DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Status of the Claims
The response and amendment filed 03/23/2026 is acknowledged.
Claims 19-41 are pending.
Claims 1-18 were cancelled.
Claims 25-41 are new.
Applicant’s election without traverse of Group II, claims 19-24 in the reply filed on 03/23/2026 is acknowledged.
Applicant’s election without traverse of lower esophageal spasms as species of condition treated in the reply filed on 03/23/2026 is acknowledged.
Applicant indicates claims 19-41 read on the elected species and invention.
Claims 19-41 are treated on the merits.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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.
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 23-24 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 pre-AIA the applicant regards as the invention.
Claims 23-24 recite a concentration, e.g., ppm and ppb respectively, in parts by weight with respect to the total weight of the composition. The skilled artisan cannot determine what this limitation means.
Concentration, e.g., parts per million or parts per billion (PPM/PPB), is mass of solute (NO/H2) per unit volume, e.g., ppm = mg/ml. Concentration in ppm/ppb will vary depending on the volume. See Kramer, e.g., 0073, 6.4 ppm NO generated in the cabinet is roughly 56 ppm generated in the stomach with smaller volume. No volume is specified in the claim.
It is also not clear how one would determine the PPM or PPB of a gas in parts by weight with respect to the total weight of the composition of claim 19. It is not clear, e.g., how one would calculate PPM or PPB based on a total weight of the composition.
Further, since the method of claim 19 does not require administering a gas, it is not clear how claims 23-24 were intended to further limit the subject matter of claim 19.
Clarification is required.
Claims 40-41 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 pre-AIA the applicant regards as the invention.
Claim 40 includes the limitation of the method of claim 19, further comprising a hydrogel-forming polymer selected from the group consisting of konjac glucomannan, xanthan gum, chitosan, chitosan oligosaccharide, kappa carrageenan, lambda carrageenan, sulfated polysaccharide, alginate, pectin, and combinations thereof.
It is not clear what further comprises a hydrogel forming polymer. For the purposes of examination this is interpreted to mean the composition comprising a base metal powder, a nitrogen-containing salt, and an acid further comprises a hydrogel-forming polymer selected from the group consisting of konjac glucomannan, xanthan gum, chitosan, chitosan oligosaccharide, kappa carrageenan, lambda carrageenan, sulfated polysaccharide, alginate, pectin, and combinations thereof.
Claim 41 includes the limitation of wherein the hydrogel-forming polymer is present at a concentration from 5 wt% to 70 wt%. However, claim 41 does not state the total weight the percent is calculated from. Therefore, the skilled artisan cannot reasonably determine the metes and bounds for which applicant is claiming protection.
Clarification is required.
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.
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 19-35, 37 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Stamler, US 6472390 and Kramer, US 20220249796 A.
Kramer teaches a composition which generates nitric oxide (NO), which composition comprises a base metal powder (Kramer, e.g., 0032 and 0037 and 0043 and 0057 and 0060), a nitrate salt or botanical source of nitrate (Kramer, e.g., 0009, 0016, 0038, 0042, 0043) – which is a nitrogen containing salt – and, an acid such as citric acid (Kramer, e.g., 0008, 0043). See also Kramer, e.g., claims 27-30. Oral compositions having the claimed combination are disclosed (Kramer, e.g., 0077 and example 10). Kramer teaches the composition as a known alternative for NO donors (Kramer, e.g., 0002). Kramer teaches the composition generates the NO agent with little to no toxic NO2 generation (Kramer, e.g., 0077 and 0093). Kramer teaches the composition effective to produce NO agent in a cost effective and simpler manner than other NO generating methods (Kramer, e.g., 0024).
Kramer teaches the composition effective to benefit subjects in need of increased NO levels (Kramer, e.g., 0035). Kramer teaches the composition effective for treating high blood pressure, cardiopulmonary conditions, treating respiratory illness, or hypertension (Kramer, e.g., 0002 and 0014). Kramer does not expressly teach treating subjects for lower esophageal spasms.
Stamler teaches methods of treating esophageal spasms with a composition comprising an NO donor which generates nitric oxide and associated bioactivity thereof (Stamler, e.g. claims 1 and 5, and c3:65-c5:24). Stamler does not expressly teach a composition comprising a base metal powder, a nitrogen containing salt, and an acid.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to combine the teachings of Kramer and Stamler to practice a method of treating lower esophageal spasm by administering a composition comprising a base metal powder, a nitrogen containing salt, and an acid with a reasonable expectation of success.
