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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.
Applicant's submission filed on 08/24/2026 has been entered.
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 08/24/2026 is acknowledged. Claims 4 and 13 are amended. Claims 1-3, 5-11, and 17-18 are cancelled. Claims 20-24 are newly added.
Accordingly, claims 4, 12-16, and 19-24 are pending and being examined on the merits herein.
Withdrawn Rejections
The cancellation of claims 17-18 renders the prior art rejections and nonstatutory double patenting rejections over these claims moot.
The 35 USC 102 rejection over Vega for claims 4, 12-16, and 19 are withdrawn because this rejection relied on arriving at the claimed composition that is in the form of a liquid, and the claims have been amended such that the composition must now be in the form a solid dosage unit suitable for oral administration, which was not previously considered.
The 35 USC 103 rejection over Vega in view of Grassauer for claims 4, 12, and 17-18 are withdrawn because this rejection relied on arriving at the claimed composition that is in the form of a liquid, and the claims have been amended such that the composition must now be in the form a solid dosage unit suitable for oral administration, which was not previously considered.
The nonstatutory double patenting rejections over US’820, US’537, US’969, US’914, and US’449 are withdrawn because these rejections relied on arriving at the claimed composition that is in the form of a liquid, and the claims have been amended such that the composition must now be in the form a solid dosage unit suitable for oral administration, which was not previously considered.
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) 22-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
Bruce discloses a method of treating COVID-19 infection in a subject comprising administering dextran sulfate, or a pharmaceutically acceptable salt thereof, having an average molecular weight equal to or below 10,000 Da (claims 22 and 24 in Bruce).
Bruce teaches that the subject is preferably human (paragraph 0147).
Bruce demonstrates in Example 13 (paragraphs 0498-0502) and Figure 37 that low molecular weight dextran sulfate (LMW-DS) administered at concentrations such as 60, 300, or 600 ug/mL in saline was effective in inhibiting and reducing the interaction between SARS-CoV-2 spike protein and ACE2, and that this inhibition would be predicted to be beneficial to patients by reducing the ability of the SARS-CoV-2 virus to gain entry to human cells (paragraph 0502).
Bruce teaches a 60-600 ug/mL saline solution containing dextran sulfate as an antiviral ingredient to treat COVID-19 infection.
Therefore, instant claim 22 is anticipated.
In regards to instant claim 23, even though Bruce does not demonstrate the administration of a pharmaceutical composition comprising dextran sulfate to a human subject, an ordinary skilled artisan would have been able to readily envisage administering the LMW-DS saline composition in Example 13 of Bruce to a human based on its effectiveness in inhibiting SARS-CoV-2 spike protein and ACE2 interaction, which reduces the ability of the SARS-CoV-2 virus to gain entry to cells in a human subject. See MPEP 2131.02 III.
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, 12-16, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020).
Zhu discloses the application of sulfated polysaccharides in resisting novel coronavirus (Abstract).
Zhu discloses that sea cucumber polysaccharides, fucoidans, or carrageenans can prevent cell membranes of body cells from adsorbing and internalizing the SARS-CoV-2 virus by binding to an S protein on the surface of the SARS-CoV-2 virus, thereby preventing the SARS-CoV-2 virus from infecting the body cells (Abstract).
Zhu discloses that these polysaccharides can be used to prepare protective articles having functions of prevention and treatment of novel coronavirus infection including inhalations, hand lotions, oral liquids, and respirators (Abstract). Zhu further discloses medication dosage forms including effervescent tablets, powders, and others (paragraph 0013), and further including additional pharmaceutically acceptable adjuvants including solvents, solubilizers, stabilizers, and others (paragraph 0012).
Zhu discloses that carrageenans can be classified into seven types including t-carrageenan (iota-carrageenan) and others (paragraph 0007). Zhu discloses that these carrageenans are known to be used as a thickener, a gelatinizer, a suspending agent, an emulsifier, a stabilizer and the like in industrial fields such as food and daily chemicals (paragraph 0007).
