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
Amended Claims 1-17 (dated 09/26/2024) are pending and now under consideration.
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/JP2023/012614 filed on 03/28/2023 and claims the priority date of Japan application 2022-054328 filed on 03/29/2022; however, no English translation of said foreign priority application has been provided. Therefore, the priority date for instant claims under consideration is deemed to be the filing date of 371 of PCT/JP2023/012614 filed on 03/28/2023.
Information disclosure statement
The information disclosure statement (IDS) submitted on 09/26/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Objections-Abstract/Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. The specification contains hyperlinks to various site domains, for example, page 21, line 5 of the instant application. Applicants’ are required to thoroughly scrutinize the specification and delete all embedded hyperlink and/or other form of browser-executable code. See MPEP § 608.01. Appropriate correction is required.
Claims Objections
I. Recitation of “and/or” in claim 2 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. Claims 3-7, 12-13 and 15-17 are objected to, due to the following informality: Claims 3-7, 12-13 and 15-17 recites the phrase “… an amino acid sequence according to SEQ ID NO: 2, 8, 12 and 16”, 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: 2, 8, 12 and 16 and having the recited activity. Examiner suggests amending the claim to recite “the amino acid sequence” Appropriate correction is required. For examination purposes claims 3-7, 12-13 and 15-17 are interpreted to encompass variants and mutants of the recited sequence(s).
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 2 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention; recitation of “and/or” in claim 2 makes the claims indefinite, as it is not clear what limitations must be present. The metes and bounds of claim 2 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 …”.
II. Claims 3-7 (claims 8-11 depending therefrom); claims 12-13 and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claims 3-7, 12-13 and 15-17 recite the phrase “…an amino acid sequence represented by SEQ ID NO: 2, 8, 12 and 16”, 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: 2, 8, 12 and 16 and having the recited activity. Examiner suggests amending the claim to recite “the amino acid sequence” Appropriate correction is required. For examination purposes claims 3-7 (claims 8-11 depending therefrom); claims 12-13 and 15-17 are interpreted to encompass variants and mutants of the recited sequence(s).
III. Claims 3-7 (claims 8-11 depending therefrom); claims 12-13 and 15-17 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.
Claim 3-7, 12-13 and 15-17 recites the phrase “an amino acid sequence represented by SEQ ID NO: 2, 8, 12 and 16”. The metes and bounds of the term “represented by” 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 NO: 2, 8, 12 and 16? or is a representative member of a genus/merely exemplary. Examiner suggests amending the claim to make a direct reference to SEQ ID NO: 2, 8, 12 and 16. Clarification and correction required.
IV. Claims 14-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claims 14-17, “An agent” is a limitation that invokes 35 U.S.C. 112(f) or 35 U.S.C. 112 (pre-AIA ), sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for the claimed function. “A agent” is non-structural term and the scope of the term in claims 14-17 is indefinite.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or 35 U.S.C. 112 (pre-AIA ), sixth paragraph; or
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the claimed function, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
For examination purposes claims 14-17 are interpreted to encompass “protocatechuate decarboxylase polypeptide, encoding polynucleotide or a vector/plasmid comprising the encoding polynucleotide”; furthermore no patentable weight is given to the preamble “An agent for decarboxylating mesaconic acid or an isomer thereof and promoting production of methacrylic acid”, as rejected claims 14-17 are considered to be “method of use of the product” claims and therefore, patentable weight is given only to the claimed product and not to the method of use.
