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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 October 7, 2025 has been entered.
Response to Arguments
Applicant's arguments filed October 7, 2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that because Miller teaches aspirating material from holes in the needle side wall, Miller does not teach a device comprising a scalpet assembly including at least one scalpet to evacuate the tissue from the target site via the open distal end, although the ‘configured’ limitation is removed, the limitation remains functional. Since vacuum is applied to the lumen of 60a, the lumen and open distal end of 60a would be capable of evacuating select small or light tissue samples via the open distal end and the lumen. As long as the prior art meets the structural limitations in the claim and is capable of performing the recited functional limitations, the prior art meets the claim. Therefore, applicants argument is 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 52-66, 67-77 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller (2005/0171504).
Regarding claim 52, Miller discloses a device comprising a scalpet assembly (12, 61a, 60b) including at least one scalpet comprising a cylindrical shaft including a lumen (figure 60) and an open distal end (60a is open at distal end thereof, 62 is also an opening in the distal end) configured as a circular scalpel including a cutting surface (paragraph 0168) for rotational fractional resection of tissue at a target site of a subject, wherein the scalpet assembly is configured to removably couple a rotational force from a drive system (37, 18, 17, 11, 10) to the at least one scalpet, wherein the scalpet assembly is configured to couple a vacuum force to the target site via the open distal end and the lumen (paragraph 0170, vacuum force applied to aperture defining opening in distal end 61a, 61b) of at least one scalpet to evacuate the tissue from the target site using vacuum force via the open distal end (61a and 62, paragraph 0170; Since vacuum is applied to the lumen of 60a, the lumen and open distal end of 60a would be capable of evacuating select small or light tissue samples via the open distal end and the lumen).
Regarding claim 53, Miller discloses all of the limitations set forth in claim 52, wherein the a lumen (probe 60 is hollow) extends at least partially from a distal end towards a proximal end of the at least one scalpet.
Regarding claim 54, Miller discloses all of the limitations set forth in claim 53, wherein the at least one scalpet (60) comprises a cylindrical scalpet configured to rotate around a central axis of the scalpet, wherein a distal region proximate to the distal end is configured to incise and receive tissue (figure 64A).
Regarding claim 55, Miller discloses all of the limitations set forth in claim 54, wherein the distal region includes a cutting surface (65, 65a, figure 64A, paragraph 0173).
Regarding claim 56, Miller discloses all of the limitations set forth in claim 55, wherein the cutting surface (65, 65a) includes at least one of a sharpened edge, at least one sharpened point, and a serrated edge (figure 60-62C).
Regarding claim 57, Miller discloses all of the limitations set forth in claim 54, wherein the at least one lumen and the proximal end of the at least one scalpet is configured to pass tissue from the target site (paragraph 0173).
Regarding claim 58, Miller discloses all of the limitations set forth in claim 54, wherein the at least one scalpet includes at least one aperture (61a-61c, 62, and distalmost opening) positioned axially adjacent the lumen (figure 62a-62C).
Regarding claim 59, Miller discloses all of the limitations set forth in claim 58, wherein the at least one scalpet includes a plurality of apertures (61a-61c) positioned axially adjacent the lumen (figure 62C).
Regarding claim 60, Miller discloses all of the limitations set forth in claim 58, wherein the at least one aperture is located in a distal region of the lumen (figure 62C).
Regarding claim 61, Miller discloses all of the limitations set forth in claim 58, wherein the at least one aperture is configured to pass tissue from the target site (paragraph 0173).
Regarding claim 62, Miller discloses all of the limitations set forth in claim 58, wherein the at least one aperture (distalmost opening) includes at least one cutting surface (serrated edge, figure 62C).
Regarding claim 63, Miller discloses all of the limitations set forth in claim 58, wherein the at least one aperture is configured to divert received tissue at least one of radially outward from the lumen and radially inward toward the lumen (paragraph 0173).
Regarding claim 64, Miller discloses all of the limitations set forth in claim 58, comprising a vacuum manifold (69, figure 66) configured to removably couple to a distal end of the scalpet assembly, wherein the vacuum manifold includes a vacuum port (figure 66, arrow to suction, swivel connector, paragraph 0177) configured to couple to a remote vacuum source (foot switch).
Regarding claim 65, Miller discloses all of the limitations set forth in claim 64, wherein the vacuum manifold is configured to couple to the lumen and configured to direct the vacuum force to the target site intraluminally via the lumen (paragraph 0177).
Regarding claim 66, Miller discloses all of the limitations set forth in claim 64, wherein the vacuum manifold is configured to couple to the lumen via the at least one aperture and direct the vacuum force to the lumen via the at least one aperture.
Regarding claim 69, Miller discloses all of the limitations set forth in claim 64, wherein a distal end of the vacuum manifold is configured for use with a depth guide (13, all of the components of the device are configured for use together).
Regarding claim 70, Miller discloses all of the limitations set forth in claim 64, wherein the vacuum manifold comprises an overlay encasement (27, 69, 68, figure 66).
Regarding claim 71, Miller discloses all of the limitations set forth in claim 64, wherein the vacuum manifold is configured for manual control of delivery of the vacuum force to the target site (paragraph 0177, foot switch can be depressed manually).
