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 .
Restriction/Election
Applicant’s election without traverse of group I, claims in the reply filed on 04/24/26 is acknowledged.
Claims 51, 58, 59 and 63 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/24/26.
Applicants further elected the subgenus SEQ ID NO: 1 (AKXSXXXTXK) as the elected species, wherein each X at position 3, 6, and 7 is independently a proline or a 4-hydroxyproline, and each X at position 5 and 9 is independently a tyrosine or a 3,4- dihydroxyphenylalanine. Although applicants have responded that the fully defined species of claim 38 is exemplary of the smaller elected subgenus of SEQ ID NO: 1, which is a repeat of mefp-1 that gets enzymatically oxidized to l-dopa.
Applicants have also responded that claims 1, 2, 4-6, 9, 11-16, 18, 35, 38, 39, 40, 47, 49, 51, 56, and 58-63 encompass the elected species; however, this is not the case. Claims 19-21, 23, 30 are not drawn to the elected subgenus of SEQ ID NO: 1, but to entirely different peptides (SEQ ID NOs: 2-15) that do not read on the elected species. Claim 18 also does not read on the elected species because mefp-1 does not comprise a helix-loop-helix motif, as it is known in the art to be a random coil with its decapeptide segments (See S. Haemers et al. Biomarerials, 26, 120051 pp. l23l-1236; p. 1232, Col. 2). As such, these claims are withdrawn.
As to applicants’ election of FX1 with a norbornene homopolymer backbone. Because applicants elected FX1 and the substructure of S1b, claims 40-42 and 45-46 are withdrawn because they read on FX2. The elected invention and species read on claims 1, 2, 4-6 , 9, 11-16, 35, 36, 38-39, 47, 49, 51 and 60-62, which are currently under examination. Additionally, upon completing the search, the art read on the peptide species SEQ ID NO 10: GSGSGS of claim 30 as well, so this claim will be included. An Office action on the merits follows.
Claim Rejections 35 USC 112(b)
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.
Regarding claim 1, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Appropriate correction is s required.
Note that this phrase is present in withdrawn claims 40 and 59 as well.
Claim Rejections 35 USC 102(A)(1)
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 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.
Claim(s) 1, 4-6, 9, 11-14, 35, 36, 47, 49 and 60 are rejected under 35 U.S.C. 102(A)(1)as being anticipated by Wilke et al. (European Polymer Journal 62 (2015) 374–379).
Wilke teaches peptide-polymer conjugates composing of a poly( ethylene oxide) (PEO) block polymer and a precursor segment from mussel foot protein-1 (mefp-1) are enzymatically oxidized by tyrosinase (abstract). This reference teaches that mefp-1-block-PEO bioconjugates with PEO-block lengths of 850, 3200 and 5200 g/mol were synthesized and investigated to eluci-date effects of PEO-block length on the enzyme activable formation of antifouling coatings on aluminum oxide surfaces, and showed a functional transition from weak/reversible binders to strong/irreversible adsorption onto aluminum oxide surfaces (abstract). This reference further teaches that PEO-block length variation systematically affects the activation kinetics of the bioconjugates by tyrosinase, the adhesion behavior of the activated bioconjugates, the stability of the resulting aluminum oxide coatings and the antifouling properties of coated aluminum oxide surfaces, where mefp-1-block-PEO3200 exhibits the best enzyme activation and adhesive properties (abstract). Wilke also teaches using the polymer peptides as adhesion peptides in biomedical applications (p. 374, Col. 2).
This meets the limitations of claim 1 where B1 and/or B2 are PEO subunits and T1 and T2 are the termination groups of the polymer, as there are no structural requirements for T1 or T2, L1 is a linking group, which can be a covalent bond, and P1 is the mefp-1 peptide, where the peptide comprises SEQ ID NO: 1 (AKXSXXXTXK), which is AKPSYPPTYK and repeats (See e.g., residues 221-429 of mefp-1). Claims 4-6, 9 and 11 are me because mefp-1 is mussel foot protein, which comprises AKPSYPPTYK. Claim 12 is met because mefp-1 is all L-amino acids. Claim 13 is met because there is a catechol residue. Claim 14 is met because the peptide comprises lysine. Claim 35 is met because P1 is ten residues. Claim 36 is met because there is no structural guidance for the peptides of claim 1, meaning that the peptide can be any sequence containing any portion of a naturally occurring peptide, and gaps can be any residue. As such, any peptide having any stretch of 4 amino acids meets this limitation, as an amino acid gap in an amino acid sequence is not limited to anything other than an amino acid residue between any other two amino acid residues.
Claim 49 is met because the adhesion peptides are used in medical and diagnostic adhesive applications (see abstract), and the recitation of the specific type of adhesive is an intended is of what the peptide known to have adhesive properties.
The MPEP states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id
As such, the same adhesive peptide-polymer is taught, and the capability to be used in the claimed applications are inherent to the composition itself. Similarly, the performance of the polymer on an atomic force microscopy adhesion test in claim 47 is also inherent to the same composition, meeting the 100pN limitation of the claims.