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 1-17 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 1-17, as interpreted are directed to encompass a genus of structures i.e., a method for producing methacrylic acid, comprising: decarboxylating mesaconic acid or an isomer thereof in the presence of any protocatechuate decarboxylase of undefined limited and undefined structures including variants, mutants and homologs (as in claims 1-2 and 14); comprising “…an amino acid sequence represented by SEQ ID NO: 2, 8, 12 and 16” and having protocatechuate decarboxylase of undefined and unlimited structures (as in claims 3-13 and 15-17; as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 2, 8, 12 and 16 but any fragment/subsequence within SEQ ID NOs: 2, 8, 12 and 16 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 2, 8, 12 and 16 (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., a method for producing methacrylic acid, comprising: decarboxylating mesaconic acid or an isomer thereof in the presence of any protocatechuate decarboxylase of undefined limited and undefined structures including variants, mutants and homologs (as in claims 1-2 and 14); comprising “…an amino acid sequence represented by SEQ ID NO: 2, 8, 12 and 16” and having protocatechuate decarboxylase of undefined and unlimited structures (as in claims 3-13 and 15-17; as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 2, 8, 12 and 16 but any fragment/subsequence within SEQ ID NOs: 2, 8, 12 and 16 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 2, 8, 12 and 16 (also see claims objections and 35 U.S.C. 112(b), rejection above for claim interpretation).
No information, beyond the characterization of isolated polypeptides comprising the amino acid sequences of SEQ ID NO: 2, 8, 12 and 16 and specific recited variants/mutants of SEQ ID NO: 2 having the associated activity has been provided by the applicants, which would indicate that they had possession of the claimed genus of polypeptides and encoding polynucleotides i.e., a method for producing methacrylic acid, comprising: decarboxylating mesaconic acid or an isomer thereof in the presence of any protocatechuate decarboxylase of undefined limited and undefined structures including variants, mutants and homologs (as in claims 1-2 and 14); comprising “…an amino acid sequence represented by SEQ ID NO: 2, 8, 12 and 16” and having protocatechuate decarboxylase of undefined and unlimited structures (as in claims 3-13 and 15-17; as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 2, 8, 12 and 16 but any fragment/subsequence within SEQ ID NOs: 2, 8, 12 and 16 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 2, 8, 12 and 16 (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 amino acid sequences of SEQ ID NO: 2, 8, 12 and 16 and specific recited variants/mutants of SEQ ID NO: 2 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 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, scope of enablement, because the specification, while being enabling for the characterization of isolated polypeptides comprising the amino acid sequences of SEQ ID NO: 2, 8, 12 and 16 and specific recited variants/mutants of SEQ ID NO: 2 having the associated activity, does not reasonably provide enablement for genus of polypeptides and encoding polynucleotides i.e., a method for producing methacrylic acid, comprising: decarboxylating mesaconic acid or an isomer thereof in the presence of any protocatechuate decarboxylase of undefined limited and undefined structures including variants, mutants and homologs (as in claims 1-2 and 14); comprising “…an amino acid sequence represented by SEQ ID NO: 2, 8, 12 and 16” and having protocatechuate decarboxylase of undefined and unlimited structures (as in claims 3-13 and 15-17; as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 2, 8, 12 and 16 but any fragment/subsequence within SEQ ID NOs: 2, 8, 12 and 16 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 2, 8, 12 and 16 (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 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., a method for producing methacrylic acid, comprising: decarboxylating mesaconic acid or an isomer thereof in the presence of any protocatechuate decarboxylase of undefined limited and undefined structures including variants, mutants and homologs (as in claims 1-2 and 14); comprising “…an amino acid sequence represented by SEQ ID NO: 2, 8, 12 and 16” and having protocatechuate decarboxylase of undefined and unlimited structures (as in claims 3-13 and 15-17; as such, the term “an amino acid sequence” in broadest reasonable interpretation encompasses not only SEQ ID NO: 2, 8, 12 and 16 but any fragment/subsequence within SEQ ID NOs: 2, 8, 12 and 16 due to the recitation of indefinite article “an”; given that the claim language recites “an amino acid sequence”, it is deemed to encompass and read on “any two/dipeptide sequences of SEQ ID NOs: 2, 8, 12 and 16 (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).
III. Claim 10 (directed to a host cell comprising the encoding polynucleotide and the encoded polypeptide of claims 8-9) is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement when given the broadest reasonable interpretation, because, while claim 10 is enabling for an isolated host cell transformed with the recombinant expression vector, does not reasonably provide enablement for transgenic multi-cellular organisms or host cells within a multi-cellular organism that have been transformed with the synthetic nucleic acid. 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 claims.
