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 .
Application Status
This action is written in response to applicant’s correspondence received on 10/11/2024. Claims 1-6, 11-13, 22-23, 28-29, 34, 51-54, and 56-57 are pending. Claims 7-10, 14-21, 24-27, 30-33, 35-50, and 55 have been previously cancelled. All pending claims are currently under examination.
Nucleotide and/or Amino Acid Sequence Disclosures
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’s electronic filing system (see Section I.1 of the Legal Framework for EFS-Web or Patent Center (https://www.uspto.gov/patents-application- process/filing-online/legal-framework-efs-web), 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 EFS-Web or Patent Center 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 EFS-Web or Patent Center 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.
Specific deficiencies and the required response to this Office Action are as follows:
Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 recites “propionic academia” (line 1) which should be amended to read “propionic acidemia.”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 6, claim 6 depends from claim 1. Claim 1 recites that the first and second mRNA encode a polypeptide of SEQ ID NOs 1 and 2, respectively. Thus, claim 1 requires that the polypeptide/protein encoded comprises SEQ ID NO 1 and 2 for the first and second mRNA. However, the proteins encoded by the ORFs of SEQ ID NOs 7 and 8 do not encode a protein which comprises SEQ ID NOs 1 and 2. For instance, both SEQ ID NOs 7 and 8 comprise a deletion in the ORF which render frame shift mutations in the reading sequence (see alignment of SEQ ID NO 7 with SEQ ID NO 5, and SEQ ID NO 8 with SEQ ID NO 6, below):
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(ORF of SEQ ID NO: 7, top, aligned with SEQ ID NO: 5, bottom)
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(ORF of SEQ ID NO: 8, top, aligned with SEQ ID NO: 6, bottom)
Thus, the ORFs of both SEQ ID NOs 7 and 8 contain frameshift mutations which render polypeptides which do not read on SEQ ID NOs 1 and 2 as required by claim 1. Claim 6 therefore does not require the limitations of the claim from which it depends (claim 1) which requires that the polypeptide comprise SEQ ID NOs 1 and 2. Note that, although claim 1 recites that the nucleotides SEQ ID NOs 5 and 6 are only required to be 80% identical, the polypeptide which SEQ ID NOs 5 and 6 encode are required to be SEQ ID NOs 1 and 2 by the language of claim 1. Claim 6 therefore does not read on the limitations of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6, 11-13, 22-23, 28-29, 34, 51-54, and 56-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jiang (WO 2019/104195 A1, published 5/31/2019). The rejection is further evidenced by NCBI BLAST alignments NP_000273 (NCBI BLAST Accession number NP_000273, hereafter ‘273, published 2015) and NCBI BLAST NP_000523 (NCBI BLAST Accession number NP_000523, hereafter ‘523, published 2015).
Regarding claim 1, Jiang is a patent document which teaches compositions and delivery formulations comprising a polynucleotide, e.g., a mRNA, encoding PCCA or PCCB and methods for treating propionic acidemia (PA) in a human subject in need thereof by administering the same, whereby the formulations of the invention are used in methods for reducing the levels of propionic acid in a human subject in need thereof to treat PA, where the mRNAs are encapsulated in a lipid nanoparticle (Abstract, and throughout/entire document). Jiang also teaches a method of alleviating the symptoms of propionic acidemia in a human subject comprising the administration of a composition or formulation comprising a polynucleotide encoding PCCA and/or PCCA to that human subject (e.g., an mRNA encoding a PCCA polypeptide) and/or a PCCB polypeptide by
intravenous administration (paragraphs 7, 10-12, and 809; claims 73-97). For instance, Jiang teaches that the method comprises administering mRNAs encoding ORFs of PCCA and PCCB to a subject to alleviate PA by intravenous administration (paragraph 12).
Jiang teaches that the ORFs encoding PCCA and PCCB can comprise the wildtype PCCA/PCCB, where Jiang teaches that wildtype PCCA is encoded by SEQ ID NO: 1 and wildtype PCCB is encoded by SEQ ID NO: 15 (paragraph 169). Jiang teaches that wildtype PCCA (i.e., SEQ ID NO 1 of Jiang) is shown in NCBI BLAST Accession number NP_000273.2 (paragraph 164), where wildtype PCCB (i.e., SEQ ID NO: 15) is shown in NCBI BLAST Accession number NP_000523 (paragraph 167). As evidenced by ‘273, SEQ ID NO 1 of Jiang is a 100% match of instant SEQ ID NO 1 (page 1 of ‘273). As evidenced by ‘523, SEQ ID NO 15 of Jiang is 100% match of instant SEQ ID NO 2 (page 1 of ‘523).
