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 .
Status of Claims
Claims 1-20 are pending.
Claims 5, 6, 8-10, 12, 13 and 16 are amended.
Claims 17-20 are new.
Claims 1-20 are currently under examination on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The U.S. effective filing date of all claims under examination is set at 07/26/2021 based on the provisional application 63/225,840 (filed 07/26/2021).
Claim Rejections - 35 USC § 112(b)
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 10-13, 16, 19 and 20 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.
Claim 10 recites in line 3 “…the wild-type VSIG3 receptor”. There is insufficient antecedent basis for “the wild-type VSIG3 receptor” in the claim. Claims 11-13, 16, 19 and 20 which are dependent on claim 10 are also rejected here.
Claim 10 recites in line 3 “…the wild-type VSIG3 receptor”. It is unclear which wild-type VSIG3 receptor is being referred to in the claim since according to instant specification Table 1, there are VSIG3 Variants 1 to 11 as well as VSIG3 Isoforms X1 to X8 that are all wild-type splice variants of VSIG3. Claims 11-13, 16, 19 and 20 which are dependent on claim 10 are also rejected here.
Claim 12 recites in (d) “expression of the wild-type VSIG3….” There is insufficient antecedent basis for “the wild-type VSIG3” in the claim.
Claim 12 recites in (e) “expression of the wild-type VSIG8….” There is insufficient antecedent basis for “the wild-type VSIG8” in the claim.
Claim Rejections 35 U.S.C.112(a) (first)
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 10-13, 16, and 19-20 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.
In the instant case, claims 10-13, 16, and 19-20 are inclusive of a genus of modified polypeptide comprising an amino acid sequence sharing at least 90% sequence identity with any one of SEQ ID NOs: 20-30, wherein the polypeptide is a dominant-negative receptor as compared to activity of wild-type VSIG3 receptor.
Further, the structural limitations of the polypeptide, namely comprising at least 90% identity to recited SEQ ID NOs: 20-30, encompass wild-type constructs that are clearly not dominant-negative constructs, as well as nearly countless point mutations thereof. Limiting constructs encompassed by the claims to those having at least 90% identity to any one of the recited SEQ ID NOs: 20-30 clearly does not limit the constructs to those that function as dominant negative because wild-type constructs are disclosed to have 90% identity to recited SEQ ID NOs. As shown in the alignment of instant SEQ ID NO: 20 with instant SEQ ID NO: 6 which is wild-type VSIG3 Splice Variant 6 (Alignment 1 below), there is 100% identity between the two sequences in terms of “Query Match” and “Best Local Similarity”, which fulfills the at least 90% sequence identity limitation of the claims. Similarly, the alignment of instant SEQ ID NO: 20 with instant SEQ ID NO: 1 which is wild-type VSIG3 Splice Variant 2 (Alignment 2 below) shows that there is 97.9% identity between the two sequences in terms of “Query Match” and 90.6% identity in terms of “Best Local Similarity”, which also fulfills the at least 90% sequence identity limitation of the claims.
Alignment 1: Alignment of instant SEQ ID NO: 20 (top) with instant SEQ ID NO: 6 wild-type VSIG3 Splice Variant 6 (bottom)
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Alignment 2: Alignment of instant SEQ ID NO: 20 (top) with instant SEQ ID NO: 1 wild-type VSIG3 Splice Variant 2 (bottom)
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The written description however, in this case only sets forth in the instant specification in Table 1 (Pg 11-12), eleven species of DNVISG3 mutants, namely DNVISG3 Mutants 1 to 11, with amino acid sequences corresponding to SEQ ID NOs: 20-30 and nucleic acid sequences corresponding to SEQ ID NOs: 50-53, 82 and 54-59 respectively that function has dominant negative polypeptide constructs. Of note, the instant specification on Pg 45 Example 1 discloses that dnVSIG3 (SEQ ID NO:20) was created by truncating the C-terminus of VSIG3 wild-type variant 6 (SEQ ID NO:6) by 166 amino acids, wherein this dnVSIG3 features a near complete loss of the intracellular domain, leaving only 4 amino acids of the intracellular domain. Therefore, the specification does not disclose, and the art does not teach, the genus of modified polypeptide and the genus of polynucleotide sequence as broadly encompassed in the claims.
