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 .
Priority
The instant application is a Continuation of U.S. Application No. 17/908,509 (filed 08/31/2022). Acknowledgement is made of Applicants’ claims for benefit of U.S. Provisional Application No. 62/984,716 (filed 03/03/2020).
Response to Amendment
The amendment filed on 06/08/2026 has been received and entered into the application file.
Claim Interpretation
The following comments are made to establish broadest reasonable interpretation for the record.
Regarding claim 1: Claim 1 has been amended to recite, “…wherein the at least one soluble exogenous factor comprises a dimeric soluble CD4 protein or fragment thereof, and wherein the dimeric soluble CD4 comprises a sequence having at least 95% sequence identity to SEQ ID NO: 9, SEQ ID NO: 76, or SEQ ID NO: 77.” However, SEQ ID NOs: 9, 76, and 77 are nucleotide sequences. A protein may comprise an amino acid sequence, as a protein’s primary structure is dictated by and necessarily includes a specific, ordered sequence of amino acids. However, a protein is encoded by a nucleic acid sequence, as the nucleotides of a given nucleic acid sequence are translated by ribosomes for protein synthesis. A rejection under 35 USC 112(b) is necessitated, as below. However, for purposes of compact proseuction, claim 1 is interpreted as:
A viral vector comprising a therapeutic cargo portion, wherein the therapeutic cargo portion comprises a nucleotide sequence that encodes at least one soluble exogenous factor, and a T cell-responsive promoter that regulates expression of the nucleotide sequence,
wherein the at least one soluble exogenous factor comprises a dimeric soluble CD4 protein or a fragment thereof, and
wherein the dimeric soluble CD4 is encoded by a sequence having at least 95% sequence identity to SEQ ID NO: 9, SEQ ID NO: 76, or SEQ ID NO: 77.
Additionally, claims 2-3 and 8-9 recite limitations which do not correlate to the subject matter of amended claim 1.
Regarding claims 2-3: Claims 2-3 are directed to soluble exogenous factors other than dimeric soluble CD4. These claims recite the soluble exogenous factor of claim 1 as an anti-HIV antibody (claim 2), specifically VRC01 or 3BNC117 (claim 3).
Regarding claims 8-9: Claims 8-9 recite the nucleotide sequence of claim 1 as comprising a sequence as set forth in SEQ ID NOs: 1-10, 78, 80-85, and 87 (claim 9), or at least 95% sequence identity thereto (claim 8).
Some of these sequences (e.g., SEQ ID NOs: 2, 4, 6) are directed to a vector encoding anti-HIV antibody VRC01 or 3BNC117 with a CMV promoter and IL-2 secretory signal sequence (see e.g., Table 1 on pg. 38 of the instant specification). Other sequences (e.g., SEQ ID NO: 78) are directed to a vector encoding inhibitory RNA sequences targeting CCR5 and HIV Vif/Tat (Table 1). Still others (e.g., SEQ ID NOs: 80-82) are directed to a vector encoding soluble CD4-IgG1 Fc fusion protein with antibody secretory signal sequence (Table 1).
Therefore, under broadest reasonable interpretation, the sequences recited in claims 8-9 are interpreted as referring to the nucleotide sequence of claim 1 which encodes at least one soluble exogenous factor capable of inhibiting HIV infection.
Status of Prior Rejections/Response to Arguments
RE: Rejection of:
claim 1 under 35 U.S.C. 102(a)(2) over Thomas;
claim 1 under 35 U.S.C. 102(a)(1) and (a)(2) over Meruelo; and
claim 1 under 35 U.S.C. 102(a)(2) over Zeng:
The amendment to claim 1 requiring the at least one soluble exogenous factor comprises a dimeric soluble CD4 protein or fragment thereof, wherein the dimeric soluble CD4 is encoded by a sequence having at least 95% sequence identity to SEQ ID NO: 9, SEQ ID NO: 76, or SEQ ID NO: 77 is sufficient to obviate the rejections of record, as SEQ ID NOs: 9, 76, and 77 are free from the prior art.
Accordingly, the rejections have been withdrawn.
RE: Provisional rejection of claim 1 on the ground on nonstatutory double patenting over copending Application No. 17/908,509:
The terminal disclaimer filed on 06/08/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of any patent granted on Application No. 17/908,509 has been reviewed and is accepted. The terminal disclaimer has been recorded, and is sufficient to overcome the rejection of record.
Accordingly, the rejection is withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-12 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.
Regarding claim 1: As set forth above, claim 1 recites, “…wherein the at least one soluble exogenous factor comprises a dimeric soluble CD4 protein or fragment thereof, and wherein the dimeric soluble CD4 comprises a sequence having at least 95% sequence identity to SEQ ID NO: 9, SEQ ID NO: 76, or SEQ ID NO: 77.” However, SEQ ID NOs: 9, 76, and 77 are nucleotide sequences; while a protein may comprise an amino acid sequence, a protein is encoded by a nucleic acid sequence. The disjointed claim language does not clearly or precisely define the metes and bounds of the instant claim, as proteins cannot comprise nucleotides, rendering claim 1 indefinite.
Please see the Examiner’s Comments section for suggestions and further guidance as to how this rejection may be overcome.
Claims 2-12 depend directly from claim 1, inherit its deficiencies, and are likewise rejected as indefinite.
Regarding claims 2-3: These claims are directed to soluble exogenous factors other than dimeric soluble CD4, reciting the soluble exogenous factor of claim 1 as an anti-HIV antibody (claim 2), specifically VRC01 or 3BNC117 (claim 3). This creates confusion as to what is required by the instant invention: are the instant claims directed to an invention other than that of claim 1? Does the viral vector comprise an anti-HIV antibody in addition to dimeric soluble CD4? The metes and bounds are not clearly or precisely defined, rendering claims 2 and 3 indefinite.
