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 .
Response to Amendment
In response to the amendment filed on 01/16/2025, Claims 1-34 have been cancelled, and newly added Claim 35-56 are pending.
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 44 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 44 recites the limitation " the longitudinal lumen" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Allowable Subject Matter
Claims 35-43 and 45-49 are allowed.
Claim 44 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Serina (US PGPub 2010/0198192) and Vaska (US PGPub 2003/0069577) does not disclose or fairly suggest, either singly or in combination of any of the prior art of record, the claimed invention of Independent Claims 35, which recite, inter alia "wherein the tissue depth indicator comprises a radiopaque indicator wire having a proximal portion and a distal portion that is more compliant than the proximal portion.”
The closest prior arts of record, Serina (US PGPub 2010/0198192), teaches a tissue depth indicator similar to that of Claims 35, however the external stop/tissue depth indicator (532; see Figure 5C; Paragraph 0089) does not have a distal portion which is more compliant than the proximal portion, as required by present Claim 35.
The closest prior arts of record, Vaska (US PGPub 2003/0069577), teaches a tissue anchor delivery device similar to that of Claim 35, however Vaska does not disclose the claimed first and second configuration of the tissue depth indicator in combination with the limitations that the depth indicator has a distal portion more compliant than a proximal portion. Vaska discloses an elongate body as claimed, however Vaska fails to teach a tissue depth indicator (40; Figures 2D-2F of Vaska) having a wire which is more compliant in a distal portion as claimed.
The Examiner notes that a double patenting rejection was not applied to parent US Patent 10,058,321, US Patent 10,980,529, and US Patent 12,102,316 because of the language “wherein the radiopaque indicator wire in the first configuration is configured to delineate a surface of a target tissue”.
Because none of the prior art documents of record teach a method as recited in Claims 35-56 it would not have been obvious to one of ordinary skill in the art at the time the invention was made to arrive at the technical solutions of Claims 35-56 according to the prior art documents or a combination thereof. Therefore, in view of the prior art at its deficiencies, Applicant’s invention is rendered novel and non-obvious and thus is allowable as claimed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMED GAMIL GABR whose telephone number is (571)272-0569. The examiner can normally be reached M-F 9am-5pm.
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MOHAMED GAMIL GABR
Primary Examiner
Art Unit 3771
/MOHAMED G GABR/Primary Examiner, Art Unit 3771