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 .
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.
Claims 18, 25-30, and 32 are rejected under 35 U.S.C. 103 as being unpatentable over CN 107648734 (Zhang, see attached machine translation) in view of U.S. Patent Application Publication No. 2021/0008382 (Vaidya) and CN 113288117 (Chen, see attached machine translation).
Regarding claim 18, Zhang teaches a treatment cap configured to provide visual guidance for transcranial energy delivery to a target location of a patient’s head (“magnetic stimulation”, abstract; transcranial magnetic stimulation, pg. 2, paragraph 4; Figures 1 and 4), comprising a skull cap (6) having indicia markings (12a, 12b, 14a) on the cap configured to align to the tragus of an ear of the patient (markings 12a, 12b and line 14a have a positional relationship to a tragus of the patient’s ear: Figures 1 and 4; see also “invention content”, translation: pg. 3, paragraph 6; positioning cap 6 includes line 14a and mark points 12a and 12b, translation: pg. 3, paragraph 8 and pg. 5, paragraph 4).
Zhang does not specify the cap includes cutouts for ears of the patient, and a pointed midline brim configured to align to the patient's nasion or a point bisecting a line connecting the patient's pupils.
However, Vaidya teaches a treatment cap configured to provide visual guidance for transcranial energy delivery to a target location of a patient’s head (abstract; Figures 6A-B), comprising: a skull cap (300) having cutouts for ears of the patient, and printed indicia on the cap to align to anatomical landmarks of the patient ([0059]; Figures 6A-B). 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 skill cap of Zhang to include cutouts of the patient’s ears as taught by Vaidya in order to allow the cap to be repeatably secured under the patient’s chin, such that the cap will lay close to the patient’s head surface (Vaidya: Figures 6A-B).
Zhang as modified does not teach a pointed midline brim configured to align to the patient's nasion or a point bisecting a line connecting the patient's pupils.
However, Chen teaches a treatment cap (4) configured to provide visual guidance for a medical procedure (“mapping cap”, pg. 3, paragraph 12; Figure 1), comprising a skull cap (4) having a pointed midline brim (2) configured to align to the patient's nasion or a point bisecting a line connecting the patient's pupils (“middle point pointer 2 is aligned with the nose tip of the patient”, see translation: pg. 3, paragraph 12; Figure 1). 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 skull cap of Zhang as modified to include a pointed midline brim configured to align to the patient's nasion or a point bisecting a line connecting the patient's pupils as taught by Chen in order to facilitating alignment of the cap with a static anatomical landmark on the patient’s head to ensure proper positioning for treatment (“middle point pointer 2 is aligned with the nose tip of the patient”, see translation: pg. 3, paragraph 12; Figure 1).
Regarding claim 25, Zhang in view of Vaidya and Chen teaches all the limitations of claim 18. Zhang as modified teaches the indicia markings (12a, 12b, 14a) include patterns (Figure 4) configured to indicate orientation of a treatment device, relative to a target area (translation: pg. 5, paragraph 4; Figures 1 and 4).
Regarding claim 26, Zhang in view of Vaidya and Chen teaches all the limitations of claim 18. Zhang as modified teaches the indicia markings (12a, 12b, 14a) are selected from the group consisting of symbols and text (Figures 1 and 4).
Regarding claim 27, Zhang in view of Vaidya and Chen teaches all the limitations of claim 18. Zhang as modified teaches the cap midline brim (Chen: 2) comes to a point on the midline of the cap (see discussion for claim 18; Chen: “middle point pointer 2 is aligned with the nose tip of the patient”, see translation: pg. 3, paragraph 12).
Regarding claim 28, Zhang teaches a head cap (6) configured to be placed over a patient's head to guide transcranial energy delivery to a target location of said patient's head (abstract; Figures 1 and 4), said cap including printed indicia (12a, 12b, 14a) with anatomical markers printed on the cap configured to identify specific target locations in the head of the patient (“said locating cap is light colored…the surgeon or operator can be marked on the locating cap marked with the marking pen, clearly not easy to erase”, see “invention content”, translation: pg. 3, paragraph 6; positioning cap 6 includes line 14a and mark points 12a and 12b, translation: pg. 3, paragraph 8 and pg. 5, paragraph 4; Figure 4).
Zhang does not teach the cap includes a brim that comes to a point on a midline of the cap, and wherein the cap includes cutouts for the patient’s ears.
