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 .
Claim Status
Claims 1, 3-4, 8, 10, 31, 33, 54, 60-62, 67, 70-71, 75 and 82-85 are pending. Claims 4, 8, 54, 60-62 and 75 are withdrawn. Claims 1, 3, 10, 31, 33, 67, 70-71 and 82-85 are rejected.
Response to Amendment/Arguments
Applicant’s amendments have overcome the previously presented rejections therefore arguments directed to the obviousness of the claims in view of the previously cited rejections will not be addressed.
Election/Restrictions
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicant’s elected invention where the elected species of co-solvent is lactic acid is not allowable. Therefore, examination has been limited to claims embracing the elected species which are claims 1, 3, 10, 31, 33, 67, 70-71 and 82-85. Claims 1, 3, 10, 31, 33, 67, 70-71 and 82-85 have been examined to the extent that they are readable on the elected embodiment. Subject matter not embraced by the elected embodiment is withdrawn from further consideration. Any subject matter discussed outside this scope was discovered incidental to the expanded search and is presented in the interest of compact prosecution.
Claims 4, 8, 54, 60-62 and 75 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Rejections - 35 USC § 112(a)
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, 3, 10, 31, 33, 67, 70-71 and 82-85 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.
Claim Scope (MPEP 2163(II)(A)(1))
MPEP 2163 outlines the methodology for determining adequacy of written description. MPEP 2163(II)(A)(1) instructs “For Each Claim, Determine What the Claim as a Whole Covers”.
The invention of instant claim 1 is directed to a composition comprising caffeine citrate, water and one or more co-solvents, wherein the composition is in the form of a solution, and wherein the solubility of caffeine citrate is greater than about 100 mg/mL at room temperature.
Independent claim 67 is directed to a composition comprising a solution of caffeine citrate, water, and lactic acid wherein the solubility of the caffeine citrate is between about 200 mg/mL and about 300 mg/ml at room temperature.
Disclosed Support (MPEP 2163(II)(A)(2))
MPEP 2163(II)(A)(2) instructs “Revise the Entire Application to Understand How Applicant Provides Support for the Claimed Invention Including Each Element and/or Step”. The specification discusses the field of endeavor and states (paragraph [0018]):
The disclosure is directed to compositions comprising caffeine citrate and one or more co-solvents and the uses of such compositions, for example, in accelerating recovery in patients who are under general anesthesia during medical procedures. The term "co- solvent" refers to a non-water based solvent for which caffeine citrate has some solubility when the co-solvent is a liquid.
The disclosure recites several types of co-solvents including alcohols, organic acids, and inorganic acids in paragraph [0019].
The specification also provides results for solubility trials with varying percentages of co-solvent (page 20):
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272
790
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.
Examples of solutions where the solubility of caffeine citrate is at least 100 mg/mL in the composition are limited to three examples in the table displayed above and Solution 15 of Table 4 (page 18) which was prepared using the following solvent percentages and 49.4 mg of caffeine citrate (Table 1, page 15):
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170
758
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32
752
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.
The only claims that specify the percentages of the solvents are dependent claims 70 and 71 which require the following percentages of solvents and caffeine citrate:
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98
778
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106
778
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Claim 67 requires that the solubility of the caffeine citrate in is between about 200 mg/ml and about 300 mg/ml at room temperature however, the suitable examples provided by Applicant contain percentages of lactic acid and water outside of the ranges listed in claims 70 and 71.
Determination of Sufficient Support (MPEP 2163(II)(A)(3))
MPEP 2163(II)(A)(3) instructs “Determine Whether There is Sufficient Written Description to Inform a Skilled Artisan That Inventor was in Possession of the Claimed Invention as a Whole at the Time the Application Was Filed”. This section of the MPEP further provides the following guidance:
Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
In this situation and as discussed above, Applicant has failed to provide “disclosure of relevant, identifying characteristics, i.e., physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession” of the claimed invention.
