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 .
Election/Restrictions
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 05/28/2026.
Applicant’s election without traverse of claims 1-16 in the reply filed on 05/28/2026 is acknowledged.
For the elected Species E: Fig. 4, the following claims fail to read on the elected species, and are therefore withdrawn by the examiner:
Claims 14-16 define nonelected species G: Fig. 9 (single component cylindrical body). Claim 14 claims a needle device comprising only one extension “a first end portion having an extension configured to be inserted into the first open end of the hollow body and to extend into the interior of the hollow body; a second end portion disposed at the second end of the hollow body”. Claim 15 further claims “wherein one of the end portions is integrally formed with the cylindrical body and the other is fixed with respect to the cylindrical body after a suture is positioned between the extensions”. Para. 0033 of the specification states that the elected embodiment (Fig. 4) has “Cylindrical body 402 [that] may be hollow (as shown in the cylindrical body 602 of FIG. 7) and may be configured to receive extensions 417, 419 of each end 404, 406” which further supports that the embodiment of Fig. 4 has two extensions inserted into the hollow body. Para. 0039 of the specification describing Fig. 9 further states “In some examples, medical device 600 may also include end 604 including a solid cylindrical extension similar to end 404. Alternatively, end 604 and cylindrical body 602 may be integral with each other and may form a single component of medical device 600. As shown in FIG. 9, needle suture component 900 includes a cylindrical body 902, end 906, concave portion 908, opening 916, extension 917, and interior portion 914 similar to previously described embodiments of cylindrical bodies and ends. Needle suture component 900 may be integrally formed such that cylindrical body 902 and end 906 form a single component for use in a suture needle device. For example, medical device 600 may be assembled using end 606 (shown in FIG. 8) and needle suture component 900, allowing medical device 600 to include two components, a needle suture component 900 and an end 606, instead of three, a cylindrical body 602 and two ends 604, 606. Therefore, claims 14-16 are directed to species G (Fig. 9) of the restriction filed 04/11/2026.
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 4 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 4 recites the limitation "the extension" in line 1. It is unclear to the examiner if “the extension” is meant to further define “the extension of the first end portion”, “the extension of the second end portion”, or both. For examination purposes, “the extension” is interpreted as “the extension of at least one of the first end portion or the second end portion”.
Claim Rejections - 35 USC § 103
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 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.
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) 1-4 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto (US 20150230790) in view Mitelberg et al. (US 20160045197) [hereinafter Mitelberg].
Regarding claim 1, Hashimoto discloses a medical device 2 (Fig. 2, para. 0030) comprising:
a hollow body formed of a wall defining an interior therein (see annotated Fig. 2 of Hashimoto below, para. 0030: “an end of the suture 6 is fixed between the respective groove portions 5 at an intermediate portion of the suture needle 2”);
a first end portion 3, 5 (Fig. 2, para. 0030);
a second end portion 4, 5 (Fig. 2, para. 0030);
a suture 6 having a portion held within the interior of the hollow body, and a portion extending out of a radial opening defined radially through the wall of the hollow body (Fig. 2, para. 0030: “an end of the suture 6 is fixed between the respective groove portions 5 at an intermediate portion of the suture needle 2”).
However, Hashimoto fails to disclose the hollow body formed by a wall extending longitudinally between a first open end and a second open end, an extension of the first end portion being inserted into the first open end of the hollow body and extending into the interior of the hollow body, an extension of the second end portion being inserted into the second open end of the hollow body and extending into the interior of the hollow body.
Mitelberg in the same field of endeavor needle devices 44 teaches that it is known in the art for the needle device to comprising a hollow body 76 formed by a wall extending longitudinally to an open end (Fig. 8, para. 0197: “Needle tip 76 has a sharp distal end and a hollow proximal end having a suture slot 78”), an end portion 74a, 79 (Fig. 8, para. 0197: “Needle body 74 has a rounded or blunt tapered proximal end 74a…with the proximal end 74a presenting a shoulder 79 between end 74a and the remainder of the needle body 74”) comprising an extension 74a inserted into the open end of the hollow body (see Fig. 7 which illustrates a distal end of the extension 74 inserted into the hollow body 76, para. 0197: “needle assembly 44 which comprises a needle body 74, a needle tip 76…FIG. 8 shows a detailed exploded view of two components of needle assembly 44…A distal end 74b of the needle body 74 has a suture slot 80 adapted to concentrically engage needle tip 76…The components may be joined using standard joining techniques such as…mechanical crimping.) for the purpose of retaining a suture 46 in a middle of the needle device (Fig. 7, para. 0197: “Flexible suture material is positioned on the distal end of needle body 74 extending through the aligned suture slots 78 and 80”).
