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 Office Action is a response to applicant’s arguments and amendment filed 02/19/2026. Claims 223-242 are amended. Claims 1-222 are cancelled. Claim 243 is new. Claims 223-243 are currently pending.
The objection to the drawings has been withdrawn due to applicant’s amendment.
The objection of claims 224-225 and 229 has been withdrawn due to applicant’s amendment.
The objection of claims 223, 230, 232, 234 and 240 has been maintained; see below.
The rejection of claims 223-229 and 231-241 under 35 U.S.C. 112(b) has been withdrawn due to applicant’s amendment.
The rejection of claims 230 and 242 under 35 U.S.C. 112(b) has been maintained; see below.
Response to Arguments
Applicant’s arguments, see Remarks, filed 02/19/2026, with respect to the rejection(s) of claim(s) 223-226 and 230-242 under 35 U.S.C. 103 as being unpatentable over Umar; and claims 227-229 under 35 U.S.C. 103 as being unpatentable over Umar in view of Devroye, have been fully considered but are not persuasive, in combination with the amendments to the claims. The rejection has been modified, necessitated by applicant’s amendment to the claims.
1) Applicant argues there is no frustoconical portion in Umar (Remarks, pg. 10).
In response to applicant’s first argument, it is respectfully submitted applicant admits the flared end of Umar could be considered frustoconical (pg. 10), and does not provide reasoning as to why the structure of the flared end does not meet the claim limitation of a frustoconical portion. Therefore, the claim limitation is considered to be met.
2) Applicant further argues the frustoconical axis ratio is not met, because the distal and proximal ends are being referred to in an opposite manner to Umar, such that Umar teaches a contrast to the claimed axis ratio; para. [0032] of Umar is being interpreted unreasonably broad, and the modification would turn the flare upside down in Umar (Remarks, pgs. 10-13).
In response to applicant’s second argument, it is respectfully submitted the Office Action refers to the proximal and distal ends consistent with the customary meaning, which is also consistent with the disclosure of Umar (i.e. customary meaning of ‘proximal’ references the disclosed distal portion in Umar). Further, applicant states the modification would turn the flare upside down, however, attorney arguments cannot take the place of evidence (MPEP 2145(I)), and the rejection does not rely on a change in shape such that the flare would be upside down. The claim language recites a proximal end radius and a distal end radius that do not preclude an outer diameter of the device from being encompassed within the limitation. As further discussed below, Umar discloses in para. [0032] a ratio between diameters of the distal and proximal ends being the same (i.e. 1:1 ratio), and further discloses the diameter of the customary proximal end being greater than the diameter of the customary distal end. The claimed range encompasses a 1:1.10 ratio, and as discussed in MPEP 2144.05(I), a prima facie case of obviousness exists when ranges in the prior art do not overlap but are close. Therefore, it would have been obvious to modify the ratio as claimed since the disclosed ratio does not overlap but is close, such that one of ordinary skill would’ve understood a 0.10 difference in the ratio to be obvious.
3) Applicant further argues a modification of the claimed angle range would be outside what one of skill in the art would consider a variance of the configuration because it would be a 50% increase about the upper limit of Umar (Remarks, pgs. 13-14).
In response to applicant’s third argument, it is respectfully submitted applicant has not provided reasoning as to why the disclosed angle of the cutting tip cannot be considered a result-effective variable that could meet the claimed range of angles through routine optimization. Further, attorney arguments cannot take the place of evidence with respect to the modification being a 50% increase that one of skill in the art would not consider (MPEP 2145(I)). As further discussed below, Umar discloses a range of angles in which the cutting tip can extend or point away from the central axis, and further discloses variations dependent on the size of the hair follicle and the size of the punch, such that the angle the cutting tip extends is considered to be a result-effective variable, in that changing the angle of the cutting tip would change the point of entry, grasping of the hair follicle, etc. such that one of ordinary skill could meet the claimed range through routine experimentation in order to grasp the hair follicle appropriately.
Applicant’s arguments with respect to claim 243 have been fully considered, and new claim 243 is rejected as discussed below.
Claim Objections
Claims 223, 227-228, 230-235, 239-240 and 243 are objected to because of the following informalities:
In claim 223, it is suggested to reword the preamble to remove unnecessary punctuation to the following: “A punch for removing hair follicles, the punch comprising:”
In claim 223, line 6, it is suggested to amend the phrase “the generally frustoconical proximal portion” to recite “a generally frustoconical proximal portion”.
