DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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 (i.e., changing from AIA to pre-AIA ) 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.
Claim Rejections - 35 USC § 112
3. 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.
4. Claims 1, 3, 6, 8, 9, and 14, as well as Claims 2, 4-5, 7, and 10-11 based on their dependencies to Claims 1 and 9, 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.
5. The term “about” in claim 1 is a relative term which renders the claim indefinite. The term “about” 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 of whether “less than about 50 nm” means 50 nm or less, or it must be less than 50 nm, rendering the claim indefinite. For examination purposes, the broader interpretation will be assumed (i.e., ‘50 nm or less’).
6. The term “about” in claim 3 is a relative term which renders the claim indefinite. The term “about” 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 of whether “less than about 200 micrometers” means 200 micrometers or less, or it must be less than 200 micrometers, rendering the claim indefinite. For examination purposes, the broader interpretation will be assumed (i.e., ‘200 micrometers or less’).
7. The term “about” in claim 3 is a relative term which renders the claim indefinite. The term “about” 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 of whether “less than about 100 micrometers” means 100 micrometers or less, or it must be less than 100 micrometers, rendering the claim indefinite. For examination purposes, the broader interpretation will be assumed (i.e., ‘100 micrometers or less’).
8. The term “about” in claim 6 is a relative term which renders the claim indefinite. The term “about” 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 of whether “less than about 30 nm” means 30 nm or less, or it must be less than 30 nm, rendering the claim indefinite. For examination purposes, the broader interpretation will be assumed (i.e., ’30 nm or less’).
9. Claim 8 recites the limitation "the silver foil" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 8 depends from Claim 1, where there is no recitation of a ‘silver foil’, rendering Claim 8 indefinite. Since, Claim 7 recites ‘a silver foil’, it will be assumed that Claim 8 depends from Claim 7 for examination purposes.
10. Claim 9 recites the limitation "the carrier system" in line 1. There is insufficient antecedent basis for this limitation in the claim. Claim 9 depends from Claim 1, where there is no recitation of a ‘silver foil’, rendering Claim 9 indefinite. Proper correction is required.
11. The term “about” in claim 14 is a relative term which renders the claim indefinite. The term “about” 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 of whether “less than about 30 nm” means 30 nm or less, or it must be less than 30 nm, rendering the claim indefinite. For examination purposes, the broader interpretation will be assumed (i.e., ’30 nm or less’).
Claim Rejections - 35 USC § 102
12. 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.
13. Claims 12, 13, 15, and 18-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jeffrey U.S. 2015/0335876 (herein referred to as “Jeffrey”).
14. Regarding Claim 12, Jeffrey teaches a system for transmitting electrical signals to or from the head of a subject (Figs. 1A-1D and 6; para 0101), the system comprising:
a. a base layer (Fig. 2A, ref num 108) having a top surface (see Fig. 1A and 2A), a bottom surface (opposite of the top surface, Figs. 1A and 2A), a proximal end, and a distal end (see Fig. 1A for proximal and distal ends);
b. an electrical connector attached to a proximal end of the base layer (Fig. 1A, ref num 115 and 117); and
c. a conductive circuit (para 0099, “The base may be a flex circuit material”) including:
c.1 an electrode supported along the top surface of the base layer at the distal end of the base layer (Fig. 1C, ref num 103, 105); and
c.2 a conductive trace supported along the top surface of the base layer, the conductive trace extending between and electrically connecting the electrode and the electrical connector (para 0099, “ The base may be a flex circuit material, e.g., that is relatively insulating, flexible out of the plane of the material, but rigid in the plane (meaning it can be bent up/down out of the plane, but has rigidity when pushed/pulled in the direction of the plane of the material). The flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces. The base may be a flex circuit material, e.g., that is relatively insulating, flexible out of the plane of the material, but rigid in the plane (meaning it can be bent up/down out of the plane, but has rigidity when pushed/pulled in the direction of the plane of the material). The flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces… the back (patient-facing) side of the base of the cantilever electrode apparatus is shown with the snaps attached so that the base of the snaps extends along the back side and can be in electrical contact in one case with the electrically conductive first active region forming part of the first electrode portion. The second snap is offset from the first electrically active region and may contact a conductive trace (e.g., printed on the body 108 of the base) and extending along the elongate body region 107 until it contacts the second active region. In this manner, the first and second connectors may establish electrical communication between the active regions and the neurostimulator”);
c.3 wherein the conductive trace is formed from a conductive, non-ferrous material (para 0210, “the conductive metal may include gold, silver, copper, aluminum, or any other type of conductive material”) deposited along the upper surface of the base layer using a thin-film deposition process (para 0213), and the electrode is formed as a polymer thick film (para 0112) printed on the conductive trace at the distal end of the base layer (para 0211).
