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
This office action is responsive to the amendment filed on 01/28/2026. As directed by the amendment: claims 16, 26, and 36 have been amended, claims 1-15 and 31-35 have been cancelled and claims 38-39 have been added. Thus, claims 16-30 and 36-39 are presently pending in this application with claims 20-23 and 27 withdrawn.
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 38 is 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 38 recites “keyhole opening” which has an unclear scope. Specifically, what makes the opening a “keyhole” (e.g. is it the shape of the opening, the function of the opening)? Furthermore, if it is the shape of the opening, there are many different types of keys and thus different shapes rendering the scope unclear. Appropriate correction is required.
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 16-19, 24-26, 28-30, 36, 37, and 39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhong et al. (US 20210045747 A1).
Regarding claim 16 Zhong discloses (fig. 11 and 22) an over-the-scope clip (see fig. [0097] and fig. 22), comprising:
a first jaw 1 and a second jaw 3, each of the first and second jaws extending along a curve from a first end to a second end (see fig. 11);
a first hinge 2 connecting the first ends of the first and second jaws and a second hinge 4 connecting the second ends of the first 1 and second 3 jaws (see fig. 11) so that the first and second jaws are movable between at open configuration, in which the first and second jaws are separated from one another (see fig. 22 and [0097]), and a closed configuration, in which the first 1 and second 3 jaws are drawn toward one another to grip tissue therebetween (see fig. 11 and [0097]), at least one of the first 2 and second 4 hinges being biased to draw the clip toward the closed configuration (see [0097]); and
one or more connecting portions 7, each portion of the one or more connecting portions 7 connecting an end of one of the first 2 and second 4 hinges to a corresponding one of the first and second ends of the first 1 and second 3 jaws (see fig. 11 and [0076]), a first end of each connecting portion 7 being integral to an end of one of the first 1 and second jaws 3 and a second end of each connecting portion being integral to an end of one of the first 2 and second 4 hinges (integral is defined by dictionary.com as “of, relating to, or belonging as a part of the whole; consisting or composed of parts that together constitute a whole”; first 1 and second 3 jaws, connection portions 7 and first 2 and second 4 hinges are all connected to form a whole clip, thus they are integral), at least one of the one or more connecting portions 7 including an engaging feature (slots in 7, see fig. 11) configured to be engaged a through- the scope device (see note below) to extract the clip as a single integral piece from a tissue over which it has been clipped upon a deployment thereof (see [0040]).
Note: The language “engaging feature configured to be engaged a through- the scope device to extract the clip as a single integral piece from a tissue over which it has been clipped upon a deployment thereof” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Zhong meets the structural limitations of the claim, and the engaging feature is capable of being engaged via a through- the scope device to extract the clip from a tissue over which it has been clipped upon a deployment thereof. Fig. 22 shows a through- the scope device. This through the scope device can have a grasping member to engage the features to open the clip and extract the clip as a single integral piece as all parts of the clip are connected to form the whole.
Regarding claim 17 Zhong further discloses (fig. 11 and 22) the engaging feature includes a first notch extending along a portion of an exterior edge of the connecting portion 7 in alignment with a corresponding the first jaw 1 (see annotated fig. 11 below claim 18).
Regarding claim 18 Zhong further discloses (fig. 11 and 22) the engaging feature 7 includes a second notch extending along a portion of the exterior edge of the connecting portion in alignment with a corresponding the first hinges (see annotated fig. 11 below).
PNG
media_image1.png
491
490
media_image1.png
Greyscale
Regarding claim 19 Zhong further discloses (fig. 11 and 22) the first and second notches are configured as slots which are aligned with one another (see annotated fig. 11 above).
Regarding claim 24 Zhong further discloses (fig. 11 and 22) each of the first 2 and second 4 hinges includes a curve extending toward and between the first 1 and second 3 jaws (see fig. 11).
Regarding claim 25 Zhong further discloses (fig. 11 and 22) each of the first 1 and second 3 jaws include a plurality of teeth configured to grip tissue received therebetween (see fig. 11 and [0069]).
Regarding claim 26 Zhong discloses (fig. 11 and 22) an over-the-scope clip (see fig. [0097] and fig. 22), comprising:
a first jaw 1 and a second jaw 3, a first end of the first jaw 1 being integrally connected to a first end of the second jaw 3 via a first hinge 2 (integral is defined by dictionary.com as “of, relating to, or belonging as a part of the whole; consisting or composed of parts that together constitute a whole”; first 1 and second 3 jaws and first 2 hinge are connected as part of a whole clip, thus they are integral) and a second end of the first jaw 1 being integrally connected to a second end of the second jaw 3 via a second hinge 4 (see fig. 11 and [0069]; integral is defined by dictionary.com as “of, relating to, or belonging as a part of the whole; consisting or composed of parts that together constitute a whole”; first 1 and second 3 jaws and second 4 hinge are connected as part of a whole clip, thus they are integral) wherein the over-the-scope clip including the first and second jaws and the first and second hinges is a single integral piece (integral is defined by dictionary.com as “of, relating to, or belonging as a part of the whole; consisting or composed of parts that together constitute a whole”; first 1 and second 3 jaws, connection portions 7 and first 2 and second 4 hinges are all connected to form a whole single clip), so that the first and second jaws are movable between at open configuration, in which the first and second jaws are separated from one another (see fig. 22 and [0097]), and a closed configuration, in which the first 1 and second 3 jaws are drawn toward one another to grip tissue therebetween (see fig. 11 and [0097]), at least one of the first 2 and second 4 hinges being biased to draw the clip toward the closed configuration (see [0097]); and
a first engaging feature extending from an edge of the first jaw 1 which faces away from the second jaw 3 and a second engaging feature extending from an edge of the second jaw 3 which faces away from the first jaw 1 (see annotated fig. 11 below).
