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 .
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.
DETAILED ACTION
Claims 1-21 are pending in the instant application.
Priority
This application is a 371 of PCT/FI2022/050464, filed on 6/23/2022 which claims priority to the European applications EP21186231.3 filed on 7/16/2021 and EP21186223.0 filed on 7/16/2021.
Information Disclosure Statement
The information disclosure statements (IDS) dated 1/12/2024 and 1/30/2024 comply with the provisions of 27 CFR 1.97, 1.98, and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Objections to the Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code on pg 12, para 3. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Correction is required. See MPEP § 608.01.
Multiply Dependent Claims Present
In the following office action, multiply dependent claims, such as claim 17 being dependent on either claim 1 or claim 16, will be represented using the formalism: 17(1) and 17(16).
Notice
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 4,5
In the instant case, claim 5 states the native residue of phytase, whereas claim 4 does not. The mutations proposed are however identical. For example, there is no material difference between a sequence comprising a 121K mutation of SEQ ID NO: 1, versus a sequence comprising a P12K mutation of SEQ ID NO: 1. As such, despite a difference in how the mutation is stated, claims 4 and 5 are substantial duplicates.
Claim 7,8
Similarly, applicant is also advised that if claim 7 is found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. In the instant case, claim 8 states the native residue of phytase, whereas claim 7 does not. The mutations proposed are however identical. For example, there is no material difference between a sequence comprising a 121K mutation of SEQ ID NO: 1, versus a sequence comprising a P12K mutation of SEQ ID NO: 1. As such, despite a difference in how the mutation is stated, claims 7 and 8 are substantial duplicates.
Objections to the Claims
Claims 9-10 contain too many conjunctions. The bulleted list of lettered options that were deleted should be returned to these claims, wherein list items are delineated by a semi-colon. For example the list of claim 9 should read:
“a. the amino acids 126H and 204N/T;
b. the amino acids 126H and 212G;
…
i. the amino acids 126H, 204T, 212G, and 258N; or
j. the amino acids 121K, 126H, 204N, 212G, and 216T.”
Claim 19 contains too many conjunctions and mixed delineations of options. Please return the lettered bullet points, so that the claim language follows a consistent structure such as:
“An animal feed comprising the variant polypeptide of claim 1 or the enzyme composition of claim 16, and at least one protein source of plant origin; wherein said animal feed optionally comprises:
at least one additional enzyme selected from protease, amylase, phytase, xylanase, endoglucanase, beta-glucanase, mannanase, cellulase, or a combination thereof; or
at least one ingredient selected from maltodextrin, flour, salt, sodium chloride, sulphate, sodium sulphate, or a combination thereof.”
Correction is required. See MPEP § 608.01(m).
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.
Claim 17 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 17
Claim 17 is drawn to a method of “us[ing] the variant polypeptide”. The method of claim 17 lacks any positive steps towards completing the claimed method or even a description of what the method achieves. Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: “[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon” was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986). See MPEP § 2173.05(q).
Claim Rejections – 35 USC § 112(d)
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.
Claims 16 and 20 are 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.
Claim 16
Claim 16 is drawn to a composition comprising no other components other than the phytase described in parent claim 1. Thus claim 16 fails to further limit parent claim 1.
Claim 20
Claim 20(1) and 20(16) is drawn to a feed supplement wherein the composition comprises other components other than the phytase described in parent claim 1. Thus claim 20 fails to further limit parent claim 1 or 16, by virtue of all the selections being “optional”.
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
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.
Claims 1, 3-6, 13-14, and 16-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wu (US20200277582).
Claim 1
Regarding claim 1, Wu teaches a phytase comprising 95.6% sequence identity to SEQ ID NO: 1 (SEQ ID NO: 5) and a 126D mutation, shown below.
