Prosecution Insights
Last updated: April 19, 2026
Application No. 18/727,935

MEDICAL KIT FOR USE IN THE TREATMENT OF BALDNESS IN ONCOLOGICAL PATIENTS

Non-Final OA §103§112
Filed
Jul 10, 2024
Examiner
RUIZ MARTIN, LUIS MIGUEL
Art Unit
3772
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Hair Medical Device S R L
OA Round
1 (Non-Final)
46%
Grant Probability
Moderate
1-2
OA Rounds
2y 10m
To Grant
97%
With Interview

Examiner Intelligence

Grants 46% of resolved cases
46%
Career Allow Rate
47 granted / 103 resolved
-24.4% vs TC avg
Strong +51% interview lift
Without
With
+51.1%
Interview Lift
resolved cases with interview
Typical timeline
2y 10m
Avg Prosecution
30 currently pending
Career history
133
Total Applications
across all art units

Statute-Specific Performance

§101
1.9%
-38.1% vs TC avg
§103
44.7%
+4.7% vs TC avg
§102
24.0%
-16.0% vs TC avg
§112
26.4%
-13.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 103 resolved cases

Office Action

§103 §112
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 07/10/2024 was filed after the mailing date of the application on 07/10/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Election/Restrictions Applicant’s election without traverse of claims 1-2 in the reply filed on 02/02/2026 is acknowledged. 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 1-2 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. The phrase “very thin” in claim 1 is a relative term which renders the claim indefinite. The phrase “very thin” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what thickness is required for the film to be considered “very thin”. 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 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: the 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 29-31); - foaming a polymeric material on a concave surface of said mold (col 3, lines 10-13); 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 very thin 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” and “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”. 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 Any inquiry concerning this communication or earlier communications from the examiner should be directed to LUIS MIGUEL RUIZ MARTIN whose telephone number is (571)270-0839. The examiner can normally be reached M-F 8 Am - 5 PM (EST). Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. 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. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LUIS RUIZ MARTIN/ Examiner, Art Unit 3772 /ERIC J ROSEN/Supervisory Patent Examiner, Art Unit 3772
Read full office action

Prosecution Timeline

Jul 10, 2024
Application Filed
Feb 11, 2026
Non-Final Rejection — §103, §112 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
46%
Grant Probability
97%
With Interview (+51.1%)
2y 10m
Median Time to Grant
Low
PTA Risk
Based on 103 resolved cases by this examiner. Grant probability derived from career allow rate.

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