15. Regarding Claim 13, Jeffrey teaches the conductive, non-ferrous material comprises aluminum that has been printed as thin film along the upper surface of the base layer (para 0210, “the conductive metal may include gold, silver, copper, aluminum, or any other type of conductive material”).
16. Regarding Claim 15, Jeffrey teaches the electrode is secured relative to the conductive trace using an electrically conductive adhesive (para 0159).
17. Regarding Claim 18, Jeffrey teaches a method of forming a system for transmitting electrical signals to or from the head of a subject (Figs. 1A-1D and 6; para 0101), the method comprising:
a. providing a base layer (Fig. 2A, ref num 108);
b. depositing a layer of conductive, non-ferrous material along an upper surface of the base layer using a thin-film deposition technique (para 0099, “ The base may be a flex circuit material, e.g., that is relatively insulating, flexible out of the plane of the material, but rigid in the plane (meaning it can be bent up/down out of the plane, but has rigidity when pushed/pulled in the direction of the plane of the material). The flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces. The base may be a flex circuit material, e.g., that is relatively insulating, flexible out of the plane of the material, but rigid in the plane (meaning it can be bent up/down out of the plane, but has rigidity when pushed/pulled in the direction of the plane of the material). The flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces… the back (patient-facing) side of the base of the cantilever electrode apparatus is shown with the snaps attached so that the base of the snaps extends along the back side and can be in electrical contact in one case with the electrically conductive first active region forming part of the first electrode portion. The second snap is offset from the first electrically active region and may contact a conductive trace (e.g., printed on the body 108 of the base) and extending along the elongate body region 107 until it contacts the second active region. In this manner, the first and second connectors may establish electrical communication between the active regions and the neurostimulator”; para 0210, “the conductive metal may include gold, silver, copper, aluminum, or any other type of conductive material”; para 0213);
c. patterning the deposited non-ferrous material into a conductive trace that extends between a proximal end and a distal end of the base layer (para 0099); and
d. electrically coupling a thick film forming an electrode relative to a distal end of the conductive trace (para 0112, 0211).
Regarding method claim 18, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claims 1 and 12, since operation of the prior art relied on to reject apparatus claims 1 and 12 would naturally result in the step of method claim 18 being satisfied.
18. Regarding Claim 19, Jeffrey teaches the electrode is electrically coupled to the conductive trace using a conductive adhesive (para 0159).
19. Regarding Claim 20, Jeffrey teaches comprising a protective cover layer atop the conductive trace (para 0095, “Both adhesive and conductive hydrogel that may cover an active electrode region function more effectively on skin with little or no hair”; para 0099, “The flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces”).
Claim Rejections - 35 USC § 103
20. 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.
21. Claims 1-8 and 14 rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey and in view of Lieber U.S. 2018/0328884 (herein referred to as “Lieber”).
