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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 08 December 2025 has been entered.
Status of Claims
Receipt is acknowledged of claim amendments filed on 08 December 2025.
Claims 1-4 have been amended.
Claims 5-9 are cancelled.
Claims 1-4 are pending and presented for examination herein.
Rejections Withdrawn
The rejection of claims 1-4 and 8-9 under 35 U.S.C. 103(a) 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filing date of 28 November 2018) and PANICHEVA (US 2020/0138953 A1, effective filing date of 08 January 2020), is withdrawn in view of the claim amendments file 08 December 2025.
Claim Objections
Claim1 is objected to because of the following informalities: Claim 1 recites “HOCL” which contains a typographical error. Appropriate correction is required.
New Grounds of Rejections
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.
Claims 1-4 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 KEEP (US 7,446,093 B1; patent date of 04 November 2008).
Regarding the recitation “for the temporary relief of Parkinson’s Disease Symptoms” (e.g. claims 1 and 9), Applicant is reminded that a preamble that recites the use or purpose of the claimed invention generally does not limit the claim. Catalina, 62 USPQ2d at 1785. In the instant case, the recitation for the temporary relief of Parkinson’s Disease Symptoms” in claims 1 and 8-9 only recites the use of the composition.
Additionally, the intended use of a claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Note: MPEP 2111.02 [R-3].
Gabizon is primarily directed towards a composition for the treatment and/or delaying the onset of clinical symptoms and/or delaying the progress of a neurodegenerative disorder caused by prions (abstract).
Regarding claim 1, 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 a pharmaceutical composition comprising as active ingredient DMSO (page 5, third paragraph). Gabizon discloses that the concentration of DMSO is from about 1% (w/v) to about 100% (w/v) (page 6, first paragraph). The amount of DMSO in instant claim 1 is calculated to be about 2.26% (e.g., (70%)(1 part by volume)=(x)(31 parts by volume); (70%* 1)/31=x; x ~ 2.26%). Thus, the amount of DMSO disclosed by Gabizon of about 1% (w/v) to about 100% (w/v) overlaps the amount of DMSO in the composition of claim 1.
Regarding claim 1, Gabizon discloses that forms for administration including nose sprays (page 13, second paragraph).
Gabizon does not specifically teach that the composition comprises 0.02 to 0.035 % stabilized, equilibrium concentration of Hypochlorous acid in electrolyzed water. Gabizon does not specifically teach DMSO acts as a carrier to facilitate transport of HOCL through the nasal epithelium and into neural tissue via the olfactory nerve tract, resulting in substantially instantaneous alleviation of Parkinson’s motor and cognitive symptoms. The deficiencies are made up for by the teachings of Loff, Panicheva and Keep.
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]).
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 having a pH of from about 5 to about 7 and contains hypochlorous acid prepared by electrolysis of saline (e.g., hypochlorous acid in electrolyzed water) (paragraph [0009]). The solution is stabilized for at least six months (paragraph [0009]). Panicheva teaches that equilibrium of the hypochlorous acid and hypochlorite is “determined predominately by the pH (that is, pH effects the concentration of each component)” (paragraph [0025]). 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 (paragraph [0025]). Panicheva teaches any unit volume including about 100 ml (paragraph [0036]).
Keep is primarily directed towards a composition comprising cyclosporin and DMSO (abstract).
Regarding claim 1, Keep teaches tissue penetrating capabilities of DMSO facilitate penetration of cyclosporin to come into contact with neurons to make it work better (column 4, lines 21-23).
Regarding claim 2, Panicheva teaches that the solution of the invention may also be hypertonic, hypotonic, or isotonic with respect to physiological fluids (blood, plasma, tears, etc.) and that the solution when used for medicine, contains from about 0.02% to about 0.9% w/v NaCl (paragraph [0037]). Panicheva teaches that the solution includes a normal saline solution (paragraph [0037]). The amount of NaCl concentration in the solution in regards to instant claim 2 is about .24% to about .71% (e.g., (0.5% to 1.5%)(28 parts by volume)=(x)(59 parts by volume (total of all the parts by volume)); [(0.5% to 1.5%)*28]/59~x; x~.24% to about .71%). Panicheva teaches any unit volume including about 100 ml (paragraph [0036]).
