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 .
DETAILED ACTION
Status of the Claims
Claims 1-39, 54, and 55 are currently pending. Claims 1-8, 22, 25-27, 36-39, 54, and 55 are the subject of this Office Action. This is the first Office Action on the merits of the claims. Non-elected claims 9-21, 23, 24, 28-35 are withdrawn from consideration.
Election/Restrictions
Applicants' election of Group I (claims 1-39) in the reply filed on 08/17/2026 is acknowledged. Applicants have cancelled non-elected claims 40-53 (drawn to Groups II and III. Applicants have elected Group I with traverse.
The traversal is on the ground(s) that Chmielewski is different from the instant claim. This traversal is not found to be persuasive because Chmielewski reads on the claimed invention. While applicants opine that "the recited binding partner must be a part of the peptide" (response, p. 6), there is no indication of what this is even intended to mean, or how it distinguishes over Chmielewski 's covalently attached (i.e., crosslinked) moieties. A covalently attached moiety (e.g., the integrin binding peptides of Chmielewski) are very much "a part of the peptide".
Thus, the restriction requirement is still deemed proper and is therefore made FINAL.
In the reply, applicants elected the following species:
Binding partner: integrin binding sites*
Binding partner number: 2
Binding partner attachment site and type: direct at the end of the CHP
It is noted that applicants did not elect a sequence or type of binding partner as required at p. 5 of the restriction.
In the reply (p. 6), applicants have stated that claims 1-27, 29-31, 34, 36-39, and 54-55 encompass the elected species. However, these claims cannot be the proper claims to be examined since at least claims 9-17 20, 21, 23, 24, 28-35 do not read on/encompass the elected species or number of binding partner.
Claims 1-8, 22, 25-27, 36-39, 54, and 55 will be examined further on the merits of the claims.
*Because claim 1 does not recite "integrin" per se, the election made in the election made in the response filed 08/17/2026 was confusing and the examiner contacted applicants' representative by phone. Applicants' representative returned the call on 09/04/2026 and stated that the election was meant to be "integrin binding sites". See the indefiniteness rejection below regarding the term "integrin binding sites".
Information Disclosure Statement
The references cited on the information disclosure statement(s) were considered and have been made of record to the extent that each was provided.
Specification Objections
The specification is objected to because par. [0076] states:
"In Table 6, "x" refers to an amino acid residue, and in particular a naturally occurring amino acid residue." (par. [0076])
However, no "x" appears to be present in Table 6. Applicants should check whether par. [0076] was intended to refer to Table 7 instead.
Claim Objections
Claims 54 and 55 are objected to because they do not comply with the sequence rules of 37 CFR §§ 1.821-1.825.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR §§ 1.821-1.825 for the reason(s) set forth in the Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Applicants must comply with the requirements of the sequence rules (37 CFR §§ 1.821-1.825) in order to effect a complete response to this office action.
While applicants have submitted the proper sequence listing, the application is not fully in compliance because the sequences of the claims and specification require a Sequence Identifier (SEQ ID NO) for each of the recited sequences.
Specifically, the application fails to comply with CFR 1.821(d), which states:
(d)Where the description or claims of a patent application discuss a sequence that is set forth in the “Sequence Listing” in accordance with paragraph (c) of this section, reference must be made to the sequence by use of the sequence identifier, preceded by “SEQ ID NO:” in the text of the description or claims, even if the sequence is also embedded in the text of the description or claims of the patent application.
Claims 54-55 contain a peptide sequence of at least 4 amino acids, at least 4 of which are specifically defined. Applicants are required to check the entire disclosure for any other nucleic acid or protein sequences and list them in a sequence listing and identify them with a proper SEQ ID NO. The specification and sequence listing must be amended to bring it into sequence compliance. For any response to this office action to be fully compliant, the response has to bring the application into compliance with the sequence rules. The claims/specification must be amended to be consistent with 37 CFR 1.821 (d). Appropriate correction is required.
