DETAILED ACTION
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 .
1. Claims 1-19 are pending in the instant patent application.
Claims 1-19 are under examination.
Claim Objections
2. Claims 8, 12 and 16 are objected to because of the following informalities:
The claims recite “v-SNARE” without first providing the full name of the term. It is suggested that the term be spelled out at its first use and in all independent claims so that it is clearly understood what it stands for. Appropriate correction is suggested.
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.
3. Claims 5-7, 8 and 12-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
4. Claims 5-7 are indefinite wherein they recite functional language. The Office has issued new guidance May and September 2016, which has been incorporated into the current MPEP rewrite dated August 2017, at section 2173.05(g), wherein it states: “the use of functional language in a claim may fail ‘to provide a clear-cut indication of the scope of the subject matter embraced by the claim' and thus be indefinite.” It further states: “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim.” In the instant case, the claims recite a product of claim 1 but then define it —for preventing disease— by functional language. While a functional limitation can provide a patentable distinction (limit the claim scope) by imposing limits on the function of a structure, material or action, in the instant case it is unclear what material/structural or manipulative differences are encompassed by recitation of intended use of the product. Since the claims fail to meet the criteria set forth in MPEP 2173.05(g), then the claims are rejected as being indefinite.
5. Similarly, claims 8 and 12 recite the product of claim 1 but then further define it by functional language, “wherein the peptide inhibits the binding.” This renders the claim indefinite.
6. Also, the term “inhibit” in claims 8 and 12 a relative term which renders the claims indefinite. The term “to inhibit” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Providing a point of reference or comparison within the claims would obviate this ground of rejection.
7. Claim 13 recites the limitation "a composition" in claim 1. There is insufficient antecedent basis for this limitation in the claim.
8. Claim 16 is vague and indefinite insofar as it employs the term “subject requires inhibiting the binding of alpha-synuclein oligomers and v-SNARE protein” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of subjects. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of a “subject requires inhibiting the binding of alpha-synuclein oligomers and v-SNARE protein”, an artisan cannot determine if a subject which meets all of the other limitations of a claim would then be included or excluded from the claimed subject matter by the presence of this limitation.
9. Claims 14, 15 and 17-19 are indefinite for being dependent from indefinite claim(s).
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.
10. Claims 1 and 5-16 are 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.
Claims 1 and 5-16 are directed to parts of a peptide composed of the entire amino acid sequence of SEQ ID NO: 1. The claims do not require that the parts possess any particular conserved structure or other disclosed distinguishing feature. Thus, the claims are drawn to a genus of peptides that is defined only by sequence similarity, if any, see section 4 earlier, to the peptide composed of the entire amino acid sequence of SEQ ID NO: 1. However, the instant specification fails to describe the entire genus of peptides, which are encompassed by these claims.
MPEP §2163(I)(A) states:
“The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional or known in the art. Consider the claim "A gene comprising SEQ ID NO:1." The claim may be construed to include specific structures in addition to SEQ ID NO:1, such as a promoter, a coding region, or other elements. Although SEQ ID NO:1 is fully disclosed, there may be insufficient description of other structures embraced by the claim (e.g., promoters, enhancers, coding regions, and other regulatory elements).”
“An invention described solely in terms of a method of making and/or its function may lack written descriptive support where there is no described or art-recognized correlation between the disclosed function and the structure(s) responsible for the function. For example, the amino acid sequence of a protein along with knowledge of the genetic code might put an inventor in possession of the genus of nucleic acids capable of encoding the protein, but the same information would not place the inventor in possession of the naturally-occurring DNA or mRNA encoding the protein. See In re Bell, 991 F.2d 781, 26 USPQ2d 1529 (Fed. Cir. 1993); In re Deuel, 51 F.3d 1552, 34 USPQ2d 1210 (Fed. Cir. 1995) (holding that a process could not render the product of that process obvious under 35 U.S.C 103).”
To provide adequate written description and evidence of possession of a 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 this case, the only factor present in the claim is a partial structure in the form of a recitation of the term “part.” There is not even identification of any particular portion of the structure that must be conserved. As stated above, it is not even clear what region of the peptide of SEQ ID NO: 1 has the activity necessary to support the asserted utility of the instant invention, such as being useful for clinical administration. The specification does not provide a complete structure of those peptides that are part of the peptide of SEQ ID NO: 1, all suitable for treatment of neurodegenerative diseases, and fails to provide a representative number of species for the claimed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the claimed genus.
Vas-Cath Inc. v. Mahurkar, 19USPQ2d 1111, clearly states “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 [he or she] invented what is claimed.” (See Vas-Cath at page 1116). As discussed above, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus of peptides, 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 compound 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. The specification provided only the bovine sequence.
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).
11. Claims 5-19 are further rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 5-12 encompass peptides composed of the amino acid sequence of SEQ ID NO: 1 or part thereof and pharmaceutical compositions comprising the peptides wherein the peptides are for preventing or treating a neurodegenerative disease. Claims 13-19 are directed to methods of treating a neurodegenerative disease by administration of peptides of claims 5-12. However, the specification does not provide sufficient guidance to enable practice the instant claimed invention without undue experimentation.
