DETAILED ACTION
Notice of 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 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.
Status of the Claims
Claims 1-4 and 7-11 are pending.
Claims 5-6 are canceled.
Claims 1, 3 and 8 are independent.
Claims 1-4, 7-8 and 10-11 are objected to.
Claims 1-2 and 11 are rejected.
Claims 3-4 and 7-10 are allowable but for objections.
Withdrawal Objections and Rejections
Applicant's response, filed 11/25/2025, has been fully considered.
In view of the amendment and remarks from 11/25/2025, these rejections are withdrawn:
all previous 35 USC § 112(b) rejections, however new rejections are applied;
claims 1-6 under 35 U.S.C. § 101 as further discussed below and
claims 1-6 under 35 U.S.C. § 102 as further discussed below.
The following rejections and/or objections are either maintained or newly applied for claims 1-4 and 7-11. They constitute the complete set applied to the instant application. Herein, "the previous Office action" refers to the Non-Final Rejection of 06/02/2025.
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 101
The Amendments and Remarks of 11/25/2025 are persuasive regarding 101 for the reasons below:
Referring to the 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 1st consideration relating to an improvement over the previous state of the technology field integrating possible judicial exceptions into a practical application (MPEP 2106.04(d) and (d)(1)). The instant improvement is to the operation of the recited voltage clamp data simulations that generate electrophysiology data sets for a channel exhibiting activation and inactivation, wherein the improvement in this instance comprises the inversion procedure having been extended to process the data produced by the recited voltage clamp protocols in a manner to recover the gating parameters from an inversion of the Hodgkin-Huxley formalism. Said limitations integrate any judicial exceptions into a practical application (decrease the duration of the application of voltage to the cell membrane voltage at large depolarization potential, which is damaging to the cells) and improve the operation of the voltage clamp technique at Step 2A, Prong 2 analogous to the reasoning in MPEP-cited case law including Enfish, BASCOM and McRO (MPEP 2106.04(d) and (d)(1)). In this regard, Applicant's 11/25/2025 remarks at pg. 12 para. 3 and pg. 13 para. 2-3 further support withdrawal of the rejection.
Additionally, referring to 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 4th consideration transformation or reduction of a particular article to a different state or thing that affect the real world, as discussed in MPEP § 2106.05(c). The instant transformation is in the judicial elements output (voltage clamp protocols and data originated from such) which feed into the control of the recited "cell". In this regard, Applicant's 11/25/2025 remarks at pg. 12 para. 2 further support withdrawal of the rejection.
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 102
No prior art is applied to the following claims. Claims 1-4 and 7-11 are free of the analogous art at least because close art, e.g. Willms and Jackson on the 06/02/2025 form 892, as cited in the now withdrawn art rejections as well as art found on the IDSs and in the search histories, either individually or in obvious combination, does not teach the claim 1 recited combination of "voltage clamp data simulations" that generate data sets for channel exhibiting activation and inactivation, in a manner to recover the gating parameters from an inversion of the Hodgkin-Huxley formalism." Independent claims 1, 3 and 8 recite similar limitations and also are free of the art. Additionally, Applicant's 11/25/2025 remarks at p. 22 para. 3-5 support withdrawal of the rejection.
Priority
This application is a CON of Application No. 16/255,180 (01/23/2019), which claims priority from US Application No. 14/689,653 (04/17/2015), which claims priority from provisional US Application No. 61/981,000 (04/17/2014) as reflected in the filing receipt mailed on 01/12/2023. As detailed on the 01/12/2023 filing receipt, the application claims priority as early as 04/17/2014. The claims to the benefit of priority are acknowledged. Claim 2 recites
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60
744
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, not found in provisional application 61/981,000. Claims 7 recites evaluating
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42
463
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, not found in provisional application 61/981,000. Claim 11 recites
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79
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144
484
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and
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541
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not found in provisional application 61/981,000. Claims 2, 7 and 11 are interpreted as being according the priority date of the 371 of PCT application US Application No. 14/689,653 (04/17/2015). The effective filing date of claims 1, 3-4 and 8-10 is 04/17/2014.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code [0263, 0267, 0271 and 0274]. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim interpretation
The following claim interpretations apply to all instances of the following terms throughout all claims. Dependent claims, if comprising similar recitation, are interpreted similarly, unless otherwise noted below.
112(f) interpretation of particular recitations
Recited instances of "voltage clamp stimulation protocol" (claims 1, 3 and 8) – first "providing" recitation
The above recitations include means (or an equivalent, nonce term, here "protocol") and function and/or result (here "voltage clamp stimulation").
The above recitations are not sufficiently well-known and not accompanied by sufficient structure to prevent invoking. Therefore, each is interpreted as invoking.
Having invoked, each above recitation has been analyzed as clearly linking to sufficient structure in the specification, as supported at ([119]). Thus, the above recitations have been interpreted as properly invoking 112(f).
Recited instances of "inversion process" (claims 1, 3 and 8) – first "providing" recitation
The above recitations include means (or an equivalent, nonce term, here "process") and function and/or result (here "inversion").
The above recitations are not sufficiently well-known and not accompanied by sufficient structure to prevent invoking. Therefore, each is interpreted as invoking.
Having invoked, each above recitation has been analyzed as clearly linking to sufficient structure in the specification, as supported at ([69-108]). Thus, the above recitations have been interpreted as properly invoking 112(f).
Recited instances of "electrophysiology apparatus" (claims 1, 3 and 8) – first "providing" recitation
The above recitations include means (or an equivalent, nonce term, here "apparatus") and function and/or result (here "electrophysiology").
