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 .
Status of Application
Receipt of the Preliminary Amendment filed on 12-21-2023 is acknowledged.
Claims 1-9 and 11-12 are pending in this application.
Claims 10 and 13-14 have been cancelled.
Claims 1-9 and 11-12 have been amended.
All claims are under examination in this application.
Information Disclosure Statement
There are no Information Disclosure Statements filed in this application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-9 and 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As noted in the instant specification on page 15, the focus on the encapsulated version of the of the griffithsin designed to eliminate intracellular viral reservoirs or propagating pathogens, which is suitable for the prophylactic treatment preceding viral infection or as a therapeutic treatment during viral infection or as a post-exposure prophylaxis following viral infection.
However, an effective intracellular delivery and resulting antiviral effect have been demonstrated in the instant application only with the targeting ligand of Fuc-C4-Chol in association with targeted CRD/CLR-positive cells which are or may be infected with SARS-CoV-2 (Example 3 and figures 1-3). It is noted that the antiviral efficacy of targeted encapsulated GRFT in Example 3 with respect to SARS-CoV-2. There is no shown efficacy of H1N1 viral infection in Example 4 since a non-encapsulated GRDT is used in addition to targeted encapsulated GRFT.
The instant specification does not provide sufficient evidence or teachings for the extrapolation of effective efficacy for all the instantly claimed combinations of ligands and respiratory viruses falling within the scope of the instant claims.
Claims 1-9 and 11-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating an infection, does not reasonably provide enablement for prevention. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. There are no teachings within the specification that demonstrate an extracellular antiviral action of the encapsulated GRFT, and therefore, the potential prevention of an infection caused by a respiratory virus. The extracellular antiviral action is disclosed to be triggered by non-encapsulated GRFT.
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 1-9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over O’Keefe et al. (Broad Spectrum In Vitro Activity and In Vivo Efficacy of the Antiviral Protein Griffithsin against Emerging Viruses of the Family Coronaviridae, Journal of Virology, vol 84, no 5, 23 December 2009, pages 2511-2521; cited on ISR dated December 21, 2023) in view of Gieseler et al. (WO 2005092288).
O’Keefe discloses the potent antiviral protein griffithsin (GRFT) in the prevention of Severe Acute Respiratory Syndrome coronavirus (SARS-CoV) infection both in vitro and in vivo (page 2511). It is noted the SARS-CoV refers to the lethal SARS outbreaks in China and Canada in 2002-2003, which has been interpreted as SARS-CoV1 in the instant specification.
Regarding claim 5, as noted above, SARS-CoV1 is disclosed.
Regarding claim 8, the GRDT was administered intranasally (page 2513).
O’Keefe does not disclose the GRFT is encapsulated in a lipid based or polymer based nanocarrier and at least one carbohydrate as a targeting ligand.
Gieseler discloses a liposome functionalized with Fuc-C4-Chol for the intracellular delivery of a plant lectin into virus reservoir cells for the treatment and prevention of viral infections, including influenza (claims 1, 6, 9, and 77).
The targeting ligand specifically binds a non-C-type lectin receptor expressing C-type lectin like carbohydrate recognition domains (CRD) (claim 42).
Regarding claim 2, as noted above, liposomes are disclosed.
Regarding claim 3, as noted above, CRD’s are disclosed. The CRD’s can be negative, positive, or neutral (page 40). Targeting locations include lymph nodes (page 44).
Regarding claim 4, T-lymphocytes and natural killer cells are disclosed (page 87).
Regarding claim 6, as noted above, Influenza is disclosed.
Regarding claim 7, one or more accessory factors, such as bivalent cations, co-enzymes, enzyme activators, or pH-modifying agents can be added (claim 16).
Regarding claim 9, as noted above, Fuc-C4-chol is disclosed.
Regarding claim 11, Intracellular activity is triggered by the encapsulated GRFT, whereas extracellular activity is triggered by unencapsulated GRFT, therefore, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used a combination of the two to effectively treat viral infections.
Regarding claim 12, Applicant is reminded that where the general conditions of the claims are met, burden is shifted to applicant to provide a patentable distinction. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454 105 USPQ 233,235 (CCPA 1955).
It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the invention to have used the encapsulating system being a liposome functionalized with a CLR-binding ligand, in particular FucC4-Chol, as an alternative formulation of the antiviral lectin GRFT of O’Keefe for the treatment of an infection caused by the viral respiratory infection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA S MERCIER whose telephone number is (571)272-9039. The examiner can normally be reached M-F 6:30 am to 4 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A Wax can be reached at 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MELISSA S MERCIER/Primary Examiner, Art Unit 1615