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 .
In view of the Appeal Brief filed on 18 August 2025, PROSECUTION IS HEREBY REOPENED. New grounds of rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/BRIAN-YONG S KWON/ Supervisory Patent Examiner, Art Unit 1613
Priority
The instant application was filed on 22 November 2021. Acknowledgement is made to
provisional application no. 63/116,237 filed on 20 November 2020. The effective filing date of
the instant application is therefore 20 November 2020.
Examiner’s Note
Applicant's amendments and/or arguments filed 18 August 2025 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. 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and/or objections not reiterated from previous office actions are hereby withdrawn.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 Applicant’s Appeal Brief, filed 18 August 2025, it is noted that there are no new amendments or claims since the claim set filed 27 February 2025. No new matter has been added.
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.
Claim(s) 1, 4, 6, 8, 12, 13, 15-17, 21-24, 27-32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glick (US 10980756 B1), Desbarats (US 20170128486 A1) and Nuckchady (Hyperpyrexia and metabolic alkalosis in a COVID-19 patient, Journal of Medical Virology, 2020). and further in view of Eastalabamahealth.com, Baker (Repurposing Quaternary Ammonium Compounds as Potential Treatments for COVID-19, 2020), and Kiassos (US 8840934 B2).
Glick teaches methods of treating COVID-19 in a subject in need (entire teaching, abs) by administering a composition that may include a lysosomotropic agent such as ammonium chloride (col. 29, lns. 46-50), a disintegrant such as 0.5-5% (col. 75, lns. 51-57) of sodium croscarmellose, a thickener such as 0.05-55% (col. 77, lns. 65-67) of hydroxypropyl methylcellulose (col. 73, ln. 11), an additive ingredient such as vitamin D2 or D3 (col. 56, ln. 32), and a lubricant such as 0.05-1% (col. 76, lns. 1-8) of magnesium stearate (col. 74, lns. 5-14), addressing claims 8 and 13. The composition may be in an oral delivery form (interpreted as a unit dosage form) with an enteric coating, such as a capsule (col. 70, lns, 2-5) or timed-release capsules, extended-release tablets, immediate release tablets/capsules, delayed release tablets (interpreted as sustained release) (col. 71, lns. 46-55), microspheres (col. 71, ln. 17), or topical administration to the skin (col. 80, lns. 26-29), addressing claims 4, 6, 15-17, 21, 23, 24, 27, and partially claim 1. Glick describe a method of measuring the level of SARS-CoV-2 RNA in a subject throughout treatment given (col. 20, ln. 58-col. 22, ln. 14), addressing claim 12. Treating the disease includes curing the viral disorder, reducing viral shedding, or decreasing viral RNA load (col. 14, lns. 43-58), which is interpreted as measuring the viral load until the viral disorder is cured, addressing claim 31. Glick teaches that the active compounds and excipients in the composition may be delivered to different parts of the GI tract, such as the small intestine (col. 11, ln. 38-48). Since the composition may be a delayed release formulation, the capsule is interpreted as sustained release of the active component in the small intestine, addressing claim 28. The composition may also include compounds that protect and limit the irritation of the GI tract (col. 70, lns. 29-44), which is interpreted as mitigating gastric side effects, addressing claim 30. Glick’s method further includes using reverse transcription PCR to monitor the viral load of a subject with COVID-19 (col. 20, lns. 58-60 and claim 9), addressing claim 29.
Glick does not teach specific amounts of ammonium chloride and vitamin D. Glick also does not teach a method of measuring the blood pH or administering the formulation so that the subject is not exhibiting alkalosis or acidosis, or administrating the formulation until antibodies are detected.
Desbarats teaches a composition that may comprise 30-120 mg/g of ammonium chloride (para. 121) and magnesium stearate (para. 127) in a suitable dosage (para. 15), and may be incorporated into a capsule (para. 18). The composition also includes components useful for treating and preventing alkalosis (para. 72). Treating and preventing in this context refers to maintaining blood pH in a range of 7.35 to 7.45 (para. 61). Successfully keeping the blood pH in this desired range is also interpreted as the subject not experiencing alkalosis or acidosis. The limitation of monitoring the blood pH is obvious based on the process of maintaining the pH, and a skilled artisan would understand that monitoring is performed as a result of maintaining the pH. The composition may further comprise vitamin D in an amount of 20 μg/L to 40 μg/L, which falls in the range of 1000-4000 IU (25-100 μg). The dosages and effective amounts of the compounds will depend on different factors and the subject’s blood parameters (para. 141). Therefore, it is interpreted that one of ordinary skill in the art will be able to decide an effective concentration of lysosomotropic agent, addressing claim 32.
Nuckchady teaches that acidosis and alkalosis may be experienced in a patient infected with SARS-CoV-2.
