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 .
MATTER OF RECORD
The Examiner notes that an incorrect Application number and Applicant names are listed on the claim set. The Application number should be 17/794,724 and the Applicants should be Garcia Quiroz and Fuchs. Appropriate correction is required.
Status of Application, Amendments and/or Claims
The amendment and Applicant’s arguments, filed 16 March 2026, have been entered in full. Claims 2-5, 7, 9, 11, 14, 20, 25, 26 and 29 are canceled. Claims 22-24, 27, 28, 30-32 are withdrawn from consideration as being drawn to a non-elected invention. Claims 1, 6, 8, 12, 13, 17 and 18 are amended. Claims 1, 6, 8, 10, 12, 13, 15-19 and 21 are under examination.
Withdrawn Objections And/Or Rejections
The objection to the drawings as failing to comply with 37 CFR 1.84(p)(5), as set forth at pages 2-3 of the previous Office Action (15 December 2025), is withdrawn in view of the amendment (16 March 2026).
The objection to claims 4, 8, 17 and 18, as set forth at page 4 of the previous Office Action (15 December 2025), is withdrawn in view of the amendment (16 March 2026).
The rejection to claims 1, 2, 4, 6-8, 10, 12, 13, 15-19 and 21 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as set forth at pages 4-7 of the previous Office Action (15 December 2025), is withdrawn in view of the amendment (16 March 2026).
The rejection to claims 1, 7, 8, 12, 13, 15-19 and 21 under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Stout et al. (US 2013/0018000; published Jan. 17, 2013), as set forth at pages 14-16 of the previous Office Action (15 December 2025), is withdrawn in view of the amendment (16 March 2026).
The rejection to claims 1, 7, 8, 10, 16 and 21 under 35 U.S.C. 102(a1) and 35 U.S.C. 102(a2) as being anticipated by Bernard et al. (US 2013/0324477; published Dec. 5, 2013), as set forth at pages 16-17 of the previous Office Action (15 December 2025), is withdrawn in view of the amendment (16 March 2026)..
Claim Rejections-35 USC § 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph
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.
Claims 1, 6, 8, 10, 12, 13, 15-19 and 21 remain 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.
The basis for this rejection is set forth at pages 7-14 of the previous Office Action (15 December 2025).
APPLICANT’S ARGUMENTS: Applicant traverses the rejection and submits that the specification provides suitable and adequate description of accessory protein(s) and artificial client protein(s). Applicant directs the Examiner’s attention to amended claim 1.
Applicant argues pursuant to claim 1, the one or more accessory protein provides a detectable or functional label, or is an enzyme. Pursuant to claim 1, including as amended, the one or more artificial client protein has intrinsic disorder that engages in ultra-weak phase separation-specific amino acid interactions with one or more target component proteins, is a low complexity sequence and wherein the artificial client protein sequence comprises similar compositional bias or comprises related sequence patterns with low sequence identity to the amino acid sequence of a naturally-occurring intrinsically disordered protein or protein region within a larger protein and which is responsible for driving assembly of said biomolecular condensate.
Applicant directs the Examiner’s attention to the specification. Applicant argues that the specification details detectable or functional labels, or enzymes that are suitable as accessory proteins. Applicant cites various paragraphs from the specification.
Applicant argues that the specification details artificial client proteins. Applicant cites various paragraphs from the specification. Applicant argues that the specification describes and provides suitable and known native or target intrinsic disordered protein (IDP) sequences and generates and describes, by way of examples and studies detailed in the specification, sensors comprising artificial client proteins targeting, associating with, and partitioning with these target IDPs. Applicant argues that the specification's TABLE 1 provides a list of numerous such target IDP sequences and that over 40 target IDP sequences are listed in this table, each of which is a distinct sequence.
Applicant’s arguments have been fully considered but are not found persuasive for the following reasons:
1. The Examiner notes that Claim 1, line 3 recites, “..wherein the first domain comprises one or more accessory protein..”
But, Claim 1, line 16-17 recites, “..wherein at least one accessory protein provides a detectable or functional label or is an enzyme”.
Claim 1 only requires that “one accessory protein” of the “one or more accessory protein” provides a detectable or functional label or is an enzyme.
Therefore, the claims still encompass a genus of “accessory proteins” that lack any structural limitations but must have the claimed biological function.
2. As was stated in the previous Office Action, the written description requirement for a claimed genus may be satisfied through establishment of a structure-function correlation (show a structure is correlated with the function) OR through a sufficient description of a representative number of species (show a representative number of species that have the function). There must be enough species that are representative of the full breadth of the genus.
3. Regarding Applicant’s arguments that the specification teaches various functional labels, detectable labels or enzymes:
The Examiner disagrees with this assessment.
The specification fails to define “detectable label”. Applicant discusses examples of “fluorescent proteins” and examples of “radioactive labels”. However, the Applicant does not clearly point out in the specification, wherein the specification specifically defines a “detectable label” or states “examples of detectable labels include..”. The Examiner maintains that a detectable label can include any molecule that detects. For example, antibodies can detect antigens, anti-sense DNA can detect its complementary sense DNA.