Zhu demonstrates in Example 7 (paragraphs 0080-0081) and FIGS. 9-10 that t-carrageenan (iota-carrageenan) administered at a concentration of 62.5-500 ug/mL (0.0625-0.5 mg/mL) significantly inhibited a SARS-CoV-2 live virus from infecting Vero E6 cells. Zhu further discloses that this concentration range also showed no cytotoxicity as seen in FIG. 11 (paragraph 0081).
Zhu also demonstrates in Examples 14-16 the incorporation of carrageenan into several products such as nasal, respirator filter cartridge, and wash-free hand sanitizer at concentrations ranging from 5-20 mg/mL (paragraphs 0090-0092).
Even though Zhu does not demonstrate incorporating their iota-carrageenan into a solid dosage unit suitable for oral administration such as a tablet at the recited effective amounts, it would have been prima facie obvious before the effective filing date of the claimed invention to have incorporated the iota-carrageenan into an oral dosage form such as an effervescent tablet as disclosed in Zhu.
One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Zhu provides guidance of including their polysaccharides into dosage forms such as an effervescent tablet, and Zhu further discloses that carrageenan is known to be used as a component in foods.
Furthermore, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the iota-carrageenan and arrive at the recited effective amounts based on Zhu demonstrating that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus and further demonstrating the incorporation of the iota-carrageenan at 5-20 mg/mL concentration into various products. See MPEP 2144.05 II.
In regards to instant claim 12, even though Zhu does not demonstrate the treatment of a human at risk of or suffering from SARS-CoV-2 infection, it would have been prima facie obvious before the effective filing date of the claimed invention to have administered the iota-carrageenan composition of Zhu as described above to this human patient population with a reasonable expectation of success because Zhu demonstrates that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus from infecting cells.
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 comprises 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 prima facie obvious because Zhu meets all of the limitations of instant claims 4 and 12 as described above.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020), as applied to claims 4 and 12 above, and further in view of Alqahtani et al. (Plos One, published 05/11/2020 in PTO-892).
The teachings of Zhu are as described above and teach the method of claim 12 as discussed above.
Zhu, however, does not disclose a high-risk patient such as a COPD-patient.
Alqahtani disclose the prevalence, severity, and mortality associated with COPD and smoking in patients with COVID-19 (Abstract).
Alqahtani concludes that although COPD prevalence in COVID-19 cases was low in current reports, COVID-19 infection was associated with substantial severity and mortality rates in COPD and that effective preventive measures are required to reduce COVID-19 risk in COPD patients and current smokers.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the treatment method of Zhu described above by administering to a COPD patient as disclosed in Alqahtani to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to a COPD patient because Alqahtani discloses substantial severity and mortality rates in COPD patients with COVID-19.
One of ordinary skill in the art would have a reasonable expectation of success because Zhu demonstrates that the iota-carrageenan was effective in inhibiting the SARS-CoV-2 virus from infecting cells, and Alqahtani recommends effective preventive measures to reduce COVID-19 infection in COPD patients.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020), as applied to claim 4, and further in view of Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020) and Statista (Data from Statista website, published 01/14/2019 in PTO-892).
The teachings of Zhu are as described above and teach the composition of claim 4 as discussed above.
Zhu, however, does not disclose the antiviral ingredient is cellulose sulphate and/or dextran sulphate in the recited antiviral effective amounts.
The teachings of Bruce as described above. Furthermore, Bruce discloses that the dextran sulfate can be administered via oral, nasal, topical, etc, administration and can be formulated with a suitable excipient or carrier (paragraph 0150). Bruce discloses that a suitable dosage is 1 ug/kg to 100 mg/kg of bodyweight (paragraph 0151), which would be 0.09 mg to 9000 mg based on an average human adult male bodyweight of 90 kg and 0.077 mg to 7000 mg based on an average human adult female of 77 kg according to Statista (see the figure on page 1 in Statista).
