Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 2 August 2023, 12 November 2024, and 10 February 2025 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. See attached copy of PTO-1449.
Status of Application
2. The instant application is a national stage entry of PCT/US2022/014963 filed 2 February 2022. Claims 1 and 74-92 are currently pending. Claims 2-73 are cancelled. Claims 1 and 74-92 are examined on the merits within.
Examiner’s Note: The specification states “As used herein the term “about” refers to an amount that is near the stated amount by plus or minus 10%. As used herein the term “about” a range refers to that range minus 10% of its lowest value and plus 10% of its greatest value.” See paragraph [0118].
Claim Rejections – 35 U.S.C. 112(b)
3. 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.
4. Claims 77, 79, 80, 88, and 90-92 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.
5. Claim 77 recites the limitation "the capsule" in line 1. There is insufficient antecedent basis for this limitation in the claim.
6. Claim 79 recites the limitation "the hydrogel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
7. Claim 80 recites the limitation "the capsule" in line 4. There is insufficient antecedent basis for this limitation in the claim.
8. Regarding claim 88, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
9. Regarding claim 88, the phrase "for example (e.g.)" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
10. Claims 90-92 recites the limitation "the hydrogel" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections – 35 U.S.C. 102
11. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
12. Claim(s) 1, 74-76, 78-80, 83-86, and 88-92 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pittz (WO2020/023396).
Regarding instant claims 1 and 74, 76, and 84-85, Pittz discloses an aqueous glucomannan solution containing molecular hydrogen comprising an aqueous solvent, 0.00001 %w/v to 7.5% w/v glucomannan and 0.005% to 2% w/v magnesium metal powder. See paragraph [0004]. Essentially, any food or drink product that contains water, or is intended to contain water, can be formulated with the magnesium metal powder - glucomannan biotechnology - to generate and release molecular hydrogen and expand the gel volume. See paragraph [0127]. The compositions are formulated for oral administration. Further provided are methods, compositions, or solutions, further formulated for esophageal delivery. See paragraph [0008]. The oral formulation can be a capsule, powder, tablet or other delivery vehicle. See paragraph [0019].
Regarding instant claims 75, 78-80, and 89-92, Pittz discloses the same combination of ingredients administered in the same manner and thus should function the same, i.e., release the composition into the stomach at most about 40 minutes following introduction of the food into the stomach, expand to a volume of about 100 milliliters to about 2000 milliliters in acidic solution to form a hydrogel or associate with acidic solution, remain at constant volume within the stomach for at 4 hours to 7 hours, a viscosity of at least about 15000 millipascal-second, induce satiety or weight loss and comprise a volume of about 8 to 16 ounces. 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).
Regarding instant claim 83, Table 14 demonstrates 1 g glucomannan.
Regarding instant claim 86, glucomannan is present in 4 grams. See Table 5.
Regarding instant claim 88, Table 17 comprises citric acid and sucralose as an acid and sweetener.
Thus the instant claims are anticipated by Pittz.
Claim Rejections – 35 U.S.C. 103
13. 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, 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.
14. Claim(s) 1, 74-76, and 78-92 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pittz (WO2020/023396).
Regarding instant claims 1 and 74, 76, and 84-85, Pittz teaches an aqueous glucomannan solution containing molecular hydrogen comprising an aqueous solvent, 0.00001 %w/v to 7.5% w/v glucomannan and 0.005% to 2% w/v magnesium metal powder. See paragraph [0004]. Essentially, any food or drink product that contains water, or is intended to contain water, can be formulated with the magnesium metal powder - glucomannan biotechnology - to generate and release molecular hydrogen and expand the gel volume. See paragraph [0127]. The compositions are formulated for oral administration. Further provided are methods, compositions, or solutions, further formulated for esophageal delivery. See paragraph [0008]. The oral formulation can be a capsule, powder, tablet or other delivery vehicle. See paragraph [0019].
