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
Claims 1-13 are pending and is now under consideration for examination.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a CON of PCT/CN2023/091440 filed on 04/28/2023 and claims the priority date of China application 2022116348669 filed on 12/19/2022; 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 CON of PCT/CN2023/091440 filed on 04/28/2023.
Information disclosure statement
The information disclosure statement (IDS) submitted on 09/13/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Claims Objections
I. Claim 1 and claims 2-5 and 9-13 depending therefrom are objected to, due to the following informality: Claims 1 and 3 recites the phrase “… an amino acid sequence according to SEQ ID NO: 1, 9, 10 and 11”, as such, given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on polypeptides comprising “any two/dipeptide sequences of SEQ ID NO: 1, 9, 10 and 11 and having the recited activity. Examiner suggests amending the claim to recite “the amino acid sequence” Appropriate correction is required. For examination purposes claims 1-5 and 9-13 are interpreted to encompass variants and mutants of the recited sequence(s).
II. Recitation of “and/or” in claim 2 and claim 3 depending therefrom and claim 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 …”; additionally “knocks down” in claim 2 is a non-scientific “jargon”; examiner suggests replacing “knocks down” to “disrupted”.
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. Claim 1 and claims 2-5 and 9-13 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.
Claims 1 and 3 recites the phrase “… an amino acid sequence according to SEQ ID NO: 1, 9, 10 and 11”, as such, given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on polypeptides comprising “any two/dipeptide sequences of SEQ ID NO: 1, 9, 10 and 11 and having recited activity. Examiner suggests amending the claim to recite “the amino acid sequence”. Appropriate correction is required. For examination purposes claims 1-5 and 9-13 are interpreted to encompass variants and mutants of the recited sequence(s). The scope of the claims are unclear, as such it is unclear how homologous/identical to the amino acid sequences of SEQ ID NOs: 1, 9, 10 and a sequence of interest must be to be included within the scope of the claims and furthermore, it is not clear whether a full-length or a partial fragments of SEQ ID NOs: 1, 9, 10 and 11 is encompassed within the scope of the claims.
II. Claims claim 2 and claim 3 depending therefrom and 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; recitation of “and/or” in claims 1 and 11 makes the claims indefinite, as it is not clear what limitations must be present. The metes and bounds of claims 2-3 and 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 6 (claims 7-8 depending therefrom) recites the phrase “… a sequence shown in SEQ ID NO: 1”. The metes and bounds of the term “shown in” in claim 6 is not clear in the context of the claims. It is not clear to the examiner if the recited amino acid sequence has the sequence of SEQ ID NO: 1? or is a representative member of a genus/merely exemplary? Examiner suggests amending the claims to make a direct reference to SEQ ID NO: 1. Clarification and correction required.
IV. Claim 9 (claims10-12 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.
Regarding claims 9 and 10, “A system” is a limitation that invokes 35 U.S.C. 112(f) or 35 U.S.C. 112 (pre-AIA ), sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for the claimed function. “A system” is non-structural term and the scope of the term in claims 9 (claims10-12 depending therefrom) is indefinite.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or 35 U.S.C. 112 (pre-AIA ), sixth paragraph; or
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For examination purposes claims 9 (claims10-12 depending therefrom) are interpreted to encompass “a method for synthesizing a lipid, comprising the recombinant strain of claim 1 in a fermentation medium comprising an acetate and ammonium salt” .
Claim Rejections: 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
I. Claims 1-13 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.
Claims 1-13, as interpreted are directed to encompass in the claimed recombinant strain and methods: an amino acid sequence according to SEQ ID NO: 1 having alpha-acetyl-CoA synthetase activity of undefined and unlimited structures and “amino acid sequence shown in SEQ ID NO: 1” (as in claim 1-2 and 6); an amino acid sequence set forth in SEQ ID NO: 9 having citrate lyase activity, an amino acid sequence set forth in SEQ ID NO: 10 having glucose-6-phosphate dehydrogenase activity of undefined and unlimited structures, and an amino acid sequence set forth in SEQ ID NO: 11 having g-subunit of the sucrose non-fermenting related protein kinase activity of undefined and unlimited structures (as in claim 3); as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 1, 9, 10 and 11 but any fragment/subsequence within SEQ ID NOs: 1, 9, 10 and 11 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 1, 9, 10 and 11 (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation); and a method of regulating an oleaginous microorganism to synthesize lipid (as in claims 6-12) and a method of extracting for extracting total protein in said oleaginous microorganism (as in claim 13).
