CTNF 19/028,637 CTNF 80840 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority 02-09 AIA Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows: 02-10 AIA The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc. , 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994). The disclosure of the prior-filed application, Application No s. 14/924,087; 13/328,003; and 12/485,576 as well as Provisional Application Nos. 61/459,970; 61/483,679; 61/162,249; and 61/073,340, each fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. None of the cited priority documents discloses a suturing system comprising a blunt tip portion at a distal/second end of the tubular body. Accordingly, claims 1-20 have a priority date of June 28, 2019 (i.e., the filing date of 16/456,692 appears to be the first instance of disclosure having proper support for “a blunt tip portion”) . 07-30-03-h AIA Claim Interpretation 07-30-03 AIA The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. 07-30-05 The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as "configured to" or "so that"; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. 07-30-06 This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a retaining structure” in claim 4. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Objections 07-29-01 AIA Claim 15 (and thereby dependent claims 16-20) is objected to because of the following informalities: In claim 15, there is an apparent minor typographical error in line 6 at “having a a first end” (wherein a minor amendment such as “having a [[a]] first end” will moot this objection) . Appropriate correction is required. Claim Rejections - 35 USC § 112 07-30-02 AIA 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. 07-34-01 Claims 3-8 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. The current claim set includes two separate instances of a claim 3 , thereby introducing uncertainty and ambiguity as to which claim 3 is the claim from which claims 4-8 depend. Appropriate correction is required. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. 07-20-aia AIA 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. 07-23-aia AIA The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim (s) 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mitelberg (US 2012/0150200) in view of Yoon (US 6,086,601) . Mitelberg discloses (see Figs. 70-78) an endoscopic needle assembly comprising the following claim limitations: (claim 1) An endoscopic suturing system comprising: an end effector assembly (as shown in Figs. 72A-75) including a base (734, Fig. 72A) couplable to an endoscope (712, Fig. 72A), and an anchor holder arm (740, Fig. 72A) rotatable relative to said base (734) (rotation shown in Figs. 72A-73B); and a suture anchor (741, Figs. 72A and 76A) having a proximal end (e.g., adjacent 808a/808b, Fig. 78) configured to be operably couplable with said anchor holder arm (740) (as expressly shown in Fig. 78), and a tip portion (802, Fig. 78) at a distal end (e.g., adjacent 804a/804b, Fig. 77B) thereof (as expressly shown in Figs. 76A-78); (claim 2) wherein said suture anchor (741) comprises a tubular body with a tubular wall (as shown in Figs. 76B) defining a suture hole (809, Fig. 76B) extending radially through the tubular wall and configured to receive an end of a suture (as shown in Fig. 76A); (“first” claim 3) wherein said tubular body includes one or more suture tabs (806a/806b, Figs. 76A-76B) extending radially inwardly to engage the suture (748) to retain the suture (748) within said tubular body (as shown in Fig. 76A; [0227]); (“second” claim 3) wherein said suture anchor (741) comprises a tubular body configured to removably engage said anchor holder arm (740) to removably retain said suture anchor (741) on said anchor holder arm (740) (as shown in Figs. 77B-78; [0227]-[0228]); (claim 4) wherein said tubular body defines a retaining structure (808a/808b, Figs. 76A-78) at an open proximal end (as shown in Fig. 76B) thereof configured to receive and engage a distal end of said anchor holder arm (740) (as expressly shown in Fig. 78); (claim 5) wherein said retaining structure includes one or more needle holder tabs (808a/808b) extending radially inwardly from said tubular body to engage said anchor holder arm (740) received within said tubular body (as expressly shown in Fig. 78); (claim 6) wherein said tubular body has an open distal end configured to receive a portion of said tip portion (802) (as expressly shown in Figs. 76A-78); (claim 7) wherein said tubular body includes one or more tip tabs (804a/804b, Fig. 77B) extending radially inwardly to engage the portion of said tip portion (802) received in the open distal end of said tubular body (as expressly shown in Figs. 77-78); (claim 8) wherein said tip portion (802) defines a tab groove portion (814, Fig. 77B) configured and positioned to be engaged with said tip tabs (804a/804b) of said tubular body to retain said tip portion (802) with respect to said tubular body (as expressly shown in Figs. 77B-78); (claim 9) wherein said tip portion (802) defines a capture groove (812, Fig. 77B) configured to be engaged by a capture device (730, Fig. 79) configured to remove said suture anchor (741) from said anchor holder arm (740) (as shown in Fig. 83B; [0225]; [0227]; [0229]; [0231]; [0232]); (claim 10) further comprising an endoscope (712, Figs. 70-73B); (claim 11) An endoscopic suturing system anchor and suture assembly comprising: an end effector assembly (as shown in Figs. 72A-75) including a base (734, Fig. 72A) couplable to an endoscope (712, Fig. 72A), and an anchor holder arm (740, Fig. 72A) rotatable relative to said base (734) (rotation shown in Figs. 72A-73B); a suture anchor (741, Figs. 72A and 76A) configured to be operably coupled with said anchor holder arm (740) and having a tip portion (802, Fig. 78) (as expressly shown in Fig. 78); and a tissue grasper (26, Figs. 14-15) configured to grasp tissue to pull tissue into the path of said anchor holder arm (740) (as expressly shown in Figs. 24-28); (claim 12) wherein said suture anchor (741) is configured to be removably coupled with said anchor holder arm (740) (see Fig. 78; [0228]; removable coupling expressly disclosed); (claim 13) wherein said suture anchor (741) includes a tubular body configured to engage a suture (748) (as expressly shown in Figs. 76A-78); (claim 14) further comprising an endoscope (712, Figs. 70-73B); (claim 15) An endoscopic suturing system comprising: an end effector assembly (as shown in Figs. 72A-75) including a base (734, Fig. 72A) couplable to an endoscope (712, Fig. 72A), and an anchor holder arm (740, Fig. 72A) rotatable relative to said base (734) (rotation shown in Figs. 72A-73B); a suture anchor (741, Figs. 72A and 76A) having a first end releasably coupled (via 808a/808b, Fig. 78) with said anchor holder arm (740) and a second end (via 804a/804b, Fig. 77B) with a tip (802, Fig. 76A); and a capture device (730, Fig. 79) configured to engage said suture anchor (741) to remove said suture anchor (741) from engagement with said anchor holder arm (740) and to retain said suture anchor (741) in engagement with said capture device (730) (as expressly shown in Fig. 83B); (claim 16) wherein said suture anchor (741) includes a tubular body with one or more needle holder tabs (808a/808b) extending radially inwardly for releasably retaining said tubular body relative to said needle holder arm (740) (as shown in Fig. 76A and 77B-78); (claim 17) wherein said needle holder tabs (808a/808b) are elastically deformable to allow said tubular body to be released from said needle holder arm (740) when engaged with said capture device (730) (see Fig. 83B; [0228]; [0231]); (claim 18) wherein said tip (802) defines a capture groove portion (812, Fig 77B) configured to be engaged by said capture device (730) to retain said tip (802) engaged with said capture device (730) (as shown in Fig. 83A; [0231]; capture and engagement expressly disclosed); (claim 19) wherein said suture anchor (741) comprises a tubular body (shown in Fig. 76B) having a first end (i.e., adjacent 808a in Fig. 76B) defining an opening at the first end of said suture anchor (741) configured to releasably receive an end of said anchor holder arm (740) (as expressly shown in Fig. 78), and a second end (i.e., adjacent 804 in Fig. 76B) from which said tip (805) extends (as shown in Fig. 76A), wherein a suture opening (809, Fig. 76B) is defined radially through said tubular body (as shown in Figs. 76A-76B), said system further comprising a suture (748, Fig. 76B) with an end (818) extending through the suture opening (809) and retained within said tubular body (as expressly shown in Figs. 76A and 77A-77B); and (claim 20) further comprising an endoscope (712, Figs. 70-73B). Mitelberg, as applied below, claims an endoscopic suturing system comprising all the limitations of the claim except for the tip portion being blunt. Yoon teaches a similar suturing system comprising a blunt tissue penetrating tip (col. 11, lines 16-22). Accordingly, Yoon teaches that it is known that a sharp tissue penetrating tip and a blunt tissue penetrating tip are elements that are functional equivalents for providing passage through tissue for a suturing system or method. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the blunt tissue penetrating tip taught by Yoon for the sharp tissue penetrating tip of Mitelberg because both elements were known equivalents for providing passage through tissue for a suturing system or method within the suturing art. The substitution would have resulted in the predictable results of providing passage through tissue for the suturing system or method of Mitelberg . Double Patenting 08-33 AIA 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. 08-34 AIA Claim s 1-7, 9-10 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 6-12 of U.S. Patent No. 9,198,562 in view of Yoon (US 6,086,601) . Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the instant application are broader variants of the claims of the patent and this anticipate the claims of the patent, as set forth below. See MPEP 2131.02(I) . U.S. Patent No. 9,198,562, as applied below, claims an endoscopic suturing system comprising all the limitations of the claim except for the tip portion being blunt. Yoon teaches a similar suturing system comprising a blunt tissue penetrating tip (col. 11, lines 16-22). Accordingly, Yoon teaches that it is known that a sharp tissue penetrating tip and a blunt tissue penetrating tip are elements that are functional equivalents for providing passage through tissue for a suturing system or method. Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have substituted the blunt tissue penetrating tip taught by Yoon for the sharp tissue penetrating tip of Mitelberg because both elements were known equivalents for providing passage through tissue for a suturing system or method within the suturing art. The substitution would have resulted in the predictable results of providing passage through tissue for the suturing system or method of Mitelberg. Present Invention U.S. Pat. No. 9,198,562 1 6-12 2 12 3 8,10-12 4 6-12 5 8 6 10-12 7 11 9 6-12 10 6-12 15 6-12 16 8 17 8 18 9 19 12 20 6-12 Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : see Le et al. (US 5,545,180) also teaching the substitutability of blunt needle points for tapered/cutting needle points (col. 8, lines 56-60) . 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 Application/Control Number: 19/028,637 Page 2 Art Unit: 3771 Application/Control Number: 19/028,637 Page 3 Art Unit: 3771 Application/Control Number: 19/028,637 Page 4 Art Unit: 3771 Application/Control Number: 19/028,637 Page 5 Art Unit: 3771 Application/Control Number: 19/028,637 Page 6 Art Unit: 3771 Application/Control Number: 19/028,637 Page 7 Art Unit: 3771 Application/Control Number: 19/028,637 Page 8 Art Unit: 3771 Application/Control Number: 19/028,637 Page 9 Art Unit: 3771 Application/Control Number: 19/028,637 Page 10 Art Unit: 3771 Application/Control Number: 19/028,637 Page 11 Art Unit: 3771 Application/Control Number: 19/028,637 Page 12 Art Unit: 3771 Application/Control Number: 19/028,637 Page 13 Art Unit: 3771 Application/Control Number: 19/028,637 Page 14 Art Unit: 3771 Application/Control Number: 19/028,637 Page 15 Art Unit: 3771 Application/Control Number: 19/028,637 Page 16 Art Unit: 3771 Application/Control Number: 19/028,637 Page 17 Art Unit: 3771
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