DETAILED ACTION
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 .
Priority
Applicant cannot rely upon the certified copy of the foreign priority application to overcome rejections herein because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Any certified translation should set forth that the same is an accurate translation of the certified copy of the priority document as found in the file wrapper.
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.
Claim 10 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. MPEP 2173.05(q). Claim 10 sets forth a use that is not apparently limited to a process, machine, manufacture, or composition of matter and therefore fails to comply with 35 U.S.C. 101.
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.
Claims 5 and 10 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.
Regarding claim5, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).It is unclear if the various values in units of [Symbol font/0xB0]C are or are not limitations of the claim such that an ordinarily skilled artisan cannot understand how to avoid infringement.
Further in claim 5, the claim states stability values “are defined temperatures at which a 50 µg/ML preparation of the phytase variant still has 50% residual activity after 15, 30 or 60 minutes of exposure,” and then further states “the residual activity . . . is determined on the basis of a reaction . . . over a period of 6 min.” The only antecedent basis for “the residual activity” is in paragraph a) of claim 5. As such, the cited claim language raises substantial confusion over whether 50% residual activity is measured over a time period of 6, 15, 30 or 60 minutes and/or how “over a period of 6 min” modifies the prior recitation of “50% residual activity after 15, 30 or 60 minutes of exposure” such that it is unclear how infringement of claim 5 can be avoided.
Regarding claim 10, It is appropriate to reject a claim that recites a use but fails to recite steps under 35 U.S.C. 101 and 35 U.S.C. 112(b) if the facts support both rejections. MPEP 2173.05(q). Since claim 10 fails to clearly recite a process, machine, manufacture, or composition of matter as set forth in the rejection under 35 U.S.C. 101 above, and ordinarily skilled artisan is unable to determine how to avoid infringement of a “use” as recited in claim 10.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
The rejection of claim 3 under 35 U.S.C. 102(a)(1) below is incorporated and referenced herein.
Claim 3 depends from claim 1. Claim 1 requires at least 82% identity to SEQ ID NO: 1 or 2 while further dependent claim 3 expands the base sequences to which present identity is measured to any of SEQ ID NO: 1, 2, 8, 9, 10 or 11, although requiring at least 90% identity. The broadest reasonable interpretation of claim 3 is any chimeric phytase having at least 90% identity to any of SEQ ID NOS: 8-11 including phytases having exactly 90% identity thereto.
As shown below in the rejection under 35 U.S.C. 102(a)(1) over Lassen et al. (U.S. 2010/0083392 A1), a phytase can have an amino acid sequence having at least 90% identity to SEQ ID NO: 8 but not having at least 82% identity to SEQ ID NO: 1 or 2. As such, claim 3 fails to include all of the limitations of claim 1 from which claim 3 depends, such limitation being a requirement for an amino acid sequence having at least 82% identity to SEQ ID NO: 1 or 2. Further, for the same reasons, phytase chimeras having at least 90% identity to any of SEQ ID NOS: 9-11 also includes species not having at least 82% identity to SEQ ID NO: 1 or 2 as recited in claim 1. If claim 3 is intended simultaneously require at least 82% identity to SEQ ID NO: 1 and at least 90% identity to one of SEQ ID NOS: 8-11, then the claim can be amended to recite the same.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 (i.e., changing from AIA to pre-AIA ) 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.
Claim(s) 3 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lassen et al. (U.S. 2010/0083392 A1).
The rejection under 35 U.S.C. 112(d) above is incorporated herein by reference.
Lassen, abstract, teaches
The present invention relates to phytases having at least 76% identity to a phytase derived from Hafnia alvei and comprises at least one modification in the amino acid sequence thereof. These phytase variants have modified, preferably improved, properties, such as, reduced protease sensibility, preferably they exhibit improved properties in respect of thermal performance, such as heat-stability (temperature stability, thermostability), steam stability, pelleting stability and/or temperature profile; and/or protease stability, in particular pepsin stability, pH profile, specific activity, substrate specificity, performance in animal feed (such as an improved release and/or degradation of phytate), susceptibility to glycation, and/or glycosylation pattern. The invention also relates to DNA encoding these phytases, methods of their production, as well as the use thereof, e.g., in animal feed and animal feed additives.
“In the sequence listing SEQ ID NO:1 and 2 provide DNA and amino acid sequences for the Hafnia alvei DSMZ 19197 phytase.”
