DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 1-3 are pending.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/RU2021/000278, filed on June 29, 2021. This application also claims the benefits of foreign priority to RU2020123856, filed on July 17, 2020.
Specification - Abstract
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
Currently, the abstract is separated into two paragraphs and exceeds 150 words.
Additionally, the abstract discloses the use of certain compounds identified by trademarks (i.e., Tamerit, Triazavirin®, and Maktavirin®). For clarity and consistency, ensure that the trademarks are accompanied by their corresponding generic names.
The instant claim set and specification is directed towards a method of protecting against a coronavirus infection. Therefore, for the sake of consistency:
The first sentence of the abstract should read:
“The invention is related to medical and biological applications and is intended to protect against coronavirus infections…”;
The second sentence of the abstract should read:
“A method for the protection against coronavirus infection is presented…”
Appropriate correction is required.
Specification - Disclosure
The disclosure is objected to because of the following informalities:
The specification discloses the use of certain compounds identified by trademarks or brand names (e.g., Tamerit, Triazavirin®, Maktavirin®, and Arbidol). For clarity and consistency, ensure that all trademarks and brand names are accompanied by their corresponding generic names.
Additionally, Examiner could not find a structure of Maktavirin on the STN database or in the two references provided by the STN database:
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For clarity, a structure of Maktavirin® is respectfully requested.
In Example 1 and Table 1 on pg. 7, the protective efficacy of Tamerit was studied in a model of experimental coronavirus infection caused by SARS (strain SARS-Covktp3). Examiner was unable to find references pertaining to this strain of SARS-CoV and is unsure whether “ktp3” is merely a typographical error. Clarification of the “ktp3” designation is respectfully requested. If “ktp3” is a typographical error, please correct the designation to the proper strain in Example 1 and throughout the application where necessary.
Specification is missing a “Brief Description of the Drawings” section.
According to 37 C.F.R. 1.74:
“When there are drawings, there shall be a brief description of the several views of the drawings and the detailed description of the invention shall refer to the different views by specifying the numbers of the figures, and to the different parts by use of reference letters or numerals (preferably the latter).”
Ensure a brief description of the drawings is included in the specification.
On pg. 8, Example 2, 3rd sentence, “…to SARS-Cov infected people…” should read “…to SARS-CoV infected mice…”
The 2nd column of the table on pg. 16 still contains Russian text. Please ensure that all text is translated into English.
On pg. 19, Table 1 should be renumbered to Table 5. Ensure all tables following Table 1 on pg. 19 is also re-numbered accordingly.
Appropriate correction is required.
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Drawings
The drawings are objected to because of the following informalities:
For clarity, the caption for Fig. 2 should read:
“Bifunctional effect of the Tamerit drug on macrophages and neutrophil granulocytes.”
Claim Objections
Claim 3 is objected to because of the following informalities:
“…to the sub-unit in need…” should read “…to the subject in need…”
“azoloazinovyh” should read “azoloazine” to be consistent with the abstract.
Appropriate correction is required.
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.
Claim 3 is 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 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 use the invention.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims a vaccine (which comprises a drug, Tamerit, in an effective amount and pharmaceutically acceptable carriers and/or diluents) that is used in a method of protection against coronavirus infection in a subject when either used alone or in combination with antiviral agents, antimalarials, or preparations of interferon.
State of the prior art
According to the closest prior art, patients with viral hepatitis C can be treated using interferon inducer drugs in combination with interferon drugs [Red’kin, J. V. E. et al. (Red’kin) (RU2306934C1; published September 27, 2007; para. 0002, 2nd sentence)]. Although not stated explicitly in Red’kin, Galavit is also an interferon inducer drug (Silin, D. S. et al. Synthetic and Natural Immunomodulators Acting as interferon Inducers. Current Pharmaceutical Design 2009, 15, 1238-1247.; abstract). The only difference between Tamerit and Galavit is that Tamerit is the hydrated salt of 5-aminophthaloylhydrazide and Galavit is a mixture of two polymorphs of the anhydrous salt of 5-aminophthaloylhydrazide (Rybakov, V. B. et al. On the Structure of Luminol Sodium Salts. Crystallography Reports 2014, 59, 383-393.; abstract). There is no difference between a solution comprising Tamerit and a solution comprising Galavit. Note: Galavit is normally dissolved in water before injection into a patient intramuscularly (Romantseva, N. E. et al.; RU2383342C1; published March 10, 2010; English-translation, pg. 4, lines 31-34: “Before administration, the drug is diluted in 2 mL of water for injection”). Therefore, Tamerit (which is also typically dissolved in water before subcutaneous administration to a subject; Abidov, M. T. et al, US6489326B1, published December 3, 2002; col. 3, last sentence) is also an interferon inducer drug.
