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
This application is a 371 of PCT/CA2021/051682.
The amendment filed on September 29, 2025 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I with a species election of SEQ ID NO:1 as the prenyltransferase, GPP as the prenyl donor, chrysoeriol as the substrate, and cannflavin A as the resulting product in the reply filed on September 29, 2025 is acknowledged.
Claims 12-14, 16, 38-40, and 48-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 29, 2025.
Status of Claims
Claims 1-3, 6-8, 12-16, 32, 38-40, and 48-50 are pending.
Claims 12-14, 16, 38-40, and 48-50 are withdrawn.
Claims 1-3, 6-8, 15, and 32 are under examination.
Claim for Domestic Priority
Applicants' claim for domestic priority under 35 USC 119(e) to US provisional application 63/118,428, filed on 11/25/2020 is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 19, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
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.
Claim 1 and claims 2-3, 6-8, 15, and 32 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation “A polypeptide encoding a prenyltransferase..”. The metes and bounds of the limitation in the context of the above claim are not clear. It is unclear how a polypeptide can encode an enzyme. Clarification is requested.
Claim 3 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 applications subject to pre-AIA 35 U.S.C. 112, 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) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “at least 80%...100%”, “at least 85%..100%”, and etc, and the claim also recites “100%”, which is the narrower statement of the range/limitation. The limitation “at least 80%” is equivalent to a range of “80%-100%”, the limitation “at least…100%” is equivalent to 100%. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 3 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 3 recites the limitation "polypeptide listed in Table 1, or a fragment of any thereof". The metes and bounds of the limitation in the context of the claim are not clear. Claims are to be complete in themselves. Incorporation by reference to a specific figure or table is permitted only in exceptional circumstances. See MPEP 2173.05(s).
Claim 7 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation “variant or derivative thereof”. The metes and bounds of the limitation in the context of the above claims are not clear. The specification does not define “variant or derivative thereof” of prenyl donors. Therefore, it is unclear what prenyl donors are considered as a “derivative” or “variant” of GPP. Clarification is requested.
Claim 8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 8 recites the limitation “derivative thereof”. The metes and bounds of the limitation in the context of the above claims are not clear. The specification does not define “derivative thereof” of polyphenols. Therefore, it is unclear what polyphenols are considered as a “derivative” a flavonoid. Clarification is requested.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
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.
Claims 1-3, 6-8, 15, and 32 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.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In this case, the examiner has broadly interpreted the claims to encompass any polypeptide, any microbial polypeptide, or any polypeptide having at least 80% sequence identity to SEQ ID NO:1 or any fragments thereof, wherein the polypeptide prenylates any polyphenol, any flavonoid, or chrysoeriol using any prenyl donor or GPP. Therefore, the claims are drawn to a genus of polypeptides having unknown structure, wherein the polypeptide has the function of prenylating a genus of polyphenols, flavonoids, or chrysoeriol using a genus of prenyl donors or GPP.
MPEP 2163 I. states that to “satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention.
MPEP 2163. II.A.3.(a) sates that “Possession may be shown in many ways. For example, possession may be shown by describing an actual reduction to practice of the claimed invention. Possession may also be shown by a clear depiction of the invention in detailed drawings or in structural chemical formulas which permit a person skilled in the art to clearly recognize that inventor had possession of the claimed invention. An adequate written description of the invention may be shown by any description of sufficient, relevant, identifying characteristics so long as a person skilled in the art would recognize that the inventor had possession of the claimed invention.
According to MPEP 2163.II.A.3.(a).ii), “Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus…Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’"
The recitation of “prenyltransferase”, “prenylating”, and “prenylates” fails to provide a sufficient description of the genus of the polypeptides as it merely describes the functional features of the genus without providing any definition of the structural features of the species within the genus. The specification does not specifically define any of the species that fall within the genus. The specification does not define any structural features commonly possessed by members of the genus that distinguish them from others. One skilled in the art therefore cannot, as one can do with a fully described genus, visualize or recognize the identity of the members of the genus.
Kuzuyama (US 7,361,483 - form PTO-892) discloses a Streptomyces sp. strain CL190 prenyltransferase having the amino acid sequence of SEQ ID NO:2, which is identical to the prenyltransferase of SEQ ID NO:1 of the instant application (Figure 1C, Figure 2B, Column 4 lines 22-67, Column 9 lines 39-59, and claims 1-2). However, the claimed genus of polypeptides having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP were not known in the art.