PNG
media_image2.png
776
643
media_image2.png
Greyscale
Regarding claim 28 Zhong further discloses (fig. 11 and 22) each of the first 1 and second 3 jaws extend along a curve corresponding to a surface of an end cap of an endoscope over which the clip is to be mounted (see fig. 22 and [0097]).
Regarding claim 29 Zhong further discloses (fig. 11 and 22) each of the first 2 and second 4 hinges includes a curve extending toward and between the first and second jaws (see fig. 11).
Regarding claim 30 Zhong further discloses (fig. 11 and 22) each of the first and second jaws includes a plurality of teeth configured to grip tissue received therebetween (see fig. 11 and [0069]).
Regarding claim 36 Zhong further discloses (fig. 11 and 22) the first hinge 2 defines a first end coupled to the first jaw 1 and a second end coupled to the second jaw 3 (see fig. 11) and wherein the first notch is formed at the first end of the first jaw 1 and a second notch is formed at the second end of the first jaw 1 (see annotated fig. 11 below claim 37).
Regarding claim 37 Zhong further discloses (fig. 11 and 22) the second hinge 4 defines a first end coupled to the first jaw 1 wherein a third notch is formed at the first end of the second jaw 3 and a fourth notch is formed at the second end of the second jaw 3 (see annotated fig. 11 below).
PNG
media_image3.png
668
570
media_image3.png
Greyscale
Regarding claim 39 Zhong further discloses (fig. 11 and 22) at least one of the first engaging feature and the second engaging feature is configured to be engaged to a through-the scope device to extract the clip as a single integral piece from a tissue over which it has been clipped without disassembling or cutting the clip. The language “at least one of the first engaging feature and the second engaging feature is configured to be engaged to a through-the scope device to extract the clip as a single integral piece from a tissue over which it has been clipped without disassembling or cutting the clip” constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. Furthermore, the claim is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Zhong meets the structural limitations of the claim, and at least one of the first engaging feature and the second engaging feature is capable of being engaged to a through-the scope device to extract the clip as a single integral piece from a tissue over which it has been clipped without disassembling or cutting the clip. The first engaging feature and the second engaging feature are notches that can be engaged by a through clip device. The clip elements are connected to form a single integral clip and thus the whole clip can be removed by a through clip device engaging one of the engaging features.
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.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Zhong in view of Sharma et al. (US 20220378432 A1).
Regarding claim 38, Zhong discloses the claimed invention substantially as claimed, as set forth above for claim 16. Zhong is silent regarding one or more keyhole openings extending through one of the first and second jaws, the one or more keyhole openings configured to be releasably coupled to a distal end of a control element configured to move the clip.
Sharma, in the same filed of endeavor, teaches (fig. 23-24) a clip 602 comprising one or more keyhole openings 678 extending through one of the first and second jaws 618 (see fig. 23-24 and [0118]), the one or more keyhole openings 678 configured to be releasably coupled to a distal end 646 of a control element 610 configured to move the clip (see fig. 23-24 and [0117]-[0118]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Zhong to have one or more keyhole openings extending through one of the first and second jaws, the one or more keyhole openings configured to be releasably coupled to a distal end of a control element configured to move the clip as taught by Sharma, for the purpose of being able to move the extending member into a fixed position to keep the clip attached and prevent unwanted detachment (see Sharma [0117]-[0118]).
Response to Arguments
Applicant’s arguments, see pg. 6, filed 01/28/2026, with respect to the rejection of claims 36 and 37 under 35 U.S.C. 112(b) have been fully considered and are persuasive. The rejection of claims 36 and 37 under 35 U.S.C. 112(b) has been withdrawn.
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive.
Applicant argues that “Zhong does not disclose or suggest one or more connecting portions integrally formed with the jaws and the hinges such that a first end of each connecting portion is integral to an end of one of the first and second jaws and a second end of each connecting portion is integral to an end of one of one of the first and second hinges” because “the tube 7 in Zhong is a separate element from both the engagements members 1 and 3 (equated to the claimed first and second jaws) and the resilient members 2 and 4 (equated to the claimed first and second hinges)”. The Office respectfully disagrees. Integral is defined by dictionary.com as “of, relating to, or belonging as a part of the whole; consisting or composed of parts that together constitute a whole”; first 1 and second 3 jaws, connection portions 7 and first 2 and second 4 hinges are all connected to form a whole clip, thus they are integral. The Office notes that applicant appears to be interpreting integral as monolithic, but as explained above, the broadest reasonable interpretation of integral is quire different from monolithic.
Applicant further argues that the clip of Zhong is not configured to be integrally removed because [0040] of Zhong states “The endoscopic clip does not have to be integrally removed, whereas it can be disassembled first and then be removed”. The Office respectfully disagrees. Zhong discloses that endoscopic clip does not have to be integrally removed, whereas it can be disassembled first and then be removed. In other words, the clip of Zhong can be removed by disassembling it first but not that it has to be. Furthermore, the claim language at issue is functional language indicating that the claimed device need only be capable of being used in such a manner. The clip of Zhong can be integrally removed by pulling on the clip without first disassembling it. Therefore, Zhong teaches the amended claim limitations.
Applicant further argues that the “configured to” claim language in the claim does not constitute functional language and that the prior art must be designed and constructed to perform the claimed function. The Office disagrees that the “configured to” language is not function because it recites an intended use of the device in an apparatus claim. The Office does however agree that the prior art must be designed and constructed to perform the claimed function. In the instant case the clip of Zhong is designed and constructed to perform the claimed function because it is a single integral clip that can be removed as one piece if it is not disassembled.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 am-4:00 pm.
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.
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
Prosecution Insights