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 the Claims
Claims 13, 15, and 25-30 are pending and under current examination. Claims 1-12, 14, and 21-24 are cancelled.
Withdrawn Claim Rejections
All rejections pertaining to claims 1-12, 14, and 21-24 are moot because the claims are cancelled in the amendment filed 10/27/2025.
All rejections not reiterated have been withdrawn.
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.
Claim 15 is 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 a method of inhibiting viral infection and replication in a subject infected by a virus, does not reasonably provide enablement for a method of treating a disease caused by a virus comprising administering to the subject a therapeutically effective amount of an amphiphilic block copolymer wherein the amphiphilic block copolymer promotes cell repair and recovery, increases survival of cells infected by the virus, inhibits a cellular metabolic response, a gene transcription response, an unfolded protein response, or prevents death of a tissue infected by the virus.
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 the claim.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (A)). These include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based
on the content of the disclosure
All of the Wands factors have been considered with regard to the instant claims,
as discussed below:
(A) The breadth of the claims: The term “virus” represents a broad genus of viruses causing a broad range of conditions, including but not limited to influenza, hepatitis B, rubella, polio, rabies, measles, Ebola, HIV/AIDS, norovirus, yellow fever, and some cancers (pg. 1682 Table 134-1 and pg. 1690 Viruses and Cancer, of record).
(B) Nature of the invention: The invention pertains to preclinical and clinical drug development. Specifically, the nature of the invention is the use of one molecule, an amphiphilic block copolymer, to treat a disease caused by a virus.
(C) The state of the prior art: In order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must discover a biological target, then validate the drug in pre-clinical testing, followed by phase I-III clinical trials to evaluate the drug’s safety and efficacy in humans (Hughes, pg. 1240, fig. 1 and 2, of record).
(D) The level of one of ordinary skill: The artisans in the field of drug development and patient treatment would be a collaborative team of physicians and basic researchers possessing an advanced degree in biomedicine and/or a doctor of medicine degree, thus the level of skill is high.
(E) The level of predictability in the art: The level of unpredictability in the art of drug development and patient treatment for all conditions, including diseases caused by a virus, is very high. As noted above, in order to identify a pharmaceutical as both safe and effective for use in the general population, the skilled Artisan must discover a biological target, then validate the drug in pre-clinical testing, followed by phase I-III clinical trials to evaluate the drug’s safety and efficacy in humans (Hughes pg. 1240, fig. 1 and 2, of record). Each state of the process is fraught with complexity. Regarding target development, cationic amphiphilic drugs are known for off-label use as antiviral agents and are effective in vitro against a wide number of viruses because of their ability to accumulate into acidic organelles in the body, thereby inducing cellular alterations that affect the viral replication cycle of several viruses, mainly at the entry step, but, in some cases, also at the level of the viral assembly/budding. However, limited in vivo studies support the in vitro observations (Salata et. al. Expert Review of Anti-Infective Therapy, pg. 483-492, publication year: 2017; pg. 488 Conclusion, of record). Furthermore, polyethylene oxide/polypropylene oxide block copolymers have been shown to enhance and accelerate the growth of flaviviruses in vitro (Stinchcomb, U.S. Patent Application No. 2010/0144015, publication year: 2010, [0011 and 0009], in vitro). However, how this might impact disease development and progression among the many diseases caused by the genus “virus” is wholly unclear. This lack of predictability is demonstrated here by exemplifying certain disease states caused by a pathogen encompassed by the genus “virus”. Viruses are known to cause an immense variety of diseases with vastly differently clinical presentations and symptoms, such as influenza, hepatitis B, rubella, polio, rabies, measles, Ebola, HIV/AIDS, norovirus, yellow fever, and some cancers (pg. 1682 Table 134-1 and pg. 1690 Viruses and Cancer, of record). Rabies, an RNA virus of the rhabdovirus family, is a disease of the central nervous system that causes severe neurological symptoms and almost 100% morality (Dietzschold et. al., Future Virology, pg. 1-14, publication year: 2008; pg. 8, Conclusions, of record). Ebola virus infection results in a severe hemorrhagic fever caused by an RNA virus belonging to the filoviridae family (De Clercq, Biochemical Pharmacology, pg. 1-10, publication year: 2015; pg. 1 Introduction, of record). Hepatitis B virus is a DNA virus from the hepadnavirus family that infects the liver and causes an inflammatory response in and the subsequent damage of hepatocytes (Wu, World of Gastroenterology, pg. 188-204, publication year: 2016; pg. 188 Introduction, of record). With regard to amphiphilic block copolymers, amphiphilic block copolymers consisting of polyethylene oxide and polypropylene oxide are effective pharmaceutical excipients for their ability to form nanostructured delivery vehicles for poorly soluble drugs (Bodratti et. al. Expert Opinion on Drug Delivery, pg. 1085-1104, publication year: 2018; abstract, of record). While not specifically encompassing amphiphilic block copolymers, known cationic amphiphilic drugs are effective in vitro against a wide number of viruses because of their ability to accumulate into acidic organelles in the body, thereby inducing cellular alterations that affect the viral replication cycle of several viruses, mainly at the entry step, but, in some cases, also at the level of the viral assembly/budding. However, limited in vivo studies support the in vitro observations (Salata et. al. Expert Review of Anti-Infective Therapy, pg. 483-492, publication year: 2017; pg. 488 Conclusion, of record). In view of the above, there exists a great variability in mechanisms underlying the many conditions that may be classified as a disease caused by a virus and great variability in the use of similar amphiphilic drugs as antiviral agents, and accordingly it would be difficult for a person of ordinary skill in the art to predict which viruses might respond to treatment with the amphiphilic block copolymers embraced by the instant claim 13.
