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
Claims 1-10 and 12-18 are pending in the application. Claims 1-8 have been withdrawn from consideration. Claims 11 and 19-22 have been canceled. Claims 9, 10, 12-15, 17, and 18 have been amended.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/3/25 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 9, 10, and 12-18 are 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 9 recites the limitation "the deployed elastic band" in line 26. There is insufficient antecedent basis for this limitation in the claim. NOTE: in addition to the insufficient antecedent basis, it is unclear if the claim is referring to the first of the two or more elastic bands or the second of the two or more elastic bands, or both. Appropriate correction is required.
Claims 10 and 12-18 are all dependent on rejected claim 9, thus are also rendered indefinite. Appropriate correction is required.
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.
Claims 9, 10, and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Stokes et al. (US 2012/0165842 A1) (“Stokes”) in view of Ducharme (US 2008/0287965 A1) and Noda (US 2012/0253362 A1).
Regarding claims 9, 12-14, and 17, Stokes discloses (Figures 1, 15, 16A-16C) a method for resecting a body tissue in a patient to treat excess weight/obesity/diabetes (paragraphs 0002-0008), comprising: providing a device (1510) configured to pass through an endoscope (2) comprising: a cap (1520) positioned on the distal end of the device, wherein the cap comprises a lumen; and two or more elastic bands (1560a, 1560b) positioned around an outer surface of the cap (Figure 15, 16A-16C), each of the two or more elastic bands is configured to change from a first configuration (Figure 16A) when positioned on the cap to a second configuration (Figure 16C) once deployed off the cap, wherein each of the two or more elastic bands is separately deployable off the cap (via pull strings 1572a, 1572b, paragraphs 0118, 0120), wherein, in the second configuration, each of the two or more elastic bands is configured to encircle a portion of said body tissue (8); inserting the device (1510) through the endoscope into the patient and advancing the device such that a distal end of the device is positioned in a gastrointestinal tract of the patient; activating a suction source to apply a negative pressure through the lumen of the cap (paragraph 0120); drawing a portion of body tissue into the lumen of the cap (Figures 16A, 16B); deploying a first (1560a) of the two or more elastic bands (1560a, 1560b) from the device around a base of the body tissue (Figures 16B, 16C); and deploying a second (1560b) of the two or more elastic bands (1560a, 1560b) from the device around a base of the body tissue (paragraph 0120).
However, Stokes fails to disclose that each of the two or more elastic bands has an inner surface comprising at least one anchor that anchors into the tissue in the second configuration using the at least one anchor, wherein the at least one anchor comprises a wire having at least one first portion attached to one of the two or more elastic bands and at least one second portion extending out of and toward a center of the one of the two or more elastic bands, wherein the wire comprises Nitinol (a shape memory material), wherein, in the second configuration, the at least one second portion of the wire is configured to attach to the body tissue, and wherein, in the second configuration, the at least one second portion of the wire is in the shape of a spike and is configured to pierce the body tissue. Stokes fails to explicitly disclose constricting the tissue and reducing blood flow to the tissue and permitting the deployed elastic band to remain around the body tissue and to cut off blood flow to the body tissue. Stokes fails to disclose the portion includes at least 1 square centimeters of body tissue. Stokes also fails to explicitly disclose removing the device from the patient.
Ducharme teaches (Figures 1-6) that applying an elastic band or ligature (45) around a portion of tissue (40) cuts off blood or fluid flow and causes the tissue to necrose and separate from adjacent healthy tissue (paragraphs 0004 and 0027). Once the tissue has necrosed, the tissue along with the elastic band passes through the body (paragraph 0027). Ducharme further teaches (Figure 6) removing the device from the body after applying the band/ligature.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Stokes such that the tissue is constricted by each of the two or more elastic bands to reduce blood flow to the tissue and to permit the two or more elastic bands to remain around the body tissue and to cut off blood flow to the body tissue, as taught by Ducharme. It would have also been obvious to remove the device from the patient after applying the elastic bands, as taught by Ducharme. These modifications would cause the tissue to necrose and separate from adjacent healthy tissue and pass through the body (Ducharme, paragraph 0027).
