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 .
Claim Objections
Claim 6 is objected to because of the following informalities: the word “circumferentially” is misspelled. Appropriate correction is required.
Claim 9 is objected to because of the following informalities: the word “across” is misspelled. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: the word “wherein” is misspelled. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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) 1-6, 8-10, and 16-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0361066 A1 to Wolfe (hereinafter “Wolfe”) (cited in an IDS dated 12/17/2024).
Regarding claim 1, Wolfe discloses (see abstract; Figs. 1-5; and [0001] & [0008]-[0027]) a device (10) capable of closing a wound (see [0001] & [0026]/[0027]), comprising: a closure element (92) having a delivery configuration ("stretched elastic bands 92", [0023]) and a deployed configuration (Fig. 5; [0024]; "prior to being stretched to fit around the barrel 90"), the closure element configured to extend circumferentially over and around the exterior of an endcap (90) of an endoscope (16) in the delivery configuration (see Fig. 4 and [0023]); and a release filament (94) having a distal end releasably coupled to the closure element (see Fig. 4 and [0023]) and a proximal end extendable within the endcap (see Fig. 4 and [0023]).
Wolfe further discloses (claim 2) wherein the release filament is translatable through the endoscope to displace the closure element off of the distal end of the endcap (see Fig. 4 and [0023]); (claim 3) wherein the proximal end of the release filament extends proximally through the endoscope and terminates outside of a proximal end of the endoscope (at activation cord 34, see Figs. 1/4 and [0023]/[0025]); (claim 4) where the proximal end of the release filament terminates at a handle (32) for actuation within or outside the endoscope (see Figs. 1-2 and [0025]); (claim 5) wherein the release filament is proximally translatable to transition the closure element from the delivery configuration extending over and around the exterior of the endcap to the deployed configuration off the endcap (see [0025]-[0026]); (claim 6) further comprising a plurality of the closure elements that are each separately and releasably coupled to the release filament in the delivery configuration circumferentially disposed over and around the exterior of the end of the endoscope (see Fig. 4 and [0023]); (claim 8) wherein the distal end of the release filament comprises a loop (shown looping over the end of the barrel in Fig. 4); (claim 9) wherein the distal end of the release filament extends across the entire length of the closure element (see Fig. 4); and (claim 10) wherein the closure element, release filament, and endcap are preloaded on an endoscope prior to insertion into a patient (see [0025]-[0026]).
Regarding claim 16, Wolfe discloses (see abstract; Figs. 1-5; and [0001] & [0008]-[0027]) a method of closing a wound (see [0025]-[0027]), the method comprising: inserting an endcap (90) of an endoscope (16) into a patient, wherein at least one closure element (92) is disposed circumferentially around the exterior of the endcap (see Fig. 4 and [0025]) and a release filament (94) extends proximally from a distal end releasably coupled to the at least one closure element, through the interior of the endcap, and to a proximal end (see [0023]-[0026]); placing the end of the endcap about a wound (see [0026]); and translating the release element through the interior of the endcap to transition the at least one closure element from a delivery configuration disposed about the end cap to a deployed configuration about the wound (see [0026]-[0027]).
Wolfe further discloses (claim 17) wherein translating the release element comprises proximally pulling on the release element (see [0023]/[0026]); (claim 18) proximally pulling on the proximal end of the release element from outside the patient (see [0023]/[0026]); (claim 19) further comprising applying suctional force to the endcap to apply suction to the wound to displace at least a part of the wound into the endcap (see [0026]); and (claim 20) further comprising decoupling the distal end of the release filament from the closure element as the release filament is translated proximally into the endcap (see [0023]/[0026]/[0027]).
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.
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.
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolfe.
Regarding claim 7, Wolfe discloses wherein the release filament and the closure element each have a tensile strength (materials inherently have a given tensile strength as this is an inherent property of a particular material), but fails to disclose wherein the release filament tensile strength is greater than the closure element tensile strength. However, it would have further been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, as a matter of being obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (see KSR International Co. v. Teleflex Inc., 550 U.S. 398,82 USPQ2d 1385,1395-97(2007)), to obtain the predictable result of determining the suitable relative tensile strengths of the release filament and closure element such that the release filament can be tensioned to release the closure element without breaking the release filament, since the only three options for the relative tensile strengths are 1) release filament tensile strength greater than closure element tensile strength, 2) release filament tensile strength equal to closure element tensile strength, or 3) release filament tensile strength less than closure element tensile strength. These are finite choices which would allow a person of ordinary skill to determine which relationship of tensile strengths is best suited for allowing the release filament to deploy the closure elements. Further, Applicant's specification does not discuss that the release filament tensile strength being greater than the closure element tensile strength provides an advantage, is used for a particular purpose, or solves a stated problem. The only mention of tensile strength in the specification as filed is at [0006] which merely says that "the release filament may have a tensile strength that is greater than a tensile strength of the closure element", and thus indicates that the tensile strength relationship "may" be in the claimed manner.
Claim(s) 11 and 14-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolfe in view of US 2021/0128157 A1 to Kikuchi (hereinafter “Kikuchi”) (cited in an IDS dated 12/17/2024).
