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 . Claims included in the prosecution are claims 39, 40, 42-44, 46-54 and 76-80.
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 54 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 54 is indefinite since it is not clear how the dosage in claim 54 is obtained when using the injectable composition of claim 39. Claim 39 recites amounts of each trace element in micrograms and claim 54 recites amounts of each trace elements in milligrams that do not overlap with the amounts recited in claim 39.
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
1. Claims 39, 40, 42-44, 46, 50, 51, 76 and 78 are rejected under 35 U.S.C. 103 as being unpatentable over JP 5669408 B2 (Feb. 12, 2015) (hereinafter JP) in view of Stiefel (US 2007/0178192, Aug. 2, 2007).
JP discloses a trace element preparation containing no iron for preventing various deficiency symptoms derived from deficiency of essential trace elements such as manganese, zinc, copper, and iodine, and suppressing the occurrence of side effects associated with excessive intake of iron (abstract). Insufficient trace elements are present in humans (page 1 of translation). The preparation is a mixed solution suitable for intravenous infusion (page 5 of translation, third paragraph). The trace element preparation comprises 0.01 to 4 µmol of manganese (0.55 µg to 219.75 µg), 0.05 to 200 µmol of zinc (3.269 µg to 13,076 µg), 0.01 to 20 µmol of copper (0.635 µg to 1,270.92 µg), and 0.01 to 11 µmol of iodine in 1 mL of an aqueous liquid (page 4 of translation, fifth paragraph). The amount of each element per patient as a daily dose is preferably 0.1 to 4 μmol of manganese, 0.5 to 200 μmol of zinc, 0.1 to 20 μmol of copper and 0.1 to 11 μmol of iodine. Manganese, zinc, copper, and iodine are added to 1 to 20 mL of water for injection so that each trace element in the trace element preparation is in the above range, and the daily amount for the patient is in the above range (page 4 of translation, sixth and seventh paragraphs). The zinc may be zinc sulfate heptahydrate. The copper may be copper sulfate pentahydrate. The manganese may be manganese sulfate (page 4 of translation, fourth paragraph). The pH of the trace element preparation is not particularly limited as long as manganese, zinc, copper, and iodine are stably contained without causing aggregation or precipitation. The pH of the trace element preparation may be 4.5 to 6.5 (page 5 of translation, third paragraph). Sodium hydroxide may be used to adjust the pH (page 7 of translation, Example 1). The pH may also be adjusted with hydrochloric acid and succinic acid (page 9 of translation, Example 5). The trace element preparation is sealed, stored, distributed, and sold in a container (page 5 of translation, eighth paragraph). Suitable containers include vials (page 5 of translation, ninth paragraph). The trace element preparation is subjected to high-pressure steam sterilization (page 11 of translation, first paragraph). The trace element preparation may contain one or more other trace elements such as chromium and selenium (page 5 of translation, fourth paragraph).
JP differs from the instant claims insofar as not disclosing wherein the trace element preparation comprises about 4 µg to about 90 µg selenium.
However, Stiefel discloses a nutrition trace element composition containing 0.04 – 2 mg of selenium (40 µg to 2000 µg), wherein iron is not contained as a trace element (claim 1). The composition exists as an aqueous solution for injection purposes (claim 5).
JP discloses wherein the trace element preparation may comprise selenium but does not disclose an amount of selenium. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 0.04 – 2 mg of selenium (40 µg to 2000 µg) into the trace element preparation of JP since this is a known and effective amount of selenium for a trace element composition as taught by Stiefel.
Regarding instant claim 39 reciting wherein the injectable composition has no chromium, this limitation would have been obvious since JP discloses wherein chromium is optional.
Regarding instant claims 50 and 51 reciting wherein the injectable composition is in a multi-dose vial, wherein the multi-dose vial contains 10 mL of the injectable composition, this recitation is merely a recitation of the intended use of the injectable composition. The claims recite a method of making an injectable composition. Putting 10 mL of the injectable composition into a multi-dose vial is not a method of making an injectable composition since the injectable composition is already made. JP discloses wherein the preparation may be stored in a vial. Therefore, the preparation of JP is capable of being used in a multi-dose vial. JP also discloses wherein the preparation may comprise 1 to 20 mL of water for injection. Therefore, the preparation of JP is capable of being 10 mL in a vial.
Regarding instant claim 76, the claim encompasses all human patients. Therefore, since the preparation of JP is administered to a human, the claim limitation is met.
2. Claims 47-49 and 54 are rejected under 35 U.S.C. 103 as being unpatentable over JP 5669408 B2 (Feb. 12, 2015) (hereinafter JP) in view of Stiefel (US 2007/0178192, Aug. 2, 2007), and further in view of Liu (CN 108853139 A, Nov. 23, 2018).
The teachings of JP and Steifel are discussed above. JP and Steifel do not teach wherein the trace element preparation comprises benzyl alcohol, selenious acid, and manganese sulfate monohydrate.
