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 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.
Claim 73 is 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 73, broadly neutralizing antibody 10E for HIV does not exist in the literature and is not described in the specification and therefore, is indefinite. 10E8 is described in the literature. To overcome this rejection, the applicant may amend the Claim as “10E8” in place of “10E” on line 2.
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.
Claims 65 – 69, 71, and 74 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Immusoft Corporation, US 2018/0002664 A1, published Jan. 4, 2018.
Regarding Claim 65, Immusoft recites, “a method of producing a modified B cell composition comprising … transfecting the expanded B cell population with a trans gene” (p. 16, [0005]) and “[T]he transfecting comprises a non-viral vector. In a further embodiment, the non-viral vector is selected from the group consisting of … a minicircle, … [and] a mini-intronic plasmid” (p. 16, [0011]). Immusoft also recites, “the transgene encodes an antigen-specific antibody, or antigen-binding fragment” (p. 16, [0012]), and “the antibody is an anti-HIV antibody” (p. 17, [0012). Together, Immusoft teaches a nucleic acid encoding an HIV specific antibody, wherein the nucleic acid is a minicircle or a mini-intronic plasmid. Therefore, Immusoft anticipates Claim 65.
Regarding Claim 66, Immusoft recites, “In one embodiment, the nucleic acid encodes an antibody or antigen-binding fragment thereof. Exemplary antigen binding fragments include domain antibodies, sFv, scFv, Fab, Fab', F(ab')2, and Fv.” (p. 27, [0109]). Immusoft teaches the nucleic acid of Claim 65 wherein the HIV specific antibody is a sFv, scFv, Fab, Fab', F(ab')2, and Fv. Therefore, Immusoft anticipates Claim 66.
Regarding Claim 67, Immusoft recites, “In this regard, the protein of interest may comprise an IgG-antigen fusion protein” (p. 27, [0112]). Therefore Immusoft teaches the nucleic acid of Claim 65 wherein the HIV specific antibody is an IgG antibody.
Regarding Claims 68 and 74, Immusoft recites, “In one embodiment, the anti-HIV antibody is the broadly neutralizing monoclonal antibody VRC01” (p. 28, [0115]). Therefore Immusoft teaches the nucleic acid of Claim 65 wherein the HIV specific antibody is a broadly neutralizing antibody and the use of VRV01. Therefore Claims 68 and 74 are anticipated by Immusoft.
Regarding Claim 69, Immusoft recites, “In a further embodiment, the antibody encoded by the nucleic acid of interest comprises Fuzeon™ (T-20/enfuvirtide/pentafuside/DP-178). DP-178 is an amino acid sequence from gp41 on HIV” and “In this regard, in one embodiment, a peptide or binding domain encoded by the nucleic acid of interest may bind any of the target proteins described herein, such as a … HIV gp120” (p.28, [0118]). Immusoft teaches the nucleic acid of Claim 65 wherein the HIV specific antibody binds to gp120 or gp41. Therefore, Claim 69 is anticipated by Immusoft.
Regarding Claim 71, Immusoft recites, “In one embodiment, the antibody encoded by the nucleic acid comprises at least the antigen binding domain of the HIV neutralizing antibody, b12” (p. 27, [0110]). Immusoft teaches the nucleic acid of Claim 65 wherein the broadly neutralizing antibody comprises B12. Therefore, Claim 71 is anticipated by Immusoft.
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 70 and 72 are rejected under 35 U.S.C. 103 as being unpatentable over Immusoft Corporation, US 2018/0002664 A1, published Jan. 4, 2018, Awi, N. et. al., Hindawi, Vol. 2018, Article ID 8723539, p. 1-9 (Jun. 3, 2018), and Julg, B. et. al., Journal of Virology, Vol. 91, Issue 16, p. 1 – 15 (May 24, 2017).
Regarding Claims 70 and 72, Immusoft teaches Claim 65 and 68 as described above.
Immusoft does not teach the use of broadly neutralizing antibodies comprising 10E8.4, N6-LS, and, PGDM1400.
Awi teaches the use of broadly neutralizing antibodies comprising 10E8.4, and PGDM1400; see Table 1 and Table 2 (p. 3).
Julg teaches the use of broadly neutralizing antibodies comprising N6-LS; “These results confirm the robust antiviral activity of N6-LS in vivo, supporting the further clinical development of this antibody” (p. 1, Abstract).
