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 .
Response to Arguments
Applicant's arguments filed March 26, 2025 have been fully considered but they are not persuasive.
In response to applicant’s argument that neither Bellantoni nor Bridges provide any motivation to combine with the other, respectively, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Bridges teaches providing a vacuum chamber integrated with the collection device to evacuate resected tissue from a target site, wherein this collection allows for continual removal (C:3, L:6-10) of hair follicles in the harvesting tube and depositing them on a perforated plate or screen to accumulate hair follicles for hair transplantation (C:3, L:15-22) collection. Therefore, based on this teaching, it would have been within the level of one with ordinary skill in the art at the time of the invention to look to Bridges to modify the device of Bellantoni to accomplish this, since the harvesting device of Bellantoni requires a more labor-intensive and time consuming technique of repositioning the grafts to the implantation before being able to harvest the next patch of hair follicles. Therefore, Bridges provides a teaching and motivation to modify the device of Bellantoni as set forth below, and applicant’s argument is not persuasive.
In response to applicant’s argument that one skilled in the art would just opt to use the device of Bridges instead of modifying or using the device of Bellantoni, the determination for obviousness is not whether or not one in the art would use one device over the other or would not be motivated to produce a claimed invention, it is whether or not the claimed invention would have been obvious to one with ordinary skill in the art at the time of the invention based on the teachings and knowledge available at the time of the invention. So long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and there would have been a motivation to modify the prior art, the obviousness rejection is proper. Therefore, applicant’s argument is not persuasive.
In response to applicant’s argument that the gear housing, shanks and cutter tool elements of Bellantoni are not capable of being combined with the vacuum chamber, gear housing, and harvesting tube of bridges, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Therefore, since Bridges teaches a vacuum chamber and a collection chamber, integrated with the handle and the gear housing, configured to route vacuum via the gear housing and the collection chamber to evacuate resected tissue from a target site to the collection chamber via the cannula, it would have been suggested to one with ordinary skill in the art at the time of the invention modify the device of Bellantoni to also include this feature and within the skill of one with ordinary skill in the art at the time of the invention to modify the device to meet these limitations. Therefore, applicant’s arguments are not persuasive.
In response to applicant’s argument that the combination would not have a vacuum chamber integrated with a gear housing as claimed, the limitation “integrated” would be sufficiently broad to encompass all of the components of the integrated together in to form the housing as a whole. Therefore, since Bridges discloses the vacuum chamber and its components being integrated with the housing, it would also be integrated with the gear housing therein, and applicant’s arguments that all of the claim limitations are not met 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.
Claim 58, 64-66, and 69 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 claims 58, Bellantoni discloses system comprising: a cannula assembly including a cannula (31, 32) comprising a gear (29, figure 3) coupled to a drive shaft (26, C:6, L:19); a gear housing (24) coupled to the cannula assembly and housing the gear (figure 5). Bellantoni does not specifically disclose a vacuum chamber integrated with the housing and coupled to a collection chamber, wherein the vacuum chamber is configured route vacuum via the housing and the collection chamber to evacuate resected tissue from a target site to the collection chamber via an aperture in a proximal region the cannula. Bridges teaches a hair follicle harvesting device comprising a vacuum chamber (flow of saline solution through a venturi or tube constriction) integrated with a housing and coupled to a collection chamber (22), wherein the vacuum chamber is configured to route vacuum via the housing and the collection chamber to evacuate resected tissue from a target site to the collection chamber (C:6, L:45-67) via a aperture in the proximal region of the cannula to facilitate removal of the loosened hairs and hair follicles into the saline stream , wherein the vacuum chamber is integrated with the handle (figure 1) to allow for continual removal (C:3, L:6-10) of hair follicles in the harvesting tube and depositing them on a perforated plate or screen to accumulate hair follicles for hair transplantation (C:3, L:15-22) collection. 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 chamber and a collection chamber, integrated with the handle and thus the gear housing (the limitation “integrated” would be sufficiently broad to encompass all of the components of the integrated together in to form the housing as a whole, and thus integrating the vacuum chamber with the handle would also integrate it with the gear housing of Bellantoni), configured to route vacuum via the gear housing and the collection chamber to evacuate resected tissue from a target site to the collection chamber via the cannula , such as the one taught by Bridges, in the device of Bellantoni in order for the hair follicles to be continually and selectively removed by vacuum from a segment of scalp by the removal device.
