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 06/11/2026 and 03/11/2026 have been considered by the examiner.
Status of the Claims
The response filed 09/25/2026 is acknowledged.
Claims 30-55 are pending.
Applicant’s election of Group I, claims 30-37, and 53-54 in the reply filed on 09/25/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
New claim 55 is directed to a method of treating diabetes and would have been placed in its own group if presented previously. Since Applicant elected the compositions for examination, claim 55 is withdrawn with the other method claims presented.
Claims 38-52 and 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 09/25/2026.
Claims 30-37 and 53-54 are treated on the merits in this action.
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 Rejections not reiterated herein have been withdrawn.
Specification
The disclosure is objected to because of the following informalities: the specification contains graphs and drawings which should be removed. For example, pg. 25, contains Fig. 6, a spectrum, which is a graph. Additional graphs are found on pp. 25, 26, 27, 29, and 30. See MPEP 608.01 VI. ILLUSTRATIONS IN THE SPECIFICATION.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Appropriate correction is required.
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 35-36 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.
Claim 35 includes the limitation of wherein the nanosuspension is in a water solution in a Fed State Simulated Intestinal Fluid (FeSSIF). The skilled artisan is unable to determine what claim 35 requires since the claim appears to require a nanosuspension and a solution. This is interpreted as an intended use since a solution would not require the nanoparticle limitations of claim 30 from which it depends.
Claim 36 includes the limitation of wherein solubility is determined after 10 minutes in a FeSSIF. It is not clear what solubility is determined. This claim is also interpreted as an intended use limitation since a solution would not require the nanoparticle limitations of claim 30 from which it depends.
Clarification is required.
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.
Claims 30-37 and 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Devane, US 20110064803 A as evidenced by Drouet, US 20200079718 A1.
Devane teaches a composition comprising vitamin K2 nanoparticles sized in the range required by claims 30 and 53-54. Devane teaches wherein the vitamin K2 species is MK-4, or variant thereof (Devane, e.g., 0004 and 0091) which compositions are for treatments of conditions, e.g., osteoporosis (Devane, e.g., 0011-0012). Devane teaches wherein vitamin K2 is MK-4, aka menatetrenone (Devane, e.g., table 8). Structure is shown at Devane 0004.
The claimed particle size of an average particle size of less than 125 nm is within the range of particle sizes taught by Devane, e.g., claim 4, and Devane exemplifies formulations containing vitamin K2 with an average particle size close to the claimed range, e.g., D50 (average) less than 134 nm and mean 136-138 nm (Devane, e.g., Table 10, Sample 5). D50 means the average particle sizes are less than the recited values, e.g., D50 of 134 nm means the average particle size is less than 134 nm. All recited particle sizes are within the prior art ranges D50 ranges of Devane, e.g., table 10. Further, Devane teaches compositions comprising vitamin K2 in nanoparticulate form (Devane, e.g., Abstract), wherein the nanoparticles have a size in the claimed range, e.g., less than about 2000 nm or less than about 50 nm (Devane, e.g., 0084 and claim 4). Devane exemplifies nanoparticulate compositions of vitamin K2, which contain surface stabilizers, e.g., tween 80, aka, polysorbate 80 (Devane, e.g., Table 8, composition 12). Less than about 50 nm is within each of the recited ranges. Devane suggests minimizing the particle size since the narrower ranges are lower. The claimed range is within and overlaps with each of the ranges suggested by Devane.
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.
Devane teaches nanoparticulate forms of vitamin K2 offer several advantages including, e.g., increased rate of dissolution of vitamin K2 compositions (Devane, e.g., 0046).
Devane teaches the nanoparticles may be dispersed in carriers, e.g., water (Devane, e.g., 0150) to facilitate administration, e.g., parenteral injection or as a liquid formulation for oral administration (Devane, e.g., 0153). Further, Devane exemplifies several suspension formulations in water (Devane, e.g., Table 8).
Alternative surface stabilizers, including polyoxyethylene castor oil derivatives are taught (Devane, e.g., claim 9). Polyoxyethylene castor oil derivatives meet the limitation of comprising polyoxyl castor oil as recited in claim 1.
Devane teaches liquid formulations may comprise solubilizing agents and emulsifiers (Devane, e.g., 0153
Devane does not expressly teach a single embodiment of a composition of menatetrenone nanoparticles in water, wherein the menatetrenone nanoparticles have an average particle size of less than 125 (or the sizes recited in claims 53-54), AND where the composition comprises polyoxyl castor oil. That is, the compositions of Devane, table 8, differ from the subject matter of claim 1 in that none of the exemplified formulations comprise polyoxyl castor oil.
