DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-2, 4-6, 8, 10, 12, 15-17, 19, 28, 30-31, 33-34, 43, 47, 90 are pending.
This action is Non-Final.
Election/Restrictions
Applicant’s election of Group I in the reply filed on 11/25/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Claims 30-31, 33-34, 43, 47, 90 are withdrawn from further consideration.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. Specifically, “References (1) and (2)” discussed in paragraphs 4 and 62-63 were not cited on any of the IDS submitted, nor were copies of the documents submitted. It is noted each of these documents is incorporated by reference. Applicant is reminded of Rule 1.56.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figures 2-4 have numerous elements in brackets which are not explained in the disclosure. These are likely all unnecessary elements that should be deleted from the Figures. Figure 4 also includes a “1.” and “2.” these are not discussed in the specification, and these element numerals are already in use in Figure 1. If applicant is keeping such in Figure 4 then new notation should be used and also added to the specification. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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. 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.
Specification
The disclosure is objected to because of the following informalities: The drawing elements and specification elements are not in agreement, see Drawing Objections above.
Appropriate correction is required.
The use of the terms Wi-Fi, Bluetooth, IEEE, which each is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Not an objection, but there is an issue in the PGPub paragraph 14 missing -about “5”-. This is not an objection because the as filed specification is correct. This is merely for the record and applicant awareness to look for this typographical Office sourced error in printing should the application be issued at some point in time.
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 1-2, 4-6, 8, 10, 12, 15-17, 19, 28 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 claim 1, the limitations “the device comprising a size and a shape configured to be positioned wholly below a scalp and to extend at least partly within the bone of the skull without penetrating an interior of the bone of the skull” renders the claim indefinite. While the reference to the bone is mere intended sizing, the defining features do not make sense. How can the size and shape be within bone without penetrating an interior of the bone? Seems like these are opposites. Potentially, applicant means without penetrating through the entire bone? For these reasons the metes and bounds of the claim are unclear which renders the claim indefinite.
Regarding claim 2, the limitation “The intra-osseous device of Claim 1, comprising at least one of an electrical brain activity recording electrode and an electrical brain stimulation electrode” (emphasis added) render the claim indefinite as being inconsistent with the disclosure as filed, MPEP 2173.03:
A claim, although clear on its face, may also be indefinite when a conflict or inconsistency between the claimed subject matter and the specification disclosure renders the scope of the claim uncertain as inconsistency with the specification disclosure or prior art teachings may make an otherwise definite claim take on an unreasonable degree of uncertainty. In re Moore, 439 F.2d 1232, 1235-36, 169 USPQ 236, 239 (CCPA 1971); In re Cohn, 438 F.2d 989, 169 USPQ 95 (CCPA 1971); In re Hammack, 427 F.2d 1378, 166 USPQ 204 (CCPA 1970). For example, a claim with a limitation of “the clamp means including a clamp body and first and second clamping members, the clamping members being supported by the clamp body” was determined to be indefinite because the terms “first and second clamping members” and “clamp body” were found to be vague in light of the specification which showed no “clamp member” structure being “supported by the clamp body.” In re Anderson, 1997 U.S. App. Lexis 167 (Fed. Cir. January 6, 1997) (unpublished). In Cohn, a claim was directed to a process of treating an aluminum surface with an alkali silicate solution and included a further limitation that the surface has an “opaque” appearance. Id. The specification, meanwhile, associated the use of an alkali silicate with a glazed or porcelain-like finish, which the specification distinguished from an opaque finish. Cohn, 438 F.2d at 993, 169 USPQ at 98. Noting that no claim may be read apart from and independent of the supporting disclosure on which it is based, the court found that the claim was internally inconsistent based on the description, definitions and examples set forth in the specification relating to the appearance of the surface after treatment, and therefore indefinite. Id. In addition, inconsistencies in the meaning of terms or phrases between claims may render the scope of the claims to be uncertain. Tvngo Ltd. (BVI) v. LG Elecs. Inc., 861 Fed. Appx. 453, 459-60, 2021 USPQ2d 697 (Fed. Cir. 2021) ("The issue is not breadth of the dependent claims but their use of the disputed phrase in a way that contradicts the independent claims. The dependent claims state that 'said overlay activation criterion includes . . . a user command information,' which conflicts with the independent claim's use of this same phrase."). "When faced with this unknown and undefined phrase, a skilled artisan would look for clarification not only in the specification but also in '[o]ther claims of the patent in question,' which 'can also be valuable sources of enlightenment as to the meaning of a claim term.'" Id. at 460 (quoting Philips v. AWH Corp., 415 F.3d 1303, 1314, 75 USPQ2d 1321, 1327 (Fed. Cir. 2005)).
