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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/08/2026 was filed after the mailing date of the Non-final Rejection on 01/08/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of claims / Response to Amendment
This office action is in response to an amendment filed on July 8, 2026.
Claims 2, 9, 11-12, 19, 22, 25, 38 and 71 were previously pending. Applicant amended claims 2, 9, 11; cancelled claim 19; claims 72-74 are newly added.
Claims 2, 9, 11-12, 22, 25, 38 and 71-74 are currently pending and under consideration.
Improper Amendment to the Claims: Claim 2 is improperly amended for having incorrect status identifier. While the claim is amended with markups, it is incorrectly identified as "previously presented" when "currently amended" should be used. Amendments to the claims filed on or after July 30, 2003 must comply with 37 CFR 1.121(c)(2) which states: "When claim text with markings is required. All claims being currently amended in an amendment paper shall be presented in the claim listing, indicate a status of “currently amended,” and be submitted with markings to indicate the changes that have been made relative to the immediate prior version of the claims."
In the interest of compact prosecution, however, the examiner will consider the claim listing on its merits. MPEP 714.03 (“Where an amendment substantially responds to the rejections, objections, or requirements in a non-final Office action (and is a bona fide attempt to advance the application to final action) but contains a minor deficiency . . . , the examiner may simply act on the amendment and issue a new (non-final or final) Office action.”) The examiner reserves the right to send a PTOL-324 Notice of Noncompliant Amendment in the event of more severe deficiencies, which may result in loss of patent term.
All of the previously presented rejections have been withdrawn as either being addressed or obviated by the amendment of the claims, which introduces new combinations of elements that were not previously considered in the prior rejection (e.g., the amended claim 2 now requires "wherein the AAV particles of the first composition and reference composition are genetically identical," which were not presented in prior claims and not considered in the prior office action).
Thus, the scope of the claims has been changed in a manner that were not considered in the previous rejections.
Applicant' s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follow.
This office action contains new grounds for rejection necessitated by amendment.
Claim Objections
Claims 2 and 71 are objected to because of the following informalities:
Claim 2 has been amended to recite "rAAV" instead of "AAV" throughout the claim. However, lines 5, 7, and 11 still recite "AAV" and should read "rAAV" for consistency within the claim.
Similarly, claim 71, line 1, recites "the AAV," which should read "the rAAV."
Priority
The priority date of the instant claims 2, 9, 11-12, 22, 25, 38 and 71-74 is 10/15/2018, filling date of the US provisional application NO. 62/745,859.
Claim Interpretation -- Updated
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, claim 2 has been amended to recite:
"e) using the AAV genome titer determined in step b) to produce a pharmaceutical unit dosage comprising a predetermined quantity of the isolated rAAV particles calculated to produce a desired therapeutic effect when the relative infectivity indicates that the isolated rAAV particles meet a predetermined quality,"
This recited step in claim 2 is interpreted under BRI as a contingent limitation that does not limit the scope of the claimed method.
MPEP §2111.04 states: "The broadest reasonable interpretation of a method (or process) claim having contingent limitations requires only those steps that must be performed and does not include steps that are not required to be performed because the condition(s) precedent are not met."
Here, the limitation "… produce a pharmaceutical unit dosage … when the relative infectivity indicates that the isolated rAAV particles meet a predetermined quality" formulated as contingent language is not essential to the operation of the claimed method, as it does not require an action upon every practice of the claim. For instance, in the scenario which the isolated rAAV particles does not meet a predetermined quality, the step is not performed.
Claim 2 recites the term “parallel-line model,” which is defined the applicant's disclosure in para [0035]:
"The parallel-line method is a robust biostatistical analysis method for comparing one or more test substances against a reference substance based on their relative potency. Finney, D.J., Statistical method in biological assay (Charles Griffin & Co., Ltd. 1952); Wardlaw, A.C., Practical Statistics for Experimental Biologists 210 (Wiley 1986) (2000)."
New Grounds of Rejections - 35 USC § 112(b)
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.
Claims 2, 9, 11-12, 22, 25, 38 and 71-74 are rejected under 35 U.S.C. 112(b), 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.
Claim 2 has been amended to recite "pharmaceutical unit dosage comprising a predetermined quantity of the isolated rAAV particles calculated to produce a desired therapeutic effect."
