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 .
Election/Restrictions
Applicant’s election in the reply filed on 3/4/2026 is acknowledged:
PNG
media_image1.png
84
630
media_image1.png
Greyscale
PNG
media_image2.png
122
636
media_image2.png
Greyscale
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 4, 5, 7, 8, 10, 12-14, 16, 18, 20-22 and 24 read on the elected invention and are treated on merits, below. Claims 28-31 are withdrawn from consideration as exclusively covering a non-elected invention.
Specification
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
This application contains polynucleotide and/or polypeptide sequences. Applicant is required to review the application for conformity with the above.
Claim Rejections - 35 USC § 112
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.
Claims 1, 4, 5, 7, 8, 10, 12-14, 16, 18, 20-22 and 24 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.
The rejected claims cover methods of inducing an immune response with RNA encoding at least two different antigenic epitopes and RNA encoding an amino acid sequence comprising IL2, and functional variants and fragments thereof.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”).
With regard to the recited genus of RNA encoding antigenic epitopes and genus of RNA encoding IL2, the following applies:
Ariad Pharmaceuticals Inc. v. Eli Lilly & Co., 94 USPQ2d 1161 (Fed. Cir. 2010) states that “...a generic claim may define the boundaries of a vast genus of chemical compounds...the question may still remain whether the specification, including the original claim language, demonstrates that the applicant invented species sufficient to support a claim to a genus”. See page 1171.
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 Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
See also Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a “laundry list” disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not “reasonably lead” those skilled in the art to any particular species.
Amgen, Inc. v. Chugai Pharmaceutical Co., Ltd., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) states that “it is well established in our law that conception of a chemical compound requires that the inventor be able to define it so as to distinguish it from other materials, and to describe how to obtain it”.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or structural features common to the members of the genus, which features constitute a substantial portion of the genus, so that one of skill in the art can “visualize or recognize” the members of the genus (Emphasis added). Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997).
A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v. Lederman, 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when ... the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004).
In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
Courts have stated that “[i]n claims involving [non-genetic] chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089 (1998). (emphasis added).
There is no such specificity here, nor could one skilled in the art identify particular RNA encompassed by the claims. Specifically, Applicant fails to disclose any other RNA, besides those specific RNA disclosed by the specification, and in relation to the above, these disclosed species or subgenre do not represent the substantial variety covered by the genus of RNA.
With regard to the functional definition of RNA encoding at least two different antigenic epitopes for stimulating T cells specific for the antigenic epitopes, or maintaining and/or further stimulating T cells, 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) because the specification contains almost no information by which a person of ordinary skill in the art would understand that the inventors possessed the all of the recited compounds. At best, it simply indicates that one should test an inordinate number of RNA to see if the polynucleotides provide epitopes and IL2 that can perform the required functions. In this connection, the specification contains no generic structural characteristics of those RNA which provide functional epitopes and IL2 required by the claims, see In re ’318 Patent Infringement Litigation, 583 F.3d 1317, 1327 (Fed. Cir. 2009) (“[A]t the end of the day, the specification, even read in light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient.”).
The Examiner acknowledges that a working example or exemplified embodiment is not necessarily a requirement for description. However, where a generic claim term is present in a claim, as in the present application, and defined only by functional characteristics, the specification must convey enough information, e.g., via sufficient representative examples, to indicate invention of species sufficient to constitute the genus. Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 967 2 (Fed. Cir. 2002). The written description requirement “requires a description of an invention, not an indication of a result that one might achieve if one made that invention.” Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997); see also Novozymes A/S v. DuPont Nutrition Biosciences APS, 723 F.3d 1336, 1350 (Fed. Cir. 2013) (“A patent...‘is not a reward for the search, but compensation for its successful conclusion.’ ... For that reason, the written description requirement prohibits a patentee from ‘leaving it to the ... industry to complete an unfinished invention.’” (citations omitted)).
Accordingly, the specification lacks adequate written description for the recited RNA encoding at least two different antigenic epitopes and RNA encoding an amino acid sequence comprising IL2, and functional variants and fragments thereof.
Claims 1, 4, 5, 7, 8, 10, 12-14, 16, 18, 20-22 and 24 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.
The rejected claims recite a functional variant of IL2, or a functional fragment of the IL2 or the functional variant for maintaining and/or further stimulating T cells. The claims also recite functional variants and fragments with percent identities of IL2 sequences (claim 21). The claims also recite functional fragments and variants of albumin (claim 18).
