FINAL 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
Receipt is acknowledged of the claim amendments filed on 27 March 2026.
Claims 1-9 are cancelled.
Claims 10-17 have been added.
Claims 10-17 are presented for examination herein.
Rejections Withdrawn
The rejection of claims 1-4 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), 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A1, effective filing date of 08 January 2020) and KEEP (US 7,446,093 B1; patent date of 04 November 2008), is withdrawn in view of the claim amendments filed on 27 March 2026.
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 10-17 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 “producing rapid neurological uptake and alleviation of Parkinson’s motor and cognitive symptoms within minutes and exhibiting 3-4 hours of consistent effectiveness without tachyphlaxis or diminished response” (e.g., claim 10), 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 claims 10 and 14, 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 10 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%). 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 10. 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. 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 10 and necessarily is sufficient to enhance trans-epithelial transport (e.g., claim 14), especially in the absence of evidence to the contrary. 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 % hypochlorous acid in electrolyzed saline solution. Gabizon does not specifically teach DMSO facilitate transport of HOCL through the nasal epithelium and along the olfactory nerve pathway to neural tissue, producing rapid neurological uptake and alleviation of Parkinson’s motor and cognitive symptoms within minutes and exhibiting 3-4 hours of consistent effectiveness without tachyphlaxis or diminished response. 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 claims 10 and 14, 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 10, 13 and 14, 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 (e.g., stabilized hypochlorous acid in equilibrium) (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 claims 10 and 14, 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 claims 11 and 15, 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]). The amount of about 0.02% to about 0.9% w/v overlaps the amount of “about 0.5-1.5% NaCl by weight” recited in claims 11 and 15. Thus, the ranges are rendered prima facie obvious. See MPEP 2144.05 (quoted supra).
Regarding claims 12 and 16, 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).
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 hypochlorous acid composition in electrolyzed saline); 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 with a pH of about 5.4 that is prepared by electrolysis of saline (e.g., stabilized hypochlorous acid composition) as 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).
Regarding the recitations “DMSO facilitates transport of hypochlorous acid across the nasal epithelium and along the olfactory nerve pathway to neural tissue, producing rapid neurological uptake and alleviation of Parkinson’s motor and cognitive symptoms within minutes and exhibiting 3-4 hours of consistent effectiveness without tachyphlaxis or diminished response” (e.g., claims 10 and 14), “maintains bioavailability suitable for neural transport via the olfactory pathway” (e.g., claim 13), and “provides rapid neurological transport to central nervous system tissue following intranasal administration” (e.g., claim 17); 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 hypochlorous acid composition in electrolyzed saline); 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 identical or substantially identical as the instant claimed composition (e.g., substantially identical amount of DMSO, substantially identical amount of HOCl, administered by including nasal spray), therefore, necessarily possesses the same characteristics, e.g., when administered by nasal spray provides transport of hypochlorous acid across the nasal epithelium and along the olfactory nerve pathway to neural tissue, producing rapid neurological uptake and alleviation of Parkinson’s motor and cognitive symptoms (e.g., if administered to a patient with Parkinson’s disease, an intended use) within minutes and exhibiting 3-4 hours of consistent effectiveness without tachyphlaxis or diminished response, maintains bioavailability suitable for neural transport via the olfactory pathway, and provides rapid neurological transport to central nervous system tissue following intranasal administration. 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).
Response to Arguments and the Declaration Under 37 C.F.R. 1.132
Applicant’s arguments will be addressed as they pertain to the new grounds of rejection above.
Applicant argues on page 7 that Gabizon does not teach or suggest the claimed composition. Applicant argues that Gabizon does not teach or suggest the inclusion of hypochlorous acid, nor does it disclose stabilized HOCl solutions within the claimed concentration ranges. Applicant argues that Gabizon does not describe intranasal delivery or transport via the olfactory nerve tract to produce immediate neurological effects. Applicant argues on page 8 that Loff and Panicheva relate to topical or disinfectant uses of HOCl. Applicant argues that Loff describes stabilized hypochlorous acid formulations for ophthalmic solutions and eye drops, which are intended for antimicrobial use and preservation in ocular environments. Applicant argues that Panicheva describes stabilized hypohalous acid solutions primarily for disinfecting or sanitizing applications. Applicant argues that Neither reference teaches neurological delivery, intranasal administration, or the use of HOCl for treating Parkinson’s disease symptoms.
Applicant's arguments filed on 27 March 2026 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.
Applicant argues on page 8 that the prior art fails to suggest the claimed combination or mechanism. Applicant argues that there is no teaching or motivation in the cited prior art suggesting that HOCl should be combined with DMSO for intranasal neurological transport. Applicant argues that the cited prior arts address different technical problems of antimicrobial disinfection, ocular solutions, and prior disease treatment, and none of which suggest the claimed therapeutic approach. Applicant argues on page 9 that the cited references address different technical fields and purposes. Applicant argues that Gabizon concerns treatment of prion-related neurodegenerative diseases using DMSO, Loff discloses stabilized hypochlorous acid formulations for ophthalmic antimicrobial applications, Panicheva relates to stabilized hypohalous acid solutions used primarily for disinfection and sanitations, and Keep discusses penetration enhancement of certain compounds using DMSO. Applicant argues that none of the references suggest combining hypochlorous acid with DMSO for neurological therapy, intranasal delivery targeting the olfactory nerve pathway, rapid neurological transport to neural tissue, and immediate symptomatic relief of Parkinson’s disease. Applicant argues that the Examiner’s reasoning relies on impermissible hindsight reconstruction of the claimed invention. Applicant argues that the claimed neurological transport mechanism is not suggested by the prior art. Applicant argues that the unexpected result of rapid neurological effects within minutes and provides 3-4 hours of symptomatic relief of Parkinson’s disease symptoms is evidence of non-obviousness. Applicant argues on page 10 that present claims are directed not merely to a composition but to a composition possessing a previously unknown neurological transport capability, e.g., trans-epithelia transport through the nasal mucosa and along the olfactory nerve tract, delivering hypochlorous acid to neural tissue.