This limitation is indefinite. It is unclear what qualifies as a "desired therapeutic effect" and how a quantity is calculated to produce such an effect. The specification does not provide a definition, description, or criteria for determining whether a therapeutic effect is "desired" or "desirable." The specification also does not provide guidance on how the calculation is carried out to achieve any specific therapeutic effect.
Although broadness in scope does not by itself render a claim indefinite, the issue here is the subjective term "desired." Without a clear definition or objective criteria, a skilled artisan would not be able to ascertain the metes and bounds of "a desired therapeutic effect" with reasonable certainty.
Claims 9, 11-12, 22, 25, 38 and 71-74 are rejected for depending from claim 2 and not remedying the indefiniteness.
New Grounds of 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 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.
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 2, 9, 11-12, 22, 25, 71, 74 are rejected under 35 U.S.C. 103 as being unpatentable over Ranheim (Ranheim et al., Development and application of a quantitative RT-PCR potency assay for a pentavalent rotavirus vaccine (RotaTeq). J Virol Methods. 2006 Feb;131(2):193-201. doi: 10.1016/j.jviromet.2005.08.013. Epub 2005 Oct 7. PMID: 16214228) , in view of
Hinderer (WO2017136500A1 - Gene therapy for treating mucopolysaccharidosis type ; published on 2017-08-10);
François (François et al., Accurate Titration of Infectious AAV Particles Requires Measurement of Biologically Active Vector Genomes and Suitable Controls. Mol Ther Methods Clin Dev. 2018 Jul 27;10:223-236. doi: 10.1016/j.omtm.2018.07.004. PMID: 30112419; PMCID: PMC6090651.; cited in IDS filed 04/14/2021);
Pei (Pei et al. , Copy number of adenoviral vector genome transduced into target cells can be measured using quantitative PCR: application to vector titration. Biochem Biophys Res Commun. 2012 Jan 20;417(3):945-50. doi: 10.1016/j.bbrc.2011.12.016. Epub 2011 Dec 19. PMID: 22202173);
Limberis (US20180155412A1 - Aav-mediated expression of anti-influenza antibodies and methods of use thereof; published 2018-06-07);
EMA (Committee for Medicinal Product for Human Use, E. M. A. (2010). Guidelines on quality, non-clinical and clinical aspects of live recombinant viral vectored vaccines. European Medicines Agency) ; as evidenced by
BIOSTATISTICS (PubH 7405: BIOSTATISTICS METHODS FOR TRANSLATIONAL & CLINICAL RESEARCH; Archived Sept 08, 2017 on WaybackMachine; web.archive.org/web/20170908181957/https://www.biostat.umn.edu/~chap/SS10-Day4-RegApplications-PartC.pdf ).
A) Ranheim teaches an improved RT-PCR-based method for determining the infectivity of viral components of the pentavalent rotavirus vaccine, over the traditional TCID50 approach (p. 194, right-hand col, para. 1-2).
Regarding claim 2, Ranheim teaches determining the infectivity of a first composition relative to the infectivity a the reference composition comprises
preparing serial dilutions of the first composition and the reference rAAV composition (Abstract, lines 3-5; Fig. 1);
inoculating target cells separately with the serial dilutions of the first composition and the reference rAAV composition (Abstract, lines 3-5; Fig. 1); and
calculating the infectivity of the first composition relative to the reference rAAV composition using a parallel-line model (Fig. 1).
Ranheim teaches that its method “has proven to be accurate, precise, robust, and amenable to high throughput testing in a quality control laboratory.” (p. 194, right-hand col, para. 2, lines 8-10) Ranheim suggests that its method represents a significant improvement over the TCID50 approaches for potency determination, and that it should be readily generalizable to other live virus potency assays (p. 200, right-hand col, para 1).
Although Ranheim does not explicitly teach applying its method for determining viral product infectivity specifically to rAAV, this feature would have been obvious in view of the knowledge in the prior art.
TCID50 assays for measuring infectious titer for rAAV are well-known in the art, as supported by Hinderer (p. 93, E. Infectious Titer) and François ( p. 224, right-hand col., lines 4-6).
