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 .
DETAILED ACTION
This action is in response to Applicant’s amendment filed December 10, 2025 in reply to the Non-final Office Action mailed September 10, 2025. Claim 1 has been amended; claims 2-7 and 12-19 have been canceled; and claims 20-22 have been newly added. Claims 8-11 have previously been withdrawn. Newly added claim 21 is directed to non-elected subject matter, and is thus hereby also withdrawn. Claims 1, 20, and 22 are currently under examination.
Withdrawal of Prior Claim Rejections - 35 USC § 112(a)
Claim 1 has been satisfactorily amended to remove new matter. Therefore, the 35 USC 112(a) rejection presented in the Non-final Office Action mailed September 10, 2025 is hereby withdrawn.
Claim Objections
Claims 20 and 22 are objected to because of the following:
1. In claims 20 and 22, there should be a comma between the preamble and the wherein clause.
2. In claim 20, the expression “.9%” is in improper form. Applicant is advised that the proper form is “0.9%”. Further, the expression “wherein the sodium chloride is .9% w/v” would not be well understood either by one of ordinary skill. Critical information appears to be missing. Presumably, Applicant intends to recite something like “wherein the sodium chloride is present in the formulation in the amount of 0.9% w/v”.
Appropriate correction is required.
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.
Claims 20 and 22 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.
Claim 20 stipulates in a wherein clause that “the sodium chloride is .9% w/v”. One of ordinary skill in the art would not understand such a limitation. Nobody of ordinary skill in the art would understand that “sodium chloride” itself is somehow synonymous, with or one and the very same thing as, “.9% w/v”. It would appear that Applicant is attempting to limit a concentration, but the claim does not specify the necessary details, e.g. .9% w/v of what?
***For examination at this time, the claim is being interpreted as intending to limit the concentration of sodium chloride in the formulation to 0.9% w/v.
Claim 22 stipulates in a wherein clause that “the liquid parenteral formulation is chemically stable without biological excipients”, which renders the claim indefinite for the following reasons:
1. The term “biological excipients” is not defined by the claim or the specification. Neither the phrase “biological excipients” nor the term “biological” appears anywhere at all in the original specification and claims. One of ordinary skill in the art cannot definitively ascertain the metes and bounds of “biological excipients”, and which excipients are “biological” and which are not “biological”. For example, are “biological excipients” any compound found in nature (which would include e.g. quartz)? Or, alternatively, are “biological excipients” any compound naturally present in humans (which would not include e.g. quartz)? Or, alternatively, are “biological excipients” limited to large biomolecules such as proteins and lipids? Or what?
2. While claim 22 stipulates that the formulation is chemically stable without biological excipients, one of ordinary skill in the art cannot definitively ascertain whether the formulation necessarily excludes any and all biological excipients. Indeed, the formulation could be said to have the property of being “stable without biological excipients” whether or not the actual formulation contains biological excipients or not. There is also some degree of indefiniteness as to whether the claim thus implies that the formulation is necessarily not stable with biological excipients.
3. Claim 22 depends from claim 1, which is directed to a formulation consisting of foseprepitant dimeglumine, sodium chloride, and water. That’s it. Without question, sodium chloride and water would be understood to fall under the purview of “biological excipients”, as they are found in nature and are also natural constituents of humans and other organisms. One of ordinary skill in the art thus cannot make heads or tails out of how claim 22 limits claim 1. Is the saline now being excluded, such that claim 22 is directed to the compound foseprepitant dimeglumine only? Or is claim 22 stating that the foseprepitant dimeglumine compound would be chemically stable even without the saline present? Or what?
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.
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, 20, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Malhotra et al. (U.S. Patent Application Pub. No. 2017/0119800).
Applicant Claims
Applicant’s elected subject matter is directed to a liquid formulation consisting of 20-60 mg/ml fosaprepitant dimeglumine, 0.9% w/v sodium chloride, and water.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Malhotra et al. disclose a liquid formulation comprising fosaprepitant dimeglumine and a vehicle; wherein the fosaprepitant dimeglumine can be present in the amount of e.g. about 49 mg/ml, or about 0.5-200 mg/ml, wherein the vehicle can be e.g. 0.9% sodium chloride, i.e. normal saline (i.e. understood in the art to consist of sodium chloride and water); wherein the pH is e.g. 7.2, or preferably 7-9 (see 0008, 0021, 0024, 0027, 0041, 0045; 0071, 0093, 0097, 0099).
Further, Malhotra et al. disclose that their fosaprepitant dimeglumine formulation is storage stable at 2-8C, or 0-60C, for (at least) a period of 6 months with no significant increase in impurities, including aprepitant (pargraphs 0021, 0071, Figure 1).
Ascertainment of the Difference Between the Scope of the Prior Art and the Claims (MPEP §2141.02)
Malhotra et al. do not anticipate verbatim the composition consisting of the requisite fosaprepitant dimeglumine amount in 0.9% normal saline in one specific example or preferred embodiment. However, the Malhotra et al. disclosure is sufficient to render the claimed subject matter prima facie obvious within the meaning of 35 USC 103.
Finding of Prima Facie Obviousness Rationale and Motivation
(MPEP §2142-2143)
It would have been prima facie obvious for one of ordinary skill in the art at the time the present application was filed to employ the teachings of Malhotra et al., outlined supra, to devise Applicant’s presently claimed formulation.
Malhotra et al. disclose a liquid formulation comprising fosaprepitant dimeglumine, and a vehicle; wherein the pH is e.g. 7.2, or preferably 7-9, and wherein the solution is for injection that is stable upon storage over prolonged periods of time. Since Malhotra et al. explicitly disclose that a suitable vehicle is 0.9% sodium chloride (i.e. isotonic sodium chloride solution or normal saline) (see e.g. paragraphs 0027, 0045), one of ordinary skill in the art would thus be motivated to employ fosaprepitant dimeglumine in 0.9% sodium chloride aqueous solution, with the reasonable expectation of success that the resulting formulation will be suitable and ready-to-use for injection.