In claim 223, line 8, it is suggested to remove the comma after “wherein” as it is unnecessary.
In claim 227, line 2, the phrase “continues in circular concave course” should read “continues in a circular concave course”.
In claim 228, line 2, the phrase “continues in circular concave course” should read “continues in a circular concave course”.
In claim 230, the phrase “cutting tip that is slanted in an angle” should read “cutting tip is slanted at an angle” or similar language for readability purposes.
In claim 231, it is suggested to amend the phrase “a cutting end surface” to recite “a surface of the distal cutting end” for consistency purposes.
In claim 232, it is suggested to amend the phrase “the textured cutting end surface” to recite “the textured surface of the distal cutting end”.
In claim 233, it is suggested to amend the phrase “the textured cutting end surface” to recite “the textured surface of the distal cutting end”.
In claim 234, it is suggested to amend the phrase “the textured cutting end surface” to recite “the textured surface of the distal cutting end”.
In claim 235, it is suggested to amend the phrase “the textured cutting end surface” to recite “the textured surface of the distal cutting end”.
In claim 239, it is suggested to amend the phrase “the textured cutting end surface” to recite “the textured surface of the distal cutting end”.
In claim 240, it is suggested to reword the claim for readability purposes to the following: “wherein the punch is configured to rotate 10-60 degrees relative to the skin surface so that the cutting tip engages the skin with an initial cut, the textured surface of the distal cutting end upon engaging the skin guides the cutting tip forward in a screw-like manner towards the hair follicle using a hair shaft as a guide to safely score around the hair follicle while minimizing graft damage”.
In claim 243, the claim recites “a FUE device” without providing the full term for the acronym- it is suggested to provide the full terminology before claiming the acronym.
In claim 243, it is suggested to reword the claim in a similar manner to the following: A method of using a follicular unit extraction (FUE) device having a punch for removing hair follicles, the method comprising using the punch of claim 233 for hair follicle removal (see also 112(b) rejection below).
Appropriate correction is required.
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 230 and 242-243 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.
Regarding claim 230, the claim recites “to increase sharpness of the cutting end with decreasing angulation”. It is unclear what the angulation is being decreased relative to. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the claimed angle range meeting the claimed limitation of decreased angulation.
Regarding claim 242, the claim recites “lines of discontinuities”. It is unclear whether the phrase is referring to the lines of discontinuities previously introduced, or introducing new, separate lines of discontinuities. Therefore, the scope of the claim is indefinite. For examination purposes, the phrase is interpreted to refer to the lines of discontinuities previously introduced.
Regarding claim 243, the claim recites “in a method of using a FUE device having a punch for removing hair follicles, the improvement comprising using the punch… for hair follicle removal”. The claim is directed towards a method of using a device, and attempts to claim a process without setting forth any steps involved in the process (see MPEP 2173.05(q)). The term “using” does not recite any active, positive steps, such that the claim is considered to be a “use” claim, and is therefore indefinite for failing to recite any active, positive steps delimiting how the use is actually practiced. For examination purposes, a disclosure of the device in use is considered to meet the claimed limitation.
Claim Rejections - 35 USC § 103
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) 223-226 and 230-243 are rejected under 35 U.S.C. 103 as being unpatentable over Umar (US 2011/0160746 A1) (all references previously of record).
