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 Objections Claim 1 is objected to because of the following informalities: “common focal point is as to permit” should read --common focal point so as to permit--. Appropriate correction is required. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: imaging device of claim 11 (corresponding structure disclosed as a visual light camera, ultraviolet light camera, or an infrared light camera) . Note : while this limitation “imaging device” appears in other claims, at this time only the instance of claim 11 is interpreted to invoke 35 U.S.C. 112(f) since, as written, the “one or more imaging devices” are interpreted as a different set of imaging device(s) than that of claim 1 and those instances in dependent claims which further limit that of claim 1. Since the instance of claim 11 meets the three-prong test for interpretation as means-plus-function ( i.e. , “devices” is a nonce term for “means”, function recited as “imaging”, and no structural modifiers for performing the function recited), the limitation of claim 11 is interpreted as noted herein. Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. 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, 4, 10, 12, and 16 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 “two coil windings” while parent claim 1 recites “one or more coil windings”. It is unclear whether the coil windings of clam 2 are intended to reference the same winding(s) as that of claim 1. Claim 4 recites the limitation “one or more imaging devices” while parent claim 1 recites “one or more imaging devices”. It is unclear whether applicant intends to reference the same imaging device(s). Claim 10 recites “the contact sensors” while parent claim 9 recites “one or more contact sensors”. Since “one or more” encompasses one, at least one, or a plurality, it is unclear how many contact sensors applicant intends to require in claim 10. Claim 12 recites “the one or more imaging devices”, while parent claims 11 and 1 each recite “one or more imaging devices”. It is unclear which previously recited imaging device(s) applicant intend to reference. Claim 16 recites “markings” while parent claim 14 recites “grid markings” and “color markings”. It is unclear which markings applicant intends to reference in claim 16. Claim Rejections - 35 USC § 102 The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claims 1- 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 107648734 (Zhang, see attached machine translation). Regarding claim 1 , Zhang teaches a transcranial magnetic stimulation (TMS) coil head (5) configured to be placed over a target brain region for treatment (abstract; Figure 1 ), wherein the TMS coil head comprises a housing (8a, 8b) containing one or more coil windings (9a, 9b) within the housing, wherein said one or more coil windings are configured to generate a maximum magnetic field at a common focal point (coils configured to stimulate a “target point”, abstract; electrical field generated by stimulation represented by arrow 11, construed as “common focal point”, translation: pg. 5, paragraph 1; Figure 4 ) ; and one or more imaging devices (1a, 1b) including a single camera configured to overlie the common focal point so as to permit direct visualization of a position of the TMS coil head relative to a target position (10, 12a, 12b) on a patient's head (Camera 1a is construed as the “single camera”. The limitation “to overlie the common focal point so as to permit direct visualization of a position of the TMS coil head relative to a target position on a patient's head” is functional language. Since the “TMS coil head” 5 is capable of being moved relative to the patient’s head during positioning, the “single camera” 1a is capable of being placed so as to overlie stimulation target point 10 to permit direct visualization of the “TMS coil head” 5 position relative to the target position 10 on the patient’s head. See translation: pg. 5, paragraphs 1, 4, and 5; Figures 1 and 4. ). Regarding claims 2 and 3 , Zhang teaches the TMS coil head (5) comprises two coil windings (9a, 9b) located to either side of a center of the TMS coil head; wherein the two coil windings are mirror images of one another (translation: pg. 4, paragraph 13; Figure 2 ). Regarding claim 4 , Zhang teaches the one or more imaging devices (1a, 1b) comprises one or more cameras, including the single camera overlying the common focal point of the one or more coil windings (see discussion for claim 1; translation: pg. 4, paragraphs 11 and 13). 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. Claim 5 is 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. 2017/0366773 ( Kiraly ). Regarding claim 5 , Zhang teaches all the limitations of claim 1. Zhang teaches the imaging devices include two “cylindrical industrial endoscopes” (“Specific execution examples”, description of Figure 1 , page 4 of machine translation). Zhang does not specify the type of cameras in the endoscopes. However, Kiraly teaches an endoscope comprising a visible light imaging camera (abstract; [0005]; [0031]). 