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
Applicant’s election of Group I, corresponding to claims 1-11 without traverse in the reply filed on 03/13/2026 is acknowledged, in said amendment applicants have cancelled claims 12-14. Thus, amended claims 1-11, 15, 17-18 and 22-24 are pending in this application; Group I, corresponding to claims 1-11 reading on the elected invention is now under consideration for examination; claims 15, 17-18 and 22-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a 371 of PCT/EP2022/069145 filed on 07/08/2022 and claims the priority date of France application FR2107500 filed on 07/09/2021; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/EP2022/069145 filed on 07/08/2022.
Information disclosure statement
The information disclosure statement (IDS) submitted on 11/20/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Claims Objections
Claims 7 and 10-11 are objected: Recitation of “and/or” in claims 7 and 10-11 makes the claim indefinite, as it is not clear what limitations must be present. Correction and clarification is required. Examiner suggests amending the claim to recite “…or …”.
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.
I. Claims 2-4 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 pre-AIA the applicant regards as the invention.
The examples refer to a proportion of 14C atoms in all tables, but no compound on earth having a 14C content of 100% of all carbon atoms has ever been prepared. Indeed 14C occurs in trace amounts, making up about 1 or 1.5 atoms per 10¹² atoms of carbon in the atmosphere. This means that in a compound where 100% of the carbon atoms are derived from CO₂ directly extracted from the atmosphere, there will be 98.89% of ¹²C atoms, 1.11% of ¹³C atoms and `10⁻¹² of 14C atoms. It is very unlikely that the nature and proportion of 14C has any influence on the properties of the compound, since it is trace amounts. It can only be used to determine the proportion of atoms from non-fossil origin. It cannot be held responsible for changes in reaction yield or presence of impurities. Obtaining compounds from the treatment of municipal waste or from the recycling of carbon dioxide or recycled polymer does not necessarily mean that it will lead to the desired bio-sourced carbon content measured according to the standard ASTM D6866-21 Method B in claims 2-4, if the municipal waste, polymer or carbon dioxide is from fossil origin. Moreover, the term bio-sourced is usually considered to mean obtained from plant material, which would not be the case if municipal waste, recycled carbon dioxide or recycled polymer material as in claim 11, is used as carbon source, particularly on large or industrial scale. Therefore, a lack of clarity arises from the use of this term.
II. Claims 7 and 10-11 depending therefrom 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 pre-AIA the applicant regards as the invention; recitation of “and/or” in claims 7 and 10-11 makes the claims indefinite, as it is not clear what limitations must be present. The metes and bounds of claims 7 and 10-11 are not clear and thus, it would not be possible to one of ordinary skill in the art to define the metes and bounds of the desired patent protection. The rejection may be overcome by amending the claims to recite “… or …”. Correction and clarification is required. Examiner suggests amending the claim to recite “…or …”.
III. Claim 11 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 pre-AIA the applicant regards as the invention.
Claim 11 is indefinite in the recitation of “derived”. The metes and bounds of the term “derived” is not clear in the context of the claim. . Claim 11 recites “… derived from …”. It is not clear to the examiner as to what the phrase “…derived from…” means in the context of the above claim, is this synonymous with “obtained from specific source…? or does it include any source? Furthermore, literally while the term “derived” means to “to isolate from or obtain from a source”, the above term could also mean “to arrive by reasoning i.e., to deduce or infer” or also mean “to produce from another substance and would not allow one of skill in the art to differentiate between these sources and the structures of (meth)acrylic acids and alkylamines. Therefore, unless applicants’ have defined the term “derived…” as equivalent to “obtained from the specific source”, the term “derived…” does not further limit the recited “(meth)acrylic acids and alkylamines”. Clarification and correction is required. Examiner suggests amending the claims to recite ”obtained from…”. Clarification and correction required.
Claim Rejections: 35 USC § 112(a)
The following is a quotation 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.
Enablement
Claims 8-9 (depending from claim 1) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, because the specification, while being enabling for a method for producing (meth)acrylic acids and alkylamines as disclosed in prior art, the method comprising a reaction step comprising at least two biocatalyst/enzymes (as described in prior art US 7,285,406 see 35 USC 103 rejection below; and also see pages 12-14 of specification), and the specification does not reasonably provide enablement for a method for producing (meth)acrylic acids and alkylamines, the method comprising any enzyme(s) obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims without undue experimentation.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claims 8-9 (depending from claim 1) broadly encompass a method for producing (meth)acrylic acids and alkylamines, the method comprising any enzyme(s) obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures. Predictability of which process for production of any (meth)acrylic acids and alkylamines comprising a genera of enzymes obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures requires a knowledge of biochemical and biological characteristics of the claimed enzymes, and guidance with regard to how said enzymes relates to the desired outcome. However, in this case the disclosure is limited to a method for producing (meth)acrylic acids and alkylamines as disclosed in prior art, the method comprising a reaction step comprising at least two biocatalyst/enzymes (as described in prior art US 7,285,406 see 35 USC 103 rejection below; and also see pages 12-14 of specification).