Claim 10 is so broad as to encompass transgenic multi-cellular organisms and host cells transformed with specific nucleic acids, as well as within any multi-cellular organism. The enablement provided is not commensurate in scope with the claim due to the extremely large number of transgenic multicellular organisms encompassed by the claims which the specification fails to teach how to generate. While methods for transforming cells in vitro are well known in the art, methods for successfully transforming cells within complex multi-cellular organisms are not routine and are highly unpredictable. Furthermore, methods for producing a successfully transformed cell within the multi-cellular organism are unlikely to be applicable to transformation of other types of multi-cellular organism as multi-cellular organisms vary widely.
However, in this case the disclosure is limited to only isolated prokaryotic or eukaryotic host cells. 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 broadly including the use of host cells within a multi-cellular organism. The scope of claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA)). Without sufficient guidance, expression of genes in a particular host cell and having the desired biological characteristics is unpredictable, 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 USPQ 2nd 1400 (Fed. Cir., 1988). It is suggested that the Applicants’ limit the claim to “An isolated host cell …”.
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 14-15 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. Claims 14-15 are directed to a law of nature or a natural phenomenon. Claim 14-15 as interpreted are directed to polypeptides comprising the amino acid sequences SEQ ID NO: 2, 8, 12 or 16 and encoding polynucleotides (For examination purposes claims 14-17 are interpreted to encompass “protocatechuate decarboxylase polypeptide, encoding polynucleotide”; furthermore no patentable weight is given to the preamble “An agent for decarboxylating mesaconic acid or an isomer thereof and promoting production of methacrylic acid”, as rejected claims 14-17 are considered to be “method of use of the product” claims and therefore, patentable weight is given only to the claimed product and not to the method of use; see 35 U.S.C. 112(b) rejection above). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons stated below.
The “2014 Interim Guidance on Patent Subject Matter Eligibility” 79 FR 74618 (Dec. 16, 2014) directs that claims drawn to 1) a composition of matter, 2) a law of nature or a natural phenomenon and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception are ineligible for patenting under 35 U.S.C. 101. See, 79 FR, page 74621 (flow chart). Nature-based compositions of matter are not directed to significantly more than a judicial exception when the claimed "naturally occurring products and some man-made products ... are essentially no different from a naturally occurring product ... that fall under the laws of nature or natural phenomena exception.” 79 FR, page 74623, left column. That is, a patent-eligible composition of matter must be "markedly different" in terms of the "product's structure, function, and/or other properties." 79 FR, page 74623, center column. Further, processes directly to isolating nature-based compositions of matter have also been found to be directed to nothing more than a judicial exception when only routine purification techniques are employed. 79 FR, page 74622, center column (e.g. isolating DNA or other nature-based products).
Here, naturally-occurring polypeptides comprising the amino acid sequences of SEQ ID NOs: 2, 8, 12 or 16 and annotated as protocatechuate decarboxylase are disclosed in the following references: (i) UniProtKB/TrEMBL Accesion#B9A9M6 having 100% sequence identity to SEQ ID NO: 2 of the instant application; (ii) UniProtKB/TrEMBL Accesion#A0AAN2PGR3 having 99.6% sequence identity to SEQ ID NO: 8 of the instant application; (iii) UniProtKB/TrEMBL Accesion#A0ABD7INW2 having 100% sequence identity to SEQ ID NO: 12 of the instant application; and (iv) UniProtKB/TrEMBL Accesion#A0A7L7KV35 having 100% sequence identity to SEQ ID NO: 16 of the instant application (see provided sequence alignments). The features of claims 14-15 is met by the reference polypeptides and the encoding polynucleotides in the disclosed references above. Since the features of the claims are met by the structure of a polypeptides of SEQ ID NOs: 2, 8, 12 or 16 and the encoding polynucleotides of the instant application and the claims do not recite additional features or elements that amount to significantly more than the judicial exception, since the structure recited in claims 14-15 is "essentially no different from a naturally occurring product” such that there is no marked difference in the "product's structure, function, and/or other properties. As such, the claims 14-15 recite patent ineligible subject matter for the reasons stated.
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.
