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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/17/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 1-12 and 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franco (WO 2021168448 A1) in view of Oostman (US 2015/0032129 A1).
Regarding claim 1, Franco discloses:
A hair transplant system (see Fig. 2), comprising:
a casing (housing 12, see Fig. 2);
an extracting needle (extracting needle 26, see Fig. 2); and
a pin extending through a center of the casing and configured to cause the extracting needle to selectively take in or eject a hair follicle (pin 80, see Fig. 4; see also Para. [0075] and [0077]-[0078]).
However, Franco does not expressly disclose:
wherein the extracting needle comprises a first groove extending longitudinally from a distal end of the extracting needle;
the first groove including a notch; and
a lock disposed on the extracting needle and configured to selectively close at least a portion of the first groove.
In the same field of endeavor, namely devices for removing or implanting hair follicles, Oostman teaches a hair transplant system (see Figs. 30A-30C) comprising: an extraction needle (cannula 460, see Fig. 30A; see also Para. [0159]); wherein the extraction needle comprises a first groove (trough formed underneath finger portion 463; see Figs. 30A-30C; see also Para. [0159]) including a notch (notches formed at the attached edges of the finger portion 463, see Figs. 30A-30B); and a lock disposed on the extracting needle and configured to selectively close at least a portion of the first groove (telescoping outer cannula 467; see Fig. 30C; see also Para. [0159]); wherein the first groove and lock are configured to operate together to capture/lock in-place a harvested follicular unit through the trough in the finger portion after the distal tip has been pushed through several skin layers into the subcutaneous tissue to a depth surrounding the hair follicular unit (see Para. [0159]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the extracting needle of Franco to comprise a first groove, including a notch therein, disposed along a lateral surface thereof; and a lock shaft slidably disposed around the needle configured to selectively close at least a portion of the first groove as disclosed by Oostman to, in this case, provide a hair follicle capture system that impedes the movement of the target hair follicle in the distal direction of the extracting tool to capture and hold in-place a harvested follicular unit through the trough in the finger portion after the distal tip has been pushed through several skin layers into the subcutaneous tissue to a depth surrounding the hair follicular unit (see Oostman Para. [0159]).
Regarding claim 2, the combination of Franco and Oostman disclose the invention of claim 1, Franco, as modified by Oostman, further discloses an implanting needle attachment removably coupled to the casing (implanting unit 16, see Franco Figs. 1, 4 and 13; see also Para. [0058]-[0061] and [0086]), the implanting needle attachment including an implanting needle (implanting needle 32, see Franco Figs. 3-4 and 13; see also para. [0061]) and a second groove (slots 40, see Franco Figs. 3-4) configured to provide access to the lock in a state of the implanting needle attachment being coupled to the casing and overlying the extracting needle (slots 40 are capable of providing access to the lock, as incorporated from the teachings of Oostman, as they provide coupling means; see Franco Para. [0086]; as the lock of Oostman, as incorporated into the device of Franco, needs to be in slidably coupled around and engaged with the extracting needle 26, the slots 40 of the implanting unit are thereby seen to allow access to the lock since the implanting unit is disposed exterior to the extraction unit; see also Para. [0061]).
Regarding claim 3, the combination of Franco and Oostman disclose the invention of claim 2, Franco, as modified by Oostman, further discloses wherein, in a state of the implanting needle attachment being coupled to the casing, the second groove is aligned with the first groove (slots 40 of implanting unit 16 align with the extracting needle 26; see Figs. 3-4 and Para. [0061]).
Regarding claim 4, the combination of Franco and Oostman disclose the invention of claim 2, Franco further discloses wherein the implanting needle attachment is configured to removably couple to the casing via a friction fit (see Para. [0060]-[0061] mentioning wherein the implant unit is attached to the extraction unit via mating of slots 40 with guideway protrusions 30; as no additional securement means are disclosed, this securement is understood to be held together via friction absent any discussion of a locking mechanism holding the components together).
Regarding claim 5, the combination of Franco and Oostman disclose the invention of claim 2, Franco further discloses wherein, in a state of the implanting needle attachment being coupled to the casing, actuation of the pin is configured to cause the extracting needle to implant the hair follicle via the implanting needle (see Para. [0077]).