Claim Rejections - 35 USC § 112(a) or (pre-AIA ), § 112 (1st Paragraph)
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Written Description
Claims 1-8, 22, 25-27, 36-39, 54, and 55 are rejected under 35 U.S.C. 112, first paragraph or 35 U.S.C. 112(a), as failing to comply with the written description requirement. The claim 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(s), at the time the application was filed, had possession of the claimed invention. Specifically, claim 1 recites "integrin sites", "integrin binding sites", "crosslinking sites", "matrix metalloproteinase (MMP) cleavage sites", "Cathepsin K (CATK) sites".
Regarding the requirement for adequate written description of chemical entities, Applicants' attention is directed to MPEP §2163. In particular, an adequate written description requires a precise definition, such as by structure, formula, chemical name, or physical properties, "not a mere wish or plan for obtaining the chemical invention claimed. An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics," including, inter alia, "functional characteristics when coupled with a known or disclosed correlation between function and structure..." Enzo Biochem, Inc. v. Gen-Probe Inc., 296 F.3d 316, 1324-25 (Fed. Cir. 2002) (quoting Guidelines, 66 Fed. Reg. at 1106). Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. MPEP §2163. However, if a biomolecule is described only by a functional characteristic, without any disclosed correlation between function and structure of the sequence, it is “not sufficient characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.” MPEP §2163.
The disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described. Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1886, 1892 (CAFC 2004). A description of what a material does, rather than of what it is, usually does not suffice to provide an adequate written description of the invention. Univ. of Cal. V. Eli Lilly, 119 F.3d 1559, 1568 (Fed. Cir. 1997). The recitation of a functional property alone, which must be shared by the members of the genus, is merely descriptive of what the members of the genus must be capable of doing, not of the substance and structure of the members. See Centocor Ortho Biotech Inc. v. Abbott Labs., 97 USPQ2d 1870, 1875, 1877-78 (Fed. Cir. 2011). Furthermore, to the extent that a functional description can meet the requirement for an adequate written description, it can do so only in accordance with PTO guidelines stating that the requirement can be met by disclosing "sufficiently detailed, relevant identifying characteristics," including "functional characteristics when coupled with a known or disclosed correlation between function and structure." Univ. of Rochester v. G.D. Searle, 69 USPQ2d 1427, 1432 (DC WNY 2003).
"It is 'not a question of whether one skilled in the art might be able to construct the patentee's device from the teachings of the disclosure ....Rather, it is a question whether the application necessarily discloses that particular device.'" Martin v. Mayer , 823 F.2d 500, 505 (Fed. Cir. 1987), quoting Jepson v. Coleman, 314 F.2d 533, 536 (CCPA 1963)). Here, because the specification lacks a description of structural features required to exhibit the recited properties, the specification does not support a finding that the particular composition is necessarily disclosed.
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.
In the instant case, while the specification repeatedly refers to "integrin sites", "integrin binding sites", "crosslinking sites", "von Willebrand Factor (VWF)", "discoidin domain receptor (DDR) 1", "DDR 2", "SPARC binding peptides", "fibronectin binding peptides", "engineered integrin binding peptides" "matrix metalloproteinase (MMP) cleavage sites", and "Cathepsin K (CATK) sites", and "osteoclast-associated receptors (OSCAR)" the actual structural features of this critical claim limitation are not clearly described. The specification teaches that GFOGER is a binding site for α1β1 and α2β1 integrins ([0047]), and that "integrin binding sites" may be the sequences in Tables 3-6. The specification teaches that "crosslinking sites" may be the sequences in Table 7, "VWF" may be the sequences in Table 8, "fibronectin binding motifs" may be the sequences in Table 9 (however, this designations is unclear at least because par. [0082] states that the sequences in Table 9 are "crosslinking sites"), and "MMP cleavage sites" may be the sequences in Table 10. No examples are given for VWF, DDR 1, DDR 2, SPARC binding peptides, or OSCAR. However, even the exemplified sequences are limited to short, sequences that are not clearly defined in the aforementioned tables. Further, the term "site" is not defined in the instant application, and is clearly not limited to a sequence of amino acids at all, let alone the sequences disclosed in the application. The limited number of sequences for each of the genera claimed do not describe a sufficient number of "sites" or example sequences so as to convey possession of the entire genus encompassed by the claims. The skilled artisan would have been unable to readily envision the chemical structures and/or sequences of the claimed subject matter. As such, the instant claims lack adequate written description of "integrin sites", "integrin binding sites", "crosslinking sites", "von Willebrand Factor (VWF)", "discoidin domain receptor (DDR) 1", "DDR 2", "SPARC binding peptides", "fibronectin binding peptides", "engineered integrin binding peptides" "matrix metalloproteinase (MMP) cleavage sites", and "Cathepsin K (CATK) sites", and "osteoclast-associated receptors (OSCAR)" as recited in claim 1. In the present case, other than the specific sequences mentioned, the disclosure fails to describe the claimed components in a manner that complies with the written description requirement of 35 USC § 112(a).
