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 .
DETAILED ACTION
Claims 1-20 are pending.
Receipt and consideration of Applicants' amended claim set and remarks/arguments filed on 01/09/2026 are acknowledged. Claims 1-3 and 9 are amended and new claims 17-20 are added. Claims under consideration in the instant office action are claims 1-20.
Applicants' arguments, filed 01/09/2026, have been fully considered but they are not deemed to be persuasive. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
In the interest of compact prosecution, examiner contacted the applicants with a proposal of the following amendments, applicants preffered that the examiner send out the action.(see the attached interview summary).
Claim 1, Delete picornovirus and prevention, narrow down the list of agents to those which are not already known in the art, add wherein the nidovirus is Coronavirus. Cancel claims 17-20
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 1-16 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated Hsu et al. (US 7,544,712
Instant claims are drawn to a method of treating or preventing a nidovirus or picornavirus infection in a subject, the method comprising administering to a subject in need thereof an effective amount of an active agent of butamben, butylparaben, conivaptan, amphotericin B, pentoxyverine, lapatinib, vilazodone, imatinib (STI57 1), benztropine, raloxifene, solifenacin, retapamulin, bafetinib (INNO-406), imipramine, trimipramine, tolterodine, clomipramine, velpatasvir, cediranib (AZD2171), azolastino, desloratadine, nortriptyline, propafenone, mebeverine, elbasvir, copharanthino, fluponthixol, or a pharmaceutically acceptable salt thereof.
Hsu et al. discloses a method for treating coronavirus infection by administering to a subject in need of the treatment an effective amount of one or more of the following compounds: nortriptyline, Mebeverine and trimipramine among several other drugs (Abstract), They disclose that their mentioned compounds may be used in treating Severe acute respiratory syndrome (SARS-CoV) infections (col.4, lines 19-26). They disclose their compounds to be utilized in salt form such as mebevarine hydrochloride and trimipramine maleate (col. 2 ,line 5). Hsu et al, discloses that the subject is Human (col.3, line 13).
Therefore the method disclosed by Hsu et al. fully anticipates instant claims 1-6.
Claims 1 and 4-8 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated by Ju et al. (WO 2021/155119)
Ju et al. disclose a method for treating a viral infection caused by coronavirus in a human subject afflicted with the infection, comprising administering a therpeuticall y active dose of NS5A inhibitor such as Velpatasvir and Elbasvir among other wherein he NS5A inhibitors inhibit the exonuclease of the coronavirus (page 18, lines 17-27, figure 54). They further disclose methods for the treatment of viral infection caused by SARS-CoV-2, SARS-CoV, MERS-CoV (page 6, lines 11-14)
Therefore the method disclosed by Ju et al. fully anticipates instant claims 1 and 4-8
Claims 1-2 and 4-8 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated Goren et al. (US 2021/0299209)
Instant claims are as recited above.
Goren et al. discloses a method of treatment of COVID-19 (SARS-CoV-2) patient involves administering an anti-androgen to a COVID-19 patient where there anti-androgen is includes solifenacin succinate among others [0102], abstract) where in the subject is human[0079]
Therefore the method disclosed by Goren et al. fully anticipates instant claims 1-2 and 4-8
Claims 1, 3 and 4-16 are rejected under 35 U.S.C. 102 (a) (1) and under 35 U.S.C 102(a)(2) as being anticipated Ostrov et al. (WO 2021/207213)
Instant claims are as recited above.
Ostrov et al. discloses methods of preventing or treating SARS-CoV related beta coronavirus infections by administering (abstract, claims 19-21)a small molecule antiviral drug to the subject, which includes desloratadine (page 7 compound (o))
Therefore the method disclosed by Ostrov et al. fully anticipates instant claims 1, 3 and 4-16.
.Claim Rejections - 35 USC § 112
New Grounds of Rejection
The following is a quotation of the first paragraph of 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.
Newly added claims 17-20 are rejected under 35 U.S.C. 112, first paragraph, because the claims are not enabled for treatment of picornavirus infection with all the different compounds instantly claimed.
