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 .
Claims 2, 3, 6, 10, 13, 22, 24-46 have been canceled. Claims 47-49 have been added. Claims 1, 4, 5, 7-9, 11, 12, 14-21, 23, 47-49 are pending and under consideration.
Applicant's arguments filed 12-12-25 have been fully considered but they are not persuasive.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Objections
The phrase “single-cell” in the phrase “single-cell zygote” in claim 1 is redundant. All zygotes are defined as a diploid single cell resulting from the fusion of two haploid gametes; therefore, the term “zygote” will suffice.
Step a) of claim 1 uses inverted syntax and can be written more clearly as ---a) delivering a 1st nucleic acid comprising a 1st integrase attachment site to a zygote---.
The phrase “to obtain…” in step a) of claim 1 is an intended use and does not necessarily have to occur. The step should have clear functional language that “culturing” results in a multi-cell embryo, e.g. ---b) culturing the zygote such that a multi-cell embryo whose genome comprises the 1st integrase attachment site is obtained---.
Step c) of claim 1 uses inverted syntax and can be written more clearly as ---c) delivering a 2nd nucleic acid sequence comprising a 2nd integrase attachment site and a sequence encoding a product of interest and a 3rd nucleic acid encoding an integrase into the embryo---.
The phrase “to obtain…” in step d) of claim 1 is an intended use and does not necessarily have to occur. The step should have clear functional language that “culturing” results in a multi-cell embryo whose genome contains the sequence encoding the product of interest, e.g. ---b) culturing the embryo obtained in step c) such that a multi-cell embryo whose genome comprises the sequence encoding the product of interest is obtained---.
Claim Rejections - 35 USC § 112
The rejection of claim 30 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite has been withdrawn because the claim has been canceled.
Claims 1, 4, 5, 7-9, 11, 12, 14-21, 23, 47-49 as newly amended 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to “A method comprising the following sequential steps:(a) delivering to a single-cell zygote a first nucleic acid comprising a first integrase attachment site;(b) culturing the single-cell zygote to produce a multi-cell embryo comprising the first integrase attachment site in the genome of the multi-cell embryo; [[and]] (c) delivering to the multi-cell embryo (_i a second nucleic acid comprising a second integrase attachment site and a sequence encoding a product of interest and (ii) a third nucleic acid encoding a cognate integrase; and(d) culturing the multi-cell embryo to produce an engineered embryo comprising in its genome the sequence encoding a product of interest.”
The claim is limited to sequential delivery of a 1st nucleic acid comprising integrase attachment site into a zygote (single-celled) followed by delivery of a 2nd nucleic acid comprising integrase attachment site and a sequence encoding a “product of interest” and a 3rd nucleic acid encoding a “cognate integrase” to a multi-cell embryo obtained from the zygote. The claim encompasses doing so in utero or in isolated zygotes/embryos, performing the method in any species including invertebrates, insects, fish, amphibians, reptiles, birds, and mammals, performing the second “delivery” into any embryo with two cells up to but not including the point where it becomes a fetus. The claim encompasses any “cognate integrase” (e.g. Bxb1); however, the specification and the art at the time of filing do not define when an integrase is “cognate”. The claim requires that the genome of the embryo comprise the sequence encoding the product of interest at the end and performing the 2nd “delivery” at any point while the embryo has multiple cells. The claim encompasses using any “integrase attachment site” (attP, attB, attL, attR, bxb1) in combination with any a sequence encoding any “cognate integrase” (unknown metes and bounds).
The specification is limited to sequential delivery of a 1st nucleic acid into an isolated mouse zygote followed by delivery of a 2nd nucleic acid comprising integrase attachment site and a sequence encoding a hACE2 and a 3rd nucleic acid sequence encoding Bxb1 to a multi-cell embryo obtained from the zygote (Examples). The specification does not correlate performing the method in isolated zygotes/embryos to doing so in utero. The specification does not correlate performing the method in mammalian cells any invertebrates, insects, fish, amphibians, reptiles, or birds zygotes/embryos. The specification does not correlate performing the second “delivery” into any embryo with any number of cells other than two cells. The specification does not correlate Bxb1 to any other “cognate integrase”. The specification does not correlate performing the 2nd “delivery” to a two-cell embryo such that the genome of the embryo contains the sequence encoding the product of interest to performing the delivery into a 4, 8, 16, 32, 64, 128, etc.-cell embryo and obtaining a genome comprising the sequence encoding the product of interest. There is no reason to believe the entire genome of the embryo would contain the genetic modification unless the 2nd delivery happened during the one or two cell stage. There is no reason to believe the entire genome of the embryo would contain the genetic modification when the 2nd delivery happened at the 128 cell stage or right before the embryo became a fetus. The specification does not correlate delivering a 1st sequence comprising a bxb1 site followed by a 2nd sequence comprising a bxb1 site and a sequence of interest and a 3rd sequence encoding Bxb1 to delivering any “integrase attachment site” (attP, attB, attL, attR, bxb1) in combination with any a sequence encoding any “cognate integrase” (unknown metes and bounds). Accordingly, the concept in claim 1 lacks written description as broadly written.
