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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 13, 2025 has been entered.
Response to Arguments
Applicant's arguments filed October 13, 2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that Bellantoni does not disclose configuring a depth guide to partially enclose a distal region of the plurality of scalpets for variable selection of an insertion depth of the plurality of scalpets as claimed in claim 108, applicant’s arguments are not persuasive in view of the rejection set forth below addressing the limitations. Bellantoni’s depth guide (33, 51, 52, 74, 76, 79) partially encloses a distal region the plurality of scalpets for variable selection of an insertion depth of the plurality of scalpets (C:2, L:35-54; C:3, L:32-45), as shown in the annotated image below. The limitation ‘a distal region’ is sufficiently broad to encompass the region identified in the annotated feature. Therefore, applicant’s arguments are not persuasive.
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 108-121 are rejected under 35 U.S.C. 103 as being unpatentable over Bellantoni, deceased et al (US 3867942) in view of Bridges (US 6027512).
Regarding claim 108, Bellantoni discloses a method comprising: configuring a scalpet assembly to include a plurality of scalpets (figure 1); configuring a substrate (24, 65, 43) to maintain a position of the plurality of scalpets (C:4, L:31-45) ; configuring a drive system (26, motor, C:6, L:19) to couple a rotational force to the scalpet assembly; configuring a depth guide (33, 51, 52, 74, 76, 79) to partially enclose a distal region of (33 and 51 partially encloses a distal region as shown in annotated image below, the limitation ‘distal region’ is sufficiently broad to encompass the region shown below) the plurality of scalpets for variable selection of an insertion depth of the plurality of scalpets (C:2, L:35-54; C:3, L:32-45), the plurality of scalpets (31, 32) to incise and pass skin plugs (C:4,L:5-30). Bellantoni does not specifically disclose configuring the scalpet assembly to include a vacuum component to evacuate the incised skin plugs via the plurality of scalpets. However, Bridges teaches a hair follicle harvesting device comprising a vacuum component (flow of saline solution through a venturi or tube constriction) configured to evacuate the incised skin plugs via a scalpet (reduce pressure, abstract) to facilitate removal of the loosened hairs and hair follicles into a saline stream. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to include a vacuum component to generate a vacuum on the device of Bellantoni, such as the one taught by Bridges, in order for hair follicles to be continually and selectively removed by vacuum from a segment of scalp by the removal device.
PNG
media_image1.png
342
778
media_image1.png
Greyscale
Regarding claim 109, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 108, comprising configuring the drive system to include a geared drive system (29a-f, figures 3-4, C:3, L:54-67; C:4, L:1-15).
Regarding claim 110, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 109, comprising configuring the drive system to cause each scalpet to rotate around a central axis of the respective scalpet (C:7, L:31-56).
Regarding claim 111, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 109, comprising configuring the drive system to rotate the plurality of scalpets in unison (C:7, L:31-56).
Regarding claim 112, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 109, comprising configuring each scalpet of the plurality of scalpets to couple to a gear of the geared drive system (29a-f, figure 3).
Regarding claim 113, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 112, comprising configuring the gear to attach to a proximal region of each scalpet (figure 1 and 3).
Regarding claim 114, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 112, comprising configuring the drive system to include a drive shaft (26) coupled to the geared drive system.
Regarding claim 115, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 108, comprising configuring a proximal end and a lumen of each scalpet to pass the incised skin plugs received at a distal end of each scalpet (scalpet 32 is configured to come off of 31’ ( C:4, L:15-30) where the lumen of each scalpet can pass the incised skin plug received at the distal end.
Regarding claim 116, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 108, comprising configuring a depth of insertion of the plurality of scalpets to be adjustable relative to a distal end of a housing including the scalpet assembly (C:4, L:56-67).
Regarding claim 117, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 116, comprising configuring the housing (24) to include the scalpet assembly and the drive system, and to removably couple to a handpiece (20, retained by screws which can be unscrewed to remove)
Regarding claim 118, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 116, wherein Bridges teaches configuring the vacuum component (13) to couple to the housing (2) of the device and a vacuum (15).
Regarding claim 119, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 118, wherein Bridges teaches configuring the housing to couple the vacuum to the plurality of scalpets to evacuate the incised skin plugs (figure 1).
Regarding claim 120, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 108, comprising configuring the substrate (24) to include a plurality of guide plates (65, 43) to maintain a position of the plurality of scalpets (figures 5, 9).
Regarding claim 121, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 120, comprising configuring the substrate to couple to a plurality of spacers (76, 74) to control and maintain a depth of insertion (C:5, L:5-55).
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 108-110, 112, 116, 118 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 40, 41 of U.S. Patent No. 10695546.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 9, 40, 41 of Patent 10695546 recites a method of configuring the claimed scalpet assembly, substrate (carrier), drive system (motor), and vacuum component. Therefore, patent claims 1, 9, 40, 41 is in essence a “species” of the generic invention of application claims 108-110, 112, 116, 118 is “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 108-110, 112, 116, 118 are anticipated by patent claims 1, 9, 40, 41, it is not patentably distinct from patent claim 1, 9, 40, 41.
18358580
108
109
110
112
116
118
10695546
1
40
39
40
9
41
Claims 108-110, 114-119 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4, 8, 11, 12 of U.S. Patent No. 11844546.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 2, 4, 8, 11, 12 of Patent 10695546 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, 8, 11, 12 is in essence a “species” of the generic invention of application claims 108-110, 114-119 are “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claim 108-110, 114-119 are anticipated by patent claims 1, 2, 4, 8, 11, 12, it is not patentably distinct from patent claim 1, 2, 4, 8, 11, 12.
18358580
108
109
110
114
115
119
11844546
1, 11
4
1
2
8
12
Conclusion
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).
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, 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.
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.
/ANH T DANG/Primary Examiner, Art Unit 3771