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 .
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.
Election/Restrictions
Applicant’s election without traverse in the reply filed on 15 September 2025, is acknowledged.
Applicants’ compliant species election of: “arginine buffer” as a species of “buffer”; and “sodium chloride” as a species of “salt”, as claimed in the composition of instant claim 1, did not retrieve any prior art.
An extended Markush search to the full scope of instant claim 1 also did not retrieve any prior art.
The Election of Species Requirement of 15 July 2025, is withdrawn, as all claims are free of the prior art.
All claims have been examined on the merits.
Current Status of 18/016,299
This Office Action is responsive to the amended claims of 13 January 2023.
Claims 1-17 have been examined on the merits. Claims 1-2 and 12 are original. Claims 3-11 and 13-16 are currently amended. Claim 17 is new.
Priority
The effective filing date is 15 July 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4 January 2024; and 29 August 2023, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 2-10 and 16-17 are objected to as these are dependent claims. Dependent claims must begin with the article -- The -- . In contrast, independent claims begin with the articles “A” or “An”. Please revise these dependent claims accordingly.
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 7 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 7 recites the limitation "wherein the aqueous pharmaceutical composition comprises sodium chloride". There is insufficient antecedent basis for this limitation in the claim.
The limitation "wherein the aqueous pharmaceutical composition comprises sodium chloride” renders the metes and bounds of claim 7 undefined (hence rendering claim 7 indefinite) since the artisan is not certain whether “sodium chloride” of dependent claim 7 is a “buffer” of claim 1 or a limitation not disclosed within claim 1.
To render moot this rejection: consider revising claim 7 to: -- wherein the pharmaceutically acceptable buffer [[aqueous pharmaceutical composition]] comprises sodium chloride -- if the original disclosure provides support for this amendment.
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.
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 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over:
CAROFF (WO 2009/069100 A1, provided by Applicants - referenced in IDS of 29 August 2023),
in view of:
BUFFER (“Buffering agents and Buffers.” Interchim Innovations. Published online: May 4, 2018. Accessed: 10 February 2026. Available from: < http://www.interchim.fr/ft/B/BC002b.pdf > ),
and in view of:
SALTS (Berge, Stephen M., et al. “Pharmaceutical Salts.” J. Pharm. Sciences. January 1977/Vol. 66, No. 1, pp. 1-19).
The instant claims are drawn to an aqueous pharmaceutical formulation comprising the compound:
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, buffer, and water, in specific pH ranges. Dependent claims also further add specific volumes, ww percents, specific commonly used buffers, a commonly used FDA approved salt, and other concentrations of ingredients.
Determining the scope and contents of the prior art:
The prior art reference CAROFF teaches the instant claim 1 aqueous pharmaceutical composition: the actual underlying compound:
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(see CAROFF Example 2 page 65); buffer; and water (page 42; and page 65), its use in pharmaceuticals (see “Abstract”; page 43); and its preparation thereof (see Example 2 page 65). Said aqueous formulation was contained and administered via syringe (see page 42). This teaches instant claims 9 and 11.
Moreover, CARDOFF page 43 teaches the method of instant claims 13-14.
The reference BUFFER teaches that boric acid (page 2 of 16), arginine (page 9 of 16), ammonium (page 2 of 16), carbonate (page 1 of 16), phosphate (page 1 of 16), glycine (page 1 of 16), histidine, meglumine (page 9 of 16), and tris(hydroxymethyl)aminomethane (page 6 of 16)are commonly used buffers, thereby helping to teach instant claims 3 and 5.
The prior art reference SALTS teaches that sodium chloride is a commonly known/used FDA approved marketed commercial pharmaceutically acceptable salt (Table 1 on page 2). Selection and use of salts like sodium chloride permit the artisan to control the chemical, biological, physical, and economic characteristics of medicinal agents and to optimize said agents (page 1).
Ascertaining the differences between the prior art and the claims at issue:
While the prior art reference CAROFF teaches the instant claim 1 aqueous pharmaceutical composition: the actual underlying compound
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(see CAROFF Example 2 page 65); buffer; and water (page 42; and page 65), its use in pharmaceuticals (see “Abstract”; page 43); and its preparation thereof (see Example 2 page 65), the CAROFF reference does not teach the specific pH of the instantly claimed composition.
It is noted that the instant Specification does not provide any indication that it is especially unique that this pH range was chosen, and in fact seems to imply that it is based on the compound being soluble at the relevant pH.
