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 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.
Priority
The instant application is a 371 of PCT/EP2021/069238 filed on 07/09/2021, which claims foreign priority to European Application no. EP20186334.7 filed on 07/16/2020. It is noted, however, a certified copy of the EP20186334.7 application as required by 37 CFR 1.55 in the international stage of the instant application has not yet been received. Applicant’s request for USPTO to retrieve priority application filed on 01/08/2026 is acknowledged.
Status of the Claims
The claim amendments and remarks filed on 01/08/2026 is acknowledged. Claim 4 is amended. Claims 1-3 and 5-11 are cancelled. Claims 12-19 are newly added.
Accordingly, claims 4 and 12-19 are pending and being examined on the merits herein.
Withdrawn Objections/Rejections
The objection to the specification is withdrawn in view of the deletion of the prefix “http://” on page 15 lines 9-10.
The cancellation of claims 2-3 renders the 35 USC 112(b) rejection over claims 2-3 moot.
The 35 USC 112(a) rejection over claims 1-11 is withdrawn in view of claims 1-3 and 5-11 being cancelled. Furthermore, Applicant states that the instant specification provides an explicit definition of “prophylaxis” or “prophylactic” to mean a reduction in an individual’s susceptibility for a viral infection rather than prevention (page 5 lines 17-22 of instant specification), which was found persuasive.
The 35 USC 102 rejection over Grassauer for claims 1-11 are withdrawn in view of claims 1-3 and 5-11 being cancelled, claim 4 now reciting “in an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk or suffering from a SARS-CoV-2 infection”, and claims 12-19 reciting a method of treatment against SARS-CoV-2, which has changed the scope of the claims.
The nonstatutory double patenting rejections over ‘820, ‘537, ‘969, ‘914, ‘914 in view of Grassauer, and ‘449 for claims 1-11 are withdrawn in view of claims 1-3 and 5-11 being cancelled, claim 4 now reciting “in an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk or suffering from a SARS-CoV-2 infection”, and claims 12-19 reciting a method of treatment against SARS-CoV-2, which has changed the scope of the claims.
The following grounds of rejection are new as necessitated by Applicant’s amendments.
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)(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) 4, 12-16, and 19 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020).
Vega discloses a novel preventive treatment for COVID 19 and therapeutic treatment for early stages of COVID 19 or any other disease caused by SARS-CoV-2 (Abstract). Vega discloses that their treatments are based on the administration to the nasal cavity and/or the lungs of solutions containing iota Carrageenan with or without the addition of xylitol as antiviral drug substances (Abstract).
Vega discloses that their compositions comprising iota and/or kappa carrageenan is also active against coronaviruses, e.g. COVID-19, including other respiratory viruses such as, human rhinovirus, a member of the paramyxoviridae such as parainfluenza virus, metapneumovirus, or respiratory syncytial virus, a member of the orthomyxoviridae such as influenza virus, or an adenovirus subtype B (ICD-10 codes J09 and J10) (see column 13 lines 54-61). Vega discloses that their compositions may be applied after the outbreak of a viral infection to prevent or at least ameliorate late complications of respiratory viral infections, and further discloses that such complications are known in the art and include complications in connection with secondary infections by bacteria, and deterioration of preexisting diseases such as allergy or COPD (column 14 lines, 3-14). Vega discloses that the subject is a human subject (column 8 lines 28-30).
Vega demonstrates in Example 1 (columns 16-19) the in vitro inhibition of SARS-CoV-2 using three samples containing 1.7 mg/ml iota carrageenan (Sample 1), 1.2 mg/ml iota carrageenan (Sample 2), and 1.2 mg/ml iota carrageenan (Sample 3). Here, Vega discloses and demonstrates in Tables 1-3 of Example 1 that iota carrageenan significantly reduced the viral titers of SARS-CoV-2 in Vero cell cultures.
