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 Arguments
Applicant’s arguments, see Remarks filed on 05/18/2026, have been fully considered. The Examiner withdraws the rejections under 35 U.S.C. 112(b) presented in the previous Office Action, in light of Applicant’s amendments. Applicant’s arguments against the rejections in view of the prior art of record have been fully considered, but are not persuasive.
Upon careful consideration, the Examiner respectfully disagrees with Applicant’s assessments. Nemoto (US 4530810 A), primary reference relied upon, does disclose the claimed step of attaining an avatar of the patient's head (see “head model” in col 3, lines 29-31 and Figure 3). The Examiner relies on the broadest reasonable interpretation of the term avatar (being a model or a representation of a user).
Nemoto discloses superimposing the mold on the avatar, prior to foaming a polymeric material on a concave surface of the mold (col 3, lines 29-31). Nemoto does disclose automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs on said polyurethane film after forming the polyurethane film but without removing the polyurethane film from the foamed polymeric material (since the wig base, i.e. the polyurethane film, is placed on the male mold B', i.e. avatar to make hair grafting, the wig base is then placed on the mold B' inside out to effect coating on the inside of the wig base, note that said coating would be the foam polymeric material, as explained in Example 1, see the rejection of claim 1 below).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs on said polyurethane film without removing said polyurethane film from said foamed polymeric material”; there is no disclosure in the Specification or the Drawings where the grafting/transplantation of available synthetic and/or natural non-treated hairs on said polyurethane film is done without removing said polyurethane film from said foamed polymeric material.
The Examiner notes that a review of the Specification and the Drawings appears to indicate that “Once the mold is prepared and simultaneously, but separately, the virtual representation of the head of the patient is attained, the expanded polyurethane is made to foam below the mold, thus determining the head portion affected by the thickening. The avatar of the patient thus made, said head portion to be hair-thickened is covered with a thin film of medical polyurethane and the non-transplant of hairs initiates, which thus occurs directly on
the avatar of the patient according to technical and style characteristics of the same. Said method provides that, during the attainment of the skin patch, the hair distribution must occur in accordance with the technical evaluation carried out by the hair designer. All this with the intention of accurately reproducing the head portion lacking hairs. Once the manual or automated single graft/transplantation of each hair present on the patch has terminated, said method provides that the latter be removed from the avatar. All this with the result that the patch thus obtained represents a structure that is like a synthetic "'scalp" of the patient himself/herself (page 5).
However, “without removing said polyurethane film from said foamed polymeric material” is a negative limitation, i.e. the claim is requiring that the grafting without the removal of the polyurethane film from the foamed polymeric material. Negative limitations are not per se improper, but they must be supported by the originally filed disclosure. As provided by MPEP 2173.05(i), any negative limitation or exclusionary proviso must have basis in the original disclosure; if alternative elements are positively recited in the specification, they may be explicitly excluded in the claims; and the mere absence of a positive recitation is not basis for an exclusion. The specification is silent regarding the grafting without removing said polyurethane film from said foamed polymeric material. As noted above, the absence of a positive recitation is not a proper basis of support for a negative limitation. Additionally, since the specification is silent on the matter of the grafting without removing said polyurethane film from said foamed polymeric material, then the “alternative elements” rationale discussed above in the MPEP is not applicable.
Claims 2 is rejected by virtue of its dependency on claim 1.
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 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.
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) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nemoto (US 4530810 A) in view of Duffel (US 5060677 A), further in view of Kim (US 20180116321 A1).
Regarding claim 1, Nemoto’s Example 1 discloses a method for obtaining a skin patch (wig base 12), the method providing for, starting from a previously obtained mold, accurately reproducing a patient's head skin portion to be subjected to artificial hair thickening (female mold, see col 2, lines 6-15), and in sequentially carrying out the following steps: - an annotation of the aesthetic features of the mold, which include: definition of the area to be hair- thickened to a greater extent (a marking line 5 is drawn in ink to indicate a portion desired for a wig base, see col 2, lines 55-56); - attaining an avatar of the patient's head (model) and superimposing said mold (wig base) on said avatar (col 3, lines 10-13); - foaming a polymeric material on a concave surface of said mold (col 3, lines 15-17); said foaming allowing to reproduce also said area to be hair-thickened to a greater extent (since it is a coating); - covering said foamed polymeric material, as prepared in the preceding step, with a polyurethane film for medical use (col 3, lines 15-17); - automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs (col 3, lines 24-31); - removing said skin patch (wig base), as obtained in the preceding step, from said avatar of the patient's head (since the wig base is ultimately for being worn by a patient as indicated in the Abstract). However, Nemoto fails to disclose “a finishing of said mold performed by an automatic or manual filing, using specific files suited to smoothen the perimeter of said mold”, “in sequentially carrying out the following steps an annotation of the aesthetic features of the mold, which include: the color and type of hairs, if curly, smooth or wavy, the hair length, hair distribution, hair growth vortex direction; grizzling” and “automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs on said polyurethane film without removing said polyurethane film from said foamed polymeric material”.
