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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/26/26 has been entered.
Claim Status
Claims 3-4, 6-15, 17-19, 21-23 are pending.
Claims 1, 2, 5, 16, 20 are cancelled.
Claims 3-4, 6-15, 17-19, 21-23 are under examination.
Claims 3-4, 6-15, 17-19, 21-23 are rejected.
Priority
The instant application, filed 12/2/2022 and having two RCEs 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 – Retained for the Record and Updated
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 previously employed and added 3/9/26, and also per the 8/26/26 claim amendments, 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, even when reduced on 8/26/26 to a narrower scope of (I) to (IV) with more limitations regarding specific amino acids. This is at least because the same SAPs are taught in the art to be permeable, see for example US Patent No. 5670483, referred to in the instant specification, and also taught and/or exemplified in other references, such as the previously cited Gelain et al., Journal of Controlled Release 145 (2010) 231–239, previously provided, and applicant has not set forth how to achieve a differently behaving material, a fluid-impermeable barrier …effective to prevent the movement of bodily fluids through the barrier”, from the same SAPs.
Fluid-impermeable is interpreted on its face, as impermeable so preventing the movement of fluids, here understood to be aqueous fluids given the application to a body of a living subject. Based on the “thereby” clause, such barrier is claimed to prevent the movement of macrophages and inflammatory cytokines (from “pro-inflammatory cells and signals” in the claim) across or through such barrier. Given the “fluid-impermeable barrier” it would appear applicant’s claim 12 includes such barrier prevents passage of all cells and signals, whether pro-inflammatory, anti-inflammatory, or unrelated to inflammation. The inclusion of “reducing” as an alternative is addressed in a rejection below.
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
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 3-4, 6-15, 17-19, 21-23 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.
The type and the duration of the alleged “fluid-impermeable barrier” claimed in claim 12 are unclear.
Given that SAPs having some of the same amino acid sequences as instantly claimed are recognized in the art as permeable, see for example Gelain et al., Journal of Controlled Release 145 (2010) 231–239, previously provided, and US Patent No. No. 5670483, it is particularly important to clearly establish the metes and bounds of what is claimed to be able to distinguish a method that falls within vs. outside the metes and bounds of what applicant claims.
It is unclear as to the claimed (alleged) “fluid-impermeable barrier at the site of administration”:
What does this barrier prevent from passing: water (which would require very tight angstrom spaces between peptides), serum peptides, serum proteins, ions such as sodium, calcium and potassium?
How long to this claimed (alleged) impermeability to fluids last, given at least that SAPs encompassed by the claims are known to be biodegradable (this also claimed in instant claim 21) and also given the multiple durations/intervals of instant claim 18?
Also, given that what is claimed is forming a fluid-impermeable barrier, which on its face prevents passage of bodily fluids so reasonably also would prevent passage of larger moieties in such fluids, such as cells and signals, including pro-inflammatory cells and signals, it is unclear how this can be while only “reducing … the passage of pro-inflammatory cells and signals.” If the barrier is “effective to prevent the movement of bodily fluids through the barrier,” it is unclear how larger moieties than an aqueous bodily fluid can still have some passage therethrough, albeit per the claim such passage merely being reduced rather than prevented.
Independent claim 12, and all dependent claims therefrom, 3-4, 6-11, 13-15, 17-19, 21-23, are rejected on these bases.
Separately:
Claim 6 recites the limitation "the disorder" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 also is rejected because it is unclear whether the claim 12 method is somehow also, separately, administering the one or more agents separately from what is administered into a joint (there is no additional step in claim 12), or such one or more agents are co-administered into a joint with the claim 12 administering of the SAP(s), and if so whether these one or more agents are chemically combined with such SAP(s). Please note that there is no “administering” step in claim 6.
Claim 7 is rejected because it is unclear how “eye patches” are administered into a joint. (Arguendo, even if applicant were envisioning treating a crustacean that has jointed eye stalks, it is unclear how eye patches administered into such arthropod joint would achieve what is claimed.)
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.
Response to Arguments
Applicant's arguments filed 8/26/26 have been fully considered but they are not persuasive.
Applicant appears to argue that by narrowing the breadth of SAP types claimed that applicant overcomes the bases of the previous rejection under this section. That is not the case. Applicant has not explained how it is in possession of what is claimed, including “forming a fluid-impermeable barrier at a site of administration effective to prevent the movement of bodily fluids through the barrier” by such administering.
