CTNF 17/917,498 CTNF 86483 NON-FINAL REJECTION This application is a 35 U.S.C. 371 (national stage) application of PCT/EP2021/058958, filed Apr. 6, 2021, which claims benefit of priority to EP applications 20168450.3, filed Apr. 7, 2020, and 20170350.1, filed Apr. 20, 2020. Claims 1-11, as amended, are currently pending and under consideration. Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority Acknowledgment is made of applicant's claim to foreign priority under 35 U.S.C. 119(a)-(d). Information Disclosure Statement The information disclosure statements (IDS) submitted on Oct. 6, 2022, Jan. 25, 2023, Aug. 23, 2023, and Nov. 14, 2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Claim Rejections - 35 USC § 102 07-06 AIA 15-10-15 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. 07-07-aia AIA 07-07 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 – 07-08-aia AIA (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. 07-15 AIA Claim s 1 and 11 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Buck et al. (WO 2009/101132, cited on the IDS dated 10/6/2022) . Buck et al. claim pharmaceutical compositions comprising Vitamin D and 25-hydroxy-vitamin D3 (25-OH D3), formulated in tablet, capsule, or injectable form, for alleviating symptoms consistent with a 25-hydroxy-vitamin D (25-OH D) deficiency (claims 1-4). Buck et al. further claim methods of increasing, maintaining, or achieving a desired steady-state concentration of 25-OH D in human blood, serum or plasma, comprising administering Vitamin D and 25-hydroxy-vitamin D3 (25-OH D3) to a human, wherein the Vitamin D and 25-OH D3 are administered in the same dosage form (claims 11 and 13). For example, Buck et al. disclose a clinical trial to study and compare the pharmaco-kinetic characteristics of Vitamin D and 25-OH D3 administered to humans. Subjects had 25-OH vitamin D serum levels between 20-50 nmol/L (8-20 ng/ml), and a BMI from 18-27. Subjects were daily administered 20 μg 25-OH D3 and 20 μg vitamin D3, i.e., in a 1:1 ratio (p. 17, line 13 to p. 20, line 15). In addition, Buck et al. disclose single daily dosages having both Vitamin D and 25-OH D3, containing each active ingredient in an amount from about 1 μg to about 50 μg, preferably about 5 μg and 25 μg. The dosage ratio of Vitamin D to 25-OH D3 is most preferably from about 6: 1 to about 1:6 (p. 12, lines 19-26). Preferably, the Vitamin D is Vitamin D3 (p. 13, line 25; p. 14, lines 4-5, 7, 11, 13, and 22)). Thus, Buck et al. disclose and claim compositions comprising a vitamin D supplement for treatment or prophylaxis of vitamin D insufficiency or deficiency, comprising a unit dose of vitamin D3 and 25(OH)D3 in a dosage for daily administration, as recited by claims 1 and 11. Buck et al. do not specify that the patient population includes obese persons, such as those selected from claimed groups (i)-(xv), encompassing individuals with a BMI of 30 or above, with an unknown blood level of 25(OH)D, or a known level at or below 30 ng/ml, who have either a normal or unfavorable lifestyle with respect to UV light exposure and daily uptake of vitamin D, as recited by claim 1. However, the instant claims are drawn to products, not methods of treatment. Thus, "for use in the treatment of and/or prophylaxis of vitamin D insufficiency or deficiency in obese persons" and "for daily administration to" patient groups (i)-(xv), is construed as intended use language, which does not structurally distinguish the claimed compositions from those disclosed, claimed, and exemplified by Buck et al . 07-37-09 As recognized by MPEP § 2111.02 (II), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed composition 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. For the foregoing reasons, Buck et al. anticipates claims 1 and 11. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-fti The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made. 07-23-fti The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness. 07-21-fti Claim s 1-11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Buck et al. (WO2009/101132, cited on the IDS dated 10/6/2022) in view of Liel et al. ( Calcif. Tissue Int . 43: 199-201 (1988), cited on the IDS dated 1/25/2023) . Buck et al. claim pharmaceutical compositions comprising Vitamin D and 25-hydroxy-vitamin D3 (25-OH D3), formulated in tablet, capsule, or injectable form, for alleviating symptoms consistent with a 25-hydroxy-vitamin D (25-OH D) deficiency (claims 1-4). Buck et al. further claim methods of increasing, maintaining, or achieving a desired steady-state concentration of 25-OH D in human blood, serum or plasma, comprising administering Vitamin D and 25-hydroxy-vitamin D3 (25-OH D3) to a human, wherein the Vitamin D and 25-OH D3 are administered in the same dosage form (claims 11 and 13). For example, Buck et al. disclose a clinical trial to study and compare the pharmaco-kinetic characteristics of Vitamin D and 25-OH D3 administered to humans. Subjects had 25-OH vitamin D serum levels between 20-50 nmol/L (8-20 ng/ml), and a BMI from 18-27. Subjects were daily administered 20 μg 25-OH D3 and 20 μg vitamin D3, i.e., in a 1:1 ratio (p. 17, line 13 to p. 20, line 15). In addition, Buck et al. disclose single daily dosages having both Vitamin D and 25-OH D3, containing each active