DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. The Amendment filed on August 2, 2026, has been received and entered.
Claim Disposition
3. Claims 6, 20-75 and 77-118 have been cancelled. Claims 1-5, 7-19 and 76 are pending. Claims 1, 5 and 7-19 are under examination. Claims 2-4 and 76 are withdrawn from further consideration pursuant to 37 CFR 1.12(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
4. The Information Disclosure Statements filed on August 3, 2026 and October 7, 2026, have been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action. Note that references have been lined through based on missing or incomplete date citations.
Specification Objection
5. The specification is objected to for the following informalities:
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. The following is suggested: "Compositions and Methods for Improving Stability and Expression of Biologics".
Appropriate correction is required.
Claim objection
6. Claims 1, 5 and 7-19 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that 1 recite, “A method for stabilizing a [[first]] phase behavior polypeptide [[the method]] comprising…..
wherein when the fusion protein is exposed…..and wherein the oner or more.....is selected from [[any one of]] exposure to an oxidizing agent….” The dependent claims hereto are also included.
For clarity it is suggested that claim 7 is amended to recite, “….wherein the [[one or more]] condition [[s]] that would destabilize……”.
For clarity it is suggested that claim 10 is amended to read, “…..pH is exposure to a base”.
For clarity it is suggested that claims 12-17 are amended to delete ‘known”.
For clarity and precision of claim language it is suggested that claim 18 is amended to delete “one or more conditions” and instead recite, “wherein the condition is heat….”. See also claim 19 with similar language.
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.
7. Claims 1, 5 and 7-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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 claimed invention as amended is directed to “a method for stabilizing a first polypeptide comprising expressing a fusion that comprises the first polypeptide and a second polypeptide, however, the fusion is not defined as the first and second polypeptide are not described (see claim 1 in its entirety). The claimed invention is recited as having the first polypeptide losing less than 25% of its activity after exposure to the conditions listed, however said activity is not recited in the claims nor the express protein losing the activity. Thus the claimed invention is not adequately described for an ordinary skilled worker to ascertain what polypeptide in the vast amounts that exist could be the first or the second; and the criteria of loss of activity being less than 25% to the conditions recited in the claim with no express activity recited. The claimed invention also recites a list of conditions recited as known to destabilize the first polypeptide, however, the baseline activity is not provided and who are the conditions known to? An ordinary skilled worker would need to know the activity of the protein to ascertain loss of some of the activity as well as what specific proteins are in the fusion.
The claimed embodiments encompasses a large variable genus of polypeptides that can be construed as first and second and conditions that could destabilize the first and second polypeptide. The claimed invention is not adequately described because the specification at page 2 discloses that the second polypeptide with phase behavior can be an enzyme or a derivative or catalytic fragment thereof, an antibody or derivative/fragment, a signaling molecule or fragment/derivative, a structural protein or fragment/derivative, or a hormone/fragment/derivative. Note also that although not asserted the first polypeptide encompasses a polypeptide with phase behavior. The claims are clearly not commensurate in scope with the disclosure in the specification.
The art generally recognizes that polypeptides with phase behavior, most notably elastin-like polypeptides (ELPs), undergo stimuli-responsive phase separation in aqueous solutions, commonly exhibiting Lower Critical Solution Temperature (LCST) behavior, where they transition from soluble to insoluble upon heating. These materials, composed of VPGXG pentapeptide repeats, form a polymer-rich phase (coacervation) above a tunable temperature, making them essential for drug delivery, tissue engineering, and protein purification. The specification discloses that phase behavior refers to any polypeptide capable of undergoing phase transition due to the application of an environmental factor thus the first and second polypeptide claimed are capable of undergoing a phase transition or phase behavior, and note claim 1 recites exposure to one or more conditions and provides a list.
The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
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.
8. Claims 1, 5 and 7-19 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 and the dependent claims hereto are ambiguous, thus indefinite because the claim language could be construed as only the second polypeptide in set forth in SEQ ID NOs: 87 or 194 or that the entire fusion is set forth in those structures.
Claims 12-17 lacks clear antecedent basis for the recitation of ‘known’.
Response to Arguments
9. Applicant’s arguments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note the 112 rejections remains and have been modified to reflect amendments made to the claims. Applicant states that the title has been changed, however, the new specification filed with the office has the old title, correction is required. Applicant traverses the rejections under 112, first and second paragraphs. Regarding the 112, first paragraph rejection, Applicant opines that Examples 1-2 provides data showing that fusion of the second polypeptide with ectodomain of AAVR or Z domain of Staphylococcal protein A stabilizes the first polypeptide. Note that this is a specific embodiment not found in the claims. With regard to the 112, first paragraph the claims remain directed to a first and second polypeptide with no identification of what they are, what has been fused. Applicant has to know what the fusion partners are not just the structure. Note also that no express activity is provided in the claims that is asserted as being retained. Thus with no correlation of structure and function is made, thus the rejection remains.
Conclusion
10. No claims are presently allowable, however, SEQ ID NO:194 and 87 are free of the art.
11. Applicant’s amendment necessitated the new/modified 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
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