DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . This action is responsive to the set of claims received on 23 October 2023. Claims 1-20 are currently pending.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Drawings
The drawings received on 23 October 2023 are accepted by the examiner.
Claim Objections
Claim 11 is objected to because of the following informality:
In line 1, it appears that the phrase “The method” should read “A method.”
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.
Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 14 recites the limitation "the shape memory expansion mechanism" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Note: It appears that amending lines 1-2 of claim 14 to read “wherein the expansion mechanism is” (i.e. similar to the language in claim 4) would overcome this rejection. For examination purposes, claim 14 will be treated as such.
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 1-2, 10-12 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by George et al. (U.S. Patent Application Publication 2007/0156225).
Regarding claims 1-2 and 10, George et al. disclose (as to claim 1) a graft deployment system (20) comprising a device body (i.e. body defined by 38) having a handle (38), a trigger (56), and a controller (80 or 88); and an insertion mechanism (i.e. mechanism defined by 24, 25 and 1270) in operative association with the device body, the insertion mechanism having an outer sheath (25), a support shaft (1270) disposed at least partially within the outer sheath, an expansion mechanism (24) coupled with the support shaft, and a graft (32, see paragraph 0013) in contact with the expansion mechanism (see Figure 1), wherein (as to claim 2) the expansion mechanism is a balloon expansion mechanism (see paragraph 0053), and wherein (as to claim 10) the graft deployment system further comprising a fluid source that provides a fluid to the expansion mechanism (see paragraph 0056) (see Figures 1-2E, and paragraphs 0013 and 0053-0071).
Regarding claims 11-12 and 19, George et al. disclose (as to claim 11) a method of delivering a graft (32, see paragraph 0013) to a treatment site (i.e. a vessel) of a patient, the method comprising positioning a distal portion (i.e. portion defining 24) of a graft deployment system (20) at the treatment site of the patient, the graft deployment system comprising an outer sheath (1258), the graft, and an expansion mechanism (24) supporting the graft, wherein the outer sheath operates to maintain the expansion mechanism in a constrained configuration (i.e. configuration as best seen in Figure 2A) (see column 11, lines 4-57); actuating a trigger (56) of the graft deployment system to retract the outer sheath of the graft deployment system and thereby unconstrain the expansion mechanism (see paragraphs 0060-0061); delivering the graft to the treatment site of the patient after the expansion mechanism has transitioned to an unconstrained configuration (see paragraph 0071), wherein (as to claim 12) the expansion mechanism is a balloon expansion mechanism (see paragraph 0053), and wherein (as to claim 19) the method further comprises providing a fluid source to the expansion mechanism (see paragraph 0056) (see Figures 1-2E, and paragraphs 0013 and 0053-0071).
Claims 1, 3-5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park et al. (U.S. Patent 9,339,365).
Park et al. disclose (as to claim 1) a graft deployment system (see Figure 1) comprising a device body (22) having a handle (14), a trigger (16), and a controller (36); and an insertion mechanism (i.e. mechanism defined by 6 and 8) in operative association with the device body, the insertion mechanism having an outer sheath (6), a support shaft (8) disposed at least partially within the outer sheath, an expansion mechanism (i.e. mechanism defined by 4, 10, 50 and 54) coupled with the support shaft, and a graft (2) in contact with (i.e. in contact with 4 and 54) the expansion mechanism, wherein (as to claim 3) the expansion mechanism is a shape memory expansion mechanism (i.e. due to 50/54 being made of nitinol, see column 7, lines 12-19), wherein (as to claim 4) the expansion mechanism is a nitinol expansion mechanism (see column 7, lines 12-19), wherein (as to claim 5) the expansion mechanism has a curved shape (see curved shape of 4 in Figures 5-7, and column 5, lines 4-7 referring to 4 being a hollow cable formed of a coiled or spirally-wound material), wherein (as to claim 7) the trigger operates to expand the expansion mechanism (see column 4, lines 51-56), wherein (as to claim 8) the controller comprises a button (36, see Figure 1), and wherein (as to claim 9) the controller operates to contract the expansion mechanism (see column 6, lines 6-11) (see Figures 1-12, and column 3, line 38 – column 8, line 21).
