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 Arguments
Applicant's arguments filed 11/25/2025 have been fully considered but they are not persuasive. Applicant asserts that Filipi fails to discloses the fundus is pulled downwards. Although Filipi does not explicitly state that use the same language describing the fundus being pulled downwardly, Filipi clearly illustrates the concept of pulling the fundus downwardly by the suturing method. Filipi states the “upper stomach wall” indicated by dashed lines 54a and 54b in Figure 2B is “reshaped” to the configuration shown by lines 56a and 56b [0033]. As in Figures 2B-C, the lines indicated as 54a and 56a point to the top of the stomach, understood in the art as the fundus wall. Therefore, the 102 rejection under Filipi has been maintained.
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Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 7, 12-14, 16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 11 of U.S. Patent No. 11,832,808. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘808 anticipates all the recited method steps of claims 1, 13 and 16 of this application and claim 11 recites the fundus being drawn downward. It is considered obvious to bring limitations from a dependent claim into an independent claim.
Claims 3 and 7 corresponds with step (e) recited in claim 1 of ‘808.
Claim 12 corresponds with step (c) recited in claim 1 of ‘808.
Further in regards to claim 13: the limitation “suturing together at least three points spaced apart along the anterior, posterior or lateral side” is considered to be anticipated by the limitation in claim 1 of ‘808 requiring a first suture is advanced through locations at anterior, posterior and lateral sides (which requires three locations).
Claims 14 and 18 correspond with step (e) of claim 1 of ‘808.
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.
Claim(s) 1, 3-5, 7, 11-14, and 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by USPAP 2007/0276408 (Filipi et al.).
Regarding claim 1: Filipi discloses of reducing the size of a patient's stomach that comprises endoluminally passing a tissue suturing system (10) through a natural orifice to the patient’s stomach (see suturing device in Figure 2A; [0027]),
Using the tissue suturing system (10) to advance a first suture (20) through spaced apart locations through one or more of the anterior, posterior, and lateral sides of the stomach wall below the fundus (6) (see plane 8 of suture locations that includes at least the anterior, posterior OR lateral sides in Figures 1A and 1B; each T-fastener (12a-g) indicates a location at which the suture was advanced through the stomach wall; [0027]);
And cinching the first suture (20) to draw inward into approximation the one or more sutured anterior, posterior, and lateral sides of the patient's stomach below the fundus (6) (Fig. 1C-D; [0028]). Fig. 2a-c shows another method wherein a first suture (46a) is placed at a location below the fundus (6), such that cinching the suture results in the fundus being drawn downward [0032-0033]). Filipi states the “upper stomach wall” indicated by dashed lines 54a and 54b in Figure 2B is “reshaped” to the configuration shown by lines 56a and 56b [0033]. As in Figures 2B-C, the lines indicated as 54a and 56a point to the top of the stomach, understood in the art as the fundus wall.
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In regards to claim 3, the method of Figures 2a-c includes advancing a second suture (46b or 46c) through locations through one or more of the anterior, posterior, and lateral sides of the stomach wall vertically displaced above the first suture (46c) locations (at least a portion of the second suture 46b/46c locations are vertically above at least some of the first suture 46a locations).
In regards to claim 4, at least some of the locations at which the second suture (46b or 46c) is advanced through the stomach wall are also vertically below the fundus (6).
Regarding claim 5, a third suture (46c) is advanced through the stomach wall at some locations that are located within the fundus region (see for example 44c in Figure 2A).
In regards to claim 7, the first suture 46a is below the fundus and the additional suture 46c includes attachment locations within the fundus.
In regards to claim 11, a guideline is created by a cautery device [0026] before the suture is applied.
In regards to claim 12, the first suture (46a) is applied at least through posterior and anterior sides of the stomach, as Filipi describes a circumferential line around the cardia [0032], similar to that of the method illustrated in Figure 1A-B, wherein it is clearly shown that the suture (20) is passed through anterior and posterior sides of the stomach wall (see plane in Figure 1A).
Regarding claim 13: Filipi discloses of reducing the size of a patient's stomach that comprises endoluminally passing a tissue suturing system (10) through a natural orifice to the patient’s stomach (see suturing device in Figure 2A; [0027]),
Suturing together at least three points spaced apart along the anterior, posterior, and lateral sides of the stomach wall below the fundus (6) (see plane 8 of suture locations that includes at least the anterior, posterior OR lateral sides in Figures 1A and 1B; each T-fastener (12a-g) indicates a location at which the suture was advanced through the stomach wall; [0027]; and Figure 2A showing a first suture 46a with at least some locations below the fundus);
And drawing together the at least three points to draw inward into approximation the anterior, posterior, and lateral sides of the patient's stomach below the fundus (6) (see locations drawing together in Fig. 1C-D; [0028]; see Fig. Fig. 2a-c wherein cinching the suture results in the fundus being drawn downward [0032-0033]).
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In regards to claim 14, the method of Figures 2a-c includes advancing an additional suture (46b or 46c) through locations within the fundus region.
Regarding claim 16: Filipi discloses of reducing the size of a patient's stomach that comprises endoluminally passing a tissue suturing system (10) through a natural orifice to the patient’s stomach (see suturing device in Figure 2A; [0027]),
Using the tissue suturing system (10) to draw together inwardly into approximation, with a suture (20), the anterior, posterior, and lateral sides of the stomach wall below the fundus (6) (see suture 46a in Figure 2A-C that is located below the fundus 6; see sides of stomach brought into approximation by suture 20 in cross-section of Fig. 1C-D). Fig. 2a-c shows that cinching the suture results in the fundus being drawn downward [0032-0033]).
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Regarding claim 17: Filipi shows the suture (20) cross back and forth between the anterior and posterior sides [0027], which meets the broadest reasonable interpretation of “helical pattern.”
In regards to claim 18, the method of Figures 2a-c includes advancing an additional suture (46b or 46c) through locations within the fundus region.
Allowable Subject Matter
Claims 2, 6, 8-10, 15, and 19-20 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.
Conclusion
THIS ACTION IS MADE FINAL. 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 SARAH WEBB ALEMAN whose telephone number is (571)272-5749. The examiner can normally be reached M, Tu, Th, Fr 9am - 3pm.
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, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH W ALEMAN/Primary Examiner, Art Unit 3774
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