Fransceus (J Ind Microbiol Biotechnol. 2017 May;44(4-5):687-695. – form PTO-892) reviews protein engineering techniques, such as random mutagenesis and recombination, directed evolution and iterative or combinatory saturation “hotspots”. Fransceus states that “a recurring problem, however, is choosing which amino acid positions should be targeted. Answering this question is not an easy feat and requires substantial insight in the relationship between an enzyme’s sequence or structure and its properties.” Sanavia (Computational and Structural Biotechnology Journal, Volume 18, 2020, Pages 1968-1979. – form PTO-892) discloses challenges in the prediction of protein stability in the occurrence of multiple mutations. “Multiple-point mutations are common variations of the protein sequence that may be needed in protein engineering when a single-point mutation is not enough to yield the desired stability change. Dealing with multiple-site variations adds another level of complexity beyond the prediction of the effect of a single variant on protein stability, since it requires the learning of many types of combinatorial effects”.
The specification is limited to description of a prenyltransferase having the amino acid sequence of SEQ ID NO:1, wherein the prenyltransferase prenylates chryseriol using GPP as the prenyl donor. While MPEP 2163 acknowledges that in certain situations “one species adequately supports a genus,” it also acknowledges that “[f]or inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.” In view of the widely variant species encompassed by the genus, the example described above is not enough and does not constitute a representative number of species to describe the whole genus. Therefore, the specification fails to describe a representative species of the claimed genus.
Further, one of skill in the art could identify polypeptides having at least 80% sequence identity to SEQ ID NO:1 or fragment thereof. However, there is no teaching regarding which 20% of the amino acids can vary from SEQ ID NO:1 and result in polypeptide having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP. An important consideration is that structure is not necessarily a reliable indicator of function. In the instant case, there is no disclosure relating similarity of structure to conservation of function. Conservation of structure is not necessarily a surrogate for conservation of function. Since the claimed invention is that of an enzyme, and there is no disclosure of the domains responsible for the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP, the absence of information may be persuasive that those of skill in the art would not take the disclosure as generic.
While general knowledge in the art may have allowed one of skill in the art to identify other polypeptides expected to have the same or similar tertiary structure, there was no general knowledge in the art about polypeptides having at least 80% sequence identity to SEQ ID NO:1 or any fragment thereof, wherein the polypeptide has the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP.
Given this lack of description of the representative species encompassed by the genus of the claims, 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 inventions of claims 1-3, 6-8, 15, and 32.
Claims 1-3, 6-8, 15, and 32 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a prenyltransferase having the amino acid sequence of SEQ ID NO:1, wherein the prenyltransferase prenylates chryseriol using GPP as the prenyl donor, does not reasonably provide enablement for any polypeptide, any microbial polypeptide, or a polypeptide having at least 80% sequence identity to SEQ ID NO:1 or any fragments thereof, wherein the polypeptide has the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donor or GPP.. 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.
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). They include (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 claims.
The breadth of the claims.
MPEP 2111.01 states that ''[d]uring examination, the claims must be interpreted as broadly as their terms reasonably allow.'' In this case, the examiner has broadly interpreted the claims to encompass any polypeptide, any microbial polypeptide, or any polypeptide having at least 80% sequence identity to SEQ ID NO:1 or any fragments thereof, wherein the polypeptide prenylates any polyphenol, any flavonoid, or chrysoeriol using any prenyl donor or GPP. Therefore, the claims are drawn to polypeptides having unknown structure, wherein the polypeptide has the function of prenylating a genus of polyphenols, flavonoids, or chrysoeriol using a genus of prenyl donors or GPP.
The claims are not commensurate with the enablement provided by the disclosure with regard to the extremely large number of polypeptides having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP. In the instant case, the specification is limited to the prenyltransferase having the amino acid sequence of SEQ ID NO:1, wherein the prenyltransferase prenylates chryseriol using GPP as the prenyl donor.
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification.
While enzyme isolation techniques, recombinant and mutagenesis techniques were known in the art at the time of the invention, e.g. mutagenesis, and it is routine in the art to screen for variants comprising multiple substitutions or multiple modifications as encompassed by the instant claims, the specific amino acid positions within the 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.
