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
Application Status
This application is 371 of PCT/EP2023/061073, filed on 10/16/2024.
Claims 11-26 are currently pending in the instant application.
The preliminary amendment filed on 10/16/2024, canceling claims 1-10, and adding new claims 11-26 is acknowledged.
Election/Restriction
Applicant's election without traverse of Group I, claims 11-25, drawn to a process for producing fatty acid alkyl esters, said process comprising: a) providing a substrate comprising triglycerides, diglycerides, monoglycerides, free fatty acids or any combination thereof, and b) reacting the substrate with an enzyme composition comprising an sn-1,3 position lipase and an sn-2 position lipase to produce fatty acid alkyl esters; wherein the sn-1,3 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; wherein the sn-2 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 3; and wherein said lipases are in liquid form in the response filed on 07/30/2026 is acknowledged.
Claims 26 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants request for rejoinder is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11-25 are present for examination.
Priority
Acknowledgement is made of applicants claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application EPO 22170819.1 (DENMARK) filed on 04/29/2022 and claim for International Patent application PCT/EP2023/061073, filed on 04/27/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/16/2024 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copy of 1449 is enclosed herewith.
Drawings
There is no Drawing with this application.
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.
Claims 22 and 25 are rejected under 35 U.S.C. 112(b), 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.
Claims 22 and 25 are indefinite and vague in the recitation “an amino acid sequence” in the context of SEQ ID NO: 1, 2 and 3, which is confusing because “an amino acid sequence” under Broadest Reasonable Interpretation (BRI) could be interpreted as “any fragment of the amino acid sequence of SEQ ID NO: 1, 2 and 3 even in the smallest length of 4 amino acids. It is not clear to the examiner whether applicants meant by such phrase as a full length amino acid sequence of SEQ ID NO: 1, 2 and 3, or a fragment of the amino acid sequence of SEQ ID NO: 1, 2 and 3, rendering the metes and bounds of the term unclear. This rejection could be overcome by replacing “an amino acid sequence” with “the amino acid sequence”. Clarification and correction are required.
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.
A. Written Description
Claims 11-19, 22, and 25 are rejected under 35 U.S.C. 112(a), 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.
Claims 11-19, 22 and 25 are directed to a process for producing fatty acid alkyl esters, said process comprising: a) providing a substrate comprising triglycerides, diglycerides, monoglycerides, free fatty acids or any combination thereof, and b) reacting the substrate with an enzyme composition comprising an sn-1,3 position lipase and an sn-2 position lipase to produce fatty acid alkyl esters; wherein the sn-1,3 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; wherein the sn-2 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 3; and wherein said lipases are in liquid form.
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.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).
Thus, Claims 11-19, 22 and 25, are drawn to a process for producing fatty acid alkyl esters, said process comprising: a) providing a substrate comprising triglycerides, diglycerides, monoglycerides, free fatty acids or any combination thereof, and b) reacting the substrate with an enzyme composition comprising any sn-1,3 position lipase and any sn-2 position lipase derived from any sources to produce fatty acid alkyl esters; wherein the sn-1,3 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; wherein the sn-2 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 3; and wherein said lipases are in liquid form, i.e., 20% non-identity to SEQ ID NO: 1, 2, and 3 that encompasses many mutant, variant and fragments of lipase enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, i.e. No Structure-Function correlation, which is required to fulfill the Written Description (WD) requirement.
As discussed in the written description guidelines 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 the applicant was in possession of the claimed genus. 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.
Furthermore, the genus of polypeptides required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides are adequately described by the disclosure of the structures of prior art. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is a vague concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and completely eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L. (2002) teaches that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Furthermore, the genus of polypeptides or variants required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genius of polypeptides is adequately described by the disclosure of the structures of prior art, i.e., lipase variant enzymes. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight the difficulties associated with “Prediction of protein function from protein sequence and structure”; “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer, it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function, and many functionally similar proteins will have little or no structural homology to disclose proteins. For example, proteins having similar sstructureshave different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L. (2002) teaches that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Claims are drawn to very broadly any sn-1,3 position lipase and any sn-2 position lipase derived from any sources to produce fatty acid alkyl esters; wherein the sn-1,3 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; wherein the sn-2 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 3; and wherein said lipases are in liquid form, i.e., 20% non-identity to SEQ ID NO: 1, 2, and 3 that encompasses many mutant, variant and fragments of lipase enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, used in the claimed method, whose structures are not fully described in the specification. No information, beyond the characterization of variant lipases enzymes has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the variant lipase enzymes, within the scope of the claimed genus. The genus of polypeptides claimed is a large variable genus including many mutants, variant and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated enzymes (variant lipase) within the scope of these claims. The specification discloses the structure of only few representative species of the claimed genus, 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. Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and available at www.uspto.gov.