Regarding claim 6, the combination of Franco and Oostman disclose the invention of claim 1, Franco, as modified by Oostman, further discloses wherein the lock includes a cylindrical collar (see Oostman Figs. 30A-30C showing wherein the telescoping outer cannula is cylindrical) configured to receive the extracting needle therein (see Oostman Figs. 30A-30C showing wherein the telescoping outer cannula is configured to receive the harvesting cannula therein; see Oostman also Para. [0159]; the telescoping outer cannula of Oostman is therefore understood to receive the receive the harvesting/extracting needle within a lumen thereof to perform the selective closing of the finger portion thereon) such that the lock is configured to slide along the extracting needle between a first position in which the lock covers the notch and a second position in which the lock does not cover the notch (see Oostman Para. [0159]).
Regarding claim 7, the combination of Franco and Oostman disclose all of the limitations of the invention of claim 1.
However, none of either Franco or Oostman expressly disclose wherein the notch is at least one cm from the distal end of the extracting needle.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the first groove of Franco, as modified by Oostman, to have at least one notch be at least 1cm away from the distal tip since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Franco, as modified by Oostman, would not operate differently with the claimed distance/length and since Oostman discloses wherein the length of the first groove may vary depending on the target location and desired hair follicle (see Oostman Para. [0129]), one of ordinary skill in the art would have had a reasonably expectation of success that the device would function appropriately, should the target hair follicle be positioned more than 1cm away from the distal tip of the extraction needle. Further, applicant places no criticality on the distance claimed, indicating this value is merely exemplary and may change depending on the target site and hair follicle length (see Specification Para. [0030]).
Regarding claim 8, the combination of Franco and Oostman disclose the invention of claim 1, Franco further discloses wherein the pin includes a port configured for connection to a vacuum source (see Para. [0078]), and a central lumen in fluid communication with a cavity of the casing configured to receive the hair follicle from a donor site (lumen 94, see Fig. 4; see also Para. [0078]).
Regarding claim 9, Franco discloses:
A hair transplant method, comprising:
providing a hair transplant system (see Figs. 1-2) comprising an extracting needle (extraction needle 26, see Fig. 2) having a first groove (groove formed be pair of angled surfaces 56, see Fig. 5; see also Para. [0065]) extending longitudinally from a distal end of the extracting needle (see Fig. 5);
inserting a hair through the first groove (see Para. [0085]; as hair follicle is extracted it must pass through the groove defined by the angled surfaces);
extracting a follicle of the hair by piercing a donor site with the extracting needle (see Para. [0085]);
attaching an implantation unit to the hair transplant system (implanting unit 16, see Figs. 1, 4 and 13; see also Para. [0086]), the implantation unit including an implanting needle (implanting needle 32, see Figs. 3-4 and 13) and a second groove (slots 40, see Figs. 3-4 and 13) configured to align with the first groove in a state of the implantation unit being attached to the hair transplant system (slots 40 align with the groove of the extraction needle 26, see Figs. 3-4);
piercing a recipient site with the implanting needle (see Para. [0087]), and disengaging the lock and implanting the follicle (see Para. [0088]).
However, Franco does not expressly disclose wherein the first groove includes a notch;
inserting the hair through the first groove and out the notch; and
engaging a lock disposed on the extracting needle, thereby to close at least a portion of the first groove.