Bruce discloses and shows in FIG 24 that attachment and cellular entry of SARS-CoV-2 is mediated by the spike glycoprotein (SPG), and that SPG interacts not only with its receptor, angiotensin converting enzyme 2 (ACE2), but also binds to glycosaminoglycans, such as heparan sulfate (HS), which is found on the surface of most mammalian cells in the form of heparan sulfate proteoglycan (HSPG) (paragraph 0065). Bruce discloses that the binding of SPG to tethered HS on the cell surfaces increases the local concentration of virus particles at the cell surface and promotes binding of SPG to ACE2, and that their untethered dextran sulfate is capable of binding to SPG as HS prior to receptor presentation, and thereby inhibits the binding of SPG to HSPG and ACE2 on cell surfaces and prevents or at least significantly reduces local concentration, attachment and cellular entry of coronaviruses, such as SARS-CoV-2, in infected subjects (paragraph 0065). Therefore, Bruce discloses that their administered dextran sulfate can be used not only to prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces (paragraph 0065).
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the iota-carrageenan as disclosed by Zhu described above with the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both Zhu and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Lastly, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the LMW-DS and arrive at the recited effective amounts based on Bruce disclosing that that a suitable dosage is 1 ug/kg to 100 mg/kg of bodyweight (paragraph 0151) and an average human adult male bodyweight of 90 kg or an average human adult female of 77 kg according to Statista (see the figure on page 1 in Statista). See MPEP 2144.05 II.
Alternatively, It would have been prima facie obvious before the effective filing date of the claimed invention to have further included into the composition disclosed by Zhu described above the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this modification because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both Zhu and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Lastly, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosages of the iota-carrageenan of Zhu and the LMW-DS of Bruce as discussed above. See MPEP 2144.05 II.
Claim(s) 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
The teachings of Bruce are as described above and anticipate the composition of instant claim 22 as discussed above
Instant claims 23 is also rejected above as being anticipated by Bruce and is being further rejected here to provide an alternative obviousness rejection over this claim.
It would have been prima facie obvious before the effective filing date of the claimed invention to have administered the LMW-DS saline composition in Example 13 of Bruce to a human subject with COVID-19 with a reasonable expectation of success because Bruce demonstrates that their LMW-DS was effective in inhibiting SARS-CoV-2 spike protein and ACE2 interaction, which is predicted to reduce the ability of the SARS-CoV-2 virus to gain entry to cells in a human subject.
In regards to instant claim 24, it would have also been prima facie obvious before the effective filing date of the claimed invention to have modified the method of Bruce as described above by formulating the LMW-DS saline composition in Example 13 of Bruce as described above into a liquid composition such as a skin lotion, aqueous solution for disinfection or inhalation, or spray as suggested in Bruce 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 Bruce provides guidance of administering their LMW-DS compositions via topical, oral, or nasal routes, and further formulating with a suitable excipient or carrier that is selected based on the particular administration route.
Response to Arguments
Applicant’s arguments filed on 08/24/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant presents arguments based on the disclosures of Vega and Grassauer, however the new rejections above do not cite Vega and Grassauer, rendering Applicant’s arguments 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, 12-16, and 19-20 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020).
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 13 of ’820 recites the composition further comprises at least one pharmaceutically acceptable carrier and/or additive. 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.
The reference application, however, does not recite a composition comprising an effective amount in an oral solid dosage form such as tablets for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection as well as a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The teachings of Zhu are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the method recited in the reference application by administering the composition for treatment against SARS-CoV-2 in a human as disclosed in Zhu and further formulating the composition into an oral solid dosage form as suggested in Zhu 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 Zhu provides guidance that the antviral compositions in the reference application, which contain the same iota- kappa-carrageenan, is also effective against SARS-CoV-2. Furthermore, Zhu provides guidance in including their polysaccharides into dosage forms such as an effervescent tablet, and also discloses that carrageenan is known to be used as a component in foods.
