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 March 5, 2026.
Status of Claims
Claims 1-3, 9, 11, 13, 16-19, 21, 23, 25, 28, 30, 33, 36-37, 41 and 46 are currently pending and are the subject of this office action.
Claims 17-19, 21, 23, 25, 28, 30, 33, 36-37, 41 and 46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 September 18, 2025.
Claims 1-3, 9, 11, 13 and 16 are presently under examination as they relate to SARS CoV-2.
Priority
The present application is a 371 of PCT/US2021/038917 filed on 06/24/2021 and claims priority to provisional application No. 63/043,261 filed on 06/24/2020.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (Maintained Rejection)
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 1-3, 9, 11, 13 and 16 stand 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 1-3, 9, 11, 13 and 16 recite a method of treating and/or preventing a cytokine storm in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising an effective amount of gemcabene, wherein the cytokine storm is caused by or derived from the SARS CoV-2 virus (COVID-19).
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
A search of the literature revealed that although gemcabene is a well-known drug that is effective to treat vascular diseases (see Bisgaier et. al. (US 5,648,387), there is absolutely no association between gemcabene and the treatment of cytokine storms of any origin, much less of viral origin, or the treatment of viral infections, much less of COVID-19.
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Gemcabene
Regarding the treatment of COVID-19, Tao et. al. (Expert Opinion on Emerging Drugs (2020) 25:81-88) teach a few drugs in clinical trials, none of which encompasses gemcabene or similar structures. The authors conclude that: “there is no specific drug to treat COVID-19 up to date” (see page 87 under 4. Conclusions and expert opinion). Nascimento Junior et. al. (Expert Opinion on Therapeutic Patents (2020) 30:567-579) teach 62 treatments against SARS-CoV-2, distributed in different categories: like anti-viral growth, anti-inflammatory drugs, etc., none of which encompass gemcabene (see page 575, right column last complete paragraph).
Regarding the treatment of cytokine storm caused by COVID-19, Pearce et. al. (Expert Opinion on Therapeutic Targets (2020) 24:723-730) teach that “there has been a rush to treat pre-exiting immune modulating therapies, used in the treatment of chronic inflammatory conditions” (see first sentence under topic 4. New frontiers in cytokine suppression). They also teach anti-viral agents like remdesivir, hydroxychloroquine/chloroquine and arbidol (see first paragraph under topic 4. New frontiers in cytokine suppression). They also mention the IL-6 receptor blocker Tocilizumab (TCZ) (see first sentence of second paragraph under topic 4. New frontiers in cytokine suppression), the JAK/STAT pathway (see first sentence of fourth paragraph under topic 4. New frontiers in cytokine suppression), PPARs, sphingosine receptor modulator agonists (S1P1) and COX inhibitors (see first sentence of fifth paragraph under topic 4. New frontiers in cytokine suppression). None of the above categories encompass gemcabene.
Further, there are no examples in the prior art of preventing a viral infection caused by SARS CoV-2. Preventing is synonymous of 100% success, meaning that the administration of gemcabene to an individual not yet suffering from a viral infection caused by SARS CoV-2 will never get infected.
Finally, the specification states (see paragraph [0040]):
“The term “treat” or “treatment” refers to both therapeutic treatment and prophylactic or preventative measures, wherein the object is to prevent or slow down (lessen) an undesired physiological change or disorder, such as inflammation. For purposes of this disclosure, beneficial or desired clinical results include, but are not limited to, alleviation of symptoms, diminishment of extent of disease, stabilized (i.e., not worsening) state of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, and remission (whether partial or total), whether detectable or undetectable. “Treatment” can also mean prolonging survival as compared to expected survival if not receiving treatment. Those in need of treatment include those already with the condition or disorder as well as those prone to have the condition or disorder or those in which the condition or disorder is to be prevented.”
In other words, the term “treating” in claim 1 encompass “prevention”, as such the term “treating” should be replaced with “therapeutically treating”.
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 provides two prophetic examples regarding the effect of gemcabene in patients suffering from COVID-19. There is no real experimental data either in vitro or in vivo showing any correlation between the administration of gemcabene and the efficacy in treating COVID-19 or a cytokine storm caused by COVID-19.
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 of cytokine storms caused by COVID-19, is required for practice of the claimed invention.
Finally, there are no examples of preventing any viral infection.
5. The quantity of experimentation necessary
As discussed above (see: 3. the state and predictability of the art), there is absolutely no data correlating the administration of gemcabene and the efficacy in treating a cytokine storm caused by COVID-19. Based on this, and in the absence of experimental evidence commensurate in scope with the claims (see: 4. The amount of direction or guidance and the presence or absence of working examples above), the skilled in the art will not accept that gemcabene will be effective in treating or preventing any cytokine storm generated by COVID-19 as inferred by the claims and contemplated by the specification because neither the prior art nor the specification disclose a single example that correlates gemcabene with the efficacy in treating or preventing cytokine storms caused by COVID-19.
So, determining if gemcabene, will be effective in treating or preventing cytokine storms caused by COVID-19, will require assaying gemcabene in an assay that correlates with the treatment of cytokine storms caused by COVID-19, and then further determine their efficacy in a validated animal model.
All this is undue experimentation given the limited guidance and direction provided by Applicants.
6. Conclusion
Accordingly, the inventions of claims 1-3, 9, 11, 13 and 16 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 assurance of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Even though gemcabene might lower CRP, the fact is that there is no evidence that lowering CRP might be effective in treating inflammation and/or a cytokine storm. Admittedly, CRP is a biomarker for inflammation, in other words, high levels of CRP are an indication of inflammation. However, there is no evidence that lowering CRP might reduce inflammation and/or cytokine storm. The fact that CRP is a biomarker for inflammation does not mean that lowering CRP might have any influence on inflammation. CRP is a consequence of inflammation, not a causation, in other words, CRP increases in response to inflammation. In fact, a search of the literature shows that there is no correlation between lowering CRP and treating inflammation and/or cytokine storm.
Further, and as stated in the above rejection, there is no correlation between Gemcabene and the treatment of any type of inflammation and/or cytokine storm.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 mailing date of this final action.
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
March 12, 2026.
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