In regards to claims to a product defined by function, without a correlation between structure and function, the claim does little more than define the claimed invention by function. That is not sufficient to satisfy the written description requirement. See Eli Lilly, 119 at1568 USPQ2d at 1406 (“definition by function…does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is”).
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 by describing structural features common to that genus that “constitute a substantial portion of the genus.” See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997): “A description of a genus of cDNAs may be achieved by means of a recitation of a representative number of cDNA, defined by nucleotide sequence, falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus.”
The inventions at issue in Lilly were DNA constructs per se, the holdings of that case is also applicable to claims such as those at issue here. Further, disclosure that does not adequately describe a product itself logically cannot adequately describe a method of using that product. See Ariad, 598 F.3d at 1354-55 (“Regardless whether the asserted claims recite a compound, Ariad still must describe some way of performing the claimed methods... the specification must demonstrate that Ariad possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity so as to ‘satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed.’”) (internal citation omitted); see also Univ. of Rochester v. G.D. Searle& Co., Inc., 358 F.3d916,918 (Fed.Cir.2004) (applying the same analysis to assess written description for claims to a “method for selectively inhibiting” a particular enzyme by administering a functionally defined compound, i.e., a “non-steroidal compound that selectively inhibits activity” of the gene product for that enzyme).
The instant specification fails to provide sufficient descriptive information, such as definitive structural features that are common to the genus. That is, the specification provides neither a representative number of modified polypeptides that encompass the genus of modified polypeptide that have recited sequence identity to the SEQ ID NOs: 20-30 wherein the polypeptide is a dominant-negative receptor as compared to activity of wild-type VSIG3 receptor, nor does it provide a description of structural features that are common to the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus. “[A] sufficient description of a genus . . . requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can ‘visualize or recognize’ the members of the genus.” Ariad, 598 F.3d at 1350 (quoting Eli Lilly, 119 F.3d at 1568-69). A “representative number of species” means that those species that are adequately described are representative of the entire genus. AbbVie Deutschland GMBH v. Janssen Biotech, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (“The ’128 and ’485 patents, however, only describe species of structurally similar antibodies that were derived from Joe-9. Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the 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 to provide a "representative number” of species.
Since the disclosure fails to describe common attributes or characteristics that adequately identify members of the genus, and because the genus is highly variant, the disclosure of eleven modified polypeptides sequences of VSIG3 that can function as a dominant-negative receptor as compared to activity of wild-type VSIG3 receptor is insufficient to describe the genus. Thus, one of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus as broadly claimed.
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, even though Applicant may propose methods of screening for possible members of the genus, the skilled artisan cannot envision the detailed chemical structure of the encompassed genus, 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 isolation. 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. See Ariad, 94 USPQ2d at 1161; Centocor at 1876 (“The fact that a fully-human antibody could be made does not suffice to show that the inventors of the '775 patent possessed such an antibody.”)
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 U.S.C.112(a) (second)
Claims 10-13, 16, and 19-20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabled for dominant negative polypeptides as set forth by instant SEQ ID NOs: 20-30, does not reasonably provide enablement for just any dominant negative polypeptides sharing at least about 90% sequence identity with any one of SEQ ID NOs:20-30 that can function as a dominant genitive polypeptide compared to the wild type VSIG3 receptor. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required are summarized in Ex parte Forman, 230 USPQ 546 (BPAI 1986). They include the nature of the invention, the state of the prior art, the relative skill of those in the art, the amount of direction or guidance disclosed in the specification, the presence or absence of working examples, the predictability or unpredictability of the art, the breadth of the claims, and the quantity of experimentation which would be required in order to practice the invention as claimed.
