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 .
DETAILED ACTION
This application is in response to the papers filed on April 27, 2026. Claims 1-25, 28, 29, and 31, are currently pending. Claims 1, 3, 4, 8-13, 16, 20-22, 24, 25, 28, 29, and 31 have been amended and claims 26, 27, 30, 32, and 33 have been cancelled in Applicant’s amendment filed on January 5, 2024.
Applicant’s election with traverse of the invention of Group I, claims 1-25 drawn to a method of producing stem/progenitor cells, in the reply filed on April 27, 2026 in response to the restriction requirement filed on December 16, 2025 is acknowledged.
The applicant argues:
“Applicant respectfully traverses this rejection on the grounds that Groups II-IV each claim a method of using the composition of Group I. Annex B to PCT Rule 13 provides that "[t]he method for determining unity of invention under Rule 13.2 shall be construed as permitting, in particular, the inclusion of in addition to an independent claim for a given product, an independent claim for a process specially adapted for the manufacture of the said product, and an independent claim for a use of the said product" (emphases added). Here, because all independent claims relate to products and methods of using those products, the claims all enjoy unity of invention under the terms of Annex B to PCT Rule 13.”
The examiner argues the restriction is valid based on the special technical feature as being anticipated by Cardinal et al. As the technical features were known in the art at the time of the invention, they cannot be considered special technical features that would otherwise unify the groups. Therefore, Groups I- IV inventions lack unity under PCT Rule 13 because they do not share the same or corresponding special technical feature. The expression "special technical features" means those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art. The requirement of unity of invention shall be fulfilled only when there is a relationship among those inventions involving one or more of the same or corresponding special technical features.
Claims 28, 29, and 31 are withdrawn from further consideration by the Examiner, pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions, there being no allowable generic or linking claim. Reinstatement of claims drawn to non-elected inventions will be withdrawn during prosecution. The requirement for restriction between Groups I-IV is maintained for reasons of record, and hereby made FINAL. Applicant timely responded to the restriction (election) requirement on April 27, 2026. It is noted that when a final requirement for restriction is made by the examiner, applicant may file a petition under 37 CFR 1.144 for review of the restriction requirement. The propriety of a requirement to restrict, if traversed, is reviewable by petition under 37 CFR 1.144 . In re Hengehold, 440 F.2d 1395, 169 USPQ 473 (CCPA 1971).
Therefore, claims 1-25 are currently under examination to which the following grounds of rejection are applicable.
Priority
The present application is a 35 U.S.C. 371 national stage filing of the International Application No. PCT/US21/64222, filed December 17, 2021. Applicant’s claim for the benefit of a prior-filed parent provisional application 63/127,826 filed on December 18, 2020 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Thus, the earliest possible priority for the instant application is December 18, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 3, 2023, October 24, 2025, February 20, 2026, and April 27, 2026 were filed. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
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, 5, 7, 8-15, 18, 19, 22, 24-25 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.
Claims 1, 14, 15, 18, and 19 are indefinite in the recitation of “no more than about” for the following reason. “About” encompasses values above and below a reference point whereas “no more than” encompasses only values below the reference point. Therefore, the combination of both terms (“no more than about”) is confusing because one term is including values above the reference point whereas the other term is excluding values above the reference point.
Claim 5 is indefinite for similar reasons as described above. In this instance, claim 5 is indefinite for the recitation of “about 0.5 mM or higher magnesium chloride” as “about” encompasses values above and below a reference point whereas “higher” only encompasses values above the reference point.
Claim 7 is indefinite for similar reasons as described for claim 1. In this instance, claim 7 is indefinite for the recitation of “more than about” as “about” encompasses values above and below a reference point whereas “more than” only encompasses values above the reference point.
Claims 1, 8-15, 18, 19, 22, 24-25 are indefinite in the recitation of “optionally” as it is unclear in what instances the optional values are preferred and subsequently considered a limitation in the claim.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-16, 22-25 are rejected under 35 U.S.C. 102(a)(1)(2) as being anticipated by Cardinal et al. (US 2021/0355454 A1).
Regarding claim 1, Cardinal teaches a pharmaceutical composition comprising a recombinant adeno-associated virus (rAAV) vector, sodium chloride (NaCl), potassium chloride (KCl) disodium phosphate (Na2HPO4), monopotassium phosphate (KH2PO4), magnesium chloride (MgCl2), a polyol, and a poloxamer, optionally wherein the composition comprises no more than about 0.1 mM calcium chloride and has a pH of about 7.1 to about 7.5 (par 0039, 0407, 0417, and 0420-0422).
Regarding claim 2, Cardinal teaches wherein the polyol is sucrose (par 0416).
Regarding claim 3, Cardinal teaches wherein the poloxamer is poloxamer 188 (par 018).
Regarding claims 4-7, Cardinal teaches wherein the composition contains magnesium chloride across a wide range, e.g. 1-5 mM (par 0475).
Regarding claim 8, dependent on claim 1, Cardinal teaches wherein the composition contains about 150 to about 200 mM, optionally about 172 mM, sodium chloride (par 0444).
