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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on February 27, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 25 objected to because of the following informalities: recites “emphysema” twice. Appropriate correction is required.
Claim 25 objected to because of the following informalities: it is suggested that when an acronym (“COPD”, “ARDS”) is used for the first time, it is preceded by its full description (disease name) (i.e. Chronic obstructive pulmonary disease (COPD)). Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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.
Claim 26 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.
Claim 26 recites the limitation "the method of claim 23, wherein the bronchitis" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim as claim 23 does not recite bronchitis. The Examiner is interpreting “the bronchitis” to be referring to bronchitis listed in claim 25.
Claim 26 recites “infiltrative bronchitis,” and this is not a standard medical term. The Examiner will interpret infiltrative bronchitis to mean bronchitis with lung infiltrates. Clarification by amendment in Claim 26 is required.
Claim 27 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.
Claim 27 recites the limitation " the method of claim 23, wherein the asthma" in the first line of the claim. There is insufficient antecedent basis for this limitation in the claim as claim 23 does not recite asthma. The Examiner is interpreting “the asthma” to be referring to asthma listed in claim 25.
Claim Rejections - 35 USC § 112(a)
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.
Claim 23 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Regarding claim 23, “a method for alleviating or treating a respiratory disease” is enabled. However, “a method for preventing a respiratory disease” is not enabled.
The breadth of the claims and the nature of the invention:
The nature of the invention is drawn to the use of a composition containing cyclo-hispro and a zinc salt to prevent, alleviate, or treat respiratory diseases (specification para. [0003]). The specification at paragraph [0048] defines the term "prevention" as any act of suppressing or delaying the onset of a disease or condition. The combination of cyclo-hispro and a zinc salt is described to exhibit a synergistic effect in reducing allergic cytokines and mucus secretions. Asthma is specifically identified as a respiratory disease treated with therapeutic agents with various side effects. The technical solution identified is to develop a therapeutic agent with a new mechanism and fewer side effects (specification para. [0004-0006] and [0030]).
The breadth of claim 23 broadly includes preventing, alleviating, or treating a respiratory disease. “A respiratory disease” in claim 23 is inclusive of any respiratory disease, such as cystic fibrosis, asthma, and lung cancer.
The state of the prior art:
The prior art teaches that drug interventions and vaccines have been used to prevent respiratory infections involving viral or bacterial infections, such as pneumonia, influenza, and tuberculosis (Respiratory Diseases: Meeting the Challenges of Screening, Prevention, and Treatment, NC Med. J., 2013, 74(5)) (pages 388-389, Respiratory Infections).
In regard to lung cancer as a respiratory disease, the prior art teaches that while preventative strategies for lung cancer exist, they do not involve drug treatments. Lung cancer is preventable by eliminating tobacco smoking and environmental irritants, such as radon and asbestos (Respiratory diseases in the world, AJRM, 2014, 9(1)) (pages 9-10). Dragnev teaches there have been some studies on the use of chemopreventative agents in the prevention of lung cancer, but there has not been an agent that has had success in clinical trials (Lung Cancer Prevention, Chest, 2003, 123(1)) (page 68S). Additionally, the prior art teaches that the cause of most asthmas is unknown and thus prevention is problematic (Respiratory diseases in the world, AJRM, 2014, 9(1)) (pages 6-7). Furthermore, cystic fibrosis is a genetic disease caused by mutations in the gene encoding the cystic fibrosis transmembrane conductance regulator (CFTR), and cannot be prevented through drug intervention (Origins of Cystic Fibrosis Lung Disease, NEJM, 2015, 372(4)) (page 351, para. 1).
The prior art does not appear to provide any evidence as to the prevention of all respiratory diseases encompassed by “a respiratory disease” of claim 1.
The level of ordinary skill in the art and quantity of experimentation needed to make or use the invention based on the content of the disclosure:
An ordinary artisan in the field of respiratory diseases would have experience screening compounds for preventative activity, such as bacterial growth inhibition or inhibition of virus replication. Screening for new drug candidates is considered routine in the art, and analyzing in vitro activity to identify potential drugs is well known. However, screening for drug candidates for the prevention of respiratory diseases involving genetic alterations, malignant cancer, or the inflammation involved in asthma is not routine or well-known.
Thus, the level of ordinary skill in the art of preventing any respiratory disease, as recited in claim 23, is high. The ordinary artisan would need specialized knowledge, extensive experimentation, and additional clinical work. Additionally, new mechanisms for the causes of respiratory diseases such as cystic fibrosis and asthma would need to be elucidated to support prevention by drug intervention. Overall, the investigation of the prevention of the aforementioned respiratory diseases would require undue experimentation.
The level of predictability in the art:
The use of a drug composition in the prevention of bacterial or viral respiratory infections is supported by prior art and there are established experimental methods to analyze activity. Thus, preventing these categories of respiratory diseases with the drug composition as claimed would be predictable. However, drug intervention for treating respiratory diseases involving genetic mutations, cancer, or asthma are not well-documented or supported by the prior art. Therefore, preventing respiratory conditions in these categories is not predictable.
