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, and species following claim amendments without traverse in the reply filed on 07/27/2026 is acknowledged. Thus amended claims 1, 6, 8, 10, 32-34, 36-37, 42, 44 and 50 are pending in this application and 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 371 of PCT/SG2022/050840 filed on 11/18/2022 and claims the priority date of Singapore application 10202113177P filed on 11/26/2021.
Information disclosure statement
The information disclosure statements (IDS) submitted on 05/24/2024 and 07/22/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statements are considered and initialed by the examiner.
Objections-Abstract/Specification
I. The Abstract of the disclosure is objected to because, Abstract should be on a separate sheet of paper. The abstract of the disclosure is objected to because the abstract is presented as part of the first page of a WO publication. The abstract should be presented as a single sheet apart from all other bibliographic material including the information included on the first page of a WO publication. If EFS is used to submit a replacement abstract, the appropriate abstract (ABST) document code should be used for the one-page document. Correction is required. See MPEP § 608.01 (b).
II. The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claims Objections
Claims 6 and 36 and claim 37 depending therefrom are objected; recitation of “and/or” in claims 6 and 36 makes the claim indefinite, as it is not clear what limitations must be present. Correction and clarification is required. Examiner suggests amending the claims to recite “…or …”.
Claim Rejections: 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
I. Claim 1 and claims 6, 8, 10, 32-34, 36-37, 42, 44 and 50 depending therefrom are rejected under of 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.
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, claims 1, 33, 37 and 42 recites the broad recitation “… has at least 80% identity to SEQ ID NO: 6 … at least 80% identity to SEQ ID NO: 36”, and the claims also recite “… at least 85%… 95% identity” which is the narrower statement of the sequence identity 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. Examiner suggests for the following sequence identities “… at least 85%… 95% identity” applicants’ consider writing additional new claims as dependent claims from claim 1.
II. Claims 6 and 36 and claim 37 depending therefrom are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention; recitation of “and/or” in claims 6 and 36 makes the claim indefinite, as it is not clear what limitations must be present. The metes and bounds of claim 6 and 36 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 …”.
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, 6, 8, 10, 32-34, 36-37, 42, 44 and 50 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, 6, 8, 10, 32-34, 36-37, 42, 44 and 50, as interpreted are directed to encompass a genus of structures i.e., isolated recombinant cell comprising one or more genes selected from the group consisting of dmaW, easF, easC, easE, easD, easAisomerase, and cloA, wherein each gene codes for an enzyme from the biosynthetic pathway from tryptophan to D-lysergic acid (DLA), wherein the easE comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 6, the easAisomerase comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 17, and the cloA comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 23… further comprising multiple copies of FAD1 and PDII genes, wherein the FAD1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 35 and PDI1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 36 (as in claims 1, 33 and 42); wherein the recombinant yeast cell further comprises at least one dmaW, at least one easF, and at least one easD … wherein the recombinant yeast cell further comprises at least one easC and/or at least one easG of undefined limited and undefined structures including variants, mutants and homologs (as in claims 32 and 36); and a method of culturing said isolated recombinant cell in an appropriate culture medium, for preparing D-lysergic acid (as in claim 50; also see claims objections and 35 U.S.C. 112(b), rejection above for claim 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, there is no structure associated with function with regard to the members of the genus of polypeptides and encoding polynucleotides i.e., isolated recombinant cell comprising one or more genes selected from the group consisting of dmaW, easF, easC, easE, easD, easAisomerase, and cloA, wherein each gene codes for an enzyme from the biosynthetic pathway from tryptophan to D-lysergic acid (DLA), wherein the easE comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 6, the easAisomerase comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 17, and the cloA comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 23… further comprising multiple copies of FAD1 and PDII genes, wherein the FAD1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 35 and PDI1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 36 (as in claims 1, 33 and 42); wherein the recombinant yeast cell further comprises at least one dmaW, at least one easF, and at least one easD … wherein the recombinant yeast cell further comprises at least one easC and/or at least one easG of undefined limited and undefined structures including variants, mutants and homologs (as in claims 32 and 36); and a method of culturing said isolated recombinant cell in an appropriate culture medium, for preparing D-lysergic acid (as in claim 50; also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation).
No information, beyond the characterization of isolated recombinant cell comprising genes and encoding polypeptides; said genes comprising the nucleic acid sequences of SEQ ID NO: 6, 17 and 23 and encoding polypeptides having the associated activity and a method of producing D-lysergic acid by culturing said recombinant cell has been provided by the applicants, which would indicate that they had possession of the claimed genus of polypeptides and encoding polynucleotides i.e., isolated recombinant cell comprising one or more genes selected from the group consisting of dmaW, easF, easC, easE, easD, easAisomerase, and cloA, wherein each gene codes for an enzyme from the biosynthetic pathway from tryptophan to D-lysergic acid (DLA), wherein the easE comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 6, the easAisomerase comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 17, and the cloA comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 23… further comprising multiple copies of FAD1 and PDII genes, wherein the FAD1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 35 and PDI1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 36 (as in claims 1, 33 and 42); wherein the recombinant yeast cell further comprises at least one dmaW, at least one easF, and at least one easD … wherein the recombinant yeast cell further comprises at least one easC and/or at least one easG of undefined limited and undefined structures including variants, mutants and homologs (as in claims 32 and 36); and a method of culturing said isolated recombinant cell in an appropriate culture medium, for preparing D-lysergic acid (as in claim 50; also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation).
