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 .
Claim Status
Claims 2-4, 6-15, 17-19, 21-23 are pending.
Claims 1, 5, 16, 20 are cancelled.
Claims 2-4, 6-15, 17-19, 21-23 are under examination.
Claims 2-4, 6-15, 17-19, 21-23 are rejected.
Priority
The instant application, filed 12/2/2022 and having one RCE filed therein, is a CON of 16363890, filed 03/25/2019, which Claims Priority from Provisional Application 62647082, filed 03/23/2018.
Claim Interpretation and Comments
The claim limitations are given their broadest reasonable interpretation (BRI) consistent with the specification, MPEP 2111, and under the BRI, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification, MPEP 2111.01.
The 3/9/26 amendments to claim 12, the single independent claim, deletes ”wherein the self-assembling peptides or self-assembling peptidomimetics form a barrier to the movement of inflammatory cytokines at the site of administration,” this still allowing for some movement through a hydrogel formed by self-assembling peptides, and adds after line 2’s “the method comprising” at line 3 “forming a fluid-impermeable barrier to the movement of inflammatory cytokines by”, this followed by the non-amended administering step, which administers to the subject at a site of inflammation or at risk of inflammation a composition comprising a plurality of self-assembling peptides or self-assembling peptidomimetics in an amount effective to reduce or prevent one or more listed symptoms, followed by a listing of (I) to (XII) sequence Formulas for each of the self-assembling peptides or self-assembling peptidomimetics.
As previously noted and discussed, see also 11/3/25 Examiner Interview Summary Record, there was limited support in the application as filed for the modified wherein clause of claim 12, “wherein the self-assembling peptides or self-assembling peptidomimetics form a barrier to the movement of inflammatory cytokines at the site of administration.” Most of this scant support found in paras 200 and 214 of the US PGPUB No. 20240051997, see also Interview Summary. Para 214, which applicant references in the 3/9/26 Remarks, states in relevant part, “In some embodiments, the SAP are administered to a site of inflammation, or a site at risk of inflammation in an amount effective to provide a fluid impermeable barrier at the site of administration. In some embodiments, the barrier structure is effective to prevent the movement of bodily fluids and contaminants through the structure. Therefore, the SAP can reduce or prevent the passage of pro-inflammatory cells and/or signals from one location in the body to another.” Cytokines are understood to be a type of signal. Thus, these sentences are interpreted to articulate that an SAP barrier can reduce or prevent the passage of signals that include cytokines that are pro-inflammation.
The wording now employed and added 3/9/26 further strains a basis of support in the application as filed, particularly considering the lack of teachings, structure/function relationships, relevant guidance, and/or examples that demonstrate what is instantly claimed for a sufficient range of species/types/subtypes across the genus of possible variations of plurality of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (XII) of claim 12.
Fluid-impermeable is interpreted on its face, as impermeable so preventing the passage of fluids, here understood to be aqueous fluids given the application to a body of a living subject. “Fluid-impermeable barrier to the movement of inflammatory cytokines” is interpreted to be a barrier preventing the passage of fluids and also, perhaps particularly but not so designated, preventing the movement of inflammatory cytokines across or through such barrier. Whether the barrier is impermeable to, so stops movement of other cytokines, or other molecules, apart from fluid, remains unanswered and at this point in prosecution unaddressed as this is not claimed.
As previously stated, the transition phrase “comprising” is inclusive or open-ended and does not exclude additional, unrecited elements or method steps., see MPEP 2111.03 I. Notwithstanding the 9/4/25 amendments to claim 12, ‘the method comprising’ on its line 2 allows for additional peptides other than those specifically claimed, as well as other compounds, to be administered when practicing the claimed method.
Claim Rejections - 35 USC § 112
Response to Arguments
Applicant’s arguments, see page 8, filed 9/4/25, and claim amendments, with respect to claims 2-4, 6-15, 17-19 and 21-23 having been rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite have been fully considered and are persuasive. The rejection of claims 2-4, 6-15, 17-19 and 21-23 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph has been withdrawn.
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.
Claims 2-4, 6-15, 17-19, 21-23 are 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.
A first issue at hand is possession of claim 12’s method of administering any of the range of possible variations of plurality of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (XII) of claim 12 that achieve the newly added limitation “forming a fluid-impermeable barrier to the movement of inflammatory cytokines by” such administering. A second issue is whether there is possession through any further limitations in the dependent claims.
Regarding the requirement for adequate written description of chemical entities, Applicant's attention is directed to the MPEP §2163. In particular, Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), holds that an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "and not merely a wish or plan for obtaining the claimed chemical invention." Eli Lilly, 119 F.3d at 1566.
Applicant is alerted that "a sufficient description of a genus ... requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus." AriadPharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010). A "generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus." Id. at 1349. “[M]erely drawing a fence around a perceived genus is not a description of the genus.” AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014). “One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus.” Id. “Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus.” Id.
For a claimed genus, which is what is instantly claimed as to the plurality of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (XII) of claim 12 that are instantly claimed to achieve the newly added limitation “forming a fluid-impermeable barrier to the movement of inflammatory cytokines by” such administering, written description may be satisfied “through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., 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 inventor was in possession of the claimed genus (see i)(C) above)”, from MPEP 2163 II A 3 a) ii). “A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").” Id.
Applicant has not provided any examples, nor relevant guidance, such as specific structural requirements including concentrations and methods of formation, as to how to form a fluid-impermeable barrier to the movement of inflammatory cytokines by administering any one combination of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (XII) of claim 12, let alone a number of species that is representative of the claimed genus. Nor has applicant provided relevant guidance, specific rules, concentrations, or other structure/function relationships that demonstrate such possession, for using self-assembling peptides as well as for using any of the wide range of self-assembling peptidomimetics to achieve what is claimed.
