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 Arguments
This Office action is in response to the applicant’s communication filed on 9/17/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 6, with respect to Applicant’s claim amendments made in view of the previous claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn.
Applicant's arguments, see page 6, with respect to the 35 U.S.C. §112(f) interpretation of “a retaining structure” in claim 4 have been fully considered but they are not persuasive. Applicant’s arguments fail to disclosure any structure provided in “a retaining structure” and are merely conclusory “contextual” statements that fail to provide any evidence of affirmative structure found in claim 4. For at least these reasons, Applicant’s arguments are not persuasive.
Applicant’s arguments, see page 6, with respect to the 35 U.S.C. §112(f) interpretation of “a retaining structure” in claim 5 is moot. The previous office action expressly set forth the 35 U.S.C. §112(f) interpretation of “a retaining structure” only in claim 4. The Examiner agrees that claim 5 adds sufficient structure to not be interpreted under 35 U.S.C. §112(f), and therefore such a 35 U.S.C. §112(f) interpretation was not part of the previous office action regarding claim 5.
Applicant’s arguments, see page 6, with respect to Applicant’s claim amendments made in view of the previous 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn.
Applicant’s arguments, see pages 6-7, with respect to Applicant’s claim amendments made in view of the previous double patenting rejections have been fully considered and are persuasive. The previous double patenting rejections have been withdrawn.
Applicant's arguments, see pages 7-8, allege that improper hindsight reconstruction was used in the 103 rejection combination and/or that the substitution of a blunt tip for a sharp tip would not be a functional equivalent for passing a needle through tissue. In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgement on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392; 170 USPQ 209 (CCPA 1971). The Examiner’s determination of obviousness was supported by both the express disclosure and teaching found in Yoon (see Yoon, col. 11, lines 16-22; as provided in the previous rejections) and a KSR rationale provided by the Supreme Court (see MPEP 2143(I)(B) and KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007)). It is conventionally very well-known that both blunt-tipped needles and sharp-tipped suturing needles comprise tissue penetrating tips (see also Yoon, col. 11, lines 16-22, as set forth in the previous office action). The substitution of either a blunt-tipped needle or a sharp-tipped needle may further enhance and facilitate tissue penetration depending on what specific type of tissue a practitioner intends to suture using the suturing system of Mitelberg in view of Yoon. The express disclosure and teachings of Yoon directly contradict Applicant’s arguments. For at least these reasons, Applicant’s arguments are not persuasive.
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 8 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.
Regarding claim 8, the phrase "a tab groove portion" in lines 1-2 renders the claim(s) indefinite because a tab groove portion was already introduced in line 6 of claim 1, thereby rendering the scope of the claim(s) unascertainable. It is unclear whether applicant intended to refer back to the tab groove portion of claim 1 or introduce a new, additional tab groove portion. To move prosecution forward, the examiner assumed applicant intended to refer back to the tab groove portion of claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 body (800, Fig. 76A) defining a lumen therethrough (i.e., body 800 lumen expressly shown in Figs. 77A-78) and 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 thereof (e.g., adjacent 804a/804b, Fig. 77B) thereof (as expressly shown in Figs. 76A-78), said tip portion (802) defining a tab groove portion (814, Fig. 77B); wherein said body (800) includes one or more tip tabs (804a/804b, Fig. 77B) deformed radially inwardly toward the lumen and into engagement with the tab groove portion (814) to retain said tip portion (802) with respect to said body (800) (as expressly shown in Fig. 77B; [0227]);
(claim 2) wherein said suture anchor (741) comprises a tubular body (800) 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), and wherein said tubular body (800) includes one or more suture tabs (806a/806b, Fig. 77B) extending radially inwardly to engage the suture (748) to retain the suture (748) within said tubular body (800) (as shown in Fig. 77B; [0227]);
(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 (800) to retain said tip portion (802) with respect to said tubular body (800) (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 (i.e., capable of) remove said suture anchor (741) from said anchor holder arm (740) (as shown in Fig. 83B; [0225]; [0227]; [0229]; [0231]; [0232]; [0236]; needle assembly 741 removably coupled to needle holder arm 740 is expressly disclosed) and retain said suture anchor (741) in engagement with the capture device (730) (as expressly shown in Fig. 83B);
(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), said tip portion (802) defining a tab groove portion (814, Fig. 77B); wherein said body (800) includes one or more tip tabs (804a/804b, Fig. 77B) deformed radially inwardly toward the lumen and into engagement with the tab groove portion (814) to retain said tip portion (802) with respect to said suture anchor (741) (as expressly shown in Fig. 77B; [0227]); 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), said tip portion (802) defining a tab groove portion (814, Fig. 77B); wherein said body (800) includes one or more tip tabs (804a/804b, Fig. 77B) deformed radially inwardly toward the lumen and into engagement with the tab groove portion (814) to retain said tip portion (802) with respect to said suture anchor (741) (as expressly shown in Fig. 77B; [0227]); 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 suture anchor (741) 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 tissue penetrating needle tips for a suturing system. 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 tissue penetrating needle tips for suturing systems within the suturing arts. The substitution would have resulted in the predictable results of providing tissue penetrating needle tips for the suturing system of Mitelberg.
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.
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.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
