DETAILED ACTION
Notice of Pre-AIA or AIA Status
This office action is intended to supersede the Office Action previously issued on 28 April 2026.
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.
Election/Restrictions
Claims 22 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06 February 2026.
Applicant's election with traverse of Group I (claims 1-17) in the reply filed on 06 February 2026 is acknowledged. The traversal is on the ground(s) that there is no search burden. This is not found persuasive because the different inventions would require numerous search queries and classification searches.
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for using a composition comprising hypochlorite solution, does not reasonably provide enablement for a method for preventing a respiratory condition, or inflammatory or auto-immune responses. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
Breadth of Claims
The breadth of the claims is broader than the Applicant’s disclosure. Instant claims 1-17 recite a method for preventing or treating a respiratory, inflammatory, or auto-immune condition or disease. The Applicant’s specification provides examples on using compositions to treat the diseases (Examples 3-7), but does not provide examples or details for how a skilled artisan would “prevent” a respiratory, inflammatory, or auto-immune condition or disease.
Nature of the Invention
The nature of the invention is directed towards a method of using a composition comprising a hypochlorite solution to treat a respiratory, inflammatory, or auto-immune condition or disease.
Level of One of Ordinary Skill
The level of skill of one in the art is assumed to be high, with one having scientific or medical knowledge, experience, and expertise in treating respiratory conditions.
State of the Prior Art
State of prior art, National Heart, Lung, and Blood Institute (nhlbi.nih.gov), teaches that a respiratory condition, such as asthma, cannot be prevented (pg. 3) because there is no known cause. Additionally, amamedicalgroup.com teaches that arthritis, an autoimmune condition, is not curable or entirely preventable (pg. 5).
Level of Predictability in the Art
In regards to the level of predictability, there is unpredictability in the art for curing or preventing respiratory, autoimmune, and inflammatory conditions. Since there are often no known causes of these conditions, it is unclear how the method claimed by the Applicant can successfully cure or prevent a condition when an exact cause is not known.
Amount of Direction Provided by Inventor
The Applicant does not provide any substantial guidance or direction in the specification in regards to the method of preventing autoimmune, respiratory, and inflammatory conditions in order for the instant application to be enabled with respect to the full scope of the claimed method. The instant specification fails to provide details or directions for how a skilled artisan would prevent these conditions. The instant application also fails to show evidence that the claimed method will directly result in preventing these conditions from occurring.
Existence of Working Examples
In regards to the absence of working examples, the instant specification does not provide any scientific data or working examples in order to perform their method of preventing respiratory, autoimmune, and inflammatory diseases.
Quantity of Experimentation Needed
In terms of quantity of experimentation, one skilled in this art would need to conduct numerous experiments involving various subjects or patients, various doses of the hypochlorite composition administered to the patients, and detailed results and analysis of the efficacy of the prevention of the conditions. Since the Applicant does not provide evidence of experimentation in regards to their method of prevention, one would not be able to reasonably conclude that the claimed method in the instant application would result in preventing all inflammatory, autoimmune, and respiratory responses, conditions, and diseases.
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 1, 2, 5, 6, 10, 12-14, 16 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.
Claims 1, 2, 5, 10, and 13 recite language in parenthesis that are not exact synonyms for the preceding terms, such as “about 50-2000 ppm by wt,” “affecting lungs,” and “consisting of.” The parenthetical recitation renders the claim indefinite because it is unclear whether the limitations in the parenthesis are part of the claimed invention or describing an example of preference. See MPEP 2173.05(d).
Regarding claims 1, 5, 10, 12, 14, and 16, the phrase "preferably" 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).
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 § 102
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.
Claim(s) 1-5, 7, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mocny (US 2019/0328776 A1).
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 (claims 1, 4), addressing claims 1-5, 7, 8.
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) 1-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mocny (US 2019/0328776 A1).
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 (entire teaching; claims 1, 4), addressing claims 1-5, 7, 8. 75 ppm is interpreted as falling within the claimed range of 0.005-0.2 wt% (1 wt% = 10,000 ppm; 75 ppm = 0.0075 wt%). 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 9-13. 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 14-17.
Mocny does not teach an exact combination of a hypochlorite solution in a concentration range of about 0.005-0.2 wt% in claim 1.
In regards to selecting the combination of a hypochlorite solution in a concentration range of about 0.005-0.2 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, 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 0.005-0.2 wt% of hypochlorite in a solution. Pending claims 5 and 7 are considered obvious variations of claims 1 and 13 of the reference patent.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danielle Kim whose telephone number is (571)272-2035. The examiner can normally be reached M-F: 9-5 p.m. PST.
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
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