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
Claims 64-74 are pending.
A request for continued examination after final rejection under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) submitted filed on 12/12/2025 is considered. 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under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/12/2025 has been entered.
Applicant’s argument in the reply filed on 12/12/2025 in their response of office action of 03/05/2025 is acknowledged.
Applicants’ argument submitted on 12/12/2025 is considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claim Rejections
35 USC 112(b) Rejection
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 64, 68, 74 and 65-67, 69-74 58-63 ( depend on claim 64, 68) 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.
For the following reason:
Claim 64, 68 and 74 recite “consists essentially “ render the claims 64, 68 and 74 indefinite because the metes and bounds of the claim is indefinite.
Claim Rejections, 35 U.S.C 112 1st Paragraph
The following is a quotation of the first paragraph of 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.
New Matter Rejection
35 U.S.C. § 112, first paragraph (Written Description)
Claims 65 and 69 are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph - written description requirement, 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(s), at the time the application was filed, had possession of the claimed invention.
The amendments filed on 12/12/2025 are objected under 35 U.S.C. 132 because it introduces new matter into the disclosure (claims & specification). 35 U.S.C. 132 states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows:
Claims 65 and 69, recites the phrase ‘at least 30 contiguous amino acids”. The phrase added into the claims was not part of the original specification and the invention as claimed was not envisioned or foreseen as originally filed.
Applicant is required to cancel the new matter in the reply to this Office Action.
Claims 64, 68 and 73 are rejected under 35 U.S.C. § 112, first paragraph, as the disclosure is enabling only for claims limited to a therapeutic effective amount of a polypeptide.
Factors to be considered in determining whether undue experimentation is required, are summarized in re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988) [ Ex parte Forman [230 USPQ 546 (Bd. Pat. App. & Int. 1986)]. The Wands factors are: (a) the quantity of experimentation necessary, (b) the amount of direction or guidance presented, (c) the presence or absence of working example, (d) the nature of the invention, (e) the state of the prior art, (f) the relative skill of those in the art, (g) the predictability or unpredictability of the art, and (h) the breadth of the claim.
It is neither taught nor any data is provided for using the polypeptide in as a therapeutic affective amount in a composition for the treatment of any of the diseases or disorders. There is no evidence presented that said polypeptide is associated with any of the known diseases or disorders or can be treated by administering the polypeptide. Without such a data or evidence, claims to comprising said polypeptide, would amount to a composition or potential drug for treatment for any disorder or disease, which is not enabled. Given the lack of direction or guidance and the nature of the invention, obtaining such a polypeptide for one of skill in the art would be highly unpredictable. This is because the polypeptide when associated with a particular disease or disorder would be expressed differentially. Manipulating or controlling these levels depends upon the disease or disorder, and may not always be controlled by supplementing with such a polypeptide composition. Further, no guidance in provided, pertaining to the fate of the administrated polypeptide in vivo.
Since it is not routine in the art to engage in de novo experimentation to prepare numerous compositions comprising said polypeptide to be therapeutically effective where the expectation "of success is unpredictable", the skilled artisan would require additional guidance, specific to individual disorder or disease, in order to make and use the polypeptide in a manner reasonably commensurate with the scope of the claims, i.e therapeutically effective. Without such guidance, the experimentation left to those skilled in the art is undue.
Claims 65 and 69 are rejected under 35 U.S.C. 112, first paragraph, as containing 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.
The claims are directed toto a method of modulating stem cell recruitment or a related process in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a polypeptide comprise 30 amino acids of SEQ ID NO: 1
It is noted that MPEP 2111.01 states that "[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow." In this case, in light of the specification, the examiner has broadly interpreted " method of modulating stem cell recruitment or a related process in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a polypeptide as claimed in the claims 65, 69. Therefore claims are directed to a very small fragment of mammalian Decorin polypeptide of SEQ ID NO: 1 ( 30 aa residues out of 360 residues which has therapeutic activity..
