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 .
DETAILED ACTION
Election/Restriction
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-14, drawn to a method for fabricating, classified in A61B 2562/125.
II. Claims 15-18, drawn to a multilayer biologic apparatus, classified in G01N 33/5438.
III. Claims 19-20, drawn to a method for determining the viability of living cells, classified in A61B 5/4848.
The inventions are independent or distinct, each from the other because:
Inventions [I,III] and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the process of [I] can be practiced by another materially different apparatus such as one involving first, second, and third composite layers in a particular design, or in one not involving a tissue layer, and the process of [III] can be practiced by another and materially different apparatus such as one involving a multilayer electrode biologic sensor and means for measuring electrical cellular impedance spectroscopy.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
--the inventions have acquired a separate status in the art in view of their different classification;
--the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
--the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries).
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
During a telephone conversation with Kurt McWilliams on November 12th, 2025 a provisional election was made without traverse to prosecute the invention of II, claims 15-18. Affirmation of this election must be made by applicant in replying to this Office action. Claims 1-14, 19, and 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Request for Information under 37 CFR 1.105
No IDS was filed for this application. The applicant and/or the assignee of this application are required under 37 CFR 1.105 to provide the following information that the examiner has determined is reasonably necessary to the examination of this application (see MPEP §§ 704.10 - 704.13). In response to this requirement, please provide a copy of any related and pertinent information, such as non-patent literature, published application(s) or patent(s) (U.S. or foreign), that was used to assist in the drafting of this application. The applicant is reminded of the duty to disclose information that is material to patentability (see 37 CFR § 1.56). A complete reply to the instant Office action must include a complete reply to this requirement. The time period for reply to this requirement coincides with the time period for reply to the instant Office action.
Claim Objections
Claims 16 and 17 are objected to because of the following informalities: Claims 16 and 17 are recited to depend from claim 14, which is drawn to a separate independent method of manufacturing, and it appears that Applicant intends to provide dependency to claim 15, which is drawn to the apparatus. Appropriate correction is required. For purposes of Examination, claims 16 and 17 are construed to depend form claim 15.
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 15-18 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.
The metes and bounds of the sought arrangement to the multilayer biologic apparatus are indefinitely defined as the present recitation amounts to a parts listing of three elements involved in that of a sterilizable support matrix, a tissue layer, and a conductive layer without correlations/provisions to their relative arrangement to one another so as to form the sought embodiment.
Further to this end, while the preamble calls for a multilayer biologic apparatus, the listing of the parts as recited herein does not provide a relatively arranged and multi-layered device. The nominal descriptors of “layer” to the tissue layer and conductive layer do not suffice to arrange these elements in a layered fashion (let alone with respect to the arrangement relative to the support matrix) as may be intended by Applicant.
It is also noted that while the preamble sets forth an intended functionality of “toxicity screening…” the positively claimed elements in the body of the claim are without individual and/or collective functionality so as to particularly realize this provision in the preamble. To this end, prior art that provides to disclose the positively recited structural elements of the claim will be said to be fully capable of such functionality in as much as claimed and required herein.
Clarification is required.
Claim Rejections - 35 USC § 102
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.
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.
Claim(s) 15, 17, and 18 as best understood, is/are rejected under 35 U.S.C. 102a1 as being anticipated by Martin et al. (US 2007/0060815), hereafter Martin.
Martin discloses biologically integrated electrode devices (abstract). With regard to claim 15, Martin discloses a multilayer biologic apparatus as claimed comprising a sterilizable support matrix (the living tissue that provides both a nutritive and physically supportive environment wherein living tissue is fully capable of being sterilized; see par.[0058], a tissue layer (biocompatible hydrogel 120, seeded with living cells 110 as in cl. 17), and a conductive layer (i.e. conductive polymers patterned on the substate surface/electrode conductive substrate or conductive polymer network 130) (pars.[0021,0024,0058,0145], figs.5,7, for example). With regard to claim 18, Martin discloses that the hydrogel tissue layer is a polyethylene glycol (par.[0059]). Further, as Martin likewise disclose a polyethylene glycol to the hydrogel, this likewise material is said to have a gel melt(set) temperature of greater than 40C in as much as claimed and required herein.
See also MPEP 2112.01, II
“Products of identical chemical composition can not have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. “The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada’s polymer latexes for lack of novelty.”).
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 16, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Martin in view of Okabe et al. (USPN 5,611,339), hereafter Okabe.
Martin has been discussed above.
Martin does not specifically disclose that the sterilizable support matrix is one of a polyester, a glass, a polyethylene, a polycarbonate, or combinations thereof.
Okabe discloses a printed electrode with hydrophilic gel for biological use wherein the support is one of a polyester, polyethylene, and polycarbonate (line 62, col. 2 – line 17, col. 3; lines 35-39, col. 3, for example).
It would have been obvious to one of ordinary skill in the art to modify Martin so as to provide a support matrix as one of a polyester, polyethylene, or polycarbonate such as suggested by the analogous prior art of Okabe to biological electrodes in order to provide a compatible, both mechanically and biologically, for application to a biological electrode to be used in-vitro as an analogous application to the in-vivo implementation provided in Martin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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, Jill Warden can be reached at 571 272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEIL N TURK/Primary Examiner, Art Unit 1798