Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim status
Claims 1-22 are pending.
Claims 9-22 are withdrawn to non-elected invention group.
Claims 6 and 7 are withdrawn to non-elected species.
Claims 1-5, and 8 are under examination in this office action.
Election/Restrictions
Applicant’s election without traverse of invention Group I (e.g., claims 1-8) in the reply filed on December 1, 2025 is acknowledged.
Claims 9-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 1, 2025.
Applicant’s election without traverse of the blood clotting factor of claim 2 as the species of type of heterologous gene among claims 2, 4, 6, and 7. (e.g., claims 1-8) in the reply filed on December 1, 2025 is acknowledged.
Claims 6 and 7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 1, 2025.
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.
Specific deficiencies and the required response to this Office Action are as follows: The Incorporation by Reference Statement regarding the Sequence Listing (page 1 of specification) is not in proper form. The size of the ASCII text file is shown in kilobytes but must be shown in bytes.
Appropriate correction is required as part of a complete response to this action.
Priority
The most recent Filing Receipt filed on July 9, 2025 states that: this US19/051,398 filed on 02/12/2025 is a CON of 18/789,395 filed on 07/30/2024 which is a CON of 18/345,191 filed on 06/30/2023 (ABN) which is a CON of 18/054,786 filed on 11/11/2022 (ABN) which is a DIV of 16/368,758 filed on 03/28/2019 (now US Patent 11680274) which is a DIV of 14/624,671 filed on 02/18/2015 (now US Patent 10301648) which is a DIV of 11/887,679 filed on 10/02/2007 (now US Patent 8999678) which is a 371 of PCT/US2006/013375 filed on 04/07/2006 which claims US priority benefit of US Provisionals 60/733,497 filed on 11/04/2005 and 60/669,083 filed on 04/07/2005.
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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, Application Nos. 18/789,395 18/345,191, 18/054,786, 16/368,758, 14/624,671, 11/887,679, PCT/US2006/013375 and US Provisionals 60/733,497, and 60/669,083, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Specifically, none of the priority documents disclose the instant SEQ ID NO: 50. Also, the specification does not recite (ii) an amino acid sequence having at least 95% identity to the full length of amino acids 204 to 738 of SEQ ID NO: 50, wherein the amino acid residues corresponding to positions 665, 686, and 697 in SEQ ID NO: 50 are N, E and W, respectively, when aligned along the full length of amino acids 204 to 738 of SEQ ID NO: 50. Example 1 shows Rh64R2 having an R697W, and V686E. However, hu.48 shows no required amino acid residues. Further, the specification shows no requirement for an N residue at position 665 for any isolate.
Thus, the effective filing date for the present claims is to this US19/051,398 filed on 02/12/2025.
Possible status as a CIP
This application repeats a substantial portion of prior Application No. 18/789,395, filed on 07/30/2024, and adds disclosure not presented in the prior application. Because this application names the inventor or at least one joint inventor named in the prior application, it may constitute a continuation-in-part of the prior application. Should applicant desire to claim the benefit of the filing date of the prior application, attention is directed to 35 U.S.C. 120, 37 CFR 1.78, and MPEP § 211 et seq. The presentation of a benefit claim may result in an additional fee under 37 CFR 1.17(w)(1) or (2) being required, if the earliest filing date for which benefit is claimed under 35 U.S.C. 120, 121, 365(c), or 386(c) and 1.78(d) in the application is more than six years before the actual filing date of the application.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The claimed subject matter of present claim 1 is not found in the specification. Specifically, the specification does not recite (ii) an amino acid sequence having at least 95% identity to the full length of amino acids 204 to 738 of SEQ ID NO: 50, wherein the amino acid residues corresponding to positions 665, 686, and 697 in SEQ ID NO: 50 are N, E and W, respectively, when aligned along the full length of amino acids 204 to 738 of SEQ ID NO: 50.
