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.
This office action is a response to applicant’s communication submitted May 1, 2024, wherein claims 2-3 and 6-10 were preliminarily amended, and claims 11-13 were added.
Claims 1-13 are pending in this application.
Priority
This application is a 371 of PCT/EP2022/080807 filed 11/04/2022 and claims foreign priority to EP21306554.3 filed 11/05/2021. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been received.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (pg. 4, line 2). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is objected to because of the following informalities: On page 7 of the instant specification, the phrase “thus can participate in regulation the mucin secretion” should read “thus can participate in the regulation of mucin secretion” or “thus can participate in regulation of mucin secretion” (pg. 7, lines 10-11).
Appropriate correction is required.
Claim Objections
Claims 8 and 10 are objected to because of the following informalities:
In claim 8, the phrase “the hyaluronic” should read “the hyaluronic acid”.
In claim 8 the phrase “participates in regulation the mucin secretion” should read “participates in regulation of mucin secretion”.
In claim 10 the term “betamethasone” appears three times and is thus redundant.
In claim 10 the terms “flunisolide”, “prednisone”, “prednisolone”, “triamcinolone”, “fluocinolone” and “methylprednisolone” appear twice and is thus redundant.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5-7, and 8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Puchelle (WO 2004/050187, IDS filed May 1, 2024) as evidenced by Adler (Frontiers in Endocrinology, 2013, cited on PTO-892). The English translation of Puchelle relied upon has been provided by the Examiner.
Regarding claims 1-2 and 8: Puchelle teaches a method of treatment of alterations in the upper airways (nasal mucosa) in respiratory diseases such as cystic fibrosis and bronchiolitis, as well as the treatment of inflammation and infection of the upper airways (English translation, pg. 4, para. 13). According to the instant specification cystic fibrosis refers to an inherited autosomal disease associated with mutations to the gene encoding the cystic fibrosis transmembrane conductor regulator (CFTR) (pg. 3, lines 27-29). Thus, wherein Puchelle teaches treatment of cystic fibrosis patients, Puchelle necessarily teaches wherein the subject suffering cystic fibrosis has at least one mutation in the CFTR gene. Hyaluronic acid with molecular weight of less than 40 kDa and a concentration of 0.1 mg /ml in physiological saline solution is administered in a pharmaceutical dose effective at the nasal level in the form of an instillation from a solution prepared in a single-dose bottle fitted with a mouthpiece having a geometry adapted to the nasal cavity of newborns, children or adults (English translation, pg. 4, para. 13). Administration can also be carried out using a pressurized bottle (for adult patients), using a formulation identical to that described above (English translation, pg. 4, para. 14). Hyaluronic acid, by its lubricating action, therefore improves the transport of respiratory mucus by ciliary activity and by coughing (English translation, pg. 4, para. 3). This lubricating action is all the more effective the lower the molecular weight of hyaluronic acid (English translation, pg. 4, para. 3). Puchelle teaches an example of hyaluronic acid having a molecular weight of 40000 Da induces a reduction in the work of adhesion of respiratory mucus (English translation, pg. 4, para. 1). In patients whose respiratory epithelium is altered by various pathologies (asthma, cystic fibrosis, chronic obstructive pulmonary disease, bronchial infections or inflammations or ENT), the mucus is frequently dehydrated and becomes adherent, on the one hand, and the integrity of the epithelial barrier can be altered, on the other hand (English translation, pg. 4, para. 10). According to Adler secretory epithelial cells of the proximal airways synthesize and secrete gel-forming polymeric mucins. Adler discloses the secreted mucins adsorb water to form mucus that is propelled by neighboring ciliated cells, providing a mobile barrier which removes inhaled particles and pathogens from the lungs (abstract). Puchelle teaches the mucociliary transport of respiratory mucus is significantly increased by the hyaluronic acid (i.e. regulation of mucin, English translation, pg. 4, para. 2). Hyaluronic acid, by its lubricating action, therefore improves the transport of respiratory mucus by ciliary activity and by coughing (English translation, pg. 4, para. 3). According to the instant specification, “As used herein, the expression "lung mucosal inflammation" has its general meaning in the art and refers to swelling or irritation of the lung mucosa. As used, the term "mucosa" has its general meaning in the art and denotes the moist tissue lining body cavities which secretes mucous and covered with epithelium.” (pg. 3, lines 19-22). Thus, Puchelle teaches regulation of mucin secretion that treats lung mucosal inflammation.