Claims 1, 5-7, 11, 15-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Euteneuer et al. (U.S. Patent 9,179,961).
Regarding claims 1 and 5-7, Euteneuer et al. disclose (as to claim 1) a graft deployment system (60) comprising a device body (i.e. body defined by 60) having a handle (104), a trigger (134), and a controller (126); and an insertion mechanism (i.e. mechanism defined by 102 and 130) in operative association with the device body, the insertion mechanism having an outer sheath (102), a support shaft (132) disposed at least partially within the outer sheath, an expansion mechanism (120) coupled with the support shaft, and a graft (50, see paragraph 0062 of the applicant’s current specification referring to the use of a synthetic textile material and column 9, line 47 – column 10, line 8 of Euteneuer et al. referring to materials used to make 50) in contact with (i.e. in contact with 124) the expansion mechanism, wherein (as to claim 5) the expansion mechanism has one or more cutouts or a curved shape (see Figure 11), wherein (as to claim 6) the trigger operates to retract the outer sheath in a proximal direction (see column 10, lines 45-54), and wherein (as to claim 7) the trigger operates to expand the expansion mechanism (i.e. retraction of the sheath leads to the expansion of the expansion mechanism) (see Figures 1-11, and column 6, line 66 – column 13, line 31).
Regarding claims 11, 15-18 and 20, Euteneuer et al. disclose (as to claim 11) a method of delivering a graft (50, see paragraph 0062 of the applicant’s current specification referring to the use of a synthetic textile material and column 9, line 47 – column 10, line 8 of Euteneuer et al. referring to materials used to make 50) to a treatment site (i.e. a rotator cuff) of a patient, the method comprising positioning a distal portion (i.e. portion defining 128) of a graft deployment system (60) at the treatment site of the patient, the graft deployment system comprising an outer sheath (102), the graft, and an expansion mechanism (120) supporting the graft, wherein the outer sheath operates to maintain the expansion mechanism in a constrained configuration (i.e. configuration as best seen in Figures 10A and 10B) (see column 11, lines 4-57); actuating a trigger (134) of the graft deployment system to retract the outer sheath of the graft deployment system and thereby unconstrain the expansion mechanism (see column 11, line 58 – column 12, line 3); delivering the graft to the treatment site of the patient after the expansion mechanism has transitioned to an unconstrained configuration (see column 11, line 58 – column 12, line 3), wherein (as to claim 15) the expansion mechanism has one or more cutouts or a curved shape (see Figure 11), wherein (as to claim 16) the trigger operates to retract the outer sheath in a proximal direction (see column 10, lines 45-54), wherein (as to claim 17) the trigger operates to expand the expansion mechanism (i.e. retraction of the sheath leads to the expansion of the expansion mechanism), wherein (as to claim 18) the method comprises actuating a controller (132) of the graft deployment system to contract the expansion mechanism (i.e. to the configuration as best seen in Figure 10E), wherein (as to claim 20) the treatment site of the patient is a rotator cuff of the patient (see Figures 1-11, and column 6, line 66 – column 13, line 31).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Euteneuer et al. (U.S. Patent 9,179,961), as applied to claim 11 above, in view of Kucklick (U.S. Patent Application Publication 2022/0338910).
Euteneuer et al. disclose the claimed method except for wherein (as to claim 13) the expansion mechanism is a shape memory expansion mechanism, and wherein (as to claim 14) the expansion mechanism is a nitinol expansion mechanism or a superelastic nitinol expansion mechanism.
Kucklick et al. teach the use of an expansion mechanism (4) made from nitinol (see Figures 1-2, and paragraph 0031).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to construct the method of Euteneuer et al. with wherein the expansion mechanism is a shape memory expansion mechanism, and wherein the expansion mechanism is a nitinol expansion mechanism or a superelastic nitinol expansion mechanism in view of Kucklick et al. in order to provide a well-known, obvious resilient material for compressing and expanding to deliver the graft to the treatment site to yield predictable results. Furthermore, it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (In re Leshin, 125 USPQ 416).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY E WAGGLE, JR whose telephone number is (571)270-7110. The examiner can normally be reached TEAP: Monday - Friday (7:45am - 3:45pm).
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/LARRY E WAGGLE, JR/Primary Examiner, Art Unit 3775