inst1_126X QSEPELKLESVVIVSRHGVRAPTKFTQLMQDVTPDAWPTWPVKLGELTPRGGELIAYLGH 60
Wu_5 QSEPELKLESVVIVSRHGVRAPTKATQLMQDVTPDAWPTWPVKLGELTPRGGELIAYLGH 60
************************ ***********************************
inst1_126X YWRQRLVADGLLPKEGCPQSGQVAIIADVDERTRKTGEAFAAGLAPDCAITVHHQADTSS 120
Wu_5 YWRQRLVADELLPKCGCPQPGQVAIIADVDERTRKTGEAFAAGLAPDCAITVHHQADTSS 120
********* **** **** ****************************************
inst1_126X PDPLFXPLKTGVCQLDVANVRRAILERAGGSIADFTRHYQTAFRELERVLNFPQSNLCLK 180
Wu_5 PDPLFDPLKTGVCQLDVANVTRAILERAGGSIADFTGHYQPAFRELERVLNFPQSPLCLK 180
***** ************** *************** *** ************** ****
inst1_126X REKQDESCSLTQALPSELKVSADDVSLTGAVSLASMLTEIFLLQQAQGMPEPGWGRITDS 240
Wu_5 REKQDEPCSLTQALPSELKVSADNVSLTGAVSLASMLTEIFLLQQAQGMPEPGWGRITDS 240
****** ****************:************************************
inst1_126X HQWNTLLSLHNAYFDLLQRTPEVARSRATPLLDLIKTALTPHPPQKQAYGVTLPTSVLFI 300
Wu_5 HQWNTLLSLHNAQFDLLQRTPEVARSRATPLLDLIKTALTPHPPQKQAYGVTLPTSVLFI 300
************ ***********************************************
inst1_126X AGHDTNLANLGGALELNWTLPGQPDNYPPGGELVFERWRRLSDNSQWIQVSLVFQTLQQM 360
Wu_5 AGHDTNLANLGGALELNWTLPGQPDNTPPGGELVFERWRRLSDNSQWIQVSLVFQTLQQM 360
************************** *********************************
inst1_126X RDKTPLSLNTPPGEVKLTLAGCEERNAQGMCSLAGFTQIVNEARIPACSL 410
Wu_5 RDKTPLSLNTPPGEVKLTLPGCEERNAQGMCSLAGFTQIVNEARIPACSL 410
******************* ******************************
Wu teaches this phytase mutant has enhanced thermostability in order to enhance the phosphorus availability in plant-based feeds for livestock animals (pg 1, para 006-0012).
Claim 3-5
Regarding claims 3-5, Wu teaches the phytase also comprises a 204N mutation (SEQ ID NO: 5, shown above).
Claim 6
Regarding claim 6, Wu teaches their mutant phytase is an E.coli variant (pg 4, para 0088-0089).
Claim 13
Regarding claim 13, because Wu teaches a phytase that satisfies all the structural limitations of claim 1, it must necessarily possess the same chemical properties of having and IP4 to IP6 ratio greater than 1.3 over the wild-type phytase of SEQ ID NO: 2. MPEP § 2112.01(II) states “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.” Applicant attests in their specification that any mutation to position 126 is sufficient to increase IP4 degrading activity (pg 3, line 21-23).
Claim 14
Regarding claim 14, Wu teaches the host cell is a yeast cell (pg 4, para 0100).
Claim 16-17, 19-20
Regarding claims 16, 17(1), 17(16), 19(1), 19(16), 20(1), and 20(16), Wu teaches this phytase mutant has enhanced thermostability in order to enhance the phosphorus availability in plant-based feeds for livestock animals (pg 1, para 006-0012). Wu teaches an animal feed comprising an effective amount of their phytase mutant (pg 2, para 0060), thus satisfying the limitations of an enzyme composition and an animal feed of plant origin. Wu teaches a method of fortifying an animal feed comprising adding an effective amount of their phytase mutant into the animal feed, prior to feeding the animal (pg 3, para 0060), thus satisfying the limitation of “using” the phytase to produce a feedstuff referred to in claim 17. Note claim 17 is subject to 112(b) rejections regarding being a method that lacks material steps to perform it.
Claim 18
Regarding claim 18, Wu teaches a method of making the phytase comprising providing a polynucleotide encoding the phytase and inducing a host cell to express the phytase (claim 11).
Claim 21
Regarding claim 21(1) and 21(16), Wu teaches the phytase hydrolyzes phytate phosphorus (myo-inositol hexakisphosphate) into myo-inositol and inorganic phosphate (pg 1, para 0004). Wu teaches this phytase mutant has enhanced thermostability in order to enhance the phosphorus availability in plant-based feeds for livestock animals (pg 1, para 006-0012). Wu teaches a method of fortifying an animal feed comprising adding an effective amount of their phytase mutant into the animal feed, prior to feeding the animal (pg 3, para 0060). In sum, Wu satisfies the limitation of degrading phytate comprising adding an effective amount of their phytase to the material that comprises phytate.
Claim Rejections – 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Wu (US20200277582) as applied to claims 1, 3-6, 13-14, and 16-21 above, and further in view of Babe (WO2021102238).
Claim 15
Regarding claim 15, Wu does not teach the host cell is a plant cell.