Claims 14-15 is rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Allard et al., (US 11,124806 B2), said reference discloses a reference polypeptide having 100% sequence identity to SEQ ID NO: 2 of the instant application (see provided sequence alignment) and annotated as protocatechuate decarboxylase, said reference also discloses vectors comprising the encoding polynucleotide and expression of the polypeptide (see col. 54, lines 10-14; col. 58, lines 52-67 to col. 59, lines 1-30; and entire document), and therefore Allard et al., (US 11,124806 B2) is deemed to anticipate claims 14-15 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 14-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Allard et al., (US 11,124806 B2) having 100% sequence identity to SEQ ID NO: 2 of the instant application as applied to claims 14-15 and further in view of Park et al., (UniProtKB/TrEMBL Accesion#A0A223ECA1 having 98.5% sequence identity to SEQ ID NO: 8 of the instant application); Sun et al., (UniProtKB/TrEMBL Accesion#A0A837R8P6 having 99.8% sequence identity to SEQ ID NO: 12 of the instant application) and Jung JY., (UniProtKB/TrEMBL Accesion#A0A7L7KV35 having 100% sequence identity to SEQ ID NO: 16 of the instant application).
The disclosure of Allard et al., are silent regarding polypeptides having 90% sequence identity to the amino acid sequences of SEQ ID NOs: 8, 12 or 16 and encoding polynucleotides comprised in a vector (as in claims 14-15)
The cited references disclose the following: Park et al., (UniProtKB/TrEMBL Accesion#A0A223ECA1 having 98.5% sequence identity to SEQ ID NO: 8 of the instant application); Sun et al., (UniProtKB/TrEMBL Accesion#A0A837R8P6 having 99.8% sequence identity to SEQ ID NO: 12 of the instant application) and Jung JY., (UniProtKB/TrEMBL Accesion#A0A7L7KV35 having 100% sequence identity to SEQ ID NO: 16 of the instant application). Therefore, using the indications of Allard et al., (US 11,124806 B2) as a reference, it would have been easy for a person skilled in the art to use the DNA coding for protocatechuate decarboxylase and as disclosed in the references of Park et al., (UniProtKB/TrEMBL Accesion#A0A223ECA1 having 98.5% sequence identity to SEQ ID NO: 8 of the instant application); Sun et al., (UniProtKB/TrEMBL Accesion#A0A837R8P6 having 99.8% sequence identity to SEQ ID NO: 12 of the instant application) and Jung JY., (UniProtKB/TrEMBL Accesion#A0A7L7KV35 having 100% sequence identity to SEQ ID NO: 16 of the instant application), and clearly suggests to a skilled artisan to modify the teachings of Allard et al., and incorporate the “protocatechuate decarboxylase polypeptide, encoding polynucleotide” from Park et al., (UniProtKB/TrEMBL Accesion#A0A223ECA1 having 98.5% sequence identity to SEQ ID NO: 8 of the instant application); Sun et al., (UniProtKB/TrEMBL Accesion#A0A837R8P6 having 99.8% sequence identity to SEQ ID NO: 12 of the instant application) and Jung JY., (UniProtKB/TrEMBL Accesion#A0A7L7KV35 having 100% sequence identity to SEQ ID NO: 16 of the instant application) in the claimed vector compositions as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since “protocatechuate decarboxylase polypeptide, encoding polynucleotide” and vectors comprising encoding polynucleotides and method of making said vector compositions are well known in the art.
Therefore, claims 14-15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Allard et al., (US 11,124806 B2) having 100% sequence identity to SEQ ID NO: 2 of the instant application as applied to claims 14-15 and further in view of Park et al., (UniProtKB/TrEMBL Accesion#A0A223ECA1 having 98.5% sequence identity to SEQ ID NO: 8 of the instant application); Sun et al., (UniProtKB/TrEMBL Accesion#A0A837R8P6 having 99.8% sequence identity to SEQ ID NO: 12 of the instant application) and Jung JY., (UniProtKB/TrEMBL Accesion#A0A7L7KV35 having 100% sequence identity to SEQ ID NO: 16 of the instant application).
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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