Vega demonstrates in Example 16 (column 27) candidate nasal spray formulations to prevent transmission and alleviate symptoms and reduce viral load at an early stage of COVID-19. Vega demonstrates a nasal spray formulation that contains 1.7 mg/mL iota carrageenan, NaCl, HCl/NaOH, and water (column 27 lines 25-30). Vega discloses about 100 uL dose is applied to each nostril every 4 hours or prior to exposure to COVID-19 patients (column 27 lines 30-33).
Vega also demonstrates in Example 17 (column 28) additional formulations containing 0.01-0.5% w/v (0.1 mg/mL to 5 mg/mL) iota carrageenan alone (column 28 lines 15-18). Vega demonstrates a formulation containing iota carrageenan alone at 0.5% or 5 mg/mL (column 28 lines 20-25). Vega discloses that 200 microliter of this formulation is delivered to the subject (column 28 lines 18-25).
Therefore, claims 4, 12-14, and 16 are anticipated.
In regards to instant claim 15, instant claims 4 and 12 (claim 15 depends from claims 4 and 12) only require that the pharmaceutical composition comprise at least one of the sulphated polysaccharides in the recited group and does not limit the sulphated polysaccharide to a lambda-carrageenan. Instant claim 15 only further limits the lambda-carrageenan, but does not require that the carrageenan must be a lambda-carrageenan. Therefore, instant claim 15 is also anticipated because Vega meets all of the limitations of instant claims 4 and 12 as described above.
In regards to instant claim 19, even though Vega does not demonstrate the administration of their compositions to a recited high-risk patient, an ordinary skilled artisan could “envisage” administering to an allergy or COPD patient based on Vega disclosing that their compositions can be administered to patients with preexisiting conditions and discloses only two such conditions (allergy or COPD).
MPEP 2131.02 III states that “A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.”
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.
Claim(s) 4, 12, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020) in view of Grassauer et al. (US20120237572A1, cited in IDS filed on 02/16/2023).
The teachings of Vega are as described above and teach the composition of instant claim 4 and the method of instant claim 12.
Vega, however, does not disclose wherein the composition in a liquid form is attached by either coating or impregnation to a solid surface of a hygiene or sanitary items.
Grassauer et al. discloses the use of iota and/or kappa-carrageenan for the manufacture of an antiviral pharmaceutical composition for the prophylaxis or treatment of a pathological condition or disease caused by or associated with an infection by a respiratory virus selected from the group consisting of orthomyxovirus, paramyxovirus, adenovirus and coronavirus (see Abstract). Grassauer et al. discloses that their pharmaceutical composition may be provided in skin lotions, creams, ointments, gels, powders including powders for inhalation, sprays, foams, liquid drops or gargle solutions (claim 11). Grassauer et al. discloses that their composition further comprises at least one least one pharmaceutically acceptable carrier and/or additive (see paragraphs 0060-0063). Grassauer et al. disclose that the subject is an individual being a high-risk patient selected from the group consisting of a COPD-patient, an asthma patient, a person with allergies, a person with impaired immune, cardiac, or pulmonary system, and a transplantation patient (claim 26). Grassauer et al. demonstrates the efficacy of iota-carrageenan pretreatment in reducing plaque formation of parainfluenza virus 3 in HeLa cells at different doses ranging from a final concentration of 13 to 400 μg/ml (see FIG.4)
Grassauer et al. discloses that their composition is coated or impregnated onto a solid surface of a hygiene or sanitary item and also further administering their composition comprises the subject contacting the coated or impregnated surface of the hygiene or sanitary item (Claim 22). Grassauer et al. discloses that the sanitary item is a hygiene or sanitary glove, tissue or paper, a nasal tissue or paper, a cotton swab, dust mask or sanitary or medical facial mask (Claim 28). Grassauer discloses that these hygiene or sanitation articles can be used prophylactically or for therapeutical treatment against a viral infection and may assist in the prevention or reduction of a risk of infection (paragraph 0073).