The amount of direction or guidance present and quantity of experimentation necessary
The prior art does not disclose the use of the combination of Tamerit with either an interferon drug or an antimalarial in protecting a subject against coronavirus infection. Further, the prior art does not compare the efficacy of antimalarials or interferon drugs alone with the efficacy of their combinations with Tamerit (i.e., Tamerit + an antimalarial or Tamerit + preparation of interferon). In the absence of clear guidance, a person of ordinary skill in the art would require undue experimentation to determine the dosage of Tamerit and interferon drug (or antimalarial) necessary to achieve protection against coronavirus infection in a patient.
The presence or absence of working examples
In the instant case, the specification is not enabling because example 4 of the instant specification does not provide working examples comparing the efficacy of an interferon drug or an antimalarial administered alone to a subject versus interferon or antimalarial in combination with Tamerit. Example 4 discloses that when the first set of patients (i.e., Group 1) were only administered Tamerit, not one patient got infected with the new coronavirus infection (pg. 12, last two lines and pg. 13, first six lines). Example 4 also discloses that when the second set of patients (i.e., Group 2) were administered Tamerit in combination with exogenous interferon-alfa-2-beta, none of the patients required hospitalization (pg. 13, “Group 2 – 6 patients” section, last paragraph). Both cases led to a positive outcome. Therefore, there is no evidence that Tamerit is increasing the efficacy of the interferon drug. There is only evidence that Tamerit administered in combination with an interferon drug also leads to a positive outcome.
Also disclosed by example 4, the third set of patients (i.e., Group 3) were “prescribed complex therapy (antimalarial drug mefloquine 250 mg per day, azithromycin 500 mg per day, antithrombotic therapy with low-molecular heparins, interleukin-6 blocker kevzar)… [Since] [t]he expected clinical effect of the ongoing therapy was not obtained, correction of treatment was carried out and all 100% patients… were prescribed complex therapy” that includes Tamerit used in combination with interferon-alfa-2-beta and other drugs (pg. 14, 2nd paragraph). In other words, example 4 discloses that the first complex therapy (which includes the administration of an antimalarial) was ineffective and, therefore, a completely different complex therapy (which includes the administration of Tamerit in combination with interferon, not an antimalarial) was used. There is no evidence that the administration of Tamerit is increasing the efficacy of an antimalarial when there are no working examples of Tamerit being administered to a patient in combination with an antimalarial.
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.
Claims 1-3 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.
Claims 1-3 contain the trademark/trade name “Tamerit” in claim 1 - line 2, claim 2 - last line, and claim 3 – 3rd to last line; the trademarks “Triazavirin®” and “Maktavirin®” are in claim 3, line 3. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe an aminophthalhydrazide derivative (Tamerit) and azoloazine derivatives (Triazavirin® and Maktavirin®). Accordingly, the identification/description is indefinite.
Furthermore, claims 2 and 3 recite “salts of aminophthalhydrazide derivatives.” While the specification does disclose two other derivatives of aminophthalhydrazide salts in addition to Tamerit (Tameron and Galavit; pg. 4, last sentence and pg. 5, lines 1-5), the specification does not limit the derivatives of aminophthalhydrazide salts to those explicitly listed in the specification. Additionally, the term “derivative” is not defined in the specification and, therefore, can comprise of numerous compounds with structures that can potentially vary significantly from the structure of Tamerit. Thus, claims 2 and 3 are rendered vague and indefinite.
Claim 3 also recites “antiviral agents azoloazinovyh (Triazavirin®, Maktavirin®)” which render the claims indefinite. This is because it is unclear whether the limitation(s) following the phrase “antiviral agents azoloazinovyh” are part of the claimed invention. Specifically, it is unclear whether the limitations following the phrase are intended to further limit the claim or are merely exemplary. See MPEP § 2173.05(d).
Note on 35 USC § 102 and § 103 Rejections
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.
Claim Rejections - 35 USC § 102
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Davidson, S. (Davidson) (Davidson, S. An Investigation into non-Specific Therapy, with Special reference to Sodium Nucleinate. Edinburgh Medical Journal 1927, 34, 21-42).
Davidson teaches that:
“[s]odium nucleinate is a substance which is definitely known to produce a leucocytosis both in human beings and in animals, if injected in the correct quantities” (pg. 25, section “II. Experimental Investigation”, subsection “A. The Test Substance,” 4th sentence).
