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 .
Amendments Received
Amendments to the claims were received on 09/12/2025. However, those amendments were not entered because they were made to an incorrect, non-examined claim set rather than the claim set that was under examination. A supplemental amendment correcting this issue was subsequently received and entered on 11/18/2025.
Election/Restrictions
Newly submitted claims 18-23 are directed to an invention that is independent or distinct from the invention originally claimed. Claims 18-23 are directed to methods comprising administering a nucleic acid molecule, expression vector, or host cell encoding/expressing keratin BD-6. These embodiments correspond to the non-elected subject matter of group II of the restriction requirement of 10/16/2024. Group II was directed to the nucleic acid molecule, expression vector and host cell encoding/expressing keratin BD-6.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 18-23 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of Claims
Claims 1-14 are cancelled; claims 16-23 are newly added.
Claims 15-23 are currently pending.
Claims 15-17 are under consideration, as claims 18-23 are withdrawn.
Priority
The present application claims status as a 371 (National Stage) of PCT/CN2020/124358 filed on October 28, 2020 and claims priority to Chinese application CN201911028712.3 filed on October 28, 2019. Acknowledgment is made of applicant' s claim for foreign priority and papers submitted under 35 U.S.C. 119 (a)-(d). The present application and all claims are being examined with an effective filing date of 10/28/2019. In future actions, the effective filing date may change due to amendments or further review of priority documents.
Withdrawn Objections
In view of Applicant’s amendments, the objection to claim 15 is hereby withdrawn.
Withdrawn Rejections
In view of Applicant’s amendments, rejection of claim 15 under 35 USC § 112(a), as failing to comply with the written description requirement, is hereby withdrawn.
In view of Applicant’s amendments, rejection of claim 15 under 35 USC § 112(a), for lack of enablement (scope of enablement), is hereby withdrawn.
In view of Applicant’s amendments, rejection of claim 15 under 35 USC § 112(b) is hereby withdrawn.
Claim Objections
Claim 15 is objected to for containing informal or awkward wording. The phrase “wherein the amino acid sequence of the keratin BD-6 is set forth in SEQ ID NO: 1 in the sequence listing” is unnecessary and creates awkward claim construction. The reference to SEQ ID NO: 1 alone is sufficient. It is suggested that the claim be amended to delete the phrase “in the sequence listing”.
Appropriate correction is required.
Maintained/Modified Rejections Necessitated by Amendment
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Cetintas, S. (US20200197287, cited in a previous office action) and A0A140T867 (UniProt database, 2016, cited in a previous office action).
With respect to the recitation of “a method of antipyretic, analgesic, antitussive, expectorant, anticonvulsant, or antiepileptic…”, pursuant to MPEP 2111.02 II: the claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "'extraneous' limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. The recited therapeutic purposes do no change or structurally limit the step of administering keratin BD-6, nor do they require any particular therapeutic mechanism or physiological effect. In other words, the step of administering is the same regardless of the stated purpose. Therefore, “antipyretic, analgesic, antitussive, expectorant, anticonvulsant, or antiepileptic” recited in claim 15 will be interpreted as an intended use, and as such, not given patentable weight.
Cetintas discloses a “hair Botox” comprising keratin and water for worn hair, hair care and hair repair (Abstract and pg. 1, para 0002). Cetintas teaches a method comprising applying keratin protein mixed with water (i.e., hair Botox), directly to damaged parts of hair, for hair care, repair and protection (pg. 2, para 0012-0014). With respect to the claim 15, the subject with damaged hair receiving the hair Botox of Cetintas correlated to a subject in need of the keratin, as recited by the instant claim; and the application of the keratin treatment, or “hair Botox”, correlates to the administration of said keratin, as recited by the instant claim. Cetintas does not expressly teach the particular keratin disclosed in instant claim 1 (i.e., SEQ ID NO: 1 or an amino acid sequence that basically maintains the same biological function formed by substitution, deletion or addition of 1-35 amino acids to the amino acid sequence set forth in SEQ ID NO:1).
A0A140T867 discloses a keratin having 100% sequence identity to instant SEQ ID NO: 1 (see sequence alignment in Restriction Requirement of 10/16/2024).
