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 Arguments and Amendment filed, 08/10/2026, wherein the Amendment canceled claims 30-33, 35, 37, 40, and 47, and amended claims 34, 36, 38, 41, 42, 46, and 48-49.
Claims 34, 36, 38, 41-46, and 48-52 are pending.
Note: Claims 41 and 42 depend from claim 46 and precede claim 46, which is improper. See MPEP 608.01(n)(III). If the claims are allowed, the claims will be re-numbered so that claims 41 and 42 succeed claim 46.
Priority
This application claims the following priority:
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Election/Restrictions
Applicant elected Group I, the method of treating an airborne illness, and the species coronavirus as the airborne viral infection and spray as the form of the composition, in the reply filed on 10/17/2025.
Claims 43-45, and 50-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and subject matter, there being no allowable generic or linking claim.
Claims 34, 36, 38, 41-42, 46, and 48-49 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Abstract Objections
Applicant’s amendment to the abstract is sufficient to overcome this objection.
Specification Objections
Applicant’s amendment to the specification is sufficient to overcome this objection.
35 U.S.C. § 112(b)
Applicant’s deletion of claim 31, and amendments to claims 34, 36, 41-42, 46, and 49 are sufficient to overcome these rejections.
35 U.S.C. § 102 over Haide
Applicant’s deletion of claims 30 and 32 is sufficient to overcome this rejection.
REJECTIONS—MAINTAINED, MODIFIED, & NEW
Claim Objections
(New) Claims 34, 36, 41, 46, and 49 are objected to because of the following informalities:
-For grammatical clarity, in claim 34, “A method of treatment, prophylactic treatment or amelioration of an airborne viral infection in a subject, or a method of reducing or preventing viral replication in a subject infected with an airborne virus or exposed to an airborne virus capable of causing an airborne viral infection in the subject” should be replaced with - -A method of treating, prophylactically treating, or ameliorating an airborne viral infection in a subject; a method of reducing or preventing viral replication in a subject infected with an airborne virus capable of causing an airborne viral infection; or a method of reducing or preventing viral replication in a subject exposed to an airborne virus capable of causing an airborne viral infection- -.
-Claim 34 recites “hydrogen carbonate ions or acetate ions” as part “(ii)” of the claim. However, claim 36, which depends from claim 34, recites “from 21 to 35 mmoles/L hydrogen carbonate ions or acetate ions” as part “(iii)” of the claim. For continuity and clarity of the claims, the Roman numerals should consistently reference the same components of the composition. As such, claim 36 should be amended to recite “from 21 to 35 mmoles/L hydrogen carbonate ions or acetate ions” as part “(ii)” of the claim.
Similarly in claims 41, 42, and 46, claim 41 should be amended to recite “from 21 to 30 mmoles/L hydrogen carbonate ions or acetate ions” as part “(ii)” of the claim and to recite “from 0.1 to 200µmoles/L zinc ions” as part “(iii)” of the claim; and claim 42 should be amended to recites; “from 1 to 100µmoles/L transferrin” and “from 1 to 100µmoles/L iron ions” in part (iii) of the claim.
-For grammatical clarity, in claim 46, “A method of treatment, prophylactic treatment or amelioration of an airborne viral infection in a subject, or a method of reducing or preventing viral replication in a subject infected with an airborne virus or exposed to an airborne virus capable of causing an airborne viral infection in the subject” should be replaced with - -A method of treating, prophylactically treating, or ameliorating an airborne viral infection in a subject; a method of reducing or preventing viral replication in a subject infected with an airborne virus capable of causing an airborne viral infection; or a method of reducing or preventing viral replication in a subject exposed to an airborne virus capable of causing an airborne viral infection- -.
-For grammatical clarity in claim 49, the first 5 lines of the claim should be amended to recite - -A method of reducing the risk of viral infection with an airborne virus in a subject, the method comprising a) applying a composition to a mask or other face covering, b) bubbling an oxygen-containing gas through a composition prior to inhalation of the gas by the subject, or c) diffusing or spraying a composition into the air prior to inhalation of the air by the subject- -
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
(New) Claims 38 and 48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
-In claims 38 and 48, the parentheses following “Varicella-Zoster virus” and “Epstein-Barr virus” render the claims indefinite. It is not clear if “VZV or HHV-3” and “EBV or HHV-4” are specific species of the Varicella-Zoster virus and the Epstein Barr virus, and are thus further limitations of the claims, or if VZV or HHV-3” and “EBV or HHV-4” are merely exemplary species of the Varicella-Zoster virus and the Epstein Barr virus.