An alignment between recited SEQ ID NO: 8 and SEQ ID NO: 2 of Lassen is as follows:
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As can be seen from the alignment above, the phytase having SEQ ID NO: 2 of Lassen has at least 90% identity to recited SEQ ID NO: 8.
Regarding recitation of a “phytase chimera” in claim 3, “the phytase chimera according to the invention was created by recombination of phytases from different organisms.” The preceding is a statement regarding how a phytase chimera is made; however, claim 3 recites a composition of matter and is not limited to the performance of any method step. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." MPEP 2113. The phytase of SEQ ID NO: 2 of Lassen can be made by recombination of phytases from different organism, particularly since the claims allow for introduction of addition site-directed substitutions. As such, the phytase of SEQ ID NO: 2 of Lassen meets the features of claim 3 wherein the “patentability of a product does not depend on its method of production.”
Claim(s) 1-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Herrmann et al. (Generation of phytase chimeras with low sequence identities and improved thermal stability, J. Biotechnol. 229, July 2021, 14-21).
Hermann et al., abstract, states:
Being able to recombine more than two genes with four or more crossover points in a sequence independent manner is still a challenge in protein engineering and limits our capabilities in tailoring enzymes for industrial applications. By computational analysis employing multiple sequence alignments and homology modeling, five fragments of six phytase genes (sequence identities 31–64 %) were identified and efficiently recombined through phosphorothioate-based cloning using the PTRec method. By combinatorial recombination, functional phytase chimeras containing fragments of up to four phytases were obtained. Two variants (PTRec 74 and PTRec 77) with up to 32 % improved residual activity (90 °C, 60 min) and retained specific activities of > 1100 U/mg were identified. Both variants are composed of fragments from the phytases of Citrobacter braakii, Hafnia alvei and Yersinia mollaretii. They exhibit sequence identities of ≤ 80 % to their parental enzymes, highlighting the great potential of DNA recombination strategies to generate new enzymes with low sequences identities that offer opportunities for property right claims.
“Phytases (Burkholderia sp., C. braakii, E. coli, H. alvei, P. carotovorum and Y. mollaretii M1) were selected based on literature reports with regard to thermal stability.” “Fragment design was based on multiple sequence alignment and structural superposition of the six phytases using YASARA, resulting in the identification of four crossover points (CPs, Fig. S1−3).” “Sequencing of ten clones revealed that phytase genes were recombined from different parental enzymes (Fig. S4) and fragments were inserted in the correct order.” Herrmann, sec. 3.1.
“The most promising variants (PTRec 77 and DJ 12), which possess the highest T50 values in P. pastoris culture supernatant have the same fragment composition (A: H. alvei, B: Y. mollaretii, C: C. braakii, D: H. alvei, and E: H. alvei).” Hermann, sec. 3.2.
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Fig. 1 and Table 2 of Herrmann matches Tables 1 and Table 4 of the specification. In view of the sequences provided in Table S1 of Hermann with indicated crossover points (see also Fig. S3 of Herrmann), the PTRec 77 described by Herrmann is the same as the PTRec 77 phytase chimera disclosed in Hermann, which is recited SEQ ID NO: 1. As such, Herrmann anticipates claims 1-4. Since Table 2 of Herrmann indicates 58+/-5% residual activity after 60 minutes incubation at 90[Symbol font/0xB0]C, the features of claim 5 are met.
Regarding claim 6-9 and 11-12, Herrmann, sec. 2.2.1, describes that nucleic acids were encoded by a chromosomal integration plasmid (i.e. a vector) and transformed in to P. pastoris expressing the same and secreting the phytase chimeras. The secreted phytase chimeras are purified/recovered as set forth I Herrmann, sec. 2.2.2. Regarding claim 10, “A variety of phytases have been specifically tailored for use in animal feed, targeting properties such as pH stability or pH optima, improved specific activity on InsP6. “Herrmann, page 15, left col. As such, the phytase chimeras of Herrmann as intended for use in animal feed production.
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.
Claim 3 is rejected under 35 U.S.C. 101 because the claimed invention is directed to without significantly more. The claim(s) recite(s) a phytase chimera having at least 90% identity to recited SEQ ID NO: 8. This judicial exception is not integrated into a practical application because such a phytase chimera is a natural phenomenon. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons stated below.
