DETAILED ACTION
This is the first office action on the merits in this application. The office action is issued in view of the amendment of April 24, 2024. Claim 1 was canceled and claims 2-15 were newly presented. Claims 2-15 are pending.
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 .
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.
Claim 2-11 and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 8-10, 17, 18, 21, 27-30, 40 and 48 of U.S. Patent No. 10,232,143 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are considered to be fully anticipated by the claims of the ‘143 patent.
Claims 2-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,826,521. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are considered to be fully anticipated by the claims of the ‘143 patent.
Claim Objections
Claim 2 is objected to because of the following informalities: as presented, it is not clear which clauses are included in the “comprising” of line 2. Examiner believes only the content of lines 3-4 is intended to fall within this comprising limitation. However, as written, it is possible that lines 5-8 were also intended to fall within the comprising limitation. Examiner understands the claim in the first was as he understands the claimed “injectate delivery unit” to be a structure distinct from the delivery device. 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.
Claim(s) 2-4, 7-13 and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silverman et al. (US 6,540,789 B1).
Regarding claim 2, Silverman teaches a system as at figs. 1 and 2 for treating a patient 21 comprising:
a delivery device 41 comprising:
an elongate shaft 42 with a distal portion 43 and at least one delivery element 44 positioned on the elongate shaft 42 distal portion 43;
an injectate (saline and implant forming solution – forming implants 52) configured to expand when delivered into tissue (as by using the delivery device 41 to form ‘enlargements’ within the muscle layer of the wall 27, described at col. 8, lines 18-20); and
an injectate delivery unit (e.g. syringe – col. 2, lines 44-50) configured to determine an amount of the injectate to be delivered based on a measured luminal diameter (use of ultrasound or fluoroscopy or ultrasound to measure enlargements formed by saline: col. 8, lines 35-45) in order to be capable of narrow a lumen of a segment of the stomach to an inner diameter that is less than or equal to 10mm;
wherein the delivery device 41 is configured to deliver, based on the determined amount of injectate, the injectate through the at least one delivery element 44 into luminal wall tissue 27 of the lower stomach as in fig. 2 to be capable of narrowing the lumen of the segment of the lower stomach to the inner diameter that is less than or equal to 10mm.
Examiner treats several of the limitations in this claim as intended use limitations which are capable of being carried out by the Silverman device.
Regarding claim 3, the tissue comprises luminal wall tissue 27 as seen at fig. 2.
Regarding claim 4, the luminal wall tissue comprises submucosal tissue 34 as seen at fig. 2, col. 9, line 65 – col. 10, line 5).
Regarding claim 7, the injectate comprises at least two materials (saline and implant forming solution).
Regarding claims 8-10, the delivery device 41is capable of delivering the injectate to narrow a lumen of a segment of the stomach to an inner diameter that is less than or equal to 5mm, 4mm, or 3mm.
Regarding claim 11, the injectate comprises biocompatible polymer (col. 3, line 53 – col. 5, line 8).
Regarding claim 12, the injectate comprises collagen (col. 2, line 55 – col. 3, line 10).
Regarding claim 13, the injectate is further configured to polymerize when delivered into tissue (col. 6, lines 51-64; col. 8, lines 61-64).
Regarding claim 15, the segment of the stomach is capable of being a segment of the lower stomach as seen at fig. 2.
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(s) 5 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Silverman.
Regarding claims 5 and 6, Silverman teaches the limitations of claim 2, but does not teach use of two delivery elements.
It would have been obvious to one with ordinary skill in the art at the time of the invention to utilize additional delivery elements in order to reach different lengths, curves, or to accommodate particular patient anatomies. Even further, use of a second or third delivery element in event of failure of a first element would have been obvious. Doing so would have been merely a duplication of parts.
Regarding claim 14, Silverman teaches the limitations of claim 2 but does not teach the injectate including hyaluronic acid.
Silverman teaches a vast variety of materials which can be used as part of the injectate. (col. 3, line 10 col. 5, line 50; etc.)
No particular reason or advantage for use of hyaluronic acid is disclosed.
Examiner takes official knowledge of hyaluronic acid being used as an additive to injections to reduce post operative pain and swelling and improve healing. It would have been obvious to one with ordinary skill in the art at the time of the invention to include hyaluronic acid as an additive to the injectate in order to reduce post-operative pain and swelling and improve healing of the surgical site.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to David Bates whose telephone number is (571)270-7034. The examiner can normally be reached Monday through Friday, 10AM-6PM
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/DAVID W BATES/Primary Examiner, Art Unit 3799