In view of compact prosecution, for the purpose of applying prior art, “VZV” and “EBV” are interpreted as acronyms of Varicella-Zoster virus and Epstein Barr virus, and “HHV-3” and “HHV-4” are interpreted as merely exemplary of Varicella-Zoster virus and Epstein-Barr virus, and as not further limiting the claims.
Deleting “HHV-3” and “HHV-4” in the parenthetical recitations will overcome this rejection.
Claim Rejections - 35 USC § 112(a)-Scope of Enablement
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.
(Modified) Claims 34, 36, 38, 41-42, 46 and 48 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 a method of treating coronavirus, influenza, or rhinovirus by administering an aqueous buffer solution comprising N,N-bis(2-hydroxyethyl)-2-amino-ethanesulphonic acid (BES) or phosphate buffer, and CaCl2, MgCl2, NaHCO3, KCl, and NaCl, and having a pH of 6.7-7.9 at a temperature of 37 °C, does not reasonably provide enablement for:
a)
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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.
The criteria for enablement set out in the In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the Claims
Instant independent claims 34 and 46 encompass a method of treating, prophylactically treating, i.e., preventing, or ameliorating any infection caused by any coronavirus, any influenza virus, any rhinovirus, any Measles virus, any Mumps virus, any Rubella virus, any human respiratory syncytial virus, any Parvovirus B19, any adenovirus, any adeno-associated virus, any herpes virus, any polyomavirus, or any variola virus, by administering:
a)
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, or
b)
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.
As such, the breadth of the claims is great.
Level of Skill in Art
The level of skill in the art is a clinical or a scientist with a PhD.
State of the Prior Art
WO2017/212422 to Church (IDS of 12/29/2022) teaches a method for treating or preventing viral infections in a mammalian subject by administering an aqueous composition buffered to approximately neutral pH comprising a therapeutically effective amount of at least one pharmaceutically acceptable carbomer (pg. 59, claim 1).
Church specifically exemplifies its compositions as comprising carbomer 980 in a phosphate buffered solution (pg. 38), and as effective for the treatment of rhinovirus, influenza, and coronavirus (pgs. 40-50).
CN1451388 to Haide (Translation, PTO-892) teaches a method of treating a viral infection such as SARS by administering a composition comprising a phosphate buffer (0.01mol/L to a total of 1000-2000ml) having a pH value of 4-8 (Abstract; Claim 1, Translation).
WO 96/12470 to Scheele (IDS of 12/29/2022) teaches a method for treating the symptoms of a pulmonary condition involving insufficient secretion of surfactant by alveolar cells, by administering a pH-raising buffer (pg. 26, claim 1), wherein the typical target pH is 7-8 (pg. 4, lines 3-17).
Scheele teaches viral pneumonia as a pulmonary condition (pgs. 27-28, claim 17).
Scheele teaches the buffer as comprising bicarbonate ion, and specifically sodium bicarbonate or potassium bicarbonate (pg. 26, claims 7-8).
Thus, the prior art teaches phosphate buffer compositions at approximately neutral pH for the treatment of specific airborne viruses, i.e., rhinovirus, coronavirus, influenza, and viral pneumonia. The prior art does not teach the prevention of airborne viruses.
Predictability in the Art
Tompa (Trends and strategies to combat viral infections: A review on FDA approved antiviral drugs, International Jn. of Biological Macromolecules, published 2021, PTO-892) teaches that infections by viruses in humans causes millions of deaths around the globe (pg. 525, Col. 1). Tompa teaches that the infection process varies among viral species (pg. 525, Col. 1).
Tompa teaches drugs approved by the USFDA for treatment of viral infections. The viral infections with FDA approved drugs are HIV, Hepatitis C, Hepatitis B, Influenza, Herpes simplex virus, HPV, RSV, human cytomegalovirus, and varicella-zoster virus (pgs. 528-529, Table 1).
