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 .
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.
Claims 9-11, 13 and 14 are 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.
Claim 9 recites the limitation “in apposition between said third element and said third element” in lines 2-3. The limitation contains a typo and requires clarification as the limitation is currently indefinite.
Claim 10 inherits the same deficiency,
Claim 11 recites the limitation "said needle is a fine gauge needle" in in line 1. The term “fine gauge” renders the claim indefinite because it is not clearly defined. The term can be broadly interpreted from 23G to 33G with different gauges serving different purposes.
Claim 13 recites the limitation “the deployed configuration” in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 inherits the same deficiency.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5-9, 12, 13, 15, 16, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ewers (US20080009888A1).
Regarding claim 1, Ewers discloses a system for moving and holding a proximal anatomical structure and a distal anatomical structure in apposition with respect to each other (Paragraph [0005]), said system comprising: an apposition device comprising a first elongate element and a second elongate element movably coupled with respect to each other (Figure 19A); a needle with a lumen therethrough in which at least said second elongate element is positionable (Figure 24B); and a pusher within the needle lumen positioned proximal to said second elongate element (Figure 22); wherein at least one component of said system is structured and configured to facilitate movement of said second elongate element with respect to said first elongate element from a delivery position generally along said first elongate element to a deployed configuration transverse to said first elongate element (Figures 24B and 25A-25C).
Regarding claim 2, Ewers discloses a side port is defined in a wall of said needle configured for deployment of said second elongate element therethrough (Figures 24A-24B).
Regarding claim 3, Ewers discloses a ramp is provided within the needle lumen along said side port to facilitate deployment of said second elongate element from the needle lumen and pivoting of said second elongate member into the deployed configuration (Figures 24A-24B).
Regarding claim 5, Ewers discloses the side port is defined proximally to a distal end of said needle a distance allowing deployment of said second elongate element within a small space distal to the distal anatomical structure (Figures 24A-24B).
Regarding claim 6, Ewers discloses said apposition device further comprises a third element positioned proximal to said second elongate element and distal to said pusher and configured to push said second elongate element into the deployed position when pushed distally by said pusher (Figures 19A and 19B).
Regarding claim 7, Ewers discloses a third element configured and positioned to hold the anatomical structures in apposition (Figures 19A and 19B).
Regarding claim 8, Ewers discloses said third element is an expanded element associated with said first elongate element and positioned proximal to the proximal anatomical structure to hold the anatomical structures in apposition (Figures 19A and 19B).
Regarding claim 9, Ewers discloses said first elongate element and said third element are configured to be fixed with respect to each other to hold the structures in apposition between said third element and said third element (Figures 19A and 19B).
Regarding claim 12, Ewers discloses a system for moving and holding a proximal anatomical structure and a distal anatomical structure in apposition with respect to each other (Paragraph [0005]), said system comprising: an apposition device comprising a first elongate element and a second elongate element movably coupled with respect to each other (Figure 19A); a needle with a lumen therethrough in which at least said second elongate element is positionable (Figure 24B); wherein a side port is defined in a wall of said needle configured for deployment of said second elongate element therethrough (Figures 24A-24B).
Regarding claim 13, Ewers discloses a ramp is provided within the needle lumen along said side port to facilitate deployment of said second elongate element from the needle lumen and pivoting of said second elongate member into the deployed configuration (Figures 24A-24B).
Regarding claim 15, Ewers discloses a third element configured and positioned to hold the anatomical structures in apposition (Figures 19A and 19B), said third element is an expanded element associated with said first elongate element and positioned proximal to the proximal anatomical structure to hold the anatomical structures in apposition (Figures 19A and 19B).