“The object of this experiment was to find the optimum dose of nuclein (i.e., a 5-per cent. solution of sodium nucleinate; pg. 25, section “II. Experimental Investigation”, subsection “A. The Test Substance,” 2nd sentence) which would produce a definite leucocytosis in normal rabbits within a reasonable time limit… Having definitely established the fact that the rabbit's white cells were within normal limits, various amounts of nuclein from 0.5 to 2 c.c. were injected both intravenously and subcutaneously (pg. 25, last two lines and pg. 26, first two lines; pg. 26, 2nd paragraph, 1st sentence).
It is noted here that sodium nucleinate is registered in Russian Federation as Tamerit® (Jukić, T. et al. A Tetrahydrophthalazine Derivative >>Sodium Nucleinate<< Exerts a Potent Suppressive Effect upon LPS-Stimulated Mononuclear Cells in vitro and in vivo. Coll. Antropol. 2011, 4, 1219-1223.; pg. 1219, introduction section, 1st sentence).
It is also noted here that in Example 1 of the instant specification (pg. 7, section “Example 1,” 3rd sentence), Tamerit together with an excipient (and no other drug) were administered subcutaneously to white mice. Accordingly, Examiner interprets the term “vaccine” in instant claim 1 to be synonymous to “composition.”
Therefore, the composition disclosed by Davidson, which comprises sodium nucleinate and a diluent to yield a solution suitable for injection into a subject, anticipates the vaccine of instant claim 1.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-3 is rejected under 35 U.S.C. 103 as being unpatentable over
YuV, L. et al. (YuV) (YuV et al. Justification of the possible directions of pathogenetic therapy of a new coronavirus infection. Extreme Medicine 2020, 3, 55-63.; published online: July 15, 2020),
Minin, L. et al. (Minin) (CH683965A5; published June 30, 1994)
The citations herein refer to the English language counterpart: US5543410A; published August 6, 1996.
Red’kin, J. V. E. et al. (Red’kin) (RU2306934C1; published September 27, 2007).
YuV teaches that “[i]n case of any respiratory viral infection, it is essential to boost the local immune defenses as early as possible at the sites of primary contact of the virus with mucous membranes. Therefore, it is advisable to use therapeutic agents that stimulate local and systemic immunity so as to inhibit replication of SARS-CoV-2 in the earliest stages of infection, before the onset of pronounced clinical symptoms. The list of such medications includes interferons exerting antiviral, immunostimulatory and antiproliferative effects, peptide and synthetic immunomodulators enhancing the bactericidal activity of neutrophils, and sodium nucleinate-based immunostimulatants that activate non-specific resistance” (pg. 56, right col., last paragraph, first three sentences).
Recall that sodium nucleinate is registered in Russian Federation as Tamerit® (Jukić; pg. 1219, introduction section, 1st sentence).
YuV does not disclose a therapeutic dose of sodium nucleinate (i.e., Tamerit). Minin is relied upon for this disclosure.
Minin discloses “[a] method for treating disorders selected from the group consisting of ulcerative colitis, Crohn's disease, diffuse sclerosis, diarrhea, proctitis, hemorrhoids, anal fissures, dyspepsia, intestinal infection and proctosigmoiditis, in mammals comprising the steps of:
initially parenterally administering a dosage of a drug being 5-aminophthaloylhydrazide or a pharmaceutically acceptable salt of the drug or a mixture of the drug and the salt, at a dosage of 5 to 50 mg/kg according to kg of body weight, and at an initial low frequency of administration; and thereafter parenterally administering the drug, salt or mixture of the drug and salt, at the dosage and at a higher frequency of administration” (claim 1).
According to the STN entry below, Tamerit is a salt of 5-aminophthaloylhydrazide:
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Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to protect a subject against a coronavirus infection by administering to a subject 5 to 50 mg/kg of Tamerit (a known therapeutic dose of a salt of 5-aminophthaloylhydrazide) (reads on instant claim 2). One of ordinary skill in the art would have been motivated to protect a subject against a coronavirus infection by administering Tamerit to the subject because the prior art (YuV) has advised the use of sodium nucleinate (i.e., Tamerit)-based immunostimulatants to stimulate local and systemic immunity so as to inhibit replication of SARS-CoV-2 in the earliest stages of infection before the onset of pronounced clinical symptoms (YuV, pg. 56, right col., last paragraph, 2nd and 3rd sentence).