Furthermore, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the iota-carrageenan and arrive at the recited effective amounts based on Zhu demonstrating that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus and further demonstrating the incorporation of the iota-carrageenan at 5-20 mg/mL concentration into various products. See MPEP 2144.05 II.
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 Zhu recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4 and 21-24 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
The combination of the reference application and Zhu are as described above and recite the composition of instant claim 4 as discussed above.
The combined references, however, do not recite that the antiviral active ingredient is cellulose sulphate and/or dextran sulphate.
The teachings of Bruce as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the iota-carrageenan as disclosed by the combined references described above with the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Claims 4, 12-16, and 19-20 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020).
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 7 of ‘537 recites the composition further comprises at least one pharmaceutically acceptable carrier or additive. 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 a composition comprising an effective amount in an oral solid dosage form such as tablets for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection as well as a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The teachings of Zhu are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the method recited in the reference application by administering the composition for treatment against SARS-CoV-2 in a human as disclosed in Zhu and further formulating the composition into an oral solid dosage form as suggested in Zhu 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 Zhu provides guidance that the antiviral compositions in the reference application, which contain the same iota-carrageenan, is also effective against SARS-CoV-2. Furthermore, Zhu provides guidance in including their polysaccharides into dosage forms such as an effervescent tablet, and also discloses that carrageenan is known to be used as a component in foods.
Furthermore, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the iota-carrageenan and arrive at the recited effective amounts based on Zhu demonstrating that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus and further demonstrating the incorporation of the iota-carrageenan at 5-20 mg/mL concentration into various products. See MPEP 2144.05 II.
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 Zhu recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 10,376,537 (‘537) in view of Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
The combination of the reference application and Zhu are as described above and recite the composition of instant claim 4 as discussed above.
The combined references, however, do not recite that the antiviral active ingredient is cellulose sulphate and/or dextran sulphate.
The teachings of Bruce as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the iota-carrageenan as disclosed by the combined references described above with the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Claims 4, 12-16, and 19-20 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020).
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 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.
The reference application, however, does not recite a composition comprising an effective amount in an oral solid dosage form such as tablets for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection as well as a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The teachings of Zhu are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the method recited in the reference application by administering the composition for treatment against SARS-CoV-2 in a human as disclosed in Zhu and further formulating the composition into an oral solid dosage form as suggested in Zhu 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 Zhu provides guidance that the antiviral compositions in the reference application, which contain the same iota-carrageenan, is also effective against SARS-CoV-2. Furthermore, Zhu provides guidance in including their polysaccharides into dosage forms such as an effervescent tablet, and also discloses that carrageenan is known to be used as a component in foods.
Furthermore, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the iota-carrageenan and arrive at the recited effective amounts based on Zhu demonstrating that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus and further demonstrating the incorporation of the iota-carrageenan at 5-20 mg/mL concentration into various products. See MPEP 2144.05 II.
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 Zhu recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4 and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of U.S. Patent No. 8,282,969 (‘969) in view of Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
The combination of the reference application and Zhu are as described above and recite the composition of instant claim 4 as discussed above.
The combined references, however, do not recite that the antiviral active ingredient is cellulose sulphate and/or dextran sulphate.
The teachings of Bruce as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the iota-carrageenan as disclosed by the combined references described above with the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Claims 4, 12-16, and 20 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020)
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 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 a composition comprising an effective amount in an oral solid dosage form such as tablets for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection as well as a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The teachings of Zhu 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 treatment against SARS-CoV-2 in a human as disclosed in Zhu and further formulating the composition into an oral solid dosage form as suggested in Zhu 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 Zhu provides guidance that the antiviral compositions in the reference application, which contain the same iota-carrageenan, is also effective against SARS-CoV-2. Furthermore, Zhu provides guidance in including their polysaccharides into dosage forms such as an effervescent tablet, and also discloses that carrageenan is known to be used as a component in foods.