Claim 1 sets forth “an electrical conductor comprising an electrical contact surface configured to at least one of sense electrical signals from the brain and electrically stimulate the brain”. It is not clear how the electrical contact surface and the electrode can co-exist as separate structures since the contact surface is disclosed as the structure achieving the claimed functions [0038].
It appears “electrode” is used in the disclosure to describe the overall function of a “craniode” (“For example, the craniode 205 can be an electrical brain stimulation electrode.”). However, as set forth in the claims, the inclusion of a separate structure from the contact surface is not consistent with the disclosure as filed thus making the metes and bounds of the claim unclear. For examination purposes, claim 2 electrode is interpreted as reading on the same electrical contact surface as set forth in claim 1.
The term “about” in claim 8 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. Perhaps simply deleting about .
The dependent claims are rejected for depending on a rejected claim.
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 1-2, 4-6, 8, 10, 12, 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gribetz et al. (Gribetz, US 2020/0330749).
Regarding claim 1, Gribetz teaches an intra-osseous device configured to at least one of sense electrical signals from a brain and electrically stimulate the brain (see at least abstract), the device comprising:
an electrical conductor comprising an electrical contact surface configured to at least one of sense electrical signals from the brain and electrically stimulate the brain (see at least abstract, Figures 3 13A-C; Figure 4 23A-B; Figure 5 33A-C, Figure 6 43; Figure 8 53; Figure 10 73; Figure 12 83; Figure 13 9; Figure 14E 120; Figure 21 83);
at least a portion of a body of the device, comprising the electrical conductor, being configured to extend within a bone of a skull (see at least Figures 3-6, 8, 10, 12-13, 14E, 21); and
the device comprising a size and a shape configured to be positioned wholly below a scalp and to extend at least partly within the bone of the skull without penetrating an interior of the bone of the skull (see at least abstract, Figures 3-6, 8, 10, 12-13, 14E, 21, [0146], [0190]-[0191]).
Regarding claim 2, Gribetz teaches at least one of an electrical brain activity recording electrode and an electrical brain stimulation electrode (see at least abstract, Figures 3 13A-C; Figure 4 23A-B; Figure 5 33A-C, Figure 6 43; Figure 8 53; Figure 10 73; Figure 12 83; Figure 13 9; Figure 14E 120; Figure 21 83).
Regarding claim 4, Gribetz teaches the device being electrically coupled to a sub-scalp cable (intended use, see at least Figure 3 12A-C; [0135]).
Regarding claim 5, Gribetz teaches an electrical attachment feature configured to electrically connect the electrical conductor to a sub-scalp cable (cable claimed in inference; see at least [0135] The ICI 10 may have three electrically conducting electrodes 13A, 13B and 13C suitably attached at the ends of the elongated members 11E, 11F and 11F, respectively.).
Regarding claim 6, Gribetz teaches a wireless communications device configured to at least one of transmit and receive wireless signals (see at least Figures 15-18 telemetry module/unit).
Regarding claim 8, Gribetz teaches wherein the size and shape comprises at least one of a diameter of the device of between about 0.5 millimeters and about 5 millimeters, and a height of the device of between about 2 millimeters and about 6 millimeters (see at least [0179] where a diameter of the device components includes features 1-4mm which reasonably teaches the broad scope being claimed; it is also noted that it is taught the size and dimensions can be anything that is desired [0150], [0192], [0202]).
Regarding claim 10, Gribetz teaches wherein the portion of the body of the device comprises either a threaded feature configured to secure the device within the bone of the skull, or a peg configured to extend within the bone of the skull (see at least Figures 3-5, 10, 12-13).
Regarding claim 12, Gribetz teaches wherein the electrical conductor comprises a bottom electrical contact surface of the device configured to reside within the bone of the skull (see at least abstract, Figures 3 13A-C; Figure 4 23A-B; Figure 5 33A-C, Figure 6 43; Figure 8 53; Figure 10 73; Figure 12 83; Figure 13 9; Figure 14E 120; Figure 21 83).