The factors to be considered in determining whether a disclosure would require undue experimentation include (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art and, (8) the breadth of the claims. In re Wands, 8 USPQ2d, 1400 (CAFC 1988).
The specification discloses the structure of the peptides of SEQ ID NOS: 1, 2, 3 and 4, and asserts their use for prevention “and therapeutic effects on a neurodegenerative disease such as Parkinson’s disease by inhibiting the binding of v-SNARE protein and alpha-synuclein oligomers,” p. 1. The specification goes on to explain that “the SNARE protein plays a key role in ensuring that the information contained in [synaptic vesicle that transports dopamine] is not lost and accurately reaches and fuses with the target organ,” id.. At p. 2, the invention is described as a finding “that alpha-synuclein oligomers exhibit neural toxicity by binding to the v-SNARE protein, which is essential in the neurotransmission process.” The Working Examples at pp. 6-9, and results depicted at Fig. 1-6, demonstrate in vitro inhibitory effect by alpha-synuclein oligomers on SNARE protein-mediated vesicle membrane fusion and clustering, and also interference by the peptides of the instant invention with the interaction between alpha-synuclein and v-SNARE. There is no further information, such as factual evidence, data, actual or prophetic examples or disclosure of relevant prior art, presented within the specification as filed to support what is actually in the claims—administration of the peptides of SEQ ID NOS: 1, 2, 3 or 4, or parts thereof, to treat neurodegenerative diseases in general or Parkinson's disease, Alzheimer's disease, Pick's disease, Huntington's disease, Lou Gehrig's disease, prion disease, Lewy body dementia, multiple system atrophy, progressive supranuclear palsy, Friedreich's ataxia, temporal lobe epilepsy, and stroke in particular.
The nature of the invention involving biological molecules and their effect on a physiological system is complex and unpredictable. As was found in Ex parte Hitzeman, 9 USPQ2d 1821 (BPAI 1987), a single embodiment may provide broad enablement in cases involving predictable factors such as mechanical or electrical elements, but more will be required in cases that involve unpredictable factors such as most chemical reactions and physiological activity. This invention is in a class of invention which the CAFC has characterized as "the unpredictable arts such as chemistry and biology", Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). See also In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970); Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 927 F.2d 1200, 1212, 18 USPQ2d 1016, 1026 (Fed. Cir.), cert. denied, 502 U.S. 856 (1991).
The prior art recognizes that alpha-synuclein plays a central role in the pathology of Parkinson’s disease (PD) and in regulating synaptic vesicle trafficking and dopamine release in particular. However, finding of common etiology related to alpha-synuclein in neurodegeneration in general has not been reported.
With respect to claim breadth, the standard under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, entails the determination of what the claims recite and what the claims mean as a whole. In addition, when analyzing the enablement scope of the claims, the teachings of the specification are to be taken into account because the claims are to be given their broadest reasonable interpretation that is consistent with the specification (see MPEP 2111 [R-1], which states that claims must be given their broadest reasonable interpretation“ During patent examination, the pending claims must be "given *>their< broadest reasonable interpretation consistent with the specification." In re Hyatt, 211 F.3d 1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000). Applicant always has the opportunity to amend the claims during prosecution, and broad interpretation by the examiner reduces the possibility that the claim, once issued, will be interpreted more broadly than is justified. In re Prater, 415 F.2d 1393, 1404-05, 162 USPQ 541, 550- 51 (CCPA 1969).”
As such, the broadest reasonable interpretation of the claimed method is that it allows the treatment of any neurodegenerative disease by administration of any peptide that shares a limited similarity, “part thereof,” with peptides of SEQ ID NOS: 1-4, and is not particularly limited to specific diseases or particular peptides only. Thus, the claims encompass an unreasonable number of conditions to be treated by administration of peptides, which are not adequately described, see section 12 earlier, and the skilled artisan would not know how to evaluate. As opposed to the claims, what is disclosed about the claimed method is narrow: a single set of in vitro experiments to study SNARE mediated vesicle membrane fusion effects and no other obvious specific examples of art-recognized in vitro or in vivo models or any meaningful guidance as how to practice the full scope of instant claimed method. In fact, the specification does not describe a single embodiment that satisfies the claim limitations.
A mere wish or plan of obtaining the claimed invention is not sufficient. The standard of an enabling disclosure is not the ability to make and test if the invention worked but one of the ability to make and use with a reasonable expectation of success.
