DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Interpretation
The instant, amended claims, all newly entered on 29 August 2023, recite a limitation for “a second conductive layer between the first conductive layer and the body of the patient.” Because the originally filed disclosure does not account specifically for “a second conductive layer”—the phrase is not found in the Specification nor used as a reference in any of the Figures—an analysis is warranted to determine a reasonable interpretation of the term for prosecution on the merits and to determine which ground(s) of rejection made below should be maintained.
The Specification makes clear there is only one conductor layer in the invention (e.g., paragraphs [0016], [0017], [0086] referring to “the” conductor layer or “the” conductive layer; Figs. 5, 18B, and 23 showing various embodiments each having only one conductor layer). The Specification also states that the interstitial foam layers are non-conductive (paragraph [0086]). The Specification does, however, state that the ground layer/plane, at least as it pertains to Fig. 18B, may be conductive (e.g., paragraph [0108]).
A first possible interpretation that would account for the layers as consistently arranged throughout the disclosure would be that the claimed “first conductive layer” refers to the ground plane or ground layer, albeit in a broader manner, and that the “second conductive layer” refers to the conductor layer. While this interpretation does have written support, the usage of different terminology in the claims from that which is used throughout the disclosure creates ambiguity as to the scope and nature of the invention that creates issues under 35 U.S.C. § 112. If this is the intent of the claims, it is requested that Applicant amend to utilize language that is consistent with the disclosure and with the related issued patents to remedy this ambiguity—namely, Applicant should continue to claim a ground plane/layer and a conductor layer.
A second possible interpretation that would suggest adequate written description and possession of the invention would be that the claimed “first conductive layer” is the conductor layer as described in the disclosure and that there is indeed a second and different conductive layer that is not the ground plane/layer between the conductor layer and dielectric layer, but that the second conductive layer is merely an obvious or routine duplication of parts. Absent any new or unexpected results, though, the mere duplication of parts would raise issues under the obviousness-type double patenting analysis that follows.
A final interpretation would be similar to the above—the “second conductive layer” is indeed a second and different conductive layer that is not the ground plane/layer between the conductor layer and dielectric layer—but that Applicant intends for this undisclosed second layer to have a meaningful function, new or unexpected result, or other non-obvious significance to the invention. If this is Applicant’s intent, it would raise issues under 35 U.S.C. § 112(a) for lack of written description, as set forth below.
In summary, Examiner believes there are three potentially reasonable interpretations of the claim language relating to a “second conductive layer between the first conductive layer and the body of the patient.” Each of these three interpretations provides a proper basis for at least one of the rejections under 35 U.S.C. § 112(a), 35 U.S.C. § 112(b), and obviousness-type double patenting, or some combination thereof, as set forth 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 2-21 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.
Each of independent claims 2, 9, and 19 recite the limitation “a second conductive layer between the first conductive layer and the body of the patient.” There does not appear to be written support for this limitation, which was newly presented in the claims as amended on 29 August 2023. The Specification makes reference to only one conductor layer in the invention (e.g., paragraphs [0016], [0017], [0086] referring to “the” conductor layer or “the” conductive layer; Figs. 5, 18B, and 23 showing various embodiments each having only one conductor layer). While the Specification does, state that the ground layer/plane, at least as it pertains to Fig. 18B, may be conductive in nature (e.g., paragraph [0108]), it is not clear from the claims as phrased whether the “first conductive layer” refers to this ground layer/plan and the “second conductive layer” refers to the conductor layer, or whether the “second conductive layer” is some other additional layer not disclosed. Presuming this “second conductive layer” has a meaningful function within the invention, there is insufficient written description to support the limitation now presented.
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 2-21 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.
Regarding the same limitation of a “second conductive layer,” the usage of different terminology in the claims from that which is used throughout the disclosure creates ambiguity as to the scope and nature of the invention. It is unclear if the “first conductive layer” refers to the ground plane or the conductor layer, and relatedly whether the “second conductive layer” refers to the conductor layer or some other conductive layer not shown or described in the Disclosure. If it is the latter, any functionality of such a second conductive layer seemingly located adjacent the first conductive layer with no claimed intervening structures is also unclear.
