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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application Nos. 60/828084, 11/867679, 14/161210, 14/957234, 17/170710, and 18/609938, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Applicant’s provisional application and continuing applications appear to lack support for Claim 1 of the present case.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a surface mounted device configured to be positioned against and secured to a head of a wearer; a cannula having a channel, the cannula configured to pass through the surface mounted device, through an incision in the head of the wearer, and into body tissue of the wearer” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 21 is objected to because of the following informalities: Line 8 reading “deliver the energy” should read --deliver energy--. Appropriate correction is required.
Claim 21 is objected to because of the following informalities: Line 10 reading “delivers energy” should read --delivers the energy--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Claims 21, 23-26, 28, 41-52 are 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. Although applicant has support for claims as originally filed, the originally filed claims in the present case are directed a completely different device from that of the amended claims dated 10/29/2025. Applicant provides no figures for the embodiment of Claim 21 of the present case. Furthermore, the specification is silent as to a surface mounted device applied to a head of a user where a cannula passes through the surface mounted device into an incision on the head of a user.
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 21, 23, 25-26 and 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gill (USPGPub 2001/0003156).
Re Claim 21, Gill teaches a system for treatment, the system comprising: a surface mounted device (Gill Figs. 1-4) configured to be positioned against and secured to a head of a wearer (Gill Figs. 3-4; ¶ 0078-0079); a cannula (1) having a channel, the cannula configured to pass through the surface mounted device (Gill ¶ 0077), through an incision in the head of the wearer, and into body tissue of the wearer (Gill ¶ 0077-0079); and an energy delivering device configured to be inserted through the cannula (1), the surface mounted device, and the incision to enter the body tissue, wherein the energy delivering device is configured to deliver energy into the body tissue of the wearer (Gill ¶ 0081-0082), wherein the surface mounted device is configured to stabilize the cannula and the energy delivering device while the energy delivering device delivers the energy into the body tissue of the wearer (Gill ¶ 0082-0083).
Re Claim 23, Gill teaches wherein the body tissue comprises a brain of the wearer (Gill ¶ 0082-0083).
Re Claim 25, Gill teaches wherein the energy delivering device is configured to increase temperature of the body tissue of the wearer (Gill ¶ 0002).
Re Claim 26, Gill teaches wherein the energy delivering device is configured to provide electrical stimulation to the body tissue of the wearer (Gill ¶ 0002).
Re Claim 28, Gill teaches a method of using the system of Claim 21, the method comprising: inserting the energy delivering device through the cannula (1), the surface mounted device, and the incision such that the energy delivering device enters the body tissue (Gill ¶ 0081- 0082), wherein the body tissue is a brain of the wearer (Gill ¶ 0082); and operating the energy delivering device, after said inserting, to treat at least one of: dementia, Alzheimer's disease, hyperactivity, seizure, sleep disorders, hypothermia, arthritis, pain, or infection, or to enhance tissue healing (Gill ¶ 0001, 0042).
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 24 and 41-52 are rejected under 35 U.S.C. 103 as being unpatentable over Gill (USPGPub 2001/0003156) in view of Keidar (USPGPub 2004/0078036).
Re Claim 24, Gill teaches all of the limitations of Claim 21. However, Gill fails to teach wherein the system is configured to be operational under guidance of a computed tomography (CT) scan. Keidar teaches a system for delivering energy to a body tissue (Keidar Abstract), the system is configured to be operational under guidance of a computed tomography (CT) scan for developing a map of the area to be treated wherein location of a catheter is visualized on this map for proper placement of an area to be treated (Keidar ¶ 0120). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the system of Keidar to include operating under guidance of a computed tomography (CT) scan as disclosed by Keidar for developing a map of the area to be treated wherein location of a catheter is visualized on this map for proper placement of an area to be treated (Keidar ¶ 0120).
