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, claims 1, 3-5, 8, 12 with the addition of new claims 46-57 and sequences SEQ ID NOs: 1-4, and SgRNA sequence SgRNA32; and as species Pichia pastoris, low-carbon compound/methanol and inducible promoter: AOX1 alcohol oxidase 1 promoter without traverse in the reply filed on 06/18/2026 is acknowledged; in said response applicants’ have amended claims 1, 3-5, 8 and 12, cancelled claims 17-19, 22, 27, 32-35, 38 and 43 and added new claims 46-57. Thus, amended claims 1, 3-5, 8, 12, 15, 30 and 46-57 are pending in this application and the elected Group I, claims 1, 3-5, 8, 12 and 46-57 and sequences SEQ ID NOs: 1-4, and SgRNA sequence SgRNA32; and as species Pichia pastoris, low-carbon compound/methanol and inducible promoter: AOX1 alcohol oxidase 1 promoter is now reading on the elected invention is now under consideration for examination; non-elected sequences and non-elected species in claims 12, 49-50 and 56-57 and non-elected Group II-III claims 15 and 30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim..
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/CN2022/120499 filed on 09/22/2022 and claims the priority date of China applications: 202111116011.2 filed on 09/23/2021 and 202211137776.9 filed on 09/19/2022; however, no English translation of said foreign priority applications have been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/CN2022/120499 filed on 09/22/2022.
Information disclosure statement
The information disclosure statements (IDS) submitted on 01/21/2025, 09/12/2025, 01/22/2026 and 04/09/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements is considered and initialed by the examiner.
Specification/Claims-Objection/Sequence Compliance
Applicants’ are advised that the application is not in compliance with 37 CFR §§ 1.821-1.825. This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 CFR § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 CFR §§ 1.821-1.825. Specifically, applicants’ are required to comply with the sequence rules by inserting the sequence identification numbers of all sequences within the claims and/or specification. It is particularly noted that page 21, paragraphs [0062-0069] of specification recite many sequences; and new claims 56 and 57 recite many sequences, but applicants’ fail to provide the SEQ ID NO: (sequence identifiers) to all the sequences recited in the specification; i.e., nucleotides 10 (ten) or more and amino acids 4 (four) or more. Sequences must be referred to by their sequence identifiers, see particularly 37 CFR 1.821(d). If the sequences appearing in the specification do not have SEQ ID NO: assigned to them, then an amendment to the sequence listing will be required as well. There must not be any new matter submitted, therefore it is important to be careful to include only the sequences that are already disclosed in the current specification. Failure to correct the deficiency will be held a non-responsive to this Office action. Correction and clarification required.
Claims Objections
I. Recitation of “and/or” in claims 3 and 53 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 …”.
II. Recitation of “ingest” in claim 3 is not clear and non-scientific. Correction and clarification is required. Examiner suggests amending the claim to recite “assimilate” or “utilize”.
III. Claim 12 is objected to, due to the following informality: Claim 12 recites the phrase “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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: SEQ ID NO: 1, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity. Examiner suggests amending the claim to recite “the amino acid sequence and encoded by the gene” Appropriate correction is required. For examination purposes claim 12 is interpreted to encompass variants and mutants of the recited sequence(s).
IV. Claims 12 and 56-57 are objected to, as said claims recite non-elected subject-matter/SEQ ID NOs.
V. Claims 56-57 are objected to, as said claims recite sequences without sequence identifiers; no SEQ ID NOs are provided.
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 3-5, 8, 12 and 47-57 depending therefrom 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 applicant regards as the invention.
Claims 1 is indefinite in the recitation of “… on the basis of carbon dioxide and extracellular non-optical energy” for the following reasons. The term “on the basis” is unclear and confusing in the absence of a definition providing the intended meaning of the term or the intended parameters required to determine the value“…the basis of carbon dioxide and extracellular non-optical energy” is scientifically unclear and confusing and furthermore, the scope and breadth of “non-optical energy “ is unclear. For examination purposes “… on the basis of carbon dioxide and extracellular non-optical energy” is interpreted as method of fermenting cells in a medium comprising hydrogen, said cells having the metabolic machinery for utilizing hydrogen and furthermore, there is no support in the specification that the elected species Pichia pastoris is able to utilize hydrogen gas or electric energy; for examination purposes in claims 1, 3-5, 8, 12 and 46-57, the claimed microbial cells are interpreted to utilize any chemical comprising hydrogen and not limited to hydrogen gas.
“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)”. Clarification and correction is required.