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.
In the instant case, there is no structure associated with function with regard to the members of the genus of polypeptides in the claimed recombinant strain and methods: an amino acid sequence according to SEQ ID NO: 1 having alpha-acetyl-CoA synthetase activity of undefined and unlimited structures and “amino acid sequence shown in SEQ ID NO: 1” (as in claim 1-2 and 6); an amino acid sequence set forth in SEQ ID NO: 9 having citrate lyase activity, an amino acid sequence set forth in SEQ ID NO: 10 having glucose-6-phosphate dehydrogenase activity of undefined and unlimited structures, and an amino acid sequence set forth in SEQ ID NO: 11 having g-subunit of the sucrose non-fermenting related protein kinase activity of undefined and unlimited structures (as in claim 3); as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 1, 9, 10 and 11 but any fragment/subsequence within SEQ ID NOs: 1, 9, 10 and 11 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 1, 9, 10 and 11 (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation); and a method of regulating an oleaginous microorganism to synthesize lipid (as in claims 6-12) and a method of extracting for extracting total protein in said oleaginous microorganism (as in claim 13).
No information, beyond the characterization of isolated polypeptides comprising the amino acid sequences of SEQ ID NO: 1, 9 and 10 having the associated activity, in a specific cellular context M. alpina CCFM 501, wherein in said strain comprising gene disruption encoding the amino acid sequence of SEQ ID NO: 11 and having g-subunit of the sucrose non-fermenting related protein kinase activity (see Example 5, pages 30-33 of the specification) has been provided by the applicants’, which would indicate that they had possession of the claimed genus of polypeptides recombinant strain and methods: an amino acid sequence according to SEQ ID NO: 1 having alpha-acetyl-CoA synthetase activity of undefined and unlimited structures and “amino acid sequence shown in SEQ ID NO: 1” (as in claim 1 -2 and 6); an amino acid sequence set forth in SEQ ID NO: 9 having citrate lyase activity, an amino acid sequence set forth in SEQ ID NO: 10 having glucose-6-phosphate dehydrogenase activity of undefined and unlimited structures, and an amino acid sequence set forth in SEQ ID NO: 11 having g-subunit of the sucrose non-fermenting related protein kinase activity of undefined and unlimited structures (as in claim 3); as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 1, 9, 10 and 11 but any fragment/subsequence within SEQ ID NOs: 1, 9, 10 and 11 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 1, 9, 10 and 11 (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation); and a method of regulating an oleaginous microorganism to synthesize lipid (as in claims 6-12) and a method of extracting for extracting total protein in said oleaginous microorganism (as in claim 13).
The claimed genus of polypeptides is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides and the encoding polynucleotides is adequately described by the disclosure of the structures of the amino acid sequences of SEQ ID NO: 1, 9, 10 and 11 having associated activity/function, since one could use structural homology to isolate those encoding polypeptides recited in the claims. The art clearly teaches the “Practical Limits of Function Prediction”: (i) Devos et al., (Proteins: Structure, Function and Genetics, 2000, Vol. 41: 98-107), teach that the results obtained by analyzing a significant number of true sequence similarities, derived directly from structural alignments, point to the complexity of function prediction. Different aspects of protein function, including (i) enzymatic function classification, (ii) functional annotations in the form of key words, (iii) classes of cellular function, and (iv) conservation of binding sites can only be reliably transferred between similar sequences to a modest degree. The reason for this difficulty is a combination of the unavoidable database inaccuracies and plasticity of proteins (Abstract, page 98) and the analysis poses interesting questions about the reliability of current function prediction exercises and the intrinsic limitation of protein function prediction (Column 1, paragraph 3, page 99) and conclude that “Despite widespread use of database searching techniques followed by function inference as standard procedures in Bioinformatics, the results presented here illustrate that transfer of function between similar sequences involves more difficulties than commonly believed. Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (column 2, paragraph 2, page 105).
