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 .
Status of Claims
Claims 1-3 are pending and presented for examination herein.
Claim Objections
Claim 1 is objected to because of the following informalities: claim 1 recites “A method of for” (emphasis added) which contains grammatical/typographical error. Appropriate correction is required.
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 1-3 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 temporary treatment of Parkinson’s disease, does not reasonably provide enablement for other neurological degenerative disease. 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.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731,8 USPQ2nd 1400 (Fed. Cir, 1988). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.'" (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
(1) The quantity of experimentation necessary
In order to practice the invention across the full claimed scope, the person of ordinary skill in the art would have design, execute and evaluate different clinical trials for each of the other types of neurodegenerative diseases to see if the temporary treatment works for each of the other types of neurodegenerative diseases.
(2) The amount or direction or guidance presented
The instant specification only provides a general statement that the method is able to relieve the physical symptoms of neurodegenerative disorders and immediately stating after that it is “primarily Parkinson’s disease” (paragraph [0033]). The instant specification fails to explain how the temporary treatment applies to other neurodegenerative diseases.
(3) The presence or absence of working examples
The instant specification contains working examples only for Parkinson’s disease and there is no other working examples for any other neurodegenerative disease.
(4) The nature of the invention
The invention is a method providing temporary treatment of neurological degenerative diseases.
(5) The state of the prior art
In the field of neurodegenerative diseases, the underlying biological mechanisms vary drastically between different neurodegenerative diseases.
(6) The relative skill of those in the art
The POSITA is a neurologist, neurobiologist, or a pharmacologist specializing in central nervous system disorders.
7) The predictability or unpredictability of the art
Biotechnology, pharmacology and neurological treatments are in a class of invention which the CAFC has characterized as “the unpredictable arts such as chemistry and biology.” Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001).
(8) The breadth of the claims
The claims encompass a broad genus of any “neurological degenerative disease” which includes distinct pathologies.
The high degree of unpredictability associated with the claimed method underscores the need to provide teachings in the specification that would provide the skilled artisan with specific treatment regimens that achieve preventative benefit by in vivo therapy; however, the specification does not provide such guidance. Without such guidance in the specification and the lack of correlative working examples, to use the invention as instantly claimed would require an undue amount of experimentation without a predictable degree of success on the part of the skilled artisan. This experimentation would be undue considering the rigorous, time-consuming trial and error protocols which need to be performed in order to ascertain if the composition of the instant claims will actually treat or prevent all viral infection or a symptom thereof.
Therefore, it is suggested that the claims be amended to read that the method is for temporary treatment of Parkinson’s disease and administered to the patient in need thereof in order to overcome this rejection.
In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that
"Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
Claims 1-3 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, at the time the invention was made, of the specific subject matter claimed. The courts have stated:
"To fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that "the inventor invented the claimed invention." Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997); In re Gostelli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989) ("[T]he description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed."). Thus, an applicant complies with the written description requirement "by describing the invention, with all its claimed limitations, not that which makes it obvious," and by using "such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention." Lockwood, 107 F.3d at 1572, 41 USPQ2d at 1966." Regents of the University of California v. Eli Lilly & Co., 43 USPQ2d 1398.
In the instant case, claim 1, upon which claims 2-3 depend, include the recitation “for the temporary treatment of a patient with a neurological degenerative disease”. A review of the instant specification, only yields examples for temporary treatment of Parkinson’s disease and paragraph [0033] of the instant specification discloses “The medication is inexpensive, easy to prepare and immediately relieves the physical symptoms of neurodegenerative disorders (primarily Parkinson’s Disease) for approximately three to four hours.” Parkinson’s disease is just a single species and the field of treating neurodegenerative disease is highly unpredictable.
Hussain (“Neurodegenerative Diseases: Regenerative Mechanisms and Novel Therapeutic Approaches”, Brain Sciences, 8, 177, 37 pages, 2018) discloses that neurodegenerative diseases, including Alzheimer’s disease, Parkinson’s disease, Hungtington’s disease, and Multiple sclerosis, are associated with different regions of the brain and different therapeutics are used for treatment of each of the different neurodegenerative diseases (Figure 1). One of ordinary skill in the art could not predict that a temporary treatment that works for Parkinson’s disease would work for all neurological degenerative diseases.