The specification fails to define a “functional label” or give examples of suitable functional labels. The Examiner directs Applicant’s attention to Claim 12 (“wherein the at least one accessory protein tags one or more biomolecular condensate component with a detectable or functional molecule, peptide or marker”). What makes the label a “functional label”? Those skilled in the art would not know how a “functional label” differs from a “detectable label”. In addition, the Examiner sees no teachings, definitions, examples for a “functional molecule” or “functional peptide” or “functional marker”.
Regarding enzymes, the Examiner directs Applicant’s attention to instant Claim 13 (“at least one accessory protein modifies the target component protein in the biomolecular condensate or delivers a compound or agent to the biomolecular condensate or to a target component protein in the biomolecular condensate”). What is the structure of enzymes that have the associated biological function of “modifying the target component protein in the biomolecular condensate or delivering a compound or agent to the biomolecular condensate or to a target component protein in the biomolecular condensate”?
What is the structure of detectable labels or functional labels that have the associated biological function recited in claim 13.
What is meant by the function of modifying?
Contrary to the presented arguments, the specification fails to 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 (i.e. genus of accessory proteins).
4. Regarding Applicant’s arguments that the specification teaches various artificial client proteins and the citation of paragraphs 113-115, Table 1, paragraphs 138-141 and 144:
Paragraphs 113 and 114 fail to teach a structure of an artificial client protein that correlates with the function recited in claims 1 and 6.
The Examiner disagrees with Applicant’s assessment regarding paragraph 115 and Table 1. This is because the artificial client proteins do not represent the exact IDP protein sequences listed in Table 1.
See Paragraph 115, which teaches “…absolutely distinct non-native sequence for the artificial client protein, including wherein the chirality and orientation and/or the structure of molecule in space is absolutely distinct from the target IDP amino acid sequence” and that “..the artificial client protein sequence is a randomized or jumbled sequence corresponding to or based on the sequence of the target IDP sequence”.
There is no teaching on what amino acid residue changes (i.e. amino acid substitutions, additions and/or deletions) the skilled artisan would have to make in any of the IDP sequences depicted in Table 1 to make an artificial client protein with the claimed biological functions.
The Examiner disagrees with Applicant’s assessment regarding paragraphs 138-141, wherein Applicant states that specific and characteristics of suitable artificial client proteins are described including how to generate alternatives artificial client proteins. Adequate written description does not depend on how easy it is for one skilled in the art to isolate the product. Adequate written Description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The molecule itself is required. See Fiers V. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes V. Baird, 30 USPQ2d 1481, 1483).
Lastly, the Examiner disagrees with Applicant’s assessment regarding paragraph 144. The paragraph teaches that artificial client proteins based from filaggrin sequence or designed to target or associate with filaggrin protein-containing biomolecular condensates include those provided in any of SEQ ID NOs: 17-21. The sensors designed based on human filaggrin sequence were effective and active in targeting and associating with filaggrin protein in biomolecular condensates in human cells and in vivo in mice.
The Examiner maintains that a teaching of 5 filaggrin protein-containing species, is not tantamount to a claimed genus of artificial client proteins that lack any structure but must have the biological functions, as recited in claim 1 and 6.
In conclusion, the specification has written description for a phase separation sensor comprising: accessory proteins that are fluorescent proteins and artificial client proteins that comprise the SEQ ID Nos: recited in claim 17.
But lacks written description for a phase separation sensor as currently claimed.
The scientific reasoning and evidence as a whole indicates that the rejection should be maintained.
Please note that this issue could be overcome by the following suggested amendments:
Claim 1, line 16-17, is amended to recite, “..wherein the one or more accessory protein(s) are fluorescent proteins”; and
The artificial client protein limitations from claim 17 are incorporated into claim 1; and
Canceling claim 8 and updating claim limitations/changing claim dependency of claims 10 and 12.
NEW CLAIM REJECTIONS/OBJECTIONS
Claim Objections
Claims 1 and 6 are objected to because of the following informalities:
Claim 1, line 3 should recite “..one or more accessory protein(s)..”
Claim 1, line 6 should recite, “..one or more target component protein(s)..”
Claim 6 has a typo. The instant claim recites “The sensor of claim 1 4 wherein..”. It is not clear that the “4” is crossed out. The “4” should be removed with brackets.
Appropriate correction is required.
Claim Rejections-35 USC § 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph
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, 6, 8, 10, 12, 13, 15-19 and 21 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.
Claim 1 recites the limitations “in the cell” in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claims 6, 8, 10, 12, 13, 15-19 and 21 are included in the rejection because they depend from claim 1.
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.
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/R.M.D/Examiner, Art Unit 1647 6/4/2026
/BRIDGET E BUNNER/Primary Examiner, Art Unit 1647
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