Prosecution Insights
Last updated: October 04, 2026
Application No. 18/705,481

METHODS FOR TREATING RESPIRATORY DISEASES

Non-Final OA §102§103§112§DP
Filed
Apr 26, 2024
Priority
Oct 27, 2021 — AU 2021903441 +1 more
Examiner
IANNUZO, NATALIE NMN
Art Unit
1653
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Mucpharm Pty Ltd.
OA Round
1 (Non-Final)
12%
Grant Probability
At Risk
1-2
OA Rounds
11m
Est. Remaining
84%
With Interview

Examiner Intelligence

Grants only 12% of cases
12%
Career Allowance Rate
5 granted / 40 resolved
-47.5% vs TC avg
Strong +71% interview lift
Without
With
+71.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 4m
Avg Prosecution
55 currently pending
Career history
99
Total Applications
across all art units

Statute-Specific Performance

§101
4.7%
-35.3% vs TC avg
§103
47.0%
+7.0% vs TC avg
§102
11.4%
-28.6% vs TC avg
§112
26.4%
-13.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 40 resolved cases

Office Action

§102 §103 §112 §DP
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 . Election/Restrictions Applicant's election with traverse of the species bromelain (claim 3), acetylcysteine (claim 5), DNase (claim 6), antibacterial agents (claim 11), and chronic obstructive pulmonary disease (claim 12) in the reply filed on 07/28/2026 is acknowledged. The traversal is on the grounds that there is no serious additional burden or different search strategy needed to search the alternatives. This is not found persuasive because the instant application is a 371 application; therefore, the restriction is based on 371 PCT practice and not U.S. practice. Serious search burden is not a requirement for a 371 PCT restriction. Moreover, the species within the Markush groups are not linked as to form a single general inventive concept under PCT Rule 13.1. For example, the glycoprotein affecting proteases set forth in claim 3 all come from different sources and have different structures. The requirement is still deemed proper and is therefore made FINAL. Priority The instant application filed on 04/26/2024 is a 371 of PCT/AU2022/051294 filed on 10/27/2022 and claims priority to AU2021903441 filed on 10/27/2021. AU2021903441 finds support for the instantly claimed invention; therefore, the effective filing date of the instant application is 10/27/2021. Information Disclosure Statement The information disclosure statement (IDS) submitted on 06/05/2024 and 12/18/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. The information disclosure statement filed 04/26/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. Claim Rejections - 35 USC § 112(b), Indefiniteness 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. Claims 6, 12, and 17 are rejected under 35 U.S.C. 112(b) 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. Claim 6 recites “wherein the sputum-degrading agent comprises one or more of the group consisting of”; however, it is unclear if the sputum-degrading agent is narrowed only to the sputum-degrading agents listed in the Markush group, which is closed, or if the sputum-degrading agent is open due to the “comprising” language. Regarding claim 12, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 17 recites the limitation "the site of the disease" within the airway. There is insufficient antecedent basis for this limitation in the claim. No disease site within the airway was previously recited for direct injection to occur. Claim Rejections - 35 USC § 102, Anticipation 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. 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. Claims 1-5, 7, 9-11, 13-15, and 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Morris (WO 2014/094041; Date of Publication: June 26, 2014 – cited in the IDS filed on 04/26/2024). Morris’ general disclosure relates to “compositions containing one or more of the compounds contained in bromelain, or salts, solvates or prodrugs thereof, and one or more mucolytic agents, or salts, solvates or prodrugs thereof, for treatment of diseases involving mucin, especially mucin secreting cancers, or diseases involving blood clots (thrombi)” (see, e.g., Morris, abstract). Regarding claims 1-5 pertaining to a method of administering a glycoprotein affecting protease and a sputum-degrading agent, Morris teaches administration of bromelain and N-acetylcysteine (see, e.g., Morris, Experiments 1-3, pgs. 22-26). Moreover, Morris teaches that aerosol preparations or intranasal inhalation are suitable for administration of the composition (see, e.g., Morris, [00065], [00069]). Morris teaches an effective combination of N-acetylcysteine and bromelain, wherein