However, Liu discloses a multiple microelements injection pharmaceutical composition that prevents or treats zinc, manganese, copper, selenium, chromium, and deficiency (page 3 of translation, last paragraph). The multiple trace element composition for injection comprises selenium and manganese (page 4 of translation, first paragraph). The selenium may be selenious acid (page 4 of translation, fifth paragraph). The manganese may be manganese sulfate and the hydrate thereof (page 4 of translation, fourth paragraph). The injection pharmaceutical composition may contain a pharmaceutically preservative or bacteriostatic agent, such as benzyl alcohol (page 15 of translation, first paragraph).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated benzyl alcohol into the trace element preparation of JP motivated by the desire to prevent or treat microbes since benzyl alcohol is a known preservative/bacteriostatic agent for injectable trace element preparations as taught by Liu.
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. JP discloses wherein the trace element preparation comprises selenium and manganese. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated selenious acid and manganese sulfate hydrate into the trace element preparation of JP since they are known and effective sources for selenium and manganese, respectively, suitable for trace element preparations as taught by Liu.
Regarding the amount of benzyl alcohol recited in instant claim 48, since benzyl alcohol is a bacteriostatic agent, it would have taken no more than the relative skills of one of ordinary skill in the art to have arrived at the claimed amount through routine experimentation based on the level of antimicrobial effect desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
Regarding the dosages recited in instant claim 54, this is merely a recitation of the intended use of the injectable composition. The claims recite a method of making an injectable composition. The amount administered is a use step and not a making step. As discussed above, it would have been obvious to have formulated a composition comprising zinc sulfate heptahydrate, copper sulfate pentahydrate, manganese sulfate hydrate, and selenious acid in the claimed amounts. Therefore, the composition of the prior art is capable of being dosed at the amounts recited in claim 54.
3. Claims 52, 77 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over JP 5669408 B2 (Feb. 12, 2015) (hereinafter JP) in view of Stiefel (US 2007/0178192, Aug. 2, 2007), and further in view of Kim et al. (KR 20200077462 A, Jun. 30, 2020) (hereinafter Kim).
The teachings of JP and Steifel are discussed above. JP and Steifel do not teach wherein the trace element preparation comprises about 0.00001 µg to about 0.25 µg chromium per 1 mL of the composition and comprise sulfuric acid.
However, Kim discloses a mineral injection composition which contains at least one mineral trace element selected from copper, chromium, zinc, manganese, and selenium and has a pH of 4 to 11 (abstract). The content of chromium is 0.0019 to 0.029 mM (0.0988 µg/mL to 1.51 µg/mL) (page 2 of translation, last paragraph). The pH may be adjusted with sulfuric acid (page 6 of translation, second paragraph).
JP discloses wherein the trace element preparation may comprise chromium but does not disclose an amount of chromium. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated 0.0019 to 0.029 mM (0.0988 µg/mL to 1.51 µg/mL) into the trace element preparation of JP since this is a known and effective amount of chromium for a trace element composition as taught by Kim.
JP discloses wherein the trace element preparation comprises agents for adjusting the pH. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated sulfuric acid into the trace element preparation of JP since it is a known and effective pH adjusting agent as taught by Kim.
4. Claim 53 is rejected under 35 U.S.C. 103 as being unpatentable over JP 5669408 B2 (Feb. 12, 2015) (hereinafter JP) in view of Stiefel (US 2007/0178192, Aug. 2, 2007), and further in view of Duan et al. (CN 101095944 B, Apr. 18, 2012) (hereinafter Duan).
The teachings of JP and Steifel are discussed above. JP and Steifel do not teach wherein the trace element preparation comprises about 1 ppm to about 6 µm of aluminum per 1 mL of the composition.
However, Duan discloses wherein aluminum is a trace element beneficial to human health (page 4 of translation, first paragraph).
JP discloses wherein the trace element preparation may comprise one or more other trace elements. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated aluminum since it is a known and effective trace element and it is beneficial to human health as taught by Duan.
Regarding the amount of aluminum, since aluminum is beneficial to human health, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount depending on the amount needed to benefit human health. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
5. Claim 80 is rejected under 35 U.S.C. 103 as being unpatentable over JP 5669408 B2 (Feb. 12, 2015) (hereinafter JP) in view of Stiefel (US 2007/0178192, Aug. 2, 2007), and further in view of Gillessen et al. (US 2009/0253722, Oct. 8, 2009) (hereinafter Gillessen).
The teachings of JP and Steifel are discussed above. JP and Steifel do not teach wherein the trace element preparation comprises nitric acid.
However, Gillessen discloses an aqueous pharmaceutical composition for bolus injection or diluted for i.v. infusion (abstract). The composition may comprise nitric acid to adjust the pH of the composition (¶ [0020]).
JP discloses wherein the trace element preparation comprises agents for adjusting the pH. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated nitric acid into the trace element preparation since it is a known and effective pH adjusting agent for injectable compositions as taught by Gillessen.
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 39, 40, 42-44, 46-54 and 76-80 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39, 40, 42-44, 46-54 and 76-80 of copending Application No. 18/955,379 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims recite a more specific version of the instant claims (i.e., the conflicting claims recite narrow amount range) and thus read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 39, 40, 42-44, 46-54 and 76-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent Nos. 11,786,548, 11,975,022, and 12,150,956. Although the claims at issue are not identical, they are not patentably distinct from each other because the pending claims recite a method of making comprising mixing the elements with water. However, since the patented claims recite an injectable composition comprising trace elements in water, it would have been obvious that the trace elements in the patented claims are mixed with water.
Conclusion
Claims 39, 40, 42-44, 46-54 and 76-80 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
