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
Application Status
This application is a 371 of PCT/EP20202/086747, filed on 06/14/2024.
Claims 1-15 are currently pending in the instant application.
The preliminary amendment filed on 06/14/2024, amending claims 1-6, 8-12, and 14-15 is acknowledged.
Election/Restriction
Applicant's election with traverse of Group I, Claims 1-15, drawn to a method for producing at least one polypeptide of interest in a Bacillus host cell, said method comprising the steps of a) providing a Bacillus host cell comprising a polynucleotide encoding the at least one polypeptide of interest, wherein the Bacillus host cell is a ispA knock-out cell, b) cultivating the Bacillus host cell under conditions which allow for intracellular accumulation of said at least one polypeptide of interest, thereby producing said at least one polypeptide of interest, c) stop of aeration and addition of feed, and d) incubating the Bacillus host cell for at least five hours, in the response filed on 06/22/2026 is acknowledged.
Arguments: The traversal is on the ground(s) that there would be no burden of search for the co-examination of Group I and II because they have overlapping scope. Applicants also argue that claim 1 recites a method for producing at least one polypeptide of interest in a Bacillus host
cell, said method comprising, inter alia, providing a Bacillus host cell comprising a polynucleotide encoding the at least one polypeptide of interest, wherein the Bacillus host cell is a ispA knock-out cell, and cultivating the Bacillus host cell under conditions which allow for intracellular accumulation of said at least one polypeptide of interest, thereby producing said at least one polypeptide of interest. Borchert's strain JA4182 has an intact ispA, and Borchert's strain HYGE435 is an ispA knockout but has a secretory signal peptide fused to the polypeptide of interest, i.e., fused to xylanase. As such, HYGE435 does not allow accumulation of at least one polypeptide of interest. Moreover, Example 6 shows strain JA4182 (with intact ispA protease and no signal peptide) shows surprisingly better expression compared to cell with inactivated ispA protease (HYGE435). Accordingly, Borchert does not teach or suggest an ispA knock-out host cell and that allows for intracellular accumulation of at least one polypeptide of interest and thus does not anticipate or render any of the claims obvious. Applicant submits that the technical feature linking the claims does make a contribution over Borchert and thus requests withdrawal of the restriction requirement.es not anticipate or render
any of the claims obvious.
Response: This is not found persuasive because Restriction requirement is mainly for reduce the burden of examination and burden of search, but not the complete examination to evaluate the patentability of the claimed invention. The Examiner clearly indicated in the previous Office action about the Lack of Unity, and eventually how the claimed invention does not contribute over the prior art and lack Unity of invention.
As discussed previously, The inventions listed as Groups I - III do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons: A Bacillus host cell of Group II, a method for producing at least one polypeptide of interest in the Bacillus host cell of Group I, and a method of producing a Bacillus host cell of Group III, are each patentably distinct product and method of making and method of using said product Bacillus host cell. unrelated and chemically distinct entities. The only shared technical feature of these groups is that they all relate to a Bacillus host cell comprising a polynucleotide encoding a polypeptide of interest lacking a functional secretion sequence of ispA gene, which has been inactivated in the Bacillus host cell. However, this shared technical feature is not a “special technical feature” as defined by PCT Rule 13.2 as it does not define a contribution over the art. Borchert et al. (WO 2014/206829A1, publication 12/31/2014, see IDS) teach a Bacillus host cell HyGe435 comprising a polynucleotide encoding a polypeptide of interest lacking a functional secretion sequence of ispA gene having improved xylanase protein secretion from said host cell. Thus, a Bacillus host cell HyGe435 comprising a polynucleotide encoding a polypeptide of interest lacking a functional secretion sequence of ispA gene having improved xylanase protein secretion from said host cel, and method of use thereof does not make contribution over the prior art and lack unity of invention. Besides, 37 CFR 1.475 does not provide for multiple products and/or methods within a single application. Therefore, inventions of Group I - III lack unity of invention.
Applicants main arguments are- Bacillus host of Borchert et al. comprises intact ispA gene, which is not persuasive because Bacillus host cell HyGe435 of Borchert et al. indeed comprises a polynucleotide encoding a polypeptide of interest lacking a functional secretion sequence of ispA gene having improved xylanase protein secretion from said host cell (see, SnagIt image as shown below).
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Applicants are reminded not to sate confusing remarks, and thus the inventions of Group I - III lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants request for rejoinder is noted. However, current claims of elected Group I are not allowable at this time. When Group I would be allowable, rejoinder request would be evaluated at that time.
Claims 1-11 are present for examination.
Priority
Acknowledgement is made of applicants claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application GERMANY EPO 21215959.4, filed on 12/20/2021 without English translation. This application claim priority of International patent application PCT/EP20202/086747, filed on 12/19/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/11/2025 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are considered by the examiner. The signed copy of 1449 is enclosed herewith.
Drawings
Drawings submitted on 06/24/2024 are accepted by the Examiner.
Claim Objections
Claims 1, and 7 are objected to in the recitation ispA and aprE, mpr, bpr, vpr, epr, nprE, nprB and/or wprA; as abbreviations should not be used without at least once fully setting forth what they are used for. Appropriate correction is required.
Claim 1 is objected to in the recitation “a polynucleotide encoding the at least one polypeptide”, which should be changed to “a polynucleotide encoding at least one polypeptide”. Appropriate correction is required.
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.
Claim 3 is rejected under 35 U.S.C. 112(b), 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 is indefinite and vague in the recitation “increased”, in the context of temperature, which is confusing because it is unclear whether the phrase “increased” has any boundary, which can be any number, and thus said phrase renders the claim indefinite. Besides, the recitation “increased” is a relative term, and which renders the claim indefinite. The term is not defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claim should define and clearly state as to what the increased temperature is being compared, i.e. increased --- compared to what? Clarification is required.
