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 Status
Claims 1 – 4, 6 – 16 and 18 – 21 are pending.
Claim Rejections - 35 USC § 102
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 – 4, 6 – 7, 10 – 11, 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhu et al (Prophylactic effect of IL-10 gene transfer on induced autoimmune dacryoadenitis. Invest Ophthalmol Vis Sci. 2004 May;45(5):1375-81; hereinafter Zhu).
Regarding claims 1 – 4, 6 – 7, 10 – 11, 18 and 20, Zhu discloses a method for modulating tear film composition, treating a corneal defect, and improving corneal reinnervation, in which an adenoviral (p. 1376, Vectors) vector carrying the Epstein-Barr viral IL-10 (vIL-10) gene (cDNA subcloned into the pACCMV vector) is administered into the lacrimal gland (p. 1375, Methods) of a subject in need thereof. Zhu further discloses that the presence of vIL-10 partially suppressed the appearance of Sjögren-syndrome-like features of: reduced tear production, accelerated tear breakup, ocular surface disease, and immunopathologic response (p. 1375, Conclusions).
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.
Claims 8, 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Pena et al. (U.S. Patent Application Publication No. 2019/0216857 A1; cited on IDS, hereinafter Pena), and Wang (Lipid Nanoparticles for Ocular Gene Delivery. Journal of Functional Biomaterials. 2015; 6(2):379-394; cited on IDS, hereinafter Wang).
Regarding claims 8, 9 and 14, Zhu teaches all of the elements of the current invention as stated above except the use of messenger ribonucleic acid (mRNA) for gene delivery. However, Pena teaches that mRNA (para. [0004]) can be administered to the lacrimal gland via vesicle bodies in order to overcome the blood-retinal barrier. Regarding claim 14, Wang (p. 386, Section 8) discloses a lipid nanoparticle-mediated method for the delivery of genes to the eye. Lipid nanoparticles can also be considered as a transfection reagent.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the mRNA of Pena, the transfection reagent of Wang with Zhu’s method for modulating tear film composition. The administration of a transfection reagent with the mRNA can serve several purposes such as: protection, cellular uptake facilitation, and targeting specific cell types.
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Lai et al. (Aquaporin gene therapy corrects Sjögren's syndrome phenotype in mice. Proc Natl Acad Sci U S A. 2016 May 17;113(20):5694-9. doi: 10.1073/pnas.1601992113; hereinafter Lai) and Rocha (Transduction, Tropism, and Biodistribution, Investigative Opthalmology & Visual Science, vol. 52, no. 13, 2011; cited on IDS, hereinafter Rocha).
Regarding claim 12, Zhu teaches all of the elements of the current invention as stated above except an AAV vector. However, Lai discloses an AAV2-Aquaporin vector for correcting Sjögren’s syndrome (Abstract).
Regarding claim 13, Rocha suggests that the AAV2/5 and AAV2/9 (p. 9568, Vector Preparation; AAV serotype 2 Rep, AAV Cap genes correspond to the strains) vector may be best suited for lacrimal gland therapy (p. 9567, Results; p. 9571, last paragraph).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the viral vector (AAV) and gene combination of Lai, with the AAV2/5 vector of Rocha to incorporate these elements into Zhu’s method for modulating tear film composition. Doing so would add a different embodiment for the delivery of genes to the eye and allow for the best suited vector to be utilized for the delivery, according to Rocha.
Claims 15 – 16, 19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu in view of Carlson et al. (Redefining the Therapeutic Approach to Address Opthalmic Diseases, 2021-07-15; cited on IDS, hereinafter Carlson)
Regarding claims 15 – 16, 19 and 21, Zhu does not explicitly disclose NGF as a protein of interest. However, Carlson discloses a method to treat diseases of the ocular surface and the anterior chamber. The treatment comprises administering an AAV harboring a nucleic acid encoding NGF into the lacrimal gland. The injection of the AAV results in tear film modulation (slides 58 – 73).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adopt the method of Carlson for using NGF as a method for modulating tear film composition, treating corneal defects, and improving corneal wound healing to incorporate that into Zhu’s method for modulating tear film composition. Doing so would be advantageous for treating ocular disorders/diseases, as NGF is implicated in epithelial proliferation, immune responses, tear secretion, and angiogenesis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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, Tracy Vivlemore can be reached at 571-272-2914. 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.
/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights