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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/19/2026 has been entered.
Response to Amendment
This action is in response to the amended claims filed alongwith the RCE on 8/19/2026. In the amendment, claim 20 has been amended.
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.
Claims 20-23 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Boudjema et al. (US Pat. No. 10,813,667 B1) in view of Lewallen (US Pub. No. 2017/0065291 A1).
Regarding claim 20, Boudjema et al. disclose an implantation handpiece (Figs. 1-5F) comprising: a generally cylindrical body 2, 5 (Fig. 2) for gripping by a user of the implantation handpiece; first and second channels 110, 101 (Fig. 2) positioned on the cylindrical body 2, 5 (Fig. 2), wherein the first channel 110 is connectable to a source of vacuum (NOTE: a source of vacuum is not positively recited as part of the claimed invention, the channel merely needs to be capable of being connected thereto, which 110 is considered to be capable of; further, channel 110 is also disclosed by Boudjema et al. as being connected to a vacuum source - column 14, lines 13-15) and the second channel 101 is connectable to a source of harvested follicular units (NOTE: a source of harvested follicular units is not positively recited as part of the claimed invention, the channel merely needs to be capable of being connected thereto, which 110 is considered to be capable of; further, channel 101 is also disclosed by Boudjema et al. as being connected to a hair graft reservoir - column 13, lines 27-29); a central rod 131 (Fig. 2) and a hollow needle 6 (Fig. 2), wherein the central rod 131 and the hollow needle 6 are positioned for slidable and relative movement of the rod 131 inside the needle 6 (Figs. 3A-3B & 5A-5F), wherein in a retracted position of the rod 131 relative to the needle 6, a harvested follicular unit is delivered from the second channel 101 to an interior of the hollow needle 6 under force of pressure (or vacuum) applied to the first channel 110 at a position forward of the central rod 131, and wherein in an implantation position, slidable movement of the central rod 131 relative to the hollow needle 6 drives the follicular unit from the hollow needle 6 into an implantation site (NOTE: the harvested follicular unit is not positively recited as part of the claimed invention, therefore, the above limitations with respect to the retracted and implantation positions are read functionally with respect to the rod, needle, and channel capability to perform such an intended function; since the implantation handpiece of Boudjema et al. meets all of the structural requirements of the claims, it is considered to also be capable of performing such function in the claimed positions; furthermore, Boudjema et al. is considered to disclose these claimed positions as shown in Figs. 5A-5F). Boudjema et al. fail to further disclose wherein the second channel includes saline or a biological liquid and the saline or the biological liquid is delivered with the harvested follicular unit to an interior of the hollow needle.
However, Lewallen teaches a similar harvesting/implanting system wherein a source of saline is suggested and taught as a way to lubricate an extracted follicle’s travel through a conduit and preserve the viability of the follicle (paragraph [0025]). It is considered that one of ordinary skill in the art before the effective filing date of the claimed invention would have found it beneficial in view of the teachings of Lewallen to utilize a source of saline in the second channel of Boudjema et al.’s system for the purpose of ensuring that the extracted follicle is delivered therethrough in a way that keeps the follicle lubricated and viable for implantation. Implanting a viable follicle is crucial for a successful transplantation.
Regarding claim 21, Boudjema et al. further disclose a third channel 4 (Fig. 2) for controllable introduction of pressure under control of the user or channeling vacuum to accomplish the same function (column 7, lines 51-55), wherein introduction of pressure (or vacuum) from the third channel 4 drives the central rod 131 from the retracted position to the implantation position (column 8, lines 59-66 - note that 131 is an extension of the discussed piston 13).
Regarding claim 22, Boudjema et al. further disclose wherein in the retracted position the central rod 131 is fit loosely inside the hollow needle 6 (Figs. 2 & 4A-B), wherein the first channel 110 is positioned at a rearward side of a forward end of the central rod 131 (shown in Fig. 4B position) and the second channel 101 is positioned at forward side of the forward end of the central rod 131 (shown in Fig. 4B position), and wherein the fit of the central rod 131 inside the hollow needle 6 is sufficiently loose as to allow vacuum applied from the first channel 110 to reach alongside the central rod 131 and to suction a harvested follicular unit from the second channel 101 (NOTE: harvested follicular unit is not part of the claimed invention, the structure merely needs to be capable of performing the intended function, which it is considered to be capable of doing as seen in Figs. 4A-4C & 5A-5F).
Regarding claim 23, Boudjema et al. further disclose wherein slidable movement of the central rod 131 relative to the hollow needle 6 is effectuated manually by the user (channel 4 is disclosed by Boudjema et al. as being connected to a source of compressed air - not shown; there are many sources of compressed air known in the art, including manually effectuated sources; therefore, it is considered that since the source of the manually effectuation is not explicitly disclosed in the claim as a structure, any known source such as a manually effectuated compressed air source would be suitable to meet the criteria of the claim).
Regarding claim 40, Boudjema et al. disclose a method of loading a hair graft into an implantation handpiece (Figs. 5A-5F; column 9, lines 11-59) comprising loading a hair graft into the implantation handpiece according to Claim 20 (see rejection of claim 20 above for handpiece specific rejection; Figs. 5A-5f; column 9, lines 11-59) in preparation for a surgeon to implant the loaded hair graft to a recipient region (Figs. 5A-5F; column 9, lines 11-59).
Allowable Subject Matter
Claim 24 is allowed.
The following is an examiner’s statement of reasons for allowance: claim 24 has been rewritten in independent form in response to the previous indication of allowable subject matter (see Reasons for Allowance indicated in the Non-Final Rejection mailed on 1/15/2026).
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 20-23 & 40 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. (Teaching reference has been added to address added limitations via the amendment.)
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LAUREN FISHBACK whose telephone number is (571)270-7899. The examiner can normally be reached M-F 7:30a-3:30p.
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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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ASHLEY LAUREN FISHBACK
Primary Examiner
Art Unit 3771
/ASHLEY L FISHBACK/Primary Examiner, Art Unit 3771 August 21, 2026
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