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 of claims 36-43 and 45-47 in the reply filed on 05/15/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 44 and 48-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.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 05/15/2026.
Information Disclosure Statement
The information disclosure statement filed 01/13/2025 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the IDS requires the following:
“(a) Any information disclosure statement filed under § 1.97 shall include the items listed in paragraphs (a)(1), (a)(2) and (a)(3) of this section.
(1) A list of all patents, publications, applications, or other information submitted for consideration by the Office. U.S. patents and U.S. patent application publications must be listed in a section separately from citations of other documents. Each page of the list must include:
(i) The application number of the application in which the information disclosure statement is being submitted;
(ii) A column that provides a space, next to each document to be considered, for the examiner’s initials; and
(iii) A heading that clearly indicates that the list is an information disclosure statement.
(3) Each U.S. application listed in an information disclosure statement must be identified by the inventor, application number, and filing date”.
Therefore, the IDS filed 01/13/2025 is missing a column that provides a space, next to each document to be considered, for the examiner’s initials and fails to include the inventor and filing date of application 16/856,890. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Claim Objections
Claims 36 and 43 are objected to because of the following informalities:
Claim 36, line 5: “the distal ends” which should recite “distal ends”.
Claim 43, line 1: “the second sharpened tips” which should recite “the plurality of second sharpened tips”.
Appropriate correction is required.
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.
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) 36-43 and 45-47 are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 20170333040) [hereinafter Smith].
Regarding claims 36-37 and 40-41, Smith discloses a device for treating tissue (Fig. 1, para. 0017), comprising:
a capsule 108 extending longitudinally from a proximal end to a distal end along a longitudinal axis (Fig. 1, para. 0018); and
first and second clip arms 104, 106 (Fig. 1, para. 0018), each extending from a proximal end received within the capsule 108 (Fig. 1, para. 0018: “first and second clip jaws 104, 106 slidably received within a longitudinal channel 122 of a capsule 108”) to be moved between an open tissue receiving configuration, in which the distal ends 109, 111 of the first and second clip arms 104, 106 are separated from one another, and a closed tissue clipping configuration, in which the distal ends of the first and second clip arms 104, 106 are moved toward one another (para. 0018: “First and second clip jaws 104, 106 can be moved between an open configuration, in which the distal ends 109, 111 of the clip jaws 104, 106 are separated from one another to receive target tissue therebetween, and a closed configuration, in which the distal ends 109, 111 of the clip jaws 104, 106 are moved toward one another to grip the target tissue therebetween”),
wherein the first clip arm 104 includes a first tissue retention feature (one of the one or more hooks or barbs 120; Fig. 1, para. 0021) extending radially inward from a first portion of the first clip arm 104 toward the longitudinal axis at a first angle between 30 degrees and 100 degrees (claim 40) (para. 0021: “The barbs 120 may likewise extend from the interior face of jaws 104, 106 at various angles between 20 and 90 degrees and, more particularly, 45 degrees relative to the longitudinal axis L of the jaw 104, 106”) selected so that the first retention feature grips target tissue when in the closed tissue clipping configuration (para. 0022: “The clip jaws 104, 106 may be drawn toward the closed configuration so that the portion of the target area that is desired to be clipped is gripped between hooks or barbs 120 along the distal portion of the clip jaws 104, 106”) and subsequently releases the target tissue when the first and second clip arms are moved toward the open tissue receiving configuration (The examiner notes that the limitation is functional. Para. 0019 of the specification of the instant application recites that the first angle must be within a range of 30 to 100 degrees in order to meet the functional language. Since Smith discloses that the first angle of the first tissue retention feature may be within 20 to 90 degrees, which is within the required range, the limitation is met), and
wherein the second clip arm 106 includes a second tissue retention feature (more than one of the one or more hooks or barbs 120; Fig. 1, para. 0021) extending radially inward from a first portion of the second clip arm toward the longitudinal axis at a second angle between 30 degrees and 100 degrees (claims 40-41) (para. 0021: “The barbs 120 may likewise extend from the interior face of jaws 104, 106 at various angles between 20 and 90 degrees and, more particularly, 45 degrees relative to the longitudinal axis L of the jaw 104, 106”), the second angle being selected so that the second retention feature grips target tissue when in the closed tissue clipping configuration (para. 0022: “The clip jaws 104, 106 may be drawn toward the closed configuration so that the portion of the target area that is desired to be clipped is gripped between hooks or barbs 120 along the distal portion of the clip jaws 104, 106”) and continues to grip the target tissue when the first and second clip arms are moved to the open tissue receiving configuration (The examiner notes that the limitation is functional. Para. 0019 of the specification of the instant application recites that the second angle must be within a range of 30 to 100 degrees in order to meet the functional language. Since Smith discloses that the second angle of the second tissue retention feature may be within 20 to 90 degrees, which is within the required range, the limitation is met).