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 endoscope cameras of Zhang to each include the visible light camera of Kiraly , because Kiraly teaches an endoscopic visible light camera permits the tissue to be viewed in optical images by a practitioner ([0031]). Claim s 6 , 11, and 12 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. 2016/0015588 (Tamiya). Regarding claim 6 , Zhang teaches all the limitations of claim 1 . Zhang do es not teach the one or more imaging devices also comprise two or more cameras located to sides of the TMS coil(s). However, Tamiya teaches a transcranial magnetic stimulation system (abstract; [0058]), comprising: a TMS coil (2) ( Figure 1 ; [0058]); and one or more imaging devices including two or more cameras (8) located to sides external to the TMS coil (2), and configured to permit simultaneous visualization of the patient's head as well as the TMS coil (2) ( Figure 1 ; [0059]; plurality of coils, [0070]). 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 system of Zhang to include two or more external cameras located to sides of the TMS coil(s) for simultaneously visualizing the patient’s head and the TMS coil(s) as taught by Tamiya, because Tamiya teaches providing cameras for visualizing the TMS coil(s) and the patient’s head simultaneously improves the accuracy of the TMS coil(s) position ([0070]). Regarding claim s 11 and 12 , Zhang teaches all the limitations of claim 1 . Zhang do es not teach the system comprises one or more imaging devices configured to permit simultaneous visualization of the patient’s head as well as the TMS coil head. However, Tamiya teaches a transcranial magnetic stimulation system (abstract; [0058]), comprising: a TMS coil (2) ( Figure 1 ; [0058]); and one or more imaging devices including a camera (8) configured to permit simultaneous visualization of the patient's head as well as the TMS coil head (2) ( Figure 1 ; [0059]; [0070]). 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 system of Zhang to include a camera for simultaneously visualizing the patient’s head and the TMS coil head as taught by Tamiya, because Tamiya teaches providing a camera for visualizing the TMS coil head and the patient’s head simultaneously improves the accuracy of the TMS coil head position ([0070]). Claim 7 is 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. 2014/0343351 ( Tojo ). Regarding claim 7 , Zhang teaches all the limitations of claim 1. Zhang does not teach the one or more imaging devices also comprises two or more cameras located away from the center but within the housing of the TMS coil head. However, Tojo teaches a transcranial magnetic stimulation system ([0001]; [0047]) comprising: a TMS coil head (10) including a housing and one or more coil windings in the housing, the coil head configured to be placed over a target brain region for treatment ( Figure 1 ; [0047]; [0049]); and one or more imaging devices including two or more cameras (123, 143) located away from the center but within the housing (10) ([0068]-[0069]; Figures 2, 5A-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 system of Zhang to include two more cameras located away from the center but within the housing of the TMS coil head as taught by Tojo , because such a configuration further improves positioning accuracy of the coil(s). Claim 8 is 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. 2016/0015995 (Leung). Regarding claim 8 , Zhang teaches all the limitations of claim 1. Zhang does not teach the TMS coil head includes one or more accelerometers configured to sense orientation placement or changes in orientation of the TMS coil head. However, Leung teaches a transcranial magnetic stimulation system (abstract; [0002]) comprising: a TMS coil head (102) placed over the target region for treatment ( Figure 1 ; [0030]; [0032]); and one or more accelerometers configured to sense orientation placement and/or changes in orientation of the TMS coil head (102) ([0039]). 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 system of Zhang to include the accelerometer to sense orientation placement and changes in orientation of the TMS coil head of Leung, because Leung teaches providing such an accelerometer permits sensing “orientation, vibration, shock and falling in order to turn off the device during deviations from treatment locale” to protect the device and the user ([0039]). Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over CN 107648734 (Zhang, see machine translation) in view of U.S. Patent Application Publication No. 2019/0060659 ( Ginhoux ). Regarding claims 9 and 10 , Zhang teaches all the limitations of claim 1. Zhang does not teach the TMS coil head comprises one or more contact sensors configured to detect contact and force between the TMS coil head and the patient's head; wherein the contact sensors comprise one or more force-sensitive resistors, one or more capacitive touch sensors or one or more ultrasonic position/touch sensors. However, Ginhoux teaches a transcranial magnetic stimulation system comprising (abstract; [0001]; [0090]), comprising: a TMS coil head (2); and a contact sensor (1) configured to detect contact and force between the TMS coil head (2) and a patient’s head ([0009]; [0090]; [0108]; Figure 6A ); wherein the contact sensor (1) comprises a force-sensitive resistor ([0008]). 