Notice of Pre-AIA or AIA Status
The present application is no longer being examined under the pre-AIA first to invent provisions.
In light of amended claims 57 and 58, directed to subject matter that was introduced after 3/16/2013, the present application is being examined under the first inventor to file provisions of the AIA (see MPEPE 2159.03). The Examiner recommends Applicant submit a revised 37 CFR 1.55/1.78 statement, and/or amend the ADS to indicate an AIA application, and to request a corrected filing receipt.
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 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.
DETAILED ACTION
Claim status
Claims 56-73 are pending
Claims 62-73 are withdrawn
Claims 56-61 are under examination
Election/Restrictions
Applicant’s election of the following invention without traverse in the reply filed on 2/25/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Group I, claims 56-61, drawn to a rAAV.
Claims 62-73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/06/2023, 2/25/2026 are mostly in compliance with the provisions of 37 CFR 1.97.
Specifically, the IDS filed 7/06/2023 cites the NPLs of Zhang et al., Mol Therapy, 2010, Abstract 450, and Zhong et al., Mol Therapy, 2010, Abstract 58, but fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of a non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
The remainder of the information disclosure statements are being considered by the examiner.
Furthermore, Applicant is reminded that the listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Rejections - 35 USC § 112(a)
NEW MATTER
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 57-58 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.
The new limitation of claim 57 directed to the nucleic acid of the AAV vector as comprising an ASPA “messenger ribonucleic acid (mRNA)“ in instant claims appears to represent new matter. MPEP 2163.06 notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112(a), pre-AIA first paragraph - written description requirement. In re Rasmussen , 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).” No basis for this limitation was identified in Applicant’s remarks filed 7/05/2023, and while a review of the specification by the Examiner did reveal support for an ASPA mRNA expressed from the nucleic acid of the AAV (e.g., p. 7 2nd para., p. 9, 3rd para.), the Examiner did NOT find any specific basis for the recited AAV comprising a nucleic acid comprising a mRNA. As noted by the MPEP, new matter includes not only the addition of wholly unsupported subject matter, but may also include the introduction of claim changes which involve narrowing the claims by introducing elements or limitations which are not supported by the as-filed disclosure is a violation of the written description requirement of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571, 39 USPQ2d 1895, 1905 (Fed. Cir. 1996).
Claim Rejections - 35 USC § 112(a)
(Written Description)
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 57-58 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.
Dependent claim 57 encompass a genus of recombinant AAV comprising a nucleic acid comprising a promoter operably linked to an ASPA “messenger ribonucleic acid (mRNA)“, while the specification discloses no such rAAV.
Dependent claim 87 encompasses a genus of rAAV comprising a mRNA further comprising a genus of miRNA sites.
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
ACTUAL REDUCTION TO PRACTICE
In regard to claim 57 encompassing a genus of recombinant AAV comprising a nucleic acid comprising a promoter operably linked to an ASPA “messenger ribonucleic acid (mRNA)“, the specification describes no such rAAV.
In fact the closest example from the specification is a rAAV comprising a nucleic acid comprising a promoter operably linked to a ASPA DNA, which encodes a RNA.
Accordingly, Applicant did not demonstrate a reduction to practice of a such rAAV comprising mRNA, nor did Applicant adequately set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of rAAV.
DISCLOSURE OF STRUCTURE
The Applicant has provided no rAAV comprising mRNA. Although rAAV were known viral particles, the prior art at the time of filing was silent with respect to rAAV comprising mRNA.
SUFFICIENT RELEVANT IDENTIFYING CHARACTERISTICS
As mentioned in above, rAAV were known in the prior art, and the skilled artisan could genetically modify a rAAV to comprising a promoter operably linked to an ASPA DNA.
The breadth of the claims encompass a genus of rAAV comprising mRNA, yet the present specification provides no guidance nor description of such rAAV, therefore the skilled artisan would not know what rational approach to take to make the genus of rAAV. Therefore, it is incumbent on the applicant to provide this nexus between structure and function, in order to be given credit for possession of the claimed genus of rAAV.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
The method of making the claimed invention is not well established. Although the making of rAAV comprising a promoter operably linked to DNA was known in the state of the art, one of skill in the art would neither expect nor predict the appropriate function of an rAAV comprising a promoter operably linked to mRNA. Specifically, the review of Daya et al. “Gene Therapy Using Adeno-Associated Virus Vectors” (2008, see IDS filed 7/06/2023), describes the state of the art with respect to rAAV as viral vector comprising DNA, not mRNA.