II. Claims 3 and 53 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 3 and 53 makes the claims indefinite, as it is not clear what limitations must be present. The metes and bounds of claims 3 and 53 is 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 5 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 USPQ2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by "such as" and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 USPQ 74 (Bd. App. 1961); Ex parte Hall, 83 USPQ 38 (Bd. App. 1948); and Ex parte Hasche, 86 USPQ 481 (Bd. App. 1949).
In the present instance, claim 5 recite the broad recitation “low-carbon compound contains 1-3 carbon atoms” and also recites “optionally…” which is the narrower statement of the range/limitation (range within range). It is not clear what the applicants’ intend to encompass in the rejected claims and the metes and bounds of the claims are unclear and as being indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. Correction and clarification is required.
IV. Claim 12 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 12 recites the phrase recites the phrase “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity. Examiner suggests amending the claim to recite “the amino acid sequence and encoded by the gene” Appropriate correction is required. For examination purposes claim 12 is interpreted to encompass variants and mutants of the recited sequence(s)., 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 NOs: 1, 13-21 and SEQ ID NOs: 3, 22-30 and having the recited activity. Examiner suggests amending the claim to recite “the amino acid sequence” Appropriate correction is required. For examination purposes claim 12 is interpreted to encompass variants and mutants of the recited sequence(s).
V. Claim 12 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 12 recites the phrase “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”. The metes and bounds of the term “shown in” is not clear in the context of the claims. It is not clear to the examiner if the recited amino acid sequences have the amino acid sequences of SEQ ID NOs: 1, 13-21, and SEQ ID NOs: 3, 22-30…? or is a representative member of a genus/merely exemplary. Examiner suggests amending the claim to make a direct reference to SEQ ID NOs: 1, 13-21, and SEQ ID NOs: 3, 22-30. Clarification and correction required.
VI. Claim 47 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 47 recites the phrase “…wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase in a microorganism”; at the outset it is not clear whether the “blocking” is due to over-expression? or attenuation? or disruption? of endogenous glucan 1,4-a-glucosidase or glycogen phosphorylase gene; additionally “blocked” is non-scientific jargon, examiner suggests “disrupting” the activities of genes of interest.
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.
Written Description
I. Claims 1, 3-5, 8, 12 and 46-57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, as containing 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(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 3-5, 8, 12 and 46-57 as interpreted is directed to encompass in the claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation).
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 the scope of the instant claims encompass a genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation).
No information, beyond the characterization of single species Pichia pastoris in the claimed method, said Pichia pastoris comprising plasmids encoding the polypeptides comprising the amino sequence of SEQ ID NO: 1 (starch synthase) and the amino acid sequence of SEQ ID NO: 3 (glucose-1-phosphate adenylyltransferase) and encoding polynucleotides under the control of inducible promoter AOX1 and in said Pichia pastoris the endogenous gene glucan 1,4-a-glucosidase is disrupted by specific SgRNA structures via CRISPR method (see Example 1, ¶ [00146-0165], pages 34-28 of specification), has been provided by the applicants’, which would indicate that they had possession of the claimed genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation).
The art also teaches, even highly structurally homologous polypeptides do not necessarily share the same function and conversely functionally similar molecules do not necessarily have similar structures. For example proteins having similar structure have different activities; 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. Similarly, Wishart et al., (J. Biol. Chem., 1995, Vol. 270(10): 26782-26785) teach that a single mutation converts a novel phosphotyrosine binding domain into a dual-specificity phosphatase. The art also teaches that functionally similar molecules have different structures; Kisselev L., (Structure, 2002, Vol. 10: 8-9) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Hence, the recited genera of genes in the claimed method i.e., polypeptides and the encoding polynucleotides are interpreted to have widely variable structures, since minor changes may result in changes affecting function and no additional information correlating structure with function has been provided.
Therefore, given the lack of description of representative species encompassed by the claimed genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation), the specification fails to sufficiently describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize that applicants’ were in possession of the claimed invention. 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, 3-5, 8, 12 and 46-57 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph, because the specification, while being enabling for characterization of single species Pichia pastoris in the claimed method, said Pichia pastoris comprising plasmids encoding the polypeptides comprising the amino sequence of SEQ ID NO: 1 (starch synthase) and the amino acid sequence of SEQ ID NO: 3 (glucose-1-phosphate adenylyltransferase) and encoding polynucleotides under the control of inducible promoter AOX1 and in said Pichia pastoris the endogenous gene glucan 1,4-a-glucosidase is disrupted by specific SgRNA structures via CRISPR method (see Example 1, ¶ [00146-0165], pages 34-28 of specification), does not reasonably provide enablement for a claimed genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation). 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 or use the invention commensurate in scope with the claim.
