DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1-2, 6-10, 12, 21-22, and 25-28 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by US 5,948,000 (Larson).
1. A needle assembly (suture anchor 10) for use in association with a suturing device (tool 200) having a movable needle holder arm (plunger rod 260), the needle assembly comprising:
a tubular needle body (socket 11) having a first end (e.g., left end in FIG. 3) and a second end (e.g., right end in FIG. 3), with the second end open and configured and dimensioned to be releasably retained relative to the needle holder arm (FIG. 5-8; col. 5, lns. 4-25); and
a needle tip (pin 20) at the first end of said needle body (FIG. 1).
2. The needle tip is a distinct element from the tubular needle body (FIG. 3) and fixed relative to the tubular needle body (FIG. 1; col. 4, lns. 48-53).
6. The tubular needle body defines a suture retention tab (legs 15) deformable into an interior of the tubular needle body to fix a suture within the tubular needle body (FIG. 1 and 22; col. 4, lns. 39-53).
7. The needle assembly defines an external capture groove (barbs 16) for engagement by a tool (tube 250) for removal of the needle assembly from the needle holder arm (FIG. 5-8; col. 5, lns. 4-25).
8. The external capture groove is a circumferential groove (FIG. 3).
9. The external capture groove is located on the tubular needle body adjacent the needle tip (FIG. 3).
10. A needle and suture assembly (FIG. 1) comprising:
a needle (suture anchor 10) including
a needle body (socket 11) having a wall with a suture opening (proximal opening in FIG. 3) extending radially through the wall (FIG. 3); and
a suture (suture 30) having a first end secured within the needle body (FIG. 1-3), the suture extending, from the first end, out of the needle body though the suture opening and to a second end outside the needle (FIG. 1-3).
12. The needle body wall is tubular and defines a lumen therein (FIG. 1-3), and the suture extends through the suture opening into the lumen defined in the tubular needle body wall so that the first end of the suture is held within the lumen (FIG. 1-3 and 22).
21. A needle and suture assembly (FIG. 1) for use in association with a suturing device (tool 200) having a movable needle holder arm (plunger rod 260), the assembly comprising:
a needle (suture anchor 10) having a tubular body (socket 11) with a first end (e.g., left end in FIG. 3) and a second end (e.g., right end in FIG. 3), a needle tip (pin 20) at the first end of the tubular body, and an opening at the second end of the tubular body configured to receive an end of the needle holder arm (FIG. 5-8; col. 5, lns. 4-25); and
a suture (suture 30) extending through a suture opening (proximal opening in FIG. 3) defined in the tubular body of the needle and fixed within the tubular body.
22. The needle tip is a distinct element from the tubular body (FIG. 3) and fixed relative to the tubular body (FIG. 1; col. 4, lns. 48-53).
25. The tubular body defines a suture retention tab (legs 15) deformable into an interior of the tubular body to fix the suture within the tubular body (FIG. 1 and 22; col. 4, lns. 39-53).
26. The tubular body defines an external capture groove (barbs 16) for engagement by a tool (tube 250) for removal of the tubular body from the needle holder arm (FIG. 5-8; col. 5, lns. 4-25).
27. The external capture groove is a circumferential groove (FIG. 3).
28. The external capture groove is located on the tubular needle body adjacent the needle tip (FIG. 3).
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 1-10, 12, 17, and 21-28 fare rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,534,160 (Mitelberg ‘160). Although the claims at issue are not identical, they are not patentably distinct from each other because Mitelberg ‘160 claims:
U.S. App. No. 19/028,432
Mitelberg ‘160
Claim 1
Claim 1
Claim 2
Claim 1
Claim 3
Claim 1
Claim 4
Claim 1
Claim 5
Claim 1
Claim 6
Claim 4
Claim 7
Claim 1
Claim 8
Claim 1
Claim 9
Claim 1
Claim 10
Claim 1
Claim 12
Claim 1
Claim 17
Claim 4
Claim 21
Claim 1
Claim 22
Claim 1
Claim 23
Claim 1
Claim 24
Claim 1
Claim 25
Claim 4
Claim 26
Claim 1
Claim 27
Claim 1
Claim 28
Claim 1
Claims 1-10, 12, 17, and 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,812,951 (Mitelberg ‘951). Although the claims at issue are not identical, they are not patentably distinct from each other because Mitelberg ‘951 claims:
U.S. App. No. 19/028,432
Mitelberg ‘951
Claim 1
Claim 4, 5, or 9
Claim 2
Claim 4, 5, or 9
Claim 3
Claim 4, 5, or 9
Claim 4
Claim 4, 5, or 9
Claim 5
Claim 10
Claim 6
Claim 4 or 11
Claim 7
Claim 4, 5, or 9
Claim 8
Claim 4, 5, or 9
Claim 9
Claim 4, 5, or 9
Claim 10
Claim 8 or 11
Claim 12
Claim 8 or 11
Claim 17
Claim 11
Claim 21
Claim 4 or 9
Claim 22
Claim 4 or 9
Claim 23
Claim 4 or 9
Claim 24
Claim 4 or 9
Claim 25
Claim 4 or 11
Claim 26
Claim 4 or 9
Claim 27
Claim 4 or 9
Claim 28
Claim 4 or 9
Claims 1-10, 12, 17, and 21-28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 9,198,562 (Mitelberg ‘562). Although the claims at issue are not identical, they are not patentably distinct from each other because Mitelberg ‘562 claims:
U.S. App. No. 19/028,432
Mitelberg ‘562
Claim 1
Claim 2, 8, or 10
Claim 2
Claim 2, 8, or 10
Claim 3
Claim 2 or 8
Claim 4
Claim 2 or 8
Claim 5
Claim 3 or 8
Claim 6
Claim 4 or 12
Claim 7
Claim 2 or 8
Claim 8
Claim 2 or 8
Claim 9
Claim 2 or 8
Claim 10
Claim 1 or 12
Claim 12
Claim 2 or 12
Claim 17
Claim 4 or 12
Claim 21
Claim 2 or 12
Claim 22
Claim 2 or 12
Claim 23
Claim 2 or 12
Claim 24
Claim 3
Claim 25
Claim 4 or 12
Claim 26
Claim 2
Claim 27
Claim 2
Claim 28
Claim 2
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD J SCHERBEL whose telephone number is (571)270-7085. The examiner can normally be reached Mon - Fri 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jackie Ho can be reached at 571-272-4696. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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TJ SCHERBEL
Primary Examiner
Art Unit 3771
/TODD J SCHERBEL/Primary Examiner, Art Unit 3771
Prosecution Insights