DETAILED ACTION
Claims 1-5 are pending in the present reissue application.
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 .
Amendments
The amendment filed on May 19, 2026 has been acknowledged and has been entered into the present application file.
Consent of Assignee
This application is objected to under 37 CFR 1.172(a) as lacking the written consent of all assignees owning an undivided interest in the patent. The consent of the assignee must be in compliance with 37 CFR 1.172. See MPEP § 1410.01.
A proper assent of the assignee in compliance with 37 CFR 1.172 and 3.73 is required in reply to this Office action.
The consent document filed on May 19, 2026 states that the assignees owning an undivided interest in the original patent is Glykon Technologies Group, LLC. However, the original patent was reassigned on January 5, 2022 to Nutrition Research Group, Limited as shown by reel/frame 58559/0645. Therefore, the consent is from the previous assignee and not the current assignee.
This application is objected to under 37 CFR 1.172(a) as the assignee has not established its ownership interest in the patent for which reissue is being requested. An assignee must establish its ownership interest in order to support the consent to a reissue application required by 37 CFR 1.172(a). The assignee’s ownership interest is established by:
(a) filing in the reissue application evidence of a chain of title from the original owner to the assignee, or
(b) specifying in the record of the reissue application where such evidence is recorded in the Office (e.g., reel and frame number, etc.).
The submission with respect to (a) and (b) to establish ownership must be signed by a party authorized to act on behalf of the assignee. See MPEP § 1410.01.
An appropriate paper satisfying the requirements of 37 CFR 3.73 must be submitted in reply to this Office action.
In the present application, the 3.73 statement filed on August 17, 2023 stated that the interest of the assignee was evidenced by the assignment recorded at reel/frame 053285/0050. However, the original patent was reassigned on January 5, 2022 to Nutrition Research Group, Limited as shown by reel/frame 58559/0645. Therefore, the 3.73 statement does not provided evidence of the current assignment.
Double Patenting
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.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 9,789,076. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
The ‘076 patent claims a method consisting essentially of creating an aqueous solution of a hydroxycitrate salt and glycerol, wherein the glycerol is present in an amount of about 1 to 3 parts by volume and the water is present in an amount of about 3 to 1 parts per volume to create the aqueous solution, the hydroxycitrate salt is present in the aqueous solution at a concentration ranging from about 1.1 to 1.7 molar dosage, placing the aqueous solution in a sealed dosage container, and then orally administering the sealed dosage container such that the hydroxycitrate salt is present in an amount of 1.5 g to 4.5 g and the glycerol is present from 1.0 g to 4.0 g.
Claims 2-3 teach that hydroxycitrate salts include potassium, sodium and potassium-magnesium hydroxycitrate. Therefore, claims 1-3 and 5 are anticipated as the formulation is necessarily generated in the method of the ‘076 patent.
With respect to present reissue claim 4, the ‘076 patent is silent as to whether the glycerol is completely dissolved in the water before the hydroxycitrate salt is dissolved therein. However, the present claim is a product by process claim. From MPEP 2113(I): "[E]ven 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”
In the present case, the claims of the ‘630 indicate that the HCA salt is fully dissolved in the glycerol/water mixture. Therefore, the product would be the same even if the ‘076 patent is silent with respect to the method of making. Additionally, the ‘076 patent claims are silent with respect to the presence or absence of lactones of the hydroxycitrate salt. However, the specification of the ‘076 patent teaches that the lactone form is no longer recommended for administration due to chelating transition metals and for irritation to many tissues, and would therefore be interpreted to mean that the product is substantially free of lactones of the hydroxycitrate salt. See column 7, lines 9-44. Therefore, present reissue claim 4 is anticipated.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 9,993,448. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
The ‘448 patent claims a method consisting essentially of creating an aqueous solution of a hydroxycitrate salt and glycerol, wherein the glycerol is present in an amount of about 1 to 3 parts by volume and the water is present in an amount of about 3 to 1 parts per volume to create the aqueous solution, the hydroxycitrate salt is present in the aqueous solution at a concentration ranging from about 1.1 to 1.7 molar dosage, placing the aqueous solution in a sealed dosage container, and then orally administering the sealed dosage container such that the hydroxycitrate salt is present in an amount of 1.5 g to 4.5 g and the glycerol is present from 1.0 g to 4.0 g.
While the claim does not specify the identity of the hydroxycitrate salt, the specification defines preferred hydroxycitrate salts to include potassium, sodium and potassium-magnesium hydroxycitrate. See column 4, lines 26-43. Therefore, claims 1-3 and 5 are anticipated as the formulation is necessarily generated in the method of the ‘448 patent.