Drouet teaches similar formulations of vitamin K derivatives, wherein the composition comprises a solubility enhancing agent and wherein the solubility enhancing agent is polyoxyl castor oil (Drouet, e.g., 0109).
Drouet teaches compositions comprising vitamin K2 derivatives within the scope of the claimed invention, e.g., MKH2-8 and MKH2-10 and MKH2-11 (Drouet, e.g., claim 16).
Drouet does not expressly teach wherein the vitamin K2 derivative having a nanoparticle size within the claimed range in water with polyoxyl castor oil.
It would have been obvious before the effective filing date of the presently claimed invention to combine the teachings of Devane and Drouet to arrive at the presently claimed subject matter with a reasonable expectation of success.
Starting from Devane, the skilled artisan would have been motivated to modify Devane’s compositions with a polyoxyl castor oil solubilizer as suggested by Drouet with a reasonable expectation of success. The skilled artisan may have seen this modification as combining two known vitamin K2 solubilizers to achieve predictable results. See MPEP 2144.06, I. Alternatively, the skilled artisan may have seen this modification as a substitution of one known vitamin K2 for another where each were known and used for the same purpose. See MPEP 2144.06, II. The skilled artisan would have been motivated to reinforce Devane’s desired improvements in dissolution and bioavailability. The skilled artisan would have had a reasonable expectation of successfully formulating the nanoparticles with a surface stabilizer which includes polyoxyethylene castor oil derivatives because Devane expressly suggests this surface stabilizer may be used instead of, or in combination with surface stabilizers exemplified in Devane. The skilled artisan would have had a reasonable expectation of success because both documents teach improved formulations of vitamin K2.
Starting from Drouet, it would have been obvious before the effective filing date of the presently claimed invention to modify Drouet’s MKH2-8 and MKH2-10 and MKH2-11 compositions using techniques known from Devane to improve Drouet’s compositions in the same way with a reasonable expectation of success. The skilled artisan would have been motivated to formulate MKH2-8 and MKH2-10 and/or MKH2-11 in compositions as nanoparticles having an average size suggested by Devane for improved pharmacokinetic properties relative to comparative non-nanoparticulate formulations, bioequivalence between the fed and fasted state, and improvements in dissolution and bioavailability reported in Devane with a reasonable expectation of success. The skilled artisan would have had a reasonable expectation of successfully formulating the nanoparticles with a surface stabilizer which includes polyoxyethylene castor oil derivatives because Devane expressly suggests this surface stabilizer may be used instead of, or in combination with surface stabilizers exemplified in Devane. The skilled artisan would have had a reasonable expectation of success because both documents teach improved formulations of vitamin K2.
Applicable to claim 31: Claim 5 recites product by process language which does not appear to imply any structural features of the nanoparticles beyond that required by claim 1. Further, Devane teaches nanoparticles prepared with a homogenizer (Devane, e.g., claim 16).
Applicable to claim 32: Devane teaches compositions further comprising a compound which is capable of enhancing the absorption and/or bioavailability in a human, and wherein the enhancer is, e.g., medium chain triglycerides or medium chain fatty acids (Devane, e.g., 0179).
Applicable to claim 33: Devane teaches the composition is a nanosuspension in water, e.g., Devane, e.g., 0232, milled nanoparticles of K2 in water.
Applicable to claim 34: Devane teaches the composition comprising K2 in an amount ranging from about 99.5 to about 0.001% (Devane, e.g., claim 7). The claimed amount reads on 0.001% by weight and is within the range suggested by the prior art. The skilled artisan would have been motivated to optimize the K2 in an amount effective to achieve treatment of patients for, e.g., osteoporosis, depending on patient age, stage of disease, other health factors etc. 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 35-37: These recite characteristics or properties of the nanosuspension under certain conditions. Since the composition of the prior art has all of the structural features recited in claim 30, the properties are presumed to be the same. See MPEP, e.g., 2112.01 I-II.
Further, with respect to solubility, Devane teaches the nanoparticle compositions can attain a level of dissolution for the practically water insoluble vitamin K2 of close to 100%, e.g., in gastric juices (Devane, e.g., 0071-0074). That is, Devane teaches the nanoparticle compositions of vitamin K2 achieve increased dissolution of vitamin K2 which appears to be greater than 5 times the expected solubility of vitamin K2. Increased dissolution of the nanoparticulate vitamin K2 results in increased solubility, faster onset, and greater bioavailability. Increases in solubility overcomes the problem of bioavailability of vitamin K2 for treatments of conditions, e.g., osteoporosis (Devane, e.g., 0011-0012).