Regarding claim 223, Umar discloses (see abstract; paras. [0019]-[0049]; figs. 1-12a) a punch (fig. 1), for removing hair follicles (abstract); the punch comprising:
a generally tubular body (12, note para. [0211] of the instant spec. defines the term “generally”, para. [0020] of Umar; fig. 1) formed about a generally central axis (11) and extending from a generally tubular body proximal end (14, note Umar defines the proximal and distal ends as opposite to their normal, customary meaning, para. [0020]) to a generally tubular body distal cutting end (includes 16, fig. 1);
a generally frustoconical portion (includes flared proximal region 15), terminating in the distal cutting end (16), connected to the generally frustoconical proximal portion (connects to proximal end of region 15) with or without a straight walled cylindrical transition zone of variable length ranging from 0-3 mm (note this limitation is considered to be recited alternatively and therefore not required by the claim language);
wherein, an outer perimeter of the distal cutting end is defined by a cutting tip (cutting edge of 16, para. [0020]) which extends and points away from the generally central axis (depicted in fig. 1) in angles ranging from 4 degrees to 20 degrees (para. [0020]) to direct the cutting forces substantially away from hair follicle (flared portion considered to direct forces away from hair follicle, paras. [0023]-[0024]);
wherein the distal cutting end creates a wound to remove hair follicles (paras. [0023]-[0024]);
wherein the generally frustoconical portion further comprises a generally frustoconical proximal end (proximal end of region 15, which Umar discloses as the distal end) having a frustoconical proximal end radius from the generally central axis (radius at proximal end of region 15, which Umar discloses as the distal end) and a generally frustoconical distal end (16, which Umar discloses as the proximal end) having a frustoconical distal end radius from the generally central axis (radius at 16, which Umar discloses as the proximal end).
However, Umar fails to specifically disclose the cutting tip extending and pointing away from the generally central axis in angles ranging from 30 degrees to 120 degrees, wherein a frustoconical axis ratio between the frustoconical distal end radius and the frustoconical proximal end radius is between about 1:3 and about 1:1.10.
Umar discloses (paras. [0039]-[0040]) that the angle of the cutting tip needs to be optimized “depending on such factors as the outer diameter d1 of the punch and the size of the follicle to be extracted.” As seen in figs. 1 and 12a-b, the cutting tip of the punch is flared outward in order to direct the cutting force away from the hair follicle and tissue to be extracted (para. [0034]), and as such the angle of the cutting tip flaring outwards is disclosed to be a result effective variable in that changing the angle of the cutting tip changes the amount of cutting force directed towards the hair follicle and tissue to be extracted, which controls the effectiveness of the procedure. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the device of Umar to have an angle within the claimed range, as it involves only adjusting the dimension of a component disclosed to require adjustment. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Umar by making the angle of the cutting tip to be about 30 degrees and therefore within the claimed range, as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Umar (as modified) still fails to teach wherein a frustoconical axis ratio between the frustoconical distal end radius and the frustoconical proximal end radius is between about 1:3 and about 1:1.10.
Note Umar does disclose the diameter of the punch generally the same at the beginning and end of the segment, and further discloses the diameter at the proximal end can be greater than the diameter of the punch at the distal end (described as the distal end being greater than the proximal end, since Umar uses ‘proximal’ and ‘distal’ as opposite to the customary meanings, para. [0032]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the ratio of the distal end radius to the proximal end radius of the frustoconical portion of Umar from 1:1 (outer diameter is substantially the same, para. [0032]) to 1:1.10 since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed range (see para. [0172] indicating preferred ratio ranges).
Regarding claim 224, Umar (as modified) teaches the punch of claim 223. Umar further discloses wherein, an external wall of the distal cutting end relative to the punch's generally central axis on a lateral profile is straight (distal end at 16, described as proximal end in Umar, considered to be straight, fig. 1).
Regarding claim 225, Umar (as modified) teaches the punch of claim 223. Umar further discloses wherein an external wall of the distal cutting end relative to the punch's generally central axis on a lateral profile is curved in a concave manner to terminate in the cutting tip that extends and points outward (considered to be curved in a concave manner in flared region, cross-sectional view of fig. 1 considered to provide a lateral profile of the punch).
Regarding claim 226, Umar (as modified) teaches the punch of claim 225. Umar further discloses wherein a second frustoconical end (end of cutting tip, which appears to be consistent with para. [0019] of the published application, further note a first frustoconical end has not been previously introduced) continues in a circular concave course that terminates at a cutting edge (fig. 1) that points outwards and downwards relative to the central axis (fig. 1).
Regarding claim 230, Umar (as modified) teaches the punch of claim 225. Umar further discloses wherein the distal cutting end relative to the punch's generally central axis on a lateral profile that is viewed from the punch center to the cutting tip that is slanted at an angle that ranges from 85 degrees to 20 degrees to increase sharpness of the distal cutting end with decreasing angulation (combination considered to further teach slant of cutting tip at about 30 degrees which falls within the claimed range, considered to encompass an increase in sharpness as claimed).
