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
This office action is responsive to the preliminary amendment filed on 12/19/2024. As directed by the amendment: claims 4-9 have been cancelled. Thus, claims 1-3 and 10 are presently pending in this application.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
1
11
wherein the one end of each suture exits the suture cartridge that corresponds to it
wherein the one end of each suture exits the corresponding suture cartridge
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 10 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.
Claim 10 recites the limitation "wherein the anchor assembly that comprises the holders" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. “Holders” is not positively recited in claim 10 or claim 1, which claim 10 is dependent on as part of the anchor assembly. For the purpose of prior art examination this limitation will be interpreted as “the two suture cartridges”. 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.
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) 1-3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Madsen et al (US 20180303470 A1), herein referenced to as “Madsen” in view of Gordon et al (US 5540704 A), herein referenced to as “Gordon”.
Claim 1
Madsen discloses: A kit 100 (see Fig. 3, [0074]) for assembling an incision closing trocar comprising a cannula 110 (see Fig. 3, [0074]) having a lumen hollow cannula (see Fig. 3, [0074]), a cannula proximal side proximal side of 110 (see Fig. 3) and a cannula distal side distal side of 110 (see Fig. 3), the kit comprising: an obturator 200 (see Fig. 3, [0074]) comprising: a shaft 210 (see Fig. 3, [0074]) having a distal end distal end of 210 (see Fig. 3, [0075]) and a proximal end proximal end of 210 (see Fig. 3, [0075]); at least two anchor recesses 255 (see Figs. 4 and 11, [0081], [0099], and [0101]) provided near the distal end distal end of 210 (see Figs. 4 and 11), each of the anchor recesses 255 being configured to retain a corresponding anchor 340 (see Figs. 3-4 and 11, [0077] and [0099]); a handle 360 (see Figs. 3-4, [0076]) at the proximal end proximal end of 210 that is configured to actuate (see [0075], 360 coupled to 310 which is engaged to 320) at least two pushers 320 (see Figs. 3-4, [0076]) for pushing the corresponding anchors 340 (see [0092]) from the anchor recesses 255; an anchor assembly 220 (see Figs. 10-11, [0098]) comprising two suture cartridges 230 (see Figs. 10-11, [0075], spool is a removable cartridge, number of 230 equal to number of anchors 340, 2 anchors and 2 suture cartridges), each suture cartridge 230 holding a folded or coiled suture 350 (see [0075] and [0083], coiled thread, in this case suture) having a length the length of suture (see [0075]) and one end the end of suture attached to the anchors 340 (see [0023]), wherein the one end of each suture 350 exits the suture cartridge 230 (see Fig. 11, exits through 260, [0083]) that corresponds to it the end of suture attached to the anchors 340 and is attached to the corresponding anchor 340; wherein the obturator 200 is sized to be inserted (see Figs. 3 and 16) from the proximal side proximal side of 110 into the cannula 110, such that the at least two anchor recesses 255 are within the lumen the lumen of 110 (see Figs. 3 and 16, the recesses are within 110, as 112 is the exit of the recessed at the cannula) when the obturator 200 is fully inserted into the cannula 110.
Madsen does not explicitly disclose: and an anchor holder holding the corresponding anchor such that they can easily be removed from the anchor holder, wherein the length of the suture can be pulled out from a corresponding suture cartridge when the anchor holder with the at least two anchors attached to it are pulled away from the anchor assembly, and the anchor holder is sized so that the at least two anchors can be inserted, each to a corresponding anchor recess while the anchors are held by the anchor holder, so that the sutures remain outside the cannula, and wherein the anchor holder can be removed so that each anchor is left in its corresponding anchor recess.
