DETAILED ACTION
Claims 1-20, submitted 09 September 2025, are pending in the application. Claims 10-16 have been withdrawn. Claims 1-9 and 17-20 are under examination in the instant Office 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 .
Election/Restrictions
Applicant’s election of Group I, claims 1-9 and 17-20, and the elected species of virus, retrovirus, in the reply filed on 20 January 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 10-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 20 January 2026.
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 17-20 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. To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See MPEP 2163. Searches of prior art within the technology area have not established a universal definition for the term “derivative”.
For the Applicant to meet the aforementioned written description requirement, using such descriptive means as words, structures, figures, diagrams, or formulas that fully set forth the claimed invention is necessary to meet the limitations of the claimed invention. Prior art found within the technology area and CPC A61P 31/231, detailed below show acceptable use of and definition for the term “derivative” are set forth by the MPEP 2163.
Coupland (US Patent No. 6,664,406 B1) teaches the definition of derivative for their invention by use of words, structures, figures, diagrams, and formulas. The definition provided by Coupland is as follows, “ The present invention relates to a nervonic acid derivatives of formula (I) CH3—(CH2)7—CH═CH—(CH2)13—C(O)—O—(CH2)3— OR (I) wherein R is hydrogen (H) or a residue of a carboxylic acid; or a salt of the compound where R is H; or a bioprecursor, prodrug thereof” and “compounds wherein R is H can be used to prepare the pharmacologically active derivatives”. See Abstract of Coupland.
Escriba et al. (US Patent No. 9,000,042 B2), henceforth known as Escriba, also teach the definition of derivative for their invention by use of words, structures, figures, diagrams, and formulas. The definition provided by Escriba is as follows, “where (a) and (b) can take any value between 0 and 14, (X) can be substituted by any atom or group of atoms with an atomic/molecular weight between 4 and 200 Da and (R) can be substituted by any atom or group of atoms with an atomic/molecular weight between 1 and 200 Da, both (X) and (R) being selected from: alcohols, organic acids, alkyl groups, amino groups, halogens, alkyl halogens, alkyloxy groups and mercapto groups”. See Column 5 lines 29-36.
Iinuma et al. (US Patent No. 8,987,486 B2), henceforth known as Iinuma, teaches the definition of derivative for their invention by use of words, structures, figures, diagrams, and formulas. The definition provided references the formula below:
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Wherein Iinuma states, “Y is —O—, —NR— or —S—, R is hydrogen atom, alkyl group, dialkylaminoalkyl group or the like and W is a substituent such as dialkylaminoalkyl group”. See abstract of Iinuma.
The aforementioned pieces of prior art achieve all the necessary parameters set forth by MPEP 2163 by describing the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003). However, the instant application does not similarly satisfy the written description requirement as it does not provide guidance or description of one or more derivatives to demonstrate Applicant was in possession of derivatives of a vegetable oil-derived polyol at the effective filing date of the instant application, wherein said derivatives are characterized by the property of inhibiting viral replication of any virus in any host cell prior to or after viral infection. The examiner suggests that the word “derivative” be deleted from the claims.
Claims 1-9 and 17-20 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 the inhibition of viral replication wherein the virus is a coronavirus or retrovirus, does not reasonably provide enablement for the inhibition of all virus replication in a host cell much less the inhibition of the viral replication prior to infection of the host cell. 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.
Breath of the Claims
Claim 1 recites “A method for inhibiting viral replication of a virus in a host cell, comprising, prior to and/or after the infection of the host cell by the virus…”. Claim 1 in itself is not drawn to any particular virus, and thus can be interpreted to encompass all viruses.
As it reads, claim 1 is also drawn to prophylactic treatment before the virus has infected the host cell. As found in the specification on page 14, which states, “Prevention can include reducing the severity of the onset of a disease or disorder, and/or inhibiting the progression thereof”.
Nature of the Invention
The nature of the invention is within the pharmaceutical arts with regards to inhibiting viral replication of a virus in a host cell comprising administering to the host cell a vegetable oil-derived polyol or derivative thereof wherein the virus is a retrovirus or coronavirus.
State of the Prior Art
The state of the prior art is what one skilled in the art would have known, at the
time the application was filed, about the subject matter to which the claimed invention
pertains. The relative skill of those in the art refers to the skill of those in the art at the
time the application was filed. See MPEP 2164.05(b). See Pac. Bioscience of Cal., Inc.
v. Oxford Nanopore Techs., Inc., 996 F.3d 1342, 1352, 2021 USPQ2d 519 (Fed. Cir.