22. Regarding Claim 1, Jeffery teaches a system for transmitting electrical signals to or from the head of a subject (Figs. 1A-1D and 6; para 0101), the system comprising:
a. a support structure configured for placement on a head of a human subject (Fig. 6, ref num 600); and
b. at least one lead system coupled to the support structure (Fig. 1A, ref num 100; para 0096, “FIGS. 1A-1D and 2 illustrate one variation of a cantilever electrode apparatus (“electrode apparatus”) that may be used with a neurostimulator to be is worn on a subject's head. In this example, the cantilever electrode apparatus 100 includes a plurality of electrode portions”), the at least one lead assembly comprising:
b.1 a base layer (Fig. 2A, ref num 108) having a top surface (see Fig. 1A and 2A), a bottom surface (opposite of the top surface, Figs. 1A and 2A), and extending from a proximal end to a distal end (see Fig. 1A);
b.2 an electrical connector attached to a proximal end of the base layer (Fig. 1A, ref num 115 and 117); and
b.3 a conductive circuit (para 0099, “The base may be a flex circuit material”) comprising:
b.3.i a conductive trace printed as a thin film along the top surface of the base layer and extending between and electrically connecting the electrode and the electrical connector (para 0099, “ The base may be a flex circuit material, e.g., that is relatively insulating, flexible out of the plane of the material, but rigid in the plane (meaning it can be bent up/down out of the plane, but has rigidity when pushed/pulled in the direction of the plane of the material). The flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces. The base may be a flex circuit material, e.g., that is relatively insulating, flexible out of the plane of the material, but rigid in the plane (meaning it can be bent up/down out of the plane, but has rigidity when pushed/pulled in the direction of the plane of the material). The flex circuit may have a dielectric layer covering all or part of the front and/or back side, covering and insulating conductive traces… the back (patient-facing) side of the base of the cantilever electrode apparatus is shown with the snaps attached so that the base of the snaps extends along the back side and can be in electrical contact in one case with the electrically conductive first active region forming part of the first electrode portion. The second snap is offset from the first electrically active region and may contact a conductive trace (e.g., printed on the body 108 of the base) and extending along the elongate body region 107 until it contacts the second active region. In this manner, the first and second connectors may establish electrical communication between the active regions and the neurostimulator”); and
b.3.ii an electrode formed printed on top of the conductive trace at the distal end of the base layer (Fig. 1C, ref num 103, 105); and
Jeffery fails to teach wherein a height of conductive trace as measured from the top surface of the base layer is less than about 50 nm.
Lieber teaches a system of analogous art (Fig. 1A and 1B; para 0004), wherein the system comprises a conductive trace that has a height of less than about 50 nm (para 0113, “define or register the electrode, electrical connector, conductive pathway… etc. … the thickness of one of these may be… less than about 50 nm”). It would have been an obvious matter of design choice to have the height of the conductive trace be less than about 50 nm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
23. Regarding Claim 2, Jeffery teaches the conductive trace comprises a layer of conductive, non-ferrous material (para 0210, “the conductive metal may include gold, silver, copper, aluminum, or any other type of conductive material”).
24. Regarding Claim 3, Jeffrey fails to teach a width of the conductive trace is less than 200 micrometers or less than about 100 micrometers.
Lieber teaches a system of analogous art (Fig. 1A and 1B; para 0004), wherein the system comprises a conductive trace that has a width of less than about 200 or 100 micrometers (para 0119, “10 micrometers or about 20 micrometers in length”). It would have been an obvious matter of design choice to have the width of the conductive trace be less than about 200 or 100 micrometers, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
25. Regarding Claim 4, Jeffrey teaches the conductive trace is formed of a plastic film (para 0112) coated with aluminum (para 0210).