Furthermore, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the iota-carrageenan and arrive at the recited effective amounts based on Zhu demonstrating that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus and further demonstrating the incorporation of the iota-carrageenan at 5-20 mg/mL concentration into various products. See MPEP 2144.05 II.
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 Zhu recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4, 12, 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Alqahtani et al. (Plos One, published 05/11/2020 in PTO-892).
The combination of the reference application and Zhu are as described above and recite the method of instant claim 12 as discussed above.
The combined references, however, do not recite that the human is a high-risk patient such as a COPD-patient.
The teachings of Alqahtani are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the treatment method as disclosed by the combined references described above by administering to a COPD patient as disclosed in Alqahtani to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to a COPD patient because Alqahtani discloses substantial severity and mortality rates in COPD patients with COVID-19.
One of ordinary skill in the art would have a reasonable expectation of success because the combined references described above recite that the iota-carrageenan is effective in inhibiting the SARS-CoV-2 virus from infecting cells, and Alqahtani recommends effective preventive measures to reduce COVID-19 infection in COPD patients.
Claims 4, 12, and 21-24 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
The combination of the reference application and Zhu are as described above and recite the composition of instant claim 4 as discussed above.
The combined references, however, do not recite that the antiviral active ingredient is cellulose sulphate and/or dextran sulphate.
The teachings of Bruce as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the iota-carrageenan as disclosed by the combined references described above with the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Claims 4, 12-16, and 20 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 Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020)
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 a composition comprising an effective amount in an oral solid dosage form such as tablets for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection as well as a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The teachings of Zhu are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the method recited in the reference application by administering the composition for treatment against SARS-CoV-2 in a human as disclosed in Zhu and further formulating the composition into an oral solid dosage form as suggested in Zhu 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 Zhu provides guidance that the antiviral compositions in the reference application, which contain the same iota-carrageenan, is also effective against SARS-CoV-2. Furthermore, Zhu provides guidance in including their polysaccharides into dosage forms such as an effervescent tablet, and also discloses that carrageenan is known to be used as a component in foods.
Furthermore, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the iota-carrageenan and arrive at the recited effective amounts based on Zhu demonstrating that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus and further demonstrating the incorporation of the iota-carrageenan at 5-20 mg/mL concentration into various products. See MPEP 2144.05 II.
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 Zhu recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4, 12, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,022,449 (‘449) in view of Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Alqahtani et al. (Plos One, published 05/11/2020 in PTO-892).
The combination of the reference application and Zhu are as described above and recite the method of instant claim 12 as discussed above.
The combined references, however, do not recite that the human is a high-risk patient such as a COPD-patient.
The teachings of Alqahtani are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the treatment method as disclosed by the combined references described above by administering to a COPD patient as disclosed in Alqahtani to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to a COPD patient because Alqahtani discloses substantial severity and mortality rates in COPD patients with COVID-19.
One of ordinary skill in the art would have a reasonable expectation of success because the combined references described above recite that the iota-carrageenan is effective in inhibiting the SARS-CoV-2 virus from infecting cells, and Alqahtani recommends effective preventive measures to reduce COVID-19 infection in COPD patients.
Claims 4, 12, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,022,449 (‘449) in view of Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
The combination of the reference application and Zhu are as described above and recite the composition of instant claim 4 as discussed above.
The combined references, however, do not recite that the antiviral active ingredient is cellulose sulphate and/or dextran sulphate.
The teachings of Bruce as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the iota-carrageenan as disclosed by the combined references described above with the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Claims 4, 12-16, and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,220,055 in view of Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020)
US’055 recites a method for treating viral eye infections caused by adenovirus of subtype D or influenza A virus of subtype H7 comprising administering to the eye of a subject in need thereof a pharmaceutical composition comprising between 0.2 to 0.4% by weight of an active antiviral ingredient, wherein the active ingredient consists of iota-carrageenan, and with the proviso that the composition in its ready-for-use formulation contains no a metal halide salt selected from the group consisting of sodium chloride and potassium chloride (claim 10).