With respect to predictability in the field of drug development in general, preclinical data is by and large a poor predictor of clinical outcome for various reasons, including differences in the physiology and anatomical organization between humans and experimental animals as well as the availability of disease models that recapitulate aspects of the analogous human condition in experimental animals (Lowenstein, page 3, lines 28-33, of record). Due to the complexity of real patient populations relative to model systems in terms of genetic heterogeneity as well as differences resulting from age and gender, it is nearly impossible to predict which drugs, including those that exhibit outstanding preclinical results, will be effective in the patient population at large (Lowenstein, abstract, of record). Thus, the skilled Artisan's awareness of the pharmacology underlying amphiphilic block copolymers on viral replication does not provide sufficient information to allow one of skill to predict outcome in real patient populations for the broad variety of diseases caused by a virus.
(F) The amount of direction provided by the inventor: The specification provides the general teaching that amphiphilic block copolymers inhibit a gene transcription response to viral infection, a cellular metabolic response to viral infection, or an unfolded protein response of a virus by contacting the exposed hydrophobic domain of a viral protein with an amphiphilic block copolymer [0025] and inhibiting viral entry into the cell by binding to the virus surface proteins [0031]. The specification also teaches that the amphiphilic block copolymers are capable of binding any virus with an exposed hydrophobic domain, including RNA viruses with an exposed hydrophobic domain and DNA viruses with an exposed hydrophobic domain [0034]. The amphiphilic block copolymers act as a surfactant and can comprise a hydrophilic (A) and hydrophobic (B) region in as an ABA or BAB structure, or have a core structure (A or B) with two or more pendant side chains of the structure -A (if a B core), -B (if an A core), -AB, -BA, -ABA, -BAB, or a combination thereof [0038].
(G) The existence of working examples: The specification has provided data from two experiments. The examples describe the treatment of cells infected with OC43, a human beta coronavirus, and cells infected with SARS-CoV-2, a human coronavirus, with poloxamer amphiphilic block copolymers [0120 and 0127].
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure: In view of the number of viruses embraced by the instant claims and the extraordinary efforts required to determine whether a candidate molecule can be used therapeutically in the clinic, as well as the narrow guidance provided by the instant specification, it would require undue experimentation for one of ordinary skill in the art to practice the claimed invention in the full broad scope rejected in the claims.
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.
Claim 15 is 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 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.
Applicant is referred to the Guidelines on Written Description published at FR 66(4) 1099-1111 (January 5, 2001) (also available at www.uspto.gov). The following passage is particularly relevant:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant identifying characteristics, i.e. structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between structure and function, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within a genus, one must describe a sufficient number of species to reflect the variation within the genus. What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. In an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.
For Example MPEP 2163 states, in part,
An adequate written description of a chemical invention also requires a precise definition, such as by structure, formula, chemical name, or physical properties, and not merely a wish or plan for obtaining the chemical invention claimed. See, e.g., Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 927, 69 USPQ2d 1886, 1894-95 (Fed. Cir. 2004) (The patent at issue claimed a method of selectively inhibiting PGHS-2 activity by administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product, however the patent did not disclose any compounds that can be used in the claimed methods. While there was a description of assays for screening compounds to identify those that inhibit the expression or activity of the PGHS-2 gene product, there was no disclosure of which peptides, polynucleotides, and small organic molecules selectively inhibit PGHS-2. The court held that “[w]ithout such disclosure, the claimed methods cannot be said to have been described.”).
