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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 16, 2026 has been entered.
Response to Arguments
Applicant’s arguments filed January 16, 2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that Bellantoni does not include any teaching regarding transfer of the cut patches via the shanks, it is noted that functional limitations are not given full patentable weight. As long as the prior art meets all of the structural requirements of the claim and is capable of performing the recited functions, the prior art meets the limitations. Therefore, as noted in the previous Office Action, since the scalpet 32 can be removed from 31 and the tissue can be forcibly removed from the proximal end thereof, the prior art meets the functional limitations of the proximal end being ‘configured to pass tissue from the lumen’ as recited in amended claim 1. Therefore, applicant’s arguments are not persuasive.
Applicant’s arguments to continue to state that Bellantoni does not teach gears configured to transfer a rotational force to the scalpets from a removable handpiece without specifically pointing out how the language of the claims patentably distinguishes them from the references are also not persuasive. Applicant does not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. Therefore, since all of the limitations and amendments to the claims are addressed below, applicants 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 108, 109, 112-121, and 123-125 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bellantoni, deceased et al (US 3867942).
Regarding claim 108, Bellantoni teaches a scalpet assembly comprising a scalpet array including a plurality of scalpets (89) coupled to a substrate (65) to maintain the plurality of scalpets in a configuration, wherein each scalpet comprises a cylindrical shaft including a proximal end and a distal end configured as a circular scalpel (C:4, L:13-14) including a cutting surface (C:4, L:13-14, claim 1, abstract), and a lumen configured to transfer tissue from the distal end, wherein the proximal end is configured to pass tissue from the lumen (scalpet 32 can be removed from 31 and the tissue can be removed from the proximal end thereof); and a plurality of gears (29b-f) coupled to the plurality of scalpets and configured to transfer a rotational force to the scalpets from a removable handpiece (21, C:3, L:5-15, retained by screws and therefore, can be unscrewed and removed; C:4, L:1-38).
Regarding claim 109, Bellantoni discloses all of the limitations set forth in claim 108, wherein each scalpet of the scalpet array includes a gear of the plurality of gears in a proximal region of the scalpet (C:3, L:65-67).
Regarding claim 112, Bellantoni discloses all of the limitations set forth in claim 109, wherein the plurality of scalpets rotates in unison (C:4, L:15-32).
Regarding claim 113, Bellantoni discloses all of the limitations set forth in claim 108, wherein a drive system (29b-f, coupled to motor, system includes multiple components working together) includes the plurality of gears is configured to removably couple to a handpiece assembly (C:3, L:5-15, retained by screws and therefore, can be unscrewed and removed).
Regarding claim 114, Bellantoni discloses all of the limitations set forth in claim 113, wherein the drive system includes a drive shaft (26) coupled to the gears and configured to couple rotational force to the plurality of scalpets via the gears, wherein the rotational force is configured to rotate each scalpet around a central axis of the scalpet (C:4, L:1-30).
Regarding claim 115, Bellantoni discloses all of the limitations set forth in claim 114, wherein the plurality of gears is configured to cause the plurality of scalpets to rotate in unison (C:4, L:15-32).
Regarding claim 116, Bellantoni discloses all of the limitations set forth in claim 108, wherein the handpiece assembly is configured to control at least one of activation of a rotational force to the plurality of scalpets (C:4, L:1-30).
Regarding claim 117, Bellantoni discloses all of the limitations set forth in claim 108, wherein each scalpet comprises a proximal end, and a shaft including the lumen between the proximal end and the distal end (Figure 3, C:4, L:1-31, hollow).
Regarding claim 118, Bellantoni discloses all of the limitations set forth in claim 117, wherein the distal end comprises a sharpened region around a circumference of the scalpet and forming a cutting edge (32’) configured to incise skin pixels.
Regarding claim 119, Bellantoni discloses all of the limitations set forth in claim 118, wherein the lumen is configured to pass tissue from the distal end (C:4, L:10-20).
Regarding claim 120, Bellantoni discloses all of the limitations set forth in claim 119, wherein the proximal end is configured to pass tissue from the lumen (scalpet 32 can be removed and the tissue can be removed from the proximal end thereof).
Regarding claim 121, Bellantoni discloses all of the limitations set forth in claim 118, wherein the cutting edge includes at least one of a sharpened edge (32’) and a beveled edge (figure 3).
Regarding claim 123, Bellantoni discloses all of the limitations set forth in claim 108, wherein the substrate includes an array of orifices (66, figure 5) in the configuration to receive the plurality of scalpets.
Regarding claim 124, Bellantoni discloses all of the limitations set forth in claim 108, wherein a position of the plurality of scalpets is configured to be adjustable to control a depth of insertion of the plurality of scalpets at a resection site (C:4, L:45-55).