Examples 1 and 2 of the specification do not satisfy this requirement. Example 1 is directed to an in vitro assay to assess cytokine release by human THP-1 cells in the presence of SAP. No barrier is present in Example 1 that relates to or demonstrates what is instantly claimed. Example 2 is directed to a liver punch evaluation of two of the claimed SAPs compared with saline and cauterization, and demonstrates reduced inflammation with the two SAPs relative to the saline and cauterization approaches. However, the reason(s) for this are not determined to be or include “forming a fluid-impermeable barrier at a site of administration effective to prevent the movement of bodily fluids through the barrier”; RADA-16 is known in the art to have anti-inflammatory and healing functions, including when applied as a barrier to stop bleeding, see Sankar et al., Review in Frontiers in Bioengineering and Biotechnology, June 2021, vol. 9, Article 679525, which reviews prior art studies that indicate improved healing with SAP administration, this in part attributed to forming a hemostatic barrier similar to ECM that allows for healing, see pages 10-11, and does not teach or suggest what applicant claims as the basis for the healing effects. The knowledge in the art points to other factors for healing apart from what is instantly claimed, and does not support possession of what is instantly claimed.
Claims 3-4, 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 (IV) of claim 12 that achieve the newly added limitation “forming a fluid-impermeable barrier at a site of administration effective to prevent the movement of bodily fluids through the barrier” by such administering. A second issue is whether there is possession for reducing or preventing all symptoms listed in claim 12, and a third issue regards possession of further limitations in the dependent claims, including particularly claim 6, given what may be combined with the claimed SAPs.
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 (IV) of claim 12 that are instantly claimed to achieve the newly added limitation “forming a fluid-impermeable barrier at a site of administration effective to prevent the movement of bodily fluids through the barrier” 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 by administering any one combination of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (IV) 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, previously provided. 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. US Patent No. 5670483 also teaches permeability of at least one of its SAPs, and see also Koutsopoulos et al., PNAS, March 24, 2009, vol. 106, no. 12, pp 4623-4628, and Cormier et al., ACS Nano. 2013 September 24; 7(9): 7562–7572.
A self-assembling peptide hydrogel as taught in the prior art is substantially water and applicant has not set forth guidance, examples, concentrations, ways of administering, to indicate how its method achieves “forming a fluid-impermeable barrier at a site of administration effective to prevent the movement of bodily fluids through the barrier” by such administering per claim 12 any combination of self-assembling peptides or self-assembling peptidomimetics selected from Formulas (I) to (IV) of claim 12, nor “thereby reducing or preventing the passage of pro-inflammatory cells and signals” (versus any other cells or signals), when such self-assembling peptides or self-assembling peptidomimetics are administered so as to form a hydrogel, this expected even if administering the composition in dry form that then becomes hydrated upon contact with fluids in the joint (unless such are removed, which is not taught). 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 … effective to prevent the movement of bodily fluids …”.
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 … effective to prevent the movement of bodily fluids …”. 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 that is shown to achieve what is claimed.
As to the second issue, the list of symptoms in claim 12, that are stated to be reduced or prevented by administration into a joint of the subject in need thereof, of the composition, there is no clear possession of the following symptoms that are unrelated to a joint disease/condition of such subject in need thereof as to the joint, particularly when such symptom as set forth in claim 12 is at a different location in the subject: irritation (such as due to a mosquito bite or allergy), swelling (at a location other than the joint being administered), redness or other discoloration (at a location other than the joint being administered), malaise (this a general symptom that can be caused by any number of other causes than a condition in the joint), as well as other listed symptoms that are at a location other than the joint being administered, or caused by other diseases/conditions. Applicant should reconsider what is being claimed and how claimed, to focus on symptoms clearly associated with what is being administered and where it is being administered.
As to the third issue, there are insufficient teaching, guidance, structure/function relationships, and examples for possession of the large genus of the composition administered, and/or method also administering, any of the possible genera of additional components set forth in claim 6 (as this claim is understood given the lack of whether these are being administered, see rejection above).
There is insufficient support for the breadth of the genus in the application as filed for claim 12, and for any of the claims 3-4, 6-11, 13-15, 17-19, 21-23 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).
Response to Arguments
Applicant's arguments filed 8/26/26 have been fully considered but they are not persuasive.
Applicant appears to argue that by narrowing the breadth of SAP types claimed that applicant overcomes the bases of the previous rejection under this section. That is not the case. Applicant has not explained how to achieve what is claimed, “forming a fluid-impermeable barrier at a site of administration effective to prevent the movement of bodily fluids through the barrier” by such administering.
