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
Election/Restrictions
Applicant's election with traverse of Group I, claims 76-85 and species: two or more, collagen-binding protein, VEGF 165, angiopoietin-1, and SEQ ID NO: 1 in the reply filed 07/28/2026 is acknowledged.
The traversal is on the ground(s) that the invention of Group II is basically the same as Group I, so any prior art searched for one group is applicable to the other group. This is not found persuasive because the special technical features of Group I comprises compositions comprising a growth factor (GF) protein, conjugated to one or more targeting moieties, comprising a vascular endothelial growth factor (VEGF) protein conjugated to one or more targeting moieties thereof and compositions comprising a vascular endothelial growth factor (VEGF) protein conjugated to one or more collagen binding proteins (CPBs), while the special technical feature of Group II comprises compositions comprising a growth factor (GF) conjugated to one or more avidin or streptavidin proteins, and compositions comprising a vascular endothelial growth factor (VEGF) protein conjugated to one or more avidin or streptavidin proteins. These proteins, avidin or streptavidin, are not present in any other Group set out in the restriction and thus distinguish it from Group I. For this reason, the groups have been split into distinct inventions.
The requirement is still deemed proper and is therefore made FINAL.
Claims 78, 81, 83-84, 86-95 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims. Election was made in the reply filed 07/28/2026.
Upon further consideration, the Examiner is withdrawing the species requirement for isoforms of VEGF. All species of VEGF are under consideration in the instant Office Action.
Claims 76-77, 79-80, 82, 85 and are now under consideration in the instant Office Action.
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.
Claim 85 is 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.
Instant claim 85 recites that the conjugation of the growth protein to a targeting moiety is conducted via “Click-Chemistry”. The term “Click-Chemistry” is vague in this context as there are several methods to conduct the conjugation process within a method that uses click chemistry, in addition to a variety of bonds that can arise from such a process. The claim from which the instant claim depends is drawn to a composition or product and as such, required to elucidate the entire structure. The instant claim as recited leaves elements undefined, which renders the scope of the claim unclear.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 76-77, 79-80, 82, and 85 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.
See MPEP §2163(I)(A) which states: "The claimed invention as a whole may not be adequately described where an invention is described solely in terms of a method of its making coupled with its function and there is no described or art recognized correlation or relationship between the structure of the invention and its function. A biomolecule sequence described only by a functional characteristic, without any known or disclosed correlation between that function and the structure of the sequence, normally is not a sufficient identifying characteristic for written description purposes, even when accompanied by a method of obtaining the claimed sequence.”
Claim 76 calls for a composition comprising a growth factor protein conjugated to one or more targeting moieties. There is no specific structural requirement for the composition comprising a growth factor protein conjugated to one or more targeting moieties beyond the required binding function. Claims 77 and 79-80 call for additional targeting moieties such as VEGF to be conjugated to the growth factor protein but fails to describe the structure of the protein(s) aside from a functional binding requirement. Finally, claim 85 requires that these unidentified proteins are conjugated via Click-Chemistry and continue to fail to describe any specific structure for the composition. The required function of the composition comprising a growth factor conjugated to a targeting moiety can be achieved in any form, with no specific structure required, as long as they are capable of binding to a particular target. The scope of the claim is so broad and reads on so many possible genera that it is clear that the specification fails to describe all of the possible means of achieving the response linked to its function. The claims do not require any particular composition, or that they possess any particular conserved structure or other disclosed distinguishing features. Therefore, the genera are merely defined by function and the instant specification fails to describe the full genera of the possible methods that are encompassed by these claims.
There is no structural requirement for the claimed composition comprising a growth factor conjugated to a targeting moiety beyond function. Even instant claim 82, which provides a structure for the collagen-binding moiety that is a target moiety, still lacks a complete structure as it fails to describe the identity of the entire composition comprising a growth factor. The claimed activity of the composition can be achieved in any form as long as the composition comprising the growth factor and targeting moiety provide the specifically claimed function of being capable of binding to collagen. Further, compounded by the limitation of potential variants of the composition, it is unclear what would meet the requirements for the function of “collagen targeting” as collagen is a broad genus of proteins with variations in structure.