A patent is granted for a completed invention, not the general suggestion of an idea and how that idea might be developed into the claimed invention. If mere plausibility were the test for enablement under section 112, applicants could obtain patent rights to “inventions” consisting of little more than respectable guesses as to the likelihood of their success. In the decision of Genentec, Inc, v. Novo Nordisk, 42 USPQ 2d 100, (CAFC 1997), the court held that:
“[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable” and that “[t]ossing out the mere germ of an idea does not constitute enabling disclosure.” The court further stated that “when there is no disclosure of any specific starting material or of any of the conditions under which a process is to be carried out, undue experimentation is required; there is a failure to meet the enablement requirements that cannot be rectified by asserting that all the disclosure related to the process is within the skill of the art,” “[i]t is the specification, not the knowledge of one skilled in the art, that must supply the novel aspects of an invention in order to constitute adequate enablement.”
The instant specification is not enabling because one cannot follow the guidance presented therein and practice the claimed methods without first making a substantial inventive contribution to perfect the method and complete the invention.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
12. Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Product claim(s) 1-12 are directed to naturally-occurring peptides. The claim(s) does/do not include additional elements that are sufficient to amount for the product to be recognized as markedly different for reasons that follow.
The subject matter eligibility under 35 U.S.C. 101 of natural products (i.e., whether the claimed product is a non-naturally occurring product of human ingenuity that is markedly different from naturally occurring products) was confirmed by the U.S. Supreme Court decisions including Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. , 133 S. Ct. 2107, 2116, 106 USPQ2d 1972 (2013), and Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. , 132 S. Ct. 1289, 101 USPQ2d 1961 (2012). "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. (2010). "Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalkv. Benson, 409 U. S. 63, 67 (1972).
In the instant case, based upon an analysis with respect to the claim as a whole, claims 1-12 are determined to be directed to a judicial exception. The rationale for this determination is explained below in view of controlling legal precedent set forth in 2014 Interim Guidance on Patent Subject Matter Eligibility (79 FR 74618) dated December 16, 2014 and 2019 Revised Patent Subject Matter Eligibility Guidance (84 FR 50) dated January 07, 2019.
The instant claims 1-12 encompass a composition of matter. (Step 1: Yes).
Next, Step 2 is a two-prong analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, a natural phenomenon (product of nature), and abstract ideas (the judicially recognized exceptions). (In Alice Corp. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014) the Supreme Court sets forth a two-step test for determining patent eligibility. First, determine if the claims encompass a judicial exception (a natural phenomenon/law of nature/abstract idea). If so, then ask whether the remaining elements/steps, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to ‘“transform the nature of the claim’ into a patent-eligible application.” Id. at 2355 (quoting Mayo, 132 S. Ct. at 1297). Put another way, there must be a further “inventive concept” to take the claim into the realm of patent eligibility. Id. at 2355.
In the instant case, claims 1-12 encompass peptides comprising the amino acid sequence of SEQ ID NO: 1. The peptide of SEQ ID NO: 1 is a fragment (81-140) of the naturally occurring alpha-synuclein. Thus, by broadest reasonable interpretation, the claims encompass peptide and their fragments, all of which are products of nature, and as such the claims are directed to a judicial exception. (Step 2A: Yes).
Next, claims 1-12 do not recite any elements, or combinations of elements to add significantly more to the exception and to ensure that the claimed products are markedly different from their naturally occurring counterparts. (Step 2B: No).
Thus, for reasons fully explained above, claims 1-12 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(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.
13. Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 6,184,351.
Claims 1-12 encompass peptides comprising SEQ ID NO: 1 or a pert thereof. The peptide of SEQ ID NO:1 is a (81-140) fragment of the naturally occurring alpha-synuclein protein that is fully disclosed within at least US Patent 6,184,351, see sequence alignment below. This meets the anticipation requirement of 35 U.S.C. 102(a)(1).
ALIGNMENT:
Query Match 100.0%; Length 140;
Best Local Similarity 100.0%;
Matches 60; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 TVEGAGSIAAATGFVKKDQLGKNEEGAPQEGILEDMPVDPDNEAYEMPSEEGYQDYEPEA 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 81 TVEGAGSIAAATGFVKKDQLGKNEEGAPQEGILEDMPVDPDNEAYEMPSEEGYQDYEPEA 140
US-09-405-035-1
Filing date in PALM: 1999-09-24
Sequence 1, US/09405035
Patent No. 6184351
GENERAL INFORMATION
APPLICANT: Biere, Anja Leona
APPLICANT: Citron, Martin
TITLE OF INVENTION: ALPHA-SYNUCLEIN SUPER-MUTANTS ACCELERATE
TITLE OF INVENTION: ALPHA-SYNUCLEIN AGGREGATION
FILE REFERENCE: A-565
CURRENT APPLICATION NUMBER: US/09/405,035
CURRENT FILING DATE: 1999-09-24
PRIOR APPLICATION NUMBER: EARLIER APPLICATION NUMBER: 60/101,862
PRIOR FILING DATE: EARLIER FILING DATE: 1998-09-25
NUMBER OF SEQ ID NOS: 6
SEQ ID NO 1
LENGTH: 140
TYPE: PRT
ORGANISM: ADULT HUMAN BRAIN
Conclusion
14. No claim is allowed.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
March 8, 2026