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 .
Detailed Action
Status of Application
1. Applicants’ arguments/remarks filed 2 March 2026 are acknowledged. Claims 1 and 74-92 are currently pending. Claims 2-73 are cancelled. Claims 1, 74, 76, 79, 84, 86, 88, and 90-92 are currently amended. 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].
Withdrawn Rejections
2. Applicants’ arguments, filed 2 March 2026, with respect to the 35 U.S.C. 112(b) Rejections have been fully considered and are persuasive. The 35 U.S.C. 112(b) Rejections of claims 77, 79, 80, 88, and 90-92 have been withdrawn. The 35 U.S.C. 102(a)(1) Rejections have been withdrawn in view of the claim amendments.
Modified Rejections
Claim Rejections – 35 U.S.C. 103
3. 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.
4. 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. Since Pittz teaches 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, and teach the composition can be formulated as a capsule, the composition would be expected to behave in the same manner following co-administration. 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).
5. 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
6. 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.
7. Claims 1 and 74-92 are again 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.
8. Claims 1 and 74-92 are again 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.
Response to Arguments
Applicants’ arguments filed 2 March 2026 have been fully considered but they are not persuasive.
9. Applicants argued, “Unexpectedly an encapsulated glucomannan/magnesium metal powder formulation when mixed with 300 mL of 5% acetic acid affects a reduced hydrogel volume of 288.9 mL. Surprisingly the inclusion of xanthan gum, GMN and MMP in the capsule increases efficiency of gel formation and expansion. Ingesting the capsules with food facilitates the dissolution of the contents. Pittz does not disclose or suggest the issue of hydrogel volume shrinkage when the composition is encapsulated, let alone using XG to increase the efficiency of gel formation and expansion and co-administration with food to promote release of the encapsulated composition.”
In response to applicants’ arguments, claim 1 is directed to co-administering food with a composition comprising glucomannan, xanthan gum and magnesium metal powder. Pittz teaches 0.00001 %w/v to 7.5% w/v glucomannan and 0.005% to 2% w/v magnesium metal powder. See paragraph [0004]. Pittz also teaches anticaking agents, such as xanthan gum, are present in amounts of 0.1 to 5% and the formulation can be a capsule. See paragraphs [0019] and [0031]. Thus, Pittz teaches the same combination of ingredient enclosed in a capsule as cited in claim 1.
Pittz further details that 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]. Thus, the formulation is intended to be co-administered with food to generate hydrogen. Since Pittz teaches the same combination of ingredients, formulated and administered in the same manner, it would have been expected to function in the same manner devoid of evidence to the contrary. If the function is different, it raises the question as to whether all of the essential components necessary for the function are claimed.
Thus this rejection is maintained.
10. Applicants argued, “Sack does not cure the defects.”
In response to applicants’ arguments, the prior art of Sack was provided to make obvious the type of capsule material, i.e., gelatin capsules.
Thus this rejection is maintained.
11. Applicant has requested that the provisional rejections be held in abeyance until patentable subject matter is identified. However, this request cannot be considered, especially in view that no patentable subject matter has yet been identified.
The obviousness double patenting rejections are hereby maintained.
Conclusion
12. THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Correspondence
13. No claims are allowed at this time.
14. 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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