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 .
Priority
The instant application was filed 12 January 2024 and is the national stage entry of PCT/EP2022/069154 filed 08 July 2022. The Applicant claims priority to foreign application GB2110146.4 filed 14 July 2021. An English copy of the foreign document has been provided. Therefore, the effective filing date of the instant application is 14 July 2021.
Examiner’s Note
The Applicant's amendments and arguments filed 04 August 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections
not reiterated from previous office actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant’s response, filed 04 August 2026, it is noted that claims 1, 2, 5-7, 12-14 have has been amended, claims 9, 10, 16, and 17 have been canceled, and claims 25-28 have been newly added. Support for the amendment(s) and new claim(s) can be found on at least pg. 3 of the instant specification. No new matter has been added.
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 2 and 6 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.
Regarding claims 2 and 6, the phrase "such as" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
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.
Claim(s) 1-8, 11-15, 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mocny (US 2019/0328776 A1) and ECDC Technical Report (March 2020).
Mocny teaches a method for treating a pulmonary infection, interpreted as an acute respiratory condition and inflammatory condition of the lungs, comprising administering a subject through inhalation of an inhaler or nebulizer (para. 16) with 75 ppm of hypochlorite (entire teaching; claims 1, 4) or 4-100 ppm of sodium hypochlorite (para. 77, claim 22), addressing claims 1-5, 7, and 8. 75 ppm and 100 ppm are interpreted as falling within the claimed range of “about 0.04-0.06 wt% (1 wt% = 10,000 ppm; 75 ppm = 0.0075 wt%; 100 ppm = 0.01 wt%) for claims 1 and 5. The composition may also be used for arthritis (para. 59), addressing claim 6. The formulation may include 4-100 ppm of sodium hypochlorite (para. 77, claim 22), sodium chloride (para. 75) in an amount of 0.01-10% (para. 71), and diluents/water (para. 81), addressing claims 11-13. The composition may include buffers, such as citrate buffers (para. 87), but is not required (para. 79), and the composition may have a pH range of 5-8.5 (para. 88), addressing claims 14 and 15.
Regarding new claims 25 and 26, the composition may comprise 0.01-10% (para. 71) of sodium chloride (para. 75).
Regarding new claim 27, Mocny teaches a method for treating a pulmonary infection, interpreted as an acute respiratory condition and inflammatory condition of the lungs, comprising administering a subject through inhalation of an inhaler or nebulizer (para. 16) with 75 ppm of hypochlorite (entire teaching; claims 1, 4) or 4-100 ppm of sodium hypochlorite (para. 77, claim 22), addressing claims 1-5, 7, and 8. 75 ppm and 100 ppm are interpreted as falling within the claimed range of “about 0.04-0.06 wt% (1 wt% = 10,000 ppm; 75 ppm = 0.0075 wt%; 100 ppm = 0.01 wt%). Furthermore, the amounts of components can be viewed as a variable that achieves the recognized result of successfully making the hypochlorite composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Mocny. The optimum or workable range of amounts can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B).
Regarding new claim 28, Mocny teaches that clinical manifestations of cystic fibrosis include pancreatitis (para. 4). The composition taught by Mocny treats cystic fibrosis and is interpreted as addressing a method for treating pancreatitis, especially with use of anti-inflammatory agents (para. 6).
Mocny does not teach an exact combination of a hypochlorite solution in a concentration range of about 0.04-0.06 wt% in claim 1. Mocny does not specifically teach a concentration of sodium hypochlorite in the range of 0.04-0.06 wt% in claims 1 and 5.
In regards to selecting the combination of a hypochlorite solution in a concentration range of about 0.04-0.06 wt %, “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G.Pro, 425 U.S. 273, 282 (1976)). “When the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Mocny teaches a method for treating a pulmonary infection, interpreted as an acute respiratory condition and inflammatory condition of the lungs, comprising administering a subject through inhalation with 75 ppm of hypochlorite or 100 ppm of sodium hypochlorite, whereas the claimed invention is directed towards a method for treating a respirator condition comprising a hypochlorite solution in a concentration range of about 0.005-0.2 wt%. Since Mocny teaches the individual components of the claimed composition, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients to arrive at the claimed invention with a reasonable expectation of success.
In regards to selecting particular excipient amounts and conditions, such as pH, buffers, etc., the adjustment of particular conventional working conditions (e.g., determining result effective amounts of the ingredients beneficially taught by the cited references, especially within the broad ranges instantly claimed), is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Accordingly, this type of modification would have been well within the purview of the skilled artisan and no more than an effort to optimize results. Therefore, it would be obvious to adjust the pH, buffers, NaCl, etc., to maintain a stable composition for the intended purpose, e.g. for use as a medical or drug delivery device or composition.
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 5 and 7 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 13 of U.S. Patent No. 10188676 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference patent recites a method for treating an inflammatory response of a hypochlorite solution consisting of water, 0.05-0.1 wt% of sodium hypochlorite, and sodium chloride. Similarly, claim 13 of the reference patent recites a method for treating an inflammatory response comprising a hypochlorite solution consisting of water, 0.005-0.2 wt% of sodium hypochlorite, and sodium chloride. The claims correspond to instant claims 5 and 7, which recite a method for preventing or treating an inflammatory condition and an acute inflammatory condition comprising administering about 0.04-0.06 wt% of sodium hypochlorite in a solution. Pending claims 5 and 7 are considered obvious variations of claims 1 and 13 of the reference patent.