Regarding claims 5-7: Puchelle further teaches hyaluronic acid is also meant to include pharmaceutically acceptable salts, such as those of potassium, magnesium, sodium (pg. 1, 3rd para. from bottom of page). Given the disclosure of hyaluronic acid and salts potassium, magnesium, and sodium, a genus of three species, a person of ordinary skill in the art would at once envisage these salt forms used in the method of Puchelle (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.
Claims 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Puchelle (WO 2004/050187, IDS filed May 1, 2024) and Adler (Frontiers in Endocrinology, 2013, cited on PTO-892) as applied to claims 1-3 and 8 above.
Regarding claims 5-7: Even if assuming for the sake of argument claims 5-7 were not anticipated by Puchelle, the claims would still have been rendered obvious. Puchelle teaches hyaluronic acid is also meant to include pharmaceutically acceptable salts, such as those of potassium, magnesium, sodium (pg. 1, 3rd para. from bottom of page). Although Puchelle does not explicitly demonstrate the use of the sodium salt, wherein Puchelle teaches sodium as an alternative salt, it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Puchelle (WO 2004/050187, IDS filed May 1, 2024) and Adler (Frontiers in Endocrinology, 2013, cited on PTO-892) as applied to claims 1-3 and 5-8 above in view of Zahm (Matrix Biology, 2011, IDS filed WO 2004/050187).
Regarding claim 3: Puchelle teaches the method of claim 1. Puchelle teaches bacterial colonization of the upper respiratory tract (especially at the nasal level) can predispose to colonization of the bronchial airways, in particular in serious respiratory pathologies of the infant such as cystic fibrosis and bronchiolitis (English translation, pg. 5, para. 5). Eliminating the nasal carriage of bacteria like Staphyloccus aureus reduces the incidence of bacterial infections (English translation, pg. 5, para. 6). The increase in nasal mucociliary transport thanks to the acid prevents bacterial colonization at the nasal level (bacteria reservoir) and prevents infection at the bronchial level (English translation, pg. 5, para. 5).
Puchelle does not specifically teach wherein the lung inflammation is caused by lung infection.
However, Zahm teaches hyaluronan 40 kDa protects the airway epithelium against injury induced by bacterial products during infection (abstract). Zahm teaches hyaluronan has a protective effect against the virulence factors produced by Staphylococcus aureas (pg. 389, col. 2, para. 3). Zahm further hypothesizes the therapeutic potential of hyaluronan in chronic obstructive pulmonary disease or in cystic fibrosis (pg. 391, col. 2, para. 1).
Taken together, it would have been prima facie obvious to apply the method of Puchelle to a cystic fibrosis patient suffering from a bacterial infection as suggested by Zahm. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as low molecular weight hyaluronic acid is known to beneficial in bacterially infected patients, and cystic fibrosis patients are susceptible to bacterial infections, thus, this patient population exists and is in need of treatment. The treatment of lung mucosal inflammation necessarily occurs as a result of treating the underlying condition.
Claims 4 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Puchelle (WO 2004/050187, IDS filed May 1, 2024), Adler (Frontiers in Endocrinology, 2013, cited on PTO-892), Zahm (Matrix Biology, 2011, IDS filed WO 2004/050187) as applied to claims 1-3 and 5-8 above further in view of Biffi (WO 2021181276, cited on PTO-892)
Regarding claims 4 and 12: As discussed above, Puchelle and Zahm render obvious the method of claim 3.
They do not teach wherein the subject suffers from COVID-19, a viral infection.