the N-acetylcysteine is 50 mM and bromelain is 25 g/ml (see, e.g., Morris, Figure 10 & [000131]). Morris teaches that the composition can be administered to treat lung cancer (see, e.g., Morris, [00025], cystic fibrosis, sputum retention, and chest infection (see, e.g., Morris, [00024]). Regarding claim 7 pertaining to administration of the glycoprotein affecting protease and sputum-degrading agent, Morris teaches that the mucolytic agent and the biologically active compound are administered simultaneously, separately, or sequentially (see, e.g., Morris, [00019] & claim 10). Regarding claim 9 pertaining to administration via an inhaler, Morris teaches “Aerosol preparations suitable for inhalation may include solutions and solids in powder form, which may be in combination with a pharmaceutically acceptable carrier, such as an inert compressed gas, e.g. nitrogen” (see, e.g., Morris, [00065]). Regarding claims 10-11 pertaining to additional therapeutic agents, Morris teaches that the composition can comprise an additional biologically active compound, wherein the compound can be an antibacterial agent, such as an antibiotic (see, e.g., Morris, claim 6). Regarding claims 13-14 pertaining to the type of respiratory disease to be treated, Morris teaches that the composition can be administered to treat lung cancer (see, e.g., Morris, [00025], cystic fibrosis, sputum retention, and chest infection (see, e.g., Morris, [00024]). These diseases are not viral infections and not bacterial infections involving biofilms. Regarding claim 15 pertaining to a method of instilling a glycoprotein affecting protease and a sputum-degrading agent, Morris teaches administration of bromelain and N-acetylcysteine (see, e.g., Morris, Experiments 1-3, pgs. 22-26). Moreover, Morris teaches that aerosol preparations or intranasal inhalation are suitable for administration of the composition (see, e.g., Morris, [00065], [00069]). Morris teaches an effective combination of N-acetylcysteine and bromelain, wherein the N-acetylcysteine is 50 mM and bromelain is 25 g/ml (see, e.g., Morris, Figure 10 & [000131]). The Examiner has interpreted “instilling” to be synonymous with “administering”. Additionally, claim 15’s preamble recitation of “treating a respiratory disease in a patient” is considered inherent. Morris teaches the same method steps and the same composition being administered with no specific patient population required; therefore, administration of Morris’ composition comprising bromelain and N-acetylcysteine would be capable of treating a respiratory disease. Regarding claim 18 pertaining to a method of administering a glycoprotein affecting protease, Morris teaches administration of bromelain, which is a glycoprotein affecting protease (see, e.g., Morris, Experiments 1-3, pgs. 22-26). Moreover, Morris teaches that aerosol preparations or intranasal inhalation are suitable for administration of the composition (see, e.g., Morris, [00065], [00069]). Morris teaches an effective combination of N-acetylcysteine and bromelain, wherein the N-acetylcysteine is 50 mM and bromelain is 25 g/ml (see, e.g., Morris, Figure 10 & [000131]). Additionally, claim 18’s preamble recitation of “treating a respiratory disease or condition in a patient” is considered inherent. Morris teaches the same method steps and the same composition being administered with no specific patient population required; therefore, administration of Morris’ composition comprising bromelain and N-acetylcysteine would be capable of treating a respiratory disease or condition. Regarding claim 19 pertaining to a method of administering a glycoprotein affecting protease and a sputum-degrading agent, Morris teaches administration of bromelain and N-acetylcysteine (see, e.g., Morris, Experiments 1-3, pgs. 22-26). Moreover, Morris teaches that aerosol preparations or intranasal inhalation are suitable for administration of the composition (see, e.g., Morris, [00065], [00069]). Morris teaches an effective combination of N-acetylcysteine and bromelain, wherein the N-acetylcysteine is 50 mM and bromelain is 25 g/ml (see, e.g., Morris, Figure 10 & [000131]). Claim 19’s preamble recitation of “inhibiting cytokine activity in a patient or for reducing an inflammatory response in a patient” is considered inherent. Morris teaches the same method steps and the same composition being administered with no specific patient population required; therefore, administration of Morris’ composition comprising bromelain and N-acetylcysteine would be capable of inhibiting cytokine activity in a patient or for reducing an inflammatory response in a patient. Claim Rejections - 35 USC § 103, Obviousness 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. 