Regarding claim 125, Bellantoni discloses all of the limitations set forth in claim 124, wherein the substrate is configured for use in the adjustment of the position of the plurality of scalpets (C:4, L:35-55).
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 110 is rejected under 35 U.S.C. 103 as being unpatentable over Bellantoni, deceased et al (US 3867942), as applied to claim 109 above, and further in view of Savage et al (US 6039748).
Regarding claim 110, Bellantoni discloses all of the limitations set forth in claim 109, but does not disclose the gears comprise at least one of polymer and metal. Savage et al (hereafter Savage) teaches it was known in the art at the time of the invention for drive gears for surgical instruments to be comprised of metallic or polymeric materials (C:4, L:59-67). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to make the gears of Bellantoni comprise at least one of polymer and metal, as taught as a known material for gears at the time of the invention by Savage, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use. In re Leshin, 125 USPQ 416.
Claim 111 is rejected under 35 U.S.C. 103 as being unpatentable over Bellantoni, deceased et al (US 3867942), as applied to claim 109 above, and further in view of Shabaz et al (US 20050159677).
Regarding claim 111, Bellantoni discloses all of the limitations set forth in claim 109, but does not specifically disclose each gear is secured to the corresponding scalpet via at least one of direct molding, adhesive, and press fitting. However, Shabaz et al (hereafter Shabaz) teaches it was known in the art at the time of the invention to attach gears by adhesive (paragraph 0047). Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make each gear is secured to the corresponding scalpet via adhesive, since it has been held that adhesive is a known attachment means for gears at the time of the invention by Shabaz, and it has been held that mere substitution of art-recognized equivalents at the time of the invention involves routine skill in the art.
Claim 122 is rejected under 35 U.S.C. 103 as being unpatentable over Bellantoni, deceased et al (US 3867942), as applied to claim 118 above, and further in view of Tezel (US 4476864).
Regarding claim 122, Bellantoni discloses all of the limitations set forth in claim 118, but does not disclose each scalpet includes a diametric dimension approximately in a range 0.5 millimeters to 4.0 millimeters. Tezel teaches a combined multiple punch hair transplant cutting device, wherein it was known in the art at the time of the invention to make the diameter of the scalpets between 2.54 millimeters and 3.81 millimeters. Therefore, it would have been within the level of one with ordinary skill in the art at the time of the invention to make each scalpet include a diametric dimension approximately in a range 0.5 millimeters to 4.0 millimeters, as taught as known by Tezel, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 126-128 are rejected under 35 U.S.C. 103 as being unpatentable over Bellantoni, deceased et al (US 3867942), as applied to claim 108 above, and further in view of Bridges (US 6027512).
Regarding claim 126, Bellantoni discloses all of the limitations set forth in claim 108, but does not disclose the scalpet assembly is configured to couple to a vacuum component configured to generate a vacuum. However, Bridges teaches a hair follicle harvesting device comprising a vacuum component (flow of saline solution through a venturi or tube constriction) configured to generate a vacuum (reduce pressure, abstract) to facilitate removal of the loosened hairs and hair follicles into the 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, 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.
Regarding claim 127, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 126, comprising a housing (24) configured to include the scalpet assembly, wherein Bridges teaches a housing (2) is configured to couple the vacuum to a resection site via a scalpet (10). Therefore, it would have been obvious to one with ordinary skill in the art at the time of the invention to for the housing of Bellantoni to couple the vacuum taught by Bridges to a resection site via the plurality of scalpets, in order to subject selected growing hair follicles in the scalp flap to a corresponding vacuum zone which operates through the hollow interior of the needle as the distal end of the needle is inserted over the growing hair follicles and penetrates the scalp, as taught by Bridges (C:6, L:15-30).
Regarding claim 128, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 126, wherein the vacuum taught by Bridges would be configured to evacuate incised tissue generated by the plurality of scalpets.
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, 109, 112, 117, 118, 122 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, and 11 of U.S. Patent No. 9987473.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 9987473 recites the claimed scalpet assembly coupled to a substrate to rotate the plurality of scalpets, as recited in claim 108. The claims don’t recite a plurality of gears coupled to the plurality of scalpets, wherein each scalpet of the scalpet array includes a gear of the plurality of gears in a proximal region of the scalpet. However, Bellantoni teaches a scalpet assembly comprising a scalpet array including a plurality of scalpets (89) coupled to a substrate (65) to maintain the plurality of scalpets in a configuration; and a plurality of gears (29b-f) coupled to the plurality of scalpets such that the gears of the plurality of scalpets intermesh (C:3, L:59-67; C:4, L:1-11), wherein the gears are configured to couple to a drive system configured to cause the plurality of scalpets to rotate (C:4, L:1-38). It would have been obvious to one of ordinary skill in the art to include a plurality of gears coupled to the plurality of scalpets in order to make a train for rotation in unison.