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, the teachings of Cetintas, that keratin (mixed with water) is applied to the hair of subjects in need of hair repair, would have led said practitioner to substitute the keratin of Cetintas with the keratin disclosed by A0A140T867, and expect predictable results (see MPEP 2144.06, “Substituting equivalents known for the same purpose”). Given that Cetintas demonstrates a successful method of administering keratin to a subject in need thereof, and given that A0A140T867 is a keratin that was known at the time of the claimed invention, said practitioner would have readily predicted that the combination of teachings would successfully result in a method comprising administering the keratin set forth in instant SEQ ID NO: 1, to a subject in need thereof. Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Cetintas and A0A140T867, as applied to claim 15 above, and further in view of Snider and Omary (Post-translational modifications of intermediate filament proteins: mechanisms and functions, Nat Rev Mol Cell Biol. 2014 March ; 15(3): 163–177, herein “Snider”, cited in PTO-892).
The teachings of Cetintas and A0A140T867, as applied to claim 15, have already been discussed above. Briefly, Cetintas teaches administering a keratin-containing “hair Botox” formulation to a subject in need thereof, and A0A140T867 discloses a keratin protein having 100% sequence identity to the keratin recited in the instant SEQ ID NO:1. However, Cetintas does not expressly teach that the keratin has a conventional modification as recited in claims 16-17.
Regarding claim 16, Snider teaches that intermediate filament (IF) proteins, including cytoplasmic keratins, “undergo various functionally important post-translational modifications (PTMs)” such as phosphorylation, glycosylation, sumoylation, acetylation, and prenylation (see Preface). Snyder further identifies specific keratins as known glycosylation targets, stating that “known IF glycosylation targets are K8, K13, K18, vimentin, and neurofilaments” (O-linked glycosylation section). Keratin BD-6, as encoded by SEQ ID NO:1, corresponds to a type I cytoskeletal keratin (keratin 17), which belongs to the same IF keratin family as K8, K13, and K18 (made up of both type I and type II keratins). Because cytoplasmic keratins share conserved structural and regulatory PTM biology, and because phosphorylation, glycosylation, and acetylation are well-established, conventional PTMs across proteins, including the keratin family, a person of ordinary skill in the art would have reasonably expected keratin 17 to undergo the same types of modifications as other keratins in the IF family.
Claim 17 depends from claim 16 and further limits the “tag for detection or purification” to specific affinity or reporter tags. Because claim 16 is rejected based on the conventional modification embodiment (e.g., phosphorylation, glycosylation, acetylation) rather than the tagging embodiment, the additional limitations of claim 17 fail to overcome the rejection applied to claim 16. Accordingly, claim 17 is likewise rejected for the same reasons set forth above.
An invention would have been obvious to a person of ordinary skill in the art if some teaching in the prior art would have led that person to combine prior art reference teachings to arrive at the claimed invention. Before the effective filing date of the claimed invention, in view of Snider’s teaching that keratins conventionally undergo post-translational modifications including those explicitly listed in claim 16, and given that substituting a modified form of a known protein for its unmodified counterpart represents a routine and predictable design choice, a person of ordinary skill would have found it obvious to use a conventionally modified form of the BD-6 keratin recited in claim 15, and expect predictable results. See MPEP 2144.06 (“Substituting Known Equivalents for the Same Purpose”). Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention.
Response to Arguments for Rejections under 35 USC § 103
In the response filed on 09/12/2025, applicant argues that Cetintas fails to teach or suggest the use of keratin in the antipyretic, analgesic, antitussive, expectorant, anticonvulsant, or antiepileptic fields, and therefore does not render claim 15 unpatentable. Applicant further argues that A0A140T867 likewise does not teach keratin being used in these therapeutic contexts. These arguments are not persuasive because the recited therapeutic fields appear only in the preamble of claim 15. As discussed in the rejection above, the preamble recitations (“a method of antipyretic, analgesic, antitussive, expectorant, anticonvulsant, or antiepileptic…”) do not provide a structural or functional limitation on the method step. The body of the claim already sets forth a complete method — “administering to the subject an effective amount of keratin BD-6” — and the preamble merely states the intended purpose for administering the keratin. As such, the preamble is not given patentable weight. The relevant limitation in claim 15 is simply the administration of keratin BD-6 to a subject, which Cetintas teaches. The A0A140T867 reference provides the specific amino acid sequence corresponding to the claimed keratin BD-6.
Accordingly, the rejection of claim 15 under 35 U.S.C. §103 is therefore maintained.
Conclusion
No claim is in condition for allowance.
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 NAGHMEH NINA MOAZZAMI whose telephone number is (703)756-4770. The examiner can normally be reached Monday-Friday, 9:00-5:00.
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/NAGHMEH NINA MOAZZAMI/ Examiner, Art Unit 1652
/ROBERT B MONDESI/ Supervisory Patent Examiner, Art Unit 1652