Baker teaches that ammonium chloride is known in the art to treat metabolic acidosis and is also a known treatment for coronavirus (Table 1), and Kiassos teaches that ammonium chloride is known in the art to treat metabolic alkalosis (col. 2, lns. 50-55).
Eastalabamahealth.org teaches that antibody tests are commonly used to detect past infection of COVID (pg. 2). A skilled artisan would be able to administer the correct test, such as a PCR test or antibody test, as both the viral load and antibody tests are used for essentially determining whether or not a treatment has been effective.
In regards to the lysosomotropic agent interfering with uncoating, providing a viral-static effect, and allowing immunological mechanisms of the subject to product antibodies against the virus, these limitations in claim 1 are interpreted as inherent properties of ammonium chloride. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). The U.S. Patent Office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the exact same ingredients and applicant's own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise.
In regards to the amount of vitamin D, ammonium chloride, sodium croscarmellose, hydroxypropyl methylcellulose, magnesium stearate in claims 13 and 15, Glick teaches 0.5-5% of sodium croscarmellose, 0.05-55% of hydroxypropyl methylcellulose, and 0.05-1% of magnesium stearate. Desbarats teaches 30-120 mg/g of ammonium chloride and vitamin D in an amount of 20 μg/L to 40 μg/L in their composition. Therefore, the optimum or workable range of concentration or amounts can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts or concentration of components as nonobvious.
In regards to selecting a combination of vitamin D, ammonium chloride, sodium croscarmellose, hydroxypropyl methylcellulose, magnesium stearate, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of
obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out
precise teachings directed to the specific subject matter of the challenged claim, for a court can
take account of the inferences and creative steps that a person of ordinary skill in the art would
employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of
ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various
combination of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Glick teaches an oral or topical composition and method for treating COVID-19 using ammonium chloride. The claimed invention is directed towards methods and compositions comprising administering ammonium chloride as a lysosomotropic agent to treat SARS-CoV-2 virus. Since Glick teaches the individual components of ammonium chloride as a lysosomotropic agent, vitamin D, sodium croscarmellose, hydroxypropyl methylcellulose, and magnesium stearate that may be in the form of a capsule or microsphere for topical or oral administration, it is obvious for one of ordinary skill in the art to pick and choose the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
Since Glick does not teach a method of measuring the blood pH or administering the formulation so that the subject is not exhibiting alkalosis/acidosis or a step of antibody testing in claims 1 and 21-23, one of ordinary skill in the art would have been motivated to ammonium chloride to treat and prevent alkalosis and maintain blood pH from Desbarats, he teaching that acidosis and alkalosis may be experienced in SARS-CoV-2 patients from Nuckchady, the known treatment of ammonium chloride to treat acidosis, and the use of antibody tests to check for antibodies during COVID-19 infection from Eastalabamahealth.org to address the deficiencies in Glick’s teachings to arrive at the claimed method with a reasonable expectation of success.
Response to Arguments
Applicant's arguments filed 18 August 2025 have been fully considered but they are not persuasive.
The Applicant argues that the references do not teach the claimed method steps for treating viral infections and that there is no reason to modify the art to get to the claimed invention (Appeal Brief, pgs. 8-12).
Applicant’s argument is not found persuasive. The method steps taught by the prior art are addressed in the following way. Glick teaches administering a composition comprising a lysosomotropic agent (ammonium chloride) to a subject to treat COVID-19, where the composition includes an enteric coating and in a sustained release form (col. 70, lns. 2-5 and col. 71, lns. 46-55). Interfering with coating, providing viral-static effect, and allowing immunological mechanisms are inherent properties of ammonium chloride. Desbarats teaches maintaining blood pH in a certain range to prevent alkalosis or acidosis, as well as adjusting the pH to 7.35-7.45 (para. 61). The limitation of monitoring is obvious to a skilled artisan based on the action of maintaining the pH. Nuckchady is evidence that acidosis and alkalosis are conditions known to be experienced in covid/SARS-CoV-2, where it is known in the art that ammonium chloride is used to treat acidosis/alkalosis (Baker, table 1 and Kiassos, col. 2, lns. 50-55). Eastalabamahealth.org teaches that antibodies tests are commonly used to detect past infection of COVID-19, where a skilled artisan would be able to administer the correct test during treatment in a subject with COVID, as both the viral load and antibody tests are used for essentially determining whether or not the treatment is effective.
The Applicant argues that Glick only describes general treatment concepts without teaching specific steps for monitoring and adjusting treatment (Appeal Brief, pgs. 12-14).