Regarding claim 9, dependent on claim 1, Cardinal teaches wherein the composition contains about 2.5 to about 3.0 mM, optionally about 2.7 mM, potassium chloride (par 0466).
Regarding claim 10, dependent on claim 1, Cardinal teaches wherein the composition contains about 5 to about 10 mM, optionally about 8 mM, disodium phosphate (par 0423-0424).
Regarding claim 11, dependent on claim 1, Cardinal teaches wherein the composition contains about 1.0 to about 2.0 mM, optionally about 1.5 mM, monopotassium phosphate (par 0434).
Regarding claim 12, dependent on claim 1, Cardinal teaches wherein the composition contains about 0.5% to about 2% (w/v), optionally about 1 % (w/v), sucrose (par 034).
Regarding claim 13, dependent on claim 1, Cardinal teaches wherein the composition contains about 0.01 % to about 0.1 % (w/v), optionally about 0.05% (w/v), poloxamer 188 (par 0615).
Regarding claims 14 and 15, which further limit the concentrations of the components listed in the composition recited in claim 1, the rejections above for these particular component concentrations as described in the claim 2-13 rejections in combination with the rejection to claim 1 are applied herein as they lie within the ranges taught by Cardinal, and are therefore anticipated.
Regarding claim 16, dependent on claim 1, Cardinal teaches wherein the rAAV comprises a genome comprising an expression cassette for a therapeutic protein (par 0216).
Regarding claims 22 and 23, both dependent on claim 1, Cardinal teaches wherein the composition contains the rAAV at about 1.0E+ 12 to about 1.0E+ 14 vector genomes (vg) per mL, optionally about 1.0E+13 to about 5.0E+13 vg per mL (par 0021).
Regarding claim 24, dependent on claim 1, Cardinal teaches wherein the rAAV comprises an AAV6 capsid protein, optionally inverted terminal repeats (ITRs) of AAV2 (par 0080, 94).
Regarding claim 25, dependent on claim 1, Cardinal teaches a vial comprising 5-10 mL, optionally 6.4 mL, of the composition of claim 1 based on teaching a vial to comprise the composition, and purification for large volumes of the formulation (par 367, 774; Table 12).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 17-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cardinal et al. (US 2021/0355454 A1) as applied to claims 1-16, 22-25 above, and further in view of Conner et al. (US 2021/0171982 A1).
Regarding claims 1 and 16 , the disclosure of Cardinal is applied as in the 102 rejections above, the content of which is incorporated above, in its entirety.
Regarding claims 17, 20, and 21 Cardinal teaches the formulation recited in claim 1, wherein the rAAV comprises a genome comprising an expression cassette for a therapeutic protein as described in the claim 16 rejection above. However, Cardinal does not teach the therapeutic protein as the human factor VIII polypeptide, and moreover the related polypeptide of instant SEQ ID NO: 1, and wherein the genome of the rAAV comprises SEQ ID NO:2 or nucleotides 131-5,024 of SEQ ID NO:2.
Conner teaches AAV vectors expressing Factor VIII, the therapeutic protein as the human factor VIII polypeptide as seen in SEQ ID NO: 1 that is 100 % identical to instant SEQ ID NO: 1 (Result #1, Duplicate App No. 17/265,750); and the polypeptide encoded in expression cassette flanked by the inverted terminal repeat sequences as seen in SEQ ID NO: 5 that is 100 % identical to instant SEQ ID NO: 2 nucleotides 131-5,024 (Result #1, Duplicate App No. 17/265,750). All the alignments are provided with this Office Action.
It would have been prima facie obvious for one of ordinary skill in the art at the time of the effective filing date to have modified the composition that comprises a rAAV encoding a therapeutic polypeptide as taught by Cardinal et al. to substitute the therapeutic protein with the human factor VIII polypeptide (as taught by Conner et al.) because it would have been obvious to substitute one known element for another to obtain predictable results. Substituting the therapeutic polypeptide as taught by Cardinal for the human factor VIII polypeptide in the composition of Conner would have led to predictable results with a reasonable expectation of success because Conner teaches AAV vectors expressing Factor VIII and methods of treatment of hemophilia with such vectors (par 0008), and additionally Cardinal does not limit the encoded therapeutic polypeptide comprised in the composition further stating such polypeptides are those useful in the fields of human disease (par 0216).
Regarding claims 18 and 19, these claims further limit the concentrations of the components listed in the composition recited in claim 1, the rejections above for these particular component concentrations as described in the claim 2-13 rejections are applied herein as they lie within the ranges taught by Cardinal, in combination with the rejection to claim 1 and claim 17 that is related to the therapeutic polypeptide as human factor VIII.
Conclusion
Claims 1-25 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL A RIGA whose telephone number is (571)270-0984. The examiner can normally be reached Monday-Friday (8AM-6PM).
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, Maria G Leavitt can be reached at (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL ANGELO RIGA/Examiner, Art Unit 1634
/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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