Against this lack of relevant support, there being not even one example let alone sufficient support for the genus, is contrasted Gelain et al., Journal of Controlled Release 145 (2010) 231–239. Gelain clearly and abundantly teaches that cytokines are released from self-assembling scaffolds that are constructed with the same RADA16 that falls within the genus of instantly claimed self-assembling peptides, Abstract, Introduction (which reviews release of various molecules from self-assembled peptide structures), section 3 including Fig. 1.
A self-assembling peptide hydrogel is substantially water and applicant has not set forth guidance on how its method achieves “forming a fluid-impermeable barrier to the movement of inflammatory cytokines by” administering per claim 12 any combination of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (XII) of claim 12 to stop movement of cytokines, or inflammatory cytokines in particular, when such self-assembling peptides or self-assembling peptidomimetics are administered so as to form a hydrogel. The examiner notes that if self-assembling peptides or self-assembling peptidomimetics are administered in pure dry form they likely would draw fluids from nearby tissues, perhaps damaging such tissues, yet in any case such application was neither taught, suggested, nor demonstrated to yield or likely results in “forming a fluid-impermeable barrier to the movement of inflammatory cytokines.”
The skilled artisan cannot envision the chemical structure nor overall structure(s) of the composition(s) that are claimed that form “a fluid-impermeable barrier to the movement of inflammatory cytokines.” Adequate written description requires more than a mere statement that it is part of the invention. One cannot properly describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483 (BPAI 1993). In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. The specification provided only the bovine sequence. Here there is not even a single demonstrated embodiment.
There is insufficient support for the breadth of the genus in the application as filed for claim 12, and for any of the claims depending from it, these not providing any reasonable basis for attaining the newly added limitation. Therefore, the full breadth of the claims does not meet the written description provision of 35 U.S.C. §112, first paragraph Applicants are reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. § 112 is severable from its enablement provision (see page 1115).
Claims 2-4, 6-15, 17-19, 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
From MPEP 2164.01:
“Any analysis of whether a particular claim is supported by the disclosure in an application requires a determination of whether that disclosure, when filed, contained sufficient information regarding the subject matter of the claims as to enable one skilled in the pertinent art to make and use the claimed invention.
A specification may call for a reasonable amount of experimentation to make and use a patented invention. What is reasonable in any case will depend on the nature of the invention and the underlying art. … The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue.
In order to determine compliance with the enablement requirement of 35 U.S.C. 112(a), the Federal Circuit developed a framework of factors in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), referred to as the Wands factors to assess whether any necessary experimentation required by the specification is "reasonable" or is "undue."
These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (See MPEP 2164.01(a)).
The analysis of instant claim 12 and claims depending from it follows.
(A) The breadth of the claims: claim 12 is broad in that any combination of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (XII) of claim 12 to stop movement of cytokines, or inflammatory cytokines in particular, when such self-assembling peptides or self-assembling peptidomimetics are administered, which administering is effective to “forming a fluid-impermeable barrier to the movement of inflammatory cytokines.” Dependent claims further limit range of such self-assembling peptide, concentrations, and other types of limitations, but neither the claims nor the application as filed indicate how such further limitations achieve limitation “forming a fluid-impermeable barrier to the movement of inflammatory cytokines.”
(B) The nature of the invention: physicochemical and biological, requiring an interaction of what is administered and a resultant formation of a barrier, that is, “forming a fluid-impermeable barrier to the movement of inflammatory cytokines.”
(C) The state of the prior art: self-assembling peptides are known to be used to form hydrogels in living subjects, including Gelain et al., Journal of Controlled Release 145 (2010) 231–239, which clearly and abundantly teaches that cytokines are released from self-assembling scaffolds that are constructed with the same RADA16 that falls within the genus of instantly claimed self-assembling peptides, Abstract, Introduction (which reviews release of various molecules from self-assembled peptide structures), section 3 including Fig. 1. This establishes a teaching that is contrary to what is instantly claimed.
(D) The level of one of ordinary skill is moderately high.
(E) The level of predictability in the art is moderately high, relying on known physicochemical properties of hydrogels and self-assembling peptides.
(F) The amount of direction provided by the inventor: SCANT as to how to achieve what is instantly claimed, as to “forming a fluid-impermeable barrier to the movement of inflammatory cytokines.” A few general statements are found, none specific to a barrier particularly to the movement of only inflammatory cytokines, and there is no relevant guidance, examples, nor teachings of structure/function that provides for “forming a fluid-impermeable barrier to the movement of inflammatory cytokines.”
(G) The existence of working examples: NONE; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: given that the general knowledge in the art, when forming hydrogels in a subject with self-assembling peptide or peptidomimetics, would lead one to the conclusion that there is movement of cytokines therethrough, see Gelain reference cited above, a great quantity of experimentation would be required to achieve, if possible, what is instantly claimed, including when considering the further limitations of the dependent claims.
In summary, no claim is enabled and undue experimentation would be required to operate the invention.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 7-11, filed 3/9/26, and substantial claim amendments, with respect to the rejections under 35 USC 103 have been fully considered and are persuasive. The rejections under 35 USC 103 have been withdrawn.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH FISCHER whose telephone number is (571)270-7925. The examiner can normally be reached on Monday to Friday, 9:00 AM to 5:00 PM, however noting that the examiner will not normally be working on Wednesday-Friday and on Monday/Tuesday on alternating weeks, but will promptly answer messages upon his return to work.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MELISSA FISHER, can be reached on 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
Prosecution Insights