Response to Arguments
Applicant's arguments filed 04 August 2026 have been fully considered but they are not persuasive.
The Applicant argues that claims 2 and 6 have been amended to remove “such as” (Remarks, pgs. 6-7).
Applicant’s argument is not found persuasive. The term “such as” remains in the most recently filed claim set. Therefore, the 112b rejection is maintained. See MPEP § 2173.05(d).
The Applicant argues that Mocny fails to disclose a sodium hypochlorite solution for use in the prevention or treatment of a respiratory condition or disease, or inflammatory response, comprising 400-600 ppm sodium hypochlorite (Remarks, pg. 8). The Applicant further argues that no other concentrations other than 75 ppm are taught by Mocny (Remarks, pg. 8).
Applicant’s argument is not found persuasive. Mocny teaches 75 ppm of hypochlorite (entire teaching; claims 1, 4) or 4-100 ppm of sodium hypochlorite (para. 77, claim 22). 75 ppm and 100 ppm are interpreted as falling within the claimed range of “about 0.04-0.06 wt% (1 wt% = 10,000 ppm; 75 ppm = 0.0075 wt%; 100 ppm = 0.01 wt%). Furthermore, the amounts of components can be viewed as a variable that achieves the recognized result of successfully making the hypochlorite composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Mocny. The optimum or workable range of amounts can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B).
The Applicant argues that no other experimental interrogation is disclosed in Mocny, other than those using 75 ppm (Remarks, pg. 8).
Applicant’s argument is not found persuasive. The Applicant is erroneously pointing to narrow embodiments expressly disclosed within the prior art reference as representing the sum total of information conveyed by each. Art is art, not only for what it expressly teaches, but also for what it would reasonably suggest to the skilled artisan, including alternative or non-preferred embodiments (see MPEP § 2123).
The Applicant argues patients who received sodium hypochlorite in the claimed range amount experienced fewer side effects, as allegedly exemplified in Examples 3-7 and 9 (Remarks, pgs. 9-11).
Applicant’s argument is not found persuasive. In regards to the claimed range of 0.04-0.06% for sodium hypochlorite in claims 1 and 5, Mocny teaches 75 ppm of hypochlorite (entire teaching; claims 1, 4) or 4-100 ppm of sodium hypochlorite (para. 77, claim 22). 75 ppm and 100 ppm are interpreted as falling within the claimed range of “about 0.04-0.06 wt% (1 wt% = 10,000 ppm; 75 ppm = 0.0075 wt%; 100 ppm = 0.01 wt%). Additionally, ECDC Technical Report teaches that 0.05% of sodium hypochlorite can be used on cleaning surfaces “to reduce the irritant effects on the mucosae” (pg. 2), therefore implying that when or if inhaled, an amount of 0.05% of sodium hypochlorite is not expected to cause serious harm or irritation. Therefore, it is not unexpected or surprising that patients who received this amount of sodium hypochlorite through some form of inhalation would not experience adverse reactions. Furthermore, the amounts of components can be viewed as a variable that achieves the recognized result of successfully making the hypochlorite composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Mocny. The optimum or workable range of amounts can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B).
The Applicant argues that Mocny does not teach the limitations in claim 27 (Remarks, pg. 11).
Applicant’s argument is not found persuasive. Regarding new claim 27, Mocny teaches a method for treating a pulmonary infection, interpreted as an acute respiratory condition and inflammatory condition of the lungs, comprising administering a subject through inhalation of an inhaler or nebulizer (para. 16) with 75 ppm of hypochlorite (entire teaching; claims 1, 4) or 4-100 ppm of sodium hypochlorite (para. 77, claim 22), addressing claims 1-5, 7, and 8. 75 ppm and 100 ppm are interpreted as falling within the claimed range of “about 0.04-0.06 wt% (1 wt% = 10,000 ppm; 75 ppm = 0.0075 wt%; 100 ppm = 0.01 wt%).
Response to Double Patenting Arguments
Applicant's arguments filed 04 August 2026 have been fully considered but they are not persuasive.
The Applicant argues that a prima facie case of obviousness has not been established and that the cited references do not teach the limitations of the rejected claims (Remarks, pg. 11).
Applicant’s argument is not found persuasive. As recited above, although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the reference patent recites a method for treating an inflammatory response of a hypochlorite solution consisting of water, 0.05-0.1 wt% of sodium hypochlorite, and sodium chloride. Similarly, claim 13 of the reference patent recites a method for treating an inflammatory response comprising a hypochlorite solution consisting of water, 0.005-0.2 wt% of sodium hypochlorite, and sodium chloride. The claims correspond to instant claims 5 and 7, which recite a method for preventing or treating an inflammatory condition and an acute inflammatory condition comprising administering about 0.04-0.06 wt% of sodium hypochlorite in a solution. Pending claims 5 and 7 are considered obvious variations of claims 1 and 13 of the reference patent. Therefore, the double patenting rejection of instant claims 5 and 7 over claims 1 and 13 of US 10188676 B2 is maintained.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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