With respect to present reissue claim 4, the ‘448 patent is silent as to whether the glycerol is completely dissolved in the water before the hydroxycitrate salt is dissolved therein. However, the present claim is a product by process claim. From MPEP 2113(I): "[E]ven 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”
In the present case, the claims of the ‘630 indicate that the HCA salt is fully dissolved in the glycerol/water mixture. Therefore, the product would be the same even if the ‘448 patent is silent with respect to the method of making. Additionally, the ‘448 patent claims are silent with respect to the presence or absence of lactones of the hydroxycitrate salt. However, the specification of the ‘448 patent teaches that the lactone form is no longer recommended for administration due to chelating transition metals and for irritation to many tissues, and would therefore be interpreted to mean that the product is substantially free of lactones of the hydroxycitrate salt. See column 7, lines 24-48. Therefore, present reissue claim 4 is anticipated.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10,376,483. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
The ‘483 patent claims a method consisting essentially of creating an aqueous solution of a hydroxycitrate salt and glycerol, wherein the glycerol is present in an amount of about 1 to 3 parts by volume and the water is present in an amount of about 3 to 1 parts per volume to create the aqueous solution, the hydroxycitrate salt is present in the aqueous solution at a concentration ranging from about 1.1 to 1.7 molar dosage, placing the aqueous solution in a sealed dosage container, and then orally administering the sealed dosage container such that the hydroxycitrate salt is present in an amount of 1.5 g to 4.5 g and the glycerol is present from 1.0 g to 4.0 g.
Claims 2-5 of the ‘483 patent details that the hydroxycitrate salt is a stable salt including the potassium, sodium, and potassium-magnesium salts. Additionally, claims 2, 4, and 5 of the ‘483 patent are the same language as present claims 2-4. Therefore, present reissue claims 1-5 are anticipated.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 10,561,630. Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons.
With respect to present reissue claims 1-3, claim 1 of the ‘630 patent is drawn to a gelatin capsule oral delivery system that comprises a liquid formulation consisting essentially of a salt of hydroxycitric acid (HCA), water, and glycerol, whereby the HCA salt is completely dissolved in the water and glycerol. The ratio of glycerol to water is from about 1:3 to 3:1. The concentration of HCA salt is from 1.1 to 1.7 molar dosage.
Claim 2 of the ‘630 patent specifies that the HCA salt is a stable salt selected from the group consisting of sodium, potassium, potassium-magnesium or magnesium, double- or triple-metal salts based on the counter ions selected from the group consisting of magnesium, potassium and sodium; and any workable combination thereof. Therefore, present reissue claims 1-3 are anticipated.
With respect to present reissue claim 4, the ‘630 patent is silent as to whether the glycerol is completely dissolved in the water before the hydroxycitrate salt is dissolved therein. However, the present claim is a product by process claim. From MPEP 2113(I): "[E]ven 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, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”
In the present case, the claims of the ‘630 indicate that the HCA salt is fully dissolved in the glycerol/water mixture. Therefore, the product would be the same even if the ‘630 patent is silent with respect to the method of making. Additionally, the ‘630 patent claims are silent with respect to the presence or absence of lactones of the hydroxycitrate salt. However, the specification of the ‘630 patent teaches that the product of the ‘630 patent achieves the goal of preventing lactone formation, and would therefore be interpreted to mean that the product is substantially free of lactones of the hydroxycitrate salt. See column 12, lines 7-16. Therefore, present reissue claim 4 is anticipated.
With respect to present reissue claim 5, the ‘630 patent claims are silent with respect to the amount of hydroxycitrate salt and glycerol that is present in the formulation. However, the ‘630 patent specification specifically mentions that a dosage of HCA can be in a range of 3000 mg to 4500 mg per day (3 to 4.5 g.) See column 8, lines 14-20. Additionally, the amount of glycerol present in the examples is about 250 mg per capsule (about 1mL 1:3 glycerol: purified water assuming density of about 1 g/mL). Example 1 contains 750 mg HCA salt per capsule, meaning a dosage of 4 capsules would be needed to achieve 3000 mg HCA salt, and about 1 g of glycerol. See Example 1, column 10, lines 6-20. Therefore, claim 5 is anticipated.
Response to Arguments
The Applicant submitted a terminal disclaimer over the four patents listed in the non-statutory double patenting rejections on May 19, 2026. However, the terminal disclaimer was filed by Glykon Technologies Group, LLC, which is not the current owner of the original patent. The original patent was reassigned on January 5, 2022 to Nutrition Research Group, Limited as shown by reel/frame 58559/0645. Therefore, the terminal disclaimer was not filed by the present owner.
A new terminal disclaimer from the current patent owner is necessary. No new terminal disclaimer fee is required with this submission.
Duty to Disclose
Applicant is reminded of the continuing obligation under 37 CFR 1.178(b), to timely apprise the Office of any prior or concurrent proceeding in which Patent No. 11,219,610 is or was involved. These proceedings would include any trial before the Patent Trial and Appeal Board, interferences, reissues, reexaminations, supplemental examinations, and litigation.
Applicant is further reminded of the continuing obligation under 37 CFR 1.56, to timely apprise the Office of any information which is material to patentability of the claims under consideration in this reissue application.
These obligations rest with each individual associated with the filing and prosecution of this application for reissue. See also MPEP §§ 1404, 1442.01 and 1442.04.
Conclusion
Claims 1-5 are rejected.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Joseph Kosack whose telephone number is (571)272-5575. The examiner can normally be reached M-F 8:00-4:30.
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Signed:
/JOSEPH R KOSACK/Patent Reexamination Specialist
Central Reexamination Unit 3991
Conferees:
/Alan Diamond/
Patent Reexamination Specialist
Central Reexamination Unit 3991
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