Tompa teaches swine flu, Ebola virus, and coronavirus as major viral pandemics in the 21st century (pg. 532).
Tompa concludes by stating “This article provides information about the strategic developments of different antiviral agents that have been used/using to inhibit the growth of viral infections in humans, to provide comprehensive idea on the up-to-date FDA approved antiviral drugs. Although these drugs show effective inhibitory activities on the viral infections, research should be focused on developing clinical strategies to completely cure the infections. . .the multitudinous virus population that infects humans across the globe emphasizes the need for extensive and effective research to develop novel antiviral therapeutics to counter the existing viral infections, newly emerging infections likes SARS-CoV-2 and the outbreak of new viruses in future” (pg. 534, Conclusion).
Sanyal (Crossroads in virology: current challenges and future perspectives in the age of emerging viruses, The Company of Biologists, published 2023, PTO-892) teaches that there are ongoing global health challenges posed by emerging and reemerging viruses (abstract), and that a key challenge in dealing with emerging and re-emerging viruses is their unpredictability (pg. 3). Sanyal teaches that knowledge of viruses is often limited at the outset, hampering timely and effective responses (pg. 3).
In view of the teachings of Tompa and Sanyal, the art of treating individual viruses is unpredictable, and a method of treating one virus does not translate to a method of treating all coronaviruses, influenza viruses, rhinoviruses, Measles viruses, Mumps viruses, Rubella viruses, human respiratory syncytial viruses, Parvovirus B19’s, adenoviruses, adeno-associated viruses, herpes viruses, polyomaviruses, or Variola viruses, let alone preventing these viruses.
Working Examples
Example 1 exemplifies an aqueous buffer solution prepared by stirring the following components in 1L of sterile water:
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(pgs. 72-73).
Example 2 is a hypothetical aqueous buffer solution in 1L of sterile water:
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(pg. 73).
Example 3 is a hypothetical example of the capacity of the aqueous buffer solutions to prevent or reduce viral infection of human bronchial epithelial cell cultures (pg. 73). The effect of the buffer solution on virus-induced depolarization of the cell layer can be measured by trans-epithelial electrical resistance (TEER) (pgs. 73-74).
Example 4 exemplifies the following aqueous buffer solutions:
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(pg. 75).
Example 5 exemplifies antiviral trial tests with aqueous buffer to assess SARS-CoV-2 entry interference (pg. 76). Vero cells were infected with SARS-CoV-2 in the presence or absence of test buffers (pg. 76).
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, and Trial A and B are negative and positive controls, respectively (pg. 77), wherein the results are as follows:
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(Fig. 2).
Example 6 tests the effect of the buffers to prevent or decrease viral entry/first cycle of replication (pg. 78). Fig. 3 shows that buffers A and B of example 4 effectively inhibited the infection of HuH7 cells with SARS-CoV-2 spike pseudo-type reporter particles.
Example 9 evaluates the virucidal effects of the composition of example 7A against SARS-CoV-2 and Influenza A in vitro, wherein composition example 7A comprises:
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(pgs. 80, 82), wherein the results are as follows:
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(pgs. 83-84).
Example 10 studies the effects of composition example 7B on inhibition of proteases (pg. 84) and determined that the composition resulted in 16%, 18.4%, 66.7%, and 45.7% inhibition of 3CL, DPPR, cathepsin L and furin protease (pgs. 85-86).
Example 11 studies the effect of example 7B on inhibition of spike S1-ACE2 interaction (pg. 86), and determined that the composition inhibited SpikeS1-ACE2 binding by 63.9% as compared to the control (pg. 87).
Thus, the instant working examples are all in vitro examples directed toward the effect of a composition on the inhibition of either SARS-CoV-2 or influenza A, wherein the composition either comprises:
BES, CaCl2, MgCl2, NaHCO3, KCl, NaCl, D-glucose, glycerol, glutamic acid, glutamine, aspartic acid, carnitine ‘inner salt,’ choline chloride, and optionally ZnCl2 or thiamine pyrophosphate chloride, or
NaCl, KCl, MgCl2, NaHCO3, xylitol, EDTA, CaCl2, ZnCl2, glycerol, HPMC, ginger oil, eucalyptus oil, basil oil, clove oil, water, poloxamer 188, benzalkonium chloride, phosphate buffer, and sodium hyaluronate.