However, Biffi teaches the use of hyaluronic acid for oral use as an antiviral agent for the treatment of viral infections of the respiratory system (e.g. COVID-19) (abstract). Biffi teaches hyaluronic acid and the salts thereof are macromolecules (pg. 12, lines 23-24). in particular, hyaluronic acid or the salt thereof, preferably sodium hyaluronate, in the context of the present invention preferably has an average molecular weight comprised from 20 kDa to 4000 kDa(pg. 12, lines 24-25). The presence of hyaluronic acid in the composition of the invention combined with acetylcysteine or a salt thereof boosts the mucolytic efficacy of N-acetylcysteine (decrease in mucus viscosity and ease of expectoration/elimination of the mucus for the subject suffering from mucus hyper--production) (pg. 13, lines 1-3). Symptoms or disorders deriving from or relating to said viral infection of the respiratory tract (upper respiratory tract and/or lower respiratory tract), preferably a coronavirus infection as defined above (e.g. SARS-CoV, SARS-CoV-2 or 2019-nCoV, SARS-CoV-like) can be: severe acute respiratory syndrome (SARS), respiratory complications, asthma, chronic obstructive pulmonary disease (COPD), bronchitis, emphysema, cystic fibrosis, cough, pertussis, pneumonia, pleuritis, bronchiolitis, cold, sinusitis, rhinitis, tracheitis, pharyngitis, laryngitis, acute laryngotracheobronchitis, epiglottitis, bronchiectasis, difficulty breathing, dyspnoea (breathlessness, shortness of breath,) fever, fatigue, muscle ache and/or pain, nasal congestion, runny nose, sore throat, gastrointestinal symptoms such as for example nausea and diarrhoea, renal insufficiency, loss of appetite and/or general feeling of malaise (pg. 7, lines 16-24).
Taken together, it would have been prima facie obvious to a person of ordinary skill to apply the method to a cystic fibrosis patient with a covid-19 infection. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes that compositions comprising hyaluronic acid can be used to treat covid 19 by decreasing in mucus viscosity and ease of expectoration/elimination of the mucus for the subject suffering from mucus hyper—production.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Puchelle (WO 2004/050187, IDS filed May 1, 2024), and Adler (Frontiers in Endocrinology, 2013, cited on PTO-892) as applied to claims 1-3 and 5-8 above further in view of Cresta (BMJ Case Rep., 2013, cited on PTO-892) and Ross (Paediatr. Drugs. 2009, IDS filed May 1, 2024).
Regarding claims 9-11: As discussed above, Puchelle teaches the method of claim 1.
Puchelle does not teach administration of hyaluronic acid in combination with a corticosteroid, such as budesonide.
However, Cresta teaches the administration of a composition comprising hyaluronic acid as a maintenance therapy to a subject with cystic fibrosis (abstract). Cresta teaches the subject has F508del/G542X genotype (pg. 1, col. 2, para. 2). Cresta teaches the subject was administered inhaled maintenance therapy with corticosteroid budesonide (pg. 1, col. 2, para. 3). Cresta teaches the subject required frequent oral steroid therapy with betamethasone due to frequent upper respiratory tract infections (pg. 1, col. 2, para. 4). Additionally Ross teaches that corticosteroids are widely prescribed anti-inflammatory agents in CF (abstract).
Taken together it would have been prima facie obvious to administer the composition of Puchelle in combination with a corticosteroid, such as budesonide as suggested by Cresta and Ross. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as administering corticosteroids to cystic fibrosis patients is a known practice in the art in order to combat upper respiratory tract infections. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose (See MPEP 2144.06 (I)). Additionally, a person of ordinary skill in the art would have had the motivation to administer to cystic fibrosis patients with a F508del mutation as suggested by Cresta. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as compositions comprising hyaluronic acid have been administered to this subject population for treating cystic fibrosis, and this subject population is known in the art in need of treatment.
Claims 11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Puchelle (WO 2004/050187, IDS filed May 1, 2024) and Adler (Frontiers in Endocrinology, 2013, cited on PTO-892) as applied to claims 1-3 and 5-8 above further in view of Kummarapurugu (American Journal of Respiratory Cell and Molecular Biology, 2021, cited on PTO-892).