2021).
The state of the prior art provides evidence for the degree of predictability in the
art and is related to the amount of direction or guidance needed in the specification as
filed to meet the enablement requirement. The state of the prior art is also related to the
need for working examples in the specification. See MPEP 2165.05(a).
Prior art teaches that vegetable oil-derived polyols acts as stabilizers in hydrogel
nanoparticles and microparticles. For example, Vashist (Vashist et al., “Development of
Multifunctional Biopolymeric Auto-Fluorescent Micro- and Nanogels as a Platform for Biomedical Applications”. Front Bioeng. Biotechnol. 2020 Apr 30;8:315.) teaches that
it’s anticipated that linseed oil introduces an element of hydrophobicity which would aid
in the compositions passing into the blood-brain barrier (pg.2, Right Column, Section
“Introduction”, last para. Before “Experimental Section” section). The linseed oil polyol
was also hypothesized by Vashist to result in stability of the nanogel system (pg. 8, Left
column, Section “Biocompatibility Evaluation of Nanogels in vitro”, 1st para.). Vashist
establishes that the linseed oil polyols has use in biomedicinal applications but does not
establish or suggest the polyol as having antiviral or antibacterial properties. Thus, this
supports the notion of great unpredictability in using linseed oil polyol as an antiviral agent on its own.
Landovitz (Landovitz, R. J., Scott, H., & Deeks, S. G. (2023). Prevention,
treatment and cure of HIV infection. Nature Reviews Microbiology, 21(10), 657-670.)
teaches that “Based on current conceptual models, the ideal cure vaccine would result
in a sustained T cell response that targets the most vulnerable (often conserved)
regions of the HIV genome” (pg. 10, Left column, Section “Ubiquitous role of vaccines
and vaccine adjuvants”, para. 1st full paragraph).
Furthermore, Este ("Current status and challenges of antiretroviral research and therapy." Antiviral research 85.1 (2010): 25-33.) teaches the inhibition of replication of the HIV-1 virus with the use of azidothymidine (AZT), as the reference states “a collaboration between the U.S. National Cancer Institute (NCI) and the pharmaceutical company Burroughs-Wellcome led to the discovery that AZT was able to suppress HIV-1 replication in cell culture” (pg. 26, Section “Milestones in the development of antiretroviral therapy”, Right Col., 1st paragraph). This prior art reference teaches the ability of a compound, AZT, to inhibit the replication of the HIV-1 virus, however, Este does not teach the use of a vegetable oil-derived polyol in the inhibition of the replication of the virus. Therefore, there is unpredictability in the prior art with the use of a vegetable oil-derived polyol to inhibit the viral replication of a retrovirus, wherein the retrovirus is HIV.
Level of Skill in the Art
The person of ordinary skill in the art is a person who is presumed to have known the relevant art at the relevant time. Factors that may be considered in determining the
level of ordinary skill in the art may include: (A) "type of problems encountered in the
art;" (B) "prior art solutions to those problems;" (C) "rapidity with which innovations are
made;" (D) "sophistication of the technology; and" (E) "educational level of active
workers in the field. In a given case, every factor may not be present, and one or more
factors may predominate." In re GPAC, 57 F.3d 1573, 1579, 35 USPQ2d 1116, 1121
(Fed. Cir. 1995); Custom Accessories, Inc. v. Jeffrey-Allan Indus., Inc., 807 F.2d 955,
962, 1 USPQ2d 1196, 1201 (Fed. Cir. 1986); Environmental Designs, Ltd. V. Union Oil
Co., 713 F.2d 693, 696, 218 USPQ 865, 868 (Fed. Cir. 1983). See MPEP 2141.03 (I).
The invention described pertains to the medical or pharmaceutical arts. One of
ordinary skill would be trained in pharmacology, biochemistry, medicine, or a related art
field with a Ph. D or other advanced degree in these or other related fields.
