Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
The amendments to claim 883 have overcome the previously presented 35 USC 102b rejections over Pugsley, Jr. et al.
Applicant's arguments filed 10/31/2025 with respect to the amendments to the claims distinguishing the claimed invention from the prior art of Balbierz in view of Swanstrom and Harris have been fully considered but they are not persuasive. Applicant asserts that the amendment requiring that the stomach fundus wall is affixed to the patient’s esophagus “by suture stitching of the stomach fundus wall and the esophagus” distinguishes around the suturing taught by Swanstrom. The examiner respectfully disagrees. The word “stitching” does not appear in the instant application as originally filed and thus “suture stitching” is given its broadest reasonable interpretation of passing suture through tissue to affix two pieces of tissue together. This is consistent with the instant application’s specification, which discloses sutures passing through tissues to hold the tissues together (in instant application: see fig: 7c; suture 1009c; see fig. 7g: suture 1009e, 1009d). Swanstrom teaches affixing the patient’s stomach fundus wall to the patient’s esophagus by passing a needle through tissue (figs. 5a-5e or 8c-e), thereby passing a piece of suture (60) through the fundus wall and the esophagus to affix the fundus wall to the esophagus via the suture, which is considered to read on “by suture stitching of the stomach fundus wall and the esophagus”.
Applicant also asserts that it would not have been obvious to further modify the method of Balbierz in view of Swanstrom to perform the step of affixing the patient’s stomach fundus wall to the patient’s esophagus laparoscopically in view of the teachings of Harris since Harris does not expressly disclose affixing stomach fundus wall to an esophagus. This is not found persuasive. Swanstrom is relied upon for its teaching of affixing a patient’s stomach fundus wall to the patient’s esophagus. Harris teaches that it is known to affix gastro-intestinal tissue together laparoscopically and further teaches that the laparoscopic approach is advantageous over endoscopic approaches (e.g., down the esophagus) because it avoids the substantial risk of perforating the esophagus and injuring adjacent organs, and allows for extragastric visualization, thereby providing advance warning of a developing life-threatening situation that may require a rescue operation ([0012]). It would have been obvious to one of ordinary skill in the art to have modified the prior art method of Balbierz in view of Swanstrom to perform the affixing and creating steps laparoscopically by first and second instruments as taught by Harris in order to provide the advantages associated with a laparoscopic approach including minimizing the risk of esophageal perforation and allowing extragastric visualization. Applicant asserts that it is unclear how the procedure of affixing the stomach fundus wall to the esophagus using the tool taught by Swanstrom could be performed laparoscopically. This is not found persuasive as Swanstrom discloses that the needle can be inserted through the esophagus and stomach fundus wall from outside the stomach to suture stitch the tissue together (see figs. 8C, 8D, 8E), and thus it is clear that affixing the stomach fundus wall to the esophagus using the tool of Swanstrom could be carried out laparoscopically.
Claim Objections
Claim 895 is objected to because of the following informalities: line 1 should read “…wherein the patient’s stomach fundus wall…”. Appropriate correction is required.
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 894 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.
A dependent claim must include all limitations of the claim from which it depends, such that a dependent claim cannot remove (i.e., disclaim) or contradict a limitation in a claim from which it depends. In view of the amendment to claim 883 requiring affixing the patient’s stomach fundus wall to the patient’s esophagus “by suture stitching of the stomach fundus wall and the esophagus”, it is unclear if applicant is trying to disclaim or remove the requirement of suture stitching in claim 894 since claim 894 includes affixing the patient’s stomach fundus wall to the patient’s esophagus “by suturing or stapling” (noting 894 depends from 883). Note that, if applicant’s intent is to disclaim the earlier limitation, a 35 USC 112d rejection would be appropriate. If the wording in claim 894 is not meant to disclaim the earlier limitation appearing in claim 883, it is unclear how stapling could be considered to read on “suture stitching”. For purposes of claim interpretation, claim 894 is being treated as though it reads “suturing
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 883, 888, 890, 892-896 and 898 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Balbierz et al. (US 2005/0261712) in view of Swanstrom et al. (US 2006/0135971) and Harris et al. (US 2008/0249566). Balbierz discloses a method of preparing for implantation of a movement restriction device for treating a reflux disease in a patient ([0025]-[0027]), the method comprising the steps of creating a pouch from the patient’s stomach tissue only for containing a movement restriction device (10; see fig. 5 or fig. 7, noting pouch formed entirely of stomach wall tissue), the pouch comprising stomach fundus wall tissue of the patient. The movement restriction device creates an obstruction to reduce the effective stomach volume in order to induce weight loss in addition to treating reflux by slowing passage of food into the stomach. Balbierz does not expressly disclose affixing the patient’s stomach fundus wall to the patient’s esophagus, noting the pouch is formed in the fundal wall according to Balbierz ([0027]; fig. 5).
Swanstrom discloses another method for treating reflux disease in a patient, the method comprising affixing the patient’s stomach fundus wall to the patient’s esophagus by suture stitching of the stomach fundus wall and the esophagus in order to modify the angle of His (fig. 5A-5E; [0014], [0076], noting suture “stitching” is being given its broadest reasonable interpretation of passing suture through tissue to affix two pieces of tissue together). It would have been obvious to have modified the prior art of Balbierz to include the step of affixing the patient’s stomach fundus wall to the patient’s esophagus by suture stitching of the stomach fundus wall and the esophagus as taught by Swanstrom in order to further facilitate treatment of gastro-intestinal reflux disease by modifying the angle of His, for the predictable result of further reducing acid reflux.
Balbierz in view of Swanstrom discloses the invention substantially as stated above, but does not expressly disclose that the affixing step is performed laparoscopically.