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the compositions of Vega by coating or impregnating these compositions onto a hygiene or sanitary glove, tissue or paper, a nasal tissue or paper, a cotton swab, dust mask or sanitary or medical facial mask as disclosed in Grassauer to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to make this modification because Grassauer provides guidance that the coating of carrageenan compositions onto hygiene or sanitation articles may assist in the prevention or reduction of a risk of viral infection. One of ordinary skill in the art would have a reasonable expectation of success because both Vega and Grassauer disclose that the carrageenan in their respective compositions is effective for the prophylactic or therapeutic treatment against viral infections.
Response to Arguments
Applicant’s arguments filed on 01/08/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that Grassauer does not teach or suggest treatment of SARS-CoV-2, however the new rejection above now cites Vega, which anticipates the claimed composition and treatment method against SARS-CoV-2. Therefore, Applicant’s arguments over Grassauer are rendered moot.
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.
Claims 4 and 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,342,820 (‘820) in view of Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020)
Claim 1 of ‘820 recites a method of treating a subject having an upper respiratory tract infection caused by a virus selected from the group consisting of paramyxovirus, human influenza A virus, and adenovirus of subtype B, comprising administering to the subject a pharmaceutical composition comprising a carrageenan component as the sole antiviral active ingredient in an antiviral effective amount, wherein in the administering, the carrageenan component is the sole antiviral active ingredient administered, wherein: the carrageenan component comprises iota-carrageenan, or kappa-carrageenan, or a combination of iota- and kappa-carrageenan, or salts thereof in an amount of 80% by weight or more relative to the total dry weight of all carrageenans or salts thereof present in the composition. Claim 9 of ‘820 recites the antiviral pharmaceutical composition is administered topically on skin or mucosa in the form of one of a skin lotion, cream, ointment, gel, powder, spray, foam, liquid drops, or a gargle solution. Claim 10 of ‘820 recites the composition is liquid or semi-solid and comprises as a ready-for-use preparation iota-carrageenan in an amount of between 0.01% and 10% by weight, relative to the total volume of the preparation, which equals to 100 ug/ml at 0.01% w/w. Claim 13 of ’820 recites the composition further comprises at least one pharmaceutically acceptable carrier and/or additive. Claim 18 of ‘820 recites the composition is coated or impregnated onto a solid surface of a hygiene or sanitary item and the administering comprises the subject contacting the coated or impregnated surface of the hygiene or sanitary item. Claim 20 of ‘820 recites the subject is an individual being a high-risk patient selected from the group consisting of a COPD-patient, an asthma patient, a person with allergies, a person with impaired immune, cardiac, or pulmonary system, and a transplantation patient. Claim 21 of ‘820 recites the sanitary item is a hygiene or sanitary glove, tissue or paper, a nasal tissue or paper, a cotton swab, dust mask or sanitary or medical facial mask.
The reference application, however, does not recite an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection. The reference application also does not recite a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The independent teachings of Vega are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the reference application by administering the composition for the prophylactic or therapeutic treatment against SARS-CoV-2 as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vega provides guidance that the compositions in the reference application, which contain the same antiviral effective amounts of iota- and/or kappa-carrageenan, is also effective against SARS-CoV-2.
In regards to instant claim 15, instant claims 4 and 12 (claim 15 depends from claims 4 and 12) only require that the pharmaceutical composition comprise at least one of the sulphated polysaccharides in the recited group and does not limit the sulphated polysaccharide to a lambda-carrageenan. Therefore, instant claim 15 is also prima facie obvious because the combination of the reference application and Vega recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4 and 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,376,537 (‘537) in view of Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020)
Claim 1 of ‘537 recites a method of reducing the risk of acquiring a rhinovirus infection in a subject in need thereof, the method comprising administering to the subject a pharmaceutical composition comprising, as the sole active antiviral ingredient, an iota-carrageenan homopolymer and/or heteropolymer in an antiviral effective amount. Claim 2 of ‘537 recites subject suffers from at least one disease selected from the group consisting of asthma, chronic obstructive pulmonary disease, cystic fibrosis, allergy, and inflammatory disease. Claim 3 of ‘537 recites the composition comprises the iota-carrageenan homopolymer and/or heteropolymer in an amount of between 0.01% and 20% (w/w) of the composition, which equals to 100 ug/ml at 0.01% w/w. Claim 7 of ‘537 recites the composition further comprises at least one pharmaceutically acceptable carrier or additive. Claim 12 of ‘537 recites the composition is coated onto a solid surface of a hygiene or sanitation article, and the administering comprises the subject contacting the coated surface of the hygiene or sanitation article. Claim 13 of ‘537 recites the composition is coated onto a solid surface of a hygiene or sanitary glove, tissue or paper. Claim 15 of ‘537 recites the composition is administered as a nose spray, a powder, a gel, an ointment, a foam, or a liquid solution.