However, Gordon in a similar field of invention an endoscopic suturing system 304 (see Figs. 25-27) with an obturator 306 (see Figs. 25-27) with a distal end the distal end of 306 with at least two anchor recesses 364 (see Figs. 25-27), at least two anchors 314a + 314b (see Figs. 25-27), sutures 316a + 316b (see Fig. 25). Gordon further teaches: and an anchor holder 346 (see Figs. 27-28C, col. 23, lines 17-23) holding the corresponding anchor 314a + 314b (see Fig. 27, each 350B of 346 holds 314) such that they can easily be removed from the anchor holder (see Figs. 28A-28C, col. 23, lines 23- 43, the anchors being removed from 346 into the corresponding anchor recesses 364) and the anchor holder 346 is sized so that the at least two anchors 314a + 314b can be inserted, each to a corresponding anchor recess 364 (see Figs. 27-28C) while the anchors 314a + 314b are held by the anchor holder 346, and wherein the anchor holder 364 can be removed (Figs. 27-28C, col. 23, lines 17-43, 346 is a needle loader, that loads the needles (314), and then can be removed after loading the needles, see Figs. 25-26, the device without the loader) so that each anchor 314a + 314b is left in its corresponding anchor recess 356.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Madsen to incorporate the teachings of Gordon and teach a kit for assembling an incision closing trocar with an anchor holder holding the corresponding anchor such that they can easily be removed from the anchor holder, and the anchor holder is sized so that the at least two anchors can be inserted, each to a corresponding anchor recess while the anchors are held by the anchor holder, and wherein the anchor holder can be removed so that each anchor is left in its corresponding anchor recess. Motivation for such can be found in Gordon as this allows a user to have a loading system to quickly and easily place needles onto the applicator to prepare it for use in the body (see col. 4, lines 19-24).
The language, " wherein the length of the suture can be pulled out from a corresponding suture cartridge when the anchor holder with the at least two anchors attached to it are pulled away from the anchor assembly," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Madsen and Gordon meets the structural limitations of the claim, and is capable of the length of sutures be pulled from the spool cartridges while the anchor holder has the two anchors attached to it, as the modified device (see Gordon Fig. 27), the anchors have the suture attached before loaded into the suture recesses, pulling the anchor holder away would pull out the suture from the spools, which are part of the anchor assembly which is integral to the trocar unlike the anchor holder.
The language, " so that the sutures remain outside the cannula," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Madsen and Gordon meets the structural limitations of the claim, and is capable of having the suture remain outside of the cannula, as the suture is at the distal tip of end of the obturator which extends out of the cannula, hence the suture would remain outside of the cannula.
Furthermore, wherein in product and apparatus claims, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See MPEP 2112.01 I.
Claim 2
The combination of Madsen and Gordon teaches: The kit of claim 1, see 103 rejection above. Madsen further discloses: wherein the anchor assembly 220 further comprises a connecting member 224 + 228 (see Figs. 10-11, [0098]) connecting the two suture cartridges 230, and wherein the connecting member 230 is sized so that the anchor assembly 220 can be attached (see Fig. 2-3 and 16, 220 can be inserted through the proximal port of 110 to be attached as whole along with 200 to 110, see Fig. 16) to an insertion cup the proximal port of 110 (see Fig. 3) of the cannula 110.
Claim 3
The combination of Madsen and Gordon teaches: The kit of claim 1, see 103 rejection above. Madsen further discloses: wherein the anchor assembly 220 further comprises a sealing set 226 (see Fig. 10, [0098], protrusions that match into depression to ensure a tight connection, hence a sealing set).
Claim 10
The combination of Madsen and Gordon teaches: The kit of claim 1, see 103 rejection above. Madsen further discloses: wherein the anchor assembly 220 that comprises the holders 230 (see 112b rejection above interpreted as the suture cartridges, see Fig. 11, [0098], 230 is within the shaft 210 of 200, hence integrated with 200) is integrated into the obturator 200.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAIHAN R KHANDKER whose telephone number is (571)272-6174. The examiner can normally be reached Monday - Friday 7:00 PM - 3:00 PM.
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771