Regarding claim 15, Gribetz teaches the electrical conductor comprises a top portion, a bottom portion and a shaft portion extending between the top and bottom portions, the bottom portion defining the electrical contact surface; an electrically insulating material clad about the top portion and the shaft portion of the electrical conductor; the top portion of the electrical conductor configured to be positioned wholly below the scalp (see at least abstract, Figures 3-4, 10 where bottom has the contact, top is anywhere located near the top, and shaft is any portion between what is considered a top portion and bottom portion, where insulation is on 12, 22, 72), said top portion configured to be electrically coupled to the sub-scalp cable (further limits inference, but the insulating portions at the top most are interpreted as this structure, and/or cable used in basic circuit design as in Figures 15-17 such as in lead selection in stimulation and sensing designated circuit lines); the shaft portion and the bottom portion of the electrical conductor configured to be positioned into a hole extending into the bone of the skull, such that the electrical contact surface is positioned within the bone of the skull to sense brain activity from an intra-osseous space (see at least abstract, Figures 3-4, 10).
Claims 1, 5, 15-16, 28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Russell (US 2008/0312716).
Regarding claim 1, Russell teaches an intra-osseous device configured to at least one of sense electrical signals from a brain and electrically stimulate the brain (see at least abstract, [0065]), the device comprising:
an electrical conductor comprising an electrical contact surface configured to at least one of sense electrical signals from the brain and electrically stimulate the brain (see at least abstract, Figures 1-2, 7-10, element 50);
at least a portion of a body of the device, comprising the electrical conductor, being configured to extend within a bone of a skull (see at least abstract, Figures 1-2, 7-10); and
the device comprising a size and a shape configured to be positioned wholly below a scalp and to extend at least partly within the bone of the skull without penetrating an interior of the bone of the skull (see at least abstract, Figures 1-2, 7-10).
Regarding claim 5, Russell teaches an electrical attachment feature configured to electrically connect the electrical conductor to a sub-scalp cable (see at least [0040] cable is claimed as inference).
Regarding claim 15, Russell teaches wherein: the electrical conductor comprises a top portion, a bottom portion and a shaft portion extending between the top and bottom portions, the bottom portion defining the electrical contact surface (see at least Figures 8-10); an electrically insulating material clad about the top portion and the shaft portion of the electrical conductor (see at least Figures 8-10 130); the top portion of the electrical conductor configured to be positioned wholly below the scalp, said top portion configured to be electrically coupled to the sub-scalp cable (see at least Figures 8-10, further limiting inference cable but also taught connection to 70); the shaft portion and the bottom portion of the electrical conductor configured to be positioned into a hole extending into the bone of the skull, such that the electrical contact surface is positioned within the bone of the skull to sense brain activity from an intra-osseous space (see at least Figures 1, 8-10, [0065]).
Regarding claim 16, Russell teaches a surgical metal bone screw, wherein the top portion of the electrical conductor is a head with cross-drive grooves, the shaft portion of the electrical conductor is threaded and is coated with the electrically insulating material, and the bottom portion is an uninsulated tip defining the electrical contact surface (see at least Figures 8-10, [0039]).
Regarding claim 28, Russell teaches comprising the electrical attachment feature configured to electrically connect the electrical conductor to the sub-scalp cable, the electrical attachment feature comprising an elastic flap under which a portion of the sub-scalp cable can be inserted to make electrical connection with the electrical conductor (see at least [0040] interpreted as snap mechanisms).
Allowable Subject Matter
Claims 17, 19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The art of record teaches related systems and methods to the features claimed, but fails to teach, suggest, or make reasonably obvious the claimed features of claims 17 including wherein the cross-drive head is coated with the electrically insulating material except for an inner surface of the cross-drive grooves, and wherein the cross-drive grooves are adapted to receive an electrical contact portion of the sub-scalp cable, in view of the requirements of claims 16, 15, 5, and 1, when considered together and as a whole. Claim 19 depends on claim 17 and is allowed for the same reasons as claim 17.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 8057519 and US 2020/0022739 teaches bone screws with attachable rods near the threads; US 2009/0112280 teaches related sensing systems and techniques to the claimed features.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791