In the absence of: (a) rational and predictable scheme for making any polypeptide having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP, and (b) a correlation between structure and the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP, the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful. One of skill in the art would have to test these infinite possible polypeptides to determine which encode polypeptides have the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP. While enablement is not precluded by the necessity for routine screening, if a large amount of screening is required, as is the case herein, the specification must provide a reasonable amount of guidance which respect to the direction in which the experimentation should proceed so that a reasonable number of species can be selected for testing. In view of the fact that such guidance has not been provided in the instant specification, it would require undue experimentation to enable the full scope of the claims.
The state of prior art, the relative skill of those in the art, and predictability or unpredictability of the art.
Since the amino acid sequence of the mutant 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 a knowledge of and guidance with regard to which amino acids in the protein's sequence, 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 proteins' structure relates to its function. In the instant case, neither the specification or the art provide a correlation between structure and activity such that one of skill in the art can envision the structure of any polypeptides having galactose oxidase activity or predict said function of a polypeptide from its primary structure. In addition, the art does not provide any teaching or guidance as to (1) which amino acids within any prenyltransferase, any microbial prenyltransferase, or the prenyltransferase of SEQ ID NO:1 or any fragment thereof that can be modified and which ones are conserved such that one of skill in the art can make the recited polypeptides having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP, (2) which segments of any prenyltransferase, any microbial prenyltransferase, or the prenyltransferase of SEQ ID NO:1 that are essential for having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP, and (3) the general tolerance of any prenyltransferase, any microbial prenyltransferase, or the prenyltransferase of SEQ ID NO:1 to structural modifications and the extent of such tolerance. The art clearly teaches that changes in a protein's amino acid sequence to obtain the desired activity without any guidance/knowledge as to which amino acids in a protein are required for that activity is highly unpredictable. At the time of the invention there was a high level of unpredictability associated with altering a polypeptide sequence with an expectation that the polypeptide will maintain the desired activity. For example, Studer (Residue mutations and their impact on protein structure and function: detecting beneficial and pathogenic changes. Biochem. J. (2013) 449, 581–594. – form PTO-892) teach that (1) protein engineers are frequently surprised by the range of effects caused by single mutations that they hoped would change only one specific and simple property in enzymes, (2) the often surprising results obtained by experiments where single mutations are made reveal how little is known about the rules of protein stability, and (3) the difficulties in designing de novo stable proteins with specific functions.
Kuzuyama (US 7,361,483 - form PTO-892) discloses a Streptomyces sp. strain CL190 prenyltransferase having the amino acid sequence of SEQ ID NO:2, which is identical to the prenyltransferase of SEQ ID NO:1 of the instant application (Figure 1C, Figure 2B, Column 4 lines 22-67, Column 9 lines 39-59, and claims 1-2). However, the claimed genus of polypeptides, wherein the polypeptides have the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP were not known in the art.
Fransceus (J Ind Microbiol Biotechnol. 2017 May;44(4-5):687-695. – form PTO-892) reviews protein engineering techniques, such as random mutagenesis and recombination, directed evolution and iterative or combinatory saturation “hotspots”. Fransceus states that “a recurring problem, however, is choosing which amino acid positions should be targeted. Answering this question is not an easy feat and requires substantial insight in the relationship between an enzyme’s sequence or structure and its properties.” Sanavia (Computational and Structural Biotechnology Journal, Volume 18, 2020, Pages 1968-1979. – form PTO-892) discloses challenges in the prediction of protein stability in the occurrence of multiple mutations. “Multiple-point mutations are common variations of the protein sequence that may be needed in protein engineering when a single-point mutation is not enough to yield the desired stability change. Dealing with multiple-site variations adds another level of complexity beyond the prediction of the effect of a single variant on protein stability, since it requires the learning of many types of combinatorial effects”.
The amount of direction or guidance presented and the existence of working examples.
The specification is limited to the prenyltransferase having the amino acid sequence of SEQ ID NO:1, wherein the prenyltransferase prenylates chryseriol using GPP as the prenyl donor. However, the speciation fails to provide any information as to (1) specific substrates associated with the claimed polypeptides or (2) structural elements required in a polypeptide having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP. No correlation between structure and function of having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP has been presented. There is no information or guidance as to which amino acids residues in any prenyltransferase, any microbial prenyltransferase, or the prenyltransferase of SEQ ID NO:1 that can be modified and which ones are to be conserved to create a polypeptide having the function of prenylating any polyphenol, any flavonoid, or chrysoeriol using any prenyl donors or GPP.
