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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claims 4 - 19 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim cannot depend from any other multiple dependent claim . See MPEP § 608.01(n). Accordingly, the claims 4 - 19 not been further treated on the merits.
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.
Claims 1 - 3 are rejected under 35 U.S.C. 103 as being unpatentable over LentiviewTM Lentivirus Analysis Kits (White paper, 2022 hereinafter, "Lentiview"), and further in view of Daaboul et al. (US20220113313A1, hereinafter, "Daaboul") .
Regarding claim 1, 2, and 3, Lentiview teaches the use of a microarray chip that uses several antibodies to capture lentiviral particles to determine whether the particle is carrying a full payload, a partial payload, or an empty payload through the use of fluorescent agents composed of an antibody and a fluorescent label. This is done by contacting a population of lentivirus vectors that can be fully loaded, partially loaded, or empty on a substrate comprised of anti-envelope protein antibodies, with at least one portion of the substrate being the first binding molecule anti-vesicular stomatitis virus-G protein (VSV-G) antibodies (Sections – “Each Kit Contains”, Specifications – Secondary Antibodies, Figure 1). The captured lentiviral vectors bind with at least two fluorescent agents comprised of a fluorescent label and an antibody that binds to the envelope protein of the lentiviral vector. The captured lentiviral vectors are then illuminated with light resulting in excitation of the fluorescent agents (Sections – “Each Kit Contains”). The change in excitation is detected through wavelength emission and then characterized through data analysis (Figure 2, reproduced below). Lentiview teaches the use of three different fluorescent probes using three different wavelengths, with one of these probes being dedicated to VSV-G protein, one being dedicated to p24 protein (Figure 1, Sections – “Each Kit Contains”).
[AltContent: textbox ([img-media_image1.png]
Figure 1)][AltContent: textbox ([img-media_image2.png]
Figure 2)]
Lentiview fails to teach the third fluorescent label binding a payload of the lentiviral vector.
However, Daaboul teaches a known and effective method for identifying the contents of the payload using nucleic acid dyes, which can include permeant nucleic acid dyes, after a payload is bound by antibodies on a microarray. This is done through the detection of payloads within particles, including viruses (¶0002), by contacting the particle on a substrate comprised of a binding probe and contacting the payload with a fluorescent dye, including nucleic acid dyes that can be used to stain for RNA and DNA in and/or on the particle (¶0211) followed by the detection and characterization of wavelength emission.
Lentiview and Daaboul are considered to be analogous to the claim invention because they are in the same field of detecting and characterizing particles and their payloads. Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to utilize the art-recognized method use the nucleic acid dye taught by Daaboul as a third fluorescent probe in the method taught by Lentiview because doing so would advantageously allow one to detect and characterize not only whether a lentiviral particle is full, empty, or somewhere in between but also if the payload contains nucleic acid. One of ordinary skill in the art would have reasonable expectation of success in using a nucleic acid dye on a substrate that binds lentiviral particles given that this method is well known, has been successfully demonstrated, and commonly used in the prior art.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
The prior art made of record and not relied upon is considered pertinent to applicant's
disclosure:
Lentiview white paper (Nano Biosciences, 2022)
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danyal H Alam whose telephone number is (571)272-1102. The examiner can normally be reached M - F 9am - 5pm.
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/DANYAL HASSAN ALAM/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672