since, both anchors are attached to the suture (12).
Regarding claims 13 and 14, see Figs. 2A-3D disclosing the buttons and the suture.
Regarding claim 16, the scaffold (spacer) paragraphs 79 and 84 discloses a scaffold made of biological material or polymers.
Regarding claim 20, see Figs. 3A-3D showing a “spacer (scaffold) having a cylindrical configuration.
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.
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 2 rejected under 35 U.S.C. 103 as being unpatentable over DelSignore US Patent Pub. 2010/0106254A1.
DelSignore discloses multiple embodiments, the embodiment of Figs 4A-B shows two anchors (106 and 400) capable of holding in place the implant in the targeted area.
Figs. 1A-B and Fig. 3 discloses a different embodiment showing a bone anchor (106) and an anchoring mechanism (sutures attached to the bone by two holes in the thumb metacarpal via knots, see paragraph 43) for the purpose of holding the second part of the strand in place.
It would have been obvious to one ordinary skill in the art to replace the bone anchor (400) of Fig. 4A with two holes and a suture anchoring mechanism (knots) of Fig. 3, since it has been held to be within the general skill of a worker in the art to select an equivalent known element on the basis of its suitability for the intended use as a matter of obvious design choice.
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over DelSignore US Patent Pub. 2010/0106254A1 in view of Agnello et al US Patent Pub. 2021/0402050A1.
DelSignore discloses the invention substantially as claimed. However, Del Signore does not disclose a suture tape.
Agnello et al discloses medical graded textiles for medical devices, such as, sutures, suture tapes, suture with anchors, methods of making sutures, method of suturing, etc.. As disclosed in the specification, the composite suture can be made in a circular cross section or a suture tape. This suture tape can have rounded rectangular, oblong, oval shape for the purpose of creating a larger footprint against the patient’s tissue and spread the forces over a wider surface area.
Therefore, it would have been obvious to one ordinary skill in the art to modify the rounded suture of the DelSignore reference with the rounded rectangular of oblong shapes of the Agnello et al reference in order to create a larger footprint against the patient’s tissue and spread the forces over a wider surface area.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALVIN J STEWART whose telephone number is (571)272-4760. The examiner can normally be reached Monday-Friday 8:30AM-6PM EST.
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/ALVIN J STEWART/Primary Examiner, Art Unit 3799 1/28/26