Thus, because the instant specification only discloses for a single species, the instant specification does not provide written description support for an expansive genus of “neurological degenerative disease”. The phrase "primarily Parkinson's Disease" (paragraph [0033]) acts as an admission that the inventor's focus and data are specifically to Parkinson’s Disease. While having written description for temporary treatment of Parkinson’s disease, the specification is devoid of “temporary treatment of a patient with a neurological degenerative disease”.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.") Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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 1-3 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.
Claim 1 recites “70% concentration”, “0.02 to 0.035 % concentration”, “97.796%”, “1.7 to 2.2 % NaCl” and “0.7 – 0.9 percent NaCl” which renders the claim indefinite because it is unclear if the percentages are percentage of w/w, v/v, w/v or any other unites of concentration. Claims 2-3, which are dependent on claim 1, are also indefinite for failing to remedy the deficiencies. As written, one skilled in the art would not be reasonably apprised of the metes and bounds of the claims.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over GABIZON (WO 03/015760 A1, publication date of 27 February 2003) in view of LOFF (US 2020/0069728 A1, effective filing date of 28 November 2018), PANICHEVA (US 2020/0138953 A1, effective filing date of 08 January 2020) and KIECHEL (US 4,885,305; date of patent: 05 December 1989).
Gabizon is primarily directed towards a composition for including treatment a neurodegenerative disorder caused by prions (abstract).
Regarding claims 1-3, Gabizon discloses use of DMSO and composition containing DMSO to treat prion diseases including neurodegenerative disorder caused by prions (page 5, second and third paragraphs). Gabizon discloses that the concentration of DMSO is from about 1% (w/v) to about 100% (w/v), comprising a dosage of DMSO of about 0.2g/kg daily or from about 0.1g to about 30g daily (page 6, first paragraph). The amount of DMSO in the mixed solution in instant claim 1 is calculated to be about (calculation: 1 part (DMSO mix with distilled water) + 58 parts (30 parts electrolyzed anhydrous chloride + 28 parts normalized saline solution) = 59 parts; amount of DMSO in 1 part 0.70 (e.g., .7 x 1=.7); 0.70 parts DMSO/59 total parts ~0.011864; 0.011864x100~1.19% DMSO). The amount of DMSO disclosed by Gabizon of about 1% (w/v) to about 100% (w/v) overlaps the amount of DMSO calculated of about 1.19% in the mixed composition of claim 1. Thus, the amount is rendered prima facie obvious. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also MPEP 2144.05. Gabizon discloses the composition is for preferably including two times per day (e.g., morning and night) (page 11, last paragraph). Gabizon discloses that the composition are in a dosage that includes physiologically acceptable carriers including sodium chloride (page 13, second paragraph). Gabizon discloses that forms for administration includes nose sprays (page 13, second paragraph). Gabizon discloses using bottles for DMSO made of glass because DMSO rapidly dissolve rubber (e.g., material not soluble in DMSO) (page 17, second paragraph).
Gabizon does not specifically teach mixing a homogeneous solution of 1 part DMSO mixed to 70% concentration with distilled water, 30 parts electrolyzed anhydrous chloride (HOCl) of a 0.02 to 0.035 % concentration, made of more than 97.796% electrolyzed H2O and 1.7 to 2.2% NaCl, and 28 parts normalized saline solution having a concentration of 0.7 - 0.9 percent NaCl with distilled water; and administering at least one atomized dose of the homogeneous solution of approximately .4 ml into each nasal cavity of a patient. The deficiencies are made up for by the teachings of Loff, Panicheva and Kiechel.
Loff is primarily directed towards a hypochlorous acid composition comprising stabilized hypochlorous acid (abstract).
Regarding claim 1, Loff teaches that hypochlorous acid has clinically been shown to kill all known pathogens even prions and hypochlorous acid is naturally produced in the body by white blood cells (paragraph [0007]). Loff teaches hypochlorous acid in a range of 50 ppm-500 ppm (e.g., 0.005% to 0.05%) (paragraph [0029]). The amount of HOCl in the mixed solution in instant claim 1 is calculated to be about 0.010% to about 0.0178% (calculation: 59 parts total; amount of HOCl in it the 1 part=0; amount of HOCl in the 30 part = 30 x (.0002 to .00035) = 0.006 to 0.0105; amount of HOCl in the 28 part = 0; 0.006 low end parts HOCl/59 total parts ~0.000102; 0.000102x100~0.010% low end parts of HOCl; 0.0105 high end parts of HOCl/59 total parts 0.000178; 0.000178x100~0.0178%). The amount of hypochlorous acid in a range of 50 ppm-500 ppm (e.g., 0.005% to 0.05%) overlaps the calculated range of hypochlorous acid of claim 1 of about 0.010% to about 0.0178%. Thus, the amount of hypochlorous acid is rendered prima facie obvious. See MPEP 2144.05 (quoted supra).