The reference application, however, does not recite an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection. The reference application also does not recite a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The independent teachings of Vega are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the reference application by administering the composition for the prophylactic or therapeutic treatment against SARS-CoV-2 as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vega provides guidance that the compositions in the reference application, which contain the same anitviral effective amounts of iota- and/or kappa-carrageenan, is also effective against SARS-CoV-2.
In regards to instant claim 15, instant claims 4 and 12 (claim 15 depends from claims 4 and 12) only require that the pharmaceutical composition comprise at least one of the sulphated polysaccharides in the recited group and does not limit the sulphated polysaccharide to a lambda-carrageenan. Therefore, instant claim 15 is also prima facie obvious because the combination of the reference application and Vega recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4 and 12-19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 8,282,969 (‘969) in view of Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020)
Claim 1 of ‘969 recites a method for treating a subject having of a rhinovirus infection comprising administering to the subject a composition comprising iota-carrageenan in an antiviral effective amount as an active antiviral ingredient. Claim 4 of ‘969 recites the composition further comprises at least one pharmaceutically acceptable carrier or additive. Claim 5 of ‘969 recites the composition is adapted for topical use and comprises iota-carrageenan in an amount of between 0.01% and 20% (w/v) of the composition, which equals to 100 ug/ml at 0.01% w/w. Claim 9 of ‘969 recites the composition is coated onto a solid surface of a hygiene or sanitation article, and the administering comprises the subject contacting the coated surface of the hygiene or sanitation article. Claim 11 of ‘969 recites the subject is an individual being a high-risk patient selected from the group consisting of an asthma patient, a person suffering from allergy, and a person suffering from an inflammatory disease. Claim 12 of ‘969 recites the composition is administered as a nose spray, a powder, including a powder for inhalation, a gel, an ointment, a foam, or a liquid solution including a lotion, a gargle solution, or drops. Claim 17 of ‘969 recites the composition is coated onto a solid surface of a hygiene or sanitary glove, tissue or paper
The reference application, however, does not recite an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection. The reference application also does not recite a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The independent teachings of Vega are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the reference application by administering the composition for the prophylactic or therapeutic treatment against SARS-CoV-2 as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vega provides guidance that the compositions in the reference application, which contain the same antiviral effective amounts of iota- and/or kappa-carrageenan, is also effective against SARS-CoV-2.
In regards to instant claim 15, instant claims 4 and 12 (claim 15 depends from claims 4 and 12) only require that the pharmaceutical composition comprise at least one of the sulphated polysaccharides in the recited group and does not limit the sulphated polysaccharide to a lambda-carrageenan. Therefore, instant claim 15 is also prima facie obvious because the combination of the reference application and Vega recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4, 12-16, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,660,914 (‘914) in view of Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020)
Claim 1 of ‘914 recites a hyperosmolar aqueous solution which has an immediate stuffy nose deblocking activity and which is active against viral infections of the respiratory tract, wherein: the hyperosmolar aqueous solution comprises a non-ionic osmolality adjusting agent in combination with an ionic osmolality adjusting agent, and a carrageenan component as an active antiviral ingredient in an antivirally effective amount; the carrageenan component is the sole antiviral active ingredient in the hyperosmolar aqueous solution and is selected from the group consisting of iota-carrageenan, kappa-carrageenan, and a mixture of iota- and kappa carrageenan. Claim 9 of ‘914 recites for use as an antiviral agent in the prophylactic or therapeutic treatment of viral infections of the upper respiratory tract, and claim 10 of ‘914 recites the viral infections are selected from the group consisting of infections caused by human rhinovirus, human coronavirus, members of the paramyxoviridae, members of the orthomyxoviridae and adenovirus subtype B. Claim 15 of ‘914 recites the hyperosmolar aqueous solution is in a form of a nasal spray. Claim 20 of ‘914 recites the concentration of the carrageenan component is from 0.1% to 0.3% weight by volume (g/L) of the formulation that is to be administered, which equals to 100 to 300 ug/ml. Claim 4 of ‘914 recites the hyperosmolar aqueous solution further comprises at least one physiologically acceptable additive selected from the group consisting of a preservative, an anti-oxidant, a humectant, an emollient, a moisturizer, and a flavoring agent. Claim 16 of ‘914 recites the hyperosmolar aqueous solution is in a form of a nasal spray.