Regarding claim 59, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 58, wherein the cannula includes a scalpet (31) comprising a shaft having a lumen, and a distal end sharpened (32) around a circumference of the tube (31) and forming a cutting edge (figure 1).
Regarding claim 60, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 59, wherein the scalpet includes the aperture (distal end of 32’) positioned in the scalpet adjacent the lumen and configured to pass the resected tissue.
Regarding claim 61, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 60, wherein Bridges teaches the vacuum chamber is configured to couple vacuum to the lumen via the aperture, wherein the vacuum is configured to evacuate the resected tissue via the lumen and the vacuum chamber (C:6, L:45-67).
Regarding claim 62, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 61, wherein the vacuum chamber is configured to couple to a remote vacuum source (15, Bridges).
Regarding claim 63, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 61, wherein Bridges teaches the housing includes a vacuum seal configured to maintain vacuum forces at an approximately constant level in at least one of the vacuum chamber and the gear housing (gasket, C:7, L:18-30).
Regarding claim 64, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 58, wherein the cannula assembly comprises a multi- scalpet array (figure 1, multiple scalpets).
Regarding claim 65, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 64, wherein the at least one cannula includes a plurality of scalpets (figure 1) configured to operate in unison (paragraph 0170, operate together at the same time, and thus in unison(C:4, L:17-30), and each scalpet of the plurality of scalpets comprises a tube (32) comprising a lumen, and a distal end sharpened around a circumference of the tube and forming a cutting edge (32’).
Regarding claim 66, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 65, wherein the MSA includes a drive shaft (26, C:6, L:19) coupled to a proximal region of a central scalpet of the scalpet array, wherein the drive shaft is configured to couple rotational force from a remote source to the plurality of scalpets (31a, C:6, L:15-30).
Regarding claim 69, Bellantoni in view of Bridges teaches all of the limitations set forth in claim 66, wherein each scalpet of the scalpet array includes a gear (29a-29f) in a proximal region of the scalpet, wherein the gears of the plurality of scalpets intermesh(C:3, L:60-68; C:4, L:1-10).
Claim 70 is rejected under 35 U.S.C. 103 as being unpatentable over Bellantoni, deceased et al (US 3867942) in view of Bridges (US 6027512), as applied to claim 69 above, in view of Shabaz et al (US 20050159677).
Regarding claim 70, Bellantoni in view of Shabaz teaches all of the limitations set forth in claim 69, 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.
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 58, 60-62, 64, 69, 70, 73-77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7, 8, 13, 23, 25, 35, 36, 40, 42, 44 of U.S. Patent No. 11751904.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 7, 8, 13, 23, 25, 35, 36, 40, 42, 44 of Patent 11751904 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, 7, 8, 13, 23, 25, 35, 36, 40, 42, 44 is in essence a “species” of the generic invention of application claims 60-79 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 60 is anticipated by patent claims 1, 7, 8, 13, 23, 25, 35, 36, 40, 42, 44, it is not patentably distinct from patent claim 1, 7, 8, 13, 23, 25, 35, 36, 40, 42, 44.
18358580
58, 69, 60
70
73
74
75
76
77
64
11751904
1, 23
25
35
36
40
42
44
13
18358580
61
62
11751904
7
8
Claims 58, 69-71, 73-74, 76, 77 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 29, 31, 34, 40, 41, 46, 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 1, 29, 31, 34, 40, 41, 46, 49 of Patent 11759231recites 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 claim 10 is in essence a “species” of the generic invention of application claims 58, 69-71, 73-74, 76, 77 are “anticipated” by a “species” within the scope of the generic invention. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims 58, 69-71, 73-74, 76, 77 are anticipated by patent claims 1, 29, 31, 34, 40, 41, 46, 49, it is not patentably distinct from patent claims 1, 29, 31, 34, 40, 41, 46, 49.
18358580
58, 69,
70
71
73
74
76
77
11759231
1, 29
31
34
40
41
46
49
Conclusion
THIS ACTION IS MADE FINAL. 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).
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.
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/ANH T DANG/Primary Examiner, Art Unit 3771