As a general rule, enablement must be commensurate with the scope of claim language. MPEP 2164.08 states, “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)” (emphasis added). The “make and use the full scope of the invention without undue experimentation” language was repeated in 2005 in Warner-Lambert Co. v. Teva Pharmaceuticals USA Inc., 75 USPQ2d 1865, and Scripps Research Institute v. Nemerson, 78 USPQ2d 1019 asserts: “A lack of enablement for the full scope of a claim, however, is a legitimate rejection.” The principle was explicitly affirmed more recently in Liebel-Flarsheim Co. v. Medrad, Inc., 481 F.3d 1371, 82 USPQ2d 1113; Auto. Tech. Int’l, Inc. v. BMW of N. Am., Inc., 501 F.3d 1274, 84 USPQ2d 1108 (Fed. Cir. 2007), Monsanto Co. v. Syngenta Seeds, Inc., 503 F.3d 1352, 84 U.S.P.Q.2d 1705 (Fed. Cir. 2007), and Sitrick v. Dreamworks, LLC, 516 F.3d 993, 85 USPQ2d 1826 (Fed. Cir. 2008).
Pursuant to In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988), one considers the following factors to determine whether undue experimentation is required: (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. Some experimentation is not fatal; the issue is whether the amount of experimentation is “undue”; see In re Vaeck, 20 USPQ2d 1438, 1444.
The analysis is as follows:
(1) Breadth of claims
Scope of the diseases covered. The broadest claims cover any picornavirus infection.
The Picornaviruses (single stranded, positive sense) are divided into 9 genus’s: 1. Enteroviruses (Bovine enterovirus, Human enterovirus A (21 types, including some coxsackie A viruses), Human enterovirus B ( 57 types, including assorted enteroviruses, coxsackie B viruses, echoviruses, and swine vesicular disease virus), Human enterovirus C (14 types including some coxsackie A viruses and enteroviruses), Human enterovirus D (2 types), Human enterovirus E Poliovirus (3 types), Porcine enterovirus A Porcine enterovirus B, and Simian enterovirus A(20 types). 2. Rhinoviruses (Human rhinovirus A, Human rhinovirus B). 3. Cardiovirus (Theiler's murine encephalomyellitis virus (TMEV), Vilyuisk human encephalomyelitis virus (VHEV), Theiler-like virus (TLV) of rats, Saffold virus (SAFV-1 and SAFV-2), Columbia SK virus, Maus Elberfeld virus and Mengovirus). 4. Aphthovirus (Foot-and-mouth disease virus (in 10 forms) and Equine rhinitis A virus) 5. Hepatovirus (Hepatitis A virus, avian encephalomyelitis virus). 6. Parechovirus (Human parechovirus (HPeV) 1, HPeV-2, HPeV-3, HPeV-4, HPeV-5, HPeV-6 and Ljungan virus) 7. Erbovirus (equine rhinitis B virus (ERBV) 1, ERBV-2, ERBV-3) 8. Kobuvirus (Aichi virus, bovine kobuvirus) 9. Teschovirus (porcine teschovirus in 11 serotypes). In addition, there are numerous unassigned viruses that are normally placed with the Picronaviruses, including Acid-stable equine picornaviruses, Avian entero-like virus 2, Avian entero-like virus 3, Avian entero-like virus 4, Avian nephritis virus 3, Barramundi virus-1+, Cockatoo entero-like virus, Duck hepatitis virus 1, Duck hepatitis virus 3, Equine rhinovirus 3, Guineafowl transmissible enteritis virus, Harbour seal picorna-like virus, Sea-bass virus-1+, Sikhote-Alyn virus, Smelt virus-1+, Smelt virus-2+, Syr-Daria Valley fever virus, Taura syndrome virus of marine penaeid shrimp, Turbot virus-1, Turkey entero-like virus, Turkey hepatitis virus, Turkey pseudo enterovirus 1, and Turkey pseudo enterovirus 2.
Scope of the compounds covered: The active agent include butamben, butylparaben, conivaptan, amphotericin B, pentoxyverine, Page 3 of 7 lapatinib, vilazodone, imatinib (STI57 1), benztropine, raloxifene, solifenacin, retapamulin, bafetinib (INNO-406), imipramine, trimipramine, tolterodine, clomipramine, velpatasvir, cediranib (AZD2171), desloratadine, nortriptyline, propafenone, mebeverine, elbasvir, cepharanthine, flupenthixol, or a pharmaceutically acceptable salt thereof.
(2) The nature of the invention and predictability in the art:
The invention is drawn to a method treatment of a method of treating or preventing a picornavirus infection in a subject, the method comprising administering to a subject in need thereof an effective amount of an active agent of butamben, butylparaben, conivaptan, amphotericin B, pentoxyverine, Page 3 of 7 lapatinib, vilazodone, imatinib (STI57 1), benztropine, raloxifene, solifenacin, retapamulin, bafetinib (INNO-406), imipramine, trimipramine, tolterodine, clomipramine, velpatasvir, cediranib (AZD2171), desloratadine, nortriptyline, propafenone, mebeverine, elbasvir, cepharanthine, flupenthixol, or a pharmaceutically acceptable salt thereof.. As such the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
(3) Direction or Guidance and presence of working examples:
There is no direction or guidance provided in the disclosure with regards to treatment of any of the picornavirus infections. Instant disclosure does not provide any guidance or examples to demonstrate the activity of any of the agents claimed against any of the picornaviruses.