Claim Rejections - 35 USC § 102
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 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 names another inventor and was effectively filed before the effective filing date of the claimed invention.
MPEP-2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]
A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV.
"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
MPEP-2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
(A) Prove the primary reference contains an "enabled disclosure;"
(B) Explain the meaning of a term used in the primary reference; or
(C) Show that a characteristic not disclosed in the reference is inherent.
Claims 11-19, 20-24 and 25 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as anticipated by Basheer et al. (Robust multienzyme preparation of the synthesis of fatty acids ester. US 2009/0133322A1, publication 05/28/2009, see IDS).
The Broadest Reasonable Interpretation (BRI) of claim 1, which is drawn to a process for producing fatty acid alkyl esters, said process comprising: a) providing a substrate comprising triglycerides, diglycerides, monoglycerides, free fatty acids or any combination thereof, and b) reacting the substrate with an enzyme composition comprising an sn-1,3 position lipase and an sn-2 position lipase to produce fatty acid alkyl esters; wherein the sn-1,3 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; wherein the sn-2 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 3; and wherein said lipases are in liquid form,
Regarding claims 11-19, 20-24 and 25, Basheer et al. teach a process for the preparation of short-chain alkyl esters of fatty acids in solvent-free system comprising providing a fatty acid source, stepwise adding a short-chain free alcohol, preferably methanol, a C1 alcohol, or any other alcohol donor, to said fatty acid source in the presence of a lipase preparation and allowing the reaction to proceed under suitable conditions, until said fatty acid source triglycerides are converted to fatty acid methyl esters (FAME), an alkyl-fatty acid ester as claimed, wherein said lipase preparation comprises at least two lipases, said lipases being separately or jointly immobilized on a suitable support and wherein at least one of said lipases has increased affinity for partial glycerides and at least one of said lipases is sn-1,3 positional specific, wherein said sn-1,3 positional specific lipase derived from Thermomyces lanuginose, which is 100% identical to SEQ ISD NO: 1, 2 and 3 of the instant application, wherein said fatty acid source comprises at least one of soybean oil, canola oil, rapeseed oil, olive oil, castor oil, palm oil, sunflower oil, peanut oil, cotton seed oil, Jatropha oil, animal-derived fat, waste cooking oil, oil triglycerides derived from inedible plant sources, or any mixture of at least two thereof., wherein said lipases arc jointly immobilized on a suitable support, wherein each of said lipases is immobilized on a suitable support, and wherein the supports on which the said lipases are immobilized are identical or different, wherein said support is a porous support which is organic or inorganic, wherein said inorganic porous support is silica-based or alumina-based, and said organic porous supports is polymer-based, and wherein said support may optionally contain active functional groups selected from epoxy and aldehyde groups, or ionic groups, wherein the conversion of the fatty acid acyl groups or free fatty acids comprised in said fatty acid source to fatty acid methyl esters is monitored at various time points during the reaction, the reaction medium is removed by suitable means at any desired time point during the reaction, thereby stopping the reaction, and the formed fatty acid methyl esters and optionally the formed glycerol are isolated from the reaction medium, wherein the reaction is stopped when the conversion of the fatty acid acyl groups or free fatty acids comprised in said fatty acid source to fatty acid methyl esters has reached at least 70% (see, abstract, title, and claims 1-44)
Therefore, Basheer et al. anticipate claims 11-19, 20-24 and 25 of the instant application as written.
Claim Rejections - 35 U.S.C. § 103
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 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 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.
According to MPEP 2143:
“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.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.”
