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 .
DETAILED ACTION
Status of Claims
Claims 39-40, 42-44, 46-54, and 76-80 are pending.
Claim Rejections - 35 USC § 112 (b)
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 42 and 49 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.
The recitation of the adjective “elemental” in claim 42 and 49 is unclear. Conventionally, “elemental” refers to free atoms of the respective element that have no charge, i.e., a non-ionized state. Is it intended to mean the claimed metals such as zinc, copper, selenium, and manganese are present in elemental state, not in ionized state in the water? In the context of the claims, this is problematic because (i) all the recited salts are highly soluble in water and (ii) the injectable trace element composition is aqueous. With this in mind, it appears that the zinc, copper, manganese, and selenium each is in cationic form not elemental state. Thus, such recitation renders the scope of the claims 42 and 49 indefinite.
For examination purpose, it is interpreted to be in “ionized state”.
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 39-40, 42-44, 46-52, 54, 76-78, and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by SELEPEN Product Monograph (Selenium IV Additive for use with TPN, 1/15/2008; hereafter, SELEPEN PM; cited in the IDS filed on 11/21/2024).
SELEPEN PM teaches that Selepen® is a sterile, nonpyrogenic solution for use as an additive to solution for total parenteral nutrition (TPN) and each ml of the solution contains:
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285
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(page 2, description). One of ordinary skill in the art would have at once envisaged a method of preparing the injectable solution by mixing the ingredients with water as shown in the Table.
SELEPEN PM further discloses that the single dose preparation is in a 10 ml flip-top vial and the multiple dose preparation is 30 ml flip-tap vial which is preserved with 0.9 % benzyl alcohol (page 6, availability of dosage forms).
SELEPEN PM further teaches that the suggested additive dosage level is 20 to 40 µg selenium/day and for pediatric patients, the suggested additive dosage level is 3 µg/kg/day (p5, DOSGA and ADMINSITRATION).
As to the amounts of chromium recited in claim 39, 52, and 77, SELEPEN PM does not teach chromium as ingredients of the Selepen®. Also, the injection solution of Selepen® is prepared by using the same selenious acid, water for injection and nitric acid as claimed. Thus, the composition necessarily contains no chromium or claimed amount of chrominum.
Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
As such, the instant claims are anticipated by SELEPEN PM.
Claims 39-40, 42-44, 46, 49-54, 76-78, and 80 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Prescribing Information for Selenious Acid Injection (Reference ID 4426638, 04/2019; hereafter, SAI PI; cited in the IDS filed on 11/21/2024).
SAI PI discloses selenious acid injection comprising 600 µg/10 ml (60 µg/1ml) of selenium as a pharmacy bulk package vial, wherein it is a sterile, nonpyrogenic, clear, colorless solution intended for use as a trace element and additive to intravenous solutions for parenteral nutrition (TPN) (p1, Dosage Forms and Strengths and p7, section 11).
SAI PI further discloses that each ml of the solution contains: 60 µg selenium present as 98 µg of selenious acid and water for injection, the pH range is 1.8 to 2.4 adjusted with nitric acid and each bulk package vial contains 10 ml of selenious solution and does not contain preservatives (p7, section 11). One of ordinary skill in the art would have at once envisaged a method of preparing the injectable solution by mixing the ingredients with water as stated above.
SAI PI teaches that selenious acid injection contains aluminum that may toxic and patients with impaired kidney function including preterm neonates who receive greater than 4 to 5 mcg/kg/day of parenteral aluminum can accumulate to levels associated with central nervous system and bone toxicity (p4, section 5.3) SAI PI further teaches that the injection solution contains no more than 2500 µg/L of aluminum (2.5 µg/mL), which falls within the range recited in claim 53.
SAI PI further teaches that recommended dosage of selenium is 60 µg/day for adults, 2 µg/kg/day for pediatric patients 7 kg and above, and 2 to 4 µg/kg/day for pediatric patients less than 7 kg (p3, section 2.5).
As to the amounts of chromium recited in claim 39, 52, and 77, SAI PI does not teach chromium as ingredients of the injection solution. Also, the injection solution is prepared by using the same selenious acid, water for injection, and nitric acid as claimed. Thus, the composition necessarily contains no chromium or claimed amounts of chromium.