Harris teaches that it is known to create pouches in gastro-intestinal tissue and affix invaginated gastro-intestinal tissue laparoscopically (figs. 6A-6D; [0025], abstract). Harris further teaches using a first instrument (640/645; figs. 6A-6D) laparoscopically to affix the folded tissue and a second instrument (620/625; fig. 6b) laparoscopically to create the pouch. According to Harris, the laparoscopic approach is advantageous over endoscopic approaches (e.g., down the esophagus) because it avoids the substantial risk of perforating the esophagus and injuring adjacent organs, and allows for extragastric visualization, thereby providing advance warning of a developing life-threatening situation that may require a rescue operation ([0012]). It would have been obvious to one of ordinary skill in the art to have modified the prior art method of Balbierz in view of Swanstrom to perform the affixing step laparoscopically by a first instrument as taught by Harris in order to provide the advantages associated with a laparoscopic approach including minimizing the risk of esophageal perforation and allowing extragastric visualization.
Regarding claim 888, Harris teaches creating a pouch laparoscopically as noted above and it would have been obvious to one of ordinary skill in the art to have modified the prior art of Balbierz in view of Swanstrom to create the pouch laparoscopically in view of the teaching of Harris to allow extragastric visualization and to minimize risk of esophageal perforation.
Regarding claim 890, Balbierz discloses an instrument (claimed “second instrument”) used to create the pouch (see for example, instrument used in figs. 13A-F to create pouch) and Swanstrom teaches an instrument (claimed “first instrument”) that is used to affix the patient’s stomach fundus wall to the esophagus (see instrument used in figs. 5A-5E) and it would have been obvious to have used each of these two instruments in the method of Balbierz as modified by Swanstrom and Harris to carry out their respective steps.
Regarding claim 892, as taught by Swanstrom, affixing the patient’s stomach fundus wall to the patient’s esophagus (figs. 5E-5D) is preceded by a step of dissecting an area of the patient’s stomach and/or esophagus (see needle assembly 74, which pierces esophagus and stomach; [0075] and figs. 5A-5C/ 8C-8E of Swanstrom)
Regarding claim 893, creating the pouch is preceded by the step of dissecting an area of the patient’s stomach (see figs. 13A-13D of Balbierz, noting tissue-piercing instrument 40; [0040]).
Regarding claim 894, affixing the patient’s stomach fundus wall to the patient’s esophagus is achieved by suturing as taught by Swanstrom (see suture 60; [0069] and fig. 5e).
Regarding claim 895, the patient’s stomach fundus wall is affixed to a lower portion of the patient’s esophagus (see fig. 5E of Swanstrom).
Regarding claim 896, the pouch is created so as to form a pouch exhibiting only one opening (i.e., opening at the top of the fold that forms the pouch, noting that the pouch comprises the fold disclosed by Balbierz in which the movement restriction device is inserted as illustrated in fig. 5).
Regarding claim 898, the pouch is created so as to form a pouch having a volume of more than 15 mL (noting movement restriction device can have a volume of 200cc as per claim 3 of Balbierz, and the movement restriction device is held in the pouch).
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 883, 888, 893, 894, and 895 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 8,567,409. Although the claims at issue are not identical, they are not patentably distinct from each other because instant claims 883, 888, and 893-895 are merely broader than claim 16 of ‘409 and are therefore “anticipated” by claim 16 of ‘409, noting that affixing the patient’s stomach fundus wall to the patient’s esophagus “by providing sutures” is considered to make obvious affixing the patient’s stomach fundus wall to the patient’s esophagus by suture stitching, noting that “stitching” is given its broadest reasonable interpretation of connecting pieces of tissue using suture passed through the tissue. Because claim 16 of ‘409 includes the use of laparoscopic ports and a camera, and the movement restriction device is introduced through the hole in the stomach formed by the dissecting tool inserted through the trocar, the creating step of claim 16 of ‘409 is carried out laparoscopically, and it would have been obvious to also carry out the affixing step of claim 16 of ‘409 laparoscopically in order to minimize incisions by using the same laparoscopic ports under visualization of the camera for both the creating and affixing steps.
Claim 890 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of U.S. Patent No. 8,567,409 in view of Harris et al. (US 2008/0249566). Claim 16 of ‘409 claims the invention substantially as stated above including the creating and affixing steps of instant claim 890, but does not claim that the affixing is performed via a first instrument and the creating is performed via a second instrument. Harris teaches that it is known to create pouches in gastro-intestinal tissue and affix invaginated gastro-intestinal tissue laparoscopically (figs. 6A-6D; [0025], abstract). Harris further teaches using a first instrument (640/645; figs. 6A-6D) laparoscopically to affix the folded tissue and a second instrument (620/625; fig. 6b) laparoscopically to create the pouch. According to Harris, the laparoscopic approach is advantageous over endoscopic approaches (e.g., down the esophagus) because it avoids the substantial risk of perforating the esophagus and injuring adjacent organs, and allows for extragastric visualization, thereby providing advance warning of a developing life-threatening situation that may require a rescue operation ([0012]). It would have been obvious to one of ordinary skill in the art to have modified the prior art method of claim 16 of ‘409 to perform the affixing and creating steps laparoscopically by first and second instruments, respectively, as taught by Harris in order to provide the advantages associated with a laparoscopic approach including minimizing the risk of esophageal perforation and allowing extragastric visualization.
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 KATHLEEN SONNETT HOLWERDA whose telephone number is (571)272-5576. The examiner can normally be reached M-F, 8-5, with alternate Fridays off.
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KSH 12/1/2025
/KATHLEEN S HOLWERDA/Primary Examiner, Art Unit 3771