Nor does applicant explain what it does differently with the same claimed SAPs of Modulus I, such as RADA-16, that the prior art teaches is permeable.
The concentration ranges taught overlap with those that form hydrogels that the prior art teaches are permeable.
As to the examples, Example 1 is directed to an in vitro assay to assess cytokine release by human THP-1 cells in the presence of SAP. No barrier is present in Example 1 that relates to or demonstrates what is instantly claimed. Example 2 is directed to a liver punch evaluation of two of the claimed SAPs compared with saline and cauterization, and demonstrates reduced inflammation with the two SAPs relative to the saline and cauterization approaches. However, the reason(s) for this are not determined to be or include “forming a fluid-impermeable barrier at a site of administration effective to prevent the movement of bodily fluids through the barrier”; RADA-16 is known in the art to have anti-inflammatory and healing functions, including when applied as a barrier to stop bleeding, see Sankar et al., Review in Frontiers in Bioengineering and Biotechnology, June 2021, vol. 9, Article 679525, which reviews prior art studies that indicate improved healing with SAP administration, this in part attributed to forming a hemostatic barrier similar to ECM that allows for healing, see pages 10-11, and does not teach or suggest what applicant claims as the basis for the healing effects. The suppression of ED-1 and GFAP macrophage activation markers does not unequivocally indicate the formation of the claimed fluid-impermeable barrier when considering other effects of the SAPs and the known permeability of RADA-16 and other SAPs. The knowledge in the art points to other factors for healing apart from what is instantly claimed.
Given the above, and the teachings of the cited references, the examiner disputes the conclusion that, even when limited to Modulus I peptides subset as claimed, the quantity of experimentation to practice the full scope of the claimed method is low. What is claimed is contradictory to the prior art that teaches permeability of the same SAPs including RADA-16.
Claims 3-4, 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.” (emphases added)
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.
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 (IV) of claim 12 wherein the composition is administered into a joint, the steps of the method comprising
By administering to the subject at a site of inflammation or at risk of inflammation a composition comprising a plurality of self-assembling peptides, wherein the amino acid sequence of each self-assembling peptide in the plurality of self-assembling peptides is the same and conforms to any one of Formulas I-IV (as set forth in claim 12) in an amount effective to reduce or prevent one or more symptoms selected from the group consisting of pain, irritation, swelling, redness or other discoloration, loss of sensation, reduced mobility, fever, headache, itching, discharge of pus, headache, chills, muscle stiffness, immobility of a joint, loss of function of an organ, stimulation of nerve endings by bradykinin, increased blood flow, malaise, and physiological responses associated with production of histamine and/or heparin
Forming a fluid-impermeable barrier at the site of administration
Effective to prevent the movement of bodily fluids through the barrier
Thereby reducing or preventing the passage of pro-inflammatory cells and signals.
Dependent claims further limit range of such self-assembling peptide, concentrations, and other types of limitations, including per claim 6 (and not excluded by claim 12) one or more additional agents, but neither the claims nor the application as filed indicate how such further limitations achieve limitation “forming a fluid-impermeable barrier” or other stated results of such administering.
(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 bodily fluids through the barrier.”
(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. See also Nagai et al., Journal of Controlled Release 115 (2006) 18–25, which also teaches release of molecules in a RADA-16 hydrogel. These references establish SAP hydrogels that exhibit characteristics 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: EXTREMELY SCANT as to how to achieve what is instantly claimed, as to “forming a fluid-impermeable barrier to the movement of bodily fluids through the barrier.” There are only a few general statements are found, none are 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 bodily fluids through the barrier.” There is no meaningful direction as to how to achieve this when, per claim 6, additional agents are combined if these are part of the resultant SAP-based hydrogel or other structure, or if these one or more additional agents are joined with any SAP peptide sequence (and how that might affect the claimed fluid-impermeability).
(G) The existence of working examples: none relevant to forming a barrier in a joint, and none clearly demonstrating “forming a fluid-impermeable barrier to the movement of bodily fluids through the barrier.” The suppression of ED-1 and GFAP macrophage activation markers does not unequivocally indicate the formation of the claimed fluid-impermeable barrier when considering other effects of the SAPs and the known permeability of RADA-16 and other SAPs.
(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. This is especially the case when additional agents are added, as in claim 6.
In summary, no claim is enabled and undue experimentation would be required to practice the claimed invention. Claims 3-4, 6-15, 17-19, 21-23 are rejected as not being enabled.
Conclusion
No claim is allowed.
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/JOSEPH FISCHER/Primary Examiner, Art Unit 1658