How much identity is required to claim a variant of a known nucleic acid sequence when the function of the nucleic acid is recited in the claims? The Patent Trial and Appeal Board (PTAB) provides some insight on this question in Ex parte Livshits (Appeal 2013-001807; US Patent Application 11/106,455)
https://www.bradley.com/insights/publications/2016/02/how-much-homology-is-enough-under--112
The answer in this case was no. The PTAB agreed with the Examiner that a PHOSITA could envision sequences that met the percent identity requirement and hybridized under the recited conditions to SEQ ID NO:3.
Further, the Examiner admitted that by using conservative substitutions, a PHOSITA could likely envision a DNA sequence that encoded a polypeptide having the same tertiary structure as the polypeptide encoded by SEQ ID NO:3.
However, the PTAB found there was no teaching that the conservation of structure (whether in the DNA or encoded polypeptide) would be a surrogate for conservation of the function claimed (over-expression of L-amino acids in the culture medium). In other words, PTAB wanted some teaching as to which of the 5 pent of residues of the in the recited single domain antibody could be altered while still conserving the function of the encoded polypeptide.
The specification demonstrated the recited function for the polypeptide encoded by SEQ ID NO:3, but offered no teaching as to what regions of the recited protein were critical for conservation of the recited function and which regions could be modified.
The PTAB stated that the specification “leaves it to others to discover the nature and scope of substitutions, deletions, and insertions that can be made to arrive at a 95% homology sequence that additionally allows for recited activity.”
The applicants attempted to use BLAST homology data to argue that a PHOSITA would be able to address the issue, but the evidence was accorded little weight and characterized as an “invitation to experiment” by the PTAB.
Here, even though RNA/polypeptides could be envisioned by a PHOSTIA which could be tested as set forth in the specification for conservation of the recited function, this is not enough to describe the structure so that a PHOSITA could determine beforehand whether or not a particular RNA or encoded IL2 or albumin meets the functional requirements. Specifically, the recited RNA variants encoding the recited IL2 are claimed by homology and function of the expressed protein, but PHOSITA cannot determine if the RNA produce a protein that accomplishes the recited function from the specification itself in order to meet the written description requirement.
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, 4, 5, 7, 8, 10, 12-14, 16, 18, 20-22 and 24 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.
It is unclear what sequences Applicant intends to cover by IL2 functional variants or functional fragments of IL2 or the IL2 functional variant. Also, the exact sequence of IL2 intended by “human IL2” (claim 13) is not defined.
Similarly, it unclear what fragments and functional fragments of albumin Applicant intends to cover in claim 18.
The claims recite “preferably” (claim 4) or “for example” (claim 8). It is unclear if Applicant intends the claims to be limited to the preferred embodiments.
Claim 10 recites “comprise or consist of”. The claim is indefinite since the transitional phrases “comprising” and “consisting of” define the scope of a claim differently with respect to what unrecited additional components or steps, if any, are excluded from the scope of the claim, see MPEP 2111.01.
“GS” in claim 20 is undefined and lacks antecedent basis.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 5, 7, 8, 10, 12-14, 16, 18, 20-22 and 24 rejected under 35 U.S.C. 103 as being unpatentable over WO 2020/200481 (WO 481) or WO 2019/154985 (WO 985), both in view of Wang et al., Information Sciences 432 (2018) 63–78 (Wang).
WO 481 discloses a method and kit for inducing a T cell immune response to an antigen in a subject by administration of a RNA encoding IL2, and RNA encoding IFN-Ɣ; the antigen may be a cancer antigen and be administered in the form of RNA encoding a peptide or protein (page 3, I. 10 - page 9, I. 26), see claims 1, 4, 5, 10.
The IL-2 is attached to a pharmacokinetic modifying group and is provided as a fusion with albumin (page 35, I. 15 - page 36, I. 12; page 38, I. 3 - page 44, I. 30), see claims 14, 16, 18, 20
The antigen can be a polyepitope cancer antigen or cancer neoantigen (page 57, I. 5 - page 58, I. 7), see claim 12
The RNA can be administered in the form of RNA lipoplex (page 62, I. 11 - page 64, I. 2) by intravenous route (page 69, I. 1-10) simultaneously or sequentially (page 69, I. 12-17) see claims 7, 8, 22.
Example 2 shows vaccination with OVA mRNA lipoplexes followed, after 3 days, by albumin-fused IL2 RNA administration, see claim 13, 21, 24.
WO 985 discloses a method for inducing an immune response to an antigen in a subject by administration of (i) a RNA encoding an antigen and (ii) a RNA encoding IL2, i.e. an albumin fusion of PK-IL2 (page 1, I. 5-10; page 3, I. 4-23, I. 29-30; page 30, I. 9-30; page 38, I. 14-24), as well as a kit therefore (page 6, I. 25-29), see claims 1, 4, 5, 10.
