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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/07/2025 has been considered by the examiner.
Status of the Claims
The claims filed 03/07/2025 are under consideration.
Claims 1-19 and 21 are pending.
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 Rejections not reiterated herein have been withdrawn.
Duplicate Claim Warning
Applicant is advised that should claim 19 be found allowable, claim 21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 706.03(k). In the present case, both claims refer to the same claim and recite the same subject matter.
Claim Interpretation
The term “D90” refers to a particle size population upper limit. See Brown, US 20200061700, e.g., ¶ 0033: D90 is defined as the size which 90% of the sample lies below. That is, a D90 of 100 microns means that 90% of the particles in the sample have a size of less than 100 microns.
Thus, the claimed particle size ranges – e.g., D90 of the homogenous mixture is greater than or equal to 50 microns and less than or equal to 300 microns - reads on any particle size range less than the stated D90 upper limit, i.e., less than 50 microns to less than 300 microns.
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 6 and 15 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 6 and 15 contain the trademark/trade name Selenium Select 5000. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a serial diluted selenium source and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 19 and 21 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Crum, US 20160101079.
Claims 19 and 21 are product by process claims. The particle size is explicitly optional.
Crum teaches compositions comprising glutamine/glutamic acid, cystine, glycine, and a selenium source (Crum, e.g., claims 1 and 3, 0032, 0035, 0057, 0065, 0067, 0107-0110, 0160, 0161, 0174).
Compositions are stable under conditions of manufacture and storage (Crum, e.g., 0182).
Crum anticipates the subject matter of instant claims 19 and 21.
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 1-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Crum, US 20160101079 A1 in view of Walsh, US 20020155170 A1, and L-(+)-Selenomethionine A Bioavailable Selenium Supplement, Sabinsa, 1999 (Sabinsa).
Crum teaches compositions comprising glutamine, cystine, glycine, and a selenium source (Crum, e.g., claims 1 and 3, 0032, 0035, 0057, 0065, 0067, 0107-0110, 0160, 0161, 0174).
Applicable to claims 1 and 10: glutamic acid and glutamine are equivalent glutamate sources (Crum, e.g., 0160). Thus, the selection of glutamine or glutamic acid as a source of glutamate would have been obvious to one skilled in the art before the filing date of the presently claimed invention to prepare a composition effective to increase glutathione.
Compositions are stable under conditions of manufacture and storage (Crum, e.g., 0182).
Crum teaches the composition in the form of a powder (Crum, e.g., 0182, 0186, 0193).
Applicable to claims 2, 7, 11, and 16: Crum teaches the ratio ranges from 0.5:1:0.5 to 1:0.5:1 (Crum, e.g., 0166). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05
The prior art discloses overlapping ranges of composition. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP 2144.05.
Applicable to claims 3 and 12:
Crum teaches the composition comprising selenium in an amount ranging from 1 to 100 µg and compositions having a mass of from 200 mg to 2000 mg (Crum, e.g., 0187-0188). This means Crum teaches the selenium may be present in the composition in an amount ranging from about 0.00005% (1 µg / 2000 mg) to 0.05% (100 µg / 200 mg). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Crum further teaches compositions effective to provide 10 – 75 µg daily dose (Crum, e.g., 0169). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
Applicable to claims 4-6 and 13-15: Crum teaches the selenium source is selenomethionine (Crum, e.g., 0172).
Crum teaches preparing the composition by mixing the individual components (Crum, e.g., 0162). Crum does not expressly teach milling and/or sieving the components to give a particle size (D90) within the claimed ranges, e.g., greater than or equal to 50 microns and less than or equal to 300 microns.
Walsh teaches preparing solid nutrient supplements which method comprises using a mill to mix the ingredients to form a powder, i.e., a blending step comprising milling, wherein the blending is done under conditions which yield particle sizes of less than about 50 microns (Walsh, e.g., 0053). This range overlaps with all the recited ranges. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. Walsh further teaches the particle size may vary depending on the desired final form of the supplement.
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 production methods in Crum by milling the ingredients to a desired particle size, e.g., less than about 50 microns as suggested by Walsh with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to facilitate the formulation powder into a desired dosage form, e.g., capsule or tablet. The skilled artisan would have had a reasonable expectation of success since Walsh teaches formulating similar nutrient supplements, e.g., comprising selenium and amino acids.
The combined teachings of Crum and Walsh teach selenomethionine but do not expressly teach a serial dilution of the selenium source. This is interpreted to read on a diluted selenium source.
Sabinsa teaches a triturated selenomethionine with dicalcium phosphate which contains 5000 µg per gram of supplement, i.e., is a diluted selenium source (Sabinsa, e.g., pg. 1, ¶ 1). The formulation is said to be safer and more bioavailable (Sabinsa, e.g., pg. 1, ¶ 3).
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 a method and formulation suggested by the combined teachings of Crum and Walsh using a known diluted selenomethionine source as understood from Sabinsa to improve the formulation in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to make this modification to simplify addition of selenomethionine using a commercial source, and for the improved stability and bioavailability reported in Sabinsa. The skilled artisan would have had a reasonable expectation of success since the diluted selenomethionine was a known alternative for the pure selenomethionine.
Accordingly, the subject matter of claims 1-19 and 21 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.
Correspondence
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/WILLIAM CRAIGO/Examiner, Art Unit 1615
