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 .
Receipt is acknowledged of Amendments and Remarks filed on 07/27/26. Claims 1-2, 10, 13, 19, 23, 25, 30, 91-92 and 100 have been amended, new claim 167 has been added and claims 18, 28 and 85 have been canceled. Thus, claims 1-3, 7, 10-11, 13, 19, 23, 25-27, 29-30, 34, 41, 46, 55, 88-95, 100-101 and 167 are pending. Claims 34, 41, 46 and 55 remain withdrawn. Accordingly, claims 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are under examination on the merits.
Rejections and/or objections not reiterated from the previous Office Action are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Claim Objections
Claim 10 is objected to because of the following informalities:
In claim 10, line 3, a comma is missing after -polysorbate 80-.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 93-94 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claim 93, the recitation of “secondary infection in the subject is prior to the respiratory viral infection” is vague and not in proper English.
Claim 94 recites the limitation "the secondary infection" in method of claim 1. There is insufficient antecedent basis for this limitation in the claim. Claim 1 does not support a secondary infection.
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 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,464,749 in view of Baker et al (US 20160375034), Saha et al (US 20110092589) and Morse et al (Learning from the past: Possible urgent prevention and treatment options for sever acute respiratory infections caused by 2019-nCov).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Baker et al, Saha et al and Morse et al.
Examined claim 1 is directed to a method of treating, managing or lessening the severity of symptoms associated with a respiratory viral infection in a subject, the method comprising administering to the subject a bismuth-thiol (BT) composition that comprises BisEDT suspended therein, wherein administering the BT composition is via inhalation, orally or nasally, using an aerosol device. Claim 2 recites the particle size range.
Reference claim 1 is directed to a method of treating, managing or lessening the severity of cystic fibrosis (CF) symptoms and infections in a subject, the method comprising administering to the subject an aerosol comprising a plurality of dispersed liquid droplets, wherein the liquid droplets comprise a bismuth-thiol (BT) composition that comprises bismuth-1,2-ethanedithiol (BisEDT) microparticles suspended therein, the BisEDT microparticles having a D90 of less than about 2 μm as measured by laser diffraction, and wherein at least 70% of the liquid droplets have a mass median aerodynamic diameter (MMAD) from about 0.4 μm to about 5 μm as measured by cascade impaction or laser time of flight.
The difference is that examined claims recite a method of treating or managing or lessening the severity of symptoms associated with a viral respiratory infection, while the reference claims disclose this method for cystic fibrosis or infection. However, as disclosed by Baker et al compositions comprising a BT compound such as BisEDT are known to treat or manage symptoms of a viral infection on natural surfaces including respiratory tract. Reference claims also do not recite treating SARS, the secondary infection producing superantigens, treating cytokine storm and do not recite adding remdesivir. However, these are known in the art as taught by Saha et al and Morse et al and it would have been obvious to one of ordinary skill in the art to have incorporated them into the examined claims with a reasonable expectation of success.
Claims 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-13 of U.S. Patent No. 9,028,878 in view of Baker et al (US 20160375034), Saha et al (US 20110092589) and Morse et al (Learning from the past: Possible urgent prevention and treatment options for sever acute respiratory infections caused by 2019-nCov).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Baker et al, Saha et al and Morse et al.
Examined claim 1 is directed to a method of treating, managing or lessening the severity of symptoms associated with a respiratory viral infection in a subject, the method comprising administering to the subject a bismuth-thiol (BT) composition that comprises BisEDT suspended therein, wherein administering the BT composition is via inhalation, orally or nasally, using an aerosol device. Claim 2 recites the particle size range.
Reference claim 1 is directed to a method for protecting a natural surface against one or more of a bacterial pathogen, a fungal pathogen and a viral pathogen, comprising: contacting the surface with an effective amount of a BT composition under conditions and for a time sufficient for one or more of:
(i) prevention of infection of the surface by the bacterial, fungal or viral pathogen,
(ii) inhibition of cell viability or cell growth of substantially all planktonic cells of the bacterial, fungal or viral pathogen,
(iii) inhibition of biofilm formation by the bacterial, fungal or viral pathogen, and
(iv) inhibition of biofilm viability or biofilm growth of substantially all biofilm-form cells of the bacterial, fungal or viral pathogen,
wherein the BT composition comprises a plurality of solid microparticles that exhibit a unimodal size distribution when the BT composition is analyzed on a particle size analyzer and that comprise a bismuth-thiol (BT) compound that has not been micronized, milled or subjected to super-critical fluid processing, substantially all of said microparticles having a volumetric mean diameter of from about 0.4 μm to about 5 μm, wherein the BT compound comprises bismuth or a bismuth salt and a thiol-containing compound and the BT composition comprises at least one antibiotic compound that is capable of acting synergistically with, or enhancing, the BT compound, wherein the antibiotic compound comprises an antibiotic that is selected from methicillin, vancomycin, nafcillin, gentamicin, ampicillin, chloramphenicol, doxycycline, clindamycin, gatifloxacin, cefazolin and an aminoglycoside antibiotic, and wherein the aminoglycoside antibiotic is selected from the group consisting of amikacin, arbekacin, gentamicin, kanamycin, neomycin, netilmicin, paromomycin, rhodostreptomycin, streptomycin, and apramycin.
