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 .
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-19) in the reply filed on 10 August 2026 is acknowledged.
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10 August 2026.
Claims 1-19 are under current consideration.
Drawings
The drawings are objected to because the drawing contains color but no color petition has been filed and accepted as discussed below. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Rejections - 35 USC § 112
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.
Claim 14 is 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.
Claim 14 recites a composition (i.e., a product) then further recites method step of active being released following oral consumption (rather than, for example, reciting a capability or function), and thus the claim recites both a product and a process, which renders the claim indefinite per MPEP 2173.05(p)(II).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 13 fails to include all the limitations of claim 12 upon which it depends in that claim 13 specifies that the active is creatine but claim 12 requires one or more active selected from beta-alanine, probiotics, caffeine, berberine, and melatonin, which does not encompass creatine.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claim(s) 1-9, 11, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. (US 2003/0215496 A1; published 20 November 2003) in view of Funda et al. (US 2019/0053531 A1; published 21 February 2019).
Patel et al. discloses a pharmaceutical composition including a solid carrier that may have a substrate and an encapsulation coat thereon and wherein the solid carrier is formed of different combinations of hydrophilic or hydrophobic pharmaceutical active ingredients such as drugs or nutritional agents, hydrophilic surfactants, lipophilic surfactants, and triglycerides (abstract) wherein the substrate can be a beadlet (paragraphs [0116], [0237]) wherein additives are contained in the encapsulation coat and/or contained within components of the solid carrier (paragraph [0120]) wherein additives can include solubilizers to increase the solubility of the pharmaceutical active ingredient (paragraph [0123]) including glycerol, hydroxypropylmethylcellulose (i.e., a polymer), and cyclodextrins (paragraph [0124]) wherein additives can include gums such as gum arabic and cellulosic-based shellacs such as ethyl cellulose (i.e., a polymer) (paragraph [0165]) wherein additives can include diluents or fillers such as sodium chloride and potassium chloride (i.e., metal halide salts) (paragraph [0155]) wherein additives can include disintegrants such as microcrystalline cellulose (paragraph [0156]) wherein additives can include natural vegetable colorants (paragraph [0152]) wherein the amounts of such additives can be readily determined by one skilled in the art according to the particular properties desired (paragraph [0166]) wherein the dosage form can be designed for extended release (paragraph [0169]) wherein extended release dosage forms can be readily designed to achieve delivery to the small and/or large intestine (paragraph [0172]) wherein the substrate may be about 100-2000 microns in size (paragraph [0236]) wherein the active ingredients suitable for use in the composition are not particularly limited, and may be dispersed in the encapsulation coat (i.e., a polymer beadlet shell) (paragraph [0033]).
Patel et al. does not disclose that the cyclodextrins therein are γ-cyclodextrin as claimed.
Funda et al. discloses a coating system for coating solid particles comprising at least one cyclodextrin for dietary supplements and/or pharmaceutical products (abstract) wherein the core of the composition can be a beadlet (paragraph [0040]) wherein the cyclodextrin can be γ-cyclodextrin (paragraphs [0017]-[0018]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patel et al. and Funda et al. as discussed above and to make the composition of Patel et al. with the constituents/ingredients as discussed above wherein the cyclodextrin therein is γ-cyclodextrin as suggested by Funda et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include therein a cyclodextrin known to be suitable for use in dietary supplement and/or pharmaceutical product beadlets and coatings thereon per Funda et al., given that Patel et al. suggests including a cyclodextrin as an additive therein, and also given that the selection of a known material (e.g., γ-cyclodextrin) based on its suitability for its intended use (e.g., use as a cyclodextrin in dietary supplement and/or pharmaceutical product beadlets and coatings thereon) supports a prima facie obviousness determination per MPEP 2144.07.
Further regarding claim 2, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize gum properties of the composition of Patel et al. in view of Funda et al. as discussed above by varying the concentration of gum arabic therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such gum arabic as included therein as a gum, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including gums can be readily determined by one skilled in the art according to the particular properties desired.
Further regarding claim 3, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize disintegration properties of the composition of Patel et al. in view of Funda et al. as discussed above by varying the concentration of MCC therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such MCC as included therein as a disintegrant, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including disintegrants can be readily determined by one skilled in the art according to the particular properties desired.
Further regarding claim 4, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize solubility properties of the composition of Patel et al. in view of Funda et al. as discussed above by varying the concentration of HPMC therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such HPMC as included therein as a solubilizer, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including solubilizers can be readily determined by one skilled in the art according to the particular properties desired.
Further regarding claim 5, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize solubility properties of the composition of Patel et al. in view of Funda et al. as discussed above by varying the concentration of glycerol therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such glycerol as included therein as a solubilizer, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including solubilizers can be readily determined by one skilled in the art according to the particular properties desired.
Further regarding claim 6, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize solubility properties of the composition of Patel et al. in view of Funda et al. as discussed above by varying the concentration of γ-cyclodextrin therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such cyclodextrin as included therein as a solubilizer, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including solubilizers can be readily determined by one skilled in the art according to the particular properties desired.