MPEP 2106(III) directs that claims drawn to 1) a composition of matter (step 1), 2) a law of nature or a natural phenomenon or a product of nature (step 2A) and 3) lacking recitation of additional elements that make the claims directed to significantly more than a judicial exception (step 2B) are ineligible for patenting under 35 U.S.C. 101. See MPEP 2106(III), flow chart. Step 2A into two prongs as set forth in MPEP 2106.04(II)(A).
“If the claim includes a nature-based product that does not exhibit markedly different characteristics from its naturally occurring counterpart in its natural state, then the claim recites a "product of nature" exception, and requires further analysis in Step 2A Prong Two to determine whether the claim as a whole integrates the exception into a practical application.” MPEP 2106.04(c). “It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart.” MPEP 2106.04(b)(II).
“The markedly different characteristics analysis is part of Step 2A Prong One, because the courts use this analysis to identify product of nature exceptions.” MPEP 2106.04(c). “The markedly different characteristics analysis compares the nature-based product limitation to its naturally occurring counterpart in its natural state. Markedly different characteristics can be expressed as the product’s structure, function, and/or other properties, and are evaluated based on what is recited in the claim on a case-by-case basis. If the analysis indicates that a nature-based product limitation does not exhibit markedly different characteristics, then that limitation is a product of nature exception. If the analysis indicates that a nature-based product limitation does have markedly different characteristics, then that limitation is not a product of nature exception.” MPEP 2106.04(c)(II).
Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.” MPEP 2106.04(c)(I).
The rejections under 35 U.S.C. 112(d) and 102(a)(1) set forth above are incorporated herein by reference. The phytase being SEQ ID NO: 2 of Lassen et al. (U.S. 2010/0083392 A1) is a naturally-occurring enzyme from Hafnia alvei DSMZ 19197 as further evidenced by Uniprot, Accession No. G9Y2J2, 2019, www.uniprot.org. The phytase being SEQ ID NO: 2 of Lassen meets all of the features of claim 3 for the reasons set forth above.
Since the natural product (e.g. amylase having SEQ ID NO: 2 of Lassen) recited in the claim is naturally-occurring, for step 2A, prong 1, “there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception.” It is noted that even if embodiments of the claims were amended towards polypeptides isolated or separated from the environment wherein the phytase if found in situ in nature, such an isolated protein/enzyme is compared to is closest naturally occurring counterpart (e.g. a protease having SEQ ID NO: 2 of Lassen) to determine if it has markedly different characteristics. There is no indication in the record that isolation of any of the recited phytase polypeptides has resulted in a marked difference in structure, function, or other properties. Examiners should keep in mind that if the nature-based product limitation is naturally occurring, there is no need to perform the markedly different characteristics analysis because the limitation is by definition directed to a naturally occurring product and thus falls under the product of nature exception,” which is the case here such that for step 2A, prong 1, no markedly different characteristic is present. MPEP 2106.04(c)(I).
Regarding, step 2A, prong 2, “Prong Two asks does the claim recite additional elements that integrate the judicial exception into a practical application? In Prong Two, examiners evaluate whether the claim as a whole integrates the exception into a practical application of that exception.” MPEP 2106(II)(A)(2). “Examiners evaluate integration into a practical application by: (1) identifying whether there are any additional elements recited in the claim beyond the judicial exception(s); and (2) evaluating those additional elements individually and in combination to determine whether they integrate the exception into a practical application, using one or more of the considerations introduced in subsection I supra, and discussed in more detail in MPEP §§ 2106.04(d)(1), 2106.04(d)(2), 2106.05(a) through (c) and 2106.05(e) through (h).” MPEP 2106.04(d). Here, claim 3 does not recite any additional elements other than a genus of chimeric phytases that includes naturally-occurring phytases.
Regarding Step 2B for the claims, “Step 2B asks: Does the claim recite additional elements that amount to significantly more than the judicial exception”? MPEP 2106.05(II). Here, claim 3 does not recite any additional elements other than a genus of chimeric phytases that includes naturally-occurring phytases.
The claim is directed towards ineligible subject matter for the reasons stated.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure Herrmann, Phytase engineering for efficient phosphate recovery from press cakes, RWTH Aachen University, Thesis, 2021.
Conclusion
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/TODD M EPSTEIN/Primary Examiner, Art Unit 1652