In the same field of endeavor, namely devices for removing or implanting hair follicles, Oostman teaches a hair transplant system (see Fig. 30A) comprising: an extraction needle (cannula 460, see Fig. 30A; see also Para. [0159]); wherein the extraction needle comprises a first groove (trough formed underneath finger portion 463, see Figs. 30A-30C; see also Para. [0159]) including a notch (notches formed at the attached edges of the finger portion 463, see Figs. 30A-30B); wherein hair inserted through the first groove exits out of the notch (see Para. [0159]; harvested follicular unit may be captured and clamped within the trough by the finger portion 463); engaging a lock disposed on the extracting needle, thereby to close at least a portion of the first groove (telescoping outer cannula 467, see Fig. 30C; see also Para. [0159]; outer cannula is slidably disposed around the extraction cannula to selectively close a portion of the trough); and disengaging the lock and implanting the follicle (see Para. [0159]; as the finger captures the follicular unit until a depth is reached).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the extraction needle of Franco to comprise an enlarged first groove/finger portion, including a notch therein, disposed along a lateral surface thereof; and a lock disposed around the needle configured to selectively close at least a portion of the first groove as disclosed by Oostman to, in this case, provide a capture system that captures, holds and impedes the movement of a target hair follicle in the axial direction to capture and hold in-place a harvested follicular unit through the trough in the finger portion after the distal tip has been pushed through several skin layers into the subcutaneous tissue to a depth surrounding the hair follicular unit (see Oostman Para. [0159]).
Regarding claim 10, the combination of Franco and Oostman disclose the method of claim 9, Franco further discloses wherein the operation of attaching the implantation unit does not include manipulating the follicle (see Para. [0086] and [0142]).
Regarding claim 11, the combination of Franco and Oostman disclose the method of claim 9, Franco further discloses prior to the operation of inserting the hair, performing a treatment on the donor site (see Para. [0089]).
Regarding claim 12, the combination of Franco and Oostman disclose the method of claim 11.
However, Franco does not expressly disclose wherein the treatment includes cooling a tissue of the donor site.
Oostman further discloses wherein applying a cooling solution to target tissue using lubricant (see Para. [0173]) allows for an easier, more efficient extraction/transplantation procedure (see Para. [0173]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the implantation method of Franco to include providing a cooling and lubricious fluid at the distal end of the extraction needle to, in this case, help keep harvested follicular units moist to allow for an easier, more efficient extraction/transplanting procedure (see Oostman Para. [0173])
Regarding claim 15, the combination of Franco and Oostman disclose all of the limitations of the method of claim 9, Franco, as modified by Oostman, further discloses wherein the operation of engaging the lock includes tensioning the hair (see Oostman Para. [0159]; tension in the follicular unit is maintained when captured and held within the trough of the extraction needle).
Regarding claim 16, the combination of Franco and Oostman disclose the method of claim 9, Franco further discloses wherein the hair transplant system further comprises a casing (housing 12, see Fig. 1) and a pin extending through a center of the casing (pin 80, see Fig. 4 and Para. [0078]), and wherein the operation of extracting the follicle includes applying a vacuum via the pin (see Para. [0078] and [0086]).
Regarding claim 17, the combination of Franco and Oostman disclose the method of claim 9, Franco further discloses wherein the hair transplant system further comprises a pin extending through a center of the casing (pin 80, see Figs. 3-4 and Para. [0078]), and wherein the operation of implanting the follicle includes actuating the pin (see Para. [0075]-[0077] and [0088]).
Regarding claim 18, the combination of Franco and Oostman disclose all of the limitations of the method of claim 9, Franco, as modified by Oostman, further discloses wherein the operation of engaging the lock includes sliding the lock along the extracting needle from a first position in which the notch is exposed to a second position in which the hair passes through the notch and the lock is advanced to close the groove in the extracting needle (see Oostman Para. [0159]).
Regarding claim 19, the combination of Franco and Oostman disclose the method of claim 9, Franco further discloses after the operation of disengaging the lock and implanting the follicle, removing the hair transplant system from the recipient site (see Para. [0090]).
Regarding claim 20, Franco discloses:
A method of manufacturing a hair transplant system, comprising:
providing an extracting unit (see Figs. 1-3), the extracting unit including:
a casing (housing 12, see Fig. 2);
an extracting needle (extracting needle 26, see Fig. 2) having a first groove extending longitudinally from a distal end of the extracting needle (groove formed between angled surfaces 56, see Fig. 5; see also Para. [0065]);
a pin extending through a center of the casing and configured to cause the extracting needle to selectively take in or eject a hair follicle (pin 80, see Fig. 4; see also Para. [0075] and [0077]-[0078]); and
providing an implantation unit (implanting unit 16, see Figs. 1, 4 and 13; see also Para. [0086]), the implantation unit including an implanting needle (implanting needle 32, see Figs. 3-4 and 13) and a second groove (slots 40, see Figs. 3-4 and 13);
wherein the implantation unit is configured to be removably coupled to the casing such that, in a state of the implantation unit being coupled to the casing (see Para. [0060]-[0061] and [0065]-[0066]), the second groove is aligned with the first groove (slots 40 align with the groove of the extraction needle 26, see Figs. 3-4).