Regarding claim 3, Gabizon discloses using bottles for DMSO made of glass because DMSO rapidly dissolve rubber (e.g., material non-soluble in DMSO) (page 17, second paragraph).
Regarding claim 4, Gabizon discloses dissolving DMSO in distilled water to make a solution (page 17, fourth paragraph).
Regarding the recitation of “said Hypochlorous acid is of a 0.02 to 0.035 % concentration, made of more than 97.796% electrolyzed H2O and 1.7 to 2.2% NaCl” (e.g., claim 4), even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). See MPEP 2113.
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 produce a solution (e.g., homogeneous solution) for administration by including nose sprays that comprises DMSO in an amount of from about 1% (w/v) to about 100% (w/v), stabilized hypochlorous acid with a pH of about 5.4 that is prepared by electrolysis of saline (e.g., stabilized, equilibrium concentration of Hypochlorous acid in electrolyzed water); wherein the amount of hypochlorous acid is from about 10 to about 10,000 ppm (e.g., about 0.001% to about 1%); and wherein the DMSO provides better tissue penetration of the hypochlorous acid. The person of ordinary skill in the art would have been motivated to make those modifications to: 1) include another active for treatment and/or delaying the onset of clinical symptoms and/or delaying the progress of a neurodegenerative disorder caused by prions by including hypochlorous acid which Loff teaches can kill prions and is naturally produced in the body; 2) obtain a hypochlorous acid that is stable for at least 6 months by using the stabilized hypochlorous acid taught by Panicheva; and 3) facilitate penetration of hypochlorous acid by combining the hypochlorous acid with the DMSO which Keep teaches facilitate penetration of an active when the active is present with DMSO. 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 a pharmaceutical composition comprising as active ingredient DMSO (page 5, third paragraph). Gabizon discloses that the concentration of DMSO is from about 1% (w/v) to about 100% (w/v) (page 6, first 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]). 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 having a pH of from about 5 to about 7 and contains hypochlorous acid prepared by electrolysis of saline (e.g., hypochlorous acid in electrolyzed water) (paragraph [0009]). Keep teaches tissue penetrating capabilities of DMSO facilitate penetration of cyclosporin to come into contact with neurons to make it work better (column 4, lines 21-23).
Response to Arguments
Applicant’s arguments will be addressed as they pertain to the new grounds of rejection above. Applicant’s first argument is that Gabizon discloses DMSO but not HOCl, nasal administration, neurological transport, and treatment of Parkinson’s Disease. Applicant argues that Loff and Panicheva disclose stabilized HOCl but only for dermatological use, ophthalmic solutions, or surface disinfecting, and that neither teaches HOCl absorption through the olfactory nerve tract nor any neurological effect. Applicant argues that nothing in the cited art suggests that combining DMSO with HOCl would yield a formulation capable of instantaneous neurological symptom relief. Applicant argues that there is no motivation to combine.