Claim 15 is directed towards “the method of claim 13, wherein administering to the subject the therapeutically effective amount of the amphiphilic block copolymer promotes cell repair and recovery, increases survival of cells infected by the virus, inhibits a cellular metabolic response, a gene transcription response, or an unfolded protein response of the virus comprising an exposed hydrophobic domain and/or prevents death of a tissue infected by the virus.”
With respect to the genus embraced by the claims, the phrase “virus” is very broad embracing both known viruses as well as viruses yet to be discovered. as well as conditions yet to be discovered as caused by a virus Accordingly, the breadth of the rejected claims is immense.
As discussed in more detail below, the specification provides inadequate and insufficient examples to show possession of an amphiphilic block copolymer capable of rendering any of the described cellular response caused by the genus of any virus. The specification as filed does not sufficiently describe the characteristics of diseases caused by a virus that will render them responsive to treatment with amphiphilic block copolymers. This is important because, as discussed below, not all amphiphilic block copolymers inhibit the growth of viruses.
Claim 15 embraces the amphiphilic block copolymers of claim 13 that render the cellular effects for a cell infected by any virus. As an indication of the number of diseases caused by viruses, Chappell et. al. (Mandell, Douglas, and Bennett’s Principles and Practice of Infectious Diseases, pg. 1681-1693, publication year: 2014, of record) teaches 14 families of RNA-containing viruses and 7 families of DNA-containing viruses, with each family containing a wide variety of viruses associated with vastly different diseases, including influenza, hepatitis B, rubella, polio, rabies, measles, Ebola, HIV/AIDS, norovirus, yellow fever, and some cancers (pg. 1682 Table 134-1 and pg. 1690 Viruses and Cancer, of record). Thus, the genus of diseases caused by a virus that can be treated by the claimed genus of amphiphilic block copolymers is vast. However, as detailed below, not all amphiphilic block copolymers have the instantly claimed therapeutic activity, thus it falls to the specification to provide an adequate written description of the fraction of possible amphiphilic block copolymers which are capable of treating any virus.
The prior art shows that amphiphilic block copolymers consisting of polyethylene oxide and polypropylene oxide are effective pharmaceutical excipients for their ability to form nanostructured delivery vehicles for poorly soluble drugs (Bodratti et. al. Expert Opinion on Drug Delivery, pg. 1085-1104, publication year: 2018; abstract, of record). While not specifically encompassing amphiphilic block copolymers, known cationic amphiphilic drugs are effective in vitro against a wide number of viruses because of their ability to accumulate into acidic organelles in the body, thereby inducing cellular alterations that affect the viral replication cycle of several viruses, mainly at the entry step, but, in some cases, also at the level of the viral assembly/budding. However, limited in vivo studies support the in vitro observations (Salata et. al. Expert Review of Anti-Infective Therapy, pg. 483-492, publication year: 2017; pg. 488 Conclusion, of record). Furthermore, polyethylene oxide/polypropylene oxide block copolymers have been shown to enhance and accelerate the growth of flaviviruses in vitro (Stinchcomb, U.S. Patent Application No. 2010/0144015, publication year: 2010, [0011 and 0009], of record). This provides evidence that not all amphiphilic block copolymers are capable of treating all viruses. In light of this evidence, an adequate description of the claimed genus of amphiphilic block copolymers would require information that would allow one of skill to immediately determine which amphiphilic block copolymer comprised the requisite antiviral activity. As discussed above, such information could take the form of a description of structural characteristics that are common to the members of the genus, wherein the structural characteristics may convey the required function. However, the specification fails to provide such a description. Accordingly, it remains unclear what structural features of the amphiphilic block copolymers, and of the viruses themselves, are necessary for antiviral effects, particularly in light of the disclosure of Stinchcomb in which a polyethylene oxide/polypropylene oxide amphiphilic block copolymer enhances that growth of flaviviruses.