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 system of Zhang to include a force-sensitive resistor contact sensor detecting contact and force between the coil and the patient’s head as taught by Ginhoux , because Ginhoux teaches providing such a contact sensor permits informing “the user about the intensity of the pressure applied to the sensor so that the contact is soft and painless for the patient” ([0109]). Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over CN 107648734 (Zhang, see machine translation) in view of U.S. Patent No. 10,286,222 (Nishikawa). Regarding claim 13 , Zhang teaches all the limitations of claim 1. Zhang does not teach the TMS coil head comprises a memory device configured to create a record of the TMS coil head position before and during treatment. However, Nishikawa teaches a transcranial magnetic stimulation system (abstract; col. 9, lines 6-22) comprising: a TMS coil head (11) configured to be placed over the target brain region for treatment ( Figure 1 ; col. 9, lines 9-22); and a memory device (23) configured to create a record of the TMS coil head position before and during treatment ( Figure 3 ; col. 11, lines 11-19). 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 system of Zhang to include a memory device for creating a record of the TMS coil head positions before and during treatment as taught by Nishikawa, because Nishikawa teaches providing such a memory device for storing the TMS coil position ensures the coil is optimally positioned for a treatment session and for subsequent sessions (col. 11, lines 11-18). Claims 14-16 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. 2016/0184601 ( Gleich ) . Regarding claim 14 , Zhang teaches a transcranial magnetic stimulation (TMS) kit comprising a transcranial magnetic stimulation system (abstract; Figure 1 ), comprising: a TMS coil head (5) as claimed in claim 1 configured to be placed over a target brain region of a patient for treatment (translation: pg. 5, paragraphs 4-5; Figures 1 and 4 ) ; and a patient head cap (6) having at least one of grid markings, text and color markings configured to overlie anatomical locations on 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 11 and mark points 12a, 12b , translation: pg. 3, paragraph 8 and pg. 5, paragraph 4; Figure 4 . The markings made by a practitioner on the cap 6 are construed as “color markings”, as any color visible on the “light colored” cap is considered a “color”. See also “working process” description under “invention content”, translation: pg. 3.). Zhang describes consideration of a pulse generator in operation of a TMS system (“pulse per second”, “pulse current”, “to form a pulse magnetic field”, see translation: “Background”, pg. 1-2), but does not expressly disclose the TMS system comprises a pulse generator. However, Gleich teaches a TMS system (abstract; [0001]; [0173]), comprising: a pulse generator (2) ([0006]; [0089]; Figure 2 ). 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 TMS system of Zhang to include a pulse generator as taught by Gleich in order to permit a practitioner to generate a pulse sequence with adjustable stimulation parameters “to generate a complex pulse sequence” to be “applied to a stimulation coil in order to generate the magnetic field” to provide TMS treatment to a patient ([0006]). Regarding claim 15 , Zhang in view of Gleich teaches all the limitations of claim 14. Zhang teaches the kit includes markings configured to overlie target areas 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 11 and mark points 12a, 12b, translation: pg. 3, paragraph 8 and pg. 5, paragraph 4; Figure 4 .). Regarding claim 16 , Zhang in view of Gleich teaches all the limitations of claim 14. Zhang teaches the kit includes markings configured to permit continuous measurement of a relative position and orientation of the cap versus the patient’s head before, during, and after treatment (The limitation “to permit continuous measurement of a relative position and orientation of the cap versus the patient’s head before, during, and after treatment” is functional language. Since Zhang teaches “markings” are provided on the cap 6 at anatomical locations of the patient’s head, the markings are capable of performing the claimed function of allowing continuous measurement of the position and orientation of the cap relative to the patient’s head before, during, and following treatment. See “invention content”, translation: pg. 3, paragraph 6; positioning cap 6 includes line 11 and mark points 12a, 12b, translation: pg. 3, paragraph 8 and pg. 5, paragraph 4; Figure 4 ). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Carrie R Dorna whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)270-7483 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT 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, FILLIN "SPE Name?" \* MERGEFORMAT Alexander Valvis can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT 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