The reference application, however, does not recite a composition comprising an effective amount in an oral solid dosage form such as tablets for prophylactic or therapeutic treatment of a human individual at risk of or suffering from a SARS-CoV-2 infection as well as a method of prophylactic or therapeutic treatment against SARS-CoV-2 comprising administering the recited composition.
The teachings of Zhu are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the method recited in the reference application by administering the composition for treatment against SARS-CoV-2 as disclosed in Zhu and further formulating the composition into an oral solid dosage form as suggested in Zhu 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 Zhu provides guidance that the antiviral compositions in the reference application, which contain the same iota-carrageenan, is also effective against SARS-CoV-2. Furthermore, Zhu provides guidance in including their polysaccharides into dosage forms such as an effervescent tablet, and also discloses that carrageenan is known to be used as a component in foods.
Furthermore, an ordinary skilled artisan would have been able to perform routine optimization to determine the optimal dosage of the iota-carrageenan and arrive at the recited effective amounts based on Zhu demonstrating that the iota-carrageenan at 0.0625-0.5 mg/mL concentration was effective in inhibiting the SARS-CoV-2 virus and further demonstrating the incorporation of the iota-carrageenan at 5-20 mg/mL concentration into various products. See MPEP 2144.05 II.
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 Zhu recite all of the limitations of instant claims 4 and 12 as described above.
Claims 4, 12, and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,220,055 in view of Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Alqahtani et al. (Plos One, published 05/11/2020 in PTO-892).
The combination of the reference application and Zhu are as described above and recite the method of instant claim 12 as discussed above.
The combined references, however, do not recite that the human is a high-risk patient such as a COPD-patient.
The teachings of Alqahtani are as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have modified the treatment method as disclosed by the combined references described above by administering to a COPD patient as disclosed in Alqahtani to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to administer to a COPD patient because Alqahtani discloses substantial severity and mortality rates in COPD patients with COVID-19.
One of ordinary skill in the art would have a reasonable expectation of success because the combined references described above recite that the iota-carrageenan is effective in inhibiting the SARS-CoV-2 virus from infecting cells, and Alqahtani recommends effective preventive measures to reduce COVID-19 infection in COPD patients.
Claims 4, 12, and 21-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,220,055 in view of Zhu et al. (US20220125827A1 in PTO-892, this application was filed 01/04/2022 and has an effective filing date of 06/18/2020) and Bruce (US20230346827A1 in PTO-892, this application was filed on 04/14/2021 and has an effective filing date of 04/15/2020).
The combination of the reference application and Zhu are as described above and recite the composition of instant claim 4 as discussed above.
The combined references, however, do not recite that the antiviral active ingredient is cellulose sulphate and/or dextran sulphate.
The teachings of Bruce as described above.
It would have been prima facie obvious before the effective filing date of the claimed invention to have substituted the iota-carrageenan as disclosed by the combined references described above with the LMW-DS of Bruce to arrive at the claimed invention.
One of ordinary skill in the art would have been motivated to make this substitution because Bruce teaches that their LMW-DS not only can prevent or at least inhibit coronavirus infection but will also, once a subject has been infected by coronavirus, restrict spread and replication of coronavirus in the subject body by interfering with the interaction between the coronavirus and ACE2 and HSPG on cell surfaces.
One of ordinary skill in the art would have a reasonable expectation of success because both the combined references described above and Bruce disclose the use of their agents for preventing the SARS-CoV-2 virus from entering and infecting cells. Furthermore, Bruce discloses that their LMW-DS can be administered orally and formulated with a suitable excipient or carrier for this type of administration.
Response to Arguments
Applicant’s arguments filed on 08/24/2026 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant presents arguments based on the disclosures of Vega and Grassauer, however the new rejections above do not cite Vega and Grassauer, rendering Applicant’s arguments moot.
Conclusion
No claim is found allowable.
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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner
Art Unit 1693
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