Starting from Kramer, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify Kramer’s methods of treatment comprising administering a composition comprising a metal powder, a nitrite or nitrate salt, and an acid by administering the composition to subjects suffering from esophageal spasm with a reasonable expectation of success. The skilled artisan would have been motivated to treat esophageal spasm using Kramer’s nitric oxide generating composition since Stamler clearly taught that nitric oxide generating composition may be administered to treat conditions involving constriction of smooth muscle generally, including hypertension (high blood pressure) and esophageal spasm specifically. The skilled artisan would have seen this as the use of a known composition to achieve the predictable result of treating muscle spasm in the esophagus. The skilled artisan would have had a reasonable expectation of success since Kramer teaches the composition generates NO in amounts sufficient to elicit treatments benefits such as reducing blood pressure and since Stamler teaches nitric oxide generating compositions effective for treating hypertension are also effective for treating other smooth muscle related disorders including esophageal spasm.
Starting from Stamler, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to practice Stamler’s method for treating esophageal spasm using Kramer’s nitric oxide generating composition with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification since Kramer teaches the composition is effective to generate NO in a more cost effective and safe manner. The skilled artisan may have seen this modification as the substitution of one known nitric oxide generating composition for another to achieve predictable results. See MPEP 2144.06, II. The skilled artisan would have had a reasonable expectation of success since Kramer teaches the composition generates NO in amounts sufficient to elicit treatments benefits such as reducing blood pressure and since Stamler teaches nitric oxide generating compositions effective for treating hypertension are also effective for treating other smooth muscle related disorders including esophageal spasm.
Applicable to claim 20: Stamler teaches administering the composition comprising the NO donor topically (Stamler, e.g., c5:63-37).
Applicable to claim 21: Kramer teaches the composition in the form of a gel or paste or liquid (Kramer, e.g., 0013).
Applicable to claim 23: This claim is interpreted as reciting a property of the composition of claim 19. The prior art composition is the same as that claimed. Therefore, the prior art composition is capable of generating NO at a concentration from 50 ppb to 150 ppm, in parts by weight with respect to a total weight of the composition, for a time period from 0.1 hour to 50 hours. Kramer teach the composition is able to generate NO in the claimed range, e.g., 1-500 ppm NO (Kramer, e.g., 0019).
Applicable to claim 24: This claim is interpreted as reciting a property of the composition of claim 19. The prior art composition is the same as that claimed. Therefore, the prior art composition is capable of generating H2 at a concentration of from 50 ppb to 3000 ppb, in parts by weight with respect to a total weight of the composition, for a time period from 0.1 hour to 50 hours. Kramer teach the composition is able to generate H2 in the claimed range, e.g., 1-10000 ppm hydrogen gas (Kramer, e.g., 0019: note 1 ppm is 1000 ppb, thus the prior art range overlaps with the claimed range).
Applicable to claim 25: Kramer clearly teaches the composition generates and sustains NO and hydrogen gas when mixed with water (Kramer, e.g., 0020 and 0069).
Applicable to claim 26: Kramer teaches zinc, magnesium or calcium (Kramer, e.g., claim 2 and 30 and 0008 and 0012 and 0016 and 0031).
Applicable to claims 27-34: Kramer teaches compositions containing 1-2000mg elemental metal and 30-4000 mg nitrate anion (Kramer, e.g., claim 7 and 0009). Additional effective amounts are found in Kramer, e.g., 0014. Kramer also teaches compositions comprising, e.g., 1000 potassium nitrate, and 200 mg elemental magnesium and 1000 mg citric acid (Kramer, e.g., 0055). This is 45% nitrate salt, 10% base metal, and 45% citric acid based on the total weight of the solid ingredients. Kramer also teaches a composition comprising 1000 mg citric acid, 1200 mg KNO3, and 200 mg magnesium metal and 50 mg zinc metal. This is about 41% citric acid, 49% KNO3, and 10% metal powder. Thus, it would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to formulate a composition comprising a nitrate salt, elemental magnesium, and citric acid within the claimed percent ranges to predictably arrive at a composition effective to generate NO when added to water or consumed based on the teachings of Kramer.
Applicable to claims 35 and 37: Kramer expressly teaches the nitrate source may include beet powder, celery powder, spinach powder (Kramer, e.g., 0038).