The reference application, however, does not recite an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection. The reference application also does not recite a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The independent teachings of Vega are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the reference application by administering the composition for the prophylactic or therapeutic treatment against SARS-CoV-2 as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vega provides guidance that the compositions in the reference application, which contain the same antiviral effective amounts of iota- and/or kappa-carrageenan, is also effective against SARS-CoV-2.
In regards to instant claim 15, instant claims 4 and 12 (claim 15 depends from claims 4 and 12) only require that the pharmaceutical composition comprise at least one of the sulphated polysaccharides in the recited group and does not limit the sulphated polysaccharide to a lambda-carrageenan. Therefore, instant claim 15 is also prima facie obvious because the combination of the reference application and Vega recite all of the limitations of instant claims 4 and 12 as described above.
In regards to instant claim 19, it would have been also been prima facie obvious to administer the modified composition as described above to a patient with a preexisting allergy or COPD condition as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vega provides guidance that these compositions may be applied after the outbreak of a viral infection to prevent or at least ameliorate late complications of respiratory viral infections, and further discloses that such complications are known in the art and include complications in connection with secondary infections by bacteria, and deterioration of preexisting diseases such as allergy or COPD (column 14 lines, 3-14).
Claims 4, 12, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,660,914 (‘914) in view of Grassauer et al. (US20120237572A1, cited in IDS filed on 02/16/2023) and Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020).
The claims of the reference application are as described above.
The reference application, however, does not recite an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection. The reference application also does not recite a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition and wherein the composition in a liquid is attached by either coating or impregnation to a solid surface of a hygiene or sanitary item such as a hygiene or sanitary glove, a hygiene or sanitary tissue or paper, a cotton swab, a dust mask, a sanitary facial mask, and a medical facial mask.
The independent teachings of Grassauer and Vega are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the reference application by either coating or impregnating the composition to a solid surface of a hygiene or sanitary item such as a hygiene or sanitary glove, a hygiene or sanitary tissue or paper, a cotton swab, a dust mask, a sanitary facial mask, and a medical facial mask as disclosed in Grassauer and further administering this modified composition for the prophylactic or therapeutic treatment against SARS-CoV-2 as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made these modifications with a reasonable expectation of success because Grassauer provides guidance that a liquid composition comprising a carrageenan for therapeutical treatment against a viral infection such as the composition recited in the reference application can be coated on hygiene or sanitary items, which may assist in the prevention or reduction of a risk of viral infection. Furthermore, Vega provides guidance that the compositions in the reference application, which contain the same effective amounts of iota- and/or kappa-carrageenan, is also effective against SARS-CoV-2.
Claims 4, 12-16, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,022,449 (‘449) in view of Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020)
Claim 1 of ‘449 recite a pharmaceutical composition for the treatment of a symptom, condition or disease caused by an infection with influenza virus or by a co-infection with influenza virus and at least one other respiratory virus, the composition comprising an antiviral effective amount of at least one carrageenan selected from the group consisting of iota carrageenan and kappa carrageenan; and
an antiviral effective amount of zanamivir as a neuraminidase inhibitor; the concentration of the carrageenan being 1.2 mg/ml (1200 ug/ml) and the concentration of the zanamivir being 0.1 mg/ml in the composition. Claim 2 of ‘449 recites the composition is adapted as a nasal spray. Claim 3 of ‘449 recites wherein the at least one other respiratory virus is selected from the group consisting of rhinovirus, coronavirus, and paramyxovirus. Claim 5 of ‘449 recites a kit of parts comprising the pharmaceutical composition comprising a first container comprising the antiviral effective amount of the at least one carrageenan selected from the group consisting of iota carrageenan and kappa carrageenan together with a pharmaceutically acceptable carrier.
