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 .
Status of Claims and Response to Amendments
The amendments filed November 19, 2025 have been acknowledged and entered. Claims 1-16 and 19-26 are pending.
Information Disclosure Statements
Acknowledgement is made of the Information Disclosure Statement filed on January 15, 2026. All references have been considered except where marked with a strikethrough.
Election/Restriction
The present examination is based on Applicant's election with traverse of Group 1, claims 1-6, 15 and 17-22 in the reply filed on June 10, 2025. The requirement is still deemed proper and is maintained as FINAL for the reasons set forth in the previous office action.
Claims 7-14, 16 and 23-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are: “means for a source of sodium ions” in claim 1.
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
The Examiner suggest removing the phrase “means for” as this does not add any limitation to the claim as currently interpreted.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this Office Action has been withdrawn or rendered moot in view of Applicant’s amendments and/or
remarks.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4, line 2, recites “composition comprises” and should recite “composition further comprises”. Appropriate correction is required.
Maintained Rejections
Claim Rejections - 35 USC § 112b
Claims 3 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. The claims are indefinite for the reasons that follow:
Claim 3 is a duplicate of claim 1 because the claim recites “is essentially free from complexing solubilizing agents” which is a limitation already provided in claim 1. In addition, claim 3 is broader in scope as the limitations of claim 1 are not found in claim 3.
Response to Arguments
Applicant’s arguments filed November 19, 2025 have been fully considered but they are not persuasive.
Applicant argues claim 3 recites “essentially free from complexing solubilizing agents”. This argument is not persuasive because the agents disclosed in claim 1 carry over into claim 3. Additionally, the scope of the claim is broader than claim 1 with regard to complexing solubilizing agents.
The rejection is still deemed proper and thus maintained.
Claim Rejections - 35 USC § 103
Claims 1-6, 15 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grunenberg et al. (U.S. 9,637,459 B2; published May 2, 2017)(hereinafter “Grunenberg”).
Claim(s) 1 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Grunenberg et al. (U.S. 9,637,459 B2; published May 2, 2017)(hereinafter “Grunenberg”) as applied to claims 1-6, 15 and 17-21 above, and further in view of Pubchem (Tris(hydroxymethyl)aminomethane, 2005) (hereinafter “Pubchem”).
The reasons for these rejections were set forth in the previous Office Action mailed June 26, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed November 19, 2025 have been fully considered but they are not persuasive.
Applicant argues asserting obviousness on the basis of routine optimization of a variable requires an articulated rationale, which is not presented in the rejection. For example, the rejection fails to explain what the asserted molar ratio would be optimized for, i.e., what effect is being optimized. There is no suggestion by Grunenberg et al. that any effect/result is associated with the ratio of sodium ions with respect to letermovir, and as such Grunenberg et al. provide no suggestion of modifying this ratio to a ratio of 0.72 to 0.90 equivalents of sodium ions with respect to letermovir. In particular, there is no suggestion by Grunenberg et al. that there can be a self-buffering effect based on the ratio of sodium ions with respect to letermovir, and without such a suggestion the disclosure of Grunenberg et al. provides no suggestion that routine optimization would arrive at the ratio of 0.72 to 0.90 equivalents of sodium ions to letermovir as recited in applicants' claims.
These arguments are not found persuasive because a person skilled in the art would have modified Grunenberg into the claimed invention simply as a matter of practicing the invention disclosed in Grunenberg. MPEP 2144.05 states a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of "having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium" as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium. "The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties."). In the present case, Grunenberg explicitly states Formula (I) and the sodium counter ions may present in any ratio and the motivation to modify Grunenberg would have been the desire to practice the disclosed invention. A rational for modifying which is different from Applicant’s is permissible (See MPEP 2144).
The rejection is deemed proper and maintained. Presence of a property not possessed by the prior art is evidence of nonobviousness. In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (rejection of claims to compound structurally similar to the prior art compound was reversed because claimed compound unexpectedly possessed anti-inflammatory properties not possessed by the prior art compound) (see MPEP 716.02).
Double Patenting
Claims 1-6, 15 and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 14-22 of copending Application No. 18/722,433 or claims 1-22 of copending Application No. 17/802,557 in view of Gupta et al. (Molecules 2018 23 1719)(hereinafter “Gupta”).
Claims 1-6, 15 and 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of copending Application No. 17/802,815 (reference application) or claims 1-25 of copending Application No. 17/802,651 . Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the reference claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
The reasons for these rejection were set forth in the previous Office Action mailed June 26, 2025 and are incorporated herein by reference.
Response to Arguments
Applicant’s arguments filed November 19, 2025 have been fully considered but they are not persuasive.
Applicant argues that for the same reasons as discussed above with regards to the disclosure of Grunenberg et al., the claims of Serial No. 18/722,433 and Serial No. 17 /802,557 fail to render obvious
applicants' claimed invention.
This argument is not found persuasive at least for the reason that these rejections are not based on Grunenberg and therefore the arguments do not address the rejection.
The rejection is deemed proper and maintained.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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January 21, 2026
/K.S.M./Examiner, Art Unit 1624
/SUSANNA MOORE/Primary Examiner, Art Unit 1624