The specification provides the general teaching that amphiphilic block copolymers inhibit a gene transcription response to viral infection, a cellular metabolic response to viral infection, or an unfolded protein response of a virus by contacting the exposed hydrophobic domain of a viral protein with an amphiphilic block copolymer [0025] and inhibiting viral entry into the cell by binding to the virus surface proteins [0031]. The specification also teaches that the amphiphilic block copolymers are capable of binding any virus with an exposed hydrophobic domain, including RNA viruses with an exposed hydrophobic domain and DNA viruses with an exposed hydrophobic domain [0034]. The amphiphilic block copolymers act as a surfactant and can comprise a hydrophilic (A) and hydrophobic (B) region in as an ABA or BAB structure, or have a core structure (A or B) with two or more pendant side chains of the structure -A (if a B core), -B (if an A core), -AB, -BA, -ABA, -BAB, or a combination thereof [0038]. However, the examples provided in the specification only describe the treatment of cells infected with OC43, a human beta coronavirus, and cells infected with SARS-CoV-2, a human coronavirus, with poloxamer amphiphilic block copolymers [0120 and 0127]. The specification provided no discussion of how the amphiphilic block copolymer may affect any symptoms associated with these infections that a subject receiving treatment may experience. Thus there is no structure-function information provided in the specification relating physical or chemical features of the amphiphilic block copolymers, or of a disease caused by a virus, to the antiviral effects of the amphiphilic block copolymers such that the artisan of skill could determine which amphiphilic block copolymers embraced by the claims possess the features required to treat a disease caused by a virus, or which diseases caused by a virus would be susceptible to the recited amphiphilic block copolymers.
Applicant’s attention is also directed to In re Shokal, 113 USPQ 283 (CCPA 1957), wherein it is stated:
It appears to be well settled that a single species can rarely, if ever, afford sufficient support for a generic claim. In re Soll, 25 CCPA (Patents) 1309, 97 F2d 623, 38 USPQ 189; In re Wahlforss, 28 CCPA (Patents) 867, 117 F2d 270, 48 USPQ 397. The decisions do not however fix any definite number of species which will establish completion of a generic invention and it seems evident therefrom that such number will vary, depending on the circumstances of particular cases. Thus, in the case of small genus such as the halogens, consisting of four species, a reduction to practice of three, perhaps even two, might serve to complete the generic invention, while in the case of a genus comprising hundreds of species, a considerably larger number of reductions to practice would probably be necessary.
As stated in MPEP 2163 II: If the application as filed does not disclose the complete structure (or acts of a process) of the claimed invention as a whole, the Examiner must determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. The instant specification is devoid of a description for numerous possible amphiphilic block copolymers that may treat any disease caused by a virus. Thus, Applicants have failed to demonstrate possession of the amphiphilic block copolymers that may render the claimed effects for any virus. Disclosure of function alone is little more than a wish for possession; it does not satisfy the written description requirement. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406 (written description requirement not satisfied by merely providing “a result that one might achieve if one made that invention”); In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming a rejection for lack of written description because the specification does “little more than outline goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate”).
Disclosure of a single species of amphiphilic block copolymer with antiviral effects against two viruses does not constitute an adequate description to demonstrate possession of the numerous amphiphilic block copolymers of the instant claim 13 that may treat any virus. The analysis above demonstrates that Applicants have not described a representative number of species of the recited genus of amphiphilic block copolymers that exhibit the requisite antiviral activities, nor is it clear what structural features a virus must possess in order to be susceptible to the alleged antiviral effects of the claimed amphiphilic block copolymers. Accordingly, one of skill in the art could not conclude that Applicant was in possession of the recited genus of amphiphilic block copolymers at the time of the invention.
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
Applicant’s comments on page 5 of the remarks that the amendment to cancel claim 1 and its dependent claims obviates the rejections under 35 USC 112(a) are noted; however, claim 15 has not been cancelled, therefore the rejection of this claim has been maintained for the reasons detailed in the rejection.
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.
(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 13, 15, 25, 26, 28, and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pitard (U.S. Application No. 2015/0050297, publication date: 2/19/2015, cited in the IDS filed 7/4/2023, of record), as evidenced by Serra-Gómez et. al. (Langmuir, pg. 6398-6408; publication year: 2016, of record).