The difference is that examined claims recite a method of treating or managing or lessening the severity of symptoms associated with a viral respiratory infection via inhalation using an aerosol, while the reference claims disclose this method wherein the composition can be administered by inhalation or nasally, but there is no recitation of an aerosol. However, as disclosed by Baker et al compositions comprising a BT compound such as BisEDT are known to treat or manage symptoms of a viral infection on natural surfaces including respiratory tract wherein the inhalation is achieved by an aerosol device. Reference claims also do not recite treating SARS, the secondary infection producing superantigens, treating cytokine storm and do not recite adding remdesivir. However, these are known in the art as taught by Saha et al and Morse et al and it would have been obvious to one of ordinary skill in the art to have incorporated them into the examined claims with a reasonable expectation of success.
Claims 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-24 of U.S. Patent No. 10,960,012 in view of Baker et al (US 20160375034), Saha et al (US 20110092589) and Morse et al (Learning from the past: Possible urgent prevention and treatment options for sever acute respiratory infections caused by 2019-nCov).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Baker et al, Saha et al and Morse et al.
Examined claim 1 is directed to a method of treating, managing or lessening the severity of symptoms associated with a respiratory viral infection in a subject, the method comprising administering to the subject a bismuth-thiol (BT) composition that comprises BisEDT suspended therein, wherein administering the BT composition is via inhalation, orally or nasally, using an aerosol device. Claim 2 recites the particle size range.
Reference claim 14 is directed to a method for protecting a natural surface against one or more of a bacterial pathogen, a fungal pathogen and a viral pathogen, comprising: contacting the surface with an effective amount of the BT composition of claim 1 under conditions and for a time sufficient for one or more of:
(i) treatment of infection of the surface by the bacterial, fungal or viral pathogen,
(ii) inhibition of cell viability or cell growth of substantially all planktonic cells of the bacterial, fungal or viral pathogen,
(iii) inhibition of biofilm formation by the bacterial, fungal or viral pathogen, and
(iv) inhibition of biofilm viability or biofilm growth of substantially all biofilm-form cells of the bacterial, fungal or viral pathogen.
Composition of claim 1 is a bismuth-thiol composition, comprising a plurality of solid microparticles that comprise a bismuth-thiol (BT) compound, substantially all of said microparticles having a volumetric mean diameter of from 0.4 μm to 5 μm, wherein the BT compound comprises bismuth or a bismuth salt in association with 1,2-ethane dithiol. Claim 13 is directed to the said composition being a liquid suspension. In claim 16, the epithelial tissue surface is respiratory tract.
The difference is that examined claims recite a method of treating or managing or lessening the severity of symptoms associated with a viral respiratory infection via inhalation using an aerosol, while the reference claims disclose this method wherein the composition can be administered by inhalation or nasally, but there is no recitation of an aerosol. However, as disclosed by Baker et al compositions comprising a BT compound such as BisEDT are known to treat or manage symptoms of a viral infection on natural surfaces including respiratory tract wherein the inhalation is achieved by an aerosol device. Reference claims also do not recite treating SARS, the secondary infection producing superantigens, treating cytokine storm and do not recite adding remdesivir. However, these are known in the art as taught by Saha et al and Morse et al and it would have been obvious to one of ordinary skill in the art to have incorporated them into the examined claims with a reasonable expectation of success.
Claims 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-26 of U.S. Patent No. 8,389,021 in view of Baker et al (US 20160375034), Saha et al (US 20110092589) and Morse et al (Learning from the past: Possible urgent prevention and treatment options for sever acute respiratory infections caused by 2019-nCov).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Baker et al, Saha et al and Morse et al.
Examined claim 1 is directed to a method of treating, managing or lessening the severity of symptoms associated with a respiratory viral infection in a subject, the method comprising administering to the subject a bismuth-thiol (BT) composition that comprises BisEDT suspended therein, wherein administering the BT composition is via inhalation, orally or nasally, using an aerosol device. Claim 2 recites the particle size range.
Reference claim 13 is directed to a method for protecting an epithelial tissue surface against a bacterial pathogen, comprising: contacting the epithelial tissue surface with an effective amount of a BT composition of claim 1, under conditions and for a time sufficient for one or more of:
(i)prevention of infection of the epithelial tissue surface by the bacterial pathogen,
(ii) inhibition of cell viability or cell growth of substantially all planktonic cells of the bacterial pathogen,
(iii) inhibition of biofilm formation by the bacterial pathogen, and
(iv) inhibition of biofilm viability or biofilm growth of substantially all biofilm-form cells of the bacterial pathogen.