Nanoparticulate vitamin K2 compositions achieve improved pharmacokinetic properties relative to comparative non-nanoparticulate formulations (Devane, e.g., 0056-0062), are not affected by the fed or fasted state (Devane, e.g., 0063-0070), and show dramatic, and unexpected, improvements in dissolution (Devane, e.g., 0071-0074).
Accordingly, the subject matter of claims 30-37 and 53-54 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
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 30-37 and 53-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12453700 in view of Devane, US 20110064803 and Drouet, US 20200079718 A1.
The reference claims teach compositions comprising nanoparticles of menaquinone-9 (MK-9) or menaquinol-9 (MKH2-9), water and polyoxyl castor oil, wherein the nanoparticles have an average particle size of less than 125 nm. The limitations of claim 31 are found in reference claim 2. Medium chain triglycerides and additionally claimed emulsifiers (bioavailability enhancers) are found in reference application claim 6. Nanosuspension in water is found in reference application claim 7. The properties of claims 35-37 are expected to be similar if tested in the same way and the composition is explicitly effective for the treatment of a condition associated with vitamin K.
The reference claims differ from the presently claimed subject matter in that the present reference compositions do not expressly contain the claimed menaquinone/menaquinols. However, the presently claimed menaquinone/menaquinols were known as vitamin K2 alternatives for MK-9 or MKH2-9 and have the same core structure.
For example, MK-9 was a known vitamin k2 derivative like MK-4, MK-8 and MK-10 as evident from Drouet and Devane. Drouet teaches MK-9 was a known long chain menaquinone like MK-8 and MK-10. Thus, menaquinone/menaquinols within the scope of the claimed invention were obvious variants of MK-9 and MKH2-9 as recited in the reference claims. Both were known long chain menaquinones having similar therapeutic benefits, e.g., greater and longer lasting effects.
Devane teaches nanoparticle formulations of vitamin K2 analogs offer improved dissolution and bioavailability. Thus, Devane shows the skilled artisan was motivated before the filing date of the presently claimed invention to formulate vitamin K2 derivatives as nanoparticles having similar size since nanoparticle formulations would have been expected to offer similar improvements for longer chain vitamin K2 analogs.
It would have been obvious before the effective filing date of the presently claimed invention to modify a composition as claimed by the reference patent by including MK-4, MK-8 and/or MK-10 as known form Devan and Drouet in the form of nanoparticles having a size in the range suggested by Devane for greater dissolution and bioavailability with a reasonable expectation of success. The skilled artisan may have seen this modification as a substitution of one known menaquinone in the form of nanoparticles for another where each was known to have similar pharmacological effect and useful for treating subjects having the same indication, e.g., osteoporosis. Alternatively, the skilled artisan may have seen this modification as a combination of known menaquinone in the form of nanoparticles useful for the same purpose to arrive at a composition having the same utility. See MPEP 2144.06.
Applicable to claim 34: Devane teaches the composition comprising K2 in an amount ranging from about 99.5 to about 0.001% (Devane, e.g., claim 7). The claimed amount reads on 0.001% by weight and is within the range suggested by the prior art. The skilled artisan would have been motivated to optimize the K2 in an amount effective to achieve treatment of patients for, e.g., osteoporosis, depending on patient age, stage of disease, other health factors etc. 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.
Accordingly, the subject matter of claims 30-37 and 53-54 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 30-37 and 53-54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 12383514 in view of Devane, US 20110064803 and Drouet, US 20200079718 A1.
The reference claims teach compositions comprising nanoparticles of MK-7 (menaquinone-7) or MKH2-7 (menaquinol-7), water and polyoxyl castor oil, wherein the nanoparticles have an average particle size of less than 125 nm. The limitations of claim 31 are found in reference claim 2. Medium chain triglycerides and additionally claimed emulsifiers (bioavailability enhancers) are found in reference application claim 3. Nanosuspension in water is found in reference application claim 4. The concentration of claim 34 is found in claim 5. The properties of claims 35-37 are expected to be similar if tested in the same way and the composition is explicitly effective for the treatment of a condition associated with vitamin K (reference claims 6-7).
The reference claims differ from the presently claimed subject matter in that the present reference compositions do not expressly contain the claimed menaquinone/menaquinols. However, the presently claimed menaquinone/menaquinols were known as vitamin K2 alternatives for MK-7 or MKH2-7 and have the same core structure.