Regarding Claims 70 and 72, Immusoft teaches Claim 68 including the use of broadly neutralizing antibodies. Immusoft does not specifically teach the use of broadly neutralizing antibodies 10E8.4, N6-LS, or PGDM1400. A simple substitution of the antibodies taught by Awi and Julg into the plasmids taught by Immusoft would yield a minicircle or mini-intronic plasmid encoding broadly neutralizing antibodies, 10E8.4, N6-LS or PGDM1400. It would be predictable to one skilled in the art that such a substitution would be predictable and obvious as Immusoft allows the use of broadly neutralizing antibodies. Therefore, Claims 70 and 72 are prima facie obvious in view of combined teaching from Immusoft, Awi and Julg.
Claims 71, 73, 74 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Immusoft Corporation, US 2018/0002664 A1, published Jan. 4, 2018 and Awi, N. et. al., Hindawi, Vol. 2018, Article ID 8723539, p. 1-9 (Jun. 3, 2018).
Regarding Claims 71, 73, 74, and 80, Immusoft teaches Claim 65 and 68 as described above.
Immusoft does not teach the use of broadly neutralizing antibodies comprising 2F5, 4E10, 2G12, 10-1074, PGT145, PG9, PGT121, or PGT128. Immusoft also does not teach the use of a pharmaceutically acceptable carrier.
Awi teaches the use of broadly neutralizing antibodies comprising 2F5, 4E10, 2G12, 10-1074, PGT145, PG9, PGT121, and PGT128; see Table 1 and Table 2 (p. 3). Awi also teaches that “Table 2 shows the anti-HIV antibodies that are being evaluated in different phases of trials. HIV-1 envelope protein is a popular therapeutic target for various antiviral pharmaceuticals and vaccine design”, which reads as teaching a composition of HIV treatments with a pharmaceutically acceptable carrier.
Regarding Claims 71, 73, and 74, Immusoft teaches Claim 68 including the use of broadly neutralizing antibodies Immusoft does not specifically teach the use of 2F5, 4E10, 2G12, 10-1074V, PGT145, PG9, PGT121, and PGT128. Awi teaches the use of broadly neutralizing antibodies comprising, 2F5, 4E10, 2G12, 10-1074, PGT145, PG9, PGT121, and PGT128. A simple substitution of the antibodies taught by Awi into the plasmids taught by Immusoft would yield a minicircle or mini-intronic plasmid encoding broadly neutralizing antibodies, 10E8.4, N6-LS or PGDM1400. It would be obvious and predictable to one skilled in the art that such a substitution would be predictable and obvious as Immusoft allows the use of broadly neutralizing antibodies. Therefore, Claims 71, 73 and 74 are prima facie obvious in view of combined teaching from Immusoft and Awi..
Regarding Claim 80, Immusoft teaches the nucleic acid of Claim 65 but does not teach the combination with a pharmaceutically acceptable carrier . Awi teaches anti-HIV treatments used in a pharmaceutical composition. It would be obvious and predictable to one skilled in the art to use the nucleic acid taught by Immusoft with a pharmaceutically acceptable carrier to create a pharmaceutical composition as taught by Awi, and they would be motivated to do so to treat a patient. Therefore, Claim 80 is prima facie obvious in view of combined teaching from Immusoft and Awi Immusoft and Awi.
Claim 75 is rejected under 35 U.S.C. 103 as being unpatentable over Immusoft Corporation, US 2018/0002664 A1, published Jan. 4, 2018 and Argyros, O. et. al., Molecular Therapy, Vol. 13, Supplement 1, (May 2006).
Regarding Claim 75, Immusoft teaches the nucleic acid of Claim 65 as above.
Immusoft does not teach the use of the S/MAR region in the mini-intronic or minicircle plasmid.
Argyros teaches the “application of an S/MAR plasmid” (p. S200, para 519). Argyros provides motivation for using the S/MAR plasmid: “Currently used vectors in human gene therapy suffer from a number of limitations with respect to safety and reproducibility. The ideal vector has to be free of these effects and should allow long-term expression of a transgene in the absence of selection. Recently a novel non-viral episomal expression system which fulfils these criteria, in principle, was reported” and “. We describe the developments we have made to overcome these limitations and the results of the application of an S/MAR plasmid “ (p. S199-200, para 519).
