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 without traverse of Group I, claims 1-9, 12, and 14-15 and species: a composition comprising an expression vector that induces the expression of at least one peptide, SEQ ID NO: 119, and a method for the treatment and/or prevention of cancer comprising administering the vaccine or immunogenic composition in the reply filed 10/01/2025 is acknowledged.
Claims 3-5, 9-13 and 16-20 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.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 10/01/2025.
Claims 1-2, 6-8 and 14-15 are now under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Objections
Claim 6 is objected to because of the following informalities: the instant claim recites its limitations separated by indented lines using letters of the alphabet. See MPEP § 608.01(m), which states when a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate sub combinations or related steps.
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.
Claims 1-2, 6, 8, and 15 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.
Instant claims 1-2 and 6 recites a list of amino acids followed by a sequence identity number in parenthesis. It is unclear whether or not the sequence identifiers that follow consist of the same list of amino acids. To obviate this rejection, Applicant should strike out the list of amino acids and retain the sequence identifiers in order to claim the sequences for the antibody.
Instant claim 6 recites the claim limitations using “consisting of” language. "Consisting of" language implies a complete list of components, which is a considerably smaller scope as compared to "comprising", which suggests the listed parts are a component, but not necessarily all of them. As such, Applicant’s introduction of new sequences in the dependent claims renders the claims unclear as the new claims introduce sequences outside of the original scope. The use of “consisting of” is interpreted as a narrowing of scope and so, dependent claims should not introduce new limitations outside of the closed list.
Instant claims 8 and 15 recite that the “peptide is bound or inserted into an antibody which is specific for dendritic cells”. It is unclear what the antibody that is bound to the peptide would be, nor how it would be specific for dendritic cells. Additionally, the instant claims and disclosure are unclear about the manner in which the peptide is to be “inserted”.
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.
Claims 1-2, 6-7 and 14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product without significantly more. The claims recites a compositive comprising a peptide that is an epitope. This judicial exception is not integrated into a practical application because all of these products are naturally occurring. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim is towards products that are no different from the products found in nature.
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) (slip op., at 5). "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 brief, in Prometheus, a method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder is the focus. This method comprises a) administering 6-thioguanine to patients and b) determining the level of 6-thioguanine in the patients and c) correlate the level of 6-thioguanine, i.e. a certain level/red blood cells, with the decision whether a need for increase or decrease the amount of 6-thioguanine treatment in said patients.
In Prometheus, the Court found that "[i]f a law of nature is not patentable, neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself." Additionally, "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law". Flook, 437 U. S., at 590; see also Bilski, 561 U. S., at __ (slip op., at 14) ("[T]he prohibition against patenting abstract ideas 'cannot be circumvented by’..., adding 'insignificant post-solution activity'" (quoting Diehr, supra, at 191-192)).
The Court also summarized their holding by stating "[t]o put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately."
Thus, if the claim recites or involves a judicial exception, such as a law of nature/natural principle or natural phenomenon (e.g., the law of gravity, F=ma, sunlight, barometric pressure, etc.), and/or something that appears to be a natural product (e.g., a citrus fruit, uranium metal, nucleic acid, protein, etc.), then the claim only qualifies as eligible subject matter if the claim as a whole recites something significantly different than the judicial exception itself.
In the instant case, based upon an analysis with respect to the claims as a whole, claims 1-2, 6-7 and 14 4 are determined to be directed to judicial exception without significantly more. 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 1-2, 6-7 and 14 encompass a product. (Step 1: Yes).