However, Smith fails to explicitly disclose that the second angle is different from the first angle and/or wherein the first angle is greater than the second angle (claim 37).
Smith explicitly discloses the first retention feature of the first clip arm and the second retention feature of the second clip arm may extend at various angles within the range, which overlaps applicant’s range of 30 to 100 degrees (see cited para. 0021 of Smith above and illustrated in Fig. 3 of Smith).
In light of this disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second angle to be different from the first angle/have the first angle be greater than the second angle as an obvious matter of design choice, since applicant has not disclosed that varying the angles from one clip arm to another within the exemplary ranges as desired solves any stated problem or is for any particular purpose (Para. 0085 of applicant’s specification) and it appears that the invention would perform equally well with first and second angles within the range of 20 and 90 degrees that are equal or are different.
Furthermore, it would have been obvious to one of ordinary skill in the art to modify the second angle of second tissue retention feature to be different from the first angle of the first tissue retention feature/modify the first angle of the first retention feature to be greater than the second angle of the second tissue retention feature, within the claimed range of 30 to 100 degrees and/or wherein the second angle is between 90 and 180 degrees, in light of the Smith disclosure since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 38, modified Smith discloses wherein the first retention feature 120 is proximal of the distal end 109 of the first clip arm 104 by a first distance (see Fig. 1 of Smith).
Regarding claims 39, modified Smith discloses wherein the second retention feature 120 is proximal of the distal end 111 of the second clip arm 106 by a second distance (see Fig. 1 of Smith).
Regarding claims 42, modified Smith discloses wherein the first retention feature (one or more hooks or barbs 120; Fig. 1, para. 0021) includes a first sharpened tip extending radially inward from the first clip arm 104 (para. 0021: “Clip jaws 104, 106 include one or more hooks or barbs 120 attached to an interior side of a distal portion of clip jaws 104, 106. As shown in FIGS. 3-4, barbs 120 in this embodiment extend substantially perpendicularly from the interior face of jaws 104,106 radially inward toward the other of the jaws 104, 106”; see Fig. 4 of Smith which illustrates the barb 120 having a sharpened tip) and the second retention feature (more than one of the one or more hooks or barbs 120; Fig. 1, para. 0021) includes a plurality of second sharpened tips extending radially inward from the second clip arm 106 (para. 0021: “Clip jaws 104, 106 include one or more hooks or barbs 120 attached to an interior side of a distal portion of clip jaws 104, 106. As shown in FIGS. 3-4, barbs 120 in this embodiment extend substantially perpendicularly from the interior face of jaws 104, 106 radially inward toward the other of the jaws 104, 106”; see Fig. 4 of Smith which illustrates the barb 120 having a sharpened tip).
Regarding claim 43, modified Smith discloses wherein the first sharpened tip and the second sharpened tips are one of triangular in shape (see Fig. 4 of Smith which illustrates the barb 120 having a sharpened tip having a triangular shape).
Regarding claim 45, modified Smith discloses wherein the first and second retention features 120 are offset from one another longitudinally so that they do not interfere with closing of the first and second clip arms 104, 106 (para. 0021: “barbs 120 on each jaw 104, 106 are…offset from one another longitudinally”).
Regarding claim 46, modified Smith discloses wherein the first and second retention features 120 are offset from one another laterally so that they do not interfere with closing of the first and second clip arms 104, 106 (para. 0021: “the barbs 120 may be configured to extend in different planes so as to be received by an opposing jaw without interference from the barb 120 of the other jaw”).
Regarding claim 47, modified Smith discloses wherein the first and second retention features 120 are aligned with one another so that a tip of the first retention feature contacts a tip of the second retention feature when the first and second clip arms are in the closed tissue clipping configuration (para. 0021: “both of the barbs 120 may be configured to extend in substantially the same plane so that when jaws 104,106 are in a closed configuration ends of the barbs 120 from opposing jaws 104,106 touch one another”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
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