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 January 2, 2026.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 15-19) in the reply filed on January 2, 2026, is acknowledged.
Applicant election of ketotifen as the mast cell stabilizer is also acknowledged.
Status of Claims
Claims 15-36 are currently pending and are the subject of this office action.
Claim 20-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 2, 2026.
Claims 15-19 are under examination.
Priority
The present application is a 371 of PCT/SG2021/050295 filed on 05/27/2021 and claims priority to foreign application No. SG10202007071Q filed on 07/23/2020.
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 15-19 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 treatment of a coronavirus disease, does not reasonably provide enablement for the prevention of a coronavirus disease. 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. This is a scope of 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 15-19 recite:
A method for prophylaxis or treating a coronavirus disease comprising the administration of a composition comprising a mast cell stabilizer and/or a inhibitor of mast cell products.
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
First, the term prophylaxis is synonymous of prevention, which is synonymous with the term curing, and both circumscribe methods of treatment having absolute success (100% success). Humans in need of prevention of a coronavirus-induced disease do not yet suffer from a coronavirus-induced disease, and if they were to be administer a mast cell stabilizer and/or inhibitor of mast cell products according to the instant claims, they will never ever suffer from a coronavirus-induced disease. The general knowledge of the prior art clearly indicates that the art of preventing any diseases including coronavirus-induced disease, is highly unpredictable.
Second, an extensive search of the prior art reveals that there are no references disclosing any type of prevention of coronavirus-induced disease with any drug.
4. The breadth of the claims
The breadth of the claims is not commensurate in scope with the disclosure.
The instant claims recite a broad spectrum of coronavirus-induced diseases like: SARS-CoV, SARS-Cov-2 and MERS-CoV.
Further the claims recite a broad number of mast cell stabilizers and inhibitors of mast cell products (see for example instant claim 17).
5. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 cites: “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 is 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. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.”
The specification teaches some examples (see Example 1) that correlate with the administration of very specific mast cell stabilizers and inhibitors of mast cell products with the treatment of coronavirus-induced disease.
Thus, while the specification provides a procedure for treating coronavirus-induced disease, the specification appears to be silent on a nexus between:
treating a coronavirus-induced disease and preventing a coronavirus-induced disease.
As such, if there is no correlation then the examples do not constitute working examples.
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 prevention (100% success) coronavirus-induced diseases, is required for practice of the claimed invention.
6. 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 5), the skilled in the art will not accept that the administration of a composition comprising mast cell stabilizers and inhibitors of mast cell products, can prevent (100% success) coronavirus-induced diseases as inferred by the claims and contemplated by the specification.
7. Conclusion
Accordingly, the inventions of claims 15-19 do not comply with the scope of 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.
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)(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.
Claim(s) 15-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Elmaleh et. al. (US 2023/0149345).
For claims 15-18, Elmaleh teaches a method of treating a coronavirus infection comprising the administration of a compound of formula (I):
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90
264
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(see abstract)
wherein the compound of formula (I) can be the mast cell stabilizer cromolyn (R1 = OH and R2 = R3 = -COOH) (see [0026], [0046], [0051]-[0054], see two structures on page 15, paragraph [0178] and [0181]) and wherein the additional mast cell stabilizer can be ketotifen (see [0231], see also claims 63-64), wherein the coronavirus can be: SARS-CoV, SARS-CoV-2 or MERS-CoV (see [0205]-[0206] and claims 38-39).
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.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Elmaleh et. al. (US 2023/0149345).
Elmaleh teaches all the limitations of claim 19, except for the amounts of cromolyn and/or ketotifen administered. However, Elmaleh teaches the administration of about 10 mg/kg/day (see [0163]) which for an 80 kg adult will be the equivalent of 800 mg/day which anticipates the claimed amount of cromolyn (200 mg x 4 per day = 800 mg/day).
Before the effective filing date, it would have been prima facie obvious to administer 800 mg/day of cromolyn as anticipated by Elmaleh, thus resulting in the practice of claim 19 with a 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
January 21, 2026.
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