Composition of claim 1 is a bismuth-thiol composition, comprising: a plurality of solid microparticles that exhibit a unimodal size distribution when the composition is analyzed on a particle size analyzer and that comprise a bismuth-thiol (BT) compound that has not been micronized, milled or subjected to super-critical fluid processing, substantially all of said microparticles having a volumetric mean diameter of from about 0.4 μm to about 5 μm, wherein the BT compound comprises bismuth or a bismuth salt and a thiol-containing compound. In claim 17, the epithelial tissue surface is respiratory tract.
The difference is that examined claims recite a method of treating or managing or lessening the severity of symptoms associated with a viral respiratory infection via inhalation using an aerosol, while the reference claims disclose a method for protecting epithelial surfaces against bacterial or fungal infections and do not recite administration via an aerosol. However, as Baker et al teach, it is known that compositions comprising a BT compound such as BisEDT can treat or manage symptoms of a viral infection on natural surfaces including respiratory tract wherein the inhalation is achieved by an aerosol device. Reference claims also do not recite treating SARS, the secondary infection producing superantigens, treating cytokine storm and do not recite adding remdesivir. However, these are known in the art as taught by Saha et al and Morse et al and it would have been obvious to one of ordinary skill in the art to have incorporated them into the examined claims with a reasonable expectation of success.
Claims 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 20-30 of U.S. Patent No. 10,835,510 in view of Baker et al (US 20160375034), Saha et al (US 20110092589) and Morse et al (Learning from the past: Possible urgent prevention and treatment options for sever acute respiratory infections caused by 2019-nCov).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Baker et al, Saha et al and Morse et al.
Examined claim 1 is directed to a method of treating, managing or lessening the severity of symptoms associated with a respiratory viral infection in a subject, the method comprising administering to the subject a bismuth-thiol (BT) composition that comprises BisEDT suspended therein, wherein administering the BT composition is via inhalation, orally or nasally, using an aerosol device. Claim 2 recites the particle size range.
Reference claim 20 is directed to a method of treating a wound, comprising administering to a subject the composition of claim 1. Claim 22 is directed to a method of treating bacterial infection. Reference claim 24 is directed to method of treating an acute wound, a chronic wound or a wound of epithelial tissue surface that contains microbial biofilm in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a topical formulation that comprises the BT composition of claim 1, wherein the composition is applied to the surface of the infection.
Composition of claim 1 is a bismuth-thiol (BT) composition, comprising a plurality of solid microparticles and a pharmaceutically acceptable carrier, wherein substantially all of said microparticles having a volumetric mean diameter (VMD) of from about 0.4 μm to about 5 μm, said microparticles comprising a BT compound comprising bismuth and/or a bismuth salt, and wherein the composition does not include a liposome. Claim 18 recites that the composition is a liquid suspension and claim 19 delivers the composition via an aerosol.
The difference is that examined claims recite a method of treating or managing or lessening the severity of symptoms associated with a viral respiratory infection via inhalation using an aerosol, while the reference claims disclose a method for treating or inhibiting bacterial infection on a surface. However, as Baker et al teach, it is known that compositions comprising a BT compound such as BisEDT can treat or manage symptoms of a viral infection on natural surfaces including respiratory tract wherein the inhalation is achieved by an aerosol device. Reference claims also do not recite treating SARS, the secondary infection producing superantigens, treating cytokine storm and do not recite adding remdesivir. However, these are known in the art as taught by Saha et al and Morse et al and it would have been obvious to one of ordinary skill in the art to have incorporated them into the examined claims with a reasonable expectation of success.
Claims 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims of U.S. Patent Nos. 12,036,200; 9,408,393; 11,207,288 and 11,974,978 in view of Baker et al (US 20160375034), Saha et al (US 20110092589) and Morse et al (Learning from the past: Possible urgent prevention and treatment options for sever acute respiratory infections caused by 2019-nCov).
An obviousness-type double patenting rejection is appropriate because while the conflicting claims are not identical, the examined claims are not patentably distinct from the reference claims because the examined claims would have been obvious over the reference claims in view of Baker et al, Saha et al and Morse et al.
Examined claim 1 is directed to a method of treating, managing or lessening the severity of symptoms associated with a respiratory viral infection in a subject, the method comprising administering to the subject a bismuth-thiol (BT) composition that comprises BisEDT suspended therein, wherein administering the BT composition is via inhalation, orally or nasally, using an aerosol device. Claim 2 recites the particle size range.
Reference claims are directed to similar methods of treating, managing or lessening the symptoms of an infection on a natural surface. Like the rejections described above, the claims are not patentably distinct.
Due to the number of reference patents the rejections had to be made collectively.
Claims 1-3, 7, 10-11,13, 19, 23, 25-27, 29-30, 88-95,100-101 and 167 are rejected. Claims 34, 41, 46 and 55 are withdrawn.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mina Haghighatian whose telephone number is (571)272-0615. The examiner can normally be reached M-F, 7-5 EST.
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/Mina Haghighatian/
Mina Haghighatian
Primary Examiner
Art Unit 1616
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