(4) State of the Prior Art: The state of the prior art is such that it involves screening both in vitro and in vivo to determine which compounds exhibit the desired pharmacological activities (i.e. which compounds treat which specific amyloid associated disease). There is no absolute predictability even in view of the seemingly high level of skill in the art. The existence of these obstacles establishes that the contemporary knowledge in the art would prevent one of ordinary skill in the art from accepting any therapeutic regimen on its face.
The instant claimed invention is highly unpredictable as discussed below:
Picornaviral infections in general encompasses infections caused by different viruses which come under the broad category, including polio, foot and mouth disease ,viral gastroenteritis etc. It is noted, that the various diseases and disorder encompassed by the broad category of picornaviral infections have different causes and, molecular mechanisms which contribute to the final pathology and clinical manifestations of the disease. There is no common mechanism by which all picornaviral diseases arise. Accordingly, treatments for these diseases are normally tailored to the particular type of disease as there is no, and there can be no “magic bullet” against all picornaviral infections or disorders in general. The pathogenesis of these diseases is complex and different. The varied anatomic specificities of each of the disease need to be considered.
Accordingly, the unpredictability of treating any of the picornaviral infections with each and every agent instantly claimed is highly unpredictable.
The pharmacological art requires the screening of potential drug candidates in vitro and in vivo to determine if the drug candidates exhibit the desired pharmacological activities. Typically, this process includes in vitro laboratory screening, preclinical in vivo screening, and three phases of clinical trials. Once this arduous process has been successfully completed by a drug candidate, subsequent drug candidates will benefit from the established proof of concept. The subsequent drug candidates must demonstrate a substantial correlation between their biological activity and that of the known drug candidate.
It is noted in MPEP 2164.03 that 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 in 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 are unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with a specific and useful teaching.’ The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. .” The “predictability or lack thereof” in the art refers to the ability of one skilled in the art to extrapolate the disclosed or known results to the claimed invention. If one skilled in the art can readily anticipate the effect of a change within the subject matter to which the claimed invention pertains, then there is predictability in the art. On the other hand, if one skilled in the art cannot readily anticipate the effect of a change within the subject matter to which that claimed invention pertains, then there is lack of predictability in the art. Accordingly, what is known in the art provides evidence as to the question of predictability. Most often, additional factors, such as the teachings in pertinent references, will be available to substantiate any doubts that the asserted scope of objective enablement is in fact commensurate with the scope of protection sought and to support any demands based thereon for proof. The scope of the required enablement varies inversely with the degree of predictability involved, but even in unpredictable arts, a disclosure of every operable species is not required, 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) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). This is because it is not obvious from the disclosure of one species, what other species will work.
(6) The quantity of experimentation needed:
Especially in view of the above this is expected to be quite high. Generally speaking, the amount of experimentation to transform a molecule into medicine is vast and the success thereof is low and in the instant case, with the high unpredictability in the art and the limited guidance and examples provided by the applicant, the quantity of experimentation is very high.
Conclusion:
Thus, the specification fails to provide clear and convincing evidence in sufficient support for practicing the invention as claimed. Thus, factors such as “sufficient working examples” “guidance’ and “predictability”, etc. have been demonstrated to be sufficiently lacking in the instantly claimed methods. In view of the breadth of the claims, the chemical nature of the invention, the level of unpredictability one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the invention commensurate with the scope of the claims.
Genentech, 108 F.3d at 1366, states that “a patent is not a hunting license. It is not a reward for search, but compensation for its successful conclusion” and “[p]atent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable”.
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here.
Therefore, in view of the Wands factors discussed above, to practice the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation to test which diseases can be treated by which compound encompasses in the instant claims, with no assurance of success. Thus, rejection of claims 17-20 under 35 U.S.C. §112, first paragraph, is deemed proper.
Conclusion
Claims 1-20 are rejected. 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAVITHA RAO whose telephone number is (571)270-5315. The examiner can normally be reached on Mon-Fri 7.00 am to 4.00 pm. If attempts to reach the examiner by telephone are unsuccessful, the examiner' s supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAVITHA M RAO/ Primary Examiner, Art Unit 1691