Noda teaches (Figures 11-13D) an elastic band (122) comprising a first configuration when positioned on a delivery device (Figure 12; paragraph 0037), wherein the elastic band comprises an inner surface comprising at least one anchor (124) that anchors into the tissue in the second configuration using the at least one anchor (paragraph 0037), wherein the at least one anchor (124) comprises a wire (paragraph 0036) having at least one first portion (126) attached to the elastic band (Figure 11) and at least one second portion extending out of and toward a center of the one of the two or more elastic bands (Figures 11-13D, paragraph 0036). Noda teaches that the wire (124) comprises a shape memory material in the form of Nitinol (paragraph 0036). Noda teaches that in the second configuration (Figure 13A), the at least one second portion of the wire is configured to attach to the body tissue (130; paragraphs 0036-0037). Noda teaches that in the second configuration (Figure 13A), the at least one second portion of the wire is in the shape of a spike (paragraph 0036) and is capable of piercing the body tissue (130; paragraphs 0036-0037).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the elastic bands taught by Stokes in view of Ducharme above to further comprise an inner surface comprising at least one anchor that anchors into the tissue in the second configuration using the at least one anchor, wherein the at least one anchor comprises a wire having at least one first portion attached to one of the two or more elastic bands and at least one second portion extending out of and toward a center of the one of the two or more elastic bands, wherein the wire comprises Nitinol (a shape memory material), wherein, in the second configuration, the at least one second portion of the wire is configured to attach to the body tissue, and wherein, in the second configuration, the at least one second portion of the wire is in the shape of a spike and is configured to pierce the body tissue, as taught by Noda. This modification would provide the elastic bands with additional structure to grip and/or dig into the tissue to prevent slippage of the elastic band off of the tissue (Noda, paragraphs 0036-0037).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by Stokes in view of Ducharme and Noda such that the cap is sized to allow at least 1 square centimeter of body tissue to be drawn into the cap, since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst, Inc., 725 F.2d 1338, 220 USPQ (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the method and cap taught by Stokes in view of Ducharme and Noda would not operate differently. Further, Applicant places no criticality on the range claimed (1 square centimeter or greater), indicating simply that: “the portion includes at least 1 square centimeters of body tissue” (paragraph 0049) and “the portion includes at least 5 square centimeters of body tissue” (paragraph 0064). See paragraphs 0049 and 0064 of the specification.
Regarding claim 10, Stokes as modified by Ducharme and Noda teaches (Stokes, Figures 1, 15, 16A-16C) that each of the two or more elastic bands (1560a-d) is adapted to have a first configuration (Figure 16A) with a circumference of M when subjected to a pressure and adapted to automatically transition to a second configuration (Figure 16C) with a circumference of N when the pressure is removed, where N is less than M (Stokes, paragraph 0120).
Regarding claim 15, Stokes as modified by Ducharme and Noda teaches (Stokes, Figures 1, 15, 16A-16C) teaches that the device further comprises 1 to 8 elastic bands (1560c, 1560d) in addition to the two or more elastic bands (1560a, 1560b) and wherein each of the 1 to 8 elastic bands (1560c, 1560d) is positioned around the outer surface of the cap (Stokes, Figure 15).
Regarding claim 16, Stokes in view of Ducharme and Noda teaches that the device (1510) further comprises a catheter (1512) extending between the cap (1520) and the suction source (Stokes, paragraph 0119).
Regarding claim 18, Stokes in view of Ducharme and Noda teaches determining a therapeutic endpoint (weight loss benefit while buying time for the lifestyle changes necessary to maintain the weight loss) corresponding to the treatment of excess weight/obesity/diabetes after performing the method for resecting the patient’s body (Stokes, paragraphs 0002-0008).
Response to Arguments
Applicant’s arguments with respect to claims 9, 10, and 12-18 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. The Noda reference is newly cited in the current rejections.
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.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771