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 .
Applicants elected group I, claims 1-12 on 8/29/2025 without traverse has been received.
Claims 1-15 are pending and claims 13-15 are withdrawn from further consideration.
Claims 1-12 are under examination.
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 1-12 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.
As to claim 1, last second line, “particularly selected” lacks metes and bounds for selection. Please clarify.
As to claim 1, line 6, “the composition” lacks antecedent basis.
As to claim1, the whole claim is not clear and confused. The preamble directs to determine the capacity of a cluster 1 mammalian transcription factor for phase separation and/or forming a transcriptional condensate. However the active step is to determine the presence, localization and/or morphology of embodiment #1: a transcription factor; embodiment #2: a composition comprising the transcription factor; embodiment #3: determine activity of the transcriptional factor, wherein the transcription factor is selected from Table1 (including the specific recited transcriptional factor). Based on the above embodiments, it is not clear about the nexus between the presence of the transcription factor and the capacity of forming phase separation and/or forming transcriptional condensate, e.g. increase or decrease condensates or phase separation. In addition, which “location” of the appearance of the transcriptional factor is associated with the capacity of phase separation and/or transcriptional condensate? Or what kind of “morphological feature” is indicative of the capacity of phase separation and/or transcriptional condensate? Similarly, what “activity” of each transcriptional factor relates to such capacity of phase separation and/or transcriptional condensate. Moreover, does the determination need a control for comparison? Please clarify.
As to claim 1, recitation of using “Table 1” poses ambiguities under 35 USC, 112(b).
MPEP 2173.05(s)“Where possible, claims are to be complete in themselves. Incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993).”
As to claim 2, last second line, “particularly” lacks metes and bounds.
As to claim 4, last second line, “particularly” lacks metes and bounds.
As to claim 7, the term “including, but not limited to..” lacks metes and bounds.
As to claim 8, “such as” lacks metes and bounds.
As to claims 10-12, the main claim 10 depends on claim 1 yet directing to another embodiment, i.e. screening compound affecting phase separation and/or forming a transcriptional condensate. However no detailed active steps are shown in these claims. Please specify each step.
As to claim 12, step (i) and (ii), the term “e.g.” lacks metes and bounds.
As to claim 12, line 7-10, the term “particularly” and “such as” lacks metes and bounds.
Claim Rejections - 35 USC § 101
“Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claim(s) 1-9 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below:
The first step requires that the claimed invention ‘‘must be directed to one of the four statutory categories’’, namely process, machine, manufacture or composition, and the second step requires that the invention ‘‘must not be wholly directed to subject matter encompassing a judicially recognized exception’’, namely a law of nature, a natural phenomenon or an abstract idea (emphasis added).
Independent claim is directing to a method of measuring the levels of one or more ; comparing the results to the levels of the same biomarker(s) from control subjects, and correlating the results to
With regard to Eligibility step 1 – Yes, the claimed invention is a process (method) which is one of the four statutory categories of invention.
With regard to Eligibility Step 2A prong 1: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea? Yes, the claim recite an abstract idea, law of nature or natural phenomenon.
Here the law of nature refers to the (1) measuring natural molecules from a subject, i.e. transcriptional factor molecules listed in Table 1 in samples, and (2) correlating its presence, location and/or morphology for phase separation and/or forming a transcriptional condensate. Therefore, the natural relationship is the biomarker(s) correlating with a “condition” (phase separation and/or forming a transcriptional condensate) under judicial exception. (See Mayo Collaborative Servs. v. Prometheus Laboratories, Inc., 132 S.Ct. 1289 (2012). Note, even with mutation on the intrinsically disorder region (IDR) on the transcriptional factor (e.g. alteration of the number of hydrophobic or hydrophilic amino acids), such alteration is still a natural occurring phenomena associated with cluster 1 transcriptional factor associated-disease (claims 2-5).
Under Step 2A prong 2, whether the claims recite additional elements that integrate the judicial exception into a practical application. The answer is No. No additional step is recited in the claims.
Under Step 2B, whether a claim amounts to significantly more. The answer is No. The instant steps, such as obtaining samples, measuring biomarkers, comparing and administering are well-understood, routine, conventional activity in the field and add insignificant extra-solution activity to the judicial exception. For instance, the specification illustrates using conventional immunofluorescence and imaging methods (See Examples). These steps are recited at a high level of generality, and are necessary data gathering steps that feed into the determining step. One cannot do the determining step without getting the data. This weighs against it being significantly more.
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.
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) 1-2, 6-11 are rejected under 35 U.S.C. 103 as being unpatentable over Young (WO 2019183552).
Young teaches methods and assays for modulating transcriptional condensates. Young discloses the presence of various transcriptional factor proteins (same as recited from current Table 1) are associated with transcriptional condensates. The transcriptional factor proteins include KLF4, CDX2, SOX17, PRDM14, TCF3, OLIG2 (See Table S1; these proteins are also listed in current invention shown in Table 1). Note, in response to this office action, applicants are reminded to cross-match all the transcriptional factor proteins listed by Young with current Table 1 for amendment.
As to claim 2 and 9, Young also discusses disease-associated alteration on the hydrophobic/hydrophilic changes of amino acid on the intrinsic disorder regions or domains on the transcriptional factor (section 0005; 0185, 0199)
As to claim 6-7, Young uses microscopy in evaluating tissue samples for the assay (section 0043, 0178).
As to claim 8, Young also discusses enhancer and/or mediator involving the formation of transcriptional condensate (section 0168- 0181).
As to claim 10-11, Young teaches use of screening methods in identifying compounds capable of affecting transcriptional condensates (section 0055, 0061, 0279).
Claims 3-5 and 12 are free of prior art. The closest prior art is the Young reference where Young teaches detecting the presence of various transcriptional factor proteins in identifying transcriptional condensates (see above). However Young does not explicitly teach further detecting changes of expansion of the repeated intrinsic disorder region or domain (IDR) with alterations on hydrophobic and/or hydrophilic amino acids. However applicants are reminded that the criteria for judicial exception under 35 USC 101 are distinct from those of prior art. The genetic change (e.g. expansion of repeat IDR) on the transcriptional factor associated with genetic disease is still a natural correlation under law of nature. Moreover, claims 3-5 and 12 are also rejected under 35 USC 112(b).
Conclusion
No claim is allowed.
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CHANGHWA J. CHEU
Primary Examiner
Art Unit 1678
/CHANGHWA J CHEU/Primary Examiner, Art Unit 1678