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 1, 3-5, 8, 12 and 46-57 are so broad as to encompass: a genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation). The scope of the claims is not commensurate with the enablement provided by the disclosure with regard to the extremely large number of genes i.e., polypeptides and encoding polynucleotides broadly encompassed by the claims in a genus of cellular context in the claimed method. Since the amino acid sequence of a protein encoded by a polynucleotide determines its structural and functional properties, predictability of which changes can be tolerated in a protein's amino acid sequence and obtain the desired activity requires knowledge and guidance with regard to which amino acids in the protein's sequence and the respective codons in its polynucleotide, if any, are tolerant of modification and which are conserved (i.e., expectedly intolerant to modification), and detailed knowledge of the ways in which the encoded proteins' structure relates to its function. In view of the broad breadth of the claims, the amount of experimentation required to determine the structure of all the polypeptides or the encoding polynucleotides from any source including variants, mutants, homologs and recombinants, the lack of guidance, working examples, and unpredictability of the art in predicting function from a polypeptide primary structure (e.g., see Whisstock et al., Q Rev Biophys. 2003 Aug; 36(3): 307-340), practicing the claimed invention would require undue experimentation. As such, the specification fails to enable the entire scope of the claimed invention.
However, in this case the disclosure is limited to characterization of single species Pichia pastoris in the claimed method, said Pichia pastoris comprising plasmids encoding the polypeptides comprising the amino sequence of SEQ ID NO: 1 (starch synthase) and the amino acid sequence of SEQ ID NO: 3 (glucose-1-phosphate adenylyltransferase) and encoding polynucleotides under the control of inducible promoter AOX1 and in said Pichia pastoris the endogenous gene glucan 1,4-a-glucosidase is disrupted by specific SgRNA structures via CRISPR method (see Example 1, ¶ [00146-0165], pages 34-28 of specification), but provides no guidance with regard to the making and using of claimed genus of cellular context, and a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function in the claimed method i.e., method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation) or with regard to other uses. In view of the great breadth of the claims, amount of experimentation required to make the claimed polypeptides and encoding polynucleotides in a genus of cellular context in the claimed process, the lack of guidance, working examples, and unpredictability of the art in predicting function from a polypeptide primary structure (e.g., see Whisstock et al., Q Rev Biophys. 2003 Aug; 36(3): 307-340), the claimed invention would require undue experimentation. As such, the specification fails to teach one of ordinary skill how to make and use the full scope of genus of genes i.e., polypeptides and encoding polynucleotides encompassed by the claims in the claimed process.
While enzyme isolation techniques, recombinant and mutagenesis techniques are known, and it is not routine in the art to screen for multiple substitutions or multiple modifications as encompassed by the instant claims, the specific amino acid positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions or deletions.
The specification does not support the broad scope of the claims which encompass: a claimed genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation), because the specification does not establish: (A) regions of the protein/polynucleotide structure which may be modified without affecting the activity of the encoded gene; (B) the general tolerance of the polypeptide and the encoding polynucleotide to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any amino acid residue or the respective codon in the polynucleotide with an expectation of obtaining the desired biological function; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful.
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 and the encoding polynucleotide of undefined structure having desired activity in a genus of cellular context 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 and encoding polynucleotides sufficiently in a genus of cellular context. 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, homologs and recombinants.
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 claimed genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12); and in said genus of microorganisms wherein the metabolism of starch is blocked by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase of undefined and unlimited structures in a microorganism (as in claim 47; examiner takes the position that specific cellular context and the specific structures of genes of interest is required to disrupt the genes of interest; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation), 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).
Claim Rejections: 35 USC § 102 (AIA )
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, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
I. Claims 1,3-5, 8, 12, 46 and 49-52 (instant claims are granted the priority date of 371 of PCT/CN2022/120499 filed on 09/22/2022) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by over Silverman et al., (US 10,337043 B2).