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. Claims 6 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Morris as applied to claims 1-5, 7, 9-11, 13-15, and 18-19 above, and further in view of Faber (Enzymatic Debridement – Particular Reference to Trypsin and Desoxyribonuclease in the Control of Cough and Sputum Associated with Tuberculosis; 1954 – cited in the IDS filed on 04/26/2024). Morris’ general disclosure is discussed above. However, Morris does not teach: wherein the sputum degrading agent is DNase (claim 6); or wherein the glycoprotein in affecting protease and sputum-degrading agent are nebulized before administration (claim 8). Faber’s general disclosure relates to methods of utilizing trypsin to control cough and heavy production of sputum associated with pulmonary tuberculosis (see, e.g., Faber, “Bronchial Debridement”, pg. 46). Moreover, Faber discloses “Since the viscosity of purulent sputum is largely due to its high content of desoxyribonucleic acid, it was felt that trypsin might profitably be supplemented with desoxyribonuclease, a pancreatic enzyme which has been demonstrated specifically to depolymerize desoxyribonucleic acid in in vitro studies” (see, e.g., Faber, “Bronchial Debridement, pg. 47). Regarding claim 6 pertaining to the sputum-degrading agent, Faber teaches that patients were administered desoxyribonuclease (i.e., deoxyribonuclease) in addition to trypsin (see, e.g., Faber, “Materials”, pg. 47). One of ordinary skill in the art would know that desoxyribonucelase is an antiquated term for deoxyribonuclease. Regarding claim 8 pertaining to the glycoprotein affecting protease and sputum-degrading agent being nebulized, Faber teaches “Trypsin was administered by aerosol inhalation. The most satisfactory method was by means of a Vaponefrin nebulizer, which consisted of the nebulizer itself, a rubber bag containing host water to humidify the aerosol mixture, and a nosepiece” (see, e.g., Faber, “Technique”, pg. 47). It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer via inhalation a composition comprising a glycoprotein affecting protease and sputum-degrading agent, as taught by Morris, wherein the sputum-degrading agent is DNase, as taught by Faber. One would have been motivated to do so because Faber teaches that “the viscosity of purulent sputum is largely due to its high content of desoxyribonucleic acid”; therefore, supplementation “with desoxyribonuclease, a pancreatic enzyme which has been demonstrated specifically to depolymerize desoxyribonucleic acid in in vitro studies” would be beneficial for bronchial debridement alongside trypsin (see, e.g., Faber, “Bronchial Debridement”, pg. 47). Moreover, Morris teaches administration of bromelain and N-acetylcysteine for treatment of respiratory diseases (see, e.g., Morris, Experiments 1-3, pgs. 22-26), wherein N-acetylcysteine is a mucolytic agent that dissolves mucus and helps relieve respiratory difficulties (see, e.g., Morris, [00012]). Based on the teachings of Morris and Faber, N-acetylcysteine and DNase are both mucolytic agents that lower the viscosity of sputum. Therefore, based on the teachings of Morris and Faber, it would have been obvious to administer a composition comprising a glycoprotein affecting protease and sputum-degrading agent, wherein the sputum-degrading agent is DNase, because the viscosity of purulent sputum is largely due to its high content of desoxyribonucleic acid. It would have been secondly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer via inhalation a composition comprising a glycoprotein affecting protease and sputum-degrading agent, as taught by Morris, wherein the composition is nebulized for administration, as taught by Faber. One would have been motivated to do so because Faber teaches that nebulization of the composition resulted in no irritation of the larynx or throat due to Faber utilizing a nose nebulizer since an ordinary mouth nebulizer resulted in irritation for patients previously (see, e.g., Faber, “Technique”, pg. 47). Moreover, Morris teaches administration of bromelain and N-acetylcysteine (see, e.g., Morris, Experiments 1-3, pgs. 22-26). Morris teaches that aerosol preparations or intranasal inhalation are suitable for administration of the composition (see, e.g., Morris, [00065], [00069]). Therefore, based on the teachings of Morris and Faber, it would have been obvious to administer a composition comprising a glycoprotein affecting protease and sputum-degrading agent via a nose nebulizer in order to reduce irritation to the larynx and throat during administration. One would have expected success because Morris and Faber both teach administration of comprising a glycoprotein affecting protease and sputum-degrading agent for treatment of respiratory diseases. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Morris as applied to claims 1-5, 7, 9-11, 13-15, and 18-19 above, and further in view of Ramos (Clinical issues of mucus accumulation; 2014). Morris’ general disclosure is discussed above. However, Morris does not teach: wherein the respiratory disease is chronic obstructive pulmonary disease (COPD) (claim 12). Ramos’ general disclosure relates to mucus hypersecretion and mechanisms pertaining to this hypersecretion in COPD patients (see, e.g., Ramos, abstract). Moreover, Ramos discloses that “Mucus accumulation in COPD patients affects several important outcomes such as lung function, health-related quality of life, COPD exacerbations, hospitalizations, and mortality” (see, e.g., Ramos, abstract). Furthermore, Ramos discloses that COPD is predicted to be the third leading cause of death by 2030 (see, e.g., Ramos, abstract). Regarding claim 12 pertaining to the respiratory disease being COPD, Ramos teaches “The increased output from goblet cells and mucous glands in COPD patients is variably described as “chronic mucus hypersecretion”, “chronic sputum production”, or “chronic bronchitis” (CB)” (see, e.g., Ramos, abstract). Moreover, Ramos teaches “Mucus hypersecretion and chronic productive cough is a feature of CB.1 The primary mechanisms responsible for excessive mucus production in CB in COPD are the overproduction and hypersecretion by goblet cells, and the decreased elimination of mucus” (see, e.g., Ramos, “Mechanism of mucus accumulation in COPD”, pg. 140). Moreover, Ramos teaches that mucolytic agents can be used to treat COPD by “by reducing mucus overproduction, decreasing mucus hypersecretion by control ling inflammation, facilitating mucus elimination by increasing ciliary transport, reducing mucus tenacity, increasing shear stress to augment mucus detachment, and modifying cough (Table 2)” (see, e.g., Ramos, “Treatment options”, pg. 144). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising a glycoprotein affecting protease and sputum-degrading agent for treatment of a respiratory disease, as taught by Morris, wherein the respiratory disease is COPD, as taught by Ramos. One would have been motivated to do so because Ramos teaches that COPD patients have mucus hypersecretion and chronic productive cough due to overproduction and hypersecretion of mucus by goblet cells, as well as decreased elimination of mucus (see, e.g., Ramos, “Mechanism of mucus accumulation in COPD”, pg. 140). Additionally, Ramos teaches that mucolytic agents can be used to treat COPD (see, e.g., Ramos, Table 2). Moreover, Morris teaches administration of bromelain and N-acetylcysteine for treatment of respiratory diseases (see, e.g., Morris, Experiments 1-3, pgs. 22-26), wherein N-acetylcysteine is a mucolytic agent that dissolves mucus and helps relieve respiratory difficulties (see, e.g., Morris, [00012])Morris teaches that the composition can be administered to treat lung cancer (see, e.g., Morris, [00025], cystic fibrosis, sputum retention, and chest infection (see, e.g., Morris, [00024]). Furthermore, Therefore, based on the teachings of Morris and Ramos, it would have been obvious to administer a glycoprotein affecting protease and sputum-degrading agent to treat COPD due to the increased mucus production in COPD patients and since mucolytic agents are a common treatment regimen for COPD patients. One would have expected success because Morris and Buist both teach lung diseases with increased mucus production using mucolytic agents. Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Morris as applied to claims 1-5, 7, 9-11, 13-15, and 18-19 above, and further in view of Xiong (Management of Plastic Bronchitis using α-Chymotrypsin: A Novel Treatment Modality; 2021 – cited in the IDS filed on 06/05/2024). Morris’ general disclosure is discussed above. However, Morris does not teach: wherein the combination is directly instilled into the trachea, bronchi, or lower airway of the patient (claim 16); or wherein the combination is instilled by a direct injection to the site of the disease or mucus plug in the airway at the time of a bronchoscopy (claim 17). Xiong’s general disclosure relates to a plastic bronchitis (PB) “case that is associated with influenza A virus infection, developing in an eight-year-old boy. The diagnosis of PB was confirmed via cast observation following its removal via bronchoscopy. Specifically, the casts were successfully removed via bronchoscopy coupled with endotracheal instilled α-chymotrypsin. Thereafter, the patient gradually improved and successfully extubated. In the clinical follow-up, the patient was asymptomatic and without recurrent casts. Therefore, α-chymotrypsin may be one modality of treatment to remove casts in PB” (see, e.g., Xiong, abstract). Regarding claims 16-17 pertaining to direct installation, Xiong teaches direct installation via injection of α-chymotrypsin into the bronchial cases to remove the casts by continuous endotracheal suction during bronchoscopy (see, e.g., Xiong, pgs. 1, 3, and 5). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer a composition comprising a glycoprotein affecting protease and sputum-degrading agent, as taught by Morris, wherein the composition is administered via direct injection to the bronchi during bronchoscopy, as taught by Xiong. One would have been motivated to do so because Xiong teaches that direct instillation of α-chymotrypsin, a mucolytic agent, results in a reduction in the viscosity of sputum directly within the bronchi of a patient (see, e.g., Xiong, pg. 1). Additionally, Xiong teaches that bronchoscopy and administration of an adjuvant, such as α-chymotrypsin, hypertonic saline, hyaluronic acid, or human recombinant deoxyribonuclease, is a direct and effective method at cast removal for plastic bronchitis patients (see, e.g., Xiong, pg. 5). Moreover, Morris teaches administration of a glycoprotein affecting protease and a sputum-degrading agent, such as bromelain and N-acetylcysteine, respectively, for the treatment of respiratory diseases (see, e.g., Morris, Experiments 1-3, pgs. 22-26), wherein bromelain and N-acetylcysteine are administered via aerosol preparations or intranasal inhalation (see, e.g., Morris, [00065], [00069]). Therefore, based on the teachings of Morris and Xiong, it would have been obvious to directly instill the glycoprotein affecting protease and a sputum-degrading agent, such as bromelain and N-acetylcysteine, respectively, to the bronchi of patients in order to directly treat purulent, viscous mucus within the bronchi specifically. One would have expected success because Morris and Xiong both teach administration of mucolytic agents for the treatment of respiratory diseases. 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 1-5, 7-8, 11, 15, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 33, 35-39, and 43-44 of copending Application No. 17/922,709 (reference application – herein referred to as App’709). Although the claims at issue are not identical, they are not patentably distinct from each other because App’709 claims: A method for the prophylaxis or treatment of a viral infection in a patient, the method comprising administering to the patient a therapeutically effective amount of a combination of a glycoprotein affecting protease and a disulphide bond breaking agent (claim 33); wherein the glycoprotein affecting protease is a cysteine protease (claim 35); wherein the glycoprotein affecting protease is bromelain (claim 36); wherein the disulphide bond breaking agent is acetylcysteine (NAC) (claim 37); wherein the combination is administered into the lungs of the patient (claim 38); wherein the combination is nebulized before administration (claim 39); one or more additional therapeutic agents selected from the group consisting of antivirals, antibacterial agents and antiproteases are co-administered to the patient with the combination (claim 42); and wherein the glycoprotein affecting protease, disulphide bond breaking agent and, optionally, any other additional therapeutic agent(s), are administered to the patient simultaneously, separately or sequentially (claim 44). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. Conclusion Claims 1-19 are rejected. No claims are allowed. Correspondence Information Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST. 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, Sharmila Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NATALIE IANNUZO/Examiner, Art Unit 1653 /SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
Read full office action

Prosecution Timeline

Apr 26, 2024
Application Filed
Sep 11, 2026
Non-Final Rejection mailed — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
12%
Grant Probability
84%
With Interview (+71.4%)
3y 4m (~11m remaining)
Median Time to Grant
Low
PTA Risk
Based on 40 resolved cases by this examiner. Grant probability derived from career allowance rate.

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