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 in response to applicant’s communication filed on 5/16/23. Claims 1-10 are pending in this application and are being examined in this Office Action.
Priority
The applicant claims benefit as follows:
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, EP 20208400.0, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The application does not disclose applicant’s molar ratio or “no further solvent”. Thus, the priority date of claims 4 and 9 are 11/09/2021.
Objections
Claims 1 and 9 are objected to because of the following informalities:
Applicant’s recite “wherein a first step” in claim 1. The examiner recommends “comprising in a first step”, to incorporate the transitional phrase “comprising”.
The phraseology of claim 9 is awkward. The examiner suggests the applicant amend the claim language to clarify the use of prepositions, such as this possible amendment “wherein for step (ii)” in claim 9. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 7 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 10 is indefinite because of the claim language “room temperature (18-25 °C)”. It is unclear if the recitation of “(18-25 °C)” limits or supplants applicant’s limitation for “room temperature”, or if it is perhaps an exemplary or preferred embodiment of “room temperature”.
Claim 7 is rejected because of the recitation of “at least 1.5 bar”. Claim 1, from which claim 7 depends, also recites “at least 1.5 bar”. Thus claim 7 is not further limiting.
Appropriate correction is required.
Claim Rejections – 35 USC 102/103
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 the appropriate paragraphs of the AIA 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 of this title, 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.
Claim 1-10 are rejected under AIA 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by or, in the alternative, under 35 U.S.C. 103(a) as being obvious over Shekhar et al. (US 6271394, pub date Aug. 7, 2001, in applicant’s IDS filed 5/16/23), incorporating Roteman (US 4017513, pub date April 12, 1977, in applicant’s IDS filed 5/16/23). (Shekhar et al. disclosed “US 4,017,513” (column 1, line 9) and “All patents, patent applications and publications cited herein are incorporated by reference in their entirety” (column 2, lines 62-67). Thus Roteman is incorporated by reference.)
The instant claims are drawn to:
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Shekhar et al. teaches the process for producing amino acid amides by a first reaction step of reacting an acidic cation exchange resin with an alcohol, e.g. ethanol, and an amino acid to give an intermediate, then a second step of adding liquid ammonia (ammonia under high pressure) to give the amino acid amide product. The “liquid ammonia” is ammonia under high pressure, e.g. 114 psig (7.86 bar) at room temperature. (abstract; column 3, lines 25-31; claims and examples)
Shekhar et al. teaches the preferential use of liquid ammonia and that “essentially all of the liquid ammonia remains in the liquid phase”. Shekhar et al. also teaches reactor temperature ranges of between 20 and 65 degree C (column 4, lines 19-67).
Roteman (incorporated by reference) further teaches applicant’s step (i), the esterification reaction of 0.2 equivalents of L-phenylalanine (compound of formula II), an amino acid, and 0.2 equivalent of Dowex 50-WX8 (an acidic cation exchange resin) in 400 ml (6.85 mol) of ethanol, an alcohol, refluxed (which the examiner interprets as heated to approximately 78 degree C, since the boiling point of ethanol is 78.37 degree C to get to reflux) for 10 hours with agitation. This first reaction mixture was cooled and for applicant’s second step, step (ii), gaseous anhydrous ammonia was added (which reads on the limitation of “no further solvent is added” in claim 9, since no solvent was additionally added in this reaction step). The reaction mixture of the second step, step (ii), stood for 4 days. Afterwards, this reaction mixture was then filtered, the filtrate removed of ethanol, after adding 200 ml of benzene, and a temperature of 80 degree C was reached. Any unreacted L-phenylalanine was removed by filtration and the filtrate was cooled and crystalized to give the product of the second step, step (ii), L-phenylalanilamide (compound of formula I). (column 1, line 26- column 2, line 38; example 2, column 3, lines 5-20)
Since Roteman teaches the reaction mixture of the second step, step (ii), stood for 4 days, it would be reasonable to expect this to read on applicant’s limitation for room temperature in claim 10, since when no temperature or pressure is given in synthetic reactions, one of ordinary skill in the art would assume room temperature and ambient pressure, absent evidence to the contrary. Even if it does not, it would be obvious to optimize the temperature in order to decrease impurities and increase the yield of the product during routine optimization.
Since Roteman further teaches applicant’s esterification reaction with 0.2 equivalents (which is 0.2 moles) of L-phenylalanine (compound of formula II), in 400 ml (6.85 mol) of ethanol, an alcohol, this would give a molar ratio of the alcohol to the compound of formula II of 34:1. Thus Roteman’s 34:1 molar ratio would read on applicant's limitation in claim 4 for a molar ratio of the alcohol to the compound of formula II to be at least 2:1. Even if it does not, it would be obvious to optimize the molar ratio in order to optimize the purity and yield of the product during routine optimization.
Therefore these claims are fully met.
Conclusion
Claims 1-10 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer Cho Sawyer whose telephone number is (571) 270 1690. The examiner can normally be reached on Monday-Friday 9 AM - 6 PM PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Renee Claytor can be reached on (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-274-1690.
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Jennifer Cho Sawyer
Patent Examiner
Art Unit: 1691
/YIH-HORNG SHIAO/Primary Examiner, Art Unit 1691
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