Panicheva is primarily directed towards a stabilized hypohalous acid solution, which may be conveniently packaged for sale, or stored for later use on demand (abstract).
Regarding claim 1, Panicheva teaches that stabilized solutions of hypohalous acid including hypochlorous acid (HOCl) for including disinfecting (paragraph [0002]). Panicheva teaches stabilized hypohalous acid solution (paragraph [0008-0009]). Panicheva teaches that the solution may have an available free chlorine (AFC) content of from about 10 to about 10,000 ppm (e.g., about 0.001% to about 1% of hypochlorous acid for close to 100% hypochlorous acid) (paragraph [0009]). Panicheva teaches a solution that contains hypochlorous acid prepared by electrolysis of saline (e.g., hypochlorous acid in electrolyzed water) (paragraph [0009]). Panicheva teaches that an electrolyzed sodium chloride solution with a pH of 5.1 to 6.0 has a purity of about ≥95% hypochlorous acid and that at a pH of about 5.4 the solution will contain mostly (close to 100%) hypochlorous acid (e.g., stabilized hypochlorous acid in equilibrium) (paragraph [0025]). Panicheva teaches that solution including 0.01 to 2.0% w/v NaCl (paragraph [0037]). The amount of NaCl in the mixed solution in instant claim 1 is calculated to be about 1.197% to about 1.546% (calculation: 59 parts total; amount of NaCl in it the 1 part=0; amount of NaCl in the 30 part = 30 x (.017 to .022) = .51 to .66; amount of NaCl in the 28 part = 28 x (.007 to .009) = .196 to .252; 0.706 (e.g., .51+.196) low end parts NaCl/59 total parts ~0.01197; 0.01197x100~1.197% low end parts of NaCl; 0.912 (e.g., .66 + .252) high end parts of NaCl/59 total parts 0.01546; 0.01546x100~1.546%). The amount of NaCl 0.01 to 2.0% w/v overlaps the calculated range of NaCl of claim 1 of about 1.197% to about 1.546%. Thus, the amount of NaCl is rendered prima facie obvious. See MPEP 2144.05 (quoted supra).
Kiechel is primarily directed towards nasal pharmaceutical compositions (abstract).
Regarding claims 1-2, Kiechel teaches composition for nasal administration (column 1, lines 8-10). Kiechel teaches that the volume of nasal pharmaceutical composition in liquid form to be dispensed in one dose may vary between wide limits and include from 0.1 to 0.2 ml (column 3, lines 43-44). Kiechel teaches including a dose of 0.5 ml (e.g., approximately .4 ml) of a composition sprayed into each nostril (column 4, lines 9-11). Thus, the volume and number of times to administer in accordance to the volume chosen to deliver a desired dose can both be varied and is prima facie obvious, in the absence of evidence to the contrary.