To remedy these ambiguities, Applicant should amend the claims to utilize language that is consistent with the disclosure and with the related issued patents—namely, Applicant should continue to claim a ground plane/layer and a conductor layer.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-4 , 7-11, and 14-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 11, 15-17, and 19 of U.S. Patent No. 11,583,683 in view of either Beigel (US 2003/0169207 A1, hereinafter Beigel’207) or Cheadle (US 6,377,216 B1, hereinafter Cheadle’216).
Regarding instant independent claims 2 and 19, claims 1 and 19 of the ‘683 patent already recite a wearable antenna assembly (wherein a “wearable antenna assembly” is no more than a semantic difference from a “wearable device” as now claimed, since a wearable assembly is reasonably interpreted as a device, particularly in view of patented claim 4 wherein the assembly also comprises the wearable article) comprising an antenna configured to send one or more stimulus signals carrying electrical energy to a wireless tissue stimulator when the wireless tissue stimulator is implanted within a body wherein the antenna comprises a dielectric layer that directly contacts the body and a non-conductive layer between a conductor layer of the antenna and the dielectric layer. The narrower recitation of a tissue stimulator necessarily anticipates the broader implanted medical device now claimed. The two claims differ in that the instant claim now recites (1) “a second conductive layer between the first conductive layer and the body of the patient;” and (2) “a coaxial cable coupled to the antenna and configured to provide the received signal to the antenna.”
As to (1) the second conductive layer, a good faith interpretation of the instant disclosure accounts for two possibilities: either (A) the first conductive layer is the ground plane and the second conductive layer is the conductor layer or (B) the second conductive layer is a routine duplication of parts. For interpretation (1A), claim 2 would be anticipated by patented claim 7 as it depends from claims 1 and 6, which disclose the arrangement of a ground plane, a conductor layer closer to the body of the patient, and a dielectric layer that directly contacts (i.e. is most proximal to) the body of the patient. For interpretation (1B), a mere duplication of parts has no patentable significance unless it produces a new and unexpected result. Since the instant disclosure does not discuss a second conductive layer or any particular utility or new and unexpected result produced by such a second conductive layer, the second conductive layer has adequate written support only if it is a duplication of parts with no separate patentable significance. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Further regarding claims 2 and 19, although the ‘683 patent does not expressly claim (2) a coaxial cable coupled to the antenna, coaxial cables have long been used in the art and such a modification would be well-known and obvious in view of either Beigel’207 or Cheadle’216. Beigel’207 teaches a coaxial probe that protrudes through a ground plane to connect to a conductive patch antenna layer, which allows the antenna to provide improvements in performance size and cost (e.g., paragraph [0028]). Cheadle’216 teaches that coax cable is a connector type frequently used to connect a medical device to a wearable patch antenna, since the coax cable shielding can be connected to the ground plane of the antenna to properly ground the device while enhancing signal transmission over the coaxial lines (e.g., column 2, lines 43-48; column 5, lines 33-62; column 6, lines 33-44). The routine use of coaxial cable does not rise to the level of patentable distinction over the patented claims.
Regarding independent claim 9, merely claiming a system that also comprises the implantable medical device intended to be used with the claimed antenna does not provide patentable distinctness over a claim to the antenna itself. (If such were the case, any such system claim would necessarily be subject to restriction from any of its component parts.) Since the ‘683 patent claims the antenna and recites that it is to be used with a wireless implantable tissue stimulator, it would be a routine and obvious variation of that antenna to include it with the implantable tissue stimulator as a system to satisfy the instant claim.
Instant claims 3, 10, and 21 relate to a remaining limitation of patented claims 1 and 19 regarding the non-conductive layer.
Instant claims 4 and 11 would result from the modification of the ‘683 patent by the coaxial cable of either Beigel’207 or Cheadle’216 as discussed above.
Instant claims 7, 14, and 20 relate to the remaining limitation of patented claims 1 and 19 relating to a housing with first and second attachment features.
Instant claims 8 and 15 relates to patented claim 11, which discloses a control circuit and battery.