Jiang teaches the specific combination of the PCCA ORF of SEQ ID No: 11
and the PCCB ORF of SEQ ID No: 25 (which are identical with SEQ ID No: 5
and 6 of the present application, respectively, see paragraph 73 of Jiang and see alignment, attached, pages 1-7).
Jiang teaches that the PCCA:PCCB molar ratio is 1:1 (paragraph 1128).
Jiang teaches the co-administration of PCCA/PCCB at a dose between 0.25 mg/kg to 1 mg/kg (e.g., paragraph 1137, paragraph 107).
Thus, every element of claim 1 is taught by Jiang, where the practitioner can immediately envision the present subject matter in light of the teachings of Jiang because the mRNAs, lipid nanoparticle formulation of the mRNAs, molar ratio, and dosage are all taught by Jiang. Jiang therefore anticipates the limitations of claim 1.
Regarding claims 2-3, as discussed above, SEQ ID NOs 11 and 25 of Jiang are 100% identical to instant SEQ ID NOs 5 and 6 (see attached alignment, pages 1-7).
Regarding claims 4-6, Jiang teaches SEQ ID NOs 63 and 205 which comprise the 5’ UTR of instant SEQ ID NO 55 (claim 4), the 3’ UTR of instant SEQ ID 114 (claim 5), and are 100% identical to instant SEQ ID NOs 7 and 8 (claim 6) – see paragraphs 469 and 491.
Regarding claims 11-12, Jiang teaches that all uracils are N1-pseduomethyluracils (e.g., paragraph 64). Jiang specifically teaches that for instance SEQ ID NOs 63 and 205 can comprise all N1-pseudouracils (paragraph 64). SEQ ID NOs 63 and 205 are 100% identical to instant SEQ ID NOs 7 and 8, respectively. Jiang teaches that the mRNAs can be “capped” comprising a guanine cap nucleotide containing an N7 methylation where the 5’ termini contain 2’-O methyl (paragraph 421). Jiang teaches that the mRNAs comprise a poly-A tail that is 100 nucleotides in length (paragraph 64). Thus, Jiang teaches each of the elements of claims 11-12, where the practitioner of ordinary skill can immediately envision the well-known features of an mRNA molecule (e.g., 5’ capping with N7 methylation, polyA tail, an complete N1-pseudouracil incorporation, where each of these features are taught by Jiang).
Regarding claim 13, Jiang teaches that the doses of PCCA and PCCB can be 0.5 mg/kg (e.g., paragraphs 107 and 1120).
Regarding claim 22, Jiang teaches that multiple doses of the formulation can be given (Example 33, paragraph 1142). Given that Jiang is in general drawn to medical treatments and specifically teaches multiple-dose regimens, the practitioner can immediately envision multiple doses of a therapeutic, specifically in light of the fact that Jiang teaches multiple-dose administration.
Regarding claim 23, Jiang teaches that dosage should be every 4 weeks to combat rebounding disease/biomarker appearance (paragraph 1143). Jiang therefore teaches administration of doses at 4 weeks (paragraph 1143).
Regarding claims 28-29, Jiang teaches that classical PA is caused by loss of PCC functionality (paragraph 1). Given that the Jiang is focused on treating PA, Jiang inherently teaches that subjects for treatment of PA comprise loss of function of PCC (paragraph 1). The practitioner immediately understands and envisions that the subject could have “classical PA,” as taught by Jiang, which comprises loss of PCC functionality (paragraph 1).
Regarding claim 34, Jiang teaches administration of PCCA and PCCB mRNAs (e.g., Example 32, paragraph 814, Abstract, and throughout). Thus, the methods and treatment of Jiang inherently “increase PCCA and PCCB mRNAs” compared with baseline because the treatments/methods of Jiang involve injecting additional PCCA and PCCB mRNAs (e.g., Abstract).
Regarding claim 51, Jiang teaches Compound II (below, paragraph 573)
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Compound II reads on formula I when n is 2, l is 5, M' is C(O)O, Ra-alpha, Ra-beta Ra-gamma and Ra-delta are all H and R' is C5 alkyl, R5 and R6 are H and m is 7, M is C(O)O and R2 and R3 are each C8 alkyl . Compound II of Jiang therefore anticipates the limitations of claim 51.
