DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11, 13-18, 23 and 40 in the reply filed on 29 April 2026 is acknowledged. The requirement is deemed proper and therefore made Final.
Status of Application
Claims 1-11, 13-18, 23, 25-33, 36, 38-41, 50 and 70 are pending; Claims 25-33, 36, 38-39, 41, 50 and 70 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Thus, claims 1-11, 13-18, 23 and 40 are subject to examination on the merits.
Priority
The instant application is a CON of PCT/US2021/057429 filed 29 October 2021 which claims benefit of US Provisional application 63108009 filed 30 October 2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09 August 2023 has been considered by the examiner. See initialed and signed PTO/SB/08.
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.
Claim 4 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 1 recites a recombinant protein comprising a set of non-identical, contiguous polypeptide, the set comprising: a polypeptide consisting of a sequence of RAF1; a polypeptide consisting of a sequence of BRAF, etc. This is thus interpreted that, for example, the recombinant protein possesses a single peptide/polypeptide from RAF1; a single peptide/polypeptide from BRAF, etc.
However, claim 4 recites wherein the set comprises at least two polypeptides consisting of a sequence present in RAF1, BRAF, ARAF, etc. This, however, is inconsistent with the limitations in claim 1.
As a suggestion to overcome this rejection, the claim could be amended to something such as:
The recombinant protein of claim 1, wherein the set further comprises at leastone additional polypeptide consisting of a sequence present in RAF1, BRAF, ARAF, MP2K1, MP2K2, MKO3, MK01, RASK, RASN, or RASH; at leastone additional polypeptide consisting of a sequence present in both of RASH and RASN; and/or at leastone additional polypeptide consisting of a sequence present in each of RASH, RASN, and RASK
Claim Rejections - 35 USC § 112(a)
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.
Claims 1-5, 7-11, 15-18, 23 and 40 are rejected under 35 U.S.C. 112(a) 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 at the time the application was filed, had possession of the claimed invention.
The claims are drawn to a recombinant protein wherein said recombinant protein comprises a set of non-identical, contiguous (concatenated) peptides/polypeptides comprising: a peptide/polypeptide consisting of a sequence present in RAF1; a peptide/polypeptide consisting of a sequence present in BRAF; a polypeptide consisting of a sequence present in BRAFV600E; a polypeptide consisting of a sequence present in ARAF; a polypeptide consisting of a sequence present in MP2K1; a polypeptide consisting of a sequence present in MP2K2; a polypeptide consisting of a sequence present in MK03; a polypeptide consisting of a sequence present in MK01; a polypeptide consisting of a sequence present in RASK; a polypeptide consisting of a sequence present in RASN; a polypeptide consisting of a sequence present in RASH; a polypeptide consisting of a sequence present in each of RAF1, BRAF, and ARAF; a polypeptide consisting of a sequence present in both of RASH and RASN; a polypeptide consisting of a sequence present in both of RASN and RASK; a polypeptide consisting of a sequence present in each of RASH, RASN, and RASK; a polypeptide consisting of a sequence present in each of RASHQ61K, RASNQ61K, and RASKQ61K; a polypeptide consisting of a sequence present in each of RASHQ61R, RASNQ61R, and RASKQ61R; a polypeptide consisting of a sequence present in each of RASHG12V, RASNG12V, and RASKG12V; a polypeptide consisting of a sequence present in each of RASHG13D, RASNG13D, and RASKG13D; a polypeptide consisting of a sequence present in each of RASHG12C, RASNG12C, and RASKG12C; a polypeptide consisting of a sequence present in each of RASHG12D, RASNG12D, and RASKG12D; and a polypeptide consisting of a sequence present in each of RASHG12S, RASNG12S, and RASKG12S; wherein the recombinant protein comprises a trypsin cleavage site between each polypeptide of the set that allows separation of each polypeptide upon exposure of the recombinant protein to trypsin. It is noted, the claimed recombinant protein is interpreted as requiring all of the 22 different non-identical peptides/polypeptides listed in claim 1.
It is noted and well understood in the art, the human proteins as listed in the claims comprise the following:
RAF1 (CRAF) = 648 amino acids
BRAF = 766 amino acids
ARAF = 606 amino acids
MP2K1 (MEK1) = 393 amino acids
MP2K2 (MEK2) = 400 amino acids
MK03 (ERK1/MAPK3) = 379 amino acids
RASK (KRAS) = 189 amino acids
RASN (NRAS) = 189 amino acids
RASH (HRAS) = 189 amino acids
Thus, the claims comprise peptides/polypeptides from each of these, and specific overlapping sequences, from at times very large enzymes, wherein the peptide/polypeptide can be any size ranging from two amino acids to the full-length enzyme. This results in a very large genus of recombinant proteins. The specification, however, is limited to very specific peptides from each of these proteins or those having overlapping peptide sequences, ranging in 7 amino acids (SEQ ID NO: 29) to 26 amino acids (SEQ ID NO: 36) amino acids in length; wherein specifically peptides SEQ ID NOs: 2-40 are cited. These, however, are not representative of the entire claimed genus of at least twenty-two peptides/polypeptides from each of the proteins noted above and the overlapping sequences therein.
The MPEP in section 2163(I) states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made/filed, of the specific subject matter claimed:
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonable conclude the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
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An applicant shows that the inventor was in possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997)"
Further, for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim. In Regents of the University of California v. Eli Lilly & Co. the court stated:
"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." Fiers, 984 F.2d at 1171, 25 USPQ2d 1601; In re Smythe, 480 F.2d 1376, 1383, 178 USPQ 279, 284985 (CCPA 1973) ("In other cases, particularly but not necessarily, chemical cases, where there is unpredictability in performance of certain species or subcombinations other than those specifically enumerated, one skilled in the art may be found not to have been placed in possession of a genus ...") Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed. Circ. 1997).
MPEP § 2163 further states that 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." Furthermore, the courts have also held that 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.
Conclusion
Claims 1-5, 7-11, 15-18, 23 and 40 are rejected.
Claim 13 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 6 and 14 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath Rao can be reached at 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 13 May 2026
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