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 .
Notice of Pre-AIA or AIA Status
DETAILED ACTION
Status of the Claims
Claims 1-16 are pending. Claims 1-15 are withdrawn. Claim 16 is under examination.
Priority
This application is a national stage entry of PCT/EP2021/086775 filed on 12/20/2021, which claims priority from European application EP20383132.6 filed on 12/21/2020.
Information Disclosure Statement
The information disclosure statement filed on 06/22/2023 has been considered by the examiner.
Election/Restriction
Applicant’s election without traverse of Group II (claim 16) in the reply filed on 12/16/2025 is acknowledged.
Claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/16/2025.
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.
Claim 16 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 16 recites the broad recitation “calcium salt”, and the claim also recites “particularly calcium chloride” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
In the present instance, claim 16 recites the broad recitation “a salt of a divalent metal different from calcium”, and the claim also recites “particularly magnesium chloride” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 16 is indefinite for the phrase “excipients of carriers” as it is unclear if this is supposed to be “excipients or carriers” or if this is supposed to mean the excipients that are found in (of) the carriers. For the purpose of compact prosecution, the examiner will read the claim as “excipients or carriers”.
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 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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Meier WO2018206357A1 (English translation from family document US 20210137968A1) and European Pharmacopoeia (4.1.3- Buffer solutions, 1/2005, pages 430-435).
Applicant’s use of “optionally” for one or more pharmaceutically acceptable excipients of carriers and one or more additional active ingredients provides that these items are optional and do not have to be in the composition.
Meier teaches a composition with chondroitin sulfate (active), hyaluronic acid (active) and a dihydrogen phosphate/monohydrogen phosphate buffer system and optionally at least one physiologically compatible electrolyte (paragraphs 67-72). Meier teaches the pH being between 6.1 to 7.9 (paragraph 72). Meier teaches alkali metal dihydrogen phosphates (paragraphs 142-146). Meier teaches pH from 7.1 to 7.4 (paragraph 148). Meier teaches sodium dihydrogen phosphate (paragraphs 132-133). Meier teaches sodium and/or potassium as options for the alkali metal (paragraphs 131 and 226). Meier teaches alkali metal salts including sodium chloride as an electrolyte (paragraphs 228 and 252). Meier teaches composition A1 with chondroitin sulfate sodium, sodium hyaluronate, sodium dihydrogen phosphate, disodium hydrogen phosphate, sodium chloride and water (paragraph 258). Water serving as the carrier. Meier teaches calcium and/or magnesium salt (paragraph 174). Meier teaches “a total concentration of alkali metal dihydrogen phosphate/alkali metal monohydrogen phosphate buffer system of (1.75±1.65) mg/ml” (paragraphs 142-146). As applicant’s claimed range for sodium dihydrogen phosphate would cover concentrations of 0.96 mg/ml to 1.44 mg/ml (8 mM to 12 mM), the range of Meier overlaps as it would cover from 0.1 to 3.4 mg/ml. Meier teaches pharmaceutical compatible carrier (excipient) (paragraph 164). The concentration of sodium chloride in Composition A1 of Meier equates to 135 mM sodium chloride.
Meier does not teach a composition with the concentrations of potassium dihydrogen phosphate, calcium chloride, potassium chloride and magnesium chloride as in applicant’s claims.
European Pharmacopoeia teaches a buffer composition with pH 7.2 with 8 g sodium chloride, 0.2 g potassium chloride, 0.1 g anhydrous calcium chloride, 0.1 g magnesium chloride, 3.18 g disodium hydrogen phosphate and 0.2 g potassium dihydrogen phosphate in 1000 ml water (page 432, buffered salt solution pH 7.2). The amounts correspond to 136.9 mM sodium chloride, 2.68 mM potassium chloride, 0.901 mM calcium chloride, 1.05 mM magnesium chloride and 1.47 mM potassium dihydrogen phosphate.
One of ordinary skill in the art before the time of filing would have included the amounts of potassium dihydrogen phosphate, potassium chloride, calcium chloride and magnesium chloride into buffer solutions of Meier, which includes these ingredients, as they are recognized amounts of such pharmaceutical buffer components for making a composition with pharmaceutical buffer with dihydrogen phosphate that offers a pH 7.2 in European Pharmacopeia, which is within Meier’s pH range for its buffered pharmaceutical composition.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK V STEVENS whose telephone number is (571)270-7080. The examiner can normally be reached M-F 9:00 am to 6:00 pm EST.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613