Applicant’s argument is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed above, Glick’s teaching is for administering a composition comprising ammonium chloride to treat COVID-19. Desbarats teaches maintaining blood pH in a certain range to prevent alkalosis or acidosis, as well as adjusting the pH to 7.35-7.45 (para. 61). The limitation of monitoring is obvious to a skilled artisan based on the action of maintaining the pH.
The Applicant argues that one would need to select ammonium chloride out of a long list of options (Appeal Brief, pgs. 12-13).
Applicant’s argument is not found persuasive. It is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands. Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985).
The Applicant argues that Glick requires niclosamide (Appeal Brief, pg. 13).
Applicant’s argument is not found persuasive. The inclusion of niclosamide is allowed based on the Applicant’s open language used in the claims.
The Applicant argues that Glick does not teach monitoring and changing the pH (Appeal Brief, pgs. 13-14).
Applicant’s argument is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed above, Glick’s teaching is for administering a composition comprising ammonium chloride to treat COVID-19. Desbarats teaches maintaining blood pH in a certain range to prevent alkalosis or acidosis, as well as adjusting the pH to 7.35-7.45 (para. 61). The limitation of monitoring is obvious to a skilled artisan based on the action of maintaining the pH.
The Applicant argues that Desbarats only teaches compositions for treating motion sickness and altitude-related conditions and not a method for treating viral infections (Appeal Brief, pgs. 14-15).
Applicant’s argument is not found persuasive. Desbarats teaches an antiviral effect with their composition (para. 87). Alkalosis and acidosis are conditions that are also experience in non-viral infection-related illnesses, such as motion sickness, as well as viral infections (taught by Nuckchady).
The Applicant argues that Desbarats does not disclose a method of administration, monitoring, or adjusting the treatment (Appeal Brief, pg. 15).
Applicant’s argument is not found persuasive. Glick teaches a composition and method of administration to treat COVID-19 using ammonium chloride. Desbarats teaches maintaining blood pH in a certain range to prevent alkalosis or acidosis, as well as adjusting the pH to 7.35-7.45 (para. 61). The limitation of monitoring is obvious to a skilled artisan based on the action of maintaining the pH, and the process of adjusting the treatment is implied in order to maintain the blood pH within a certain range.
The Applicant argues that Nuckchady does not teach actively monitoring or adjusting the pH during treatment (Appeal Brief, pgs. 15-16).
Applicant’s argument is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Nuckchady’s teaching is to show that alkalosis and acidosis are experienced in patients infected with COVID-19. Desbarats’ teaching is used to monitor and maintain the blood pH in a patient experiencing alkalosis or acidosis.
The Applicant argues that there is no reason to combine the references (Appeal Brief, pgs. 16-20).
Applicant’s argument is not found persuasive. As discussed above, since Glick does not teach a method of measuring the blood pH or administering the formulation so that the subject is not exhibiting alkalosis/acidosis or a step of antibody testing in claims 1 and 21-23, one of ordinary skill in the art would have been motivated to ammonium chloride to treat and prevent alkalosis and maintain blood pH from Desbarats, he teaching that acidosis and alkalosis may be experienced in SARS-CoV-2 patients from Nuckchady, the known treatment of ammonium chloride to treat acidosis, and the use of antibody tests to check for antibodies during COVID-19 infection from Eastalabamahealth.org to address the deficiencies in Glick’s teachings to arrive at the claimed method with a reasonable expectation of success.
The Applicant argues that Eastalabamahealth.org describes antibody testing as a retrospective diagnostic tool to confirm past infection, not as a treatment monitoring mechanism (Appeal Brief, pg. 18).
Applicant’s argument is not found persuasive. As discussed above, Eastalabamahealth.org teaches that antibody tests are commonly used to detect past infection of COVID (pg. 2). A skilled artisan would be able to administer the correct test, such as a PCR test or antibody test, as both the viral load and antibody tests are used for essentially determining whether or not a treatment has been effective.
The Applicant argues that the rejections are premised on improper hindsight and that there is no reason to combine the teachings (Appeal Brief, pgs. 20-23).
Applicant’s argument is not found persuasive. In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to the Applicant’s argument about no reason to combine the teachings, since Glick does not teach a method of measuring the blood pH or administering the formulation so that the subject is not exhibiting alkalosis/acidosis or a step of antibody testing in claims 1 and 21-23, one of ordinary skill in the art would have been motivated to ammonium chloride to treat and prevent alkalosis and maintain blood pH from Desbarats, he teaching that acidosis and alkalosis may be experienced in SARS-CoV-2 patients from Nuckchady, the known treatment of ammonium chloride to treat acidosis, and the use of antibody tests to check for antibodies during COVID-19 infection from Eastalabamahealth.org to address the deficiencies in Glick’s teachings to arrive at the claimed method with a reasonable expectation of success.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613