Applicant's arguments filed on 08 December 2025 have been fully considered but they are not persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, the rejection is based on the combination of Gabizon in view of Loff, Panicheva and Keep. 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 a pharmaceutical composition comprising as active ingredient DMSO (page 5, third paragraph). Gabizon discloses that the concentration of DMSO is from about 1% (w/v) to about 100% (w/v) (page 6, first 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]). 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 having a pH of from about 5 to about 7 and contains hypochlorous acid prepared by electrolysis of saline (e.g., hypochlorous acid in electrolyzed water) (paragraph [0009]). Keep teaches tissue penetrating capabilities of DMSO facilitate penetration of cyclosporin to come into contact with neurons to make it work better (column 4, lines 21-23). In light of the disclosure of Gabizon and the teachings of Loff, Panicheva and Keep, 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 produce a solution (e.g., homogeneous solution) for administration by including nose sprays that comprises DMSO in an amount of from about 1% (w/v) to about 100% (w/v), stabilized hypochlorous acid with a pH of about 5.4 that is prepared by electrolysis of saline (e.g., stabilized, equilibrium concentration of Hypochlorous acid in electrolyzed water); wherein the amount of hypochlorous acid is from about 10 to about 10,000 ppm (e.g., about 0.001% to about 1%); and wherein the DMSO provides better tissue penetration of the hypochlorous acid. The person of ordinary skill in the art would have been motivated to make those modifications to: 1) include another active for treatment and/or delaying the onset of clinical symptoms and/or delaying the progress of a neurodegenerative disorder caused by prions by including hypochlorous acid which Loff teaches can kill prions and is naturally produced in the body; 2) obtain a hypochlorous acid that is stable for at least 6 months by using the stabilized hypochlorous acid taught by Panicheva; and 3) facilitate penetration of hypochlorous acid by combining the hypochlorous acid with the DMSO which Keep teaches facilitate tissue penetration of an active when the active is present with DMSO.
Further, “the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). See also MPEP § 2123. In the instant case, Gabizon discloses that forms for administration including nose sprays (page 13, second paragraph). Thus, it is prima facie obvious from the disclosure of Gabizon that the composition of Gabizon can be administered as a nose spray.
Regarding treatment of Parkinson’s Disease Symptoms, Applicant is reminded that a preamble that recites the use or purpose of the claimed invention generally does not limit the claim. Catalina, 62 USPQ2d at 1785. In the instant case, the recitation for the temporary relief of Parkinson’s Disease Symptoms” in the claims only recites the intended use of the composition.
Regarding HOCl absorption through the olfactory nerve tract, neurological effect, instantaneous neurological symptom relief, the method which is prima facie obvious in light of the combination of Gabizon in view of Loff, Panicheva and Keep, 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 produce a solution (e.g., homogeneous solution) for administration by including nose sprays that comprises DMSO in an amount of from about 1% (w/v) to about 100% (w/v), stabilized hypochlorous acid with a pH of about 5.4 that is prepared by electrolysis of saline (e.g., stabilized, equilibrium concentration of Hypochlorous acid in electrolyzed water); wherein the amount of hypochlorous acid is from about 10 to about 10,000 ppm (e.g., about 0.001% to about 1%); and wherein the DMSO provides better tissue penetration of the hypochlorous acid. The composition that is prima facie obvious in light of the combination of Gabizon in view of Loff, Panicheva and Keep, is substantially the same as the instant claimed composition (e.g., substantially the same amount of DMSO, substantially the same amount of HOCl, administered by including nasal spray), therefore, necessarily possesses the same characteristics, e.g., when administered by nasal spray provides neurological transport, HOCl absorption through the olfactory nerve tract, provides neurological effect and instantaneous neurological symptom relief. The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the composition of the prior art does not possess the same material, structural and steps-like characteristics of the claimed composition. In the absence of evidence to the contrary, the burden is on Applicant to prove that the claimed composition is different from that taught by the prior art and to establish patentable differences. See In re Best 562F .2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2nd 1992 (PTO Bd. Pat. App. & Int. 1989). Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.). MPEP 2112.01 (I).
Further, the composition that is prima facie obvious in light of the combination of Gabizon in view of Loff, Panicheva and Keep is expected to provide improved tissue penetration of HOCl by DMSO because Keep teaches DMSO facilitate penetration of an active when the active is present with the DMSO and administered by including nasal spray.