In response, Applicant is reminded that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). In KSR Int' 1 Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court cautioned that, "[i]n determining whether the subject matter of a patent claim is obvious, neither the particular motivation nor the avowed purpose of the patentee controls. What matters is the objective reach of the claim. If the claim extends to what is obvious, it is invalid under § 103." Id. at 419. In the instant case, in light of the disclosure of Gabizon and the teachings of Loff, Panicheva and Keep (described above); 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.
Applicant argues on page 10 that the claimed invention produces unexpected neurological effects. Applicant argues that the instantly claimed composition achieves rapid symptomatic relief of Parkinson’s disease following intranasal administration and that the rapid neurological response is not suggested by any of the cited prior art and would not have been predictable from the known properties of DMSO or hypochlorous acid individually. The declaration under 37 C.F.R. 1.132 provides an opinion that based on direct clinical observation and the data on patients with Parkinson’s disease, the neurological effects produced by the claimed composition are unexpected, reproducible, and not suggested by the prior art.
In response, the composition that is prima facie obvious in light of the combination of Gabizon in view of Loff, Panicheva and Keep (described above), is identical or substantially identical as the instant claimed composition (e.g., substantially identical amount of DMSO, substantially identical amount of HOCl, administered by including nasal spray), therefore, necessarily possesses the same characteristics, e.g., when administered by nasal spray provides transport of hypochlorous acid across the nasal epithelium and along the olfactory nerve pathway to neural tissue, producing rapid neurological uptake and alleviation of Parkinson’s motor and cognitive symptoms (e.g., if administered to a patient with Parkinson’s disease, an intended use) within minutes and exhibiting 3-4 hours of consistent effectiveness without tachyphlaxis or diminished response, maintains bioavailability suitable for neural transport via the olfactory pathway, and provides rapid neurological transport to central nervous system tissue following intranasal administration. 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).
The affidavit under 37 CFR 1.132 filed on 27 March 2026 has been carefully considered but is insufficient to overcome the rejection of claims 10-17 based upon the rejection under 35 U.S.C. 103(a) as being unpatentable over Gabizon in view of Loff, Panicheva and Keep as set forth above because:
In assessing the probative value of an expert opinion, the examiner must consider the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 227 USPQ 657 (Fed. Cir. 1985), cert. denied, 475 U.S. 1017 (1986). See also In re Oelrich, 579 F.2d 86, 198 USPQ 210 (CCPA 1978).
The declared opinion by Greg Eckel NMD suggests that based on direct clinical observation and the data on patients with Parkinson’s disease, the neurological effects produced by the claimed composition are unexpected, reproducible, and not suggested by the prior art. Claims 10-17 are rejected based upon the rejection under 35 U.S.C. 103(a) as being unpatentable over Gabizon in view of Loff, Panicheva and Keep. It would have been 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. Therefore, Gabizon in view of Loff, Panicheva and Keep teaches identical or substantially identical solution to the instantly claimed solution, which would necessarily possesses the same characteristics, e.g., when administered by nasal spray provides transport of hypochlorous acid across the nasal epithelium and along the olfactory nerve pathway to neural tissue, producing rapid neurological uptake and alleviation of Parkinson’s motor and cognitive symptoms (e.g., if administered to a patient with Parkinson’s disease, an intended use) within minutes and exhibiting 3-4 hours of consistent effectiveness without tachyphlaxis or diminished response, maintains bioavailability suitable for neural transport via the olfactory pathway, and provides rapid neurological transport to central nervous system tissue following intranasal administration. Greg Eckel NMD is the inventor of the instant application, therefore, has interest in the outcome of the case.
Although an affidavit or declaration which states only conclusions may have some probative value, such an affidavit or declaration may have little weight when considered in light of all the evidence of record in the application. In re Brandstadter, 484 F.2d 1395, 179 USPQ 286 (CCPA 1973).
As discussed above, the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness (described above). The record may establish a strong case of obviousness that the objective evidence of nonobviousness is not sufficient to outweigh the evidence of obviousness. See MPEP § 716.
Applicant argues on page 11, that there is a long-felt but unmet need, particularly, that Parkinson’s disease has long presented a need for therapies capable of providing a rapid symptomatic relief without systemic drug administration. Applicant argues on page 12 that despite decades of research into Parkinson’s treatments, no prior art suggests the instant therapeutic approach and that failure of others to discover the solution further supports non-obviousness.
In response, Applicant is reminded that establishing long-felt need requires objective evidence that an art recognized problem existed in the art for a long period of time without solution. The relevance of long-felt need and the failure of others to the issue of obviousness depends on several factors. First, the need must have been a persistent one that was recognized by those of ordinary skill in the art. Second, the long-felt need must not have been satisfied by another before the invention by applicant. See MPEP 716.04. In the instant case, objective evidence has not been provided to establish long-felt need or failure of others.
Thus, for the reasons of record and for the reasons presented above claims 10-17 are rejected under 35 U.S.C. 103(a).
Conclusion and Correspondence
No claims are allowed.
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 extension fee 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 date of this final action.
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/JOHN P NGUYEN/
Examiner, Art Unit 1619
/ANNA R FALKOWITZ/Primary Examiner, Art Unit 1600