Regarding claims 11 and 13: As discussed above, Puchelle teaches/renders obvious the methods of claims 2 and 8.
Puchelle does not teach wherein the CFTR is F508del/F508del mutated CFTR.
However, Kummarapurugu investigated whether synthetic, low–molecular weight polysulfated hyaluronan GlycoMira-1111 (GM-1111) would be effective as an anti-NE drug using ex vivo cystic fibrosis (CF) sputum. Kummarapurugu studied CF subjects with F508del/F508del genotype (pg. 261, table 1). Kummarapurugu teaches that GM-111 resulted in improvements in mucus clearance and cough clearance (pg. 266, col. 1, para. 1).
Taken together it would have been prima facie obvious to apply the method of Puchelle to a cystic fibrosis subject that is has F508del/F508del mutated CFTR as taught by Kummarapurugu. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as compositions comprising hyaluronan for improving mucus clearance are known in the art to be beneficial in this subject population which is known in the art and in need of treatment.
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 1-2 and 8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/165,864 (unpublished, cited on PTO-892).
Regarding claims 1-2 and 8: The copending claims teach a method of promoting differentiation of ciliated cells in the airway epithelium of a patient suffering from a chronic airway disease comprising administering to the patient a therapeutically effective amount of hyaluronic acid having a low molecular weight from 15,000 to 45,000 Daltons (claim 1). The copending claims teach wherein the method restores airway and pulmonary homeostasis (claim 2). The copending claims teach wherein the method improves mucociliary clearance in the patient suffering from a chronic airway disease (i.e. regulation of mucin secretion, claim 4). The copending claims teach wherein the patient suffers from asthma, cystic fibrosis or COPD (claim 5). According to the instant specification cystic fibrosis refers to an inherited autosomal disease associated with mutations to the gene encoding the cystic fibrosis transmembrane conductor regulator (CFTR) (pg. 3, lines 27-29). Thus, wherein the copending claims teaches treatment of cystic fibrosis patients, the copending claims necessarily teach wherein the subject suffering cystic fibrosis has at least one mutation in the CFTR gene.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/165,864 (unpublished, cited on PTO-892) as applied to claims 1-2 and 8 above in view of Puchelle (WO 2004/050187, IDS filed May 1, 2024). The English translation of Puchelle relied upon has been provided by the Examiner.
Regarding claims 5-7: As discussed above, the copending claims teach the method of claim 1.
They do not teach wherein the hyaluronic acid is in the form of a sodium salt.
However, Puchelle teaches a method of treatment of alterations in the upper airways (nasal mucosa) in respiratory diseases such as cystic fibrosis and bronchiolitis, as well as the treatment of inflammation and infection of the upper airways (English translation, pg. 4, para. 13). Hyaluronic acid with molecular weight of less than 40 kDa and a concentration of 0.1 mg /ml in physiological saline solution is administered in a pharmaceutical dose effective at the nasal level in the form of an instillation from a solution prepared in a single-dose bottle fitted with a mouthpiece having a geometry adapted to the nasal cavity of newborns, children or adults (English translation, pg. 4, para. 13). Puchelle further teaches hyaluronic acid is also meant to include pharmaceutically acceptable salts, such as those of potassium, magnesium, sodium (pg. 1, 3rd para. from bottom of page).
Taken together it would have been prima facie obvious to modify the copending claims such that the sodium salt of hyaluronic acid is used in the method as suggested by Puchelle. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as Puchelle establishes the sodium salt can be used in the treatment of cystic fibrosis. Wherein Puchelle teaches sodium as an alternative salt, it is prima facie obvious to substitute equivalents known for the same purpose (See MPEP 2144.06 (II)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 9-11 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/165,864 (unpublished, cited on PTO-892) as applied to claims 1-2 and 8 above in view of Cresta (BMJ Case Rep., 2013, cited on PTO-892) and Ross (Paediatr. Drugs. 2009, IDS filed May 1, 2024).