The reference application, however, does not recite an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection. The reference application also does not recite a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The independent teachings of Vega are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the reference application by administering the composition for the prophylactic or therapeutic treatment against SARS-CoV-2 as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vega provides guidance that the compositions in the reference application, which contain the same antiviral effective amounts of iota- and/or kappa-carrageenan, is also effective against SARS-CoV-2.
In regards to instant claim 15, instant claims 4 and 12 (claim 15 depends from claims 4 and 12) only require that the pharmaceutical composition comprise at least one of the sulphated polysaccharides in the recited group and does not limit the sulphated polysaccharide to a lambda-carrageenan. Therefore, instant claim 15 is also prima facie obvious because the combination of the reference application and Vega recite all of the limitations of instant claims 4 and 12 as described above.
In regards to instant claim 19, it would have been also been prima facie obvious to administer the modified composition as described above to a patient with a preexisting allergy or COPD condition as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Vega provides guidance that these compositions may be applied after the outbreak of a viral infection to prevent or at least ameliorate late complications of respiratory viral infections, and further discloses that such complications are known in the art and include complications in connection with secondary infections by bacteria, and deterioration of preexisting diseases such as allergy or COPD (column 14 lines, 3-14).
Claims 4, 12, and 17-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,022,449 (‘449) in view of Grassauer et al. (US20120237572A1, cited in IDS filed on 02/16/2023) and Vega et al. (US11013687B1 in PTO-892, filed 06/12/2020 and effective filing date of 06/08/2020).
The claims of the reference application are as described above.
The reference application, however, does not recite an antiviral effective amount for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection. The reference application also does not recite a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition and wherein the composition in a liquid is attached by either coating or impregnation to a solid surface of a hygiene or sanitary item such as a hygiene or sanitary glove, a hygiene or sanitary tissue or paper, a cotton swab, a dust mask, a sanitary facial mask, and a medical facial mask.
The independent teachings of Grassauer and Vega are described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the composition recited in the reference application by either coating or impregnating the composition to a solid surface of a hygiene or sanitary item such as a hygiene or sanitary glove, a hygiene or sanitary tissue or paper, a cotton swab, a dust mask, a sanitary facial mask, and a medical facial mask as disclosed in Grassauer and further administering this modified composition for the prophylactic or therapeutic treatment against SARS-CoV-2 as disclosed in Vega to arrive at the claimed invention. One of ordinary skill in the art would have made these modifications with a reasonable expectation of success because Grassauer provides guidance that a liquid composition comprising a carrageenan for therapeutical treatment against a viral infection such as the composition recited in the reference application can be coated on hygiene or sanitary items, which may assist in the prevention or reduction of a risk of viral infection. Furthermore, Vega provides guidance that the compositions in the reference application, which contain the same effective amounts of iota- and/or kappa-carrageenan, is also effective against SARS-CoV-2.
Response to Arguments
Applicant’s arguments filed on 01/08/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states that ‘820 does not recite prophylactic or therapeutic treatment of SARS-CoV-2 infection, however the new rejection above now cites Vega as a secondary reference, which makes obvious that the recited composition of ‘820 can be used as a prophylactic or therapeutic treatment of SARS-CoV-2 infection as described above. Therefore, Applicant’s arguments over ‘820 are rendered moot. Furthermore, it is noted that Applicant has not presented any arguments against the nonstatutory double patenting rejections over ‘537, ‘969, ‘914, and ‘449. Therefore, these rejections are also being applied in view of Vega as described above.
Conclusion
No claim is found allowable.
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.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693