The specification is silent on a method for producing (meth)acrylic acids and alkylamines, the method comprising any enzyme(s) obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures, because there is no such readily available guidance in prior art, nor does the specification provides one, it would be undue experimentation for those skilled in the art to make and use said primer derivatives and enzymes in the claimed method.
In view of the great breadth of the claims, amount of experimentation required to make and use the claimed composition in the claimed process, the lack of guidance, working examples, and unpredictability of the art in predicting the use in the claimed process in the present invention i.e., a method for producing (meth)acrylic acids and alkylamines, the method comprising any enzyme(s) obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures. For the above purpose, the claimed invention would require undue experimentation. As such, the specification fails to teach one of ordinary skill how to use the full scope of the claimed method encompassed by the claims. Without such guidance in the specification and lack of correlative working examples, the claims would require an improperly extensive and undue amount of experimentation without a predictable degree of success on the part of the skilled artisan. (See In re Wands 858 F.2d 731, 8 USPQ 2nd 1400 Fed. Cir. 1988).
Written-Description
Claims 8-9 (depending from claim 1) are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing subject matter which was not disclosed in the specification in such a way as to reasonably convey to one of skilled in the relevant art that the invention(s), at the time the application was filed, had possession of the claimed invention.
Claims 8-9 (depending from claim 1) as interpreted are directed to a method for producing (meth)acrylic acids and alkylamines, the method comprising any enzyme(s) obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures.
The specification discloses and is limited to a method for producing (meth)acrylic acids and alkylamines as disclosed in prior art, the method comprising a reaction step comprising at least two biocatalyst/enzymes (as described in prior art US 7,285,406 see 35 USC 103 rejection below; and also see pages 12-14 of specification), which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus and in the claimed method.
A sufficient written description of a genus of may be achieved by a recitation of structural features common to members of genus, which features constitute a substantial portion of the genus. There is no recited structural feature of the genus in the specification, i.e., a method for producing (meth)acrylic acids and alkylamines, the method comprising any enzyme(s) obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures, as claimed and included in the claimed genera of biocatalyst/enzymes and in the claimed method. Therefore, one skilled in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
In University of California v. Eli Lilly & Co., 43 USPQ2d 1938, the Court of Appeals for the Federal Circuit has held that “A written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula, [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials”. As indicated in MPEP § 2163, the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other 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 that Applicant was in possession of the claimed genus. In addition, MPEP § 2163 states that a representative number of species means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
The Federal Circuit in Lilly, Fiers, Rochester and many other cases has determined that the written description issue applies to situations where the definition of the subject matter of the claims fails to provide description commensurate with the genus. Case law directly supports this rejection. As the District Court in University of Rochester v. G.D. Searle & Co., Inc. (2003 WL 759719 W.D.N.Y., 2003. March 5, 2003) noted “In effect, then, the '850 patent claims a method that cannot be practiced until one discovers a compound that was not in the possession of, or known to, the inventors themselves. Putting the claimed method into practice awaited someone actually discovering a necessary component of the invention.”
This is similar to the current situation since the breadth of the current claims comprises a method for producing (meth)acrylic acids and alkylamines, the method comprising any enzyme(s) obtained from any source including variants, mutants and homologs (naturally-occurring and modified enzymes) of undefined and unlimited structures which the present inventors were not in the possession of, or which were not known to the inventors.
Hence, claims are reading on significant numbers of inoperative embodiments in the claimed process that would render claims non-enabled/lack of written-description, when the specification does not clearly identify the operative embodiments or evidence of possession and undue experimentation is involved in determining those that are operative.” Atlas Powder Co. v. E.I. duPont de Nemours & Co., 750 F.2d 1569, 1577, 224 USPQ 409, 414 (Fed. Cir. 1984); In re Cook, 439 F.2d 730, 735, 169 USPQ 298, 302 (CCPA 1971); MPEP 2164.08(b).
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, published in the Official Gazette and also available at <http://www.uspto.gov>.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 1-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Coover Jr., et al., (US 2,719,177, in IDS) and further in view Payne et al., (US 7,285,406), Matsumoto et al., (J. Biosci. Bioeng., 2020, Vol. 129(1): 99-103), ASTM International, Designation D6866 (19 pages, 03/03/2021), Iwasaki et al., (US 4,879,412) and King et al., (US 5,132,456).