However, Franco does not expressly disclose:
Wherein the first groove includes a notch; and
a lock disposed on the extracting needle and configured to selectively close at least a portion of the first groove.
In the same field of endeavor, namely devices for removing or implanting hair follicles, Oostman teaches a hair transplant system (see Figs. 30A-30C) comprising: an extraction needle (cannula 460, see Fig. 30A; see also Para. [0159]); wherein the extraction needle comprises a first groove (trough formed underneath finger portion 463; see Figs. 30A-30C; see also Para. [0159]) including a notch (notches formed at the attached edges of the finger portion 463, see Figs. 30A-30B); and a lock disposed on the extracting needle and configured to selectively close at least a portion of the first groove (telescoping outer cannula 467; see Fig. 30C; see also Para. [0159]); wherein the first groove and lock are configured to operate together to capture/lock in-place a harvested follicular unit through the trough in the finger portion after the distal tip has been pushed through several skin layers into the subcutaneous tissue to a depth surrounding the hair follicular unit (see Para. [0159]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the extracting needle of Franco to comprise an elongated first groove, including a notch therein, disposed along a lateral surface thereof; and a lock shaft slidably disposed around the needle configured to selectively close at least a portion of the first groove as disclosed by Oostman to, in this case, provide a hair follicle capture system that impedes the movement of the target hair follicle in the distal direction of the extracting tool to capture and hold in-place a harvested follicular unit through the trough in the finger portion after the distal tip has been pushed through several skin layers into the subcutaneous tissue to a depth surrounding the hair follicular unit (see Oostman Para. [0159]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franco (WO 2021168448 A1) in view of Oostman (US 2015/0032129 A1), further in view of Cotsarelis (US 2015/0072963 A1).
Regarding claim 13, the combination of Franco and Oostman disclose all of the limitations of the method of claim 11.
However, Franco does not expressly disclose wherein the treatment includes administering a hair growth inhibitor to the donor site.
In the same field of endeavor, namely means and methods of regulating hair growth, Cotsarelis teaches wherein administering a hair growth inhibitor to a target donor site may be used in combination with or as an alternative to mechanical removal to regulate/moderate hair growth (see Para. [0081]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the hair transplantation method of Franco to include administering a hair growth inhibit to the target donor site as disclosed by Cotsarelis to, in this case, provide an alternative, less intrusive means of limiting hair growth at the target donor site to prepare the donor site for the upcoming hair implantation (see Cotsarelis Para. [0081]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Franco (WO 2021168448 A1) in view of Oostman (US 2015/0032129 A1), further in view of Vo-Dinh (US 2020/0078600 A1).
Regarding claim 14, the combination of Franco and Oostman disclose all of the limitations of the method of claim 11.
However, Franco does not expressly disclose wherein the treatment includes photobiomodulation.
In the same field of endeavor, namely methods and treatments for treating a disorder or condition in a subject (including hair removal), Vo-Dinh teaches a treatment including photobiomodulation to stimulate or inhibit cellular function leading to beneficial clinical effects (see Para. [0009] and [0191], [0197]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Franco to include photobiomodulation, as disclosed by Vo-Dinh to, in this case, stimulate or inhibit target cellular functions (i.e., to regulate hair growth at a target site) (see Vo-Dinh Para. [0009] and [0191], [0197]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 2023/0329744 A1 to Cole, US 2016/0249948 A1 to Umar, US 2011/0313429 A1 to Anderson, US 2021/0145476 A1 to Franco and US 2022/0125477 A1 to Levinson all disclose hair transplant/removal devices comprising a needle having a cut-out at the distal tip thereof.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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