Level of Predictability in the Art
The amount of guidance or direction needed to enable the invention is inversely
related to the amount of knowledge in the state of the art as well as the predictability of
the art. In re Fisher, 427, F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount
of guidance or direction” refers to that information in the application, as originally filed,
that teaches exactly how to make or use the invention. The more that is known in the
prior art about the nature of the invention, how to make, and how to use the invention,
and the more predictable the art is, the less information needs to be explicitly stated in
the specification. In contrast, if little is known in the prior art about the nature of the
invention and the art in unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. The scope of the required
enablement varies inversely with the degree of predictability involved, but even in
unpredictable art, a disclosure of every operable species is not required. A single
embodiment may provide broad enablement in cases involving predictable factors, such
as mechanical or electrical elements. In re Vickers, 141 F.2d 522, 526-27, 61 USPQ
122, 127 (CCPA 1944); In re Cook, 439 F.2d 730, 734, 169 USPQ 298, 301 (CCPA
1971). However, in applications directed to inventions in arts where the results are
unpredictable, the disclosure of a single species usually does not provide an adequate
basis to support generic claims. In re Soll, 97 F.2d 623, 624, 38 USPQ 189, 191 (CCPA
1938). In cases involving unpredictable factors, such as most chemical reactions and
physiological activity, more may be required. In re Fisher, 427 F.2d 833, 839, 166
USPQ 18, 24 (CCPA 1970). See MPEP 2164.03. The applicant would need to provide
more objective evidence to support the enablement of the aforementioned claims to
contrast the unpredictability of the subject matter art.
There is unpredictability in the field of endeavor in regards to the currently
claimed method of treating all viral infections with a singular compound, treating all
infections caused by a retrovirus or a coronavirus with a singular compound, preventing
all viral infections with a singular compound, or preventing all infections caused by the aforementioned viruses, said compound being the vegetable oil-derived polyol from linseed oil. There is unpredictability in the compound as there is no prior art to suggest that this compound can be administered in the treatment of the above-mentioned infections. Moreover, Applicant has not provided any support to the notion that the linseed oil-derived polyol is generally suited to treat said viral infections.
Prior art teaches that the compound is present in a hydrogel nanoparticle or microparticle as taught by Vashist.
Further addressing the unpredictability of the art, molecular docking alone does not provide the certainty that a compound will behave as anticipated. For example, Cava (Cava et al. “Integration of Molecular Docking and In Vitro Studies: A Powerful Approach for Drug Discovery in Breast Cancer.” Appl. Sci. 2020, 10, 6981.) teaches that molecular docking and in vitro studies should be conducted as complementary methods to increase the knowledge of drug discovery and development (pg. 14, Section “Conclusion”, 4th para.). In the same paragraph, Cava goes on to explain the issue being that there is probability for the binding affinity to be inaccurate due to an incorrect ligand pose. Other important factors to consider include the environmental conditions that cannot be replicated during a docking study such as pH and temperature meaning that in vitro and in vivo studies cannot be overlooked as important validation to in silico methods (pg. 2, Section “Introduction”, 2nd full para.).
Amount of Direction Provided by the Inventor
The amount of direction provided by the inventor is correlated by the nature of
the unpredictability of the art. Given the context and scope of the claims mentioned
above, the inventor failed to provide the necessary amount of direction for one skilled in
the art to adequately use the invention across all suggested utility in the broadly stated
disease and disorders disclosed above. (See: Section (A) Breadth of the Claims).
Applicant did not provide guidance for any aspect of the limitation as applied to
claim 1 of the instant application. Guidance that would be helpful includes
but is not limited to the dosage, dosage frequency, route of administration, etc., and
further could include application of the compound to non-human subjects. The guidance
that was provided was completed using molecular docking which, as detailed above,
has set limitations when being solely relied upon and not as a complementary tool.
Quantity of Experimentation Needed to Make or Use the Invention Based on the Content of the Disclosure
As previously stated, the amount of experimentation depends on the art, the
predictability of the art, and the direction provided by the inventor. For one skilled in the
art to practice the invention as disclosed, the artisan trying to practice Applicant’s
claimed invention would be required to undertake unduly burdensome activities
including:
Experimentation to show the dosage and frequency required to prevent all viruses encompassed by the claims.
Experimentation to demonstrate in vitro application in a subject.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 and 11 of U.S. Patent No. 12,440,467. Although the claims at issue are not identical, they are not patentably distinct from each other.
USPN ‘467 claims:
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The difference between the rejected claims of the instant application and the cited conflicting claims of USPN ‘467 is that the cited claims of USPN ‘467 are drawn to a more specific method of treating a specific group of viral infections (i.e., retrovirus and coronavirus infections as opposed to any viral infection as is recited in the rejected claims) that explicitly recites the same compound as claimed in the instantly rejected claims. Consequently, the cited claims of USPN ‘467 anticipate the rejected claims of the instant application.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN CHRISTOPHER SANCHEZ whose telephone number is (703)756-5336. The examiner can normally be reached Monday -Friday (0730-1700).
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JUSTIN CHRISTOPHER SANCHEZ
Examiner
Art Unit 1622
/J.C.S./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622