There are a few specific examples of composition comprising a growth factor conjugated to a targeting moiety in the instant specification, but there is no support provided that the applicants have envisioned all the possible variants encompasses by these functional requirements of the instant claims. The scope of the terms of the “composition comprising a growth factor conjugated to a targeting moiety” is so broad and reads on so many possible genera and the instant specification fails to describe any of the compositions that are encompassed by this term. The broad terminology encompasses any conjugation of protein that has the required function, but the instant specification fails to teach all the possible compositions that are encompassed by the scope of the instant claims. The claims do not require that the “composition” possess any particular conserved structure or other disclosed distinguishing feature. The term “composition” encompasses many things including various proteins, peptides, hormones, small drugs, or other drugs as long as they achieve the required function. Thus, the claims are drawn to multiple genera of molecules that are defined only by their function as a binding agent. Therefore, the genus is merely defined by function and the instant specification fails to describe the full genus of molecules that are encompassed by this claim.
To provide adequate written description and evidence of possession of claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In the instant case, the only factors present in the claims are a recitation of prospective activity or function. There is not even identification of any particular portion of the structure that must be conserved for said activity except its function. The specification does not provide a complete structure of all possible forms of the claims agents and variants and fails to provide a representative number of species for any genera. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genera of compositions comprising a growth factor conjugate to a targeting moiety.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states that “applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed.” (See page 1117.) The specification does not “clearly allow persons of ordinary skill in the art to recognize that they invented what is claimed.” (See Vas-Cath at page 1116).
The skilled artisan cannot envision the detailed structure of the encompassed agents, fragments and variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The product itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF's were found to be unpatentable due to lack of written description for that broad class. Applicant is 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).
Therefore, claims 76-77, 79-80, 82, and 85 are rejected as failing to satisfy the written description requirement.
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.
Claims 76-77, 79-80, and 82 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al. (US 6,387,663 B1, in instant PTO-892), in view of Panitch et al. (in PTO-892 filed 05/29/2026).
Hall et al. teaches new compositions and methods to induce therapeutic angiogenesis locally comprising a growth factor (GF) protein, selected to be VEGF121 or VEGF 165, see Abstract and column 17, lines 8-10.
Hall et al. teaches that “conjugated to one or more targeting moieties, selected to be a collagen binding protein, which is a strategically modified collagen-binding sequence derived from a functional domain within bovine von Willebrand factor was utilized”, see column 17, lines 24-29. Thus, Hall teaches VEGF-CBD fusion constructs, which incorporate the collagen binding decapeptide “WREPSFMALS” into the VEGF protein, which was designed for targeting VEGF to collagen exposed by injury, see column 17, lines. 38-41 and column. 3, lines 49-51. This meets the limitations of instant claim 76 wherein a growth factor is conjugated to a targeting moiety, instant claim 77 wherein the aforementioned composition targets two or more targeting moieties, instant claim 79 wherein the growth factor is a VEGF protein, and instant claim 80 wherein the VEGF protein is specifically VEGF 121 or VEGF 165.
However, Hall fails to teach the decapeptide disclosing a collagen binding protein comprising SEQ ID NO: 1. Panitch et al. remedies this deficiency.
Panitch et al. teaches extracellular matrix-binding synthetic peptidoglycans, specifically collagen binding proteins, see Abstract. The sequence for the collagen binding peptide taught by Panitch et al. is SEQ ID NO: 60, which has 100% sequence homology to instant SEQ ID NO: 1 This meets the limitations of instant claim 82 wherein the targeting moiety is a collagen binding protein that has the sequence of SEQ ID NO: 1.
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the composition of Hall et al., which is a composition comprising VEGF and a collagen binding peptide, with the binding protein as taught by Panitch et al., which is a 100% sequence homology match for instant SEQ ID NO: 1, for the purpose of designing constructs for targeting VEGF to collagen exposed by injury (see Hall et al., column 17, lines 38-41). One would be motivated to combine the VEGF-CBD peptide construct with the specific CBD sequence as recited in the instant claims with the expectation of creating a stable molecule suited for therapeutic uses. Such would amount to the simple substitution of one of one known element for another (i.e. substituting the CBP decapeptide of Panitch et al for the CBP decapeptide of Hall et al) to obtain predictable results, see MPEP 2143(I).
Therefore, claims 76-77, 79-80, and 82 are rejected as obvious over Hall et al. and Panitch et al.
Conclusion
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/SELAM BERHANE/Examiner, Art Unit 1675
/JENNIFER A BENAVIDES/Examiner, Art Unit 1675
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