Specifically, François teaches methods for determining infectivity in recombinant AAV particles for clinical use, including TCID50 (Abstract; Table 2), which is one of the most widely used methods to titer infectious units (p. 224, right-hand col., lines 4-6).
Because Ranheim teaches an improved method over TCID50, a skilled artisan would have found it obvious to apply Ranheim's method for determining the infectious titer of rAAV.
The steps of isolating viral particles, determining genome titer, washing cells, and extracting nucleic acids are well-known processing steps in the art for obtaining infectivity titer, as taught by François.
François teaches:
isolating recombinant adeno-associated virus (rAAV) particles from an rAAV production culture comprising an impurity to produce a first composition comprising the isolated rAAV particles (page 232, right-hand col, para6, lines 4-6, “AAV8 particles in the culture supernatant were polyethylene glycol (PEG)-precipitated, then purified by double CsCl density gradient ultracentrifugation”; Abstract, AAV8 particles are recombinant adeno-associated virus serotype 8 (rAAV8));
determining the AAV genome titer of the first composition (page 233, left-hand col, “VG Titration by qPCR” VG is vector genome );
washing inoculated cells to remove extracellular viral particles (page 229, left-hand col, lines25-26);
isolating a first nucleic acid sample and a reference nucleic acid sample from the target cells inoculated with the first composition and the reference rAAV composition, respectively (page 234, right-hand col, para 2, lines 1-9).
The approach of normalizing viral genome copies obtained from infected cells using a ratio with host cell genome copies would have been obvious in view of the knowledge in the art. As taught by François (p. 234, right-hand col, para 2; p. 229, right-hand col, "Titration of AAV8 Particles in Cellular Fractions by qPCR" The qPCR results obtained with different viral genome inputs were normalized to an input of 1,000 VG/cell (Figure 5) to facilitate comparison ; p. 230, right-hand col., para 1) and Pei (p. 947, right-hand col, 3.3, lines 6-8, in PCR, viral genome and cell chromosome DNA were simultaneously measured to correct for fluctuations in the cell numbers ), such an approach normalizes viral genome copy number to nucleic acid recovery efficiency and to viral genomes per cell, thereby facilitating comparison between samples having different numbers of inoculated cells.
Accordingly, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to apply Ranheim's improved RT-PCR-based method for determining infectivity of viral components to a method for determining infectivity of recombinant AAV particles for clinical use. A skilled artisan would have been motivated to make this modification to obtain the advantages of Ranheim's method over the traditional TCID50 method (taught in François) and in view of the well-known use of TCID50 for rAAV infectivity titer.
There would have been a reasonable expectation of success because Ranheim provides an improved infectivity assay that is applicable to recombinant viral particles. This is supported by Ranheim’s suggestion that its method represents a significant improvement over the TCID50 approaches for potency determination, and that it should be readily generalizable to other live virus potency assays (p. 200, right-hand col, para 1).
Regarding the limitation “c) determining the infectivity of the first composition relative to the infectivity of a reference rAAV composition, wherein the AAV particles of the first composition and reference composition are genetically identical” and “d) using the relative infectivity determined in step c) to determine the quality of the isolated rAAV particles.”
While François teaches determining the infectivity of the first composition relative to the infectivity of a reference rAAV composition (Table 2, “VG:IU Ratio”; Figure 3), it does not explicitly teach the rAAV particles of the first composition and reference composition are genetically identical.
However, this feature would have been an obvious, as it represents the KSR principle of predictable use of prior art elements (i.e., ratios of vector genome copy and Infectious titer) according to a known method (i.e., comparing measurements between rAAV lots for quality control) to yield predictable results. (See MPEP §2143).
Using infectious titer characteristics to monitor and control lot-to-lot consistency is well-known in the art, particularly for recombinant viral vector production.
François already teaches obtaining the ratios of vector genome titer (VG/ml) and Infectious titer (IU/ml) (Table 2). Such a ratio is well-known in the art as a useful measure for product consistency from lot to lot.
For example, Hinderer teaches that the GC/IU ratio is useful for monitoring product consistency from lot-to-lot.
“the ratio of encapsidated GC to "infectious units" (described as GC/IU ratio) can be used as a measure of product consistency from lot to lot.
The GC/IU ratio is a measure of product consistency. The oqPCR titer (GC/ml) is divided by the "infectious unit (IU/ml) to give the calculated GC/IU ratio.” (Hinderer, page 93, lines 26-30).
