DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s election with traverse of group 2, claims 45, 47, 51, and 70, in the reply filed on 5/7/26 is acknowledged. Applicant has further elected SEQ ID NO: 1 as the species of epitope.
Applicant's traversal is on the grounds the ‘199 patent cited in the restriction requirement does not teach that the peptides constitute MHC class II epitopes, and therefore the present claims share a special technical feature over the prior art and have unity of invention. The ‘199 patent teaches a polypeptide of SEQ ID NO: 26, which comprises SEQ ID NO: 2 of the instant claims. Thus, the polypeptide would inherently comprise an MHC-II epitope since it is structurally identical to the claimed epitope. Thus, the polypeptide of the prior art is a polypeptide comprising a MHC-II T cell epitope comprising SEQ ID NO: 1 of the instant claims and is inherently immunogenic. Furthermore, the present claims lack a special technical feature that defines the contribution over the prior art cited below. Applicant further argues that according to MPEP 803, a proper restriction must demonstrate a serious burden. MPEP 803 is for US restriction practice, whereas the present case has been filed under 371. This is not found persuasive because undue burden is irrelevant to the restriction practice for cases filed under 35 U.S.C 371 (see MPEP Chapter 1800). Regardless, a search for the numerous different peptides, nucleic acids and methods would be an undue burden. For example, polypeptides and polynucleotides are different products that are recognized divergent subject matter and classified in different classes. in addition, the different products are distinct because their structures are different and are therefore capable of separate manufacture, use and sale. Therefore these products are distinct, and searches for all would place an undue burden upon the examiner due to divergent subject matter of each Group. Further, a prior art search also requires a literature search. It is an undue burden for the examiner to search more than one invention. Furthermore, a search for a product is more extensive than a method of using a product, since a product could be used in any number of different methods and still be applicable prior art. Furthermore, methods require consideration of factors such as timing, dosage, and efficacy that are not necessarily relevant to product claims. It is an undue burden to search and examine more than one invention
The requirement is still deemed proper and is therefore made FINAL.
Claims 10-13, 18, 23, 29, 32-33, 40, 52, 54, 63, 72, 74-75 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 45, 47, 51, and 70 are being acted upon.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
Claims 45, 47, 51, and 70 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Specifically, there is insufficient written description to demonstrate that applicant was in possession of the claimed genus of polynucleotides.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. See MPEP 2163.
The present claims are directed to a polynucleotide encoding an immunogenic population comprising a MHC class II T cell epitope, wherein the epitope comprises SEQ ID NO: 1 comprising 0-5 substitutions, or comprising 9 consecutive residues of SEQ ID NO: 1. Thus, the claims encompass polynucleotides encoding a genus of structurally distinct epitopes having up to 5 substitutions to SEQ ID NO: 1, or comprising any 9 amino acid fragment of SEQ ID NO: 1. The claims would encompass a large genus of structurally distinct epitopes that can bind to any MHC-II (i.e. human, mouse, rat, etc.)., wherein the polypeptide functions as an immunogen polypeptide. The state of the art is such that MHC-II exists as an extremely polymorphic molecule having over a thousand different alleles with different epitope binding specificities in humans (see Bui, 2006). Furthermore, amino acid substitutions in MHC-II epitopes are unpredictable and can have undesirable functional consequences in terms of MHC binding and immunogenicity (see Chen, 2013).
The instant specification does not disclose any epitopes having substitutions to SEQ ID NO: 1, nor does it disclose any species of fragment of SEQ ID NO: 1. The specification does disclose a correlation between structure and function.
The instant application has not provided a sufficient description showing possession of the necessary functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus of antibodies and inhibitors encompassing various structures, specificities and functions. Further, the Court has interpreted 35 U.S.C. §112, first paragraph, to require the patent specification to “describe the claimed invention so that one skilled in the art can recognize what is claimed. Enzo Biochem, Inc. v. Gen-Probe Inc, 63 USPQ2d 1609 and 1618 (Fed. Cir. 2002).
In evaluating whether a patentee has fulfilled this requirement, our standard is that the patent’s “disclosure must allow one skilled in the art ‘to visualize or recognize the identity of’ the subject matter purportedly described.” Id. (quoting Regents of Univ. of Cal. v. Eli Lilly & Co., 43 USPQ2d 1398 (Fed Cir. 1997)).
Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "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.)
Also, it is noted that the Court has held that the disclosure of screening assays and general classes of compounds was not adequate to describe compounds having the desired activity: without disclosure of which peptides, polynucleotides, or small organic molecules have the desired characteristic, the claims failed to meet the description requirement of § 112. See University of Rochester v. G.D. Searle & Co., lnc., 69 USPQ2d 1886,1895 (Fed. Cir. 2004).
Meeting the written description threshold requires showing that the applicant was in “possession” of the claimed invention at the time of filing. Vas-Cath, 935 F.2d at 1563-1564. Support need not describe the claimed subject matter in exactly the same terms as used in the claims. Eiselstein v. Frank, 52 F.3d 1035, 1038 (Fed. Cir. 1995). This support cannot be based on obviousness reasoning – i.e., what the written description and knowledge in the art would lead one to speculate as to modifications the inventor might have envisioned, but failed to disclose. Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997). Ariad points out, the written description requirement also ensures that when a patent claims a genus by function, the specification recites sufficient materials to accomplish that function - a problem that is particularly acute in biological arts." Ariad, 598 F.3d at 1352-3. Note the following Court Decisions regarding the written description of antibodies in the context of the current claims.
Thus, one of skill in the art would conclude that the specification fails to provide adequate written description to demonstrate that Applicant was in possession of the claimed genus. See Eli Lilly, 119 F. 3d 1559, 43, USPQ2d 1398.