The Court of Appeals for the Federal Circuit has recently held that a "written description of an invention involving a chemical genus, like a description of a chemical species, 'requires a precise definition, such as by structure, formula [or] chemical name,' of the claimed subject matter sufficient to distinguish it from other materials." University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fires v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).University of Rochester v. G.D. Searle & Co. (69 USPQ2d 1886 (2004)) specifically points to the applicability of both Lilly and Enzo Biochemical to methods of using products, wherein said products lack adequate written description. While in University of Rochester v. G.D. Searle & Co. the methods were held to lack written description because not a single example of the product used in the claimed methods was described, the same analysis applies wherein the product, used in the claimed methods, must have adequate written description (see Enzo paraphrased above).
In the instant case, there is no structure associated with function with regard to the members of a genus of polypeptide having many structural variant comprising small fragment comprising 30 aa residues of polypeptide of SEQ ID NO: 1 ( which comprise 360 residues). Therefore, the claims encompass many fragment comprising 30 aa residues of polypeptide of SEQ ID NO: 1 ( which comprise 360 residues) comprising any structure having specific activity. The genus of having many structural variant comprising small fragment comprising 30 aa residues of polypeptide having of SEQ ID NO: 1 ( which comprise 360 residues) any structure in the claimed invention is an extremely large structurally and functionally variable genus. Only a few mammalian Decorin polypeptide of SEQ ID 1-4 is disclosed . As disclosed below oligonucleotide or protein function cannot be ascertain by a structure of protein or oligonucleotide fragment of few residues. However, as described below, the art clearly teaches the "Practical Limits of Function Prediction":
A. Davos et al., (Proteins: Structure, Function and Genetics, 2000, Vol. 41: 98-107), teach that the results obtained by analyzing a significant number of true sequence similarities, derived directly from structural alignments, point to the complexity of function prediction. Different aspects of protein function, including (i) enzymatic function classification, (ii) functional annotations in the form of key words, (iii) classes of cellular function, and conservation of binding sites can only be reliably transferred between similar sequences to a modest degree. The reason for this difficulty is a combination of the unavoidable database inaccuracies and plasticity of proteins (Abstract, page 98) and the analysis poses interesting questions about the reliability of current function prediction exercises and the intrinsic limitation of protein function prediction (Column 1, paragraph 3, page 99) and conclude that "Despite widespread use of database searching techniques followed by function inference as standard procedures in Bioinformatics, the results presented here illustrate that transfer of function between similar sequences involves more difficulties than commonly believed. Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (column 2, paragraph 2, and page 105).B. Wristlock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340,) also highlight the difficulties associated with "Prediction of protein function from protein sequence and structure": "To reason from sequence and structure to function is to step onto much shakier ground", closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer (page 309, paragraph 4), it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (page 312, paragraph 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (page 313, paragraph 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein's role fundamentally (page 323, paragraph 1).C. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Kwiatkowski et al., (Biochemistry 38:11643-11650, 1999) teaches that one conservative amino acid substitution transforms a beta -ketoacyl synthase into a malonyl decarboxylase and completely eliminates beta-ketoacyl synthase activity. The art also teaches that functionally similar molecules have different structures; Kisselev L., (Structure, 2002, Vol. 10: 8-9) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
As stated above, no information beyond the characterization of a few mammalian Decorin polypeptide of SEQ ID 1 has been provided by the applicants’, which would indicate that they had the possession of the claimed genus of polypeptides having specific activity. The claimed genera of polypeptides and the encoding polynucleotides have widely variable structures and associated functions. As it is discussed above, a minor changes in structure may result in changes affecting function, since, the specification provided no additional information (species/variant/mutant) correlating structure with function, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed. Furthermore, "Possession may not be shown by merely describing how to obtain possession of members of the claimed ,genus or how to identify their common structural features" (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895). A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the .gene does (function), rather what it is (structure), see University of California v. Eli Lilly & Co., 43 USPQ2d 1938, thus above claims lack adequate written description.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Conclusion
Claims 64-74 are rejected. No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOHAMMAD Y MEAH whose telephone number is (571)272-1261. The examiner can normally be reached on monday-friday (8-7).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 4089187584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MOHAMMAD Y MEAH/ Examiner, Art Unit 1652