Also, the disclosure is objected to because of the following informalities: Each of the Tables shown in pages 43-45 are not labeled as a Table.
Appropriate correction is required.
Claim Objections
Claim 3 is objected to because of the following informalities: For improved clarity, claim 3 should be amended: … recombinant AAV genomes per kg of the subject are intravenously administered to the subject.
Appropriate correction is required.
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 pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1 and 8 are rejected under pre-AIA 35 U.S.C. 102b as being anticipated by Colosi et al (WO-2023/034996 published March 9, 2023). See Priority section above for explanation of effective filing date for the present claims which is 02/12/2025.
Regarding claims 1 and 8, Colosi et al is titled: AAV Capsid Compositions And Methods For Delivery. Colosi et al teaches that the AAV capsid comprises AAV vp1 proteins, AAV vp2 proteins, and AAV vp3 proteins, wherein their reference SEQ ID NO: 48 is 100% identical to the amino acids 204 to 738 of instant SEQ ID NO: 50. See SCV/STIC result comparing instant SEQ ID NO: 50 with Colosi et al SEQ ID NO: 48 just below and Colosi et al reference para 0008, lines 1-8. Further, Colosi et al teach the rAAV vector genome comprising a minigene having AAV2 inverted terminal repeats. See para 00246-247; Table 4 showing AAV-2 ITR sequences. Colosi et al and a heterologous gene operably linked to regulatory sequences which direct expression of the heterologous gene in a host cell. See para 00251. Colosi et al discloses a method of delivering a gene product to a subject comprising intravenous administration to the subject. (See para 00306).
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Regarding claim 8, Colosi et al discloses that the AAV vp3 capsid protein has an amino acid sequence which is 100% identical to the full length of amino acids 204 to 738 of instant SEQ ID NO: 50. See Colosi et al reference SEQ ID NO: 48 above.
Therefore Colosi et al anticipates instant claims 1 and 8.
Claim Rejections - 35 USC § 103
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claim 1-5, and 8 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Colosi et al (WO-2023/034996 published March 9, 2023) as applied to claims 1 and 8 above, in view of Venditti et al (2022/0218843 published July 14, 2022).
Colosi et al anticipates claims 1 and 8 for reasons applied above.
Regarding claims 3 and 5, Colosi et al disclose that 5 x 1010 to 5 x 1013 recombinant AAV genomes per kg are intravenously administered to the subject. (See paragraphs 00304-00306).
However, regarding claims 2 and 4, while Colosi et al teaches administration of the rAAV comprising a therapeutic heterologous gene for intravenous delivery to a subject, they do not teach that the heterologous gene encodes a blood clotting factor, and specifically Factor IX, or Factor VIII.
Regarding claims 2 and 4, Venditti et al discloses intravenous delivery for administering a gene encoding a blood clotting factor, specifically Factor IX, to successfully treat a subject for hemophilia. (See Table 6; para 0045-46; 0198). Venditti et al disclose that in some embodiments an rAAV vector comprising a capsid protein and AAV2 ITR sequences was used to carry a therapeutic transgene (heterologous gene). (See para 0009 and 0011).
It is considered that the level of ordinary skill in the art was at the level of an MD or PhD research scientist before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to use the blood clotting factor gene therapy genes, including Factor IX, discloses in Venditti et al as the therapeutic heterologous gene in the AAV gene therapy vector of Colosi et al for the rationale of using such AAV vectors for treating a blood clotting condition including hemophilia in a subject.
In would have been obvious to one of ordinary skill in the art to use a blood clotting factor gene therapy gene Factor IX discloses in Venditti et al as the therapeutic heterologous gene in the AAV gene therapy vector of Colosi et al because Venditti et al disclose they were known, available, and successfully used to treat a hemophilia condition in a subject and Colosi et al showed successful delivery of AAVs carrying therapeutic heterologous genes for use in gene therapy.
