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 1-11 are pending in the instant patent application.
Claims 1-11 are under examination.
Claim Objections
2. Claims 3, 10 and 11 are objected to because of the following informalities:
Claim 3 recites “ADHD” and claims 10 and 11 recite “PLGF” without first providing the full name of the terms. It is suggested that the terms be spelled out at their first use and in all independent claims so that it is clearly understood what they stand 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 1-11 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 1, 2 and 4-11 are vague and indefinite insofar as they employ the term “neuropsychological disease” as a limitation. This term is not known in the relevant prior art of record as being associated with well-defined genus of specific pathologies. Moreover, because the instant specification does not identify that property or combination of properties which is unique to and, therefore, definitive of a “neuropsychological disease”, an artisan cannot determine if a disease 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.
5. Claim 2 defines PLGF as “any one or more selected from” without providing a clear definition of what “any one or more.” This renders the claim indefinite. Amending the claim to recite “PLGF isoforms” or “PLGF proteins,” for example, would obviate this ground of rejection.
6. Claim 4 is vague and ambiguous for reciting limitation “wherein (a) PLGF or (b) a PLGF-derived peptide or fragment thereof is included in […] polynucleotide sequence.” The metes and bounds of the claimed product cannot be determined from the claim or the specification as filed.
7. Claims 5-8 are indefinite wherein they recite functional language. MPEP 2173.05(g) 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 pharmaceutical composition comprising PLGF but then define the composition by its functional property—promotes the regeneration of nerve cells, promotes the differentiation of nerve cells, enhances memory, enhances sociability—or 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 a recitation of the functional properties of the structurally the same proteins. Since the claims fail to meet the criteria set forth in MPEP 2173.05(g), then the claims are rejected as being indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), fourth paragraph:
Subject to the [fifth paragraph of 35 U.S.C. 112 (pre-AIA )], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
8. Claim 4 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
9. Claim 4 depends from claim 1, which is limited to a protein, see PLGF or a peptide derived therefrom, while claim 4 encompasses polynucleotides and vectors, the subject matter not present within the claim from which claim 4 depends.
Applicant may cancel the claim(s), or amend the claim(s) to place the claim(s) in proper dependent form, or rewrite the claim(s) in independent form.
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 1-11 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 3-11 specifically require possessions of peptides derived from placental growth factor, PLGF, and fragments thereof; claim 2 encompasses polypeptides with 80% sequence similarity to the proteins of SEQ ID NO: 1, 2 and 3. The claims do not require that these peptides 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 structural similarity to the original PLGF. However, the instant specification fails to describe the entire genus of proteins, 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 source of origin, PLGF. There is not even identification of any particular portion of the structure that must be conserved so to satisfy the asserted utility of the instant invention. As stated above, it is not even clear what region of the encoded polypeptide has the disclosed activity that is useful with respect to preventing or treating neuropsychological diseases. The specification does not provide a complete structure of those peptides derived from PLGF and fragments of PLGF, and fails to provide a representative number of species for the recited genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited 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 polypeptides, 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).
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.
11. Claims 1-8, 10 and 11 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) 1-8, 10 and 11 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 1-8, 10 and 11 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 1-8, 10 and 11 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 1-8, 10 and 11 encompass compositions comprising naturally occurring Placental Growth Factor, PLGF, which is a product of nature, and as such the claims are directed to a judicial exception. (Step 2A: Yes).
Next, claims 1-8, 10 and 11 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 1-8, 10 and 11 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.
12. Claim(s) 1-8, 10 and 11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent 5,919,899, 1999, the ‘899 patent hence forth.
Claims 1-8, 10 and 11 encompass a composition comprising a polypeptide defined by reference to the amino acid sequence of SEQ ID NO: 1, see claim 2. The ‘899 patent teaches a polypeptide of SEQ ID NO: 8, which has 100% sequence identity to the instant polypeptide of SEQ ID NO: 1. See sequence alignment below. Thus, the ‘899 patent fully anticipates the product of the instant claims 1-8, 10 and 11.
Patent No. 5919899
SEQ ID NO 8
LENGTH: 170
Query Match 100.0%; Score 922; Length 170;
Best Local Similarity 100.0%;
Matches 170; Conservative 0; Mismatches 0; Indels 0; Gaps 0.
Qy 1 MPVMRLFPCFLQLLAGLALPAVPPQQWALSAGNGSSEVEVVPFQEVWGRSYCRALERLVD 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 MPVMRLFPCFLQLLAGLALPAVPPQQWALSAGNGSSEVEVVPFQEVWGRSYCRALERLVD 60
Qy 61 VVSEYPSEVEHMFSPSCVSLLRCTGCCGDENLHCVPVETANVTMQLLKIRSGDRPSYVEL 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 VVSEYPSEVEHMFSPSCVSLLRCTGCCGDENLHCVPVETANVTMQLLKIRSGDRPSYVEL 120
Qy 121 TFSQHVRCECRPLREKMKPERRRPKGRGKRRREKQRPTDCHLCGDAVPRR 170
||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 TFSQHVRCECRPLREKMKPERRRPKGRGKRRREKQRPTDCHLCGDAVPRR 170
13. Claim(s) 1 and 3-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2019/229253, 2019, the ‘253 document hence forth.
Claims 1, 3-8, 10 and 11 encompass compositions comprising placental growth factor suitable for clinical administration, and claim 8 encompasses a method of treatment by administration of placental growth factor. The ‘253 document teaches placental growth factor as a drug for use in the prevention and treatment of neurological disorders, see abstract and the whole document, thus fully anticipating the instant claimed subject matter.
Conclusion
14. No claim is allowed.
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/OLGA N CHERNYSHEV/ Primary Examiner, Art Unit 1675
April 15, 2026
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