Recall that YuV advises to use therapeutic agents (such as interferons exerting antiviral, immunostimulatory and antiproliferative effects and sodium nucleinate-based immunostimulatants) to help inhibit replication of SARS-CoV-2 in the earliest stages of infection (pg. 56, right col., last paragraph, 2nd and 3rd sentence). However, YuV does not teach the use of sodium nucleinate-based immunostimulatants (i.e., an interferon inducer drug; Silin, D. S. et al. Synthetic and Natural Immunomodulators Acting as interferon Inducers. Current Pharmaceutical Design 2009, 15, 1238-1247.; abstract) in combination with interferon drugs. Red’kin is relied upon for this disclosure.
Red’kin discloses “[a]nother approach to the treatment of patients with viral hepatitis C is the use of interferon inducer drugs (amixin, neovir, cycloferon) as monotherapy or in combination with interferon drugs” (para. 0002). Although not stated explicitly in Red’kin, Galavit is also an interferon inducer drug (Silin, D. S. et al. Synthetic and Natural Immunomodulators Acting as interferon Inducers. Current Pharmaceutical Design 2009, 15, 1238-1247.; abstract). The only difference between Tamerit and Galavit is that Tamerit is the hydrated salt of 5-aminophthaloylhydrazide and Galavit is a mixture of two polymorphs of the anhydrous salt of 5-aminophthaloylhydrazide (Rybakov, V. B. et al. On the Structure of Luminol Sodium Salts. Crystallography Reports 2014, 59, 383-393.; abstract). There is no difference between a solution comprising Tamerit and a solution comprising Galavit. Note: Galavit is normally dissolved in water before injection into a patient intramuscularly (Romantseva, N. E. et al.; RU2383342C1; published March 10, 2010; English-translation, pg. 4, lines 31-34: “Before administration, the drug is diluted in 2 mL of water for injection”). Therefore, Tamerit (which is also typically dissolved in water before subcutaneous administration to a subject; Abidov, M. T. et al, US6489326B1, published December 3, 2002; col. 3, last sentence) is also an interferon inducer drug.
Therefore, one of ordinary skill in the art would have found it prima facie obvious before the effective filing date of the claimed invention to use Tamerit in combination with interferon drugs (i.e., the two therapeutic agents advised by YuV to use to help inhibit replication of SARS-CoV-2 in the earliest stages of infection; pg. 56, right col., last paragraph, 2nd and 3rd sentence) to protect a subject against coronavirus infection. Even though YuV never explicitly advised the combination usage of a sodium nucleinate-based immunostimulatants (i.e., interferon inducer) and an interferon, one of ordinary skill in the art would have been motivated to combine the two as the combination of an interferon inducer and an interferon has previously been used to treat other viral infections (i.e., viral hepatitis C).
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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.
Claim 1-2 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 3 of U.S. Patent No. 6,489,326 B1 (‘326B1).
Instant claim 1 is directed towards a vaccine comprising Tamerit and pharmaceutically acceptable carriers and/or diluents. Recall that Examiner interprets the term “vaccine” to be synonymous to “composition” based on the details reported in the instant specification. Therefore, one of ordinary skill in the art would have interpreted the “pharmaceutical composition comprising 5-amino-2,3-dihydro phthalazine-1,4-dione sodium salt and an inert carrier” (from ‘326 B1, claim 2) to encompass the vaccine of instant claim 1. Note: 5-amino-2,3-dihydro phthalazine-1,4-dione sodium salt in ‘326B1 is the same as Tamerit (‘326B1, col. 3, 2nd to last sentence).
Instant claim 2 is directed towards a method of protection against coronavirus infection in a subject, characterized by the use of drugs containing, as an active substance, salts of aminophthalhydrazide derivatives which include Tamerit. In other words, the subject is in need of an immunomodulator for protection against a coronavirus infection. Note: in the instant specification, “protection” is defined as the “prevention, therapy and rehabilitation phase of treatment of the organism” (pg. 6, 2nd to last sentence). Thus, the “method of protection against coronavirus infection in a subject” of instant claim 2 is equivalent to a “method of treating coronavirus infection in a patient.”
Claim 3 of ‘326B1 is directed towards a method of treating a patient in need of an immunomodulator comprising treating said patient with an effective amount of the composition of claim 2 which comprises Tamerit. Hence, it can be deduced that Tamerit is an immunomodulator.
As an immunomodulator is needed to treat a subject against a coronavirus infection in the instant case, one of ordinary skill in the art would find instant claim 2 to be equivalent to a method of treating a patient in need of an immunomodulator which is encompassed by claim 3 of ‘326B1.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624