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
This office action is in response to applicant’s reply filed on July 21, 2025.
Restrictions/Elections
Applicant’s election without traverse of Group I (Claims 1-13) in the reply filed on July 21, 2025, is acknowledged.
Status of Claims
Claims 1-20 are currently pending and are the subject of this office action.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 21, 2025.
Claims 1-13 are presently under examination.
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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 1-13 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This is an enablement rejection.
To be enabling, the specification of the patent application 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 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 1-13 recite a method of treating COVID-19 infection, comprising administering an antagonist of tlr-7-signaling to a subject in need thereof, wherein the antagonist of tlr-7-signaling is to be administered after seroconversion, and wherein the tlr-7 antagonist is selected from the group consisting of: chloroquine and hydroxychloroquine among others.
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D. The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
As illustrative of the state of the art regarding the treatment of COVID-19 with itlr-7 antagonists, the Examiner refers to: NIH COVID-19 Treatment Guidelines (August 27, 2020) at: https://web.archive.org/web/20200828170647/https://www.covid19treatmentguidelines.nih.gov/antiviral-therapy/chloroquine-or-hydroxychloroquine-with-or-without-azithromycin/
and
Schilling et. al. (Expert Opinion on Pharmacotherapy (2021) 22:1257-1266).
The NIH reference teaches that, even though hydroxychloroquine demonstrated antiviral activity in vitro, it did not reduce upper or lower respiratory trac viral loads or demonstrate clinical efficacy in rhesus macaque model. Also, in a large randomized controlled trial of hospitalized patients in the UK, hydroxychloroquine did not decrease 28-day mortality when compared to the usual standard of care. Participants who were randomized to receive hydroxychloroquine had a longer median hospital stay than those who received the standard care. In addition, among patients who were not on invasive mechanical ventilation at the time of randomization, those who received hydroxychloroquine were more likely to subsequently require intubation or die during hospitalization than those who received standard care. The reference concludes: ”given the lack of benefit seen in the randomized clinical trials and the potential toxicity, the Panel recommends against using hydroxychloroquine or chloroquine to treat COVID-19 in hospitalized patients”
Schilling, like the NIH reference teaches: “In hospitalized patients with severe COVID-19, Randomized Clinical Trials show clearly that 4-aminoquinolines are NOT beneficial” (see abstract).
In summary, the references teach, that contrary to Applicant’s assertions/claims, that the tlr-7 antagonists: chloroquine and hydroxychloroquine not only do not show efficacy in treating COVID-19, but the opposite is true: it was detrimental when compared with standard care.
4. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 states: “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. 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) (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”.
The specification does not provide a single example in vivo that shows any efficacy in the treatment of COVID-19 comprising the administration of tlr-7 antagonists to subjects in need thereof. Example 5 is a prophetic example with no experimental results.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the treatment or alleviation of COVID-19 comprising the administration of a composition comprising tlr-7 antagonists like chloroquine or hydroxychloroquine, is required for practice of the claimed invention, particularly when the prior art clearly teaches opposite results to the instantly claimed ones (see section 3).
5. The quantity of experimentation necessary
Because of the known unpredictability of the art (see section 3) and in the absence of experimental evidence commensurate with the claims (see section 4), the skilled in the art will not accept that the administration of comprising tlr-7 antagonists like chloroquine or hydroxychloroquine will be effective in treating COVID-19 in vivo as inferred by the claims and contemplated by the specification, because neither the prior art nor the specification disclose a single example in vivo that shows efficacy in the treatment of COVID-19 in a subject comprising the administration of the tlr-7 antagonists like chloroquine or hydroxychloroquine. In fact, as mentioned above, the prior art teaches exactly the opposite since the administration of the tlr-7 antagonists like chloroquine or hydroxychloroquine seems to be counterproductive.
.
6. Conclusion
Accordingly, the inventions of claims 1-13 do not comply with the enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention, a person of ordinary skill in the art would have to engage in undue experimentation with no reasonable expectation of success.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 30, 2025.