Claims 1,3-5, 8, 12, 46 and 49-52 as interpreted are drawn to genus of cellular context, a genus of structures (no structural limitation) for polypeptides and the encoding polynucleotides of interest with associated function, i.e., claimed method for preparing starch using carbon dioxide, comprising any microorganism comprising a genus of modifications (genus of undefined and unlimited cellular context and undefined and unlimited genetic modifications); said and said genus of microorganisms comprising a genus of up-regulated glucose-1-phosphate adenylyltransferase(s) and starch synthase(s) of undefined and unlimited structures including variants, mutants, homologs and recombinants (no structure is provided, as in claims 1, 3-5, 8 and 46-57); said glucose-1-phosphate adenylyltransferase and starch synthase comprising “… an amino acid sequence shown in SEQ ID NO: 1, 13-21; an amino acid sequence shown in SEQ ID NO: 3, 22-30; encoded by any gene sequences shown in SEQ ID NO: 2, 11; and encoded by any gene sequences shown in SEQ ID NO: 4, 12”, 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, 13-21 and SEQ ID NO: 3, 22-30 and having the recited activity (as in claim 12; also see claims objections and 35 U.S.C. 112(b) rejection above for claims interpretation); and furthermore, there is no support in the specification that the elected species Pichia pastoris is able to utilize hydrogen gas or electric energy; for examination purposes in claims 1, 3-5, 8, 12 and 46-57, the claimed microbial cells are interpreted to utilize any chemical comprising hydrogen and not limited to hydrogen gas.
Silverman et al., (US 10,337043 B2) discloses recombinant microorganisms and having the ability to utilize relatively low-cost carbon feedstock as an energy source, as well as related biomass, engineered to convert a natural gas-derived feedstock, for example, natural gas, or a C1 substrate such as methane from natural gas, engineered for enhanced production of a desired carbohydrate including starch (see Abstract; col. 3, lines 55-67; and entire document); gas mixtures are made up of methane and other compounds, including other C1 compounds, as well as other light alkane gases, carbon dioxide, nitrogen, hydrogen sulfide; “C1 compound” refers to any carbon containing molecule or composition that lacks a carbon-carbon bond. Exemplary C1 substrates include syngas, methane, methanol, formaldehyde, formic acid or a salt thereof, carbon monoxide, carbon dioxide, methylated amines (col. 1, lines 28-65); said engineered/recombinant microorganism comprising heterologous glucose-1-phosphate adenylyltransferase and a glucan/glycogen synthase (TABLE A, col. 5); said glucose-1-phosphate adenylyltransferase and a glucan/glycogen synthase having 100% sequence identity to the amino acid sequences SEQ ID NO: 1 and SEQ ID NO: 3 of the instant invention (see provided sequence alignments) and said genes are expressed under the control of inducible promoters (col. 12, lines 35-67 to col. 13, lines 1-5) and stable integration of desired gene into the host genome/chromosome (col. 9, lines 20-44); said engineered/recombinant microorganism includes suitable C1 metabolizing microorganisms useful in the practice of the present invention and include eukaryotes such as, yeast, including Candida, Yarrowia, Hansenula, Pichia, Torulopsis, Rhodotorula, and the like (col. 11, lines 15-20).
Therefore, claims 1,3-5, 8, 12, 46 and 49-52 (instant claims are granted the priority date of 371 of PCT/CN2022/120499 filed on 09/22/2022) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by over Silverman et al., (US 10,337043 B2) as written and when given the broadest reasonable interpretation.
II. Claims 1,3-5, 8, 46 and 49-52 (instant claims are granted the priority date of 371 of PCT/CN2022/120499 filed on 09/22/2022) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by over Ma et al., (US 2023/0304056 A1; PCT filed 08/19/2021).
Ma et al., (US 2023/0304056 A1; PCT filed 08/19/2021) discloses starch biosynthesis method, total artificial biosynthesis from simple compounds such as dihydroxyacetone, formaldehyde, formic acid and methanol to starch, by coupling with methods such as chemical reduction of carbon dioxide, total artificial biosynthesis of starch taking carbon dioxide as a starting raw material and the method utilizes carbon dioxide of high concentration and high density and electric energy and hydrogen energy of high energy density (Abstract; Claims and entire document); said reference method includes recombinant host cell comprising enzymes of interest obtained from Pichia (¶ [0148-0149], [0162], TABLE 1) and includes glucose-1-phosphate adenylyltransferase and starch synthase (¶ [0148-0149], [0162], TABLE 1, [0166], [0206]).
Therefore, claims 1,3-5, 8, 46 and 49-52 (instant claims are granted the priority date of 371 of PCT/CN2022/120499 filed on 09/22/2022) are rejected under 35 U.S.C. 102(a)(1) as being anticipated by over Ma et al., (US 2023/0304056 A1; PCT filed 08/19/2021) as written and when given the broadest reasonable interpretation.
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, 3-5, 8, 12 and 46-57 are rejected under 35 U.S.C. 103(a) as being unpatentable over Silverman et al., (US 10,337043 B2) as applied to claims 1,3-5, 8, 12, 46 and 49-52 or Ma et al., (US 2023/0304056 A1; PCT filed 08/19/2021) as applied to claims 1,3-5, 8, 46 and 49-52 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) above) and further in view of Hartner et al., (Nuc. Acids Res., 2008, Vol. 36(12), e76, pages 1-15) and White J., (PhD., Thesis, 2017, The Univ. Edinburgh., pages 1-226).