It is further noted that in Example 5, while buffers A-D decreased the number of infectious virus particles after 24 hours of administration of the buffers, at the 48-hour mark, a decrease was no longer observed, i.e., buffers A-D were not effective 48 hours after administration. And none of the examples demonstrate the prevention of an airborne viral infection.
Direction and Guidance
In view of what is known in the art regarding the treatment of airborne viruses, the unpredictability in the art regarding viruses and the treatment of viruses, and the instant working examples which are limited to two compositions for the treatment of either SARS-CoV-2 or Influenza A, and which provide contradictory data in Example 5, the instant specification lacks sufficient direction and guidance to use the method as instantly claimed.
Quantity of Experimentation
In view of the breadth of the claims in contrast to the narrow scope of the examples, the unpredictability of the example data, the amount of experimentation required to determine which aqueous buffer solutions treat, prophylactically treat, or ameliorate which airborne viral infections, or which aqueous buffer solutions reduce or prevent viral replication of which airborne viruses, or which aqueous buffer solutions reduce the risk of which airborne viruses, would require an astronomical amount of experimentation, amounting to invention and not development; it is an undue amount of experimentation.
Thus, while being enabling for a method of treating coronavirus, influenza, or rhinovirus by administering an aqueous buffer solution comprising N,N-bis(2-hydroxyethyl)-2-amino-ethanesulphonic acid (BES) or phosphate buffer, and CaCl2, MgCl2, NaHCO3, KCl, and NaCl, and having a pH of 6.7-7.9 at a temperature of 37 C, the instant specification does not reasonably provide enablement for:
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Response to Arguments
On pg. 12, Remarks, Applicant argues that the claimed airborne viruses require “an acidic environment of the endosome to trigger their fusion with the cell membrane and delivery of the viral nucleocapsid into the cellular cytoplasm.”
The examiner acknowledges this remark. However, it is not clear how this statement overcomes the scope of enablement rejection, and specifically how this statement provides support of enablement of a method of preventing, i.e., prophylactically treating, the instantly claimed airborne viral infections.
On pg. 12, Remarks, Applicant argues that on pg. 4 of the specification, it is stated that “the infection process of any airborne viruses other than coronaviruses is also pH-dependent, for example that of influenza viruses. . .and Variola virus.”
The examiner acknowledges this statement that is replicated on pgs. 4-5 of the instant specification. However, it is not clear how this statement overcomes the scope of enablement rejection, and specifically how this statement provides support of enablement of a method of preventing, i.e., prophylactically treating, the instantly claimed airborne viral infections.
As such, the rejection is maintained.
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 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)(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.
(Modified) Claims 34, 38, and 49 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by WO 2017/212422 to Church (published 2017, IDS of 12/29/2022).
Church teaches a method for treating or preventing viral infections in a mammalian subject by administering an aqueous composition buffered to approximately neutral pH comprising a therapeutically effective amount of at least one pharmaceutically acceptable carbomer (pg. 59, claim 1).
Church specifically teaches a composition comprising less than 2% carbomer 980, carbomer 981, pemulen TR-1, or pemulen TR-2, and/or 0.5-1.5% w/w NaCl, and/or is buffered at pH 7.2-7.5 with phosphate, bicarbonate (i.e., hydrogen carbonate), glyoxaline or citrate/phosphate buffer, and/or 0.5% phenylethanol or parabens (pg. 65, claim 53).
Church teaches coronavirus, influenza, and other airborne viral infections as viral infections, wherein influenza A and B are specifically taught and exemplified as the types of influenza (pg. 59, claims 2-3; pg. 19, lines 10-17; pg. 40, lines 9-21; pg. 45, lines 1-15).
Church teaches the treatment as administered as a nasal spray, i.e., spaying a composition into the air (pg. 61, claim 25), as required by instant claim 49.
Though the pH is not taught at a given temperature, it is reasonable to assume that the pH would be approximately neutral, as taught by Church, at 37 °C, the average normal body temperature for a human, since the pH is approximately neutral prior to administration, and the pH is taught as 7.2-7.5. See MPEP 2112.02.