The amount of direction provided by the inventor and the existence of working examples:
There is no direction provided by the inventor on a method for the prevention of a respiratory disease or any mechanistic explanation on how the claimed composition would function to prevent one of these diseases. The specification discusses a synergistic effect of the zinc and cyclo-hispro in the working example at paragraph [0096] and defines synergistic in paragraph [0042]. However, no direction on how this relationship would impact respiratory disease prevention is recited. The specification and claims provide a list of diseases and details about the composition itself.
The specification at paragraphs [0082-0096] provides a working example of treatment with the cyclo-hispro and zinc composition in an in vivo asthma model. This animal model used house dust mites to induce the symptoms of asthma, and the results showed a reduction in allergic cytokines and decreasing mucus secretion. This example provides support for the treatment of respiratory diseases involving asthma and increased allergic cytokines and mucus production. However, the working example only provides evidence for the treatment of symptoms, not the prevention of a disease.
Thus, with the previously discussed evidence taken together, the recitation of “a method for preventing a respiratory disease” in claim 23 is not enabled.
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 person shall be entitled to a patent unless –(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.
Claim(s) 23-29 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Jung et al. (WO 2022130295 A1) (hereinafter “Jung”).
The applied reference has common joint inventors and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 23, Jung teaches a composition effective in treating and/or preventing inflammation and fibrosis ([002]) comprising cyclo(His-Pro) (CHP) and zinc (e.g. zinc component of a zinc salt or zinc compound). Examples of zinc salts useful in connection with the invention include zinc chloride, zinc acetate, zinc gluconate, zinc stearate, zinc sulfate, zinc oxide, zinc picolinate, zinc orotate, or zinc citrate ([00105]). An embodiment of the methods, compositions, and uses, the subject may have lung fibrosis. It is noted that lung fibrosis reads on “respiratory disease.” It is noted that treatment reads on the claimed “alleviating” based on the special definitions in the instant application specification at paragraphs [0049-0050]. “Alleviation” is defined as any act to beneficially change the state of a disease or condition. “Treatment” is defined as relieving, mitigating or eliminating, or reversing symptoms of a respiratory disease, which are all beneficial changes to the state of the disease.
Regarding claim 24, Jung teaches in some embodiments, the weight ratio of zinc to CHP is from about 1:15 to about 20: 1. Zinc as noted above relates to the amount of zinc cation ([00104]). It is noted that the range 1:15 to about 20:1 covers the claimed “1:11 to 13.”
Regarding claim 25, Jung teaches the subject can have idiopathic pulmonary fibrosis, radiation-induced pneumonitis, chronic obstructive pulmonary disease, lung emphysema, lung chronic infections and/or inflammation. In other embodiments, the subject with lung fibrosis does not have an autoimmune disease. In other embodiments, the subject has idiopathic pulmonary fibrosis, fibrosis as a result of Graft-Versus-Host Disease (GVHD), endomyocardial fibrosis, uterine fibrosis, myelofibrosis, retroperitoneal fibrosis, scarring after surgery, asthma, aberrant wound healing, glomerulonephritis, and/or multifocal fibrosclerosis. ([0035-0036]).
Regarding claim 26, as previously discussed, Jung teaches the subject can have lung chronic infections and/or inflammation, which reads on “wherein bronchitis is one or more selected from the group consisting of chronic bronchitis and infectious bronchitis.”
Regarding claim 27, Jung teaches the subject has idiopathic pulmonary fibrosis, fibrosis as a result of Graft-Versus-Host Disease (GVHD), endomyocardial fibrosis, uterine fibrosis, myelofibrosis, retroperitoneal fibrosis, scarring after surgery, asthma, aberrant wound healing, glomerulonephritis, and/or multifocal fibrosclerosis. ([0035-0036]). The disease asthma reads on all claimed phenotypes of asthma (“bronchial asthma, atopic asthma, non-atopic asthma, exercise-induced asthma, aspirin-induced asthma, psychogenic asthma, and alveolar asthma”).
Regarding claim 28, “wherein the composition exhibits the effects of i) reducing allergic cytokines and ii) decreasing mucus secretion” is an inherent property of the composition in the instant application method. The composition of Jung is identical to the composition of claim 23, and identical chemical compositions cannot have mutually exclusive properties. Therefore, it is expected that the prior art method would exhibit the same effects as the claimed invention, therefore anticipating claim 28 (See MPEP 2112.01 (II. Composition Claims)).
Regarding claim 29, Jung teaches a composition comprising CHP alone as an active ingredient and a composition comprising zinc may be administered separately. These compositions may be administered simultaneously or sequentially ([0079]).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY L KRINOS whose telephone number is (571)270-1412. The examiner can normally be reached Monday-Thursday 9 AM – 5 PM ET.
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/E.L.K./Examiner, Art Unit 1614
/ALI SOROUSH/Supervisory Patent Examiner, Art Unit 1614
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