Regarding claims 52-55, Jiang teaches the delivery agent comprises Compound II, DSPC (i.e., a phospholipid), Cholesterol (i..e, a structural lipid), and Compound I (where Compound I of Jiang is identical to instant Compound I, see below for structural comparison, paragraph 823). Thus, Jiang teaches the recited lipid nanoparticle formulations as a preferred embodiment and therefore anticipates the claim limitations. Regarding the specific molar ratios recited in claim 55, Jiang teaches:
“a mole ratio in the range of about 30 to about 60 mol% Compound II or VI (or related suitable amino lipid) (e.g., 30-40, 40-45, 45- 50, 50-55 or 55-60 mol% Compound II or VI (or related suitable amino lipid)), about 5 to about 20 mol% phospholipid (or related suitable phospholipid or "helper lipid") (e.g., 5-10, 10-15, or 15-20 mol% phospholipid (or related suitable phospholipid or "helper lipid")), about 20 to about 50 mol% cholesterol (or related sterol or "noncationic" lipid) (e.g., about 20-30, 30-35, 35-40, 40-45, or 45-50 mol% cholesterol (or related sterol or "non-cationic" lipid)) and about 0.05 to about 10 mol% PEG lipid (or other suitable PEG lipid) (e.g., 0.05-1, 1-2, 2-3, 3-4, 4-5, 5-7, or 7-10 mol% PEG lipid (or other suitable PEG lipid),” (paragraph 823).
Thus, not only does Jiang teach the lipid nanoparticle formulations recited as preferred embodiments, but also teaches the molar% concentration ranges as presently recited. Jiang therefore anticipates the claims because they teach each element of the claims and offer them as preferred embodiments. The practitioner can therefore immediately envision the recited compositions and formulations.
Regarding claims 56-57, Jiang teaches the delivery agent comprises Compound II, DSPC, Cholesterol, and Compound I (paragraph 823). Jiang therefore teaches the same lipid formulations presently recited (paragraph 82).
Note that the specification defines Compound II as the following structure on page 87:
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Instant Compound II is therefore anticipated by Compound II of Jiang (Jiang paragraph 573).
The specification defines Compound I on page 116 (below):
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Compound I of Jiang anticipates instant Compound I (paragraph 623):
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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 1-6, 11-13, 22-23, 28-29, 34, 51-54, and 56-57 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. US 12,685,785 B2 (‘785) in view of Jiang (WO 2019/104195 A1).
Regarding claim 1, ‘785 in general recites mRNAs encoding PCCA and PCCB (e.g., claim 17). As an initial matter, although the instant application is directed to a method and does not recite products, a practitioner of ordinary skill in the art would reasonably conclude that practicing the method recited necessarily entails possession of the mRNAs, where furthermore use of such mRNAs in treatment methods of PA are known in the art a taught by Jiang (see below). One of skill in the art would consider claiming the mRNAs as an obvious variant. Thus ‘785 and the instant claims are obvious variants.
Regarding claim 1, claim 17 of ’785 recites:
“A pharmaceutical composition comprising a first mRNA and a second mRNA, wherein the first mRNA comprises (i) a first 5′-terminal cap, (ii) a first 5′ UTR, (iii) a first ORF encoding the PCCA polypeptide set forth in SEQ ID NO:1, wherein the ORF has at least 93% sequence identity to the nucleic acid sequence set forth in SEQ ID NO:11, (iv) a first 3′ UTR, and (v) a first poly-A-region, and wherein the second mRNA comprises (i) a second 5′-terminal cap, (ii) a second 5′ UTR, (iii) a second ORF encoding the PCCB polypeptide set forth in SEQ ID NO:15, wherein the ORF has at least 93% sequence identity to the nucleic acid sequence set forth in SEQ ID NO:25, (iv) a second 3′ UTR, and (v) a second poly-A-region.
As shown in the alignment (attached) instant SEQ ID NOs 1, 2, 5, and 6 are 100% identical matches of SEQ ID NOs 1, 15, 11, and 25, respectively, of ‘785. Thus, the instant mRNAs recited are identical with those recited in claim 17 of ‘785.
‘785 does not recite that the mRNAs are administered in a treatment method at a dose of 0.3 mg/kg – 1 mg/kg.