The antigen can be a polyepitope cancer antigen or cancer neoantigen (page 38, I. 24 - page 39, I. 24; page 40, I. 25 - page 42, I. 11), see claim 12.
Examples 6-12 show vaccination with gp70 mRNA lipoplexes followed, after 2 days, by albumin-fused IL2 RNA administration, see claims 7, 8, 14, 16, 18, 20-22, 24.
The difference between the applied references and the claimed inventions is that the applied references may not teach the invention with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, based on the above, the applied references teach the elements of the claimed compositions with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143). Specifically, those of ordinary skill would expect that the use of at least 2 different epitopes would further potentiate the host immune system to act against cancer.
The RNA can be administered in the form of RNA lipoplex (page 48, I. 30 - page 49, I. 18) by intravenous route (page 54, I. 1-8) simultaneously or sequentially (page 54, I. 10-23), see claims 7, 8, 22, 24. Moreover, optimization of cancer combination therapy regimens is a results-effective variable and aims to maximize tumor reduction and minimize toxicity by determining the ideal drug dosages, combinations, and timing, often using mathematical modeling, AI, and patient-specific data, see Wang (“The problem with optimizing cancer chemotherapy has often been formulated as optimal control models, which can be intractable. Such difficulty is compounded by the facts that chemotherapeutic drugs with different mechanisms of action are often used together and that dose adjustments are often warranted according to therapeutic responses in clinical practice. Against this background, this paper addresses the problem of combination chemotherapy with dose adjustment. We first construct a mathematical model of the problem by introducing two cell-cycle phase-specific chemotherapeutic drugs into a mono-chemotherapy model. Next, we design a memetic algorithm (MA) allowing dose adjustments to solve the problem. Finally, we compare the proposed MA with existing algorithms, investigate the efficacies of different treatment strategies, and identify the characteristics of the problem related to the quality of the solutions..”) see Wang, Abstract. In this manner optimizing the steps of administration, as covered by the rejected claims, is well within the optimization of those of ordinary skill, and therefore, prima facie obvious.
Double Patenting
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 1, 4, 5, 7, 8, 10, 12-14, 16, 18, 20-22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 24-29, 32-37 of copending Application No. 17/442568 in view of Wang. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the conflicting claims recite compositions comprising RNS encoding epitopes and RNA encoding IL2, and variants and fragments thereof that anticipate the rejected claims. Alternatively, the difference between the compositions recited in the conflicting claims and those recited by the rejected claims is the conflicting claims may not recite the instant compositions with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the the elements of the instant compositions with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, the use of at least 2 different epitopes would further potentiate the host immune system to act against cancer.
Moreover, optimizing dosing regimens, such as those covered in the rejected claims, was well within the purview of those of ordinary skill, as outlined above, see Wang.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 4, 5, 7, 8, 10, 12-14, 16, 18, 20-22 and 24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-49 of copending Application No. 16/966422 in view of Wang. Although the claims at issue are not identical, they are not patentably distinct from each other.
Specifically, the conflicting claims recite compositions comprising RNS encoding epitopes and RNA encoding IL2, and variants and fragments thereof that anticipate the rejected claims. Alternatively, the difference between the compositions recited in the conflicting claims and those recited by the rejected claims is the conflicting claims may not recite the instant compositions with particularity so as to amount to anticipation (See M.P.E.P. § 2131: "[t]he identical invention must be shown in as complete detail as is contained in the ... claim." Richardson v. Suzuki Motor Co., 868 F.2d 1226, 1236, 9 USPQ2d 1913, 1920 (Fed. Cir. 1989). The elements must be arranged as required by the claim, but this is not an ipsissimis verbis test, i.e., identity of terminology is not required. In re Bond, 910 F.2d 831, 15 USPQ2d 1566 (Fed. Cir. 1990).). However, the conflicting claims recite the the elements of the instant compositions with sufficient guidance, particularity, and with a reasonable expectation of success, that the invention would be prima facie obvious to one of ordinary skill (the prior art reference teaches or suggests all the claim limitations with a reasonable expectation of success. See M.P.E.P. § 2143).
Specifically, the use of at least 2 different epitopes would further potentiate the host immune system to act against cancer.
Moreover, optimizing dosing regimens, such as those covered in the rejected claims, was well within the purview of those of ordinary skill, as outlined above, see Wang.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARL J PUTTLITZ whose telephone number is (571)272-0645. The examiner can normally be reached on Monday to Friday from 9 a.m. to 5 p.m.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's acting supervisor, Gregory Emch, can be reached at telephone number 571-272-8149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/KARL J PUTTLITZ/ Primary Examiner, Art Unit 1646