Regarding claim 16, Ewers discloses a method of holding a first anatomical structure and a second anatomical structure in apposition with respect to each other (Paragraph [0002]) with an apposition device comprising a first elongate element and a second elongate element movably coupled with each other (Figure 19A), said method comprising: delivering the second elongate element of the apposition device within a lumen of a needle to a deployment position distal to the second anatomical structure (Figure 22, Paragraph [0096]); extending the second elongate element out a side port formed in a wall of the needle (Paragraph [0101]); causing the second elongate member to move to a position transverse to the first elongate element (Paragraph [0101], Figure 25C)); proximally withdrawing the needle proximal to the anatomical structures Paragraph [0096]; and pulling the first elongate element proximally to draw the second elongate element proximally to move the second anatomical structure into apposition with the first anatomical structure (Paragraph [0081]).
Regrading claim 19, Ewers further discloses advancing a pusher distally through the needle lumen to push the second elongate element out of the side port (Figure 22, Paragraph [0098]).
Regarding claim 20, Ewers further discloses pushing the second elongate element along a ramp within the needle lumen to advance the second elongate element out the side port defined in the needle wall (Paragraph [0100]).
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.
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.
Claim(s) 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ewers (US20080009888A1) as applied to claims 1 and 12.
Regarding claims 4 and 14, Ewers discloses the tube and ramp maybe be formed as a single structure (Paragraph [0100]), but does not explicitly disclose the ramp is formed from a portion of the needle wall pushed inwardly into the needle lumen to form the port. As Ewers discloses the tube and ramp maybe be formed as a single structure, the only way for that be to created is for the material of the tube to moved to form the ramp. It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ewers, with the ramp being formed from a portion of the needle wall pushed inwardly into the needle lumen to form the port since such a modification would provide the predictable results of a simplified design enabling the tube and ramp to be formed as a single structure (Paragraph [0100]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ewers (US20080009888A1) as applied to claim 1 above, and further in view of Hayhurst (US5269809A).
Regarding claim 10, Ewers does not disclose the first elongate element and said third element include interengaging ratchet features. Hayhurst discloses an anchor device (Col 1, Lines 12-19) that comprises a first elongate element and third element that include interengaging ratchet features (Figure 8). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ewers, with the first elongate element and third element including interengaging ratchet features as taught by Hayhurst, since such a modification would provide the predictable results of a suture locking to securely hold together two or more pieces of body tissue (Col 3, Lines 31-34).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ewers (US20080009888A1) as applied to claim 1 above, and further in view of Keach (US20180310951A1).
Regarding claim 11, Ewers does not disclose said needle is a fine gauge needle. Keach discloses a system for implantable devices for connecting tissue layers (Paragraph [0060]), wherein the delivery sheath for the system is similar to a surgical needle used in Fine-needle aspiration (FNA) (Paragraph [0083]). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the system as taught by Ewers, with the needle being a fine gauge needle as taught by Keach, since such a modification would provide the predictable results of a minimally invasive procedure due to the small needle gauge.
Claim(s) 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ewers (US20080009888A1) as applied to claim 16 above, and further in view of Kucklick (US20200113558A1).
Regarding claim 17, Ewers discloses pulling the first elongate element proximally to cause the second elongate member to pull the second anatomical structure in apposition with the first anatomical structure (Figures 19A and 19B). Ewers does not explicitly disclose the first elongate element extends proximally along the outside of the needle. Kucklick discloses a method for anchoring of surgical constructs to body tissue (Abstract). Kucklick further the first elongate element extends proximally along the outside of the needle (Figures 3a-3e), as this allows the second elongate element to be inserted, with the third element remaining external to the distal side of the anatomical target (Figures 3a-3e). It would have been obvious before the effective filing date of the claimed invention to one having ordinary skill in the art to modify the method as taught by Ewers, with the first elongate element extending proximally along the outside of the needle as taught by Kucklick, since such a modification would provide the predictable results of allows the second elongate element to be inserted, with the third element remaining external to the distal side of the anatomical target to secure the device (Kucklick, Figures 3a-3e).
Regarding claim 18, Ewers, as modified in claim 17, further discloses further comprising positioning a third element with respect to the first elongate element and the first anatomical structure to hold the anatomical structures in apposition (Figures 19A and 19B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Marc D Honrath whose telephone number is (571)272-6219. The examiner can normally be reached M-F 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles A Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/M.D.H./ Examiner, Art Unit 3791
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