DETAILED ACTION
1. Receipt is acknowledged of Applicant’s amendments and remarks filed 10/9/2025.
INFORMATION DISCLOSURE STATEMENT
2. No New Information Disclosure Statement has been submitted for review.
WITHDRAWN REJECTIONS
3. Rejections not reiterated from previous Office Actions are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
MAITNAINED REJECTIONS
DOUBLE PATENTING
4. 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 1-19 and 21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12, 14-16 and 19-23 of U.S. 17784339 in view of Stockhausen “Selenium in Total Parenteral Nutrition” in view of Bagley (US 20060283700) and Klek et al. (PL 228438).
The claims are not patentably distinct because both are drawn to medical product for selenium deficiency the difference being that the ‘339 does not recite inclusion of dissolved oxygen. Stockhausen discloses use of selenite as supplemental forms of selenium for total parental nutrition solutions for selenium deficiency in humans (abstract, para 153, para 1-2). Appropriate forms include sodium selenite or selenous acid. The solution of Stockhausen does not contain macronutrients selected from the group consisting of carbohydrates, proteins or lipids. Stockhausen discloses the suggested levels of Se are equivalent to those per kg of body weight. Selenous acid was added to the infusion solutions in amounts to provide 100 µg Se/d. Stockhausen discloses that an adult with daily protein intake of 50 g would be receiving 25-50 µg of Se, which should suffice to prevent negative Se balance. Therefore, it would be prima facie obvious to one of ordinary skill in the art to optimize the amount of selenium administered such as amounts of 10-200 µg in order to maintain Se balance. One of ordinary skill in the art would adjust the dose based on the body weight of the patient and the severity of the Se deficiency.
Stockhausen does not disclose dissolved oxygen.
Bagley (US 20060283700) disclose to adequately and sufficiently oxygenate and structure water insofar that when consumed, whether by internal or external absorption, there is a distinct and definite increase in hydration, oxygenation and healthy metabolic changes regarding organic life processes (para 0019). Parenteral compositions are disclosed (para 0025). In various embodiments, a physiologically ingestible composition comprising microstructured water consisting essentially of hydrogen and oxygen atoms and having a boiling point higher than the boiling point of double distilled water is used. The composition may further include dissolved oxygen that may be present in an amount of 20 ppm to 150 ppm (para 0020). The compositions are kept in containers (para 0063 and 0068). The chambers contain oxygen (para 0113-0117). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to include dissolved oxygen in the formulations of Stockhausen. One would have been motivated to do so for the purpose of providing oxygenation.
With regards to “for preventing or correcting selenium deficiency” and “administering parenterally” it is noted that this is regarded as intended use of the composition. The intended use of the 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.
It is noted that the flexible container is not mentioned but it is inherent that the formulation is housed in some sort of container.
Klek et al. (PL 228438) (hereinafter Klek et al.) disclose flexible multi-chamber container for parenteral nutrition consisting of at least three chambers where the smaller of the upper champers are intended for storage of lipids, the second larger chamber is intended for storing a mixture of ingredients in an aqueous solution in the form of amino acids, glucose and electrolytes. The decisive factor for the effectiveness of parenteral nutrition is to provide the patient with a complete and stable nutritional mixture with a composition tailored to his individual needs. There is a need to provide such a solution that will be complete, universal, simple, tailored to the needs of an individual patient and eliminating the need to purchase many types of bags with different composition and content. The flexible multi-chamber parenteral nutrition container solves this need. Since the compositions of Stockhausen disclose administering to sick children, it is believed the composition of Stockhausen would inherently be sterile. Klek et al. disclose administration of preparation in a sterile manner (see paragraph before the claims). It would have been prima facie obvious to one of ordinary skill in the art to package the parenteral nutritional formulation of Stockhausen in flexible containers as taught by Klek et al. One would have been motivated to do so to provide a solution that is simple and tailored to the needs of an individual patient eliminating the need to purchase multiple bags with different compositional contents.
The combined teachings disclose use of dissolved oxygen (DO) with the selenium compound in the form of Se(IV) (e.g., sodium selenite) and thus the properties such as storage would necessarily follow. Storing for months at a particular temperature is future intended use of the composition.
McGinnis et al. (US 20030065149) (hereinafter McGinnis et al.) disclose oxygen impermeable package to preserve the solution (paras 0031 and 0034). The purpose of the oxygen impermeable packaging would be for preservation. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have an oxygen impermeable packaging in order to preserve the contents of the solution.
RESPONSE TO ARGUMENTS
5. Applicants argue the double patenting would be considered when the claims are otherwise allowable. While the prior art teach the oxygen impermeable container, the amount of dissolved oxygen is taught to be higher than the claimed dissolved oxygen. In light of no terminal disclaimer, the double patenting rejection is maintained. Sumiyoshi et al. US 20100092446 disclose reduced dissolved oxygen content but does not provide a reason or motivation to add dissolved oxygen. The dissolved oxygen content for oxygenating the solution taught by Bagley is much higher than the claimed part per million.
CONCLUSION
6. 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 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
6. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Danah Al-awadi whose telephone number is (571) 270-7668. The examiner can normally be reached on 9:00 am - 6:00 pm; M-F (EST).
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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/DANAH AL-AWADI/Primary Examiner, Art Unit 1615