Applicable to claim 39: Kramer teaches the botanical source, e.g., beetroot powder may be preset in the composition in an amount standardized for the nitrate or nitrite content. Consequently, the skilled artisan would have optimized the amount of botanical source, e.g., beetroot powder in the composition to achieve a desired amount of nitrite or nitrate depending on factors including how much nitrate or nitrite is desired and the standardized amount of nitrite or nitrate present in the particular botanical material with a reasonable expectation of success.
Accordingly, the subject matter of claims 19-35, 37 and 39 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 36 and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Stamler, US 6472390 and Kramer, US 20220249796 A as applied to claims 19-35, 37 and 39 above, and further in view of Bryan, US 20160361353.
The combined teachings of Stamler and Kramer enumerated above teach a method according to claim 19, wherein the composition comprises a botanical source of nitrates or nitrites, but do not expressly teach the botanical sources set forth in claims 36 and 38.
However, Bryan teaches compositions for generating NO wherein the nitrate or nitrite botanical source includes, e.g., ginseng, grape, beet powder, coffee, and tea (Bryan, entire document, title, abstract, claims and description e.g., 0035-0036).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the nitric oxide generating composition used in a method suggested by the combined teachings of Stamler and Kramer using the teachings of Bryan with a reasonable expectation of success. Since Kramer teaches the nitrate or nitrite source may be botanical, the skilled artisan would have been motivated to use known, botanical sources of nitrate and/or nitrite such as ginseng, grape, beet powder, coffee, and tea suggested by Bryan with a reasonable expectation of arriving at a composition effective to generate nitric oxide in the same way. The skilled artisan may have seen this modification as a substitution of one known botanical nitrate/nitrite source for another where each were known in the prior art as effective for use in nitric oxide producing compositions to treat subjects. The skilled artisan would have had a reasonable expectation of success since Kramer suggests any botanical source may be used and names some in common with Bryan, e.g., beet root.
Accordingly, the subject matter of claims 36 and 38 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 25 and 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Stamler, US 6472390 and Kramer, US 20220249796 A as applied to claims 19-35, 37 and 39 above, and further in view of Pittz, US 20200206261.
The combined teachings of Stamler and Kramer enumerated above teach a method according to claim 19, but do not expressly teach the composition further comprising a hydrogel-forming polymer selected from the group consisting of konjac glucomannan, xanthan gum, chitosan, chitosan oligosaccharide, kappa carrageenan, lambda carrageenan, sulfated polysaccharide, alginate, pectin, and combinations thereof.
However, Pittz teaches similar compositions comprising an elemental metal powder and an acid, wherein the composition, like Kramer’s, capable of generating hydrogen gas, and wherein the composition is a powder, and wherein the powder composition further comprises glucomannan in an amount of about 52% (Pittz, e.g., 0259, Table 11) and wherein the glucomannan is konjac glucomannan (Pittz, e.g., 0257). This is a clearly enumerated value within the range recited in claim 41. Pittz teaches the glucomannan offers a number of benefits including viscosity control, the ability to formulate a sustained release delivery system (Pittz, e.g., 0264, for oral delivery: 0270-0272, for topical delivery: 0281, and generally for sustained release of gas from the system: 0317-0320). Pittz further teaches the glucomannan sustains generation and release of gas by removing the passivation coat on the metal, e.g., magnesium metal, and creating a reservoir of gas for sustained release by stabilizing gas bubbles in the gel (Pittz, e.g., 0355-0363).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention to modify the nitric oxide generating composition in the method for treating esophageal spasms suggested by the combined teachings of Stamler and Kramer by including an amount of glucomannan in the composition effective to achieve the benefits reported by Pittz with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to achieve the sustained release of nitric oxide and hydrogen gases in the same way suggested by Pittz with a reasonable expectation of success. The skilled artisan would have seen this modification as the use of known techniques to improve similar therapeutic hydrogen generating compositions in the same way. Since nitric oxide, like hydrogen, is a gas, and since Pittz teaches the composition is effective to sustained release of gasses generated in the gel, e.g., hydrogen, the skilled artisan would have reasonably expected similar sustained release of nitric oxide in the same way, thereby sustaining delivery of nitric oxide and hydrogen from the composition for improved therapeutic benefit.
Accordingly, the subject matter of claims 25 and 40-41 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Nicolaidis, US 20200222449 teaches nitrate compositions like those of Kramer.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A WAX can be reached on 571-272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
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