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 Species A (Fig. 3, claims 36-40 & 42-48, in the reply filed on 1/28/2026 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)).
Claim 41 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 1/28/2026.
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 36-38 and 43-47 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kimura et al. (US Pub. No. 2006/0271066 A1).
Regarding claim 36, Kimura et al. disclose a reloadable clipping device (Figs. 7, 8, 16A-B) for treating tissue, comprising: a capsule 63 (Figs. 7, 8, 16A-B) extending from a proximal end to a distal end; a pair of clip arms 61B (Figs. 7, 8, 16A-B), each of the clip arms 61B extending from a proximal end to a distal end, proximal ends of the clip arms 61B slidably received within a channel of the capsule 63 (Figs. 7, 8, 16A-B); and a coupler 62 (Figs. 7, 8, 16A-B) releasably coupled to the proximal end of the capsule 63 (via breakable portion 62f - Figs. 7, 8, 16A-B) and including a plurality of fingers 62e (shown in Fig. 7) configured to be mounted over a distal end of a catheter assembly to couple the coupler to the catheter assembly (fingers 62e are mounted over distal end 31 of control member 32 of the catheter assembly - Figs. 16A-B), the coupler 62 configured to fail when a proximal force exerted on the coupler 62 via a control member 32 of the catheter assembly exceeds a predetermined threshold value to disengage the capsule from the catheter assembly (paragraphs [0121]-[0123]).
Regarding claim 37, Kimura et al. further disclose wherein the proximal ends of the clip arms are connected to one another via a yoke 61A (Figs. 7 & 8) releasably coupleable to a distal end of the control member 32 (via 62b which is attached to the coupler 62 which is attached to the control member 32, 62b being connected to the coupler 62 via breakable portion 62f).
Regarding claim 38, Kimura et al. further disclose wherein the distal end 31 of the control member 32 is enlarged (as shown in Fig. 4).
Regarding claim 43, Kimura et al. further disclose wherein each of the fingers 62e extends from a proximal portion of the coupler 62 and is configured to be mounted over a distal portion of a bushing 31 coupled to the distal end of the catheter assembly (busing 31 is part of the control member which is part of the catheter assembly - Fig. 16A)
Regarding claim 44, Kimura et al. further disclose wherein the clip arms 61B are configured to be moved between a tissue receiving configuration (shown in Figs. 14 & 15), in which the distal ends of the clip arms 61B are separated from one another, and a tissue clipping configuration, in which the distal ends of the clip arms are moved toward one another (Fig. 16A-B).
Regarding claim 45, Kimura et al. further disclose wherein movement of the control member 32 relative to the catheter assembly moves the clip arms 61B between the tissue receiving configuration and the tissue clipping configuration (paragraph [0122] - control member as a whole is referred to as ‘30’ but labeled in the referred to Figures as ‘32’).
Regarding claim 46, Kimura et al. further disclose wherein at least one of the proximal ends of the clip arms includes a locking tab 61D (Fig. 7) configured to be inserted through a correspondingly shaped locking window of the capsule to lock the clip arms relative to the capsule 63 (paragraph [0080]).
Regarding claim 47, Kimura et al. further disclose wherein, when the coupler 62 fails, the coupler fractures to disengage the capsule 63 from the catheter assembly (paragraph [0123]).
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.
Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Kimura et al. (US Pub. No. 2006/0271066 A1).
Regarding claim 48, Kimura et al. fail to explicitly disclose a further capsule extending from a proximal end to a distal end; a pair of further clip arms, each of the further clip arms extending from a proximal end to a distal end, proximal ends of the further clip arms slidably received within a channel of the further capsule; and a further coupler configured to be releasably coupled to the proximal end of the further capsule after the capsule is disengaged from the catheter assembly, the further coupler including a plurality of further fingers configured to be mounted over the distal end of the catheter assembly to couple the further coupler to the catheter assembly, the further coupler configured to fail when a proximal force exerted on the further coupler via the control member of the catheter assembly exceeds a predetermined threshold value to disengage the further capsule from the catheter assembly.
However, Kimura et al. further discloses the step of ‘reloading the clip unit 60’ in paragraph [0124] involving removing the coupler of the previous capsule/clip assembly from the control member distal end 31. Since the coupler of the previous capsule/clip assembly employed a breakable connection portion 62f, it is considered to be no longer reusable for the next clip unit to be reloaded. Therefore, another clip unit with a new coupler will have to be used to reload the system. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to provide a further capsule having the same construction as the capsule disclosed in claim 36 above (as anticipated by Kimura et al.) since Kimura et al. discloses the step of reloading the system, implying that the system is reusable to apply identical clip units. Furthermore, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Allowable Subject Matter
Claims 39, 40, and 42 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art fails to further disclose, teach, or suggest wherein the coupler includes two diametrically opposed sets of V-notches on a distal portion of the coupler, each set of the V-notches including a proximal V-notch extending from a proximal end of a wall of the coupler and a distal V- notch extending from a distal end of the wall of the coupler, the sets of V-notches configured to fracture when a proximal force exerted thereon exceeds the predetermined threshold value [claim 39].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 March 5, 2026