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 Amendment
This action is in response to the preliminary amendment filed on 8/22/2025. In the amendment, claims 1-19 & 25-39 have been cancelled and claim 40 has been amended.
Drawings
The drawings are objected to because they fail to label the elements (in particular the claimed structures - ‘first channel’, ‘second channel’, ‘third channel’, ‘hollow needle’, ‘central rod’) with reference numbers. Further, the specification does not incorporate reference numbers with respect to these elements. It is requested that applicant incorporate reference numbers into both the drawings and the specification for the structures described/claimed. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the ‘one or more manually manipulable controls positioned along the cylindrical body’ (claim 24) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 22 is objected to because of the following informalities: line 4 - examiner suggests amending ‘positioned at forward side’ to --positioned at a forward side--. Appropriate correction is required.
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 20-23 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boudjema et al. (US Pat. No. 10,813,667 B1).
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 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).
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 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. NOTE: the ‘one or more manually manipulable controls positioned along the cylindrical body’ are objected to under Drawings section above as not being shown in the drawings. This objection will need to be properly overcome in order to proceed with allowance of this claim when rewritten in independent form
The following is a statement of reasons for the indication of allowable subject matter: Boudjema et al. fails to further disclose, teach, or suggest the manually manipulable control as claimed in claim 24. Examiner notes that the closest element in Boudjema et al. to a manually manipulable control is the actuatable rectilinear rod which fails to meet the functional requirements of the claim ‘to issue commands for excising a follicular unit having designated characteristics and delivering a corresponding graft to the handpiece for implantation’. For this reason, claim 24 as a whole (functional language is pertinent) is allowable over the prior art if rewritten in independent form.
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 December 11, 2025