Jiang is a patent document which teaches methods of treatment of PA (Title, Abstract, and throughout). The teachings of Jiang as they relate to the 102 rejection are incorporated herein in their entirety, and for the sake of brevity are not copied here. Briefly, Jiang teaches the identical mRNAs instantly recited, and therefore also teaches the same mRNAs recited in ‘785 (see 102 rejection, above). Jiang teaches that such mRNAs can be used in treatment methods of PA at doses between 0.3 mg/kg – 1mg/kg (e.g., Example 32, paragraph 1137).
It would have been obvious to a person of ordinary skill in the art to combine the mRNAs of ‘785 into the methods of Jiang because Jiang teaches that such mRNAs are useful in the treatment of PA. The practitioner is therefore motivated to combine the mRNAs with a therapeutic administration method such as that taught by Jiang.
Regarding the remaining claims 2-6, 11-13, 22-23, 28-29, 34, 51-54, and 56-57, these limitations are taught by Jiang, where the specific teachings of Jiang are addressed in the 102 rejection above and reiterated herein to address these limitations. The combination of Jiang with ‘785 is obvious to arrive at the present invention because both Jiang and ‘785 teach the same mRNAs. The results are predictable because ‘785 further recites similar claim elements (capping, N1-mehtylpsuedouracil, lipid nanoparticle formulations, see claims 1-37 of ‘785).
Claims 1-6, 11-13, 22-23, 28-29, 34, 51-54, and 56-57 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16 and 18-34 of copending Application No. 16/631,607 (‘607) in view of Jiang (WO 2019/104195 A1).
Regarding claim 1, ‘607 in general recites mRNAs encoding PCCA and PCCB where the mRNAs are in a lipid nanoparticle (e.g., claim 16). ‘607 further recites methods of treating PA (claims 18 and 27-34). Claim 19 of ‘607 recites that the protein encoded by the mRNA is SEQ ID NO 1 for PCCA and SEQ ID NO 4 for PCCB. As shown in the attached alignment, SEQ ID NOs 1 and 2 of the instant application are identical to SEQ ID NOs 1 and 4 of ‘607 (see attached alignment). Thus, the mRNAs recited by ‘607 used in the methods of treatment of PA encode identical proteins as those instantly recited in claim 1.
‘607 does not recite that the methods include administration at a dose of 0.3 mg/kg – 1 mg/kg, or that the nucleotide sequences are 80% identical with SEQ ID NOs 5 and 6.
Jiang is a patent document which teaches methods of treatment of PA (Title, Abstract, and throughout). The teachings of Jiang as they relate to the 102 rejection are incorporated herein in their entirety, and for the sake of brevity are not copied here. Briefly, Jiang teaches the identical protein encoded by the mRNAs instantly recited, and therefore also teaches the same protein encoded by the mRNAs recited in ‘607 (see 102 rejection, above). Jiang teaches that such mRNAs can be used in treatment methods of PA at doses between 0.3 mg/kg – 1mg/kg (e.g., Example 32, paragraph 1137). Jiang teaches that the mRNAs can comprise instantly recited SEQ ID NOs 5 and 6 (alignment provided in 102 rejection).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to combine the mRNAs encoding PCCA and PCCB with the mRNAs and methods taught by Jiang, as such a combination is the simple combination of known prior art elements to yield predictable results. In the present case, both ‘607 and Jiang teach the same protein encoded by the mRNAs; the nucleotide sequences taught by Jiang are therefore obvious embodiments, as Jiang teaches such known nucleotide sequences to encode such proteins. Furthermore, Jiang has reduced to practice such methods as treating PA at such dosages (102 rejection above, incorporated herein).
Regarding the remaining claims 2-6, 11-13, 22-23, 28-29, 34, 51-54, and 56-57, these limitations are taught by Jiang, where the specific teachings of Jiang are addressed in the 102 rejection above and reiterated herein to address these limitations. The combination of Jiang with ‘607 is obvious to arrive at the present invention because both Jiang and ‘607 teach the same proteins encoded by mRNAs to treat PA. The results are predictable because ‘607 and Jiang recite similar claim limitations, proteins encoded by mRNA, and methods of treating PA (see claims 16 and 18-34 of ‘607).
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DOUGLAS CHARLES RYAN whose telephone number is (571)272-8406. The examiner can normally be reached M-F 8AM - 5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ram Shukla can be reached at (571)-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.C.R./Examiner, Art Unit 1635
/RAM R SHUKLA/Supervisory Patent Examiner, Art Unit 1635
Prosecution Insights