Regarding claims 9-11: As discussed above, the copending claims teach the method of claim 1.
They do not teach wherein the hyaluronic acid is administered in combination with a corticosteroid, such as budesonide or to a subject with a F508del-CFTR mutation in the CFTR gene.
However, Cresta teaches the administration of a composition comprising hyaluronic acid as a maintenance therapy to a subject with cystic fibrosis (abstract). Cresta teaches the subject has F508del/G542X genotype (pg. 1, col. 2, para. 2). Cresta teaches the subject was administered inhaled maintenance therapy with corticosteroid budesonide (pg. 1, col. 2, para. 3). Cresta teaches the subject required frequent oral steroid therapy with betamethasone due to frequent upper respiratory tract infections (pg. 1, col. 2, para. 4). Additionally Ross teaches that corticosteroids are widely prescribed anti-inflammatory agents in CF (abstract).
Taken together it would have been prima facie obvious to administer the composition of the copending claims in combination with a corticosteroid, such as budesonide as suggested by Cresta and Ross. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as administering corticosteroids to cystic fibrosis patients is a known practice in the art in order to combat upper respiratory tract infections. It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose (See MPEP 2144.06 (I)). Additionally, a person of ordinary skill in the art would have had the motivation to administer to cystic fibrosis patients with a F508del mutation as suggested by Cresta. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as compositions comprising hyaluronic acid have been administered to this subject population for treating cystic fibrosis, and this subject population is known in the art in need of treatment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 11 and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/165,864 (unpublished, cited on PTO-892) as applied to claims 1-2 and 8 above in view of Kummarapurugu (American Journal of Respiratory Cell and Molecular Biology, 2021, cited on PTO-892).
Regarding claims 11 and 13: As discussed above, the copending claims teach the method of claim 1.
They do not teach wherein the subject has a F508del/F508del mutated CFTR.
However, Kummarapurugu investigated whether synthetic, low–molecular weight polysulfated hyaluronan GlycoMira-1111 (GM-1111) would be effective as an anti-NE drug using ex vivo cystic fibrosis (CF) sputum. Kummarapurugu studied CF subjects with F508del/F508del genotype (pg. 261, table 1). Kummarapurugu teaches that GM-111 resulted in improvements in mucus clearance and cough clearance (pg. 266, col. 1, para. 1).
Taken together it would have been prima facie obvious to apply the method of the copending claims to a cystic fibrosis subject that is has F508del/F508del mutated CFTR as taught by Kummarapurugu. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as compositions comprising hyaluronan for improving mucus clearance are known in the art to be beneficial in this subject population which is known in the art and in need of treatment.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 3 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/165,864 (unpublished, cited on PTO-892) and Puchelle (WO 2004/050187, IDS filed May 1, 2024) as applied to claims 1-2, and 5-8 above in view of Zahm (Matrix Biology, 2011, IDS filed WO 2004/050187).
Regarding claim 3: As discussed above, the copending claims teach the method of claim 1. Puchelle further teaches bacterial colonization of the upper respiratory tract (especially at the nasal level) can predispose to colonization of the bronchial airways, in particular in serious respiratory pathologies of the infant such as cystic fibrosis and bronchiolitis (English translation, pg. 5, para. 5). Eliminating the nasal carriage of bacteria like Staphyloccus aureus reduces the incidence of bacterial infections (English translation, pg. 5, para. 6). The increase in nasal mucociliary transport thanks to the acid prevents bacterial colonization at the nasal level (bacteria reservoir) and prevents infection at the bronchial level (English translation, pg. 5, para. 5).
They do not teach wherein the subject has an infection.
However, Zahm teaches hyaluronan 40 kDa protects the airway epithelium against injury induced by bacterial products during infection (abstract). Zahm teaches hyaluronan has a protective effect against the virulence factors produced by Staphylococcus aureas (pg. 389, col. 2, para. 3). Zahm further hypothesizes the therapeutic potential of hyaluronan in chronic obstructive pulmonary disease or in cystic fibrosis (pg. 391, col. 2, para. 1).