Claim Rejections - 35 USC § 112(a) or (pre-AIA ) 35 USC § 112 (1st Paragraph)
The following is a quotation 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.
Scope of Enablement
Claim 37 is rejected under 35 U.S.C. 112(a), as failing to comply with the enablement requirement.
Claim 37 is rejected under 35 U.S.C. 112(a) because the specification does not enable one to prepare compositions in which the CHP does not form a triple helix with other CHPs. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
In this regard, the application disclosure and claims have been compared per the factors indicated in the decision In re Wands, 8 USPQ 2d 1400 (Fed. Cir., 1988) as to undue experimentation. The factors include:
1) the nature of the invention;2) the scope or breadth of the claims;3) the state of the prior art;4) the predictability or unpredictability of the art; 5) the relative skill of those skilled in the art; 6) the presence or absence of working examples; 7) the amount of direction or guidance presented and,8) the quantity of experimentation necessary.
The relevant factors are addressed below on the basis of comparison of the disclosure, the claims and the state of the prior art in the assessment of undue experimentation.
Scope or breadth of the claims: Instant claim 37 recites:
"The composition according to claim 36, wherein the modified CHP does not form a triple helix with other modified CHPs.."
However, the instant specification as originally filed lacks adequate guidance, direction or discussion to apprise the skilled artisan of the specific conditions and/or formulation(s) to be used to produce a modified CHP having this property.
State of the prior art/Degree of predictability in the art: Collagen, including the instant CHP is known to form triple helix structures (see instant pars. [0001], [0015]-[0016], [0020], [0035], [0044], [0046]-[0047]; Figs. 1A-1B, 3A, 6).
Relative skill possessed by those in the art: The level of skill in the art is high and is at least that of a medical doctor or Ph.D. scientist with several years of experience in the field(s) of drug formulation and tissue engineering.
Presence of working examples/Amount of guidance provided: No working examples were provided showing how to formulate the CHPs of the invention such that they do not form triple helices. In considering the guidance provided in the specification, only par. [0095] mentions that the composition may be formulated such that the CHP does not form a triple helix. However, no details are provided on how this is accomplished. In the absence of working examples, undue experimentation would be necessary for one of ordinary skill in the art at the time the invention was made to make and use the claimed invention since it would be possible to produce the pharmaceutical administration form as claimed only under a limited variety of conditions.
Quantity of experimentation required to make and use the invention: In view of the factors discussed above, the state of the art with regard to formulating CHPs that do not form triple helices is fairly complex and sufficiently unpredictable such that the skilled artisan would have been required to undertake undue experimentation to determine the exact conditions and formulation to achieve this goal. Absent detailed direction or guidance as to how the skilled artisan would go about formulating the CHPs as claimed to have the specific property of not forming triple helices, the ordinary artisan would have no alternative recourse but to undertake an exhaustive, and, thus, unduly burdensome search of formulations to produce the claimed invention.
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.
Claims 1-8, 22, 25-27, 36-39, 54, and 55 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 pre-AIA the applicant regards as the invention.