18361015
108, 109, 112
117, 118
122
9987473
1
4, 3
11
Claims 108, 112, 117, 122 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 10, 21 of U.S. Patent No. 10773064.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 10 of Patent 10773064 recites the claimed scalpet assembly coupled to a substrate, as recited in claim 108. The claims don’t recite a plurality of gears coupled to the plurality of scalpets to rotate them, wherein each scalpet of the scalpet array includes a gear of the plurality of gears in a proximal region of the scalpet. However, Bellantoni teaches a scalpet assembly comprising a scalpet array including a plurality of scalpets (89) coupled to a substrate (65) to maintain the plurality of scalpets in a configuration; and a plurality of gears (29b-f) coupled to the plurality of scalpets such that the gears of the plurality of scalpets intermesh (C:3, L:59-67; C:4, L:1-11), wherein the gears are configured to couple to a drive system configured to cause the plurality of scalpets to rotate (C:4, L:1-38). It would have been obvious to one of ordinary skill in the art to include a plurality of gears coupled to the plurality of scalpets in order to make a train for rotation in unison.
18361015
108, 112
117
122
10773064
1, 10, 21
3
4
Claims 108, 112, 117, 122 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 3, 9, 20 of U.S. Patent No. 11090473.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 9 of Patent 11090473 recites the claimed scalpet assembly coupled to a substrate, as recited in claim 108. The claims don’t recite a plurality of gears coupled to the plurality of scalpets to rotate them, wherein each scalpet of the scalpet array includes a gear of the plurality of gears in a proximal region of the scalpet. However, Bellantoni teaches a scalpet assembly comprising a scalpet array including a plurality of scalpets (89) coupled to a substrate (65) to maintain the plurality of scalpets in a configuration; and a plurality of gears (29b-f) coupled to the plurality of scalpets such that the gears of the plurality of scalpets intermesh (C:3, L:59-67; C:4, L:1-11), wherein the gears are configured to couple to a drive system configured to cause the plurality of scalpets to rotate (C:4, L:1-38). It would have been obvious to one of ordinary skill in the art to include a plurality of gears coupled to the plurality of scalpets in order to make a train for rotation in unison.
18361015
108, 112
117
122
11090473
1, 9, 20
2, 3
4
Claims 108 and 112 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1of U.S. Patent No. 10219827.
Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 10219827 recites the claimed scalpet assembly coupled to a substrate, as recited in claim 108. The claims don’t recite a plurality of gears coupled to the plurality of scalpets to rotate them, wherein each scalpet of the scalpet array includes a gear of the plurality of gears in a proximal region of the scalpet. However, Bellantoni teaches a scalpet assembly comprising a scalpet array including a plurality of scalpets (89) coupled to a substrate (65) to maintain the plurality of scalpets in a configuration; and a plurality of gears (29b-f) coupled to the plurality of scalpets such that the gears of the plurality of scalpets intermesh (C:3, L:59-67; C:4, L:1-11), wherein the gears are configured to couple to a drive system configured to cause the plurality of scalpets to rotate (C:4, L:1-38). It would have been obvious to one of ordinary skill in the art to include a plurality of gears coupled to the plurality of scalpets in order to make a train for rotation in unison.
18361015
108, 112
10219827
1
Claims 108, 112, 115, 116, 118, 121, 126-128 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 33, 12-14, 17-19, 50-56 of U.S. Patent No. 10517635.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 7, 33, 12-14, 17-19, 50-56 of Patent 10517635 recites the claimed scalpet assembly and plurality of gears coupled to the scalpets, as recited in claim 108. The claims don’t recite the scalpets coupled to a substrate. However, Bellantoni teaches a scalpet assembly comprising a scalpet array including a plurality of scalpets (89) coupled to a substrate (65) to maintain the plurality of scalpets in a configuration; and a plurality of gears (29b-f) coupled to the plurality of scalpets such that the gears of the plurality of scalpets intermesh (C:3, L:59-67; C:4, L:1-11), wherein the gears are configured to couple to a drive system configured to cause the plurality of scalpets to rotate (C:4, L:1-38). It would have been obvious to one of ordinary skill in the art to couple the scalpets to a substrate as taught by Bellantoni to guide the plurality of scalpets while allowing free rotation therein.
18361015
108, 112, 115, 116
118, 121
126-128
11090473
1, 7, 33
12-14, 17-19
50-56
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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/ANH T DANG/Primary Examiner, Art Unit 3771