Applicants are advised that In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) states: "Where, as here, the claimed and prior art product is identical or substantially identical, or is produced by an identical or substantially identical process, the PTO can require an applicant to prove that the prior art product does not necessarily or inherently possess the characteristics of his claimed product ........ Whether the rejection is based on 'inherency' under 35 USC 102, on 'prima facie obviousness' under 35 USC 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO's inability to manufacture products or to obtain and compare prior art products [footnote omitted]."
As such, the instant claims are anticipated by SAI PI.
Alternatively, the following 103 rejection is applied.
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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 39-40, 42-44, 46-54, and 76-80 are rejected under 35 U.S.C. 103 as being unpatentable over SELEPEN Product Monograph (Selenium IV Additive for use with TPN, 1/15/2008; hereafter, SELEPEN PM) and Selenious acid injection (Reference ID 4426638, 4/2019; hereafter, SAI PI) in view of Fessler et al. (Nutrition in Clinical practice, 28 (6): 722-729, 2013; cited in the IDS filed on 11/21/2024).
SELEPEN PM and SAI PI as applied supra are herein applied for the same teachings in their entirety.
SELEPEN PM and SAI PI are silent about the amounts of chromium and aluminum which are present in 1 mL of the injectable composition.
As to chromium, Fessler teaches that chromium (Cr) is a significant contaminant, reported as 2.4-8.1 µg/d and 15 µg/2L (0.0075 µg/ml) of parenteral nutrition and by multiplying the value for oral adequate intake by estimated GI absorption rates, the adult parenteral Cr requirement may be as low as 0.1-0.9 µg/d (p726, col 1, para 4). Fessler teaches that Cr amount of 10-100 times normal have been found in liver, kidney, and heart tissue of patients who received long-term PN and elevated serum Cr was inversely correlated with glomerular filtration rate in children receiving PN, suggesting possible renal damage (p726, col 2, para 1). Fessler suggests that the desired ideal content of chromium in trace element products be 0-1 µg/5 ml (0-0.2 µg/ ml) (p724, table 2). Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to limit the amount of chromium to be less than 1 µg in the selenium injection solution of the prior art because Fessler teaches TPN for which the selenium solution is added already includes a significant amount of chromium contaminant and suggest the ideal amount of Cr in trace element products should be 0-0.2 µg/ ml. The skilled artisan would have been motivated to do so for avoiding administering Cr in more amount than daily requirement and thereby preventing possible toxicity of Cr overdose as taught by Fessler.
As to the amount of aluminum, while SELEPEN PM is silent about the amount of aluminum which is present in 1 mL of the injectable composition, SAI PI already teaches that the injection solution contains no more than 2500 µg/L of aluminum (2.5 µg/mL), which falls within the range recited in claim 53. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to limit the amount of aluminum in the selenium single and multi-dose solutions of SELEPEN PM to the same level as taught by SAI PI. The skilled artisan would have been motivated to do so for avoiding possible toxicity of aluminum as evidenced by SAI PI.
Claim 79 is rejected under 35 U.S.C. 103 as being unpatentable over SELEPEN Product Monograph (Selenium IV Additive for use with TPN, 1/15/2008; hereafter, SELEPEN PM) and Selenious acid injection (Reference ID 4426638, 4/2019; hereafter, SAI PI) in view of Fessler et al. (Nutrition in Clinical practice, 28 (6): 722-729, 2013; cited in the IDS filed on 11/21/2024) as evidenced by US 5079010.
SELEPEN PM, SAI PI, and Fessler et al. as applied supra are herein applied for the same teachings in their entirety.
SELEPEN PM and SAI PI do not teach the use of sulfuric acid to adjust pH.
However, it was well-known that sulfuric acid as a physiological acid could be used to adjust pH of a solution containing trace elements including selenium to the range of between about 2.0 and 3.0 as evidenced by US 5079010 (abstract and col 3, lines 7-22 and lines 36-44).