The instant claims are drawn to polypeptides comprising amino acid sequences sharing at least 90% sequence identity with any one of SEQ ID NOs: 20-30 that can function as a dominant genitive polypeptide compared to the wild type.
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).
The specification discloses eleven species of DNVISG3 mutants, namely DNVISG3 Mutants 1 to 11, with amino acid sequences corresponding to SEQ ID NOs: 20-30 that can function as a dominant genitive polypeptide compared to the wild type VSIG3 receptor (Table 1). Further, the instant specification on Pg 45 Example 1 discloses that dnVSIG3 (SEQ ID NO:20) was created by truncating the C-terminus of VSIG3 wild-type variant 6 (SEQ ID NO:6) by 166 amino acids, wherein this dnVSIG3 features a near complete loss of the intracellular domain, leaving only 4 amino acids of the intracellular domain.
One cannot extrapolate the teachings of the specification to the scope of the claims because the claims are broadly drawn to amino acid sequences with up to 10% variations or mutations in instant SEQ ID NOs: 20-30 that can function as a dominant genitive polypeptide compared to the wild type VSIG3 receptor, and Applicant has not enabled these up to 10% variations because it has not been shown which polypeptides with up to 10% mutations introduced into instant SEQ ID NOs: 20-30 function (or do not function) as a dominant genitive polypeptide compared to the wild type VSIG3 receptor.
In view of the teachings above and the lack of guidance, workable examples and or exemplification in the specification, undue experimentation would be required by one of skill in the art to determine with any predictability, which constructs with the recited homology of at least 90% to any one of SEQ ID NOs: 20-30, do (or do not) function as dominant negative constructs.
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 1-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception(s) (i.e., a law of nature, a natural phenomenon, and/or an abstract idea) without significantly more. The rationale for this determination is explained below:
Claims 1-8 are directed to natural phenomenon because the claims recite natural phenomenon (“Step 2A prong one”) and the judicial exception(s) is/are not integrated into a practical application (“Step 2A prong two”). The “natural phenomenon” is: for claims 1, 2, 5 and 6, polypeptides comprising the amino acid sequence of instant SEQ ID NOs:20-29, which are comprised within a naturally occurring protein in human cells, namely VSIG3 (also known as IGSF11); for claims 3 and 4, polypeptides comprising the amino acid sequence of instant SEQ ID NOs:61-70, which are comprised within a naturally occurring protein in human cells, namely VSIG8; for claim 7, polynucleotide sequences comprising the nucleic acid sequences of instant SEQ ID NOs: 50-59 which encode naturally occurring human VSIG3, as well as polynucleotide sequences comprising the nucleic acid sequences of instant SEQ ID NOs: 72-81 which encode naturally occurring human VSIG8; and for claim 8, a composition comprising polypeptides comprising the amino acid sequence of instant SEQ ID NOs:20-29, which are comprised within naturally occurring human VSIG3.
The above claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception(s). A claim that focuses on judicial exception(s) can be shown to recite something “significantly more” than the judicial exception(s) by reciting a meaningful limitation beyond the judicial exceptions. However, in the instant case, the above claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims are solely drawn to polypeptides and polynucleotides that are not markedly different than polypeptides and polynucleotides found in nature (“Step 2B”).
Claim Rejections - 35 USC § 102 (first)
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.
(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 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ostertag and Shedlock (WO2019173636A1 Date Published 2019-09-12) and as evidenced by UniProt Accession Q5DX21 (History: First Entry 29-Mar-2005).
Ostertag and Shedlock teaches in Table 9, exemplary therapeutic proteins (and proteins to enhance CAR-T efficacy) (Pg 310-430). They teach the amino acid sequences of IGSF11 as given by SEQ ID NOs: 6831-6838 (Pg 366). Specifically, SEQ ID NO: 6834 which is 407 residues in length was noted to match fully from residues 1-241 with instant SEQ ID NO:20 that is 241 amino acid residues in length (see Alignment 3 below).