A skilled artisan would have understood that "GC," referring to vector genome copies, and "VG," referring to vector genomes, describe the same type of vector genome copy measurement in this context.
See also Limberis ([0175]); EMA (page 9, 5.5.2 “When both infectivity and particle number are measured, the particle to infectivity ratio can be determined and this should form part of the release specification.”; 5.5.4.” Data from successive production lots should demonstrate consistency of production and be used to set limits on relevant parameters.”)
Accordingly, a skilled artisan would have found it obvious to determine the infectivity of a later-produced lot relative to an earlier-produce lot as part of quality control for lot-to-lot consistency. The skilled artisan would have readily understood that different lots of the same rAAV product would be expected to be genetically identical.
B) Regarding claim 9, François teaches calculating VGC:TCGC ratio for each dilution of test and reference composition (page 234, right-hand col, para 2, lines12-27).
Ranheim inherently teach the plotting, fitting, and calculating steps in claim 9 by teaching using parallel-line model (page 22, lines12-14). As evidenced by BIOSTATISTICS, parallel-line model comprises plotting log values of test and reference group (slide 9, 15; 3-4); fitting the test and reference data points to a test and reference line using a common slope (slides 15-16); and calculating the infectivity of the test composition relative to the reference composition as antilog
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(slides 11-12).
Regarding claim 11, François teaches incubating the target cells in the presence of viral particles for 24 hours (page 228, left-hand col, para3, lines 1-3; page 225, right-hand col, para2, line18; page 234, left-hand col, para2, line 4).
Regarding claim 12, François teaches polymerase chain reaction(page 234, right-hand col, para 2, lines12-27, TaqMan qPCR).
Regarding claim 22, François teaches BHK21 and HEK293 (page 223, right-hand col, lines 14-20).
Regarding claim 25, François teaches the first composition and the reference composition have a different titer, wherein the titer is measured as genome copy (GC) per milliliter (Table 1).
Regarding claim 71, François teaches the AAV comprises a capsid protein AAV8 serotype (entire document, abstract for example).
Regarding claim 74, François teaches isolating rAAV particles from the rAAV production culture comprises centrifugation (page 232. Right-hand col., AAV8 Vector Preparations).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Ranheim in view of Hinderer, François, Pei, Limberis, EMA, as applied to claims 1 and 12 above and further in view of Huijsmans (Huijsmans et al. , Sensitive detection and quantification of the JAK2V617F allele by real-time PCR blocking wild-type amplification by using a peptide nucleic acid oligonucleotide. J Mol Diagn. 2011 Sep;13(5):558-64. doi: 10.1016/j.jmoldx.2011.04.002. Epub 2011 Jun 30. PMID: 21723417; PMCID: PMC3157608.)
The teachings of Ranheim, Hinderer, François, Pei, Limberis, and EMA are recited above and applied as for base claims 1 and 12.
Regarding claim 38, while Ranheim and François both teach PCR (Ranheim, Table 1; François et al., page 234, right-hand col, para 2, lines12-27) with primers, and François further teaches using PCR primers and probes to detect albumin DNA sequence for determining target cell genome copy (page 234, right-hand col, para 2, lines12-27), these references do not specifically teach primers comprise any of the sequences required in claim 38.
Huijsmans teaches a method for detection and quantification of gene targets using PCR (entire document).
Regarding claim 38, Huijsmans teaches a combination of a probe, forward primer, and reverse primer for detecting albumin DNA, comprise a polynucleotide consisting of the nucleotide sequence of SEQ ID NO: 4 (Table 2, Albumin forward primer, 5-TGAAACATACGTTCCCAAAGAGTTT-3), 5 (Table 2, Albumin reverse primer, 5-CTCTCCTTCTCAGAAAGTGTGCATAT-3), and 6 (Table 2, Albumin probe, 5-FAM-TGCTGAAACATTCACCTTCCATGCAGA-TAMRA-3).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to substitute the PCR primers and probe taught in Huijsmans for those used in the PCR of the combined methods of Ranheim, Hinderer, François, Pei, Limberis, and EMA, because the teaches are related in using PCR techniques to detect and quantify target DNA sequences.
