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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/7/2026 has been entered.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 4/7/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see pages 8-11, with respect to the deficiencies of Gordon in view of the newly amended claim language (i.e., “wherein the driver comprises a solid cable”) have been fully considered and are persuasive. The previous prior art rejections under Gordon have been withdrawn.
Applicant’s arguments, see pages 11-14, with respect to the embodiment of Fig. 17 of Gayzik and/or the embodiment of Fig. 17 of Gayzik in view of the embodiment of Fig. 10B of Gayzik have been fully considered and are persuasive. Therefore, the previous prior art rejections have been withdrawn. However, upon further consideration, new ground(s) of rejection are made in under solely the embodiment of Fig. 10B of Gayzik, as set forth below.
Applicant's arguments, see page 14, alleging that “the inner bore 727 in the proximal end of the retainer 720 does not extend through the first retainer” (see Applicant’s argument, page 14) have been fully considered but they are not persuasive. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the inner bore extending through the first retainer) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 specifically requires “the release portion including an opening extending through a proximal end of the release portion”. The embodiment of Fig. 10B of Gayzik expressly discloses such a structural relationship, as set forth in annotated Fig. 10B below. For at least these reasons, Applicant’s arguments are not persuasive.
PNG
media_image1.png
240
397
media_image1.png
Greyscale
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, “the clip assembly moves distally with distal movement of the distal portion” (see claim 1, lines 18-19) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3, 6 and 8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 (and thereby dependent claims 2-3, 6 and 8) expressly requires “that the clip assembly moves distally with distal movement of the distal portion” (claim 1, lines 18-19). In Applicant’s arguments (see first full paragraph on page 11), Applicant references their embodiments of Figs. 44a-45c as providing support for the newly amended subject matter of “wherein the driver comprises a solid cable”. While “a solid cable” appears to properly be supported therein, no support is shown for the requirement “that the clip assembly moves distally with distal movement of the distal portion”. Similar to Applicant’s own arguments regarding Gayzik (see Applicant’s arguments, pages 12-14), Applicant’s embodiments of Figs. 44a-45c (and further all embodiments within the application as originally filed) do not appear to depict or disclose support for “the clip assembly moves distally with distal movement of the distal portion” requirement of claim 1. The Examiner conducted word searches within the specification for terms such as “distal”, “distally”, and/or “movement” and supporting disclosure within the specification was not found. If the Examiner has inadvertently overlooked any proper support within the originally filed application, Applicant is please requested to provide direct citations of such support for reconsideration.
Claim Rejections - 35 USC § 102
Claim(s) 1-3, 6 and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gayzik (US 2010/0016873).
Gayzik discloses (see Figs. 10A-10B, having the release mechanism of Fig. 10B) a medical clip system comprising the following claim limitations:
(claim 1) An endoscopic device comprising: a clip assembly (see 720/70’/16a/16b/16c, Fig. 10A) comprising: a first jaw (16a, Fig. 10A); a second jaw (16c, Fig. 10A); and a release portion (720’, Fig. 10B) connecting a proximal portion of the first jaw (16a) and a proximal portion of the second jaw (16c) (as shown in Fig. 10A), the release portion (720’) including an opening (i.e., proximal opening of bore 727) extending through a proximal end of the release portion (720’) (as shown in annotated Fig. 10B below); and a driving assembly (40/50/760, Fig. 10A) operably interfacing with the clip assembly (as shown in Figs. 10A-10B), the driving assembly comprising a sheath (40, Fig. 10A); and a driver (50/760, Fig. 10A) movably disposed within the sheath (40) (as shown in Fig. 10A; [0087]; retraction of element 760 into sheath 40 expressly disclosed), a distal portion (765, Fig. 10B) of the driver operably extending through the opening (of 727) of the release portion (720’) (as shown in annotated Fig. 10B below), wherein the driver (at 50/760) comprises a solid cable (as shown in Figs. 10A-10B); wherein at least one jaw (16a/16b/16c) is movable between an open position (as shown in Fig. 10A; [0072]) and a closed position via movement of the driver relative to the sheath (40) (([0069]-[0072]; [0087]-[0088]; opposed axial movement of the sheath and driver expressly bring the at least one jaw to a closed position); and wherein the distal portion (765) of the driver is configured to (i.e., capable of) operatively couple the driving assembly with the clip assembly when the distal portion (765) of the driver is disposed distally from the opening (of 727) of the release portion (720’) (as shown in annotated Fig. 10B below; [0088]) such that the clip assembly moves distally with distal movement of the distal portion (765) of the driver (as shown in Fig. 10B; distal portion 765 comprises both legs 742’/743’ in recesses 722’/723’ and directly abutting shoulders of element 760 to move the clip assembly distally when the distal portion 765 is moved distally) and the distal portion (765) of the driver is configured to be (i.e., capable of) proximally retracted through the opening (of 727) of the release portion (720’) via a predetermined proximal pull force to decouple the driving assembly from the clip assembly (as shown in annotated Fig. 10B below; [0088]; “When it is desired to disengage the retainers, second retainer 760′ is retracted proximally with respect to first retainer 720′ to urge biased elements 742′ and 743′ radially inward, i.e., out of notches 722′ and 723′. Therefore, second retainer 760′ may disengage from first retainer 720′.”);
PNG
media_image1.png
240
397
media_image1.png
Greyscale
(claim 2) wherein the distal portion (765) of the driver includes a tag with a leg (742’/743’, Fig. 10B) extending radially outwardly configured to (i.e., capable of) operably retain the driver (at 760) in the release portion (720’) (as expressly shown in annotated Fig. 10B above; [0088]);
(claim 3) wherein the leg (742’/743’) of the driver is configured to (i.e., capable of) move radially inward via the predetermined proximal pull force such that the distal portion (765) of the driver is retractable through the opening (of 727) of the release portion (720’) (as shown in annotated Fig. 10B above; [0088]; “When it is desired to disengage the retainers, second retainer 760′ is retracted proximally with respect to first retainer 720′ to urge biased elements 742′ and 743′ radially inward, i.e., out of notches 722′ and 723′. Therefore, second retainer 760′ may disengage from first retainer 720′.”);
(claim 6) wherein a laterally outer portion of at least one jaw (16a/16b/16c) includes a retention fin (97a/97b/97c) configured to (i.e., capable of) prevent a collar (at 70’, Fig. 10A) from sliding away from a distal end of the at least one jaw (16a/16b/16c) ([0069]-[0072]; [0087]-[0088]; stops 97a/97b/97c expressly may comprise any of multiple shapes and function to prevent collet 70’ from sliding off the distal ends of the jaws 16a/16b/16c); and
(claim 8) wherein the predetermined pull force is greater than a force which moves the at least one jaw (16a/16c) from the open position (as shown in Fig. 10A) to the closed position ([0087]-[0088]; first level of force moves jaws 16a/16b/16c proximally and closes the jaws, wherein thereafter a greater second level of force deforms the legs 742’/743’ inward to release the clip from the driver and sheath).
Conclusion
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 Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
Prosecution Insights