Regarding claim 11, Wolfe discloses (see abstract; Figs. 1-5; and [0001] & [0008]-[0027]) a device (10) capable of closing a wound (see [0001] & [0026]/[0027]), comprising: a closure element (92) having a delivery configuration ("stretched elastic bands 92", [0023]) and a deployed configuration (Fig. 5; [0024]; "prior to being stretched to fit around the barrel 90"), the closure element configured to extend circumferentially over and around the exterior of an endcap (90) of an endoscope (16) in the delivery configuration (see Fig. 4 and [0023]); and a release filament (94) having a distal end releasably coupled to the closure element (see Fig. 4 and [0023]) and a proximal end extendable within the endcap (see Fig. 4 and [0023]); wherein the deployed configuration of the closure element is a shape-memory configuration (see [0023]-[0024], the deployed configuration is the non-stretched configuration of the elastic band and thus is a shape-memory configuration, which can be made of rubber, it is further noted that Applicant's specification defines "rubber" as a shape-memory material as per [0048] of the spec. as filed) configured to substantially close about the wound in the deployed configuration (see [0001]/[0024]/[0026]).
Wolfe further discloses (claim 14) wherein the shape-memory configuration of the closure element is a torus (see Fig. 5 and [0024]); and (claim 15) wherein, when in the shape memory configuration, the closure element is configured to encircle the wound (see [0001]/[0024]/[0026]).
Wolfe fails to specifically disclose, with respect to claim 11, wherein the closure element is formed of a metal material. Kikuchi discloses, in the same field of endeavor, a ligation device comprising a closure element (ligation ring 5) disposed about an endcap (10) connected to an endoscope (2), wherein the closure element is formed of a metal material (see [0057], material includes a metal as listed in addition to a rubber as disclosed at [0057]) for the purpose of making the closure element radiopaque for imaging purposes (see [0057]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Wolfe's device so that the closure element contains metal in order to make the closure element radiopaque for imaging purposes.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wolfe in view of Kikuchi, as applied to claim 11 above, and further in view of US 2010/0057101 A1 to Karpiel (hereinafter “Karpiel”) (cited in an IDS dated 12/17/2024).
Regarding claims 12 and 13, the combination of Wolfe and Karpiel discloses the invention substantially as claimed as discussed above, however, the combination fails to specifically disclose wherein the closure element has a first terminal end and a second terminal end; and wherein each terminal end of the closure element includes a protrusion configured to engage tissue.
Karpiel discloses (see abstract; Figs. 1-6; and [0022]-[0028]), in the same field of endeavor, a device (20) capable of closing a wound (see [0028]), comprising: a closure element (50) having a delivery configuration (Fig. 1/Fig. 4; see also [0024]-[0027]), and a deployed configuration (Fig. 5), the closure element configured to encircle the exterior of an endcap (30) (elastic band 42, part of closure element 50, encircles the endcap as per [0023] and Figs. 1-2) of an endoscope (24) in the delivery configuration (see Fig. 1 and [0022]-[0026]); and a release filament (40 + 48) having a distal end releasably coupled to the closure element (see [0023]) and a proximal end extendable within the endcap (see Fig. 1 and [0023]-[0028]); wherein the closure element is configured to substantially close about the wound in the deployed configuration (see [0027]-[0028]), wherein the closure element extends along a length between terminal ends (see Fig. 4 of Karpiel, the length can be defined as connection members 70/72 extending out to terminal ends 60 of 56/58) and wherein the closure element includes protrusions (60, see Fig. 4 and [0024]/[0026]) configured to engage tissue for the purpose of engaging the tissue around a perforation to close the perforation in a reliable way without the need for sutures or other devices (see [0028]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Wolfe’s ligating band device (as modified above) with the ligating band deployed staple taught by Karpiel in order to engage tissue around a perforation to close the perforation in a reliable way without the need for sutures or other devices.
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 and 6-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 8 of U.S. Patent No. 12,127,742 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the current claims are broader than, and thus are “anticipated by”, the claims of the ‘742 patent as follows, with reference to the column/line numbers of the issued ‘742 patent.
Regarding current claim 1, ‘742 claim 1 recites: A device for closing a wound (C11L38), the device comprising: a closure element having a delivery configuration and a deployed configuration (C11L39-40), the closure element configured to extend circumferentially over and around the exterior of an endcap of an endoscope in the delivery configuration (C11L40-C12L3); and a release filament having a distal end releasably coupled to the closure element (C12L9-10), and a proximal end extendable within the endcap (C12L10-11).
Further, there is correspondence between current claim 6 and ‘742 patent claim 2 and current claim 7 and ‘742 patent claim 8.
Claims 11-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 9 of U.S. Patent No. 12,127,742 B2 in view of Kikuchi.
Regarding current claim 11, ‘742 claim 1 recites: 11. A device for closing a wound (C11L38), the device comprising: a closure element having a delivery configuration and a deployed configuration (C11L39-40), the closure element configured to extend circumferentially over and around the exterior of an endcap of an endoscope in the delivery configuration (C11L40-C12L3); and a release filament having a distal end releasably coupled to the closure element (C12L9-10), and a proximal end extendable within the endcap (C12L10-11); wherein the deployed configuration of the closure element is a shape memory configuration configured to substantially close about the wound in the deployed configuration (C12L12-
‘742 patent claim 1 does not recite wherein the closure element is formed of a metal material. Kikuchi discloses, in the same field of endeavor, a ligation device comprising a closure element (ligation ring 5) disposed about an endcap (10) connected to an endoscope (2), wherein the closure element is formed of a metal material (see [0057], material includes a metal as listed in addition to a rubber as disclosed at [0057]) for the purpose of making the closure element radiopaque for imaging purposes (see [0057]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 1 of the ‘742 patent so that the closure element contains metal in order to make the closure element radiopaque for imaging purposes.
Further, there is correspondence between current claim 12 and ‘742 patent claim 1; current claim 13 and ‘742 patent claim 1; current claim 14 and ‘742 patent claim 3; and current claim 15 and ‘742 patent claim 9.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771