A. Claims 1-8, 22, 25-27, 36-39, 54, and 55 are indefinite in the recitation "(Gly-X-Y)" in claim 1. This term is unclear because it includes two variables (X and Y), but only one is clearly defined. Specifically, the claim requires that at least one of X and Y is proline (or modified proline, and/or hydroxyproline), but is silent as to the identity of the other variable when both variables are not proline (or modified proline, and/or hydroxyproline). It is unknown what the metes and bounds of the other variable are when both X and Y are not proline (or modified proline, and/or hydroxyproline). For example, when X is proline (or modified proline, and/or hydroxyproline), Y could be construed to allow for ANY other molecule, even non-amino acids. The use of Y as a variable in this claim is further problematic because it is the standard single letter abbreviation for the amino acid tyrosine. It is unclear whether Y has any relation to tyrosine in the claim, or if the use of Y is intended to denote some other variable (undefined, as discussed above).
B. Claims 1-8, 22, 25-27, 36-39, 54, and 55 are indefinite in the recitation "at least one of X and Y is proline, modified proline, and/or hydroxyproline" in claim 1. It is unclear whether the claim allows for each of X and Y to be up to 3 residues. Specifically, the use of the conjunctions "and/or" means that the claim encompasses "at least one of X and Y is proline, modified proline, and hydroxyproline", requiring at least one of X and Y to be all three of proline, modified proline, and hydroxyproline. This means that X and Y together could potentially allow for up to 6 residues (i.e., two repetitions of proline, modified proline, and hydroxyproline). Alternatively, the claim could be intended to mean that at least one of X and Y must contain one selected from the group of proline, modified proline, and hydroxyproline. Clarification is required.
Note the definitions of the terms in pars. [0030]-[0031] of the pre-grant publication. Specifically, par. [0031] defines "or" to include "and". Thus, applicants should be mindful of these issues when amending the claim.
C. Claims 1-8, 22, 25-27, 36-39, 54, and 55 are indefinite in the recitations "integrin sites", "integrin binding sites", "crosslinking sites", "matrix metalloproteinase (MMP) cleavage sites", "Cathepsin K (CATK) sites" in claim 1. The metes and bounds of what constitutes a "site" are unclear for multiple reasons as discussed below. For instance, while one might construe a "site" to be a short sequence of amino acids having a particular function (e.g., binding to integrin), binding sites in proteins can, and often are, composed of amino acid residues (and sometimes other molecules) that occur far apart and are only brought into proximity when properly folded in the 3D structure of the native protein. Thus, it is unclear if the recitation of "sites" requires a certain length of amino acids (e.g. forming a 3D binding site), or excludes certain lengths of amino acids. The term "site" is also not defined in the instant application, so it cannot be said that a "site" absolutely requires amino acids at all. There is also no requirement for the binding "site" to have any particular affinity for a ligand. For instance, integrins are known to bind non-specifically to plastic surfaces. Such plastic polymers could therefore be considered "integrin binding sites" within the meaning of the instant claims. It is also unknown if "integrin binding sites" refer to a molecule which is recognized by integrin or to a molecule that recognizes integrin. This is not merely semantic because the "integrin binding site" would be different depending on the meaning (e.g., a part of the integrin or a part of the molecule that recognizes integrin). Similar uncertainty is present with the recitation of "Cathepsin K (CATK) sites". It is also unclear how the term "integrin sites" relates to the term "integrin binding sites". For example, the terms "integrin sites" and "integrin binding sites" are listed separately in the claim. It is unclear how they differ, if at all.
Even greater uncertainty occurs with the vague terms "integrin sites" and "crosslinking sites". Is an integrin site different from an "integrin binding site"? If so, what are the requirements of each? Is an "integrin site" merely any part of an integrin, such as a single amino acid? What type of crosslinking is intended? Covalent? Non-covalent (e.g., ionic)? Given that almost any functional group can be induced to crosslink by one means or another, what are the metes and bounds of a "crosslinking site"? The interpretation of the claims is further confounded by the fact that the CHP sequences and binding partner sequences can be identical (e.g., see claims 4 and 22 where SEQ ID NO: 1 is recited as both a CHP sequence (claim 22) and as a binding partner sequence (claim 4)).