Regarding claim 13, Pitard teaches an amphiphilic block copolymer [0001] that may be used in the treatment or prophylaxis of diseases and disorders in which viruses are implicated [0123 and 0124]. The amount of amphiphilic block copolymer in a vaccine of the invention may vary widely according to the nature of the vaccine, the particular dosage unit employed, the period of treatment, the age, weight, kind of adjunctive treatment, and sex of the patient treated, the nature and extent of the disorder treated, and the nature of the antigen administered [0146]. Pitard is silent on a method of inhibiting virus replication. However, the composition of the instant claims and the composition embraced by Pitard are identical, therefore it can be assumed the composition embraced by Pitard will inherently perform a method of inhibiting virus replication. See MPEP 2112.01 (I). Pitard teaches that the amphiphilic block copolymer refers to a block copolymer comprises at least one hydrophilic block and at last one hydrophobic block [0030]. They hydrophilic blocks are composed of polyethylene oxide units [0039] and the hydrophobic blocks are comprised of polypropylene oxide units [0040].
Regarding claim 15, Pitard does not disclose the promoting cell repair and recovery, increasing survival of cells infected by the virus, inhibiting cellular metabolic response, a gene transcription response or an unfolded protein response, or preventing death of a tissue infected by the virus properties as recited in claim 15. However, the invention as claimed is not structurally distinguishable from the disclosure of Pitard and therefore, the Examiner has a reasonable basis to believe that the properties claimed in the present invention are inherent in the composition taught by the prior art. Since the Patent and Trademark Office does not have the facilities for examining and comparing the claimed composition with that of the prior art, the burden of proof is shifted to the Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed composition and the composition of the prior art; i.e., to prove that the properties are not inherent. See In re Best, 562 F.2d 1252, 195 U.S.P.Q. 430 (CCPA 197) and Ex parte Gray, USPQ 2d 1922 (PTO Bd. Pat. App. & Int.). As recited in MPEP §2112.01 (II): “Products of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable.
Regarding claim 25, Pitard teaches that the block copolymer may be used to treat coronaviruses [0117 and 0124], flaviridae [0124], rhabdoviradae [0124], herpes viruses [0117], and retroviruses [0117].
Regarding claim 26, Pitard teaches that the amphiphilic block copolymer may comprise amphiphilic block copolymer 704 [0068], a derivative of poloxamine 704 [0065].
Regarding claim 28, Pitard teaches that non-ionic amphiphilic block copolymer 1107, a derivative of poloxamine [0065], is a suitable block copolymer for the invention [0068]. Serra-Gomez teaches that poloxamine T1107 is a block copolymer of poly(propylene oxide) (PPO) and a poly(ethylene oxide) (PEO) (pg. 6398, Introduction, Second paragraph).
Regarding claim 29, Pitard teaches that the block copolymer may have a molecular weight ranging from about 4000 to 35,000, in particular ranging from 5000 to 25,000 [0063].
Claim Rejections - 35 USC § 103
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 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 27 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Pitard (U.S. Application No. 2015/0050297, publication date: 2/19/2015, cited in the IDS filed 7/4/2023, of record), as applied to claims 13, 15, 25, 26, 28, and 29 above, and further in view of Kabanov (U.S. Patent No. 6,387,406, issue date: 5/14/2002, of record), as evidenced by Lee (U.S. Patent No. 5,470,568).
Determination of the scope and the content of the prior art
(MPEP §2141.01)
Pitard anticipates the relevant limitations of claims 13 and 26 in the anticipation rejection above.
Regarding claims 27 and 30, Pitard also teaches that in a preferred embodiment, a block copolymer of the invention comprises hydrophilic blocks comprising polyethylene oxide units and hydrophobic blocks comprising polypropylene oxide units [0041].
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP §2141.02)
Regarding claims 27 and 30, Pitard does not disclose an amphiphilic block copolymer comprised of a polyol of trimethylolpropane and polyoxyethylene or of the formula disclosed by the instant claim 30. However, this deficiency is cured by Kabanov.
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Kabanov teaches a composition for oral delivery that may be administered in combination with a vaccine (col. 21 line 9). The composition may contain an amphiphilic block copolymer of the formula (col. 12 line 45):
in which x, y, and z have values from about 2 to about 800 (col. 13 line 13-15). Kabanov also teaches that pluronics of the same formula, in particular Pluronic F68, has a hydrophobe weight of 1750 and a hydrophobe percentage of 20 (col. 15 line 55). Kabanov also teaches that Pluradot block copolymers are also suitable for inclusion in the composition (col. 13 line 43). Lee teaches that Pluradot polyols are composed of a block copolymer of trimethylolpropane attached to three blocks of polyoxyethylene (col. 7 lines 59-61).