Instant claim 16 relates to patented claim 15 directed to a control panel with user interface button.
Instant claim 17 relates to patented claim 16 directed to a first interface button controlling neurostimulation settings.
Instant claim 18 relates to patented claim 17 directed to the at least one neurostimulation setting comprising a setting for one or more of an amplitude, a pulse width, a frequency, and a preset program.
Claims 2-6, 8-13, 15-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-, 6-8, and 18 of U.S. Patent No. 10,293,169 in view of either Beigel’207 or Cheadle’216.
Regarding instant independent claims 2 and 19, claim 1 of the ‘169 patent already recites a wearable device for facilitating neurophysiological treatment comprising an antenna configured to transmit one or more electromagnetic signals to an implantable neural stimulator, wherein the antenna comprises a plurality of layers including a conductor layer and a dielectric layer between the conductor layer and the surface of the patient's body such that the dielectric layer is proximal to the patient's body. The two claims differ in that the instant claim now recites (1) “a second conductive layer between the first conductive layer and the body of the patient;” and (2) “a coaxial cable coupled to the antenna and configured to provide the received signal to the antenna.”
As to (1) the second conductive layer, a good faith interpretation of the instant disclosure accounts for two possibilities: either (A) the first conductive layer is the ground plane and the second conductive layer is the conductor layer or (B) the second conductive layer is a routine duplication of parts. For interpretation (1A), claim 2 would be anticipated by the patented claim 1, which discloses the arrangement of a ground plane, a conductor layer closer to the body of the patient, and a dielectric layer that directly contacts (i.e. is most proximal to) the body of the patient. For interpretation (1B), a mere duplication of parts has no patentable significance unless it produces a new and unexpected result. Since the instant disclosure does not discuss a second conductive layer or any particular utility or new and unexpected result produced by such a second conductive layer, the second conductive layer has adequate written support only if it is a duplication of parts with no separate patentable significance. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Further regarding claims 2 and 19, although the ‘683 patent does not expressly claim (2) a coaxial cable coupled to the antenna, coaxial cables have long been used in the art and such a modification would be well-known and obvious in view of either Beigel’207 or Cheadle’216. Beigel’207 teaches a coaxial probe that protrudes through a ground plane to connect to a conductive patch antenna layer, which allows the antenna to provide improvements in performance size and cost (e.g., paragraph [0028]). Cheadle’216 teaches that coax cable is a connector type frequently used to connect a medical device to a wearable patch antenna, since the coax cable shielding can be connected to the ground plane of the antenna to properly ground the device while enhancing signal transmission over the coaxial lines (e.g., column 2, lines 43-48; column 5, lines 33-62; column 6, lines 33-44). The routine use of coaxial cable does not rise to the level of patentable distinction over the patented claims.
Regarding independent claim 9, merely claiming a system that also comprises the implantable medical device intended to be used with the claimed antenna does not provide patentable distinctness over a claim to the antenna itself. (If such were the case, any such system claim would necessarily be subject to restriction from any of its component parts.) Since the ‘169 patent claims the antenna and wearable device, and recites that it is to be used with an implantable neural stimulator, it would be a routine and obvious variation of that antenna to include it with the implantable neural stimulator as a system to satisfy the instant claim.
Instant claims 3, 10, and 21 relate to a remaining limitation of patented claims 1 and 19 regarding the non-conductive layer.
Instant claims 4 and 11 would result from the modification of the ‘169 patent by the coaxial cable of either Beigel’207 or Cheadle’216 as discussed above.
Instant claims 5, 6, 12, and 13 relate to patented claims 1 and 18, which recite non-inductive coupling between the antenna(s) and wireless medical device such that the implantable device is remotely powered by energy in the transmitted electromagnetic signals, there being no other power source required.
Instant claims 8 and 15 relates to a remaining portion of patented claim 1, which discloses a control circuit and battery.
Instant claim 16 relates to patented claim 6 directed to a control panel with user interface button.
Instant claim 17 relates to patented claim 7 directed to a first interface button controlling neurostimulation settings.
Instant claim 18 relates to patented claim 8 directed to the at least one neurostimulation setting comprising a setting for one or more of an amplitude, a pulse width, a frequency, and a preset program.