CONCLUSION
Therefore, the Examiner concludes that there is insufficient written description of the instantly claimed genus of rAAV comprising a nucleic acid comprising a promoter operably linked to an ASPA mRNA, and the Examiner further concludes a skilled artisan would find the specification inadequately describes the claimed genus of rAAV.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 56, 60, and 61 are rejected under 35 U.S.C. 103 as being unpatentable over Lawlor et al., (WO2010/071454, filed 12/17/2009, published 6/24/2010, see IDS filed 7/06/2023), in view of Gao et al., (J Virol, 2004, 6381-6388, see IDS filed 7/06/2023).
Lawlor teaches a recombinant AAV vector for comprising
a nucleic acid comprising a promoter operably linked with an aspartoacylase (ASPA) sequence (p. 4, last para., p. 5, 4th para., pgs.23-24, Example 13, see also Claims 1-8 of Lawlor), and
a capsid protein having the amino acid sequence of an AAV9 (p. 5, 2nd para.,, p. 11, 2nd - 3rd para. see Fig. 8).
However, Lawlor is silent with respect to the amino acid sequence for the capsid of AAV9. Nevertheless, Lawlor cites the prior art of Gao et al. (2004) (see reference #30 of Lawlor).
Gao et al. (2004) teaches the amino acid sequence for the capsid of AAV9. Importantly, the amino acid sequence taught by Gao is 100% identical to the SEQ ID NO: 8 (SCORE Search Result 20260419, rup.file, Result #1)
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the rAAV9-ASPA vector as taught by Lawlor, and choose a nucleic acid that encodes the amino acid sequence of the AAV9 capsid as taught by Gao with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so for several reasons. First, since Lawlor cites Gao for the making of the AAV9 vector, therefore it would have been obvious to the ordinary artisan to turn to the cited art for an enabling disclosure of the AAV9 sequence. Furthermore, the successful cloning and sequencing of a DNA encoding a known protein is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009). In instant case, Lawlor provides the motivation to make and use a nucleic acid for the production of the AAV9 capsid, while Gao provides the reasonable expectation of success for doing so by describing the sequence.
In regard to claim 60, Lawlor teaches the promoter is a tissue specific promoter (p. 4, last para., p. 14, 2nd para.).
In regard to claim 61, Lawlor teaches the rAAV is delivered by infusion into a subject (p. 1, Background, 2nd para., p.11, Fig. 8, legend), which makes obvious to include a pharmaceutically acceptable carrier.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Claim 59 is rejected under 35 U.S.C. 103 as being unpatentable over Lawlor et al., (WO2010/071454, filed 12/17/2009, published 6/24/2010, see IDS filed 7/06/2023), in view of Gao et al., (J Virol, 2004, 6381-6388, see IDS filed 7/06/2023), as applied to claim 56, in further view of Wang et al., (Gene Therapy, 2003, 10:2105-2111).
As discussed previously, Lawlor and Gao suggest and rAAV9-ASPA vector comprising the capsid of SEQ ID NO:8.
However, Lawlor and Gao are silent with respect to the rAAV vector being a self-complementary (sc)AAV.
Wang teaches an rAAV comprising a promoter operably linked to a transgene, wherein the rAAV is a scAAV (Abstract, p. 2109, Materials and Methods, last para.).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the rAAV9-ASPA as suggested by Lawlor et al. and substitute the rAAV for an scAAV as taught by Wang with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Wang because the scAAV vector exhibits superior and accelerated transduction compared to the single-stranded rAAV vector (Abstract).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 56, 60, and 61 are rejected on the grounds of nonstatutory double patenting over claims 1-15, and 17-18 of U.S. Patent No. 12,491,235 (Gao et al., Patented 12/09/2025) in view of Gao et al., (J Virol, 2004, 6381-6388, see IDS filed 7/06/2023).