It would have been prima facie obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to treat a neurodegenerative disorder caused by prions (e.g., neurological degenerative disease) by producing a solution comprising DMSO dissolved in distilled water and hypochlorous acid prepared by electrolysis of saline; fill nasal spray bottle made of glass of the solution; and administer the solution using the nasal spray bottle to each nostril; wherein the concentration of DMSO is from about 1% (w/v) to about 100% (w/v); wherein the amount of hypochlorous acid is in a range of 50 ppm-500 ppm (e.g., 0.005% to 0.05%); wherein the amount of NaCl is 0.01 to 2.0% w/v; wherein the volume of a dose includes .1-.2 ml or .5 ml; and wherein the administration includes twice a day (e.g., morning and night). The person of ordinary skill in the art would have been motivated to make those modifications to continue to treat a neurodegenerative disorder caused by prions by adding another composition that can also eliminate prions including hypochlorous acid, used hypochlorous acid prepared by electrolysis of saline to obtain stable and more pure hypochlorous acid, and varied the volume of each spray for nasal administration as desired. The person of ordinary skill in the art would have reasonably expected success because Gabizon discloses use of DMSO and composition containing DMSO to treat prion diseases including neurodegenerative disorder caused by prions (page 5, second and third paragraphs). Gabizon discloses that the concentration of DMSO is from about 1% (w/v) to about 100% (w/v), comprising a dosage of DMSO of about 0.2g/kg daily or from about 0.1g to about 30g daily (page 6, first paragraph). Gabizon discloses the composition is for preferably including two times per day use (page 11, last paragraph). Gabizon discloses that the composition are in a dosage that includes physiologically acceptable carriers including sodium chloride (page 13, second paragraph). Gabizon discloses that forms for administration includes nose sprays (page 13, second paragraph). Gabizon discloses using bottles for DMSO made of glass because DMSO rapidly dissolve rubber (e.g., material not soluble in DMSO) (page 17, second paragraph). Loff teaches that hypochlorous acid has clinically been shown to kill all known pathogens even prions and hypochlorous acid is naturally produced in the body by white blood cells (paragraph [0007]). Loff teaches hypochlorous acid in a range of 50 ppm-500 ppm (e.g., 0.005% to 0.05%) (paragraph [0029]). Panicheva teaches that stabilized solutions of hypohalous acid including hypochlorous acid (HOCl) for including disinfecting (paragraph [0002]). Panicheva teaches stabilized hypohalous acid solution (paragraph [0008-0009]). Panicheva teaches that the solution may have an available free chlorine (AFC) content of from about 10 to about 10,000 ppm (e.g., about 0.001% to about 1% of hypochlorous acid for close to 100% hypochlorous acid) (paragraph [0009]). Panicheva teaches a solution that contains hypochlorous acid prepared by electrolysis of saline (e.g., hypochlorous acid in electrolyzed water) (paragraph [0009]). Panicheva teaches that an electrolyzed sodium chloride solution with a pH of 5.1 to 6.0 has a purity of about ≥95% hypochlorous acid and that at a pH of about 5.4 the solution will contain mostly (close to 100%) hypochlorous acid (e.g., stabilized hypochlorous acid in equilibrium) (paragraph [0025]). Panicheva teaches that solution including 0.01 to 2.0% w/v NaCl (paragraph [0037]). Kiechel teaches composition for nasal administration (column 1, lines 8-10). Kiechel teaches that the volume of nasal pharmaceutical composition in liquid form to be dispensed in one dose may vary between wide limits and include from 0.1 to 0.2 ml (column 3, lines 43-44). Kiechel teaches including a dose of 0.5 ml of a composition sprayed into each nostril (column 4, lines 9-11).
Regarding the amount of DMSO, the amount of HOCl, and the amount of NaCl, Gabizon discloses DMSO to treat prion diseases including neurodegenerative disorder caused by prions with concentration of DMSO from about 1% (w/v) to about 100% (w/v) (page 5, second and third paragraphs; page 6, first paragraph), Loff teaches that hypochlorous acid has clinically been shown to kill all known pathogens even prions and amount of hypochlorous acid in a range of 50 ppm-500 ppm (e.g., 0.005% to 0.05%) (paragraphs [0007] and [0029]), and Panicheva teaches including amounts of sodium chloride to provide higher purity of hypochlorous acid and teaches amount of 0.01 to 2.0% w/v NaCl (paragraphs [0025] and [0037]). The amount of the amount of DMSO, the amount of HOCl, and the amount of NaCl are art-recognized result-effective variables, e.g., treat neurodegenerative disorder caused by prions, kill prions, and provide higher purity of hypochlorous acid, respectively, which a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal DMSO amount, HOCl amount, and NaCl amount to add and administer in order to best treat neurodegenerative disorder caused by prions. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Regarding the order of mixing ingredients including DMSO in distilled water, electrolyzed anhydrous chloride (HOCl) and NaCl, the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.). Thus, in the absence of evidence to the contrary, mixing 1 part dimethylsulfoxide mixed to 70% concentration with distilled water, 30 parts electrolyzed anhydrous chloride (HOCl) of a 0.02 to 0.035% concentration, made of more than 97.796% electrolyzed water and 1.7 to 2.2% NaCl, and 28 parts normalized saline solution having a concentration of 0.7 – 0.9 percent NaCl with distilled water is prima facie obvious.
Thus, the claimed invention as a whole is clearly prima facie obvious over the teachings of the prior art.
Conclusion and Correspondence
No claims are found allowable.
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/John P Nguyen/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