(ii) Whisstock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340) also 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 (page 309, paragraph 4), it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (page 312, paragraph 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (page 313, paragraph 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein’s role fundamentally (page 323, paragraph 1).
(iii) This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polynucleotides and encoded polypeptides do not necessarily share the same function. For example, Witkowski et al., (Biochemistry 38:11643-11650, 1999), teaches that one conservative amino acid substitution transforms a b-ketoacyl synthase into a malonyl decarboxylase and completely eliminates b-ketoacyl synthase activity. Seffernick et al., (J. Bacteriol. 183(8): 2405-2410, 2001), teaches that two naturally occurring Pseudomonas enzymes having 98% amino acid sequence identity catalyze two different reactions: deamination and dehalogenation, therefore having different function. Broun et al., (Science 282:1315-1317, 1998), teaches that as few as four amino acid substitutions can convert an oleate 12-desaturase into a hydrolase and as few as six amino acid substitutions can transform a hydrolase to a desaturase.
As the claimed genera of polypeptides in the claimed recombinant strain and methods include widely variable structure and associated function, since minor changes in structure may result in changes affecting function and no additional information (species/variant/mutant) correlating structure with function has been provided. Furthermore, “Possession may not be shown by merely describing how to obtain possession of members of the claimed genus or how to identify their common structural features” (See University of Rochester, 358 F.3d at 927, 69 USPQ2d at 1895).
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. Applicants’ are 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 www.uspto.gov.
Enablement
II. Claims 1-13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement, because the specification, while being enabling for the characterization of isolated polypeptides comprising the amino acid sequences of SEQ ID NO: 1, 9 and 10 having the associated activity, in a specific cellular context M. alpina CCFM 501, wherein in said strain comprising gene disruption encoding the amino acid sequence of SEQ ID NO: 11 and having g-subunit of the sucrose non-fermenting related protein kinase activity (see Example 5, pages 30-33 of the specification), does not reasonably provide enablement for genus of polypeptides in the claimed recombinant strain and methods: an amino acid sequence according to SEQ ID NO: 1 having alpha-acetyl-CoA synthetase activity of undefined and unlimited structures and “amino acid sequence shown in SEQ ID NO: 1” (as in claim 1 -2 and 6); an amino acid sequence set forth in SEQ ID NO: 9 having citrate lyase activity, an amino acid sequence set forth in SEQ ID NO: 10 having glucose-6-phosphate dehydrogenase activity of undefined and unlimited structures, and an amino acid sequence set forth in SEQ ID NO: 11 having g-subunit of the sucrose non-fermenting related protein kinase activity of undefined and unlimited structures (as in claim 3); as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 1, 9, 10 and 11 but any fragment/subsequence within SEQ ID NOs: 1, 9, 10 and 11 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 1, 9, 10 and 11 (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation); and a method of regulating an oleaginous microorganism to synthesize lipid (as in claims 6-12) and a method of extracting for extracting total protein in said oleaginous microorganism (as in claim 13). 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 and use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or 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 claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
The breadth of claims includes overly broad genus, applicants’ disclose no direction or guidance on how to design and make any polypeptide of undefined structure having desired activity as noted in the breadth above. Thus, instant specification and prior art failed to describe how to make and use the claimed genus of polypeptides sufficiently. Although, it is possible to display and create any protein structure in computer (in silico) and manipulate in any possible way, such as inserting any amino acid(s) into preexisting three-dimensional scaffold; the creation of desired catalytic/biologic activity in a solution is highly unpredictable.
According to MPEP § 2164.02: “All questions of enablement are evaluated against the claimed subject matter. The focus of the examination inquiry is whether everything within the scope of the claim is enabled.”; “The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well-known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. Further the scope of enablement must only bear a “reasonable correlation” to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).”; and “As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. > AK Steel Corp. v. Sollac, 344 F.3d 1234, 1244, 68 USPQ2d 1280, 1287 (Fed. Cir. 2003); < In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. v. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged “pioneer status” of invention irrelevant to enablement determination).”