Finding of a Prima Facia Obviousness Rationale and Motivation
(MPEP §2142-2143)
Regarding claims 27 and 30, based on these teachings, it would have been prima facie obvious to one of ordinary skill in the art, at the time the invention was made, to substitute equivalents, each of which is taught by the prior art to be useful for the same purpose (the block copolymer of Pitard and the block copolymers of Kabanov for the purpose of a vaccine adjuvant). See MPEP 2144.06 (II).
Response to Arguments
Applicant's arguments filed 10/27/2025 have been fully considered but they are not persuasive.
On page 7, Applicant argues that Pitard does not disclose or even suggest the method of claim 13 and its dependent claims because Pitard discloses glycosylated tetrafunctional non-ionic amphiphilic block copolymers that may be used as adjuvants in combination with a vaccine. This is not found persuasive. The Examiner respectfully draws attention to MPEP 2111.03 (I), which states: “the transitional term ‘comprising’…is inclusive or open-ended and does not exclude additional, unrecited elements or method steps”. The instant claim 13 uses “comprising” as the transitional phrase and therefore does not exclude the additional elements disclosed by Pitard. Thus, the argument is not persuasive and the rejection is maintained.
On page 8, Applicant argues that the copolymers of the invention exhibit unexpected results in their ability to inhibit a viral load in cells on their own. This is not found persuasive. Please refer to MPEP 716.02 (b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
Differences in results are in fact unexpected and unobvious: The unexpected results detailed in the instant specification amount to a decreased viral load in cells lines infected with the OC43 virus or SARS-CoV-2 virus. However, Pramod et. al. (Medical Hypotheses, available 7/3/2020) teaches that a surfactant-based treatment such as a gargle or inhalation formulation could be useful in the prophylaxis of COVID-19 (pg. 1, Introduction). Pramod teaches that entrapment of viruses by surfactant micelles in a surfactant-based gargle (pg. 1, Surfactant-based prophylaxis against COVID-19) could serve as a mechanism of inactivation. Additionally, an inhaled surfactant could prevent the attachment of the virus through its spike glycoproteins (pg. 3, Surfactant-based prophylaxis against COVID-19). Poloxamer is listed as a potential approved lung-surfactant (pg. 3, Table 1). Therefore, the method embraced by the instant claim 13 is not unexpected or unobvious in view of the teachings of Pramod.
Differences are of both practical and statistical significance: The unexpected results disclosed by the examples in the instant specification amount to a decreased viral load in cells lines infected with the OC43 virus or SARS-CoV-2 virus. All of the data presented are normalized to infected cells with no amphiphilic copolymer or vehicle control and are presented with some statistical analysis with regard to error bars shown in figures 2 and 4-8, but provide no statistical analysis of the significance of the differences between cells treated with no amphiphilic copolymer or vehicle control and the cells that are treated with the amphiphilic copolymer of the invention. Therefore, the differences are of practical but not statistical significance.
Evidence of unexpected properties must be in commensurate scope with the claims: The instant claims embrace a method of inhibiting viral infection and replication of any virus in any subject by utilizing an amphiphilic block copolymer comprising any combination of the hydrophobic and hydrophilic blocks recited in the instant claim 13. The evidence of unexpected properties presented in the instant specification pertain only to the infection of human lung cells to infection with the OC43 or SARS-CoV-2 virus and three different poloxamers and one poloxamine block copolymer. Therefore, the evidence of unexpected properties described in the instant specification are not in commensurate scope with the claims.
Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
On page 8, Applicant argues that Kabanov is similar to Pitard in that Kabanov provides different methods for improving delivery of peptide drugs into a cell and that the co-polymers are to be used in combination with peptide treatments. This is not found persuasive. As described in the obviousness rejection of claim 30 above, Kabanov teaches a composition for oral delivery that may be administered in combination with a vaccine (col. 21 line 9). The composition may contain an amphiphilic block copolymer of the formula embraced by the instant claim 30 (col. 12 line 45). Furthermore, the Examiner respectfully draws attention to MPEP 2111.03 (I), which states: “the transitional term ‘comprising’…is inclusive or open-ended and does not exclude additional, unrecited elements or method steps”. The instant claims 13 and 30 use “comprising” as the transitional phrase and therefore do not exclude the additional elements disclosed by Pitard and Kabanov. Thus, the argument is not persuasive and the rejection is maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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ELIZABETH ANNE MEYERSExaminer, Art Unit 1617
/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617