Further, Applicant’s claimed formulation initially consists of 20-60 mg/ml fosaprepitant dimeglumine in 0.9% normal saline. Applicant is not actively adding fosaprepitant desfluoro impurity, aprepitant impurity, and fosaprepitant benzyl ester impurity. Rather, the claimed impurities gradually form over time and are present in the specified amounts at a snapshot in time at 4 months at 2-8C. This is effectively an inherent property of the formulation consisting of 20-60 mg/ml fosaprepitant dimeglumine in 0.9% normal saline. Since Malhotra et al. disclose the same formulation consisting of e.g. about 49 mg/ml fosaprepitant dimeglumine in 0.9% normal saline, and since Malhotra et al. disclose that their fosaprepitant dimeglumine formulation is storage stable at e.g. 2-8C for (at least) a period of 6 months with no significant increase in impurities, including aprepitant, one of ordinary skill in the art would thus be motivated to store the said Malhotra et al. formulation for periods up to 6 months at 2-8C, and at 4 months, the said formulation would no doubt have the same impurities in the same amounts present, which impurities are an inherent consequence of keeping this particular formulation at this particular time at this particular temperature.
In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed December 10, 2025 have been fully considered but they are not persuasive.
i) Applicant contends that “Malhotra et al. is silent and doesn’t teach or discuss about the stability of present invention’s ready to use composition without the mentioned excipients”, i.e. stabilizer, solubilizers, and chelators.
The Examiner, however, would like to point out the following:
1. Malhotra has not been cited for individually anticipating the presently claimed subject matter under 35 USC 102. The Malhotra disclosure is not limited to the specific examples or any single preferred embodiment, and these do not constitute a teaching away from the broader disclosure.
2. Malhotra discloses a liquid formulation comprising fosaprepitant dimeglumine and a vehicle; and expressly teaches that the vehicle can be e.g. 0.9% sodium chloride, i.e. normal saline, i.e. understood in the art to consist of sodium chloride and water. Clearly, one of ordinary skill in the art, in view of the broader disclosure of Malhotra, including what is expressly disclosed and reasonably suggested, clearly and without question could have arrived at the claimed composition, consisting of fosaprepitant dimeglumine, sodium chloride, and water.
3. Further, Malhotra discloses that their fosaprepitant dimeglumine formulation is storage stable at 2-8C, or 0-60C, for (at least) a period of 6 months with no significant increase in impurities, including aprepitant. Malhotra, like Applicant, is combining the fosaprepitant dimeglumine sodium chloride, and water to arrive at the desired formulation, and the recited impurities are being naturally formed in situ over time. Since the compositions are the same, i.e. consisting of fosaprepitant dimeglumine sodium chloride, and water, the properties must be the same as well. If Applicant’s composition consisting of fosaprepitant dimeglumine, sodium chloride, and water is “stable” for at least 3 months at 2-8C, then Malhotra’s composition consisting of fosaprepitant dimeglumine, sodium chloride, and water must be as well.
ii) Applicant contends that “Malhotra requires the use of excipients like stabilizer, solubilizer, vehicle and pH adjusting agent”, and “examples 1-10 disclose use of various excipients like albumin, edetate disodium, propylene glycol, glycerin for the composition” which is “totally different” from the present composition; that “Malhotra…claims in claim 1 a liquid composition comprising fosaprepitant or a salt thereof and at least one liquid excipient”; and that “there is no other disclosed formulation of fosaprepitant dimeglumine with sodium chloride and water”.
The Examiner, however, would like to point out the following:
1. Applicant is correct that Malhotra expressly establishes in claim 1 that their composition is a liquid composition that contains fosaprepitant or a salt thereof and “at least one liquid excipient”. However, “at least one liquid excipient” is clearly satisfied in full with only one liquid excipient. Malhotra expressly provides that the vehicle can simply be e.g. 0.9% sodium chloride (i.e. isotonic sodium chloride solution or normal saline) (see e.g. paragraphs 0027, 0045). As anyone of ordinary skill in the art would recognize, 0.9% sodium chloride constitutes “at least one liquid excipient”. Furthermore, one of ordinary skill in the art would no doubt understand 0.9% sodium chloride to consist of sodium chloride and water.
2. While Malhotra does disclose that their formulation “may” contain e.g. further excipients like a stabilizer or a solubilizer, and may even exemplify formulations that contain albumin, edetate disodium, propylene glycol, and glycerin, none of these further excipients are necessarily required. Applicant’s formulation requires a pH of 7-11.5, and this is understood to mean the claimed formulation thus requires pH adjusting agents and/or pH buffers.
3. Malhotra expressly discloses that their formulation is stable. Malhotra also provides that their formulation can consist of fosaprepitant dimeglumine and 0.9% sodium chloride. Again, as already noted, supra, Applicant has thus merely documented a property of a composition disclosed in Malhotra. This is not adequate for obtaining a U.S. Patent. Applicant simply cannot patent or re-patent a prior art composition merely by documenting a property of that composition, even if the property was not disclosed or even known in the prior art. For a U.S. Patent, Applicant must invent an entirely new and non-obvious composition.
For the foregoing reasons, the prior art rejections are hereby maintained.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Inquires
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID BROWE whose telephone number is (571)270-1320. The examiner can normally be reached Monday - Friday, 9:30 AM to 6 PM EST.
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/DAVID BROWE/Primary Examiner, Art Unit 1617