Instant claims are so broad such that, instant disclosure of instant specification and a general knowledge in the art are not commensurate with the scope of instant claims for one skilled in the art to make and use claimed invention without undue experimentation. As noted above, the breadth of instant claims encompass an overly broad genus of undefined structure including variants, mutants and homologs.
Therefore, taking into consideration the extremely broad scope of the claims, the lack of guidance, the amount of information provided, the lack of knowledge about a correlation between structure and the desired function, and the high degree of unpredictability of the prior art in regard to structural variability and its effect on function, one of ordinary skill in the art would have to go through the burden of undue experimentation in order to practice the claimed invention. Thus, applicants’ have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims. The scope of the claim must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of genus of polypeptides in the claimed recombinant strain and methods: an amino acid sequence according to SEQ ID NO: 1 having alpha-acetyl-CoA synthetase activity of undefined and unlimited structures and “amino acid sequence shown in SEQ ID NO: 1” (as in claim 1 -2 and 6); an amino acid sequence set forth in SEQ ID NO: 9 having citrate lyase activity, an amino acid sequence set forth in SEQ ID NO: 10 having glucose-6-phosphate dehydrogenase activity of undefined and unlimited structures, and an amino acid sequence set forth in SEQ ID NO: 11 having g-subunit of the sucrose non-fermenting related protein kinase activity of undefined and unlimited structures (as in claim 3); as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 1, 9, 10 and 11 but any fragment/subsequence within SEQ ID NOs: 1, 9, 10 and 11 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 1, 9, 10 and 11 (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation); and a method of regulating an oleaginous microorganism to synthesize lipid (as in claims 6-12) and a method of extracting for extracting total protein in said oleaginous microorganism (as in claim 13) having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Enablement
III. Claim 5 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. Claim 5 recites specific strain “M. alpina CCFM 501”.
It is apparent that specific strain “M. alpina CCFM 501” is required to practice the claimed invention. As such the biological material must be readily available or obtainable by a repeatable method set forth in the specification, or otherwise readily available to the public. If it is not so obtainable or available, the requirements of 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, may be satisfied by a deposit of “M. alpina CCFM 501” under the Budapest Treaty on 1 May 2018. The specification does not disclose a repeatable method to obtain “M. alpina CCFM 501”, and there is no indication in the specification as to the public availability. If the deposit was made under the terms of Budapest Treaty, then a statement, affidavit or declaration by applicants’, or a statement by an attorney of record over his/her signature and registration number, or someone empowered to make such a statement, stating that the invention will be irrevocably and without restriction released to the public upon the issuance of a patent, would satisfy the deposit requirement made herein. In order to certify that the deposit meets the criteria set forth in 37 CFR 1.801-1.809 and MPEP 2402-2411.05, applicants’ may provide assurance of compliance by statement, affidavit or declaration, or by someone empowered to make same, or by a statement by an attorney of record over his/her signature and registration number showing that:
(a) during the pendency of the application, access to the invention will be afforded to the Commissioner upon request;
(b) all restrictions upon availability to the public will be irrevocably removed upon granting the patent;
(c) the deposit will be maintained in public depository for a period of 30 years, or 5 years after the last request or for the enforceable life of the patent, whichever is longer;
(d) a test of the viability of the biological material at the time of deposit (see 37 CFR 1.807); and the deposit will be replaced if it should ever become inviable.
Although the claims are examined in the light of the specification, specification cannot be read into the claims, i.e., the limitations of the specification cannot be read into the claims (see MPEP 2111 R-5).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
Art of Interest
The closest prior art is El Tahchy et al., (US 2024/0263200 A1) disclose recombinant M. alpina comprising/overexpressing acetyl-CoA synthetase and citrate lyase for the synthesis of saturated fats (see ¶ [0265]; Table 1, pages 27-31; and entire document); however, the cited art is not used in any rejection, as the cited art does not disclose characterization of isolated polypeptides comprising the amino acid sequences of SEQ ID NO: 1, 9 and 10 having the associated activity, in a specific cellular context M. alpina, wherein in said strain comprising gene disruption encoding the amino acid sequence of SEQ ID NO: 11 and having g-subunit of the sucrose non-fermenting related protein kinase activity, as required in the instant claims 1-13.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. 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). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
Prosecution Insights