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 .
Election/Restrictions
Claims 10-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/10/2026.
Applicant’s election without traverse of Group I, Species A, Sub-Species AII in the reply filed on 3/10/2026 is acknowledged. While applicant identifies the elected invention/species corresponds to claims 1-14, it is noted that claim 10 is drawn to Sub-Species AI. Claim 10 recites “a splitting needle including a distal cutting end with movable walls” in line 3 which applies directly to Sub-Species AI: Figs. 20A-20B (see paragraphs [0106]-[0108]). Accordingly, claims 10-14 are also withdrawn.
Drawings
The drawings are objected to because: lines, numbers and letters are not uniformly thick and well defined; and numbers and reference characters are not plain and legible for all figures. This applies to shading. Solid black shading areas are not permitted, expect when used to represent bar graphs or color. See for example, Figures 1, 4A-4C, 5A-5B, 6A-6C, 7A-7C, 8A-8B, 9-11, 18-19, and 20A-20B. 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 Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 2-3 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 2 recites the limitation "the opened and closed orientations" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 3, the phrase "may comprise" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See “for example”, MPEP § 2173.05(d). The term “may comprise” appears to be a preference that leads to confusion over the intended scope of the claim. Thus, it is not clear whether the claimed narrower range of “steel and copper” is a limitation or a preference.
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(s) 1-6 and 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerling, JR. et al. (US 2014/0171827 A1) in view of Bodduluri et al. (US 2007/0078475 A1).
Regarding claim 1, Westerling discloses a hair transplant device (removal tool 640; Figs. 15A-15B, 16A-16B) comprising: a coring needle (inner tube or inner member 644) forming a coring lumen (lumen through 644; Figs. 15B, 16B) configured to extract a hair follicle from a donor site of a donor (as the tool is used for harvesting and transplantation of follicular units; [0007]), the coring needle having a distal cutting end (movable members or deformable tines 646) configured to move between an opened position (Fig. 15B) and a closed position (Fig. 16B) based on a heat memory of a material of the distal cutting end (as the inner tube tines may be made of shape memory materials, for example, Nitinol, or Elgiloy, or cobalt chromium, or similar materials; [0077]).
Westerling fails to explicitly disclose a housing at least partially surrounding the coring needle; and a user interface extending from the housing and movable relative to the coring needle to push the hair follicle from the coring lumen into a recipient site of a subject.
However, Bodduluri teaches a multi-part tool assembly (tool 32; Fig. 3) for harvesting and implanting follicular units (abstract) comprising: a coring needle (harvesting cannula 38) forming a coring lumen (harvesting cannula lumen 76; Fig. 6A) configured to extract a hair follicle from a donor site of a donor (as the harvesting cannula has an open, tissue-coring distal end, and an interior lumen sized to frictionally engage and retain a follicular unit; [0008]); a housing (including at least pin vise 43 and proximal hub 34; Figs. 3-4) at least partially surrounding the coring needle (Fig. 4); and a user interface (elongate obturator 52 and seating member 54) extending from the housing (Fig. 4) and movable relative to the coring needle (32) to push the hair follicle from the coring lumen into a recipient site of a subject (as 52 is slideably positioned in the harvesting cannula 38 and capable of pushing the hair follicle from the harvesting cannula 38 into the opening in the recipient site; Figs. 4, 6A; [0038]) for the purpose of allowing the harvested follicular unit to remain in the coring lumen undisturbed since it was harvested ([0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the hair transplant device of Westerling to include the housing and user interface as claimed as taught by Bodduluri in order to easily grip and manipulate the device as well as use the same device to both harvest and implant the hair follicle, thereby allowing the hair follicle to remain in the coring lumen undisturbed since it was harvested which would reduce trauma or damage to the hair follicle.
Regarding claim 2, Westerling modified discloses the invention as claimed above, and Westerling further discloses wherein the material of the distal cutting end comprises a bimetallic material (as Nitinol is a bimetallic material made of nickel and titanium; [0077]) or a combination of materials having differing thermal expansion coefficients to provide natural actuation between the opened and closed orientations (as Nitinol is a bimetallic material made of nickel and titanium which inherently have different rates of thermal expansion; [0077]).