It would be obvious and predictable to one skilled in the art to combine the use of the nucleic acid taught by Immusoft with techniques taught by Argyros, and one would be motivated to do so because Argyros teaches that their S/MAR plasmid improves safety and reproducibility of plasmid expression. Therefore, Claim 65 prima facie obvious in view of combined teaching from er Immusoft and Argyros.
Claim 76 and 77 are rejected under 35 U.S.C. 103 as being unpatentable over Immusoft Corporation, US 2018/0002664 A1, published Jan. 4, 2018 and Roy, U. et. al., Scientific Reports, Vol. 8, p. 1 – 12 (Jan. 25, 2018).
Regarding Claims 76 and 77, Immusoft teaches the nucleic acid of Claim 65 as above.
Immusoft does not teach the use of a nanodiamond.
Roy recites, “functionalized ND [nanodiamond] has the capacity to transport anti-HIV-1 drugs across the Blood-Brain Barrier”.
It would be obvious and predictable to one skilled in the art to combine the use of the nucleic acid taught by Immusoft with the techniques taught by Roy, and one would be motivated to do so because Roy teaches that nanodiamonds allow anti-HIV 1 drugs to cross the blood brain barrier for treatment. Therefore, Claim 76 and 77 are prima facie obvious in view of combined teaching from Immusoft and Roy.
Claim 76, 78 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Immusoft Corporation, US 2018/0002664 A1, published Jan. 4, 2018 and Lee, M. and Kim, S., Pharmaceutical Research, Vol. 22, No. 1, p. 1 – 10 (Jan. 1, 2005).
Regarding Claims 76, 78, and 79, Immusoft teaches the nucleic acid of Claim 65 as described above.
Immusoft does not teach the use of a cationic lipid, cationic polymer, or PEG-g-PLL.
Lee recites, “we explore the current progress of PEG-conjugated copolymers as gene carriers. PEG-PLL” (p. 1, Col. 2). Lee further recites, “Furthermore, the solubility of the complex with PEG-g-PLL increased compared to the same molecular PLL weight. The transfection efficiency of 10 mol% PEG-g-PLL was higher than that of PLL, irrespective of the size of PEG” (p. 4, Col. 1).
It would be obvious and predictable to one skilled in the art to combine the use of the nucleic acid taught by Immusoft with the techniques taught by Lee, and one would be motivated to do so because Lee teach that PEG-g-PLL improves transfection efficiency. Therefore, Claims 76, 78, and 79 prima facie obvious in view of combined teaching from Immusoft and Lee.
Claim 81-84 are rejected under 35 U.S.C. 103 as being unpatentable over Immusoft Corporation, US 2018/0002664 A1, published Jan. 4, 2018 and Graham B., et. al., The Journal of Infectious Diseases, Vol. 2006:194, p. 1650 – 1660 (Nov. 8, 2006).
Regarding Claims 81-84, Immusoft teaches the nucleic acid of Claim 65. as described above including where the HIV specific antibody is a sFv, scFv, Fab, Fab', F(ab')2, and Fv, see Claim 66 above.
Immusoft does not teach a method of treating a HIV infection in an individual comprising the nucleic acid of claim 65.
Graham teaches the use of a plasmid vaccine for treating HIV. Graham recites, “Here, we report the findings from a phase 1 clinical trial of a multigene, multiclade HIV-1 DNA candidate vaccine and demonstrate the induction of HIV-1–specific T cell and antibody responses” (p. 1650-1651). Graham further recites “Multiple antigens expressed by the vaccine elicit responses against multiple epitopes and may diminish the chances for immune escape” (p. 1650, Col. 2), which provides motivation for using multiple anti-HIV antibody expressing plasmids.
It would be obvious to one skilled in the art to combine the nucleic acid taught by Immusoft with the methods taught by Graham to produce a method of treatment using the nucleic acid of Claim 65. Graham provides motivation for using multiple plasmids expressing antibodies as it may diminish the chance of immune escape. Therefore, Claims 80-84 are prima facie obvious in view of combined teaching from Immusoft and Graham.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Krishna Nuggehalli Ravindra whose telephone number is (571)272-2758. The examiner can normally be reached M-Th, alternate F, 8a-5p est.
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, Neil Hammel can be reached at (571) 270-5919. 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.
/K.N.R./Examiner, Art Unit 1636
/CELINE X QIAN/ Primary Examiner, Art Unit 1637