However, Chen teaches a head cap (4) configured to provide visual guidance for a medical procedure (“mapping cap”, pg. 3, paragraph 12; Figure 1), comprising a cap (4) including a brim (2) that comes to a point on a midline of the cap (“middle point pointer 2 is aligned with the nose tip of the patient”, see translation: pg. 3, paragraph 12; Figure 1). 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 cap of Zhang as modified to include a pointed midline brim as taught by Chen in order to facilitating alignment of the cap with a static anatomical landmark on the patient’s head to ensure proper positioning for treatment (“middle point pointer 2 is aligned with the nose tip of the patient”, see translation: pg. 3, paragraph 12; Figure 1).
Zhang as modified does not teach the cap includes cutouts for the patient’s ears.
However, Vaidya teaches a head cap configured to provide visual guidance for transcranial energy delivery to a target location of a patient’s head (abstract; Figures 6A-B), comprising: a cap (300) having cutouts for ears of the patient and printed indicia on the cap to align to anatomical landmarks of the patient ([0059]; Figures 6A-B). 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 cap of Zhang as modified to include cutouts of the patient’s ears as taught by Vaidya in order to allow the cap to be repeatably secured under the patient’s chin, such that the cap will lay close to the patient’s head surface (Vaidya: Figures 6A-B).
Regarding claim 29, Zhang in view of Chen and Vaidya teaches all the limitations of claim 28. Zhang teaches the printed indicia (12a, 12b, 14a) include patterns (Figure 4) to indicate orientation of a treatment device, relative to the target area (translation: pg. 5, paragraph 4; Figures 1 and 4).
Regarding claim 30, Zhang in view of Chen and Vaidya teaches all the limitations of claim 30. Zhang teaches the printed indicia (12a, 12b, 14a) are selected from the group consisting of symbols and text (Figures 1 and 4).
Regarding claim 32, Zhang in view of Chen and Vaidya teaches all the limitations of claim 28. Zhang teaches the cap printed indicia (12a, 12b, 12c) are configured to denote where the cap is with respect to a tragus of the patient (markings 12a, 12b have a positional relationship to a tragus: Figures 1 and 4).
Response to Arguments
Applicant’s arguments, see pages 4 and 5, filed 17 June 2026, with respect to the rejections under 35 U.S.C. 112(b) and the double patenting rejections have been fully considered and are persuasive in light of the amendments to the claims. The rejections of 20 April 2026 have been withdrawn.
Applicant's arguments filed 17 June 2026 with respect to the combination of Zhang and Chen in the rejections under 35 U.S.C. 103 have been fully considered but they are not persuasive. Applicant contends Chen does not teach a “cap” as claimed but instead is a head ring providing a movable ruler to guide mapping a surgical procedure, therefore applicant contends the tool of Chen cannot be used to provide nor assist in visual guidance for transcranial energy delivery (arguments, pages 4-5).
In response to applicant's argument that Chen is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, Chen is directed to a head-worn alignment tool, seeking to solve the same problem as the inventor in guiding a medical procedure by aligning a tool to anatomical feature(s) of the patient via a non-invasive, repeatably used, pointed brim structure (Chen: “middle point pointer 2 is aligned with the nose tip of the patient”, see translation: pg. 3, paragraph 12; Figure 1: see discussion for claims 18, 28).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In this instance, Zhang is relied upon to teach a “cap” as construed by applicant to cover the user’s head in use, while Chen, also construed as a type of “cap” as it is a head-worn article, is not necessarily relied upon to teach a “cap” as construed by applicant to cover the user’s head when worn. These references, in combination, disclose a cap having a pointed midline brim (see rejections above).
Applicant’s arguments, see page 5, filed 17 June 2026, with respect to the rejections of claims 18, 28, and their dependents under 35 U.S.C. 102 and 103 citing at least Zhang have been fully considered and are persuasive in light of the amendments to the claims to require cutouts for the patient’s ears. Therefore, the rejections have been withdrawn. However, upon further consideration and as necessitated by the amendments to the claims, a new ground(s) of rejection is made in view of Zhang, Chen, and Vaidya as these references in combination better teach and/or suggest applicant’s claimed invention.
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 Carrie R Dorna whose telephone number is (571)270-7483. The examiner can normally be reached 8am-5pm.
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, Alexander Valvis can be reached at 571-272-4233. 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.
/CARRIE R DORNA/Primary Examiner, Art Unit 3791
Prosecution Insights