Alignment 3: Alignment of instant SEQ ID NO:20 amino acid sequence (top) with SEQ ID NO: 6834 as taught by Ostertag and Shedlock (bottom)
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As disclosed in instant specification Table 1 (Pg 11), VSIG3 Variant 2 (instant SEQ ID NO: 1) is also known as UniProt Accession Q5DX21. As evidenced by UniProt Accession Q5DX21, the protein is named Immunoglobulin superfamily member 11 (or IgSF11 as the short name), and the gene names are IGSF11, BTIGSF, CXADRL1 and VSIG3 (see Pg 2 of attached Q5DX21 NPL reference, Section “Gene names; Synonyms”). Therefore, the IGSF11 therapeutic protein taught by Ostertag and Shedlock is the same VSIG3 protein as disclosed in instant specification Table 1. In addition, UniProt Accession Q5DX21 also teaches that the VSIG3 protein comprises a signal peptide from position 1-22 with the sequence of “MTSQRSPLAPLLLLSLHGVAAS” (see Pg 4-5 of attached Q5DX21 NPL reference, Section “Features”). This sequence matches residues 1-22 of SEQ ID NO: 6834 taught by Ostertag and Shedlock. Therefore, the IGSF11 therapeutic protein of SEQ ID NO: 6834 taught by Ostertag and Shedlock comprises a signal peptide sequence from residues 1 to 22. Further, UniProt Accession Q5DX21 teaches that the topological domain of VSIG 3 protein is such that residues 23-241 comprises the extracellular domain (ECD) of the protein see Pg 3 of attached Q5DX21 NPL reference, Section “Subcellular Location; Features”).
Therefore, Ostertag and Shedlock fully anticipates instant claims 1, 2 and 5 by teaching SEQ ID NO: 6834, an IGSF11 protein also known as VSIG3 that comprises a signal peptide sequence and the extracellular domain of VSIG3, and which comprises the entire amino acid sequence of instant SEQ ID NO:20.
Claim Rejections - 35 USC § 102 (second)
Claims 3 and 4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schreiber et al. (US20190367581A1 Date Published 2019-12-05).
Schreiber et al. teaches chimeric proteins which include the extracellular domain of V-set and immunoglobulin domain-containing protein 8 (VSIG8) and their use in the treatment of diseases (Abstract). They teach that human VSIG8 comprises the amino acid sequence of SEQ ID NO: 1 (paragraph [0040]). SEQ ID NO: 1 of Schreiber et al. which has a length of 414 amino acid residues has been noted to match fully from residues 1-284 with instant SEQ ID NO:61 that is 284 amino acid residues in length (see Alignment 4 below). As disclosed in instant specification Table 1 (Pg 12), instant SEQ ID NO:61 is a mutant of VSIG8 Wild-Type.
Alignment 4: Alignment of instant SEQ ID NO:61 amino acid sequence (top) with SEQ ID NO: 1 as taught by Schreiber et al. (bottom)
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Therefore, Schreiber et al. fully anticipates instant claims 3 and 4 by teaching SEQ ID NO: 1 which comprises the entire amino acid sequence of instant SEQ ID NO:61.
Claim Rejections - 35 USC § 102 (third)
Claims 6 and 7 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bancel et al. (US20220273555A1 Priority Filing Date 2020-04-28).
Bancel et al. teaches modified polynucleotides for the production of membrane proteins (Title). They teach compositions and methods for the preparation, manufacture and therapeutic use of polynucleotides (Abstract). They also teach SEQ ID NO: 23931, a synthetic coding sequence that is 1245 bp in length (Sequence Listing obtained from USTPO website: seqdata.uspto.gov/seqdetail?docId=US20220273555A1&publicationNo=20220273555&seqId=23931) . When SEQ ID NO: 23931 as taught by Bancel et al. was aligned with instant SEQ ID NO: 72, it was noted to have 97.4% identity to instant SEQ ID NO:72 which is 852 bp in length (see Alignment 5 below).