Claim Rejections – Improper Markush Grouping
Claim 9 is rejected under the judicially approved “improper Markush grouping” doctrine. See Supplementary Examination Guidelines for Determining Compliance with 35 U.S.C. §112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162 (Feb. 9, 2011), page 7166.
Claim 9 is “Markush”-type claims that recite a plurality of polypeptide of interest “beta-galactosidase, xylanase, ------------ and lactoferrin of claim 9.
A Markush claim may be rejected under the judicially approved “improper Markush grouping” doctrine when the claim contains an improper grouping of alternatively useable species. A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a “single structural similarity,” and (2) the species do not share a common use.
Claim 9 is rejected as reciting an improper Markush group because they do not share a structural similarity nor a common use. When an examiner determines that the species of a Markush group do not share a single structural similarity or do not share a common use, then a rejection on the basis that the claim contains an “improper Markush grouping” is appropriate.
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.
(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.
MPEP-2131 Anticipation — Application of 35 U.S.C. 102 [R-08.2017]
A claimed invention may be rejected under 35 U.S.C. 102 when the invention is anticipated (or is "not novel") over a disclosure that is available as prior art. To reject a claim as anticipated by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. See, e.g., MPEP § 2114, subsections II and IV.
"A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. v. Union Oil Co. of California, 814 F.2d 628, 631, 2 USPQ2d 1051, 1053 (Fed. Cir. 1987). "When a claim covers several structures or compositions, either generically or as alternatives, the claim is deemed anticipated if any of the structures or compositions within the scope of the claim is known in the prior art." Brown v. 3M, 265 F.3d 1349, 1351, 60 USPQ2d 1375, 1376 (Fed. Cir. 2001) Note that, in some circumstances, it is permissible to use multiple references in a 35 U.S.C. 102 rejection. See MPEP § 2131.01.
MPEP-2131.01 Multiple Reference 35 U.S.C. 102 Rejections [R-11.2013]
Normally, only one reference should be used in making a rejection under 35 U.S.C. 102. However, a 35 U.S.C. 102 rejection over multiple references has been held to be proper when the extra references are cited to:
(A) Prove the primary reference contains an "enabled disclosure;"
(B) Explain the meaning of a term used in the primary reference; or
(C) Show that a characteristic not disclosed in the reference is inherent.
Claims 1-11 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention as anticipated by Borchert et al. (Expression of natively secreted polypeptides without signal peptide. WO 2014/206829A1, publication 12/31/2014, see IDS).
The Broadest Reasonable Interpretation (BRI) of claim 1, which is drawn to method for producing at least any one polypeptide of interest in a Bacillus host cell, said method comprising the steps of a) providing a Bacillus host cell comprising a polynucleotide encoding at least one polypeptide of interest, wherein the Bacillus host cell is a ispA knock-out cell, b) cultivating the Bacillus host cell under conditions which allow for intracellular accumulation of said at least one polypeptide of interest, thereby producing said at least one polypeptide of interest, c) stop of aeration and addition of feed, and d) incubating the Bacillus host cell for at least five hours.
Regarding claims 1-11, Borchert et al. teach a Bacillus subtilis and B. licheniformis host cell HyGe435 comprising a polynucleotide encoding a polypeptide of interest xylanase, an enzyme, wherein the Bacillus host cell lacks a functional secretion sequence of ispA gene having improved xylanase protein secretion from said host cell. Borchert et al. also teach methods of recombinantly producing a natively secreted polypeptide, and the method comprising the steps of providing a microorganism host cell comprising an exogenous polynucleotide encoding a natively secreted polypeptide without a translationally fused signal peptide; cultivating the microorganism host cell under conditions conducive to the expression of the polypeptide such as 37-41oC for 2-3days at anaerobic state (48-72 hours) and, recovering the polypeptide in increased amount, which is about 5 fold higher in the construct without signal sequence than the construct comprising signal peptide, wherein the B. licheniformis host cell unable to produce alpha-amylase, cellulase, and beta-galactosidase due to inactivation or elimination of the encoding genes, and furthermore, the Bacillus host cell also comprises lacking extracellular protease such as aprE and nprE, due to deletion or inactivation of the respective genes (see, abstract, pg 11, para 5, pg25, para 3, pg28, para 1, pg29, para 3-6, pg30, para 2-4, Example 4, Table 2, and claims , ) and as well as microorganisms, certain polynucleotides, expression constructs and protease substitution variants. Bacillus host cell HyGe435 comprising a polynucleotide encoding a polypeptide of interest lacking a functional secretion sequence of ispA gene having improved xylanase protein secretion from said host cell, wherein said xylanase gene is cloned in an expression vector and Bacillus host cell.
Claim 5 is included in this rejection because the limitations under wherein clause of claim 5 which is just an “intended result of a process step, and as per MPEP 2111.04, the court noted that “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step.’” .(quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
According to MPEP- 2111.04 “Adapted to,” “Adapted for,” “Wherein,” “Whereby,” and Contingent Clauses [R-08.2017]
I. "ADAPTED TO," "ADAPTED FOR," "WHEREIN," and "WHEREBY"
Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “adapted to” or “adapted for” clauses; (B) “wherein” clauses; and (C) “whereby” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a “wherein” clause limited a process claim where the clause gave “meaning and purpose to the manipulative step. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted that a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id.(quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
Therefore, Borchert et al. anticipate claims 1-11 of the instant application as written.
Conclusion
Status of the claims:
Claims 1-11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, PhD.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office (USPTO)
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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