Absent evidence to the contrary, it is considered that one of ordinary skill in the art would have had a reasonable expectation of success to use the blood clotting factor gene therapy genes disclosed in Venditti et al as the therapeutic heterologous gene in the AAV gene therapy vector of Colosi et al to arrive at the presently claimed invention.
Thus the claims as a whole are rendered 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 1-5, and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-14 of US Patent 7,790,449 in view of Colosi et al (WO-2023/034996 published March 9, 2023. Although the claims at issue are not identical, they are not patentably distinct from each other because although the claims are not identical they are not patentably distinct because the copending claims are essentially the same as or anticipate or render obvious the instant claims.
Regarding instant claim 1, patented claim 14 recites a method of delivering a transgene to a cell by contacting the cell with the AAV vector of patented claim 1, where the AAV vector comprises the transgene. Patented claim 2 recites an AAV vector comprising an AAV vp3 protein having the sequence of amino acid 203 to 737 of patented SEQ ID NO:2. The vector comprises a minigene comprising AAV ITRs and a heterologous gene sequence operably linked to regulatory sequences which direct expression of a product from the heterologous gene sequence in the host cell. Further, regarding instant claim 1, patented SEQ ID NO:2 meets the limitation of (ii) an amino acid sequence having at least 95% identity to the full length of amino acids 204 to 738 of SEQ ID NO:50, wherein the amino acid residues corresponding to positions 665,686, and 697 in SEQ ID NO: 50 are N, E and W, respectively, when aligned along the full length of amino acids 204 to 738 of SEQ ID NO: 50.
Regarding instant claims 2 and 4, patented claims 6-7 recite that the heterologous gene encodes the blood clotting factor, and specifically Factor IX, or Factor VIII.
However, patented claims differ in that they recite AAV ITRs but not AAV2 ITRS. Colosi et al disclose AAV2 ITRs. Colosi et al teach the rAAV vector genome comprising a minigene having AAV2 inverted terminal repeats. See para 00246-247; Table 4 showing AAV-2 ITR sequences.
Also, patented claim 8 recites delivery but does not recite intravenous delivery. Colosi et al discloses a method of delivering a gene product to a subject comprising intravenous administration to the subject. (See para 00306).
Regarding claims 3 and 5, Colosi et al disclose that 5 x 1010 to 5 x 1013 recombinant AAV genomes per kg are intravenously administered to the subject. (See paragraphs 00304-00306).
Further, especially regarding instant claim 8, Colosi et al teaches that the AAV capsid comprises AAV vp1 proteins, AAV vp2 proteins, and AAV vp3 proteins, wherein their reference SEQ ID NO: 48 is 100% identical to the amino acids 204 to 738 of instant SEQ ID NO: 50. See SCV/STIC result comparing instant SEQ ID NO: 50 with Colosi et al SEQ ID NO: 48 above and Colosi et al reference para 0008, lines 1-8.
The level of skill in the art was high before the effective filing date of the presently claimed invention.
One of ordinary skill in the art would have been motivated to the combine the elements of the patented claims with the elements of Colosi et al for the rationale of treating a subject with hemophilia with a blood clotting factor, and specifically Factor IX, or Factor VIII. It would have been obvious to do such because Colosi et al and the patented claims are in the same field of using rAAV vectors comprising expression cassettes carrying therapeutic transgenes to deliver such to a subject in need.
It is considered that one of ordinary skill in the art would have had a reasonable expectation of success to combine the elements of the patented claims and Colosi et al to arrive at the presently claimed invention.
Conclusion
No claim is allowed.
Related prior art which may be applied in a future office action if appropriate:
Wilson et al (WO2024015966-A2; IDS ref) Adeno-associated virus capsid proteins, Reference SEQ ID 36 (aka rh97) is 100% match to instant SEQ ID NO: 50.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE S HIBBERT whose telephone number is (571)270-3053. The examiner can normally be reached M-F 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CATHERINE S HIBBERT/Primary Examiner, Art Unit 1658