Claims 11-19, 20-24 and 25 are under 35 U.S.C. 103 as being unpatentable over Basheer et al. (Robust multienzyme preparation of the synthesis of fatty acids ester. US 2009/0133322A1, publication 05/28/2009, see IDS), and in view of the common knowledge of a skilled artisan in the same field.
The Broadest Reasonable Interpretation (BRI) of claim 1, which is drawn to a process for producing fatty acid alkyl esters, said process comprising: a) providing a substrate comprising triglycerides, diglycerides, monoglycerides, free fatty acids or any combination thereof, and b) reacting the substrate with an enzyme composition comprising an sn-1,3 position lipase and an sn-2 position lipase to produce fatty acid alkyl esters; wherein the sn-1,3 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 1 or SEQ ID NO: 2; wherein the sn-2 position lipase is a lipase having at least 80% sequence identity to SEQ ID NO: 3; and wherein said lipases are in liquid form,
Regarding claims 11-19, 20-24 and 25, Basheer et al. teach a process for the preparation of short-chain alkyl esters of fatty acids in solvent-free system comprising providing a fatty acid source, stepwise adding a short-chain free alcohol, preferably methanol, a C1 alcohol, or any other alcohol donor, to said fatty acid source in the presence of a lipase preparation and allowing the reaction to proceed under suitable conditions, until said fatty acid source triglycerides are converted to fatty acid methyl esters (FAME), an alkyl-fatty acid ester as claimed, wherein said lipase preparation comprises at least two lipases, said lipases being separately or jointly immobilized on a suitable support and wherein at least one of said lipases has increased affinity for partial glycerides and at least one of said lipases is sn-1,3 positional specific, wherein said sn-1,3 positional specific lipase derived from Thermomyces lanuginose, which is 100% identical to SEQ ID NO: 1, 2 and 3 of the instant application, wherein said fatty acid source comprises at least one of soybean oil, canola oil, rapeseed oil, olive oil, castor oil, palm oil, sunflower oil, peanut oil, cotton seed oil, Jatropha oil, animal-derived fat, waste cooking oil, oil triglycerides derived from inedible plant sources, or any mixture of at least two thereof., wherein said lipases arc jointly immobilized on a suitable support, wherein each of said lipases is immobilized on a suitable support, and wherein the supports on which the said lipases are immobilized are identical or different, wherein said support is a porous support which is organic or inorganic, wherein said inorganic porous support is silica-based or alumina-based, and said organic porous supports is polymer-based, and wherein said support may optionally contain active functional groups selected from epoxy and aldehyde groups, or ionic groups, wherein the conversion of the fatty acid acyl groups or free fatty acids comprised in said fatty acid source to fatty acid methyl esters is monitored at various time points during the reaction, the reaction medium is removed by suitable means at any desired time point during the reaction, thereby stopping the reaction, and the formed fatty acid methyl esters and optionally the formed glycerol are isolated from the reaction medium, wherein the reaction is stopped when the conversion of the fatty acid acyl groups or free fatty acids comprised in said fatty acid source to fatty acid methyl esters has reached at least 70% (see, abstract, title, and claims 1-44)
Therefore, before the effective filing date, it would have been obvious to one of ordinary skill in the art to arrive at the claimed invention as a whole before the effective filing date of the invention was made by combining the teachings of Basheer et al. and common knowledge of a skilled artisan in the same field to use the same techniques and same enzymes, and chemicals as taught by Basheer et al. and modify Basheer et al. to make a process for the preparation of short-chain alkyl esters of fatty acids in solvent-free system to arrive the claimed invention.
One of ordinary skilled in the art would have been motivated to use lipase enzyme and oil, fats, and glycerides as substrate in a process for the preparation of short-chain alkyl esters of fatty acids in solvent-free system, which is commercially, pharmaceutically and economically beneficial.
One of ordinary skilled in the art would have a reasonable expectation of success because Basheer et al. could successfully produce short-chain alkyl esters of fatty acids in solvent-free system.
Thus, the above references render the claims prima facie obvious to one of ordinary skill in the art.
Conclusion
Status of the claims:
Claims 11-19, 20-24 and 25 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Iqbal H. Chowdhury, Ph.D.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
Prosecution Insights