Alignment 5: Alignment of instant SEQ ID NO:72 nucleic acid sequence (top) with SEQ ID NO: 23931 as taught by Bancel et al. (bottom)
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Therefore, Bencel et al. fully anticipates instant claims 6 and 7 by teaching SEQ ID NO: 23931 which has 97.4% identity to instant SEQ ID NO:72.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 5, 6, 8, 9, 14, 15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ostertag and Shedlock (WO2019173636A1 Date Published 2019-09-12) and UniProt Accession Q5DX21 (History: First Entry 29-Mar-2005) as applied to claims 1, 2 and 5 above and further in view of Ostertag and Shedlock (WO2019173636A1 Date Published 2019-09-12).
The teachings of Ostertag and Shedlock and UniProt Accession Q5DX21 have already been described in the first 102 rejection above.
Ostertag and Shedlock and UniProt Accession Q5DX21 do not specifically teach a polynucleotide sequence: (a) encoding the polypeptide comprising an amino acid sequence sharing at least 90% sequence identity with instant SEQ ID NO:20.
Ostertag and Shedlock and UniProt Accession Q5DX21 also do not specifically teach a vector: (a) comprising the polynucleotide sequence encoding the polypeptide comprising an amino acid sequence sharing at least 90% sequence identity with instant SEQ ID NO:20; or a method of generating a modified cell, the method comprising introducing into a cell said vector; or they do not specifically teach said method of generating a modified cell, wherein: (b) the cell is a human immune cell.
Ostertag and Shedlock and UniProt Accession Q5DX21 further do not specifically teach a vector: (a) comprising the polynucleotide sequence encoding the polypeptide comprising an amino acid sequence sharing at least 90% sequence identity with instant SEQ ID NO:20, wherein the vector is a viral vector; or wherein the viral vector is a lentivirus vector.
They further do not specifically teach a composition comprising the polypeptide comprising an amino acid sequence sharing at least 90% sequence identity with instant SEQ ID NO:20.
However, these deficiencies are remedied by further teachings of Ostertag and Shedlock.
Ostertag and Shedlock teaches vectors that comprise isolated nucleic acid molecules of interest, host cells that are genetically engineered with the recombinant vectors, and the production of recombinant protein of interest by recombinant techniques that is well known in the art (paragraph [0542]). They teach that introduction of a nucleic acid sequence into a cell is by means of a viral vector that can be a lentiviral vector (paragraphs [034], [062] and [0416]). They also teach that the cell can be an immune cell (paragraphs [062] and [0526]). They further teach that polypeptides can be expressed in human cells (paragraph [0693]). They also teach compositions comprising recombinant proteins of interest (paragraph [034]).
One of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of expressing the therapeutic protein of SEQ ID NO: 6934 as taught by Ostertag and Shedlock in a host cell that can be human immune cells, using lentiviral vectors that comprise the polynucleotide that encodes for the polypeptide of SEQ ID NO: 6934 taught by Ostertag and Shedlock, because these are conventional and routine methods in recombinant DNA technique well known in the art for making recombinant therapeutic proteins that are also taught by Ostertag and Shedlock.
Regarding instant claims 9, 14 and 15, one of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to perform a combined method of making a vector as taught by Ostertag and Shedlock that comprises the polypeptide according to SEQ ID NO: 6934 also as taught by Ostertag and Shedlock; and to perform a combined method of generating a modified cell as taught by Ostertag and Shedlock, comprising introducing into the cell said vector of the above combined method; and also to perform a combined method of generating a modified cell as taught by Ostertag and Shedlock wherein the cell is a human immune cell as also taught by Ostertag and Shedlock, because these are standard recombinant DNA techniques well known in the art and because a vector would facilitate introduction of said polypeptide into target human immune cells for efficient expression as therapeutic proteins.
These are examples of (A) Combining prior art elements according to known methods to yield predictable results; and (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention. See MPEP 2143. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, absent unexpected results.
Conclusion
No claims are allowed.
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/YIE-CHIA LEE (TONYA)/Examiner, Art Unit 1642
/SEAN E AEDER/Primary Examiner, Art Unit 1642
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