Nemoto’s Example 2 discloses automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs on said polyurethane film (wig base) without removing said polyurethane film from said foamed polymeric material (since the wig base, i.e. the polyurethane film, is placed on the male mold B', i.e. avatar to make hair grafting, the wig base is then placed on the mold B' inside out to effect coating on the inside of the wig base, note that said coating would be the foaming the polymeric material, as explained in Example 1, see above), and the wig base is then turned over again on the mold B' (i.e. avatar) to finish setting of the wig; see col 3, lines 60-64). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Nemoto’s method, as explained in the Example 1, to specify the step of automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs on said polyurethane film (wig base) without removing said polyurethane film from said foamed polymeric material, as taught by Nemoto’s Example 2, since such modification would make sure that the hairs are grafted on a wig base that has an inside configuration that simulates the thickness of the user’s scalp.
Duffel discloses method for obtaining a skin patch (skull cap/sjablon, see Abstract), the method providing for, starting from a previously obtained mold (negative mold from plaster), accurately reproducing a patient's head skin portion to be subjected to artificial hair thickening (col 3, lines 5-6), and in sequentially carrying out the following steps: - a finishing of said mold performed by an automatic or manual filing, using specific files suited to smoothen the perimeter of said mold (col 3, lines 12-13); - an annotation of the aesthetic features of the mold (since the hair is chosen to match existing hair of the subject and is prepared in an aesthetic style consistent with the choice of the subject also; see col 7, lines 29-32); - attaining an avatar of the patient's head and superimposing said mold on said avatar (see model head made of aluminum, col 7, lines 21-22); - foaming a polymeric material on a concave surface of said mold; said foaming allowing to reproduce also said area to be hair-thickened to a greater extent (col 7, lines 37-40); - automated or manual graft/transplantation of available synthetic and/or natural non-treated hairs (col 7, lines 16-17); - removing said skin patch (1), as obtained in the preceding step, from said avatar of the patient's head (since the skull cap/sjablon is ultimately for being worn by a patient as indicated in col 7, lines 44-45). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Nemoto’s a method for obtaining a skin patch, to add the step of a finishing of said mold performed by an automatic or manual filing, using specific files suited to smoothen the perimeter of said mold, as taught by Duffel, since such modification would allow trimming the excess plastic to thereby accomplishing a skin patch ready for fitting.
Kim discloses methods of manufacturing wigs ([0020]). Kim discloses in sequentially carrying out the following steps an annotation of the aesthetic features of the mold, which include: the color and type of hairs, if curly, smooth or wavy, the hair length, hair distribution, hair growth vortex direction; grizzling (since the method comprises the application of artificial hair which could be synthetic hair products as well as human hair or animal hair and combinations thereof. The artificial hair may be embodied in various traditional hair colors, such as black, brown, blonde, and red, as well as non-traditional hair colors, such as blue, green, and purple, and combinations thereof, including individual strands of hair having two or more colors. The artificial hair is embodied in various hair textures, such as curly, straight, crimped, wavy, and combinations thereof. As described herein, the artificial hair is embodied in varying lengths disposed in varying amounts on the wig to provide a user with a natural and fashionable appearance [0016]). Therefore, it would have been obvious to one of ordinary skills in the art, before the effective filing date of the application, to modify Nemoto/Duffel’s a method for obtaining a skin patch, to add the step of an annotation of the aesthetic features of the mold, which include: the color and type of hairs, if curly, smooth or wavy, the hair length, hair distribution, hair growth vortex direction; grizzling, as contemplated by Kim, since such modification would make sure that each specific skin patch would provide each user with a natural and fashionable appearance.
Regarding claim 2, Nemoto, Duffel and Kim, as combined above, disclose the invention substantially as claimed. Nemoto discloses wherein said foamed polymeric material is expanded polyurethane (col 3, lines 49-57).
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 LUIS RUIZ whose telephone number is (571)270-0839. The examiner can normally be reached on M-F 8 Am - 5 PM (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Eric Rosen can be reached on (571) 270-7855. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Luis Ruiz Martin/
Patent Examiner
Art Unit 3772
/ERIC J ROSEN/ Supervisory Patent Examiner, Art Unit 3772
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