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 .
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a system” in claims 27-30.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claim(s) 1, 6, 17, 21, 26-27, 29-30 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Haas et al (WO 2021/008708).
Regarding claims 1, 17 and 21, Haas et al teach a method for characterizing virus-like particles and viral glycoproteins using asymmetric flow field-flow fractionation (A4F) (p. 69 lines 16-25) and at least two types of detectors, wherein the method comprises the steps of:
(A) fractionating by A4F a first virus-like particle sample; and determining at least one of molar mass and size distribution of the virus-like particle and viral glycoproteins in the first virus-like particle sample using Multi-Angle Light Scattering (MALS) (p. 69 lines 16-25: AF4-UV-MALS, p. 156: AF4, p. 167: MALS); and
(B) fractionating by A4F a second virus-like particle sample further comprising a fluorescence labeled detection reagent; and detecting the free glycoproteins and virus-like particle associated viral glycoproteins in the second virus-like particle sample using a fluorescence detector (p. 163: not only MALS, but fluorescent signal (FS signals) detected), wherein (A) and (B) can be performed consecutively in any order or simultaneously, and
(C) comparing the elution time profiles from (A) and (B) (Fig. 9A,9B; p. 163 line 25-p. 164 line 15 comparison of results based on FS, U, R, and MALS)
Specifically regarding claim 17, Haas teach particles selected from the group consisting of viruses and virus-like particles and (ii) anti-particle Fc-containing proteins (Haas: p. 83 lines 24-27: CH2 and CH3 make up the Fc region of the antibodies)
Specifically regarding claim 21, Haas teach free glycoproteins and virus-like particle associated viral glycoproteins (Haas: p. 83 lines 1-27 antibodies)
Regarding claim 6, and 26, Haas et al teach the virus-like particles are based on a retrovirus, an adenovirus, a vesicular stomatitis virus (VSV), parvovirus, flavivirus, paramyxovirus, or bacteriophage (P. 108 lines 23-31: parvoviridae, retroviridae)
Regarding claims 27, 29, and 30, Haas teaches for performing the method of claim of claim 1, 17, and 21 (see above).
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.
Claim(s) 2-5, 19-20 and 22-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haas in view of Nooraei et al, "Virus-like particles: preparation, immunogenicity and their roles as nanovaccines and drug nanocarriers" J Nanobiotechnology. 2021 Feb 25;19(1):59.
Regarding claims 2-5, 22 and 23, Haas et al teach the Virus Like proteins based on antigen of a virus such as influenza (p. 82 lines 18-20), but are silent to the viral glycoproteins are spike proteins; the spike proteins are influenza spike proteins; the spike proteins are a coronavirus spike proteins; the spike proteins are Ebola spike proteins.
Nooraei et al teach the VLP can be an Ebola virus envelop glycoprotein (p. 16 col. 1 para. 4- col. 2 para. 1), influenza virus Hemagglutinin protein (Table 1, p. 3, p. 15 col. 2 para. 2: reads on "spike protein"), and coronavirus spike protein (p.16 col. 2 para. 3; Table 1, p. 3, reads on "spike protein"). It is desirable to provide glycoproteins that are well known antigens of viruses on the cell surface to develop targeted vaccines to these dangerous viruses. Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the VLP and viral antigens of Haas et al for the spike proteins of Nooraei et al to provide the above advantage of providing glycoproteins that are well known viral antigens to develop targeted vaccines to dangerous viruses.
Regarding claim 19 and 20, Haas/Nooraei teach antibodies to antigens of a virus such as influenza, and the spike protein of viruses are well known targets for vaccines (See Ebola virus envelop glycoprotein (p. 16 col. 1 para. 4- col. 2 para. 1), influenza virus Hemagglutinin protein (Table 1, p. 3, p. 15 col. 2 para. 2: reads on "spike protein"), and coronavirus spike protein (p.16 col. 2 para. 3; Table 1, p. 3, reads on "spike protein”). It is desirable to provide antibodies directed to well-known viral spike proteins to detect infectious viruses. Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the antibody to well-known target spike protein antigens to provide the above advantage of producing vaccines directed at well-known surface antigens of infectious viruses.
