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 .
Election/Restrictions
Applicant’s election without traverse of Group I (drawn to a pharmaceutical composition), in the reply filed on 02/09/2026 is acknowledged.
Claims 1-5 and 7-9 are pending of which claim 6 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected INVENTION, there being no allowable generic or linking claim. The restriction requirement is still deemed proper and is made Final.
Pending claims 1-5 and 7-9 have been examined on the merits.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 5 and 7-9 recite nitrogen substituted or nitrogen substitution formulation, however, the specification does not explain the methods (e.g., gas purging, vacuum-nitrogen cycles, or other techniques) that lead to nitrogen-substituted or define the exact meaning of the term herein. Thus, a person of ordinary skill in the art (POSITA) would interpret the term “nitrogen-substitution” or “nitrogen-substituted” in multiple different ways, such as the process where a nitrogen atom in an organic compound is replaced by another atom or group. Furthermore, the specification appears to reference “nitrogen substitution” in the context of reducing the oxygen saturation in the storage container to 5% or less, but the specification does not explain how this process is achieved. The specification does not disclose the equipment or techniques or amount of nitrogen added for replacing oxygen, leading to oxygen saturation of 5 % or less. This then indicates that the specification does not have sufficient detail to demonstrate possession of “nitrogen substitution” or “nitrogen substituted.”
The specification’s failures to disclose sufficient details for the term “nitrogen substitution” or “nitrogen substituted,” clearly supports the conclusion that the specification lacks adequate written description of the claimed subject matter indicating that Applicant was not in possession of the claimed method before the effective filing date of the claimed invention in view of the disclosure of the application as filed.
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.
Claims 5 and 7-9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5 and 7-9 recite nitrogen substituted or nitrogen substitution formulation. The term “nitrogen-substitution” or “nitrogen-substituted” is indefinite because as cited, a POSITA would recognize multiple plausible interpretation, such as substitution on nitrogen, vacuum-nitrogen cycles or purge cycles. Thus, the absence of a precise definition in the specification renders the claims indefinite.
Claim Rejections – 35 USC § 102
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.
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 1-4 are rejected under 35 U.S.C. 102(a)(l) as being anticipated by CN103720647 (“CN ‘647”). All references are being made to the English translation (machine generated).
Regarding claims 1-2, CN ‘647 (abstract, page 1-2) teaches an injectable formulation comprising (S)-ibuprofen or dexibuprofen (100 mg) and arginine (67.6～118.2 mg) which include the option of L-arginine or D-arginine at a stable pH at 7-9. CN ‘647 (page 2-3) teaches the formulation is stable and that the ratio of arginine to dexibuprofen regulates the stability of the injection composition. CN ‘647 (page 2-3) teaches dexibuprofen and arginine ratio of 1:0.8-1:1:1.4, which overlaps with the claimed limitation arginine 320-330 per 400 dexibuprofen (1:0.95-0.98).
Regarding claim 3, CN ‘647 (page 2) teaches “0.9% sodium chloride solution or the rear quiet use of 5% glucose solution.”
Regarding claim 4, CN ‘647 (page 2) “uses clinically 0.9% sodium chloride solution or the rear quiet use of 5% glucose solution dilution. Solution osmotic pressure after dilution is between 280M OSmol/Kg-320M OSmol/Kg, and safety is good.” Thus, the osmotic pressure corresponds to 0.28-0.32 osmol/Kg is within the instant claim range. While CN ‘647 does not explicitly disclose a specific gravity, however, CN ‘647 teaches an aqueous dexibuprofen with arginine at a molar ratio of about 1:0.8-1:1.4 in water for injection. Given that the solution contains on the order of 0.2 g dissolved solids per ml of water, such an aqueous solution will inherently have a density slightly greater than that of water, i.e., a specific gravity just above 1.0 and far below 2.0. Therefore, it would have anticipated that the claimed specific gravity is thus an inherent property of the composition.
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 (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.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office
action.
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.
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.
Claims 5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over CN103720647 (“CN ‘647”), as applied to claims 1-4 above, in view of Tang et al., WO2019023102. All references are being made to the English translation (machine generated).
Regarding claims 5 and 7-9, and as applied to claims 1-4 above, CN ‘647 teaches a system “inflated with nitrogen” which a person of ordinary skill in the art (POSITA) would understand the container is flushed with nitrogen gas, so that oxygen is displaced and saturation is reduced. However, CN ‘647 does not explicitly teach oxygen level.
However, Tang (page 27, [0102]-[0106] and page 14, [0055]) teaches injectable formulation with headspace oxygen reduced via nitrogen overlay to levels of 5%, 2%, 1%, to improve storage stability and thus reduced compound degradation. Therefore, it would have been obvious to a POSITA to modify the teachings of CN ‘647 in view of Tang, by purging nitrogen into a storage container to reduce oxygen level to 5% or below, as doing so was a well-recognized method in the art to enhance storage stability of formulations.
Conclusion
Therefore, claims 1-5 and 7-9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PIERRE PAUL ELENISTE whose telephone number is (571)270-0589. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES H ALSTRUM-ACEVEDO can be reached at (571) 272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.P.E./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622