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 office action is a response to Applicant’s amendments/remarks after non-final rejection filed 3/13/2025.
As filed, claims 1 and 7-22 are pending, wherein claims 13-22 are new; and claims 2-6 are cancelled.
Response to Amendments/Remarks
Applicant’s amendments/remarks, filed 3/13/2025, with respect to claims 1-12, have been fully considered and are entered. The status for each rejection in the previous Office Action is set out below.
The § 112(a) written description rejection of claims 1 and 3-9 is withdrawn per amendments and cancellation of claims 2-6.
The § 112(b) indefinite rejection of claims 10-12 is withdrawn per amendments.
The § 102(a)(1)/102(a)(2) rejection of claims 1-5 and 7 by Coulter is withdrawn per amendments and cancellation of claims 2-5.
The § 103(a) rejection of claims 2-6 by Coulter is withdrawn per cancellation of the claims
The § 103(a) rejection of claims 1 and 7-9 by Coulter is maintained because there are still preferred embodiments, as taught by Coulter, that would motivate a person of ordinary skill in the art to replace Gelucire 44/01 of the composition in Table 3 of Coulter with propylene glycol in order to arrive at the instant formulation. For details, see rejection below.
The § 103(a) rejection of claims 1-12 by Adjei is withdrawn per amendments/remarks and cancellation of claims 2-6.
The claim objection of claims 8, 9, 11, and 12 is withdrawn per amendments.
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 16 and 21 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant’s amendment with respect to amended claim 16 and 21 herein has been fully considered but is deemed to insert new matter into the claims since the specification as originally filed does not provide support for the limitation, “mixture thereof”, for the instant ionic surfactant.
The instant specification and the originally filed claim (i.e. filed 10/21/2021) failed to provide support for the abovementioned limitation, according to paragraph 0046 of the instant specification, as shown below:
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and thus, “mixture thereof” for the instant ionic surfactant is considered new matter.
Adequate written description means that, in the specification, the applicant must “convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the [claimed] invention.” Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 [19 USPQ2d 1111] (Fed. Cir. 1991).
See MPEP 2163 regarding the guidelines for the written description requirement: "The proscription against the introduction of new matter in a patent application (35 U.S.C. 132 and 251) serves to prevent an applicant from adding information that goes beyond the subject matter originally filed. See In re Rasmussen, 650 F.2d 1212, 1214, 211 USPQ 323, 326 (CCPA 1981).
See MPEP § 2163.06 through § 2163.07 for a more detailed discussion of the written description requirement and its relationship to new matter. The claims as filed in the original specification are part of the disclosure and, therefore, if an application as originally filed contains a claim disclosing material not found in the remainder of the specification, the applicant may amend the specification to include the claimed subject matter. In re Benno, 768 F.2d 1340, 226 USPQ 683 (Fed. Cir. 1985).
Thus, the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed. New or amended claims which introduce elements or limitations which are not supported by the as-filed disclosure violate the written description requirement. See, e.g., In re Lukach, 442 F.2d 967, 169 USPQ 795 (CCPA 1971) (subgenus range was not supported by generic disclosure and specific example within the subgenus range); In re Smith, 458 F.2d 1389, 1395, 173 USPQ 679, 683 (CCPA 1972) (a subgenus is not necessarily described by a genus encompassing it and a species upon which it reads).”
Claim Interpretation
With regards to the preamble phrase, such as “An oral liquid dosage formulation" in claims 1 and 10, the Examiner finds “oral liquid dosage” as simply stating purpose or use within the instant formulation. See MPEP 2111.02(II).
Accordingly, this phrase is not considered a limitation and is of no significance to the claims. In addition, as the prior art teaches the instant formulation, the result would most necessarily to have the same purpose or use as recited above, specifically in the formulation taught by the prior art (see rejection below).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1 and 7-22 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8,911,777, hereinafter Coulter. See IDS filed 10/21/2021.
Regarding claims 1, 7, 10, and 13-22:
Determining the scope and contents of the prior art:
Coulter, for instance, teaches an oral, non-aqueous tacrolimus composition having other components, such as Gelucire 44/01 (i.e. solubilizing agent and emulsifying agent), fish oil, and ethanol (i.e. low molecular weight mono alcohol), which has a % w/w range from 0-20.
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(abstract)
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(column 23, table 3)
Ascertaining of the difference between the prior art and the claim at issue:
In the abovementioned formulation, Coulter, did not explicitly teach the composition is free of Gelucire 44/01 and substantially free or free of low molecular weight mono alcohol, such as ethanol.
Finding of prima facie obviousness --- rationale and motivation:
With respect to this difference, MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
Based on the teachings of the MPEP and KSR above, by employing the rationale in (A) above, it would have been obvious for one of ordinary skill to modify the abovementioned composition of Coulter to replace Gelucire 44/01 with propylene glycol in order to arrive at the instantly claimed formulation because there are preferred embodiments or blazemarks, which are shown below, that would motivate a person of ordinary skill in the art to make such change. Further, there’s a reasonable expectation of success that such modification will result in a non-aqueous, oral, liquid formulation that is free of surfactant, wetting agent, and emulsifying agent because propylene glycol and Gelucire 44/01 are both solubilizers.
In addition, by employing the rationale in (E) above, it would have been obvious for one of ordinary skill to choose from a finite number of identified, predictable solutions, such as the solubilizers shown below by the preferred embodiments of Coulter, in order to arrive at the instant formulation with a reasonable expectation of success that such modification will result in a non-aqueous, oral, liquid formulation that is free of surfactant, wetting agent, and emulsifying agent.
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(column 8, lines 26-44)
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(column 25, Table 7)
Lastly, the phrase, “substantially free”, according to paragraph 0022 of the instant specification, means that the formulation contains small amount of the component modified by the term “substantially free”. The small amount is less than 5%.
Accordingly, the Examiner finds that the abovementioned % w/w ranges of ethanol, which ranges from 0-20, overlaps with the less than 5% of the “substantially free” or 0% of the “free”. According to the guidance in MPEP 2144.05(I), the less than 5% of the “substantially free” and 0% of the “free” is considered prima facie obvious because the overlapping in the abovementioned ranges.
In addition, the Examiner does not find the less than 5% of the “substantially free” and 0% of the “free” as result-effective variables because the Applicant fails to demonstrate these parameters to impart any unexpected or novel aspect to the instant formulation (i.e. no comparative example). “[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 MPEP 2144.05. Accordingly, these parameters are viewed as routine experimentation to optimize the instant formulation, and not a patentable distinction.
Regarding claims 8, 9, 11 and 12:
Determining the scope and contents of the prior art:
Coulter, for instance, teaches the abovementioned obvious variant.
Ascertaining of the difference between the prior art and the claim at issue:
In the abovementioned obvious variant, Coulter, did not explicitly teach the concentration of tacrolimus is about 0.1 mg/mL to about 1.5 mg/mL or is about 0.5 mg/mL to about 1.0 mg/mL
Finding of prima facie obviousness --- rationale and motivation:
The Examiner does not find the abovementioned concentration range of tacrolimus as result-effective variable because the Applicant fails to demonstrate this parameter to impart any unexpected or novel aspect to the instant formulation (i.e. no comparative example). “[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 MPEP 2144.05. Accordingly, this parameter is viewed as routine experimentation to optimize the instant formulation, and not a patentable distinction.
Conclusion
Claims 1 and 7-22 are rejected.
Claims 2-6 are cancelled.
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.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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