Thus, in view of the overly broad scope of the claims, the lack of guidance and working examples provided in the specification, the high level of unpredictability of the prior art in regard to structural changes and their effect on function and the lack of knowledge about a correlation between structure and function, an undue experimentation would be necessary one having 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 claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of polypeptides having the desired biological characteristics recited in the claims are 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
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6-8, 15, and 32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kuzuyama (US 7,361,483 - form PTO-892).
Regarding claims 1-2, Kuzuyama discloses a Streptomyces sp. strain CL190 prenyltransferase having the amino acid sequence of SEQ ID NO:2, wherein the prenyltransferase prenylates a polyphenol (Figure 1C, Figure 2B, Column 4 lines 22-67, Column 9 lines 39-59, and claims 1-2).
Regarding claim 3, the prenyltransferase of Kuzuyama has 100% sequence identity to the prenyltransferase of SEQ ID NO:1 of the instant application (Figure 1C, Figure 2B, Column 4 lines 22-67, Column 9 lines 39-59, claims 1-2, and see the sequence alignment below).
Regarding claim 6-7, the prenyltransferase of Kuzuyama prenylates a polyphenol using a prenyl donor, such as GPP (Figure 2B and Column 9, lines 6-59).
Regarding claim 8, the prenyltransferase of Kuzuyama prenylates a polyphenol, such as a flavonoid (Figure 2B and Column 9, lines 39-59).
Regarding claim 15, the specification of the instant application discloses that the prenyltransferase having the amino acid sequence of SEQ ID NO:1 prenylates chrysoeriol using GPP to produce cannflavin A (See Example 1 of the specification of the instant application). MPEP 2112.01. II. states that “[p]roducts of identical chemical composition cannot have mutually exclusive properties.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”. MPEP 2112. II. states that “[t]here is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference.”. In the instant case, since the prenyltransferase of Kuzuyama has identical structure as the prenyltransferase of SEQ ID NO:1 of the instant application, the prenyltransferase of Kuzuyama inherently prenylates chrysoeriol using GPP to produce cannflavin A. The prenyltransferase of Kuzuyama inherently possesses the same material structure and functional characteristics as the prenyltransferase of the instant application since (1) both enzymes are isolated from the same source, Streptomyces sp. strain CL190, (2) both enzymes function as a prenyltransferase, and (3) the Office does not have facilities for examining and comparing applicant' s enzyme with the enzyme of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed product and the product of the prior art (i.e., that the prenyltransferase of Kuzuyama does not possess the same material structure and functional characteristics of the claimed prenyltransferase). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Figzgerald et al., 205 USPQ 594.
Regarding claim 32, the prenyltransferase of Kuzuyama is recombinant (Example 2).
Therefore, the reference of Kuzuyama anticipates claims 1-3, 6-8, 15, and 32.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 6-8, 15, and 32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Claim interpretation
Claims 1-3, 6-8, 15, and 32 are directed to a prenyltransferase having 100% sequence identity to SEQ ID NO:1.
Kuzuyama (US 7,361,483 - form PTO-892) discloses a Streptomyces sp. strain CL190 prenyltransferase having the amino acid sequence of SEQ ID NO:2, which is identical to the prenyltransferase of SEQ ID NO:1 of the instant application (Figure 1C, Figure 2B, Column 4 lines 22-67, Column 9 lines 39-59, and claims 1-2).
Step 1: This part of the eligibility analysis evaluates whether the claim falls within any statutory category (see MPEP 2106.03). Since the claims are directed to a prenyltransferase, the claims are directed to a composition of matter, which is one of the statutory categories of invention. (Step 1: YES)
Step 2A Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception (see MPEP 2106.04). The claimed prenyltransferase is not considered to have markedly different characteristics from what occurs in nature, Streptomyces sp. strain CL190 prenyltransferase as discussed above and is considered to be a law of nature exception. Regarding claim 32, there is no indication in the specification that a recombinant or synthetic form of the prenyltransferase results in the prenyltransferase having any characteristics (structural, functional, or otherwise) that are different from the naturally occurring Streptomyces sp. strain CL190 prenyltransferase. Because there is no difference in characteristics (structural, functional, or otherwise) between the claimed prenyltransferase and the naturally occurring Streptomyces sp. strain CL190 prenyltransferase, the claimed prenyltransferase is directed to a judicial exception.