The BUFFER prior art reference does not teach each of the limitations of instant claim 1.
The SALTS prior art reference does not teach each of the limitations of instant claim 1.
Resolving the level of ordinary skill in the pertinent art:
The artisan is knowledgeable in the formulation of aqueous pharmaceutical formulations, such as the instant composition, and formulation thereof with commonly used buffering agents and water. Moreover, the artisan is knowledgeable in routinely optimizing concentrations, such as pH, to maximize the therapeutic efficacy of said pharmaceutical formulations.
Considering objective evidence present in the application indicating obviousness or nonobviousness:
The artisan would find prima facie obvious the (preparation of) instant claimed aqueous pharmaceutical formulation comprising active pharmaceutical ingredient:
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, buffer, and water, especially in light of the teachings of CARDOFF, above (Example 2 page 65; page 42; see, also, “Abstract”; page 43).
The artisan would be expected to combine a pharmaceutically acceptable salt, such as sodium chloride, with the active pharmaceutical ingredient/medicinal agent of the aqueous pharmaceutical formulation since this is common practice in the pharmaceutical arts. The artisan would be motivated to add a well-known FDA approved commercially marketed pharmaceutically acceptable salt like sodium chloride (SALTS Table 1 page 2) to the underlying medicinal agent
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of CARDOFF since adding salts permits the artisan to control the chemical, biological, physical, and economic characteristics of medicinal agents and to optimize said agents (SALTS page 1). This teaches instant claim 7.
The artisan would be expected to permit the patient to self-administer said aqueous pharmaceutical formulation since CARDOFF page 43 already teaches the method of instant claims 13-14. The artisan would be motivated to devise a self-administration method for a patient previously prescribed the CARDOFF/instant claim 1 pharmaceutical formulation, which CARDOFF teaches is useful to treat myocardial infarction and thromboses (page 43). As such, a patient could easily self-administer the pharmaceutical formulation prior to re-hospitalization. This teaches instant claim 15. Any standard route of administration would be expected to work, such as subcutaneous administration, thereby teaching instant claims 16-17.
Moreover, the artisan would be expected to routinely optimize concentrations, such as pH ranges, of said aqueous pharmaceutical formulation to maximize therapeutic efficacy of the formulation. The artisan would be motivated to routinely optimize the pH, since the CARDOFF formulation, just like any aqueous formulation, would embrace a range of pH values, thereby supporting optimization of the pH range.
Also, the artisan would be expected to vary other concentrations within the aqueous formulation, such as ww percents (claim 2), the pH range of claims 3 and 6, the shelf-life standards of claim 10, and the volume of claim 4 and 8, in order to maximize therapeutic efficacy. The artisan would be motivated to routinely optimize other concentrations, such as ww percents (claim 2), pH range (claims 3), and volume (claim 4 and 8), and shelf-life standards of claim 10, as artisans routinely optimize concentrations to maximize therapeutic efficacy of the pharmaceutical formulations.
Moreover, patent law views differences in concentration (herein, the varying ranges of pH) as not supporting the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989) (Claimed ratios were obvious as being reached by routine procedures and producing predictable results); In re Kulling, 897 F.2d 1147, 1149, 14 USPQ2d 1056, 1058 (Fed. Cir. 1990)(Claimed amount of wash solution was found to be unpatentable as a matter of routine optimization in the pertinent art, further supported by the prior art disclosure of the need to avoid undue amounts of wash solution); and In re Geisler, 116 F.3d 1465, 1470, 43 USPQ2d 1362, 1366 (Fed. Cir. 1997)(Claims were unpatentable because appellants failed to submit evidence of criticality to demonstrate that that the wear resistance of the protective layer in the claimed thickness range of 50-100 Angstroms was "unexpectedly good"); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416, 82 USPQ2d 1385, 1395 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art."). See MPEP 2144.05(II)(A).
Thus, instant claims 1-17 are rejected as obvious under 35 USC 103.
Conclusion
No claims are presently allowable as written.
Please note that the method of treating or preventing claims 13-17 have guidance/enablement disclosed within pages 1-3 of the “Background” section of the Specification. It is common practice to prevent (re-)occurrence of myocardial infarction, venous and arterial thromboses by administering blood thinners, such as but not limited to: clopidogrel and prasugrel and salicyclic acid (“aspirin”).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D Kosar can be reached at (571) 272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625