Regarding claim 3, Westerling modified discloses the invention as claimed above, and Westerling further discloses wherein the material of the distal cutting end comprises a combination of materials having differing thermal expansion coefficients to provide natural actuation between the opened and closed orientations (as Nitinol is a bimetallic material made of nickel and titanium which inherently have different rates of thermal expansion; [0077]). Due to the alternative form of claim 2, additional limitations of the bimetallic material are irrelevant.
Regarding claim 4, Westerling modified discloses the invention as claimed above, and Westerling further discloses wherein the distal cutting end (646) comprises movable walls (movable members or deformable tines 646; [0077]) that move the distal cutting end between the opened position (Fig. 15B) and the closed position (Fig. 16B).
Regarding claim 5, Westerling modified discloses the invention as claimed above, and Westerling further discloses wherein the movable walls (646) form a distal cutting point in the closed position (Fig. 16B).
Regarding claim 6, Westerling modified discloses the invention as claimed above, and Westerling further discloses wherein the movable walls (646) are forced apart from each other in the opened position (as 646 are biased away from one another in the open position; Fig. 15B).
Regarding claim 8, Westerling modified discloses the invention as claimed above, and Westerling further discloses wherein the distal cutting end (646) moving toward the closed position (Fig. 16B) aids in the extraction of the hair follicle by cutting or grabbing a tissue of a skin core that has the hair follicle (Figs. 15B, 16B).
Regarding claim 9, Westerling modified discloses wherein the user interface (52, 54 of Bodduluri) comprises a pin (52) disposed within the coring needle (36), the pin prevented from extending distally past the coring needle (Fig. 6A; [0038] of Bodduluri).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerling, JR. et al. (US 2014/0171827 A1) in view of Bodduluri et al. (US 2007/0078475 A1), as applied to claim 2 above, and further in view of Nau, JR. et al. (US 2012/0041438 A1).
Regarding claim 3, Westerling modified discloses the invention as claimed above, and Westerling further discloses a bimetallic material (Nitinol; [0077]), but fails to disclose wherein the bimetallic material is steel and copper.
However, Nau teaches shape memory materials may include bimetallic strips that are formed from strips of two different metals having different thermal expansion coefficients, e.g., steel and copper. Due to the different thermal expansion coefficients of the two joined strips, when the bimetallic strip is heated, the two strips expand at different rates, causing the bimetallic strip to bend, or curve in the direction of the stirp having the lower coefficient of thermal expansion.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the heat memory material of modified Westerling to be bimetallic steel and copper as taught by Nau, 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 as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Westerling, JR. et al. (US 2014/0171827 A1) in view of Bodduluri et al. (US 2007/0078475 A1), as applied to claim 1 above, and further in view of Lenker et al. (US 2016/0100860 A1).
Regarding claim 7, Westerling modified discloses the invention as claimed above, and Westerling further discloses wherein the distal cutting end (646) is made of Nitinol, a heat memory material ([0077]); therefore, capable of moving between an opened position and a closed position based on the material properties of Nitinol, but Westerling fails to explicitly disclose wherein the distal cutting end is moved to the opened position by applying heat or cooling to the coring needle.
However, Lenker teaches an intermediate tube (104; Fig. 2) that is fabricated from shape memory nitinol and electrical energy may be applied to pre-bent regions of the inner tube to heat and cause the temperature of the intermediate tube to increase in order for the nitinol material to change its state from martensitic to austenitic so that the intermediate tube assumes a pre-determined configuration or stress state, which in this case is curved ([0109]). Thus, it was known in the art that shape memory Nitinol may be manipulated from one configuration to another by changing the temperature of the material i.e., applying heat.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal cutting end of modified Westerling to be moved to the open position by applying heat in light of the teachings of Lenker. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of opening and closing the moveable distal cutting end.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Drews (US 2010/0082042 A1) is noted for teaching a coring member with a moveable distal cutting end.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771