Regarding claim 231, Umar (as modified) teaches the punch of claim 225. Umar further discloses wherein a cutting end surface viewed from a distal inferior face thereof and viewed from the punch's center to outer margins where the cutting tip is located is textured (internal textured region 22, para. [0045]) to aid in pulling grafts upwards into a punch lumen to prevent incidents of buried grafts associated with blunt and flat punches (helps to draw follicle into chamber, considered to be capable of preventing incidents of buried grafts, para. [0044]).
Regarding claim 232, Umar (as modified) teaches the punch of claim 231. Umar further discloses where the textured cutting end surface assists in driving the punch forward to overcome the resistance to the punch’s distal progression into the tissue posed by a frustoconical gradient (interior textured region helps draw follicle into chamber and imparts suction effect on tissue follicle, considered to assist in driving the punch forward as claimed via suction force, para. [0044]).
Regarding claim 233, Umar (as modified) teaches the punch of claim 231. Umar further discloses wherein the textured cutting end surface includes lines of discontinuities approximately 12.5 micrometers deep (paras. [0043] and [0045]).
Regarding claim 234, Umar (as modified) teaches the punch of claim 231. Umar further discloses wherein the textured cutting end surface includes lines of discontinuities generally concentric about the generally central axis (paras. [0043]-[0045]).
Regarding claim 235, Umar (as modified) teaches the punch of claim 231. Umar further discloses wherein the textured cutting end surface includes lines of discontinuities that are approximately 0.15 mm apart (paras. [0043]-[0045]).
Regarding claim 236, Umar (as modified) teaches the punch of claim 225. Umar further discloses wherein the distal cutting end is configured to gather tissue around the hair follicles as the distal cutting end scores around the hair follicles to create a graft (paras. [0023]-[0024]; figs. 12a-b).
Regarding claim 237, Umar (as modified) teaches the punch of claim 225. Umar further discloses wherein a distal end region of the punch has an exterior textured region (20, para. [0043]) that does not extend through a thickness of the generally tubular body (depicted in fig. 5).
Regarding claim 238, Umar (as modified) teaches the punch of claim 237. Umar further discloses wherein the exterior textured region extends from the cutting tip proximally to a distance that ranges from 0.5 to 5 mm (extends across region 15 as depicted in fig. 5, disclosed as having a length of 1mm which falls within the claimed range, para. [0020]).
Regarding claim 239, Umar (as modified) teaches the punch of claim 231. Umar further discloses wherein the textured cutting end surface generates a corkscrew effect which drives the punch forward to help overcome resistance to forward movement of the punch caused by an expanding frustoconical gradient (lines may be helical and constructed to impart a suction effect on the tissue follicle, considered to help generate a corkscrew effect and drive the punch forward via the suction force, paras. [0043]-[0045]).
Regarding claim 240, Umar (as modified) teaches the punch of claim 231. Umar further discloses wherein the punch is configured to rotate in a 10-60 degrees to the skin surface so that the cutting tip engages the skin with an initial cut, the textured cutting end surface (22, para. [0045]) upon engaging the skin guides the cutting tip forward in a screw like manner towards the hair follicle using a hair shaft as guide to safely score around the hair follicle while minimizing graft damage (textured region may be helical and enhances suction-like effect that sucks tissue toward the punch as the punch descends, considered to help guide the punch in a screw-like manner via the helical nature of the textured region, further note the claim is an apparatus claim and covers what a device is, not what it does (see MPEP 2114(II)), therefore method steps recited in an apparatus claim are treated as functional limitations, such that the punch of Umar (as modified) is considered to be fully capable of engaging the skin as claimed and rotated relative to the skin surface as claimed, para. [0043] of Umar).
Regarding claim 241, Umar (as modified) teaches the punch of claim 237. Umar further discloses wherein the exterior textured region (20) is composed of lines of discontinuities approximately 12.5 micrometers deep (para. [0043]).
Regarding claim 242, Umar (as modified) teaches the punch of claim 241. Umar further discloses wherein lines of discontinuities are generally concentric about the generally central axis (para. [0043]; figs. 5-6).
Regarding claim 243, Umar (as modified) teaches the punch of claim 233. Umar further discloses in a method of using a FUE device having a punch for removing hair follicles, the improvement comprising using the punch for hair follicle removal (paras. [0023]-[0028]).
