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 .
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.
Election/Restrictions
Applicant's election with traverse of Invention II, drawn to a method to extract biological material from a tissue of a subject 10-14 in the reply filed on 12/19/25 is acknowledged. The traversal is on the ground(s) that there would be no undue burden to examine all the different inventions. This is not found persuasive because the inventions or groupings of patentably indistinct inventions have acquired a separate status in the art in view of their different classification; the inventions or groupings of patentably indistinct inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or the inventions or groupings of patentably indistinct inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different field of search strategies or search queries).
The requirement is still deemed proper and is therefore made FINAL.
Claim(s) 1-9 and 15-20 is/are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12/19/25.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Claim Objections
Claim 10 is objected to because of the following informalities: the claim is missing punctuation.
Claim 13 is objected to because of the following informalities: “extended” (line 1) appears that it should be “extend.”
Appropriate correction is required.
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.
Claim(s) 10-14 is/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.
For claim 10, the claim language “wherein one or more computational models are used to guide parameter selection to guide treatment and extraction parameters” does not appear to be 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of guiding parameter selection to guide treatment and extraction parameters, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Dependent claim(s) 11-14 fail to cure the deficiencies of independent claim 10, thus claim(s) 10-14 is/are rejected under 35 U.S.C. 112(a).
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.
Claim(s) 10-14 is/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.
For claim 10, the claim term “the side hole profile” (line 5) lacks antecedent basis. The claim is examined as this being a newly introduced claim term.
For claim 10, the claim language “optionally providing the extracted at least one cellular component to standard clinical diagnostic or biomedical research workflows” is ambiguous. It is unclear how this claim language limits the scope of the claim when it is just optional. The claim is examined as not being a requirement for the claim to be anticipated.
For claim 10, the claim language “standard clinical diagnostic or biomedical research workflows” is ambiguous. It is unclear what the scope of “standard” clinical diagnostic or biomedical research workflows versus non-standard. The claim is examined as meaning “clinical diagnostic or biomedical research workflows.”
For claim 13, the claim language “wherein the inner needle is configured to extend outwardly relative to the inner needle” is ambiguous. It is unclear how an inner needle is configured to extend outwardly relative to itself. The claim is examined as meaning that the inner needle is configured to extend outwardly relative to the outer needle.
Dependent claim(s) 11-14 fail to cure the ambiguity of independent claim 10, thus claim(s) 10-14 is/are rejected under 35 U.S.C. 112(b).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 10-11 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2022/0362548 to Goldberg et al. (hereinafter “Goldberg”) in view of U.S. Patent Application Publication No. 2019/0388073 to Larson et al. (hereinafter “Larson”) and U.S. Patent Application Publication No. 2019/0351224 to Sano et al. (hereinafter “Sano”).
For claim 10, Goldberg discloses a method to extract biological material from a tissue of a subject (Abstract), said method comprising:
placing at least one electrode (“electroporation-electrode,” para [0006]) with said tissue (para [0006]), wherein said electrode comprises one or more hole/opening at the end in contact with said tissue (see “opening” in Fig. 8) (also see para [0019]);
applying pulsed electric field via said at least one electrode to thereby induce permeabilization, hyperthermia, and/or other biophysical response of cells of said tissue (para [0006]) and release of at least one cellular component therefrom to an interstitial space (para [0006]); and
extracting said at least one cellular component from said interstitial space (para [0006]) and optionally providing the extracted at least one cellular component to standard clinical diagnostic or biomedical research workflows (Examiner’s Note: see 112(b) above) (alternatively, see para [0006]).
Goldberg does not expressly disclose an insulating sleeve that can be adjusted to alter the side hole profile.
However, Larson teaches an insulating (para [0152]) sleeve (105) (Figs. 1A and 1C) (para [0105]) that can be adjusted to alter the side hole profile (102) (Figs. 1A and 1C) (para [0105]).
It would have been obvious to a skilled artisan to modify Goldberg to include an insulating sleeve that can be adjusted to alter the side hole profile, in view of the teachings of Larson, as an additional means or an alternative means to acquire a sample from a patient.
Goldberg and Larson do not expressly disclose wherein one or more computational models are used to guide parameter selection to guide treatment and extraction parameters.
However, Sano teaches wherein one or more computational models are used to guide parameter selection to guide treatment and extraction parameters (para [0011] and [0221]) (also see Figs. 50A-B and 53A-B and para [106]-[0107] and [0118]) (additionally, see para [0148]) (moreover, see Abstract for an overview of the function of these models) (Examiner’s Note: para [0175]-[0182] provide examples of these models).
It would have been obvious to a skilled artisan to modify Goldberg wherein one or more computational models are used to guide parameter selection to guide treatment and extraction parameters, in view of the teachings of Sano, for the obvious advantage of being able of fine tune the surgical procedure prior to beginning the method.
For claim 11, Goldberg further discloses wherein the at least one electrode comprises a needle of a device (as can be seen in Fig. 8) (also see para [0019]).
For claim 14, Goldberg further discloses wherein the needle is adapted for aspiration (see “vacuum” in Fig. 8).
Claim(s) 12-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Larson and Sano, and further in view of U.S. Patent Application Publication No. 2014/0163414 to Lee et al. (hereinafter “Lee”).
For claim 12, Goldberg, Larson, and Sano do not expressly disclose wherein the needle is an inner needle and the device further comprises an outer needle at least partially encompassing the inner needle.
However, Lee teaches wherein a needle is an inner needle (620) and a device further comprises an outer needle (620) at least partially encompassing the inner needle (Figs. 9a-b) (para [0182]).
It would have been obvious to a skilled artisan to modify Goldberg wherein the needle is an inner needle and the device further comprises an outer needle at least partially encompassing the inner needle, in view of the teachings of Lee, for the obvious advantage of providing dual functionality with the two needles.
For claim 13, Goldberg, Larson, and Sano do not expressly disclose wherein the inner needle is configured to extend outwardly relative to the inner needle.
However, Lee teaches wherein the inner needle is configured to extend outwardly relative to the inner needle (Figs. 9a-b) (para [0182]).
It would have been obvious to a skilled artisan to modify Goldberg wherein the inner needle is configured to extend outwardly relative to the inner needle, in view of the teachings of Lee, for the obvious advantage of providing dual functionality with the two needles.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791