Since one of ordinary skill in the art could not be expected to make a reasonable distinction in the absence of further definitions and/or guidance in the specification, the metes and bounds of these claims are indefinite.
The Federal Circuit has noted that "the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation." Halliburton Energy Servs., 514 F.3d at 1255 (Fed. Cir. 2008).
Claim Rejections - 35 USC § 102
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)(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.
Claims 1-3, 36, and 37-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CHMIELEWSKI (US 2011/0081324; Pub. Apr. 7, 2011; on IDS).
Chmielewski discloses conjugates of collagen peptides (title; abstract). Chmielewski claims a synthetic collagen conjugate capable of forming a type II helix (i.e., a CHP) comprising a peptide comprising the sequence Gly-Pro-Xaa or Gly-Xaa-Hyp, where Xaa may be proline or hydroxyproline ([0016], [0063]; claims 41-43, 53). The peptides are covalently attached (i.e., crosslinked) to a metal binding moiety (claims 41, 44-46, 54). The peptides may also be linked to a drug or diagnostic agent (e.g., with a divalent linker), which may be an integrin binding peptide ([0070]; claims 56, 58). Chmielewski teaches that RGD peptides (i.e., "integrin binding sites") provide the opportunity to introduce growth factors and cell adhesion peptides that could be released in a spatially or temporally distinct fashion for cell growth/differentiation and tissue engineering/regeneration ([0118]). Chmielewski directly teaches covalent modification of collagen peptides with cell adhesion molecules (e.g., RGD-based peptides that mimic full-length integrin binding domains) ([0130]-[0131]).
Regarding claim 37 this claim recites a certain property of the claimed CHPs. MPEP § 2112.01 states that if a composition is physically the same, it must have the same properties. Thus, the property recited in claim 37 (not forming a triple helix with other CHPs) are presumed to be present in any composition that meets the structural requirements of the claims, absent evidence to the contrary. If this is not the case, then applicant is either missing essential subject matter from the claims, not enabled for the full scope of the claims, or both. Note the enablement rejection of this claim presented above.
For example, regarding functional language, the MPEP states, "While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). See MPEP § 2114.
Moreover, the property of the composition recited in claim 37 is present in a wherein clause, which does not add any structural features to the claims, and also may be directed to the intended use of the claimed composition. Regarding wherein clauses and intended use, the MPEP states, "Language that suggests or makes optional but does not require steps to be performed or does not limit a claim to a particular structure does not limit the scope of a claim or claim limitation. The following are examples of language that may raise a question as to the limiting effect of the language in a claim:
(A) statements of intended use or field of use,
(B) “adapted to” or “adapted for” clauses,
(C) “wherein” clauses…"
(D) “whereby” clauses.
This list of examples is not intended to be exhaustive. See also MPEP § 2111.04." See MPEP § 2103(I)(C). Thus, the limitation regarding the ability of the CHP to not form triple helices in claim 37 is not necessarily afforded patentable weight. Claims 37 are rejected pending clarification of this issue.
Regarding claim 38, Chmielewski teaches administration of the compounds in flowable formulations such as for injection ([0081]). This suggests a liquid vehicle or carrier to anyone of skill in this art. Chmielewski further teaches the formulations include poloxamers as said liquid components ([0081]).
Regarding claim 39, Chmielewski teaches the compositions are for cosmetic purposes (abstract; [0018]), and the compositions are considered to be artificial extracellular matrices ([0003], [0016]) .
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 at the time any inventions covered therein were effectively filed 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 at the time a later invention was effectively filed 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.
Claims 1-3, 5-8, 25-27, 36, and 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over CHMIELEWSKI (US 2011/0081324; Pub. Apr. 7, 2011; on IDS).
The teachings of Chmielewski are presented above, and are incorporated herein.
Regarding claims 5-8, Chmielewski's teachings of integrin binding domain peptides suggests the use of any known type of integrin.