Thus, it would have been recognized by one of ordinary skill in the art that applying the known technique taught by Mitelberg to the needle device of Hashimoto to modify the hollow body to be formed by a wall extending longitudinally between a first open end and a second open end and modify the first and second end portions to include extensions. As taught by Mitelberg, the extensions are meant to be inserted into the first and second open ends of the hollow body to retain and secure the suture central to the hollow body as desired by Hashimoto (see Fig. 2 of Hashimoto); KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
PNG
media_image1.png
506
397
media_image1.png
Greyscale
Annotated Fig. 2 of Hashimoto
Regarding claim 2, modified Hashimoto discloses wherein the extension 74, as taught by Mitelberg (Figs. 7-8, para. 0197), of at least one of the first end portion 3, 5 or the second end portion 4, 5 of Hashimoto (see Fig. 2, para. 0030 of Hashimoto) includes an end face (interpreted as distalmost surface of distal end 74b, see annotated Fig. 8 of Mitelberg below) with a recess 80 (Fig. 8, para. 0197 of Mitelberg: “A distal end 74b of the needle body 74 has a suture slot 80 adapted to concentrically engage needle tip 76”).
PNG
media_image2.png
240
290
media_image2.png
Greyscale
Annotated Fig. 8 of Mitelberg
Regarding claim 3, modified Hashimoto discloses wherein the recess 80 is curved or contoured (Fig. 8 of Mitelberg).
Regarding claim 4, modified Hashimoto discloses wherein the extension 74 (interpreted as either the extension of the first end portion or the extension of the second end portion; see 112(b) rejection above) extends along a longitudinal axis (Fig. 7 of Mitelberg), and the recess 80 extends across the end face in a direction perpendicular to the longitudinal axis of the extension 74 (see annotated Fig. 8 [a] below of Mitelberg below).
PNG
media_image3.png
198
221
media_image3.png
Greyscale
Annotated Fig. 8 [a] of Mitelberg
Regarding claim 6, modified Hashimoto discloses wherein the extension 74 of at least one of the first end portion or the second end portion includes an end face angled with respect to the longitudinal axis (see annotated Fig. 8 [a] of Mitelberg above which illustrates the end face angled at a 90 degree angle with respect to the longitudinal axis).
Claim(s) 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto (US 20150230790) in view Mitelberg et al. (US 20160045197) [hereinafter Mitelberg], as applied to claim 1 above, and further in view of Shearon (US 1678361).
Regarding claim 5, modified Hashimoto discloses all of the limitations set forth above in claim 1. However, modified Hashimoto fails to disclose wherein the extension of at least one of the first end portion or the second end portion includes an end face having a sharp protrusion configured to couple with the suture to hold the suture in place with respect to the end portion (claim 5)/ which is textured to increase friction between the extension and the suture (claim 7).
Shearon in the same field of endeavor of needle devices teaches that it is known in the art to utilize sharp protrusions 18, 19 to secure suture 20 to the needle device and increase the friction between the needle device and the suture (para. 11-13: “claws or prongs as, indicated by 18, preferably curved forwardly and the jaw 12 has similar teeth as indicated by 19… The teeth 19 and 20 will then be firmly engaged in the end of the thread 20 and hold the same firmly to the needle”).
In light of this teaching, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the end face of the extensions of the first end and second end portion in modified Hashimoto to include sharp protrusions/textured surface, as taught by Shearon, since end face of the first and second end portions contact the suture and since Shearon explicitly teaches that sharp protrusions help further secure the suture to the needle device (para. 11-13 of Shearon), thereby enhancing the securing capabilities of the device.
Allowable Subject Matter
Claims 8-13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding claim 8, modified Hashimoto discloses wherein the extension 74, as taught by Mitelberg (Figs. 7-8, para. 0197), of the first end portion 3, 5 and the second end portion 4, 5 of Hashimoto (see Fig. 2, para. 0197) has an end face (interpreted as distalmost surface of distal end 74b, see annotated Fig. 8 of Mitelberg above) within the interior of the hollow body, as taught by Mitelberg (see Fig. 7 of Mitelberg which illustrates a distal end of the extension 74 inserted into the hollow body 76, para. 0197 of Mitelberg: “needle assembly 44 which comprises a needle body 74, a needle tip 76…FIG. 8 shows a detailed exploded view of two components of needle assembly 44…A distal end 74b of the needle body 74 has a suture slot 80 adapted to concentrically engage needle tip 76…The components may be joined using standard joining techniques such as…mechanical crimping.). However, the combination of Hashimoto in view of Mitelberg fails to disclose that the opposing end faces of the extensions of the first end portion and the second end portion are spaced apart to define a space positioned within the hollow body, the space having a smaller diameter than the suture. In other words, the combination of Hashimoto and Mitelberg does not explicitly disclose that the extensions pinch the suture such that the space is smaller than the diameter of the suture. Therefore, claims 8-13 are objected to.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN DUBOSE whose telephone number is (571)272-8792. The examiner can normally be reached Monday-Friday 7:30am-5:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached 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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAUREN DUBOSE/Examiner, Art Unit 3771
/SARAH A LONG/Primary Examiner, Art Unit 3771
Prosecution Insights