Step 2A Prong 2: This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application (see MPEP 2106.04(d)). This evaluation is performed by (a) identifying whether there are any additional recited elements in the claim beyond the judicial exception and (b) evaluating those additional elements individually and in combination to determine whether the claim as a whole integrates the exception into a practical application. Regarding claims 1-3, 6-8, 15, and 32, there are no additional elements recited in the claim beyond the judicial exception. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claimed prenyltransferase is found naturally occurring in nature (Streptomyces sp. strain CL190). (Step2 A: YES)
Step 2B: This part of the eligibility analysis evaluates whether the claim as a whole amounts to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (see MPEP § 2106.05). The claims only recite the laws of nature and do not include any additional elements that could add significantly more to the judicial exceptions. (Step 2B: NO)
As such, the claims do not qualify as eligible subject matter.
Conclusion
Claims 1-3, 6-8, 12-16, 32, 38-40, and 48-50 are pending.
Claims 12-14, 16, 38-40, and 48-50 are withdrawn.
Claims 1-3, 6-8, 15, and 32 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
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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.
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/YONG D PAK/Primary Examiner, Art Unit 1652
Sequence alignment between the prenyltransferase of SEQ ID NO:1 of the instant application (“Qy”) and the prenyltransferase of SEQ ID NO:2 of Kuzuyama (“Db”)
US-11-342-328-2
Sequence 2, US/11342328
Patent No. 7361483
GENERAL INFORMATION
APPLICANT: KUZUYAMA, TOMOHISA
APPLICANT: NOEL, JOSEPH P.
APPLICANT: RICHARD, STEPHANE P.
TITLE OF INVENTION: NOVEL AROMATIC PRENYLTRANSFERASES, NUCLEIC ACIDS
TITLE OF INVENTION: ENCODING SAME AND USES THEREFOR
FILE REFERENCE: SALK3200-1
CURRENT APPLICATION NUMBER: US/11/342,328
CURRENT FILING DATE: 2006-01-27
PRIOR APPLICATION NUMBER: 60/648,046
PRIOR FILING DATE: 2005-01-28
NUMBER OF SEQ ID NOS: 7
SEQ ID NO 2
LENGTH: 307
TYPE: PRT
ORGANISM: Streptomyces sp.
Query Match 100.0%; Score 1584; Length 307;
Best Local Similarity 100.0%;
Matches 307; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 MSEAADVERVYAAMEEAAGLLGVACARDKIYPLLSTFQDTLVEGGSVVVFSMASGRHSTE 60
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Db 1 MSEAADVERVYAAMEEAAGLLGVACARDKIYPLLSTFQDTLVEGGSVVVFSMASGRHSTE 60
Qy 61 LDFSISVPTSHGDPYATVVEKGLFPATGHPVDDLLADTQKHLPVSMFAIDGEVTGGFKKT 120
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Db 61 LDFSISVPTSHGDPYATVVEKGLFPATGHPVDDLLADTQKHLPVSMFAIDGEVTGGFKKT 120
Qy 121 YAFFPTDNMPGVAELSAIPSMPPAVAENAELFARYGLDKVQMTSMDYKKRQVNLYFSELS 180
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Db 121 YAFFPTDNMPGVAELSAIPSMPPAVAENAELFARYGLDKVQMTSMDYKKRQVNLYFSELS 180
Qy 181 AQTLEAESVLALVRELGLHVPNELGLKFCKRSFSVYPTLNWETGKIDRLCFAVISNDPTL 240
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Db 181 AQTLEAESVLALVRELGLHVPNELGLKFCKRSFSVYPTLNWETGKIDRLCFAVISNDPTL 240
Qy 241 VPSSDEGDIEKFHNYATKAPYAYVGEKRTLVYGLTLSPKEEYYKLGAYYHITDVQRGLLK 300
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Db 241 VPSSDEGDIEKFHNYATKAPYAYVGEKRTLVYGLTLSPKEEYYKLGAYYHITDVQRGLLK 300
Qy 301 AFDSLED 307
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Db 301 AFDSLED 307
Prosecution Insights