Re Claim 41, Gill teaches a system for delivering energy to body tissue, the system comprising: a surface mounted device (Gill Figs. 1-4) configured to be positioned against and securely attached to a head of a wearer (Gill Figs. 3-4; ¶ 0078-0079); a cannula (1) defining a channel, the cannula configured to pass through the surface mounted device (Gill ¶ 0077), through an incision in the head, and into a brain of the wearer (Gill ¶ 0077-0079; 0082); an energy delivering device configured to be positioned through the cannula (1), the surface mounted device, and the incision, wherein the energy delivering device configured to deliver energy into the brain of the wearer (Gill ¶ 0082-0083). However, Gill fails to teach wherein the system is configured to be operational under guidance of a computed tomography (CT) scan.
Keidar teaches a system for delivering energy to a body tissue (Keidar Abstract), the system is configured to be operational under guidance of a computed tomography (CT) scan for developing a map of the area to be treated wherein location of a catheter is visualized on this map for proper placement of an area to be treated (Keidar ¶ 0120). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the system of Keidar to include operating under guidance of a computed tomography (CT) scan as disclosed by Keidar for developing a map of the area to be treated wherein location of a catheter is visualized on this map for proper placement of an area to be treated (Keidar ¶ 0120).
Re Claim 42, Gill in view of Keidar teach all of the limitations of Claim 41. Gill fails to teach wherein the energy delivering device comprises a laser. Keidar teaches delivering energy to a body tissue (Keidar abstract), wherein an energy delivering device comprises a laser for increasing temperature and blood flow (Keidar ¶ 0042; Claim 17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the system of Keidar to include an energy delivering device comprising a laser as disclosed by Keidar for increasing temperature and blood flow (Keidar ¶ 0042; Claim 17).
Re Claim 43, Gill in view of Keidar teach all of the limitations of Claim 41. Gill further teaches wherein the energy delivering device is configured to increase temperature of the brain of the wearer (Gill ¶ 0002; 0082-0083).
Re Claim 44, Gill in view of Keidar teach all of the limitations of Claim 41. Gill fails to explicitly teach wherein the energy delivering device is configured to increase blood flow in the brain of the wearer. However, the limitation "configured to increase blood flow in the brain of the wearer" is a functional limitation and an inherent characteristic of prior art Gill. Gill teaches an electrode at a tip of a catheter for heating tissue. This heating of brain tissue would result in the increase of blood flow in said heated brain tissue (Gill ¶ 0002; 0082-0083). This physiological of the body would be very well-understood by one of ordinary skill in the art in order for the body to maintain thermoregulation.
Re Claim 45, Gill in view of Keidar teach all of the limitations of Claim 41. Gill further teaches wherein the energy delivering device is configured to provide electrical stimulation to the brain of the wearer (Gill ¶ 0002, 0082-0083).
Re Claim 46, Gill in view of Keidar teach all of the limitations of Claim 41. Gill fails to teach wherein the energy delivering device comprises a laser. Keidar teaches delivering energy to a body tissue (Keidar abstract), wherein an energy delivering device comprises a laser for increasing temperature and blood flow (Keidar ¶ 0042; Claim 17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the system of Keidar to include an energy delivering device comprising a laser as disclosed by Keidar for increasing temperature and blood flow (Keidar ¶ 0042; Claim 17).
Re Claim 47, Gill in view of Keidar teach all of the limitations of Claim 41. Gill further teaches the method comprising: inserting the energy delivering device through the cannula (1), the surface mounted device, and the incision such that the energy delivering device enters the brain of the wearer (Gill ¶ 0082-0083); and operating the energy delivering device, after said inserting, to treat at least one of: dementia, Alzheimer's disease, hyperactivity, seizure, sleep disorders, hypothermia, arthritis, pain, or infection, or to enhance tissue healing (Gill ¶ 0001, 0042).