26. Regarding Claim 5, Jeffrey teaches the electrode is formed as a polymer thick film (para 0112).
27. Regarding Claim 6, Jeffrey fails to teach the height of the conductive trace is about 30 nm or less.
Lieber teaches a system of analogous art (Fig. 1A and 1B; para 0004), wherein the system comprises a conductive trace that has a height of less than about 50 nm (para 0113, “define or register the electrode, electrical connector, conductive pathway… etc. … the thickness of one of these may be… less than about 20 nm”). It would have been an obvious matter of design choice to have the height of the conductive trace be less than about20 nm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
28. Regarding Claim 7, Jeffrey teaches the electrode comprises a silver foil (para 0085).
29. Regarding Claim 8, Jeffrey teaches the silver foil is coated with silver chloride (para 0085).
30. Regarding Claim 14, Jeffrey fails to teach the height of the conductive trace from the top surface of the base layer is about 30 nm or less.
Lieber teaches a system of analogous art (Fig. 1A and 1B; para 0004), wherein the system comprises a conductive trace that has a height of less than about 50 nm (para 0113, “define or register the electrode, electrical connector, conductive pathway… etc. … the thickness of one of these may be… less than about 20 nm”). It would have been an obvious matter of design choice to have the height of the conductive trace be less than about20 nm, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
31. Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey and Lieber, and further in view of Gleich U.S. 2023/0037474 (herein referred to as “Gleich”).
32. Regarding Claim 9, Jeffrey fails to teach the carrier system includes a plurality of sensor mounts, each sensor mount being configured to engage a corresponding locking mount to secure the distal end of a lead assembly relative to the support structure.
Gleich teaches a system of analogous art (Figs. 1 and 2), wherein the system comprises a carrier system (Fig. 1, ref num 12) that includes a plurality of sensor mounts (Fig. 2, ref num 26; para 0025), such that each sensor mount being configured to engage a corresponding locking mount to secure a distal end of the lead assembly relative to the support structure (para 0026). This allows for adaptation to the user’s head in order to bring the sensors into contact for measuring the desired signals (para 0025-0026). 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 modified Jeffrey to include a carrier system with a plurality of mounts to secure the lead assembly to the support structure.
33. Regarding Claim 10, Jeffrey fails to teach the carrier assembly includes at least 128 sensor mounts.
Gleich teaches the carrier assembly includes at least 128 sensor mounts (para 0024, “The HD EEG net 12 may include 64, 128, or 256 EEG electrodes and hence EEG electrode channels”). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have at least 128 sensor mounts, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
34. Regarding Claim 11, Jeffrey fails to teach the carrier assembly includes at least 256 sensor mounts, and the at least one lead assembly includes 128 lead systems.
Gleich teaches the carrier assembly includes at least 256 sensor mounts and 128 lead systems (para 0024, “The HD EEG net 12 may include 64, 128, or 256 EEG electrodes and hence EEG electrode channels”; it is understood that the amount of lead system would be at least the amount of sensor mounts)(. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the desired number of sensor mounts and lead systems, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
35. Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jeffrey and in view of O’Neill U.S. 2015/0141791 (herein referred to as “O’Neill’”).
36. Regarding Claim 16, Jeffrey teaches the electrode includes silver coupled to the conductive trace through a conductive adhesive.
O’Neill teaches a system of analogous art (Fig. 2), wherein the system includes an electrode that has silver coupled to a conductive trace through a conductive adhesive (abstract, “The electrode may comprise a silver or other electrically conductive layer disposed on the electrically conductive trace and an electrolyte layer or other adhesive layer, such as a silver chloride-based electrolyte layer, disposed on the silver or other electrically conductive layer”; para 0033). This facilitates electrical contact with the target region (para 0033). 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 modified Jeffrey to have the silver coupled to the conductive tract through a conductive adhesive as this promotes electrical contact with the target tissue.
37. Regarding Claim 17, Jeffrey teaches the adhesive includes a carbon-based conductive glue (para 0126, “flexible substrate 511 (e.g. formed of a material such as polyethylene) may form the base onto which the electrodes and any circuit elements are printed and/or attached, glued, adhered, silk-screened, etc.”).
Conclusion
38. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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