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 .
Applicant’s response to restriction requirement and amendment of 8/17/26 are entered.
Claims 15 and 17 are amended.
Claims 1, 3-8, 14-20, 24-26, 29-30, and 32 remain pending.
Formalities:
The specification, as amended on 7/10/25 and 8/17/26, are accepted and entered.
The drawings are objected to (see below).
The IDS of 4/23/26 and references therein have been considered. A signed copy of the same is provided herewith.
Election/Restrictions
Applicant’s election of Invention Group I (Claims 1, 3-8, 14-20, 24-26, and 29-30) in the reply filed on 7/29/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant’s election of the species of (i) structural peptide, which is (ii) beta-sheet forming, and specifically (iii) a charged peptide of EE, (iv) VVAA; (v) VVAAEE (SEQ ID NO: 7) of Claim 15, (vi) IKVAV (SEQ ID NO: 9) of Claim 17, (vii) 1-ethyl-3-methylimidazolium for Claim 20, and (viii) and K+ for Claim 26 in the reply filed on 5/29/26 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 32 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 7/29/26.
Claims 1, 3-8, 14-20, 24-26, and 29-30 are considered herein for the elected species. However, if rejections are realized against other species during prosecution, the Examiner will make the rejection(s), even though withdrawn, in the interest of compact prosecution.
Drawings
The drawings are objected to.
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because contain characters below 1/8th an inch in height, the lines are not sharp and defined, they are fuzzy and the shading is not sufficient to fully understand the drawings. Note 37 CFR 1.84(l), 37 CFR 1.84(m), 37 CFR 1.84(p)(1) and 37 CFR 1.84(p)(3). Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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 and 5 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 3 recites “wherein the PAs and OCs co-assemble into nanofibers.” It is not clear what is being claimed. Is Applicant claiming the composition during the process of nanofiber assembly only? Or is Applicant attempting to claim the composition where nanofibers have been formed?
Claim 5 refers to the co-assembly of Claim 3, stating “the co-assembly does not result in gelation or aggregation of the nanofibers.” The scope is not clear. Is Applicant claiming the composition where the nanofibers are not aggregated/gelled? Or is Applicant claiming only that during the formation, no gelation or aggregation occurred? The latter leaves open the possibility that they are gelled or aggregated, in a process after the formation.
Claim Objections
Applicant is advised that should claim 6 be found allowable, claim 29 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 29 requires the composition to further comprise an organic cation. However, Claim 1, from which Claim 29 ultimately depends, already claims the presence of an organic cation. Thus, despite the slight difference in wording, these claims have substantially the same scope.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3, and 5 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 7,554,021 to Stupp, et al. (cited by Applicant in IDS of 4/23/26, patent document reference no. 008).
Claim 1: Stupp teaches peptide-amphiphile nanofibers (e.g., ABSTRACT). The composition comprises, e.g., a negatively-charged peptide-amphiphile and a counterion (e.g., Id.). The counterion may be a, e.g., a second oppositely-charged peptide amphiphile (which would be positively charged to bind the negatively-charged peptide amphiphile (e.g., Id.).
Claim 3: the abstract teaches they can be formed into nanofibers.
Claim 5: The abstract teaches one may form a gel, or simply a nanofiber, meaning it can be done without gelation.
Claim Rejections - 35 USC § 112
Claims 1, 3-8, 14-20, 24-26, and 29-30 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.
The claims are generic for the peptide amphiphiles and organic cations. The claims are also generic for not assembling into nanofibers, as seen by dependent Claim 3. The claims are also generic for resulting in aggregation and gelation as seen by dependent Claim 5. The claims are generic for the peptide amphiphiles do not have the structure of Claim 6. The claims are also generic for the structural peptide segment of PA not being a beta-sheet forming peptide as seen by Claim 7. The claims are also generic for structural peptide segments not comprising a valine rich segment as seen by Claim 7. The claims are also generic for the charged peptide segment not being aspartate rich. Finally, the claims are generic for the organic cation not being 1-ethyl-methylimidazolium as seen by Claim 20.
The specification teaches all of these elements throughout the specification, providing antecedent basis for the same, but this is more of a wish than a description of patentable use of these compositions. For example, page 3 teaches the peptide segment, in specific embodiments, may be E or D rich segments (lines 17-18). Thus, the embodiments are listed. However, when we go to find what is being done, and why, we see that the PAs are tested with different hydrophobic OCs (those as found in figure 46, specifically: PA comprising a palmitoyl chain linked to the C terminus of a peptide of sequence VVAAEE, and doped with one of 5 dopants comprising ID, ID1, … ID4). And their structures were probed by various methods, versus the PA alone, and they were found to have a narrower, twisted, morphology after dopant is added, as well as the PAs gaining a higher charge density, and thus, it was concluded the highly charged PA-OC assemblies had formed by the OC introduction. (Example 1). Importantly, this has no real world use, but to further study, which lacks utility to begin with. However, next, the viability was tested of the five PA-OC assemblies, finding that PA-OC1, i.e., an OC of 1-ethyl-3-methylimidazolium provided greater viability to neurons relative to that pure PA (Figure 50), while the other four reduced the viability of the neurons (p. 38, last paragraph). Importantly then, only PA-OC1 has a use that is described for a patentable use: that of growing neurons with increased viability. The others do not, because reduce the neuron viability. At that point, Applicant abandons the other OCs completely, and goes to characterize PA-OC1. Characterizing the neurons that grow, enhanced electrical activity is noted (p. 39, paragraph 1). Then, in trying to figure out how adding the OC to a negatively-charged PA would increase, rather than decrease charge density, it is found that the OCs (three equivalents) occupy the space between beta-sheets of the PA fiber by displacing structural water (p. 40, paragraph 2). This characteristic is determined by the structure of the structural peptide region and charged peptide region, and requires the amino acids of the OC to be the correct size and orientation of charge to so-occupy it. Thus, the evidence is that the beneficial characteristics are brought about by structure common only to PA and OC, and other PA structures and other OC structures would not work. For example aspartate might be too short, and tyrosine might be too bulky, thereby requiring distinct structure from the beta sheets in the PA, to work to increase the viability of the neurons, because perhaps a lower charge density, or a completely distinct structure develops. The examples go on to demonstrate and characterize only the PA-OC1 and its effects on the neurons in many beneficial aspects.
The Art at the time of filing was deeply interested in the structure and function of peptide amphiphiles: Hendricks, et al. (2017) “Supramolecular Assembly of Peptide Amphiphiles”, American Chemical Society, 50: 2440-48. In it, interest is shown in the structure-function of PAs (e.g., reviewing the sections, they discuss many distinct characteristics and what the structures are that may causing the same), as well a knowledge of beneficial effects on growth of neurons in its presence (e.g., INTROUCTION and paragraph before the conclusion). It is concluded this is an exciting area of study, and much more will come in the future. However, “Although the effects of hydrophobicity and cationic charge of soluble molecules on the cell membrane are well-known, the interactions between materials with these molecular features and cells remains poorly understood” (p. 2444, col. 2, paragraph 3). In essence, the single showing of a single showing, from the prior art, is not enough to provide evidence that any particular commonality between OCs of Applicant’s claims and any particular PA of Applicant’s claims, can elicit the same functional characteristics on neurons.
Therefore, given the limited showing by Applicant of one specific PA-OC that benefits neuron viability, and the extremely large breadth of PA structures and OC structures, The Artisan would not have understood Applicant to have in possession more than the PA-OC1 of the examples, as the utility of the others is to find out how they benefit another aspect of biological science, rather than actually benefiting neuronal growth.
Conclusion
No claim is allowed.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638
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