The disclosure of Silverman et al., as applied to claims 1,3-5, 8, 12, 46 and 49-52 or Ma et al., as applied to claims 1,3-5, 8, 46 and 49-52 is described in the rejection 35 USC § 102 above. However, Silverman et al., and Yanhe et al., are silent regarding the elected species: wherein the inducible promoter comprises at least one selected from an AOX1 alcohol oxidase 1 promoter (as in claim 53); wherein blocking on the metabolism of starch by at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase is performed by mutating a gene encoding at least one of glucan 1,4-a-glucosidase and glycogen phosphorylase (as in claim 55).
Regarding claim 53, Hartner et al., (Nuc. Acids Res., 2008, Vol. 36(12), e76, pages 1-15) provide teaching, suggestion and motivation for the utilization of inducible promoter an AOX1 promoter (PAOX1) for the expression of genes of interest in Pichia pastoris. Hartner et al., teach PAOX1 synthetic promoter library constitutes a basic toolbox to fine-tune gene expression in metabolic engineering and sequential induction of protein expression in synthetic biology (see Abstract; and entire document); said reference also teaches the use of following promoters constitutive or inducible, are available for in Pichia pastoris yeast PAOX2, PFLD1, PDAS, PPEX8 (PPER3) , PYPT1, PGAP, PTEF1, PPGK1 PICL1 (col. 2, ¶ 2, page 1); characterization of the molecular basis of PAOX1 regulation and the advantages of P. pastoris in recombinant protein production processes, especially proteins needed in the pharmaceutical, chemical and biofuel industry (col. 2, ¶ 2, page 13).
Regarding claim 55, analogous art White J., (PhD., Thesis, 2017, The Univ. Edinburgh., pages 1-226) provide teaching, suggestion and motivation for disruption of Glycogen phosphorylase (GlgP) and provide evidence that GlgP is chiefly responsible for degrading glycogen and polysaccharides of carbohydrates and deletion of GlgP results in large increase of total glycogen content and polysaccharides of carbohydrates of interest (see Fig. 1.4; pages 18-20).
Before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine and modify the teachings of Silverman et al., or Ma et al., in view of Hartner et al., and White J., because Hartner et al., provides teaching, suggestion and motivation for the utilization of inducible promoter an AOX1 promoter (PAOX1) for the expression of genes of interest in Pichia pastoris; and White J., provides teaching, suggestion and motivation for disruption of Glycogen phosphorylase (GlgP) and provide evidence that GlgP is chiefly responsible for degrading glycogen and polysaccharides of carbohydrates and deletion of GlgP results in large increase of total glycogen content and polysaccharides of carbohydrates of interest. It would be obvious to one of ordinary skill in the art to modify the teachings of Silverman et al., or Ma et al., to utilize inducible promoter an AOX1 promoter and deletion of GlgP as taught by the teachings of Hartner et al., and White J., to produce starch using carbon dioxide in a microbial host cell of interest.
One of ordinary skill in the art would have had a reasonable expectation of success, a reasonable level of predictability, and would be motivated to combine the teachings of Hartner et al., and White J., to improve the production starch because starch have been utilized as starting materials for fermentations and in many industrial settings (Silverman et al., or Ma et al.,). One of ordinary skill in the art knowing the benefit of starch production would seek the most cost effective mechanism for its production (Silverman et al., or Ma et al.,) utilizing microorganisms to generate starch form the vast resources of carbon dioxide etc., and would dramatically lower its cost of production. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention. One of ordinary skill in the art would have a reasonable expectation of success, since the generation and use of genetically modified microorganisms and a method for increased production of starch are well known in the art.
Furthermore, "it is prima facie obvious to combine two or more compositions and methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Therefore, claims 1, 3-5, 8, 12 and 46-57 are rejected under 35 U.S.C. 103(a) as being unpatentable over Silverman et al., (US 10,337,043 B2) as applied to claims 1,3-5, 8, 12, 46 and 49-52 or Ma et al., (US 2023/0304056 A1; PCT filed 08/19/2021) as applied to claims 1,3-5, 8, 46 and 49-52 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) above) and further in view of Hartner et al., (Nuc. Acids Res., 2008, Vol. 36(12), e76, pages 1-15) and White J., (PhD., Thesis, 2017, The Univ. Edinburgh., pages 1-226)
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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