Regarding claim 72, Miller discloses all of the limitations set forth in claim 52, wherein the drive system includes a drive shaft (driver, shaft extending from 11, figure 65) coupled to the scalpet assembly and configured to drive the at least one scalpet (paragraph 0102).
Regarding claim 73, Miller discloses all of the limitations set forth in claim 72, wherein the scalpet assembly is configured to removably couple to a carrier (14), wherein the carrier is configured to be hand-held (figure 65).
Regarding claim 74, Miller discloses all of the limitations set forth in claim 73, wherein the carrier couples the drive system to a rotational force and is configured to control application of the rotational force to the at least one scalpet (paragraph 0102, figure 65).
Regarding claim 75, Miller discloses all of the limitations set forth in claim 52, wherein the scalpet assembly (60a, 60b) is configured to removably couple to a vacuum component, wherein the vacuum component is configured to generate the vacuum force (paragraph 0107, 0177, chuck and swivel connector) .
Regarding claim 76, Miller discloses all of the limitations set forth in claim 75, wherein the vacuum force is configured to stabilize the target site during the fractional resection (paragraph 0177, permits suction to remain connected during drilling procedure, also vacuum force allows device to be stabilized to take multiple samples).
Regarding claim 77, Miller discloses all of the limitations set forth in claim 52, wherein the tissue includes skin plugs incised to form the fractional field during the fractional resection, and fat removed through the fractional field during the fractional lipectomy (the tissue is within a configured to clause, wherein if the prior art is capable of performing the recited functions, the prior art meets the limitations. Since the device of Miller is capable of incising skin, which includes fat, the prior art meets the limitations).
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.
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.
Claims 67 and 68 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (2005/0171504) as applied to claim 64 above.
Regarding claim 67-68, Miller discloses all of the limitations set forth in claim 64, wherein the device includes a depth guide (13) configured to control a depth of penetration of the at least one scalpet into the tissue (paragraph 0092, 0096), but does not specifically disclose the vacuum manifold includes a depth guide as a component thereof. However, It would have been obvious to one with ordinary skill in the art at the time of the invention to make the depth guide a component of the vacuum manifold, wherein the distal end of the vacuum manifold can be configured as the depth guide, since it has been held that rearranging parts of an invention (including depth guide as part of vacuum manifold) involves only routine skill in the art. In re Japikse, 86 USPQ 70.
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 52-59, 61-76 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 6, 7, 9-11, 13,14, 16-18, 20-23, 25, 26, and 40, 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, 5, 6, 7, 9-11, 13,14, 16-18, 20-23, 25, 26, and 40, 43 of Patent 10905865 recites the claimed scalpet assembly, rotational force, drive system, and vacuum force. Therefore, patent claims 1, 5, 6, 7, 9-11, 13,14, 16-18, 20-23, 25, 26, and 40, 43 is in essence a “species” of the generic invention of application claims 52-59, 61-76 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 52-59, 61-76 are anticipated by patent claims 1, 5, 6, 7, 9-11, 13,14, 16-18, 20-23, 25, 26, and 40, 43, it is not patentably distinct from patent claim 1, 5, 6, 7, 9-11, 13,14, 16-18, 20-23, 25, 26, and 40, 43.
18462183
52, 73, 77
53
54
55
56
57
58
59
10905865
1
5
16
17
18
20
21
22
18462183
60
61
62
63
64, 75
65
66
67
10905865
23
17
25, 26
6
7
6
43
18462183
68
69
70
71
74
75
76
10905865
10
9
11
13
40
40
14
Claims 52-58, 61-71 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-9, 11, 16-19 of U.S. Patent No. 11612410.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims of Patent 10905865 recites the claimed scalpet assembly, rotational force, drive system, and vacuum force. Therefore, patent claims 2-9, 11, 16-19 is in essence a “species” of the generic invention of application claims 52-59, 61-65, 67 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 52-58, 61-71 are anticipated by patent claims 2-9, 11, 16-19, it is not patentably distinct from patent claim 2-9, 11, 16-19.
18462183
52, 58, 61-63
53
54
55
56
57
64
65
11612410
2
3
16
17
18
19
4
5
11612410
66
67, 68
69
70
71
11612410
6
7
8
9
11
Claims 52-58, 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 49 of U.S. Patent No. 11751904.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims of Patent 10905865 recites the claimed scalpet assembly, rotational force, drive system, and vacuum force. Therefore, patent claims 1, 4, 49 is in essence a “species” of the generic invention of application claims 1, 4, 49 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 52-58, 63 are anticipated by patent claims 1, 4, 49, it is not patentably distinct from patent claim 1, 4, 49.
18462183
52, 53, 54, 57, 58
55
56
63
11612410
1
4
4
49
Claims 52-58, 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 49 of U.S. Patent No. 11759231.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims of Patent 10905865 recites the claimed scalpet assembly, rotational force, drive system, and vacuum force. Therefore, patent claims 1, 4, 49 is in essence a “species” of the generic invention of application claims 1, 4, 49 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 52-58, 63 are anticipated by patent claims 1, 4, 49, it is not patentably distinct from patent claim 1, 4, 49.
18462183
52, 53
55, 56
57
58
61
63
66
67
11612410
1
10
11
1
1
28
27
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