Regarding claims 8-9: These instant claims recite the nucleotide sequence of claim 1 as comprising a sequence as set forth in SEQ ID NOs: 1-10, 78, 80-85, and 87 (claim 9), or at least 95% sequence identity thereto (claim 8). As set forth above, sequences recited in the instant claims are directed to sequences encoding various soluble exogenous factors capable of inhibiting HIV infection: dimeric soluble CD4 (e.g., sCD4[D1 + D2]-IgG1 Fc fusion protein), anti-HIV antibodies (e.g., VRC01 and 3BNC117), and inhibitory RNA sequences (e.g., miR30-CCR5/miR21-Vif/miR185-Tat microRNA cluster sequences).
The sequences appear to be a Markush grouping of alternatively useable members for the nucleotide sequence encoding the at least one soluble exogenous factor of claim 1. However, which sequences are required? Are these sequences required in addition to the sequences recited in claim 1? Is claim 8 widening the scope of claim 1, as it recites SEQ ID NO: 9 as an alternatively useable member, despite its recitation in claim 1?
The confusion surrounding what is required by the instant claims is further confounded by the similarity of SEQ ID NOs: 9, 76, and 77 to some – but not all – of SEQ ID NOs: 1-10, 78, 80-85, and 87. For instance, SEQ ID NOs: 8 and 84-85 share over 80% sequence identity to SEQ ID NO: 9, while SEQ ID NOs: 10 and 80-83 share 100% sequence identity thereto. Please see Office Action Appendix I for sequence alignments and percent identity matrix. Are these sequences, which read on the sequence limitations of claim 1, the particular sequences required by the instant invention?
As currently written, claims 8 and 9 do not clearly or precisely define the metes and bounds of the invention of the instant claims; the claims are therefore rejected for indefiniteness.
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.
Claims 5 and 7 are 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 claims 5, 7: These claims fail to further limit the subject matter of a previous claim. Claim 5 recites, “The viral vector of claim 8, wherein…”; claim 7 recites, “The viral vector of claim 10, wherein…”. This technicality appears to stem from an editing error, as the claim language of instant claims 5 and 7 correspond to copending claims 9 and 11, respectively, of parent Application No. 17/908,509.
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.
EXAMINER’S COMMENTS
The following comments are made in the interest of compact prosecution:
It is set forth above claims 2-3 are directed to soluble exogenous factors other than dimeric soluble CD4. It is additionally set forth above the sequences recited in claims 8-9 are interpreted as referring to the nucleotide sequence of claim 1 which encodes at least one soluble exogenous factor.
With this in mind, the Examiner will now address how the instant claims may be amended in order to overcome the rejections under 35 U.S.C. §§ 112(b), 112(d).
Claim 1:
1. A viral vector comprising a therapeutic cargo portion, wherein the therapeutic cargo portion comprises a nucleotide sequence that encodes at least one soluble exogenous factor, and a T cell-responsive promoter that regulates expression of the nucleotide sequence,
wherein the at least one soluble exogenous factor comprises a dimeric soluble CD4 protein or a fragment thereof
encoded by a nucleotide sequence having at least 95% sequence identity to SEQ ID NO: 9, SEQ ID NO: 76, or SEQ ID NO: 77.
Claims 2-3:
2. The viral vector of claim 1, wherein the therapeutic cargo portion further comprises an anti-HIV antibody.
Should Applicants choose to amend claim 2 as set forth above, the indefiniteness issue for claim 3 would likewise be resolved. Or, alternatively:
2. (Cancelled)
3. (Cancelled)
Claims 8-9:
The following amendment is guided by the sequence percent identities of SEQ ID NOs: 1-10, 76-78, 80-85, and 87, as determined using the Clustal Omega Multiple Sequence Alignment (MSA) Tool; please see Office Action Appendix I (pg. 2). The sequences set forth below comprise at least 98.5% sequence identity to the sequences set forth in SEQ ID NOs: 9, 76, and 77; thus, the amendment as follows further narrows the scope of claim 1.
It is noted for the record SEQ ID NO: 7 is directed to a sequence encoding sCD4(D1 + D2) only; SEQ ID NOs: 9, 76, and 77 are directed to sequences encoding sCD4(D1 + D2)-IgG1 Fc, sCD4(D1 + D2)-IgG1 Fc (with antibody secretory signal) version 2, and sCD4(D1 + D2)-IgG1 Fc (with antibody secretory signal) version 3, respectively. Accordingly, as SEQ ID NOs: 9, 76, and 77 inherently encode components which are not encoded by SEQ ID NO: 7 (i.e., not required), SEQ ID NO: 7 is not included below despite sharing over 95% sequence identity to SEQ ID NOs: 9, 76, and 77.
8. The viral vector of claim 1, wherein the nucleotide sequence comprises a sequence having at least 95% sequence identity to or SEQ ID NO: 85
9. The viral vector of claim 1, wherein the nucleotide sequence comprises or SEQ ID NO: 85
Alternatively:
8. (Cancelled)
9. (Cancelled)
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GINA PRONZATI whose telephone number is (571)270-5725. The examiner can normally be reached Monday - Friday 9:00a - 5:00p ET.
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, CHRISTOPHER BABIC can be reached at (571)272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GINA PRONZATI/Examiner, Art Unit 1633
/ALLISON M FOX/Primary Examiner, Art Unit 1633
Prosecution Insights