Claim 1 and its dependent claims are broad and generic to the identity and percentages of co-solvent and water in the solution that is required to provide a solubility of caffeine citrate that is greater than about 100 mg/ml. Claim 67 identifies lactic acid as a co-solvent but is similarly generic to the required ranges. Dependent claims 70 and 71 place limitations on the components of the composition however the evidence that supports a solubility of at least 200 mg/ml caffeine citrate discloses percentages of water and lactic acid that are not embraced by the values in the claim (Table 5, page 20). Additionally, these solutions all contain sodium hydroxide which is not required by claim 67 or claim 1. The only example in the disclosure that produced a solubility of caffeine citrate greater than 100 mg/ml without the addition of sodium hydroxide was Solution 15 of Tables 1 and 4 which contained lactic acid, and 5 other co-solvents which are not required by the claims.
The results in Table 5 suggest that the solubility of caffeine citrate in the solution is dependent upon the pH of the solution wherein the samples between pH 1.69 and 2.23 produced a solubility of caffeine citrate that was at least 100 mg/mL in the composition. Applicant has not provided sufficient evidence to suggest that it is possible to produce a solution wherein the solubility of caffeine citrate is greater than 100 mg/mL independent of the solution’s pH and percentage of co-solvents/additional pH adjusters provided therein to achieve the pH where caffeine citrate is sufficiently soluble. As such, the instant disclosure does not inform a person of ordinary skill on the various ways in which one may seek to prepare a composition comprising caffeine citrate, water and one or more co-solvents wherein caffeine citrate has the required solubility in solution of instant claims 1 and 67. Dependent claims 3, 10, 31, 33, 70-71 and 82-85 fail to remedy the lack of written description.
The Examiner suggests specifying the co-solvent to be lactic acid in claim 1, including limitations for the percentage of sodium hydroxide in claims 1 and 67 and limiting the ranges of lactic acid, water and caffeine citrate to those that produce the claimed solubility in both of the independent claims.
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 1, 3, 10, 31, 33, 67, 70-71 and 82-85 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 1 recites the limitation wherein “the solubility of the caffeine citrate is greater than about 100 mg/ml at room temperature.” Likewise, claim 67 recites wherein “the solubility of the caffeine citrate is between about 200 mg/ml and about 300 mg/ml at room temperature.” As written, it is unclear what medium the caffeine citrate must present this solubility in, i.e., water the one or more co-solvents, etc. These limitations are unclear as the language of the claims does not explicitly state that the solubility of caffeine citrate is with respect to the composition itself.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-3, 10, 43-45, 64 and 67 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 7, 12, 18, 23-24, 30, 37, 45, 50, 56, 63, 65, 76, 79, 96 and 123 of copending Application No. 18034142 in view of Fong et al., "Caffeine Accelerates Emergence from Isoflurane Anesthesia in Humans, ”Anesthesiology, vol. 129, pp. 12-920 (2018). (cited in the IDS filed 06/10/2022).
Copending claim 1 teaches a composition comprising caffeine, lactic acid and water, wherein the composition is in the form of a solution as required by instant claims 1, 3, 10, 64 and 67.
Copending claim 30 teaches that the solubility of caffeine is 240 mg/ml or greater in accordance with instant claims 43-45.
The copending claims differ from the instant claims in that they do not specify that the caffeine is caffeine citrate. Copending claim 63 recites a method of accelerating emergence from anesthesia by administering the composition comprising caffeine. Fong et al. teach that intravenous caffeine citrate is able to accelerate emergence from isoflurane anesthesia without adverse effects (abstract). Accordingly, a person of ordinary skill seeking to perform the copending method of accelerating emergence from anesthesia would have been motivated to test the copending composition using caffeine citrate as suggested by Fong et al.
This is a provisional nonstatutory double patenting rejection.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLI A CHICKS whose telephone number is (571)270-0582. The examiner can normally be reached M-Th 7 a.m.- 5 p.m..
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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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/A.A.C./Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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