Re Claim 48, Gill teaches a method of treatment comprising: creating an incision in a head of a wearer (Gill ¶ 0078); positioning a surface mounted device against a head of the wearer (Gill Figs. 1-4); securing the surface mounted device to the head of the wearer (Gill ¶ 0078); passing a cannula (1) through the surface mounted device, through the incision in the head of the wearer, and into a brain of the wearer (Gill ¶ 0082-0083), wherein the cannula comprises a channel (as seen in Gill Fig. 2); inserting an energy delivering device through the cannula, the surface mounted device, and the incision into the brain of the wearer (Gill ¶ 0077-0079; 0082-0083); and activating the energy delivering device, the energy delivering device being configured to deliver energy into the brain of the wearer while activated (Gill ¶ 0081-0083), wherein the surface mounted device stabilizes the energy delivering device while the energy delivering device delivers the energy into the brain of the wearer (Gill ¶ 0082-0083).
Gill fails to teach wherein the method is configured to be performed under guidance of computed tomography (CT) scans. Keidar teaches a system for delivering energy to a body tissue (Keidar Abstract), the system is configured to be operational under guidance of a computed tomography (CT) scan for developing a map of the area to be treated wherein location of a catheter is visualized on this map for proper placement of an area to be treated (Keidar ¶ 0120). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the system of Keidar to include operating under guidance of a computed tomography (CT) scan as disclosed by Keidar for developing a map of the area to be treated wherein location of a catheter is visualized on this map for proper placement of an area to be treated (Keidar ¶ 0120).
Re Claim 49, Gill in view of Keidar teach all of the limitations of Claim 48. Gill further teaches wherein the energy delivered by the energy delivering device is operative to treat at least one of: dementia, Alzheimer's disease, hyperactivity, seizure, sleep disorders, hypothermia, arthritis, pain, or infection, or to enhance tissue healing (Gill ¶ 0001, 0042).
Re Claim 50, Gill in view of Keidar teach all of the limitations of Claim 48. Gill fails to explicitly teach wherein the energy delivering device is configured to increase blood flow in the body tissue of the wearer. However, the limitation "configured to increase blood flow in the body tissue" is a functional limitation and an inherent characteristic of prior art Gill. Gill teaches an electrode at a tip of a catheter for heating tissue. This heating of brain tissue would result in the increase of blood flow in said heated brain tissue (Gill ¶ 0002; 0082-0083).
Re Claim 51, Gill in view of Keidar teach all of the limitations of Claim 48. Gill further teaches wherein the energy delivering device is configured to provide electrical stimulation to the brain of the wearer (Gill ¶ 0002, 0082-0083).
Re Claim 52, Gill in view of Keidar teach all of the limitations of Claim 48. Gill fails to teach wherein the energy delivering device comprises a laser. Keidar teaches delivering energy to a body tissue (Keidar abstract), wherein an energy delivering device comprises a laser for increasing temperature and blood flow (Keidar ¶ 0042; Claim 17). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have configured the system of Keidar to include an energy delivering device comprising a laser as disclosed by Keidar for increasing temperature and blood flow (Keidar ¶ 0042; Claim 17).
Response to Arguments
Applicant's arguments filed 06/03/2026 have been fully considered but they are not persuasive. With regard to claim objections, it would appear applicant inadvertently amended the wrong line in Claim 21. Therefore, the previously provided claim objection remains outstanding. With regard to 102 anticipation rejections, applicant argues at the bottom of Page 6 of the response that Gill lacks a cannula configured to pass through the surface mounted device. However, Fig. 3 of Gill shows a cannula 1 configured to pass through the surface mounted device 2. PGPub paragraph 0085 of Gill reads the “electrode or catheter may be directly fixed to the head of the guide device via a protective cap” 15. Nothing in Gill teaches permanent attachment of a cannula. Furthermore, the surface mounted device is positioned against the head of a user, as seen in Gill Fig. 3. Applicant is reminded that the word ‘against’ is a synonym for the word ‘on’. At the bottom of Page 7 of the response, applicant’s arguments turn to 103 rejections. In the first full paragraph of Page 8 of the response, applicant returns to the same arguments covered under the response to 102 rejections. These arguments are covered above and are therefore, moot.
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 WILLIAM R FREHE whose telephone number is (571)272-8225. The examiner can normally be reached 10:30AM-7:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM R FREHE/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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