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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/20/2026 has been entered.
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.
Claim(s) 1,3-4 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Kumar et al. (WO 2022/058988 A1), as evidenced by Serdons et al. “The Presence of Ethanol in Radiopharmaceutical Injections” Journal of Nuclear Medicine December 2008, 49 (12) 2071. This new rejection was necessitated by amendment.
Kumar discloses a ready to infuse parenteral dosage form stored in bags and exemplifies a composition containing 1 mg/ml diltiazem HCl, 0.15 mg/cl citric acid monohydrate, sodium citrate dihydrate, water with a pH of 3.9, thus one of ordinary skill in the art would readily envisage the use of these ingredients in the amounts claimed. See entire disclosure, especially page 4 lines 4-6, page 5 lines 10-14, page 7 lines 3-6, abstract, page 8 line 28-page 9 line 5, page 11 line 4-13 and tables VI and IX. Regarding the imitation that the composition is isotonic, since the composition of Kumar, especially formulations 3a in table VI, 4a and 4k-4s in table IX, is within the scope of the claims it will feature the same properties including isotonicity. The compositions of 3a,4a and 4k-4s do not contain ethanol and alcohol appears to be an optional component, therefore it follows there are alcohol free isotonic compositions disclosed in Kumar. Regardless the amounts of alcohol solvent if used are so low they are not seen as rendering the composition hypertonic, note amounts include 1.0 % w/v and most preferably 1.35 %w/v. See page 10 lines 3-15. As evidenced by Serdons “The osmolality of ethanol is calculated to be 2,029 mOsm/kg, which means that a mixture of 1.39% ethanol in water is isotonic.”. See paragraph bridging lft and rt col of Serdons. Thus, Kumar discloses compositions with ethanol in such low amounts it would be isotonic. Regarding the new limitation on storage stability, it follows that since the dosages of Kumar are within the scope of the claims, they will feature the same properties, including their stability under storage conditions. “Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). MPEP 2112.01 [R-3] II. Regarding claim 4, the containers of Kumar include secondary packaging and overwraps; several of the materials including aluminum are opaque, thus the limitation of bag overwrapped with an opaque material is considered met. See page 19 line 1-page 22 line 25.
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 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.
Claim(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (WO 2022/058988 A1). This new rejection was necessitated by amendment.
Kumar is disclosed above. Regarding claim 2, the amount of sodium citrate dihydrate used in Kumar example 3a is 0.13 mg/ml, just outside of the claimed amount of 0.12 mg/ml. This amount is so close to the claimed value it is considered to have the same properties and effect in the composition. A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. MPEP § 2144.05. Additionally, Kumar teaches the amount of buffer agents such as sodium citrate dihydrate are adjusted such that the pH of the solution is preferably from 3.7 to 4.3. Thus, adjusting the amount of buffer in diltiazem formulations would be obvious to one of ordinary skill in order to reach the desired pH for administration. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of ingredient amounts would have been obvious at the time of applicant's invention. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Response to Arguments
Applicant's arguments filed 3/20/2026 have been fully considered but they are not persuasive.
Applicants assert the only stable compositions described by Kumar are hypertonic and not isotopic as claimed. Applicants assert Kumar requires a composition containing 1 to 10% ethanol or an osmogene to be stable and the above ingredients produce a hypertonic solution. Applicants assert Kumar has no description on the isotonicity of the formulations with ethanol.
As noted in the previous action and above the examiner has provided evidence, from the Serdons reference of record, that 1 to 1.35 wt% ethanol solutions do not render an solution isotopic. As admitted by applicants Kumar teaches compositions with 1-10 wt % ethanol, the data point of 1%, as evidenced by Serdons, is isotonic. Furthermore, the examiner must presume that any composition within the scope of the claims will feature the same properties including its isotonicity. Applicants have provided no evidence outside of opinion that Kumar’s compositions which feature low amounts of ethanol or no ethanol and other ingredients, such as sorbitol or dextrose, would not necessarily have the same isotonicity. Where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. See In re Ludtke, supra. Whether the rejection is based on 'inherency' under 35 U.S.C. § 102, on 'prima facie obviousness' under 35 U.S.C. § 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. See In re Brown, 459 F.2d 531, 59 CCPA 1036, 173 USPQ 685 (1972). In re Best, 562 F.2d 1252, 1255 (CCPA 1977). "[W]hen the PTO shows sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705,708 (Fed. Cir. 1990). A "prior art reference may anticipate without disclosing a feature of the claimed invention if that missing characteristic is necessarily present, or inherent, in the single anticipating reference." SmithKline Beecham Corp. v. Apotex Corp., 403 F.3d 1331, 1343 (Fed. Cir. 2005).
Applicants assert that since formulation 3A, which is ethanol free, is not shown in table IV, which presents stability data for 3F and 3G, it is not stable.
The relevance of this assertion is unclear. Simply because stability data is not presented for formulation 3A does not mean it is unstable. The lack of evidence does not prove it is indeed unstable. As the examiner stated above a composition within the scope of the claims must be presumed to have the same properties, including its stability.
Next applicants pick on formulations 4A and 4K-S in table IX of Kumar as having a sugar alcohol dextrose which cause the formulation to not be isotonic.
Applicants provide no support for the allegation that dextrose used in the amounts of formulations 4A and 4K-S would not provide an isotonic solution. No data is provided to show that the formulations would be outside the scope of what can be considered an isotopic solution. An unsupported allegation cannot be considered persuasive.
With regard to the obviousness rejection over Kumar applicants assert the reference teaches away from isotonic solutions as it notes the stabilizing effects of ethanol or sugar alcohols.
As noted above the compositions are within the scope of the claims and will feature the same stability. Applicants have not shown dextrose or ethanol used in the low amounts suggested by Kumar (1 wt%) will result in a non-isotopic solution. As the examiner has shown with evidence a formulation with 1 wt% ethanol is still isotonic and Kumar teaches use of this amount.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAMES W ROGERS/Primary Examiner, Art Unit 1618
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