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute nitric acid with sulfuric acid as pH adjuster for the selenium solution taught by SELEPEN PM or SAI PI with reasonable expectation of success because US 5079010 teaches that sulfuric acid is a physiological acid suitable for adjusting pH to the pH level of the selenium solution taught by SELEPEN PM or SAI PI. The person of ordinary skill in the art would have found it obvious to make such substitution because the ordinarily skilled artisans would have predicted that sulfuric acid would be safe and effective based on its suitability as pH adjuster in a solution comprising trace elements such as selenium as evidenced by US 5079010. Also see MPEP § 2144.07 (the selection of a known material based on its suitability for its intended use can support a prima facie obviousness determination).
Double Patenting Rejections
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
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 co-pending application 18/955395.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the co-pending application are also drawn to a method of making an injectable composition comprising mixing at least one of about 800 to 4,000 μg of zinc, about 40 to 400 μg of copper, about 4 to 90 μg of selenium, or about 1 to 80 μg of manganese with water to form 1 mL of the injectable composition, wherein the injectable composition comprises no chromium or chromium in an amount less than 1 μg per 1 ml of the injectable compositing and aluminum about 1 ppm to about 6 μg per 1 mL of the injectable composition. The scope of the instant claims is almost identical to those of the copending application except for the presence of “about” before the ranges. As such, the instant claims are anticipated by the claims of the co-pending application.
Claims 39-40, 42-44, 46-54, and 76-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-58 of Patent No. 11786548
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent are drawn to an injectable composition comprising water, about 60 μg of selenium, 3,000 μg of zinc, about 300 μg of copper, and about 55 μg of manganese per 1 mL of the injectable composition, wherein the injectable composition comprises no added chromium and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the injectable composition.” The amount ranges of selenium, zinc, copper, and manganese fall within those claimed. Dependent claims also recite the composition contain pH adjusting agent such as sulfuric acid. It would have been prima facie obvious to one of ordinary skill in the art to arrive at the claimed method of making the injectable composition by mixing the above components with water as claimed.
Claims 39-40, 42-44, 46-54, and 76-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of Patent No. 11975022.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite an injectable trace elements composition comprising water, about 60 μg of selenium, 3,000 μg of zinc, about 300 μg of copper, and about 55 μg of manganese per 1 mL of the injectable composition, wherein the injectable composition comprises no added chromium and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the injectable composition.” The amount ranges of selenium, zinc, copper, and manganese fall within those claimed. It would have been prima facie obvious to one of ordinary skill in the art to arrive at the claimed method of making the injectable composition by mixing the above components with water as claimed.
Claims 39-40, 42-44, 46-54, and 76-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of Patent No. 11998565.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite an injectable composition comprising water, 6 μg or 60 μg of selenium, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg per 1 mL of the injectable composition. The amount range of selenium falls within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art to arrive at the claimed method of making the injectable composition by mixing the above components with water as claimed.
Claims 39-40, 42-44, 46-54, and 76-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of Patent No. 12150957.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite an injectable composition comprising 6 μg, 40 μg, or 60 μg of selenium, no chromium or chromium in an amount not to exceed 1 μg, no aluminum or aluminum in an amount not to exceed 6 μg, no iron or iron in an amount up to 10 μg, and fluoride in an amount of 0.0001 μg to 2.7 μg per 1 mL of the injectable composition. The amount range of selenium falls within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art to arrive at the claimed method of making the injectable composition by mixing the above components with water as claimed.
Claims 39-40, 42-44, 46-54, and 76-80 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of Patent No. 12150956.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the patent recite an injectable composition comprising water, about 3,000 μg of zinc, about 300 μg of copper, about 60 μg of selenium, and about 55 μg of manganese per 1 mL of the injectable trace element composition, wherein the injectable trace element composition contains no iron or iron in an amount not to exceed 10 μg, no chromium or chromium in an amount not to exceed 1 μg and no aluminum or aluminum in an amount not to exceed 6 μg per 1 mL of the injectable trace element composition. The amount ranges of zinc, copper, selenium, and manganese fall within the claimed range. It would have been prima facie obvious to one of ordinary skill in the art to arrive at the claimed method of making the injectable composition by mixing the above components with water as claimed.
Conclusion
No claims are allowed.
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/BONG-SOOK BAEK/Primary Examiner, Art Unit 1611
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