Next, Step 2, is the two-part analysis from Alice Corp. (also called the Mayo test) to determine whether the claim is directed to laws of nature, natural phenomena, 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 recent Myriad v Ambry case, the CAFC found claims (drawn to methods comprising obtaining tissue samples, analyzing sequences of cDNA and comparing germline sequences of a gene to wild-type sequences) to encompass the abstract mental processes of ‘comparing’ and ‘analyzing’. Recitation of specific techniques (in Myriad claims 7 and 8 further recited hybridization and PCR) were deemed not “enough” to make the claims patent-eligible since the claims contained no otherwise new process. The elements/steps recited in addition to the judicial exception did nothing more than spell out what practitioners already knew). The instant claims encompass a naturally occurring peptide derived from an epitope sequence, and thus are a judicial exception. The products are naturally occurring peptides and proteins, which, as evidenced by the claims and the specification as filed and the prior art, Rauch et al. (in instant PTO-892), as discussed below, are present naturally and thus a judicial exception (Step 2A/1: Yes). Next, prong two of Step 2A requires identifying whether there are additional elements recited in the claim beyond the judicial exception(s) and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. “Integration in to a practical application” requires an additional element or combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such as the claim is more than a drafting effort designed to monopolize the exception. In the instant case, the claims do not recite any additional elements to integrate the judicial exception into a practical application because all the claims involve a natural product. The instant claims call for a composition that comprises a peptide derived from a naturally occurring epitope that is screened for certain characteristics and an expression vector that induces the expression of a peptide. Note that the pharmaceutically acceptable vehicle or excipient for the peptide recited in the instant claim is generic and the claim recites an intended use and intended result that does not change the final structure of the composition. (Step 2A/2: No). The second step is determining if the claims recite or involve judicial exceptions, such as laws of nature, natural phenomena, or natural products. In this case, the claims call for specific products that do not structurally change the instantly claimed substance, only specifically call out the naturally occurring products. The instant specification does not teach anything beyond claimed products that encompass the natural products. However, the use of an expression vector to express a peptide of interest does distinguish the product from that which occurs in nature. The claim fails to include any limitations which would distinguish the claimed products from those which occur in nature since they are towards an intended use that does not change or effect the structure or function of the claimed products. The fact that one of the instantly claimed products is a peptide that is isolated from a naturally occurring source does not mitigate the fact that it is a naturally occurring product. Breaking bonds of amino acids (isolation) is not considered markedly different under the natural product rejection. In the absence of the hand of man, naturally occurring products are considered non-statutory subject matter. Specifically, the claim, as written, do not sufficiently distinguish over the peptides or proteins that exist naturally because the claims do not particularly point out any non-naturally occurring differences between the claimed products and the naturally occurring products.
The instant claims read on a natural product because it comprises naturally occurring components that are not markedly different from the naturally occurring products. Isolating the products does not significantly change it structure or function. There are no steps that change this from a natural product, except the act of screening for certain characteristics which again does not affect the natural product. The instant claims, aside from the expression vector which expresses a peptide of interest, do not recite any elements in addition to the natural products that impose meaningful limits on the claim scope and would substantially foreclose others from using these natural products. The intended use of this composition does not further limit or change the basic structure of these naturally occurring products. The composition does not improve in any way their natural functioning. They serve the ends nature originally provided and act quite independently of any effort of the patentee. See Myriad, 133 S. Ct. at 2117.
The natural products are found in nature and do not differ from what is found in nature.
Note that the recited products cannot add significantly more to satisfy step 2B since the composition fails to integrate the products in a practical application since the claimed products are known to occur in nature. In the final step it must be determined if the claim as a whole amounts to something significantly more than the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. 1-2, 6-7 and 14 fail to include any limitations which would distinguish the claimed proteins from those which occur in nature since they all still encompass embodiments that read on natural products. In the absence of the hand of man, naturally occurring products are considered non-statutory subject matter. (Step 2B: No).
Thus, for reasons fully explained above, claims 1-2, 6-7 and 14 do not satisfy the requirement of 35 U.S.C. 101 and are therefore rejected.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 6-7, and 14 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rauch et al. (WO 2017191264 A1, in instant PTO-892).
Rauch et al. teaches polypeptides “suitable for use in treatment or prophylaxis of an infection with Norovirus or a disorder related to such an infection. In particular, the present invention concerns a Norovirus vaccine. The invention further concerns a method of treating or preventing a disorder or a disease, first and second medical uses of the artificial nucleic acid, polypeptides, compositions and vaccines”, see Abstract. Rauch et al. teaches SEQ ID NO: 2350, which is a 100% homology match to instant SEQ ID NO: 119 and is an antigen derived polypeptide. Rauch et al. also teaches that the sequence for the polypeptide comes from an antigen or immunogen that “may be derived from a pathogen, such as from bacteria or virus particles etc., or from a tumor or cancerous tissue. The antigen or immunogen stimulates the body's adaptive immune system to provide an adaptive immune response”, see page 18. Thus, Rauch et al. creates a peptide derived from tumor antigen or cancerous tissue, then creates vaccine using the known cancerous peptide sequence to program and trigger an immune response to cancer.
Therefore, claims 1-2, 6-7, and 14 are rejected as anticipated by Rauch et al.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SELAM BERHANE whose telephone number is (571)272-6138. The examiner can normally be reached Monday - Friday, 9-5.
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/SELAM BERHANE/Examiner, Art Unit 1675
/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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