Babe teaches a thermostable phytase variant wherein it can be expressed in a recombinant plant cell host (para 0017; para 0071). Babe teaches their phytase variant as a feed supplement (para 0016) to improve the availability of organic phosphorous to the animal and to decrease phosphate pollution of the environment (para 0005).
It would have been obvious to combine the teachings of Wu and Babe because both references teach a thermostable phytase variant that is designed for the augmentation of animal feed products and Babe teaches that phytases for animal feeds can be produced using plant cells as the host organism for producing the phytase. One of skill in the art would have had a reasonable expectation of success because Babe teaches that plant cells are able to be used as host organisms for the expression of phytase.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
18/578946
Claims 1-9, and 12-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/578946 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other according to the claim-by-claim analysis below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, the reference claims a phytase variant comprising a mutation at position 126 relative to SEQ ID NO: 1, wherein 80% sequence homology is maintained (claims 1-2).
Regarding instant claims 2-5 and 7-9, the reference claims 126H mutation and 204N mutation (claim 5).
Regarding instant claim 6, the reference claims the phytase is an E. coli variant (claim 1).
Regarding instant claim 12, the reference claims the phytase further comprising the mutations of 75C/V, 114T, 137E, 141T, 142D, 146R, 157G, 204C, 211W, 253Q, 267R, and 341P (claim 7).
Regarding instant claim 13, the reference claims increased phytate degradation activity over IP6 (claim 11). Because the structure is identical, it must also exhibit the same numerical enhancement of phytate degradation as instantly claimed. MPEP § 2112.01(II) states “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.”
Regarding instant claim 14, the reference claims the host cell is a filamentous fungal cell (claim 12).
Regarding instant claim 15, the reference claims the host is a transgenic plant cell (claim 13).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 16, the reference claims an enzyme composition (claim 14).
Regarding instant claim 17, the reference claims a method of using the variant polypeptide (claim 15).
Regarding instant claim 18, the reference claims a method of manufacturing the variant polypeptide comprising obtaining the DNA encoding the polypeptide and expressing it in a host cells (claim 16).
Regarding instant claim 19, the reference claims an animal feed comprising the polypeptide (claim 17).
Regarding instant claim 20, the reference claims a feed supplement (claim 18).
Regarding instant claim 21, the reference claims a method of degrading phytate (claim 19).
18/578970
Claims 1-11, and 13-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/578970 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other according to the claim-by-claim analysis below. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Regarding instant claim 1, the reference claims a phytase variant comprising a mutation at position 126 relative to SEQ ID NO: 1, wherein 80% sequence homology is maintained (claims 1-2).
Regarding instant claims 2-5 and 7-9, the reference claims 126H mutation and 204N mutation (claim 6-7).
Regarding instant claim 6, the reference claims the phytase is an E. coli variant (claim 15).
Regarding instant claim 10, the reference claims the set of mutation 126H, 204T, and 212G (claim 8, 11).
Regarding instant claim 11, the reference claims the set of mutations 121K, 126H, 216T, and 258N (claim 8, 11).
Regarding instant claim 13, the reference claims increased phytate degradation activity over IP6 (claim 5). Because the structure is identical, it must also exhibit the same numerical enhancement of phytate degradation as instantly claimed. MPEP § 2112.01(II) states “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.”
Regarding instant claim 14, the reference claims the host cell is a filamentous fungal cell (claim 15).
Regarding instant claim 15, the reference claims the host is a transgenic plant cell (claim 16).
Regarding instant claim 16, the reference claims an enzyme composition (claim 17).
Regarding instant claim 17, the reference claims a method of using the variant polypeptide (claim 18).
Regarding instant claim 18, the reference claims a method of manufacturing the variant polypeptide comprising obtaining the DNA encoding the polypeptide and expressing it in a host cells (claim 19).
Regarding instant claim 19, the reference claims an animal feed comprising the polypeptide (claim 20).
Regarding instant claim 20, the reference claims a feed supplement (claim 18).
Regarding instant claim 21, the reference claims a method of degrading phytate (claim 21).
Relevant Prior Art
Both Webel (US20030206913) and Blattmann (US20060141562) teach a variant phytase comprising a position 126 mutation and greater than 80% sequence identity to instant SEQ ID NO: 1.
Allowable Subject Matter
The variant phytase comprising the 126H mutation was not found in the prior art. Claims 2 and 7-8, and 11-12 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form, including all of the limitations of the base claim and any intervening claims. Note: In the double patenting rejections, the mutation of 258A referred to in claim 11 was not claimed in either reference application.
The closest prior art is that of Wu discussed in detail in the 102 rejection above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