Claim(s) 1, 15, 16, 30, 35, 36, 39, 45, 47, 49 and 60-62 are rejected under 35 U.S.C. 102(A)(1)as being anticipated by Blum et al. (US10,980,744).
Blum teaches a methodology for protecting active peptides from proteolysis by packaging them into high-density brush polymers via ring opening metathesis polymerization (ROMP), graft-through polymerization of norbornyl-peptide monomers (Col. 6, lines 36-60). This method results in structures that resist proteolysis relative to their monomeric analogues to maintain their intended biological function (Col. 10, lines 36-60). Blum further teaches various embodiments of compositions comprising a cell penetrating high density brush peptide polymer, drug delivery vehicles for delivering cell penetrating peptides and drugs, and methods of preparing the same.
These embodiments include:
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120
378
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(Col. 171)
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574
382
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and also teaches various GSGSG (, e.g., SEQ ID NO:1), which were reduced to practice in the M(O) formula (Claim 21).
This meets the limitations of claims 1, 35, 45 and 60-62 by teaching the same genus of formula FX1, by teaching the same Sb1:
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184
196
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where L1 is a linking group, including a covalent bond or alkyl, P1 is a peptide comprising GSGSGSG, meeting the limitation of 75% identical to any naturally occurring sequence with any GS repeats. T1 and T2 are generically terminal polymer moieties, as taught for R1 and R2. Claim 30 is met because the peptide is a GSGSGS peptide. Claims 15 and 16 are met because Claims 36 is met because any 4 amino acids can be considered to have an amino acid residue gap. Claim 49 is met because the adhesion peptides are used in biomedical applications, and the recitation of the specific application is an intended us of the composition. The MPEP states: "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel." Id
As such, the same adhesive is taught, and the capability to be used in the claimed applications are inherent to the composition itself. Similarly, the performance of the polymer on an atomic force microscopy adhesion test in claim 47 is also inherent to the same composition, meeting the 100pN limitation of the claims.
This reference further teaches examples such as:
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328
700
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, which read on claim 39, where R1 must be present and must be something other than a peptide, such as PEG or a cycloalkyl. As such, claim 39 is met where R1 is present and T1 is either a phenyl or a metal group.
This reference also teaches embodiments, such as
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318
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, which meets the elected species for Sb1. This also can be considered to meet the limitation of 75% identical to a naturally occurring tandem repeat because there is extremely wide variability in the sequence of these peptides, which is not structurally defined and does not designate the naturally occurring source for many of the peptides. As such, the KLA repeat or similar could be 75% identical to many naturally occurring peptides (e.g., GLKL; See Sakai et al. VOL.124, NO. 7, 2002 9 J. AM. CHEM. SOC., abstract), where some of the peptides are substituted, and others are gaps, as there is no guidance as to which proteins and what portions of this extremely broad genus of peptides are required because they have so much variability between the percentage that can broadly read on any peptide repeating motif, with additional amino acids filling gaps. Thus, this anticipates the elected substructure and the peptide genus claimed.
Claim(s) ) 1, 2, 4-6, 9, 11-14, 35, 36, 47, 49 and 60 are rejected under 35 U.S.C. 102(A)(1)as being anticipated by Dalsin et al. (J. AM. CHEM. SOC. 2003, 125, 4253-4258; cited in specification at para. 0268).
Dalsin teaches linear monomethoxy-terminated PEGs were conjugated either to a single DOPA residue (MPEG-DOPA) or to the N-terminus of Ala-Lys-Pro-Ser-Tyr-Hyp-Hyp-Thru-DOPA-Lys (mPEG-MAPD), a decapeptide analogue of a protein found in Mytilus edulis adhesive plaques. Gold and titanium surfaces were modified by adsorption of mPEG-DOPA and mPEG-MAPD from solution, after which surface analysis by X-ray photoelectron spectroscopy and time-of-flight secondary ion mass spectroscopy confirmed the presence of immobilized PEG on the surface (Abstract).
This meets the limitations of claim 1 by teaching FX1, which at minimum requires a polymer linked to a peptide in any configuration. T1 and T2 may be any end cap (e.g. hydrogen), as there is no structural requirement, and where m is 1 and n is zero, this anticipates the FX1 formula, as claimed, because there is nothing recited beyond the broad categories of a polymer and a peptide that is 75% identical to a naturally occurring peptide repeat motif. Claim 2 is met because mPEG-MAPD is 75% identical to a natural repeat and contains catechol. Claim 4-6, 9, 11-14, 38 and 60 are met because Dalsin teaches the mepf-1 repeat SEQ ID NO: 1 and S3. Claim 35 is met because Dalsin teaches a peptide of 5-1000 residues (10 residues). Claim 36 is met for the same reasons stated above, as the claimed peptide does not have any required specific sequence structure, and the gaps can be an amino acid.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANETTE M LIEB whose telephone number is (571)270-3490. The examiner can normally be reached M-F 10-7.
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/JEANETTE M LIEB/Primary Examiner, Art Unit 1654
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