The above recitation is not sufficiently well-known and not accompanied by sufficient structure to prevent invoking. Therefore, it is interpreted as invoking.
Having invoked, the above recitation has been analyzed as clearly linking to the specification at ([194]). However, that linked disclosure is insufficient to satisfy 112(f), and a corresponding 112(b) rejection applies below.
Recited instances of "T-step protocol" (claims 1 and 3) – second "providing" recitation
The above recitations include means (or an equivalent, nonce term, here "protocol") and function and/or result (here "T-step").
The above recitation is not sufficiently well-known and not accompanied by sufficient structure to prevent invoking. Therefore, it is interpreted as invoking.
Having invoked, the above recitation has been analyzed as clearly linking to the specification at ([00193]).
However, that linked disclosure is insufficient to satisfy 112(f), and corresponding 112(b) rejection apply below.
Regarding recitations above interpreted as invoking 112(f)
If applicant does not intend to have interpreted under 112(f), applicant may: (1) amend to avoid them being interpreted under 112(f) (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 112(f).
Product-by-process (PbP) claim interpretation
The recited instances of "providing … gating variables from previously [run] H-step and C-step protocols" are interpreted as product-by-process elements, i.e. the recited "gating variables" limited according to any structure clearly required by the recited product-by-process limitation of having been "previously [run] H-step and C-step protocols." The recited process or step of having been "previously [run] H-step and C-step protocols" is not itself claimed and is limiting only to the extent that the structure of the "gating variables" is clearly required to be limited by that process or step. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential). A related 112b rejection applies below.
Claim objections
Claims 1-4, 7-8 and 10-11 are objected to because of the following informalities. Appropriate correction is required. With regard to any suggested amendment below to overcome an objection, in the subsequent examination it is assumed that each amendment is made. However, equivalent amendments also would be acceptable. Any amendments in response to the following objections should be applied throughout the claims, as appropriate.
Claim 1, in the 2nd "providing" step, recites a second "providing" followed by "ran" which should read "run." The same applies for all other instances of "ran" in any claims (e.g. claims 3-4 and 8).
In claim 1, the last step recites inconsistent indentation. The last two lines should be further indented.
Claim 2, in the second line, recites "gap currents... obtained," which needs a space before "obtained."
Claim 7, in the main list of steps "...estimating...; and applying...; and applying..., wherein...," recites "and" twice in the same list when only once is proper.
In claim 10 the comma after "… duration vg" should be replaced by a semi-colon.
Claim 11 recites "...hold, and are used..." which is an improper comma, e.g. "X and Y" not "X, and Y."
Claim Rejections - 35 USC § 112(b)
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.
Claims 1-2 and 11 are rejected under 35 U.S.C. 112(b)as being indefinite for failing to particularly point out and distinctly claim the subject matter the invention. Dependent claims are rejected similarly, unless otherwise noted below. The following issues cause the respective claims to be rejected under 112(b) as indefinite:
Claim 1 recites improper/inconsistent use of commas vs. semi-colons. Also, as set forth in 37 CPR 1.75, where a claim sets forth a plurality of steps, each step of the claim should be separated by a line indentation (see MPEP 608.0l(i)).
Claim 1, in the 2nd "providing" step, recites an errant period. The claim recites "…T-step protocol. applying the voltage difference …" which renders the claim indefinite because it is unclear if the claim ends at " … T-step protocol." or if "… applying the voltage difference … " is part of claim 1. To overcome this rejection the claim may be amended to read "…T-step protocol; applying the voltage difference …" with the recited "applying the voltage difference … " in a new line.
Claim 1 is indefinite because, based on the above product-by-process interpretation, it is not clear how or to what extent the recited process steps, e.g. "...previously [run] H-step and C-step protocols...," must limit the structure of the recited "gating variables." This rejection might be overcome by, for example, amending to clarify or to eliminate the product-by-process interpretation.
In claim 2, 4th line, the recited "the end of the conditioning pulse" twice requires but lacks clear antecedent. Either antecedent may be identified, or possibly "the" should read "an" or "a" in each instance.
In claim 2, in the "wherein yc(i) and sG(i)..." clause, the relationship is unclear between the recited "an inversion" and the claim 1 recited "an inversion process" (1st "providing" step).
In claim 11:
The recited "estimating as if..." is not interpretable.
The recited "...were acquired..." also renders the claim indefinite as not interpretable.
The recited "...protocol where in such condition the algebraic relations..." also renders the claim indefinite as not interpretable. Similarly, the recited "...the inversion hold, and are used..." also renders the claim indefinite as not interpretable.
The recited "...evaluate at any of..." also renders the claim indefinite as not interpretable.
The recited "...at the test voltage uT and sR(i), is s(i)(u) evaluated at a reference..." also renders the claim indefinite as not interpretable at least due to unclear punctuation and improper subject-verb agreement.
The recited "...wherein... is the steady state and time constant of gating variable i at..." also renders the claim indefinite as not interpretable at least due to unclear punctuation and improper subject-verb agreement.
The recited "...wherein... is corresponding normalized test current derivative..." also renders the claim indefinite as not interpretable at least due to unclear punctuation and improper subject-verb agreement.
In the recited "...wherein the process returns...," the recited "the process" requires but lacks clear antecedent.
In claim 11, the relationships among the listed main steps are unclear at least for lack of a conjunction before the last listed step, i.e. before "adapting..." Possibly "and" should precede the last step.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCINI A FONSECA LOPEZ whose telephone number is (571)270-0899. The examiner can normally be reached Monday - Friday 8AM - 5PM ET.
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/F.F.L./Examiner, Art Unit 1685
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686