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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 30, 2026 has been entered.
Response to Arguments
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive.
In response to applicant’s argument, that Bellantoni includes no teaching regarding the shanks including a lumen, Bellantoni discloses that the cutter tool elements are hollow and sleeve shaped (C:4, L:15-21; 19-21) which discloses that the cutter tool elements 32 define a lumen. Bellantoni does not need to disclose the process of the tissue being removed from the proximal end, but the hollow and sleeve shaped cutter merely needs to be capable of performing the recited function. Tissue can forcibly be removed from either end. Functional limitations are not given full patentable weight. As long as the prior art meets the structural requirements of the claim and is capable of performing the recited functions, the prior art meets the limitations. Therefore, applicant’s arguments are not persuasive.
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.
Claims 55-72 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bellantoni, deceased et al (US 3867942).
Regarding claim 55, Bellantoni, deceased et al (hereafter Bellantoni) discloses a device comprising a scalpet assembly including a scalpet (32, 32’, 31, 74, 76) and a depth control device (33, 51, 78, 79, 76, 74) configured to removably couple to a distal region of a carrier (20, 24) and partially enclose the scalpet (figure 6, 51 and 73 enclose portion 74 of scalpet), wherein the depth control device is configured to control a depth of penetration of the scalpet into tissue (C:5, L:1-43), wherein the scalpet includes a cylindrical shaft (31, abstract, circular) comprising a distal end configured as a circular scalpel including a cutting surface (32, 32’) a lumen in communication with a sharpened distal end (32’) and at least one of an axial orifice and a proximal orifice, wherein the at least one of the axial orifice and the proximal orifice are configured to pass tissue from the sharpened distal end via the lumen (32 can be removed from 31 and tissue can be removed from either end).
Regarding claim 56, Bellantoni discloses all of the limitations set forth in claim 55, wherein the scalpet assembly is configured to couple to a motor (22).
Regarding claim 57, Bellantoni discloses all of the limitations set forth in claim 56, wherein the scalpet is configured to be driven by the motor (C:2, L:21-54).
Regarding claim 58, Bellantoni discloses all of the limitations set forth in claim 56, wherein the carrier (20, 24) includes the motor (22, figure 1)
Regarding claim 59, Bellantoni discloses all of the limitations set forth in claim 55, wherein the sharpened distal end (32’) of the scalpet includes a circular cutting surface configured to incise and receive tissue (C:2, L:41-54).
Regarding claim 60, Bellantoni discloses all of the limitations set forth in claim 59, wherein the cutting surface includes at least one of a sharpened edge, at least one sharpened point, and a serrated edge (C:4, L:12-19).
Regarding claim 61, Bellantoni discloses all of the limitations set forth in claim 55, wherein the depth control device is configured to removably couple to an outer distal region of the carrier (24 can be considered distal end of carrier 20, 24; figure 6).
Regarding claim 62, Bellantoni discloses all of the limitations set forth in claim 61, wherein the depth control device includes depth control devices (76, 74) representing a plurality of different depths (figure 6).
Regarding claim 63, Bellantoni discloses all of the limitations set forth in claim 55, wherein the axial orifice is configured to divert tissue from the lumen (tissue can be removed from the distal openings of 32).
Regarding claim 64, Bellantoni discloses all of the limitations set forth in claim 55, comprising a chuck (33) coupled to the distal region of the carrier and configured to receive a proximal region of the scalpet (figure 5).
Regarding claim 65, Bellantoni discloses all of the limitations set forth in claim 64, wherein the scalpet includes a skive scalpet (32’, 32), wherein the proximal end of the skive scalpet includes a region configured as a shank (32).
Regarding claim 66, Bellantoni discloses all of the limitations set forth in claim 65, wherein the lumen of the skive scalpet is in communication with the sharpened distal end and the axial orifice (figure 1).
Regarding claim 67, Bellantoni discloses all of the limitations set forth in claim 64, wherein the lumen of the scalpet is in communication with the sharpened distal end and the proximal orifice (lumen of 32 extends between sharpened distal end 32’ and proximal end of region 32).
Regarding claim 68, Bellantoni discloses all of the limitations set forth in claim 67, wherein the proximal orifice is configured to divert tissue from the lumen (scalpet 32 can be removed from 31 and tissue can be removed for the proximal opening thereof).
Regarding claim 69, Bellantoni discloses all of the limitations set forth in claim 68, wherein tissue passed from the lumen via the proximal orifice is capable of being deposited in a receptacle coupled to the carrier (this limitation is a functional limitation and therefore as long as the prior art is capable of performing the recited function the prior art meets the limitations).
Regarding claim 70, Bellantoni discloses all of the limitations set forth in claim 67, comprising an adapter (73, 75) configured as an interface between an outside surface of the scalpet and an inside region of the chuck (figures 6 and 7).
Regarding claim 71, Bellantoni discloses all of the limitations set forth in claim 70, wherein the chuck is configured to secure an axial position of the adapter and the scalpet relative to the carrier (Figure 6).
Regarding claim 72, Bellantoni discloses all of the limitations set forth in claim 70, wherein the adapter is configured as the depth control device (C:4,L:55-69).
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 55-61, 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 16, 18, 19, 21, 43 of U.S. Patent No. 10905865.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 16, 18, 19, 21, 43 of Patent 10905865 recites the claimed cannula assembly plurality of cannulas, lumen, vacuum source) and a depth guide slidably coupled to the housing for variable selection of an insertion depth. Therefore, patent claims 1, 2, 4, 7-9, 13, 19, 22-26, 35-36, 39, 42, and 44 is in essence a “species” of the generic invention of application claims 55-61, 63 is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 55-61, 63 is anticipated by patent claims 1, 16, 18, 19, 21, 43, it is not patentably distinct from patent claim 1, 16, 18, 19, 21, 43.
18462183
55, 56, 57, 58,
59
60
61
63
10905865
1, 43
16
18
19
21
Claims 55-60 and 69 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 13, 14 of U.S. Patent No. 11109887.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 9, 13, 14 of Patent 11109887 recites the claimed a scalpet assembly, a carrier, and a depth control device, . Therefore, patent claims 1, 9, 13, 14 is in essence a “species” of the generic invention of application claims 55-60 and 69 is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 55-60 and 69 is anticipated by patent claims 1, 9, 13, 14, it is not patentably distinct from patent claim 1, 9, 13, 14.
18462183
55, 69
56, 57, 58
59
60
10905865
1
9
13
14
Claims 55-60, 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 6, 10, 11, 29 of U.S. Patent No. 11759231.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 4, 6, 10, 11, 29 of Patent 11759231 recites a scalpet assembly, a carrier, a depth control device, . Therefore, patent claims 1, 4, 6, 10, 11, 29 is in essence a “species” of the generic invention of application claims 55-60, 63 is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 55-60, 63 is anticipated by patent claims 1, 4, 6, 10, 11, 29 it is not patentably distinct from patent claim 1, 4, 6, 10, 11, 29.
18462183
55
56
57, 58
59, 60
63
11751904
1
4
6
10, 11
29
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 ANH TIEU DANG whose telephone number is (571)270-3221. The examiner can normally be reached Monday-Thursday (9am-4pm EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANH T DANG/Primary Examiner, Art Unit 3771