Regarding claims 1-7 and 10-11, Coover Jr., et al., (US 2,719,177, in IDS) disclose a process for obtaining alkyl(meth)acrylamide comprising the reaction between (meth)acrylic acid and a primary or secondary alkylamine as well as the use of this compound for the preparation of polymers (see column 1, lines 15-45; column 2, lines 3-13; claims 1-6; and entire document). Coover Jr., et al., does not disclose the origin of the starting materials used for this preparation, so it is possible that part of the carbon- containing compounds are at least partially bio-sourced, the absence of indication of origin does not mean that the starting materials are obtained from fossil resources, and in the absence of other differentiating features, the low threshold for non-fossil content makes it credible that the materials, (meth)acrylic acid and a primary or secondary alkylamine of Coover Jr., et al., in claims 1-7 and 10-11 fall within the claimed scope.
However, Coover Jr., et al., (US 2,719,177, in IDS) is silent regarding wherein the (meth)acrylic acid and a primary or secondary alkylamine is partially renewable and non-fossil/bio-sourced (as in claims 1-10); bio-sourced carbon content being measured according to the standard ASTM D6866-21 Method B (as in claims 2-4); and wherein in said method the (meth)acrylic acid or one of the esters thereof and/or the alkylamine are derived partially or totally from a recycling process (as in claim 11).
Regarding claims 1-3, 5 and 7-10, Payne et al., (US 7,285,406), disclose recombinant expression of genes encoding (enzymes/biocatalysts) nitrile hydratase (NHase) or amidase (Am), where the NHase useful for catalyzing the hydration of nitrites to the corresponding amides, and the amidase is useful for hydrolysis of amides to the corresponding carboxylic acids including methacrylonitrile, 3-hydroxypropionitrile and isolation of said reference carboxylic acids (see col. 10, lines 25-45; and entire document).
Regarding claims 1-2, 4, 6-7 and 9-10, Matsumoto et al., (J. Biosci. Bioeng., 2020, Vol. 129(1): 99-103) disclose recombinant E.coli expressing genes encoding transaminase (enzymes/biocatalysts) cascade for the production of alkylamines (see Abstract; col. 2, ¶ 2, page 99; Fig. 3, page 102; col. 1, ¶ 2, page 103; and entire document).
Regarding claims 2-4, ASTM International, Designation D6866 (19 pages, 03/03/201) teach methods for experimentally measuring biobased contents of solids, liquids, and gaseous samples using radiocarbon analysis (col. 1, ¶ 1.1; and entire document).
Regarding claims 10-11, Iwasaki et al., (US 4,879,412) disclose methods for producing methacrylic acids including purification by recycling process (see Abstract; col. 4, lines 34-38; and entire document).
Regarding claims 10-11, King et al., (US 5,132,456) disclose methods for producing alkylamines including purification by recycling process (see Abstract; Fig. 1-2; col. 4, lines 17-18; and entire document).
Therefore, using the indications of Payne et al., and Matsumoto et al., as a reference, it would have been easy for a person skilled in the art to utilize non-fossil (meth)acrylic acid and a primary or secondary alkylamine obtained by bio-source/biological method and modify the teachings of Coover Jr., et al., and a skilled artisan would realize, as said modification is advantageous for economical and for non-polluting, less toxic method for the production of substrates such as meth-acrylic acid and a primary or secondary alkylamine, depending on the experimental need and utilize said non-fossil (meth)acrylic acid and a primary or secondary alkylamine in the production of meth-acrylamide. As such, disclosures of Payne et al., and Matsumoto et al., provide the structural and functional elements in the claimed method for utilizing non-fossil (meth)acrylic acid and a primary or secondary alkylamine in the production of meth-acrylamide and as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since basic strategy for economical and for non-polluting, less toxic method for the production of substrates such as meth-acrylic acid and a primary or secondary alkylamine are well known in the art. Additionally, a skilled artisan would easily adopt the methods of ASTM International, Designation D6866 (19 pages, 03/03/201) for experimentally measuring biobased contents of solids, liquids, and gaseous samples using radiocarbon analysis and further employ the methods for producing methacrylic acids and alkylamines including purification by recycling as taught by the references of Iwasaki et al., and King et al. Therefore, the above reference renders claims 1-11 prima facie obvious to one of ordinary skill in the art.
Therefore, claims 1-11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Coover Jr., et al., (US 2,719,177, in IDS) and further in view Payne et al., (US 7,285,406), Matsumoto et al., (J. Biosci. Bioeng., 2020, Vol. 129(1): 99-103), ASTM International, Designation D6866 (19 pages, 03/03/2021), Iwasaki et al., (US 4,879,412) and King et al., (US 5,132,456).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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