Further regarding claim 7, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize shellacking properties of the composition of Patel et al. in view of Funda et al. as discussed above by varying the concentration of ethyl cellulose therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such ethyl cellulose as included therein as a shellac, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including shellac can be readily determined by one skilled in the art according to the particular properties desired.
Further regarding claim 11, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize diluent/filling properties of the composition of Patel et al. in view of Funda et al. as discussed above by varying the concentration of sodium chloride and/or potassium chloride (i.e., metal halide salts) therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such sodium chloride and potassium chloride as included therein as diluents or fillers, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including diluents or fillers can be readily determined by one skilled in the art according to the particular properties desired.
Further regarding claim 15, the beadlets of Patel et al. in view of Funda et al. as discussed above are about 100-2000 microns in size, which overlaps the claimed range of about 500-2000 µm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Claim(s) 1-11 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. in view of Funda et al. as applied to claims 1-9, 11, and 15-16 above, and further in view of Block et al. (US 2003/0148992 A1; published 07 August 2003).
Patel et al. and Funda et al. are relied upon as discussed above.
Patel et al. and Funda et al. do not disclose magnesium chloride as in claim 10.
Block et al. discloses oral formulations in the form of a beadlet to provide sustained release of therapeutic material such as vitamin (abstract) wherein therapeutic material may include minerals (paragraph [0018]) wherein minerals may include magnesium chloride (paragraph [0019]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patel et al., Funda et al., and Block et al. by including in the composition of Patel et al. in view of Funda et al. as discussed above as an active therein magnesium chloride as suggested by Block et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include another known active (i.e., therapeutic material) therein given that Patel et al. suggests combinations of actives therein and discloses that the active ingredients suitable for use in the composition are not particularly limited.
Claim(s) 1-9, 11-13, 15-16, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. in view of Funda et al. as applied to claims 1-9, 11, and 15-16 above, and further in view of Jung et al. (US 2008/0003307 A1; published 03 January 2008).
Patel et al. and Funda et al. are relied upon as discussed above.
Patel et al. and Funda et al. do not disclose probiotics, caffeine, or melatonin as in claim 12, or creatine as in claims 13 and 19.
Jung et al. discloses nutraceuticals (title; abstract) wherein nutraceutical agents provide medical or health benefits, and include caffeine, melatonin, and creatine (paragraph [0054]) and probiotics (paragraph [0055]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patel et al., Funda et al., and Jung et al. by including in the composition of Patel et al. in view of Funda et al. as discussed above as actives therein caffeine, melatonin, creatine, and/or probiotics as suggested by Jung et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include another known active (i.e., nutraceutical, medical or health benefit agent) therein given that Patel et al. suggests combinations of actives therein and discloses that the active ingredients suitable for use in the composition are not particularly limited.
Claim(s) 1-9, 11, and 14-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. in view of Funda et al. as applied to claims 1-9, 11, and 15-16 above, and further in view of Hermelin et al. (US 2008/0193531 A1; published 14 August 2008).
Patel et al. and Funda et al. are relied upon as discussed above.
Patel et al. and Funda et al. do not disclose active release over a period of from about 10-12 hours following oral consumption as in claim 14.
Hermelin et al. discloses compositions for improving gastrointestinal nutrient and drug absorption (title; abstract) wherein ingredients formulated for extended release typically are substantially dissolved in greater than about 10 hours up to about 48 hours following oral administration to a subject (paragraph [0092]).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patel et al., Funda et al., and Hermelin et al. by making the composition of Patel et al. in view of Funda et al. as discussed above wherein the active(s) therein dissolve/release in about 10-48 hours following oral administration to a subject as suggested by Hermelin et al., with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to formulate such release in a suitable time period for extended release ingredients as suggested by Hermelin et al. given that Patel et al. discloses extended release. Such range of about 10-48 hours overlaps the claimed range of about 10-12 hours, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Claim(s) 1-9, 11, and 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Patel et al. in view of Funda et al. as applied to claims 1-9, 11, and 15-16 above, and further in view of Wiriyachitra (WO 2010/128949 A1; published 11 November 2010).
Patel et al. and Funda et al. are relied upon as discussed above.
Patel et al. and Funda et al. do not disclose paprika extract, turmeric, beta-carotene, or beet extract as in claim 17.
Wiriyachitra discloses a nutraceutical composition (title) wherein representative examples of natural food colorings include turmeric (page 21 lines 13-15).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Patel et al., Funda et al., and Wiriyachitra by including in the composition of Patel et al. in view of Funda et al. as discussed above as natural coloring turmeric as suggested by Wiriyachitra, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to use a natural colorant therein that is known for use in a nutraceutical composition, given that Patel et al. suggests including natural colorant therein.
Further regarding claim 18, it also would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to optimize color properties of the composition of Patel et al. in view of Funda et al. and Wiriyachitra as discussed above by varying the concentration of natural colorant turmeric therein through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Patel et al. discloses such natural colorant as included therein, and thus a known result effective variable, and also given that Patel et al. discloses that the amounts of such additives including natural colorant can be readily determined by one skilled in the art according to the particular properties desired.
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 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 12, and 19 of copending Application No. 18/908,686 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘686 claims merely recite additional limitations and the second core of the ‘686 claims which contains polypeptide (i.e., active) is encompassed by the instant claims’ beadlet shell.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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