Claims 2-4, 8-11, 15-19, and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5-7, and 14 of U.S. Patent No. 9,254,393 in view of either Beigel’207 or Cheadle’216.
Regarding instant independent claims 2 and 19, claim 1 of the ‘393 patent already recites a wearable device for facilitating treatment comprising an antenna configured to transmit one or more electromagnetic signals to an implantable neural stimulator, wherein the antenna comprises a plurality of layers including a conductor layer and a dielectric layer between the conductor layer and the surface of the patient's body such that the dielectric layer is proximal to the patient's body. The two claims differ in that the instant claim now recites (1) “a second conductive layer between the first conductive layer and the body of the patient;” and (2) “a coaxial cable coupled to the antenna and configured to provide the received signal to the antenna.”
As to (1) the second conductive layer, a good faith interpretation of the instant disclosure accounts for two possibilities: either (A) the first conductive layer is the ground plane and the second conductive layer is the conductor layer or (B) the second conductive layer is a routine duplication of parts. For interpretation (1A), claim 2 would be anticipated by the patented claim 1, which discloses the arrangement of a ground plane, a conductor layer closer to the body of the patient, and a dielectric layer that directly contacts (i.e. is most proximal to) the body of the patient. For interpretation (1B), a mere duplication of parts has no patentable significance unless it produces a new and unexpected result. Since the instant disclosure does not discuss a second conductive layer or any particular utility or new and unexpected result produced by such a second conductive layer, the second conductive layer has adequate written support only if it is a duplication of parts with no separate patentable significance. See In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Further regarding claims 2 and 19, although the ‘393 patent does not expressly claim (2) a coaxial cable coupled to the antenna, coaxial cables have long been used in the art and such a modification would be well-known and obvious in view of either Beigel’207 or Cheadle’216. Beigel’207 teaches a coaxial probe that protrudes through a ground plane to connect to a conductive patch antenna layer, which allows the antenna to provide improvements in performance size and cost (e.g., paragraph [0028]). Cheadle’216 teaches that coax cable is a connector type frequently used to connect a medical device to a wearable patch antenna, since the coax cable shielding can be connected to the ground plane of the antenna to properly ground the device while enhancing signal transmission over the coaxial lines (e.g., column 2, lines 43-48; column 5, lines 33-62; column 6, lines 33-44). The routine use of coaxial cable does not rise to the level of patentable distinction over the patented claims.
Regarding independent claim 9, merely claiming a system that also comprises the implantable medical device intended to be used with the claimed antenna does not provide patentable distinctness over a claim to the antenna itself. (If such were the case, any such system claim would necessarily be subject to restriction from any of its component parts.) Since the ‘393 patent claims the antenna and wearable device, and recites that it is to be used with an implantable neural stimulator, it would be a routine and obvious variation of that antenna to include it with the implantable neural stimulator as a system to satisfy the instant claim.
Instant claims 3, 10, and 21 relate to patented claim 14. The patented foam layer between the ground plane and conductor layer and second foam layer between the conductor layer and dielectric layer are non-conductive (e.g., column 7, lines 3-15 of the ‘393 patent).
Instant claims 4 and 11 would result from the modification of the ‘393 patent by the coaxial cable of either Beigel’207 or Cheadle’216 as discussed above.
Instant claims 8 and 15 relates to a remaining portion of patented claim 1, which discloses a control circuit and battery.
Instant claim 16 relates to patented claim 5 directed to a control panel with user interface button.
Instant claim 17 relates to patented claim 6 directed to a first interface button controlling neurostimulation settings.
Instant claim 18 relates to patented claim 7 directed to the at least one neurostimulation setting comprising a setting for one or more of an amplitude, a pulse width, a frequency, and a preset program.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER A FLORY whose telephone number is (571)270-5305. The examiner can normally be reached Monday, Tuesday, and Thursday, 8:30am-4:30pm (PST).
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, Benjamin Klein can be reached at (571) 270-5213. 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.
/CHRISTOPHER A FLORY/Primary Examiner, Art Unit 3792
5 December 2025