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 .
Election/Restrictions
Applicant's election with traverse of Group I:Claims 1-10 and 13-20 in the reply filed on 08 JUNE 2026 is acknowledged. The traversal is on the ground(s) that the “election is made with traverse because claims 11 and 12, as amended, each depend from claim 1.
Status of Claims
In the claim set submitted on 08 JUNE 2026, Applicant has amended claims 11 and 12 to depend from Claim 1.
While Group I was elected, Group I now consists of all claims presented in the claim set, filed on 08 JUNE 2026.
Current pending claims are Claims 1-20 and are considered on the merits below.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11 DECEMBER 2023 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification/Abstract
The abstract of the disclosure is objected to because the abstract includes the phrase "preferably" renders the abstract indefinite because it is unclear whether the limitation(s) following the phrase are part of the invention. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A ‘multiplex device for combining…a compound from a plurality of test compounds…’ in claim 2 and 4.
A ‘device’ does not connote any particular structure. The specification describes the ‘multiplex device’ is a plate reader.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim 1 is 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.
In Claim 1, in the instance of ‘the critical temperature’ lack
Claim 1 recites the limitation "the critical temperature". There is insufficient antecedent basis for this limitation in the claim. In this instance it should be "a critical temperature".
Claim 1 recites the limitation "the temperature" in step b. There is insufficient antecedent basis for this limitation in the claim. It is interpreted by the Examiner that ‘the temperature’ mentioned in step b is different than the critical temperature.
Claim 1 recites the limitation "the solution" in step b. There is insufficient antecedent basis for this limitation in the claim. It is not clear ‘a solution’ is positively claimed in the previous step.
Claim 1 recites the limitation "the condensation propensity". There is insufficient antecedent basis for this limitation in the claim.
The term “significantly” in claim 1, 2, 3, and 4 is a relative term which renders the claim indefinite. The term “significantly” 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.
In Claim 2 and 4, in step b, it recites ‘of a)’ ; however it is unclear if ‘a)’ refers to step a) in claim 1 or a) above in claim 2 or 4, respectively. This is also mentioned in step c.
In Claim 2 and 4, step c, it recites ‘ of step b)’; however it is unclear if ‘b)’ refers to step b) in claim 1 or b) above in claim 2 or 4, respectively.
Claim 3 recites the limitation "the critical time value" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the solution" in step b. There is insufficient antecedent basis for this limitation in the claim. It is not clear ‘a solution’ is positively claimed in the previous step.
Claim 7 recites the limitation "the amount" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the plurality of test compounds" . There is insufficient antecedent basis for this limitation in the claim.
All claim dependent upon any independent claim are also rejected under 112(b) as being dependent upon a rejected claim.
Claim Objections
Claim 1 is objected to because of the following informalities: In step c, line 2-3, ‘so as determining whether’; should be ‘so as to determine whether’. Appropriate correction is required. This is similarly seen in claim 2, step c.
Claims 2 and 7 are objected to because of the following informalities: In the fourth to last line the instance of ‘compound/s’ should be ‘compound(s)’. Appropriate correction is required.
Allowable Subject Matter
It should be noted that the only pending rejection/objections of the pending clam are those that are presented above. The Examiner has search the Applicant’s invention is directed towards a drug discovery assay in PTO search tools, Google and has considered any/all ISRs.
Regarding Claim 1, the invention directed towards a drug discovery assay to screen for compounds capable of shifting the critical temperature (Tc) at which a studied target forms condensates, the assay comprising: a. combining a test compound and a composition comprising the target prior to forming condensates; b. causing the formation of the target condensate in the presence of the test compound by a gradual and controlled increase of the temperature of the solution of a), wherein such gradual and controlled increase of the temperature of the solution of a) is performed at any speed selected from any value from 0.5 to 5oC degrees/minute;c. measuring the solution of a) by any spectroscopy-based measurement while performing the gradual and controlled increase of the temperature according to step b), so as determining whether the test compound shifts the critical temperature of reference at which the target forms the condensates, wherein the critical temperature of reference at which the target forms the condensates is understood as the temperature in which the target forms the condensates without the presence of the test compound; and selecting the test compound as a compound capable of shifting the condensation propensity of a studied target if the test compound significantly shifts the critical temperature of reference at which the target forms the condensates, or if the percentage of shift caused by the test compound in comparison to a reference shift caused by a reference compound is significantly greater than the shift caused by the reference compound is not found or suggested in the prior art.
Previously in the restriction requirement, the Examiner had used the MAX PLANK reference, WO 2020/078924 A1, suggesting it teaches the elements of Claim 1. However, upon further consideration of the MAX PLANK reference is silent in the use of a shift in critical temperature at which the intrinsically disordered protein forms condensate as measure to determine whether the compound tested is a suitable candidate to modulating the condensation property of the target.
Claim 3 recites similar claim language, but rather teaches a ‘shifting the critical time value’. Similarly , since the instant claim recites the shift of the critical time value and recites all the same method steps, this claim is also found to be allowable.
The Examiner has search all USPTO resources, AI search tools, inventor and assignee searches on Google/Google Scholar and upon searching; the Examiner is unable to provide a rejection which would fairly teach or suggest the claimed invention.
Claims 1-20 are allowed beside the above mentioned rejection/objections.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LYLE ALEXANDER can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797
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