Taken together, it would have been prima facie obvious to apply the method of the copending claims to a cystic fibrosis patient suffering from a bacterial infection as suggested by Zahm. A person of ordinary skill in the art would have the motivation to do so with a reasonable expectation of success as low molecular weight hyaluronic acid is known to beneficial in bacterially infected patients, and cystic fibrosis patients are susceptible to bacterial infections, thus, this patient population exists and is in need of treatment. The treatment of lung mucosal inflammation necessarily occurs as a result of treating the underlying condition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 4 and 12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of copending Application No. 19/165,864 (unpublished, cited on PTO-892), Puchelle (WO 2004/050187, IDS filed May 1, 2024), and Zahm (Matrix Biology, 2011, IDS filed WO 2004/050187) as applied to claims 1-3 and 5-8 above in view of Biffi (WO 2021181276, cited on PTO-892).
Regarding claim 4 and 12: As discussed above, the copending claims and prior art render obvious a method wherein the subject has an infection.
They do not teach wherein the subject has a Covid-19 infection, which is a viral infection.
However, Biffi teaches the use of hyaluronic acid for oral use as an antiviral agent for the treatment of viral infections of the respiratory system (e.g. COVID-19) (abstract). Biffi teaches hyaluronic acid and the salts thereof are macromolecules (pg. 12, lines 23-24). in particular, hyaluronic acid or the salt thereof, preferably sodium hyaluronate, in the context of the present invention preferably has an average molecular weight comprised from 20 kDa to 4000 kDa(pg. 12, lines 24-25). The presence of hyaluronic acid in the composition of the invention combined with acetylcysteine or a salt thereof boosts the mucolytic efficacy of N-acetylcysteine (decrease in mucus viscosity and ease of expectoration/elimination of the mucus for the subject suffering from mucus hyper--production) (pg. 13, lines 1-3). Symptoms or disorders deriving from or relating to said viral infection of the respiratory tract (upper respiratory tract and/or lower respiratory tract), preferably a coronavirus infection as defined above (e.g. SARS-CoV, SARS-CoV-2 or 2019-nCoV, SARS-CoV-like) can be: severe acute respiratory syndrome (SARS), respiratory complications, asthma, chronic obstructive pulmonary disease (COPD), bronchitis, emphysema, cystic fibrosis, cough, pertussis, pneumonia, pleuritis, bronchiolitis, cold, sinusitis, rhinitis, tracheitis, pharyngitis, laryngitis, acute laryngotracheobronchitis, epiglottitis, bronchiectasis, difficulty breathing, dyspnoea (breathlessness, shortness of breath,) fever, fatigue, muscle ache and/or pain, nasal congestion, runny nose, sore throat, gastrointestinal symptoms such as for example nausea and diarrhoea, renal insufficiency, loss of appetite and/or general feeling of malaise (pg. 7, lines 16-24). Biffi teaches viral infections of the respiratory tract affect the lungs (pg. 1, lines 16-18).
Taken together, it would have been prima facie obvious to a person of ordinary skill to apply the method of the copending claims to a cystic fibrosis patient with a covid-19 infection. A person of ordinary skill in the art would have had the motivation to do so with a reasonable expectation of success as the art establishes that compositions comprising hyaluronic acid can be used to treat covid 19 by decreasing in mucus viscosity and ease of expectoration/elimination of the mucus for the subject suffering from mucus hyper—production.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed in this action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Di Cicco (J. Cystic Fibrosis, 2014, cited on PTO-892) teaches a nasal spray formulation containing hyaluronate and tobramycin in cystic fibrosis patients with bacterial rhinosinusitis (title).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL L GALSTER whose telephone number is (571)270-0933. The examiner can normally be reached Monday - Friday 8:00 AM - 5:00 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Scarlett Y Goon can be reached at 571-270-5241. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL L GALSTER/Examiner, Art Unit 1693
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