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 45, 51, and 70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural phenomenon (product of nature) without significantly more. The claim(s) recite(s) an expressible nucleic acid or an amino acid sequence. This judicial exception is not integrated into a practical application because said nucleic acids and amino acid sequences are products of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Laws of nature and natural phenomena, as identified by the courts, include naturally occurring principles/relations and nature-based products that are naturally occurring or that do not have markedly different characteristics compared to what occurs in nature. The courts have often described these exceptions using other terms, including “physical phenomena,” “scientific principles”, “natural laws,” and “products of nature.” Product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g.,Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 (“Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.”). Thus, a synthetic, artificial, or non-naturally occurring product such as a cloned organism or a human-made hybrid plant is not automatically eligible because it was created by human ingenuity or intervention. See, e.g.,In re Roslin Institute (Edinburgh), 750 F.3d 1333, 1337, 110 USPQ2d 1668, 1671-72 (Fed. Cir. 2014) (cloned sheep); cf. J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred Int’l, Inc., 534 U.S. 130-132, 60 USPQ2d 1868-69 (2001) (hybrid plant). Instead, the key to the eligibility of all non-naturally occurring products is whether they possess markedly different characteristics from any naturally occurring counterpart. See MPEP 2106.04(b).
In the instant case, the claims are directed to a composition of matter as set forth in Step 1 of the subject matter eligibility test (see MPEP 2106). Regarding step2A, prong 1, the claims recite a polynucleotide encoding an immunogenic polypeptide comprising an MHC class II T cell epitope comprising SEQ ID NO: 1, comprising 0, 1, 2, 3, 4, or 5 substitutions. Said polynucleotides are products of nature. SEQ ID NO: 1, or those with substitutions thereof, are found in a naturally occurring bacterial lumazine polypeptides, and bacteria would comprise polynucleotide sequences encoding polypeptides comprising the epitopes of the present claims (see attached alignments, for example). The claims would encompass naturally occurring bacterial genomic sequences which encode said lumazine polypeptides. Furthermore, the fact that a polynucleotide is isolated does not rise to the level of a marked difference, because there is no change to the sequence of the polynucleotide.
Regarding step 2A prong two and step 2B, the claims do not recite additional elements that integrate the judicial exception into a practical application, nor do the claims recite any additional elements that amount to significantly more than the judicial exception. The only other limitation is the recitation of an immunogenic composition or a pharmaceutical composition. However, these limitations, recited at a high level of generality amount to nothing more than field of use or insignificant extra-solution activity.
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.
Claim(s) 45, 51, and 70 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated US 2017/0202946.
The ‘946 publication teaches a polynucleotide expression vector encoding an immunogenic polypeptide comprising the sequence ATPHFDYIASEVSKG (see Table 2, SEQ ID NO: 200 in particular). Said sequence is identical to SEQ ID NO: 1 and therefore inherently is an MHC-II T cell epitope. The ‘946 publication teaches a pharmaceutical compositions comprising said polynucleotide and a pharmaceutically acceptable carrier (see paragraph 181).
Claim(s) 45, 47, 51, and 70 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated US 20190192646.
The ‘646 publication teaches an mRNA polynucleotide encoding an immunogenic polypeptide comprising the sequence ATPHFDYIASEVSKG (i.e. it comprises an MHC-II T cell epitope of SEQ ID NO: 1 of the instant claims, see page 110, SEQ ID NO: 203 in particular). The ‘646 publication teaches pharmaceutical vaccine formulations comprising said mRNA, and that the mRNA can have a modified ribonucleotide (see paragraph 19, 59, 97-113, and 159, in particular). Said sequence is identical to SEQ ID NO: 1 and therefore inherently is an MHC-II T cell epitope.
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 45, 47, 51, and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 12,496,336, in view of US 20190192646.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘336 patent claims a method of immunization comprising administering an RNA encoding SEQ ID NO: 7, and said SEQ ID NO: 7 encodes a FDYIASEVSK which comprises 11 consecutive residues of SEQ ID NO: 1 of the instant application i.e. it is an MHC-II epitope within the scope of the instant claims. Although the ‘336 patent does not explicitly claim a modified mRNA, it would be obvious to choose a modified mRNA as a type of polynucleotide based on the teachings of the ‘646 publication. Doing so would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385).
Claims 45, 47, 51, and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 12,569,551, in view of US 20190192646.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘551 patent claims a polynucleotide encoding SEQ ID NO: 71, 72, or 74, for example, and said SEQ ID Nos. encodes a FDYIASEVSK G which comprises 11 consecutive residues of SEQ ID NO: 1 of the instant application i.e. it is an MHC-II epitope within the scope of the instant claims. The ‘551 patent claims that the nucleic acid is an mRNA. Although the ‘551 patent does not explicitly claim a modified mRNA, it would be obvious to choose a modified mRNA as a type of polynucleotide based on the teachings of the ‘646 publication. Doing so would involve choosing among a finite number of predictable options which could be pursued with a reasonable expectation of success. A person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense (see KSR International Co. V. Telefex Inc 82 USPQ2d 1385).
Claims 45, 47, 51, and 70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 55, 57, 59-70, 94, 96 of copending Application No. 18/257,808 (reference application), view of US 20190192646.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘808 application claims an immunogenic polypeptide having and MHC class II T cell epitope of ATPHFDYIASEVSKG and a viral polypeptide. The ‘808 application claims nucleic acids encoding polypeptides, and additionally, it would be obvious to encode the polypeptides using a polynucleotide, such as a modified mRNA as taught by the ‘646 publication for the reasons set forth above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
No claim is allowed.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Amy E. Juedes
Patent Examiner
Technology Center 1600
/AMY E JUEDES/Primary Examiner, Art Unit 1644
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