Specifically, Huijsmans and François share commonality of using PCR for detecting albumin gene DNA, highlighting their technical compatibility.
This substitution is a predictable use of known primer and probes within the same category -- PCR for DNA detection -- with no unexpected change in function or result. Since Huijsmans and François both use PCR to detect the same albumin gene target, using the primers and probe from Huijsmans in the context of François's method would not alter the fundamental operation of PCR but would utilize a variant of the same technology, yielding the same predictable result of accurate detection and quantification of albumin gene copies.
Therefore, it would have been obvious to use the specific set of probe and primers for detecting albumin DNA as taught by Huijsmans in the PCR method to detect albumin DNA gene copies, according to the combined teachings of Ranheim, Hinderer, François, Pei, Limberis, and EMA, representing a simple substitution of one known element for another to obtain predictable results, see MPEP §2143.
Claims 72-73 are rejected under 35 U.S.C. 103 as being unpatentable over Ranheim in view of Hinderer, François, Pei, Limberis, EMA, as applied to claims 1 and 22 above and further in view of Boye (Boye et al. Impact of Heparan Sulfate Binding on Transduction of Retina by Recombinant Adeno-Associated Virus Vectors. J Virol. 2016 Mar 28;90(8):4215-4231. doi: 10.1128/JVI.00200-16. PMID: 26865709; PMCID: PMC4810560), as evidenced by Accutase (Innovative Cell Technologies, Inc; 2012 )
Regarding claims 72-73, they recite:
72. The method of claim 2, wherein the target cells are serum starved HEK293 or Huh-7 cells, the inoculating target cells comprises incubating the target cells in the presence of viral particles for between 18 hours and 30 hours, and the washing the inoculated target cells to remove extracellular viral particles comprises treating the inoculated target cells with proteolytic and/or collagenolytic enzymes.
73. The method of claim 22, wherein the target cells are serum starved, the inoculating target cells comprises incubating the target cells in the presence of viral particles for between 18 hours and 30 hours, and the washing the inoculated target cells to remove extracellular viral particles comprises treating the inoculated target cells with proteolytic and/or collagenolytic enzymes.
These claims are analogous and overlap in scope. The only difference is that claim 72 specifically recites HEK293 or Huh-7 cells, which are already encompassed by base claim 22, from which claim 73 depends.
The claims recite an obvious assemblage of known features in the art in the context of recombinant AAV production.
François teaches incubating the target cells in the presence of viral particles for 24 hours (page 228, left-hand col, para3, lines 1-3; page 225, right-hand col, para2, line18; page 234, left-hand col, para2, line 4).
Limberis teaches serum starved HEK293 (Limberis [0090] line 14), and further teaches vector generation process further comprises harvest of vector-containing cells and culture media.
Boye teaches harvesting rAAV infected HEK293 cells by dissociating the adherent HEK293 cells with Accutase solution (p. 4219, left-hand col, para. 2, lines 5-7) , which is a cell detachment solution of proteolytic and collagenolytic enzymes and requires washing of cells prior to applying the detachment solution (see Accutase, page 1).
Therefore, the claims would have been obvious because they recite known approaches in cell handling for rAAV production and usage, representing the KSR principle of predictable use of prior art elements according to a known method to yield predictable results. (See MPEP §2143).
Prior Art
Below are relevant prior art not used in rejection but pertinent to the claims or disclosure.
The use of Q-PCR to quantify AAV vector genome and infectivity titers is well-known in the art:
See page 714, right-hand col, para 1 in Zhen et al. "Infectious titer assay for adeno-associated virus vectors with sensitivity sufficient to detect single infectious events." Human gene therapy 15.7 (2004): 709-715.: "Clark et al. (1999) first reported the use of Q-PCR as a sensitive method to quantify AAV vector genome and infectivity titers. "
Zhen et al. also teaches inoculating cells with serial dilutions of rAAV vectors to measure infectious titer (abstract), and comparing infectious titer between genetically identical samples (FIG. 3).
Conclusion
Claims 2 and 71 are objected to; Claims 2, 9, 11-12, 22, 25, 38 and 71-74 are rejected. No claims are allowed.
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.
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/TIAN NMN YU/Examiner , Art Unit 1681 /AARON A PRIEST/Primary Examiner, Art Unit 1681
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