ingredient in an amount from about 1 μg to about 50 μg, preferably about 5 μg and 25 μg. The dosage ratio of Vitamin D to 25-OH D3 is most preferably from about 6: 1 to about 1:6 (p. 12, lines 19-26). Preferably, the Vitamin D is Vitamin D3 (p. 13, line 25; p. 14, lines 4-5, 7, 11, 13, and 22)). Thus, Buck et al. disclose and claim compositions comprising a vitamin D supplement for treatment or prophylaxis of vitamin D insufficiency or deficiency, comprising a unit dose of vitamin D3 and 25(OH)D3 in a dosage for daily administration, as recited by claims 1 and 11. Buck et al. do not specify that the patient population includes obese persons, such as those selected from claimed groups (i)-(xv), encompassing individuals with a BMI of 30 or above, with an unknown blood level of 25(OH)D, or a known level at or below 30 ng/ml, who have either a normal or unfavorable lifestyle with respect to UV light exposure and daily uptake of vitamin D, as recited by claim 1. However, the instant claims are drawn to products, not methods of treatment. Thus, "for use in the treatment of and/or prophylaxis of vitamin D insufficiency or deficiency in obese persons" and "for daily administration to" patient groups (i)-(xv), is construed as intended use language, which does not structurally distinguish the claimed compositions from those disclosed, claimed, and exemplified by Buck et al. As recognized by MPEP § 2111.02 (II), a recitation of the intended use of the claimed invention must result in a structural difference between the claimed composition 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. As noted above, Buck et al. exemplify a daily dosage of 20 μg 25-OH D3 and 20 μg vitamin D3, in a 1:1 ratio. Buck et al. further disclose adjustments to these dosages within a preferable range from about 5 to 25 μg, for both vitamin D3 and 25-OH D3, which are most preferably in a ratio from about 6:1 to about 1:6. The dosages and dosage ratios of Buck et al. closely encompass the claimed dosage and ratio ranges recited by claims 2-10, as shown in the table below: Vitamin D3 dose 25-OH D3 dose Dosage Ratio Buck et al. 5 to 25 μg 5 to 25 μg 6:1 to about 1:6 Claim 2 5 to 7.5 μg 5 to 7.5 μg 1:1 Claim 3 5 to 7.5 μg 7.5 to 11 μg 1:1.5 Claim 4 5 to 7.5 μg 10 to 15 μg 1:2 Claim 5 7.5 to 11 μg 5 to 7.5 μg 1.5:1 Claim 6 7.5 to 11 μg 7.5 to 11 μg 1:1 Claim 7 7.5 to 11 μg 11 to 17 μg 1:1.5 Claim 8 11 to 15 μg 7.5 to 10 μg 1.5:1 Claim 9 11 to 15 μg 11 to 15 μg 1:1 Claim 10 11 to 15 μg 17 to 22.5 μg 1:1.5 Notably, the compositions of Buck et al. are disclosed as suitable for any indication where a Vitamin D or 25-OH D deficiency is implicated, such as people who are at risk of developing conditions characterized by Vitamin D deficiency or insufficiency. This includes especially post-menopausal women (i.e. about age 45 and older) and men who are about age 45 and older; individuals who do not receive a great deal of natural sunlight exposure, such as for people who traditionally wear long clothing, do not go out of doors regularly, or who use sunscreens when they are exposed to sunlight, or live in geographical areas significantly north or south of the equator, where sunlight is less intense (p. 7, lines 3-10). Thus, the patient population contemplated by Buck et al. overlaps with the claimed patient population of obese persons. In addition, Liel et al. report that serum vitamin D is significantly lower in obese than in nonobese individuals, and may contribute to lower serum 25-hydroxyvitamin D in obesity (Summary, p. 199). Further, Buck et al. teach that the combination of vitamin D3 and 25-OH D3 provides two significant advantages: (1) it results in a rapid and synergistic plasma response of 25-OH D; and (2) it leads to an unexpectedly pronounced and long plateau of plasma 25-OH D levels (p. 3, lines 11-28). Therefore, it would have been predictable to one of ordinary skill in the art as of the filing date to make minor adjustments within the narrow vitamin D3 and 25-OH D3 dosage ranges and ratios of Buck et al. to arrive at the claimed compositions with a reasonable expectation of success, because the compositions of Buck et al. are disclosed for treating Vitamin D deficiency or insufficiency, which was a known condition in the claimed patient population of obese persons, as shown by Liel et al. As recognized by MPEP § 2144.05 (I), 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, 191USPQ 90 (CCPA 1976); In re Woodruff , 919 F.2d 1575,16 USPQ2d 1934 (Fed. Cir. 1990). Conclusion Claims 1-11 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 9:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. 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://portal.uspto.gov/external/portal. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). /SARA ELIZABETH TOWNSLEY/Examiner, Art Unit 1629 Application/Control Number: 17/917,498 Page 2 Art Unit: 1629 Application/Control Number: 17/917,498 Page 3 Art Unit: 1629 Application/Control Number: 17/917,498 Page 4 Art Unit: 1629 Application/Control Number: 17/917,498 Page 5 Art Unit: 1629 Application/Control Number: 17/917,498 Page 6 Art Unit: 1629 Application/Control Number: 17/917,498 Page 7 Art Unit: 1629 Application/Control Number: 17/917,498 Page 8 Art Unit: 1629 Application/Control Number: 17/917,498 Page 9 Art Unit: 1629