Claim(s) 13, 15-16, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haas et al in view of Gimpel et al "Analytical methods for process and product characterization of recombinant adeno-associated virus-based gene therapies", Molecular Therapy: Methods & Clinical Development Vol. 20 March 2021, pp. 740-754.
Regarding claim 13, Haas teaches asymmetric flow field-flow fractionation (A4F) (p. 69 lines 16-25) and at least two types of detectors, wherein the method comprises the steps of:
(A) fractionating by A4F a first virus-like particle sample; and determining at least one of molar mass and size distribution of the virus-like particle and viral glycoproteins in the first virus-like particle sample using Multi-Angle Light Scattering (MALS) (p. 69 lines 16-25: AF4-UV-MALS, p. 156: AF4, p. 167: MALS); and
(B) fractionating by A4F a second virus-like particle sample further comprising a fluorescence labeled detection reagent; and detecting the free glycoproteins and virus-like particle associated viral glycoproteins in the second virus-like particle sample using a fluorescence detector (p. 163: not only MALS, but fluorescent signal (FS signals) detected), wherein (A) and (B) can be performed consecutively in any order or simultaneously, and
(C) comparing the elution time profiles from (A) and (B) (Fig. 9A,9B; p. 163 line 25-p. 164 line 15 comparison of results based on FS, U, R, and MALS)
Haas teach recombinant VLPs from adeno-associated virions (p. 108 lines 28-30: reads on "AAV") and antibodies (p. 83 lines 8-34). Haas does not explicitly teach the AAV with the AF4-MALS. Gimpel et al teach analyzing AAV with AF4-MALS is advantageous to resolve and quantify aggregates up to micrometers in size in rAAV that provide gene therapies (p. 748 col. 2 para.6). Simple substitution of one known element for another to obtain predictable results is held to be obvious. Therefore, it would have been obvious to one of ordinary skill in the art to substitute the VLPs of Haas for the AAV of Gimpel to provide the above advantage of analyzing desirable AAV virus-like particles that provide gene therapies.
Regarding claim 15, Haas/Gimpel teach the AAV comprises a transgene (Gimpel: Abstract: recombinant adeno-associated virus: rAAV for gene therapy inherently has transgene; p. 742 col. 2 para.3: transgene ).
Regarding claim 16, Haas/Gimpel teach the AAV is selected from the group of AAV1, AAV2, AAV3, AAV4, AAV5, AAV6, AAV7, AAV8, AAV9, AAV10, AAV 11, AAV12, AAV13 and AAVrh74 (Gimpel p. 743 col. 2 para. 1: rAAV1).
Regarding claim 28, Haas/Gimpel teach a system for performing the method of claim 13 (see above).
Claim(s) 14 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Haas/Gimpel and further in view of Kuklik et al, Development of a Bispecific Antibody-Based Platform for Retargeting of Capsid Modified AAV Vectors", Aug 3, 2021, Int. J. Mol. Sci., 22, 8355.
Regarding claims 14 and 18, Haas/Gimpel teach antibodies, but are silent to bispecific antibody; anti-particle Fc-containing protein is an anti-AAV antibody . Kuklik et al teach bispecific antibody is used to redirect AAV to specific receptors is advantageous during gene therapies and the antibody can be anti-AAV2 polyclonal antibodies (Kuklik p. 4 para. 1: AAV2 and anti-AAV2 polyclonal antibodies detected). Combining prior art elements according to known methods to yield predictable results is known. Therefore it would have been obvious to one of ordinary skill in the art to combine the bispecific antibody and anti-AAV antibodies of Kuklik et al to the Haas/Gimpel method to provide the above advantage of redirecting AAV to specific receptors during gene therapies.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS MICHAEL WHITE whose telephone number is (571)270-3747. The examiner can normally be reached M-F 8:30am-5pm.
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/Dennis White/Primary Examiner, Art Unit 1758
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