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the rAAV9 composition comprising a promoter operably linked to an ASPA sequence of cited patent makes obvious the composition of instant application. It is clear that elements of the cited patent claims are to be found in instant claims. The difference between the cited patent claims and the instant claims lies in the fact that the instant application claims are more specific to the AAV9 capsid sequence.
Gao et al. (2004) teaches the amino acid sequence for the capsid of AAV9. Importantly, the amino acid sequence taught by Gao is 100% identical to the SEQ ID NO: 8 (SCORE Search Result 20260419, rup.file, Result #1)
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the rAAV9-ASPA vector as claimed by cited patent, and claim a nucleic acid that encodes the amino acid sequence of the AAV9 capsid as taught by Gao with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so because the successful cloning and sequencing of a DNA encoding a known amino acid sequence is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009).
Since the instant application claims are obvious over cited patent claims in view of Gao, said claims are not patentably distinct.
Claim 59 is rejected on the grounds of nonstatutory double patenting over claims 1-15, and 17-18 of U.S. Patent No. 12,491,235 (Gao et al., Patented 12/09/2025) in view of Gao et al., (J Virol, 2004, 6381-6388, see IDS filed 7/06/2023), in further view of Wang et al., (Gene Therapy, 2003, 10:2105-2111)..
As stated supra, the subject matter claimed in the instant application is disclosed in the referenced patent as follows: the rAAV9 composition comprising a promoter operably linked to an ASPA sequence of cited patent makes obvious the composition of instant application. The difference between the cited patent claims and the instant claims lies in the fact that the instant application claims are more specific to the AAV being a scAAV.
Wang teaches an rAAV comprising a promoter operably linked to a transgene, wherein the rAAV is a scAAV (Abstract, p. 2109, Materials and Methods, last para.).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the rAAV9-ASPA as claimed by cited patent and substitute the rAAV for an scAAV as taught by Wang with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so as taught by Wang because the scAAV vector exhibits superior and accelerated transduction compared to the single-stranded rAAV vector (Abstract).
Since the instant application claims are obvious over cited patent claims in view of Gao, and in further view of Wang, said claims are not patentably distinct.
Provisional Double Patenting
Claims 56, 59-61 are provisionally rejected on the grounds of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/857,527, in view of Gao et al., (J Virol, 2004, 6381-6388, see IDS filed 7/06/2023). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented
The subject matter claimed in the instant application is disclosed in the referenced application as follows: the rAAV9 composition comprising a promoter operably linked to an ASPA sequence of cited application makes obvious the composition of instant application. It is clear that elements of the cited application claims are to be found in instant claims. The difference between the cited application claims and the instant claims lies in the fact that the instant application claims are more specific to the AAV9 capsid sequence.
Gao et al. (2004) teaches the amino acid sequence for the capsid of AAV9. Importantly, the amino acid sequence taught by Gao is 100% identical to the SEQ ID NO: 8 (SCORE Search Result 20260419, rup.file, Result #1)
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time of filing to prepare the rAAV9-ASPA vector as claimed by cited application, and claim a nucleic acid that encodes the amino acid sequence of the AAV9 capsid as taught by Gao with a reasonable expectation of success. The ordinary skilled artisan would have been motivated to do so because the successful cloning and sequencing of a DNA encoding a known amino acid sequence is obvious, and thus unpatentable, if (1) there was some suggestion or motivation in the prior art to clone the cDNA, and (2) there was a “reasonable expectation of success,” based on "detailed enabling methodology" in the prior art. Ex parte Kubin, 83 U.S.P.Q.2d (BNA) 1410 (B.P.A.I. 2007), aff'd, 561 F.3d 1351 (Fed. Cir. 2009).
Since the instant application claims are obvious over cited application claims in view of Gao, said claims are not patentably distinct.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARTHUR S LEONARD whose telephone number is (571)270-3073. The examiner can normally be reached on Mon-Fri 9am-5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Doug Schultz can be reached on 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARTHUR S LEONARD/Examiner, Art Unit 1631
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