Regarding instant claims 75, 78-80, and 89-92, Pittz teaches the same combination of ingredients administered in the same manner and thus should function the same, i.e., release the composition into the stomach at most about 40 minutes following introduction of the food into the stomach, expand to a volume of about 100 milliliters to about 2000 milliliters in acidic solution to form a hydrogel or associate with acidic solution, remain at constant volume within the stomach for at 4 hours to 7 hours, a viscosity of at least about 15000 millipascal-second, induce satiety or weight loss and comprise a volume of about 8 to 16 ounces. 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).
Regarding instant claim 83, Table 14 demonstrates 1 g glucomannan.
Regarding instant claim 86, glucomannan is present in 4 grams. See Table 5.
Regarding instant claim 88, Table 17 comprises citric acid and sucralose as an acid and sweetener.
Pittz teaches the formulation can be used to treat skin conditions, gastrointestinal conditions, inflammatory diseases, and obesity. See claims 99-102.
Pittz teaches the presence of organic acids such as citric acid in amounts of 0.1 to 15% w/v. See claim 75. Excipients are present in amounts of 0.1 to 20%. See paragraph [0023]. Anticaking agents, such as xanthan gum, are present in amounts of 0.1 to 5%. See paragraph [0031].
Pittz does not teach daily administration, 30-60% GMN and 30-60% XG.
Since Pittz teaches various uses of the formulation ranging from skin conditions, gastrointestinal, inflammatory or obesity, it would have been well within the purview of the skilled artisan to modify the dosing regimen dependent on the therapeutic use to achieve the optimal desired effect. It would have been well within the purview of the skilled artisan to modify the amounts of glucomannan and xanthan gum to achieve the desired hydrogen production and consistency of the formulation.
15. Claim(s) 77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Pittz (WO2020/023396) as applied to claims 1, 74-76, and 78-92 above and further in view of Sack et al. (U.S. Patent No. 4,548,805).
Pittz does not teach gelatin capsules.
Sack et al. teach a method of testing the breath and belches of a patient for the purpose of determining the degree of gastric acidity on an ephemeral basis comprising the steps of: collecting exhaled air and belches over a short time period; administering an acid production stimulant, and approximately 30 minutes thereafter from 10 to 200 mg of finely divided magnesium in encapsulated form; collecting exhaled air and belches for at least 90 minutes following the administration of magnesium; measuring the volume of collected air and the free hydrogen content thereof, and determining the hydrogen excretion rate per given unit of time for both pre-magnesium and post-magnesium breathing; determining the excess breath hydrogen rate over the pre-magnesium breath hydrogen rate; and using said excess breath hydrogen rate as an indication of the pH and acid secretion of the digestive system. See claim 1. Magnesium metal is administered in gelatin capsules. See column 2, lines 45-54.
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to use gelatin as the capsule material in Pittz because Sack et al. teach the effective administration of magnesium particles in gelatin capsules while determining hydrogen production. One would have been motivated, with a reasonable expectation of success, because Sack et al. teach the effective administration without adverse side effects.
Double Patenting
16. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
17. Claims 1 and 74-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,128,065.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 12,128,065 are directed to compositions comprising glucomannan and magnesium which can form a gel and generate hydrogen. The only difference lies in the fact that the instant invention administers the formulation and comprises xanthan gum. Table 17 shows that xanthan gum can be used as a thickener and Example 18 shows the composition can be administered orally. Thus the two are not patentably distinct.
18. Claims 1 and 74-92 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,318,160.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant application and U.S. Patent No. 11,318,160 are directed to compositions comprising glucomannan and magnesium which can form a gel and generate hydrogen. The only difference lies in the fact that U.S. Patent No. 11,318,160 further details the concentration of hydrogen. Since both the instant application and U.S. Patent No. 11,318,160 are directed to the same combination of ingredients, the formulations should function in the same manner. The dependent claims of the instant invention also comprise xanthan gum which is added as an thickener. See Table 17. Both the instant application and U.S. Patent No. 11,318,160 administer the formulation orally. See Example 18. Thus the two are not patentably distinct.
Conclusion
19. No claims are allowed at this time.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA WORSHAM whose telephone number is (571)270-7434. The examiner can normally be reached Monday-Friday (8-5).
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/JESSICA WORSHAM/Primary Examiner, Art Unit 1615
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