Regarding claims 25-26, Chmielewski teaches collagen fibers having functional groups incorporated at the N- and C- termini are known ([0010]). Chmielewski suggests incorporation of cell adhesion molecules at the N- or C- terminus of the peptides ([0126], [0130]).
Claims 4 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over CHMIELEWSKI (US 2011/0081324; Pub. Apr. 7, 2011; on IDS) and YU (US 2013/0164220; Pub. Jun. 27, 2013).
The teachings of Chmielewski are presented above, and are incorporated herein. Chmielewski does not expressly teach the CHP sequences recited in claims 4 or 22. However, these sequences were known and would have been obvious to use in Chmielewski's invention.
For example, Yu discloses collagen mimetic peptides to targeting collagen strands in vitro and in vivo (title; abstract). Yu teaches the collagen compounds may be conjugated to biologic agents including cell adhesion molecules such as integrin ([0061], [0065]). Yu teaches SEQ ID NO: 12, which is identical to instant SEQ ID NO: 1. Note that SEQ ID NO: 1 is recited as both a CHP sequence (claim 22) and as a binding partner sequence (claim 4).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art, to have used the known collagen mimetic peptides of Yu as at least part of the collagens of Chmielewski. One would have been motivated to do so, and would have had a high expectation of success since both Chmielewski and Yu are concerned with collagen peptides that can be conjugated to cell adhesion molecules such as integrins.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over CHMIELEWSKI (US 2011/0081324; Pub. Apr. 7, 2011; on IDS) and FARNDALE (WO 99/50281; Pub. Oct. 7, 1999).
The teachings of Chmielewski are presented above, and are incorporated herein. Chmielewski does not expressly teach the CHP sequences recited in claim 54. However, this sequence was known in the same field of endeavor and would have been obvious to use in Chmielewski's invention.
For example, Farndale discloses collagen peptides that are able to interact with integrins, useful in modulating platelets, cell aggregation, and activation (title; abstract). Farndale teaches peptides containing GFOGER spaced between up to ten GPP triplets (i.e., (GPP)1-10-GFOGER-(GPP)1-10), may be used for crosslinking two copies of the alpha 2 beta 1 integrin receptor (p. 10, lines 7-13).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art, to have used the known collagen mimetic peptides of Farndale as at least part of the collagens of Chmielewski. One would have been motivated to do so, to prepare collagen mimetics able to crosslink integrins and modulate various cell functions (e.g., platelets, cell aggregation, and activation).
Claim 55 is rejected under 35 U.S.C. 103 as being unpatentable over CHMIELEWSKI (US 2011/0081324; Pub. Apr. 7, 2011; on IDS) and RUSSELL (US 2011/0288274; Pub. Nov. 24, 2011).
The teachings of Chmielewski are presented above, and are incorporated herein. Chmielewski does not expressly teach the CHP sequences recited in claim 55. However, this sequence was known in the same field of endeavor and would have been obvious to use in Chmielewski's invention.
For example, Russell discloses synthetic collagen peptides containing inserted biologically active sequences (title; abstract). Russell teaches GFPGER (SEQ ID NO: 10), which supports adherence (i.e., binding) of integrins ([0033]-[0035]). Russell teaches that collagens containing the GFPGER motif are completely non-thrombogenic but bind integrins ([0047]-[0048]) and can therefore be a cell recruiting molecule with applications in angiogenesis, wound healing, and orthopedics ([0051]).
In light of these teachings, it would have been prima facie obvious to one of ordinary skill in the art, to have used the known collagen mimetic peptides of Russell as at least part of the collagens of Chmielewski. One would have been motivated to do so, to prepare non-thrombogenic collagen mimetics with applications in angiogenesis, wound healing, and orthopedics.
Conclusion
Claims 1-8, 22, 25-27, 36-39, 54, and 55 are rejected. Claims 9-21, 23, 24, 28-35 are withdrawn. No claims are currently allowable.
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/Kevin S Orwig/
Primary Examiner, Art Unit 3991
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