Claim(s) 227-229 are rejected under 35 U.S.C. 103 as being unpatentable over Umar in view of Devroye (US 2019/0336160 A1).
Regarding claim 227, Umar (as modified) teaches the punch of claim 225.
Umar further discloses wherein a second frustoconical end (end of cutting tip, which appears to be consistent with para. [0019] of the published application, further note a first frustoconical end has not been previously introduced) continues in circular concave course that terminates at a cutting edge (fig. 1) that points outwards relative to the generally central axis (fig. 1).
However, Umar (as modified) fails to specifically teach the cutting edge pointing outwards and at 90 degrees relative to the generally central axis.
Devroye teaches (paras. [0061]-[0064]; fig. 5), in the same field of endeavor, a punch for removing hair follicles (abstract) comprising a cutting edge (506) pointing outwards and at 90 degrees relative to the central axis of the punch (flat annular face, paras. [0031]-[0032] and [0060]), for the purpose of providing a tool that has both sharp and unsharp characteristics, allowing the tool to be supported on the skin without cutting into the epidermis when desired, greatly reducing or eliminating damage that sharp punches usually cause (paras. [0063]-[0064]).
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 cutting tip of Umar (as modified) to have a flat annular face such that the cutting edge points outwards at 90 degrees relative to the central axis, in order to provide the capability of supporting the punch on the skin without cutting into the epidermis or causing damage and focusing the sharp edge on the point of the cutting edge, which reduces or eliminates injuries/scars around the hairs, based on the teachings of Devroye (paras. [0063]-[0064]).
Regarding claim 228, Umar (as modified) teaches the punch of claim 225.
Umar further discloses wherein a second frustoconical end (end of cutting tip, which appears to be consistent with para. [0019] of the published application, further note a first frustoconical end has not been previously introduced) continues in circular concave course that terminates at a cutting edge (fig. 1) that points outwards relative to the generally central axis (fig. 1).
However, Umar (as modified) fails to teach the cutting edge pointing proximally at between 95-120 degrees relative to the generally central axis.
Devroye teaches (paras. [0061]-[0064]; fig. 5), in the same field of endeavor, a punch for removing hair follicles (abstract) comprising a cutting edge (506) pointing proximally at between 95-120 degrees relative to the central axis of the punch (may be at an angle of 95 degrees, paras. [0031]-[0032] and [0060]), for the purpose of providing a tool that has both sharp and unsharp characteristics, allowing the tool to be supported on the skin without cutting into the epidermis when desired, greatly reducing or eliminating damage that sharp punches usually cause (paras. [0063]-[0064]).
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 cutting tip of Umar (as modified) to point proximally at an angle of 95 degrees relative to the central axis, in order to provide the capability of supporting the punch on the skin without cutting into the epidermis or causing damage and focusing the sharp edge on the point of the cutting edge, which reduces or eliminates injuries/scars around the hairs, based on the teachings of Devroye (paras. [0063]-[0064]).
Regarding claim 229, Umar (as modified) teaches the punch of claim 225.
However, Umar (as modified) fails to teach wherein the distal cutting end relative to the punch's generally central axis on a lateral profile that is viewed from the punch center to the cutting tip terminates in a flat plane at 90 degrees.
Devroye teaches (paras. [0061]-[0064]; fig. 5), in the same field of endeavor, a punch for removing hair follicles (abstract) comprising a cutting edge (506) terminating in a flat plane at 90 degrees (flat annular face, paras. [0031]-[0032] and [0060]), for the purpose of providing a tool that has both sharp and unsharp characteristics, allowing the tool to be supported on the skin without cutting into the epidermis when desired, greatly reducing or eliminating damage that sharp punches usually cause (paras. [0063]-[0064]).
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 cutting tip of Umar (as modified) to have a flat annular face such that the cutting edge terminates in a flat plane at 90 degrees relative to the central axis, in order to provide the capability of supporting the punch on the skin without cutting into the epidermis or causing damage and focusing the sharp edge on the point of the cutting edge, which reduces or eliminates injuries/scars around the hairs, based on the teachings of Devroye (paras. [0063]-[0064]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 BRIGID K BYRD whose telephone number is (571)272-7698. The examiner can normally be reached Mon-Fri 8:00-5:00.
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/BRIGID K BYRD/Examiner, Art Unit 3771