Applicant argues that the instant specification provides evidence of unexpected results that support non-obviousness, where DMSO-HOCl mixture when atomized nasally produces rapid relief within minutes, exhibits 3-4 hours of consistent effectiveness, without tachyphylaxis or diminished response, which is not predictable from DMSO or HOCl independently.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., nasally produces rapid relief within minutes, exhibits 3-4 hours of consistent effectiveness, without tachyphylaxis or diminished response) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant is reminded that objective evidence which must be factually supported by an appropriate affidavit or declaration to be of probative value includes evidence of unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant. See, for example, In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984). The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965). Examples of attorney statements which are not evidence and which must be supported by an appropriate affidavit or declaration include statements regarding unexpected results, commercial success, solution of a long-felt need, inoperability of the prior art, invention before the date of the reference, and allegations that the author(s) of the prior art derived the disclosed subject matter from the applicant.
Applicant argues that HOCl stability depends critically on equilibrium chemistry, ionic concentration and solvent environment, high DMSO concentrations ordinarily destabilize reactive chlorine species, achieving a homogeneous sprayable solution with neurological bioavailability is non-routine and counterintuitive. Applicant argues the claimed ratios produces stable bioavailability and unique neurological effects.
In response, 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 a pharmaceutical composition comprising as active ingredient DMSO (page 5, third paragraph). Gabizon discloses that the concentration of DMSO is from about 1% (w/v) to about 100% (w/v) (page 6, first paragraph). The amount of DMSO in instant claim 1 is calculated to be about 2.26% (e.g., (70%)(1 part by volume)=(x)(31 parts by volume); (70%* 1)/31=x; x ~ 2.26%). Thus, the amount of DMSO disclosed by Gabizon of about 1% (w/v) to about 100% (w/v) overlaps the amount of DMSO in the composition of 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]). Panicheva teaches that stabilized solutions of hypohalous acid including hypochlorous acid (HOCl) for including disinfecting (paragraph [0002]). 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]). Keep teaches tissue penetrating capabilities of DMSO facilitate penetration of cyclosporin to come into contact with neurons to make it work better (column 4, lines 21-23). Thus, the amount of DMSO and hypochlorous acid are art-recognized result-effective variables, e.g., treat prion disease by killing prion and facilitate tissue penetration, 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 amount of DMSO and hypochlorous acid in order to effectively kill prion and provide improved tissue penetration. 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.
Additionally, the Appellant has not shown any criticality or unexpected results of the ratio of the DMSO to the HOCl. Appellant can rebut a prima facie case of obviousness by showing the criticality of the change. "The law is replete with cases in which the difference between the claimed invention and the prior art is some range or other variable within the claims. . . . In such a situation, the applicant must show that the particular range is critical, generally by showing that the claimed range achieves unexpected results relative to the prior art range." In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See also Minerals Separation, Ltd., et al. v. Hyde, 242 U.S. 261, 271 (1916) (a patent based on a change in the proportions of a prior product or process (changing from 4-10% oil to 1% oil) must be confined to the proportions that were shown to be critical (1%)); In re Scherl, 156 F.2d 72, 74-75 (CCPA 1946) ("Where the issue of criticality is involved, the applicant has the burden of establishing his position by a proper showing of the facts upon which he relies."); In re Becket, 88 F.2d 684 (CCPA 1937) ("Where the component elements of alloys are the same, and where they approach so closely the same range of quantities as is here the case, it seems that there ought to be some noticeable difference in the qualities of the respective alloys."); In re Lilienfeld, 67 F.2d 920, 924 (CCPA 1933) ("It is well established that, while a change in the proportions of a combination shown to be old, such as is here involved, may be inventive, such changes must be critical as compared with the proportions used in the prior processes, producing a difference in kind rather than degree."); In re Wells, 56 F.2d 674, 675 (CCPA 1932) ("Changes in proportions of agents used in combinations . . . in order to be patentable, must be critical as compared with the proportions of the prior processes."). MPEP 2144.05(III)B.
Thus, for the reasons of record and for the reasons presented above claims 1-4 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600