Response to Arguments
On pgs. 12-13, Remarks, Applicant argues that there is nothing in Church that discloses or suggests the buffer combination claimed in the amended claims.
This argument has been fully considered but is not found persuasive. It is respectfully pointed out that Church teaches a composition comprising both a phosphate and hydrogen carbonate ions, for the treatment of airborne viruses, such as those recited in independent amended claims 34 and 49.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Maintained) Claims 34, 36, 38, 41-42, 46, and 48-49 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-4, 7, 12, 30-31, 36-37, 39, 41-42, 46-47, 50-57 of copending Application No. 18/265981 (claim set dated 05/22/2024, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘981 claims a method of treatment, prophylactic treatment or amelioration of an airborne viral infection in a subject, or a method of reducing or preventing viral replication in a subject infected with an airborne virus or exposed to an airborne virus capable of causing an airborne viral infection in the subject, comprising administering a composition comprising from 1-500 mmoles/L buffer and from 0.1 to 200g/L essential oil or extract (claims 3, 39).
‘981 further claims the method, wherein the composition comprises an essential oil and buffer, wherein the buffer comprises:
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, or a composition comprising t 1-500mmoles/L buffer, 25-250mmoles/L phosphates, 1-45 mmoles/L hydrogen carbonate, 0.1-50umoles/L zinc, or a composition comprising calcium ions and magnesium ions at a molar concentration ratio of 5:1 to 1:1, wherein calcium ions are at a concentration of from 0.1-2.5 mmoles/L, 2.5-20 mmoles/L potassium ions, 96-126 mmoles/L chloride ions, 100-300 mmoles/L sodium ions, and further comprises one or more additional components selected from NaCl, KCl, MgCl2, xylitol, EDTA, CaCl2, glycerol, HPMC, PEG 400, poloxamer 188, benzalkonium chloride, and sodium hyaluronate, in an aqueous composition(claims 52, 54, 55)
‘981 claims the airborne viral infection as an RNA virus (claim 41).
‘981 claims a method of reducing the risk of viral infection with an airborne virus in a subject, comprising applying the composition comprising the 1-500mmoles/L buffer and 0.1-200g/L essential oil or extract, to a mask or other face covering, bubbling an oxygen containing gas through the composition prior to inhalation of the gas by the subject, or diffusing or spraying the composition into the air prior to inhalation of the air by the subject (claim 42).
‘981 claims the following compositions in the method of claim 52:
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‘981 claims the pH as from 6.7 to 7.9 at 37 C (claim 57).
‘981 additionally claims the compositions within the above methods (see claims 3-4, 7, 12, 30-31, 36-37).
Regarding the composition claims, consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
‘981 claims methods of treating coronaviruses and other airborne viruses, such as influenza A, influenza B, parainfluenza, MERS-CoV, SARS-CoV, and SARS-CoV2 (pgs. 1-5, 7, 16, 63).
Regarding the differences in amounts between ‘981 and the instantly claimed method, the optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
On pg. 13, Remarks, Applicant requests that “the Examiner hold this provision rejection in abeyance until all other issues are resolved.”
This statement is acknowledged; the rejection is maintained.
Free of the Prior Art
Claims 36, 41-42, 46 and 48 are free of the prior art.
The closest prior art is WO 2017212422 to Church (published 2017, IDS of 12/29/2022), which teaches a method for treating or preventing viral infections, such as coronavirus, in a mammalian subject by administering an aqueous composition buffered to approximately neutral pH comprising a therapeutically effective amount of at least one pharmaceutically acceptable carbomer (pg. 59, claim 1). Church specifically teaches a composition comprising less than 2% carbomer 980, carbomer 981, pemulen TR-1, or pemulen TR-2, and/or 0.5-1.5% w/w NaCl, and/or is buffered at pH 7.2-7.5 with phosphate, bicarbonate (i.e., hydrogen carbonate), glyoxaline or citrate/phosphate buffer, and/or 0.5% phenylethanol or parabens (pg. 65, claim 53).
The reference does not teach a composition further comprising calcium, magnesium, hydrogen carbonate, potassium, chloride, and sodium ions at specific concentrations, or teach a composition further comprising hydrogen carbonate ion and zinc ions or transferrin or iron ions, as required by claims 31, 35-36, 40-42, and 46-49.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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