For example, MK-7 was a known vitamin k2 derivative like MK-4, MK-8 and MK-10 as evident from Drouet and Devane. Drouet teaches MK-7 was a known long chain menaquinone like MK-4, MK-8 and MK-10. Thus, menaquinone/menaquinols within the scope of the claimed invention were obvious variants of MK-7 and MKH2-7 as recited in the reference claims. Both were known long chain menaquinones having similar therapeutic benefits, e.g., greater and longer lasting effects.
Devane teaches nanoparticle formulations of vitamin K2 analogs offer improved dissolution and bioavailability. Thus, Devane shows the skilled artisan was motivated before the filing date of the presently claimed invention to formulate vitamin K2 derivatives as nanoparticles having similar size since nanoparticle formulations would have been expected to offer similar improvements for longer chain vitamin K2 analogs.
It would have been obvious before the effective filing date of the presently claimed invention to modify a composition as claimed by the reference patent by including MK-4, MK-8 and/or MK-10 as known from Devane and Drouet in the form of nanoparticles having a size in the range suggested by Devane for greater dissolution and bioavailability with a reasonable expectation of success. The skilled artisan may have seen this modification as a substitution of one known menaquinone in the form of nanoparticles for another where each was known to have similar pharmacological effect and useful for treating subjects having the same indication, e.g., osteoporosis. Alternatively, the skilled artisan may have seen this modification as a combination of known menaquinone in the form of nanoparticles useful for the same purpose to arrive at a composition having the same utility. See MPEP 2144.06.
Accordingly, the subject matter of claims 30-37 and 53-54 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 30-37 and 53-54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30-50 of copending Application No. 19272744 in view of in view of Devane, US 20110064803 and Drouet, US 20200079718 A1.
The reference application claims teach a composition comprising nanoparticles of MK-9 (menaquinone-9) or MKH2-9 (menaquinol-9), wherein the nanoparticles have an average particle size of less than or equal to 35 nm, water and polyoxyl castor oil.
The presently claimed particle size overlaps with the range claimed by the reference application, e.g., claims 30. Medium chain triglycerides and additional claimed emulsifiers are found in reference application claim 33. Nanosuspension in water is found in reference application claim 35. The properties of claims 35-37 are expected to be similar if tested in the same way and the composition is explicitly effective for the treatment of a condition associated with vitamin K.
The reference claims differ from the presently claimed subject matter in that the present reference compositions do not expressly contain the claimed menaquinone/menaquinols. However, the presently claimed menaquinone/menaquinols were known as vitamin K2 alternatives for MK-9 or MKH2-9 and have the same core structure.
However, MK-9 was a known vitamin k2 derivative like MK-4, MK-8 and MK-10 as evident from Drouet and Devane. Drouet teaches MK-9 was a known long chain menaquinone like MK-8 and MK-10. Thus, menaquinone/menaquinols within the scope of the claimed invention were obvious variants of MK-9 and MKH2-9 as recited in the reference claims. Both were known long chain menaquinones having similar therapeutic benefits, e.g., greater and longer lasting effects.
Devane teaches nanoparticle formulations of vitamin K2 analogs offer improved dissolution and bioavailability. Thus, Devane shows the skilled artisan was motivated before the filing date of the presently claimed invention to formulate vitamin K2 derivatives as nanoparticles having similar size since nanoparticle formulations would have been expected to offer similar improvements for longer chain vitamin K2 analogs.
It would have been obvious before the effective filing date of the presently claimed invention to modify a composition as claimed by the reference patent by including MK4, MK-8 and/or MK-10 as known form Devane and Drouet in the form of nanoparticles having a size in the range suggested by Devane for greater dissolution and bioavailability with a reasonable expectation of success. The skilled artisan may have seen this modification as a substitution of one known menaquinone in the form of nanoparticles for another where each was known to have similar pharmacological effect and useful for treating subjects having the same indication, e.g., osteoporosis. Alternatively, the skilled artisan may have seen this modification as a combination of known menaquinone/menaquinols in the form of nanoparticles useful for the same purpose to arrive at a composition having the same utility. See MPEP 2144.06.
Applicable to claim 34: Devane teaches the composition comprising K2 in an amount ranging from about 99.5 to about 0.001% (Devane, e.g., claim 7). The claimed amount reads on 0.001% by weight and is within the range suggested by the prior art. The skilled artisan would have been motivated to optimize the K2 in an amount effective to achieve treatment of patients for, e.g., osteoporosis, depending on patient age, stage of disease, other health factors etc. 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.
Accordingly, the subject matter of claims 30-37 and 53-54 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615