The claimed genus of polypeptides and encoding polynucleotides 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 nucleic acid sequences of SEQ ID NO: 6, 17 and 23 having the associated activity/function, since one could use structural homology to isolate those encoding polypeptides recited in the claims. 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 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 genus of polypeptides, encoding polynucleotides and modifications, 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, 6, 8, 10, 32-34, 36-37, 42, 44 and 50 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 recombinant cell comprising genes and encoding polypeptides; said genes comprising the nucleic acid sequences of SEQ ID NO: 6, 17 and 23 and encoding polypeptides having the associated activity and a method of producing D-lysergic acid by culturing said recombinant cell, does not reasonably provide enablement for genus of polypeptides and encoding polynucleotides i.e., isolated recombinant cell comprising one or more genes selected from the group consisting of dmaW, easF, easC, easE, easD, easAisomerase, and cloA, wherein each gene codes for an enzyme from the biosynthetic pathway from tryptophan to D-lysergic acid (DLA), wherein the easE comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 6, the easAisomerase comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 17, and the cloA comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 23… further comprising multiple copies of FAD1 and PDII genes, wherein the FAD1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 35 and PDI1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 36 (as in claims 1, 33 and 42); wherein the recombinant yeast cell further comprises at least one dmaW, at least one easF, and at least one easD … wherein the recombinant yeast cell further comprises at least one easC and/or at least one easG of undefined limited and undefined structures including variants, mutants and homologs (as in claims 32 and 36); and a method of culturing said isolated recombinant cell in an appropriate culture medium, for preparing D-lysergic acid (as in claim 50; also see claims objections and 35 U.S.C. 112(b), rejection above for claim 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 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 gene encoding the 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 and encoding polynucleotides 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 and encoding polynucleotides i.e., isolated recombinant cell comprising one or more genes selected from the group consisting of dmaW, easF, easC, easE, easD, easAisomerase, and cloA, wherein each gene codes for an enzyme from the biosynthetic pathway from tryptophan to D-lysergic acid (DLA), wherein the easE comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 6, the easAisomerase comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 17, and the cloA comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 23… further comprising multiple copies of FAD1 and PDII genes, wherein the FAD1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 35 and PDI1 comprises a sequence at least 80%, at least 85%, at least 90%, at least 95% identity to SEQ ID NO: 36 (as in claims 1, 33 and 42); wherein the recombinant yeast cell further comprises at least one dmaW, at least one easF, and at least one easD … wherein the recombinant yeast cell further comprises at least one easC and/or at least one easG of undefined limited and undefined structures including variants, mutants and homologs (as in claims 32 and 36); and a method of culturing said isolated recombinant cell in an appropriate culture medium, for preparing D-lysergic acid (as in claim 50; also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation) 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).
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.
I. Claims 1, 6, 8, 10, 32, 34, 36, 42, 44 and 50 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Naesby et al., (US 9,828,617 B2), disclose isolated recombinant cell comprising one or more genes selected from the group consisting of dmaW, easF, easC, easE, easD, easAisomerase, and cloA, wherein each gene codes for an enzyme from the biosynthetic pathway from tryptophan to D- lysergic acid (DLA); said reference discloses reference polynucleotides having 100% sequence identity to SEQ ID NO: 5 and SEQ ID NO: 35 of the instant application (see provided sequence alignments) and a method of producing D-lysergic acid (DLA). Applicants are directed to the following sections in Naesby et al., (US 9,828,617 B2): see Abstract; Fig. 1-2; col. 2, lines 50-67 to col. 4, lines 1-6; col. 28, lines 25-67 to col. 29, lines 1-10; col. 85, lines 30-65; and entire document), and therefore Naesby et al., (US 9,828,617 B2) is deemed to anticipate claims 1, 6, 8, 10, 32, 34, 36, 42, 44 and 50 as written and when given the broadest reasonable interpretation.
II. Claims 1, 6, 8, 10, 32, 34, 36, 44 and 50 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Yuan et al., (CN113174399-A, in IDS; see provided English Machine Translation), disclose isolated recombinant cell comprising one or more genes selected from the group consisting of dmaW, easF, easC, easE, easD, easAisomerase, and cloA, wherein each gene codes for an enzyme from the biosynthetic pathway from tryptophan to D- lysergic acid (DLA); said reference discloses reference polynucleotide having 85.6% sequence identity to SEQ ID NO: 17 of the instant application (see provided sequence alignment) and a method of producing D-lysergic acid (DLA). Applicants are directed to the following sections in Yuan et al., (CN113174399-A, in IDS; see provided English Machine Translation): see Claims, pages 1-3; ¶ [0001], [0004], [0011], [0018-0034], [0038-0039], [0065-0088]; and entire document), and therefore Yuan et al., (CN113174399-A, in IDS; see provided English Machine Translation) is deemed to anticipate claims 1, 6, 8, 10, 32, 34, 36, 44 and 50 as written and when given the broadest reasonable interpretation.
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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