The specification lacks written description for delivering the 1st sequence comprising the 1st integrase attachment site and the 2nd and 3rd sequences as broadly encompassed by claim 1 other than with electroporating a zygote with the 1st sequence comprising the 1st integrase attachment site and a Cas9 ribonucleoprotein followed by microinjecting a two cell blastomere with a 2nd sequence comprising a 2nd integrase attachment site and a coding sequence of interest and a 3rd sequence encoding Bxb1. Claim 1 encompasses delivering the 1st, 2nd and 3rd sequences in the absence of Cas9. However, the specification is limited to electroporating a zygote with the 1st sequence comprising the 1st integrase attachment site and a Cas9 ribonucleoprotein followed by microinjecting a two cell blastomere with a 2nd sequence comprising a 2nd integrase attachment site and a coding sequence of interest and a 3rd sequence encoding Bxb1 (Fig. 1; pg 5, lines 8-14). Pg 18, line 5, says the sequence encoding Cas9 was inserted into a Rosa26 gene of the mouse embryo. The specification does not teach how to integrate the 1st site without Cas9. The specification does not teach how to integrate the Cas9 coding sequence other than the Rosa26 gene, a “safe harbor” gene. Accordingly, the concept lacks written description as broadly claimed.
The specification lacks written description for any “engineered” embryo whose genome comprises the sequence encoding a product of interest as broadly encompassed by claim 1 other than one whose genome comprises a Cas9 coding sequence operably linked to an endogenous Rosa26 promoter. Example 1 (pg 18-19) is limited to inserting a Cas9 coding sequence into an endogenous Rosa26 gene of the embryo (Fig. 1). Pg 5, line 9, says a 1st Bxb1 attP site is inserted into a CD68 gene using a Cas9-mediated repair template. Pg 5, line 10, says a sequence encoding Cas9 containing a Bxb1 attB site is inserted into a CD68 gene using Bxb1 integration. The specification does not correlate this limited embodiment to any other genetic “engineered” state as broadly encompassed by claim 1.
The specification lacks written description for any 1st integrase attachment site being “operably linked to an endogenous promoter of a gene of interest” as required in claim 11. As written, the claim seems to encompass delivering a 1st nucleic acid sequence comprising an integrase attachment site operably linked to a promoter that is “endogenous” to the zygote. However, this concept is not disclosed in the specification. Moreover, the 1st integrase attachment site cannot be operably linked to an endogenous promoter of the zygote until the 1st nucleic acid sequence has been integrated into the genome of the zygote which is missing from the claim.
The specification lacks written description for delivering any 1st integrase attachment site that is “upstream from (5’) and in frame with a transcriptional start codon or downstream from (5’) and in frame with a transcriptional start codon” as required in claim 12. As written, the claim seems to encompass delivering a 1st nucleic acid sequence comprising an integrase attachment site in frame (upstream or downstream) of a transcriptional start codon. However, this concept is not disclosed in the specification. Moreover, the 1st integrase attachment site cannot be in frame (upstream or downstream) of a transcriptional start codon until the 1st nucleic acid sequence has been integrated into the genome of the zygote which is missing from the claim.
The specification lacks written description for any 1st integrase attachment site being “flanked by nucleotide sequences homologous to nucleotide sequences in the genome of the zygote” as required in claim 14. As written, the claim seems to encompass delivering a 1st nucleic acid sequence comprising an integrase attachment site flanked by nucleotide sequences homologous to nucleotide sequences in the genome of the zygote. However, this concept is not disclosed in the specification. Moreover, the 1st integrase attachment site cannot be flanked by nucleotide sequences homologous to nucleotide sequences in the genome of the zygote until the 1st nucleic acid sequence has been integrated into the genome of the zygote which is missing from the claim.
Claims 1, 4, 5, 7-9, 11, 12, 14-21, 23, 47-49 as newly amended are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for sequential delivery of a 1st nucleic acid into an isolated mouse zygote followed by delivery of a 2nd nucleic acid comprising integrase attachment site and a sequence encoding a hACE2 and a 3rd nucleic acid sequence encoding Bxb1 to a multi-cell embryo obtained from the zygote such that the genome of the embryo encodes the hACE2, does not reasonably provide enablement for the claims as broadly written. 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/use the invention commensurate in scope with these claims.
Claim 1 and its scope are discussed above.
The specification is limited to sequential delivery of a 1st nucleic acid into an isolated mouse zygote followed by delivery of a 2nd nucleic acid comprising integrase attachment site and a sequence encoding a hACE2 and a 3rd nucleic acid sequence encoding Bxb1 to a multi-cell embryo obtained from the zygote (Examples). The specification does not correlate performing the method in isolated zygotes/embryos to doing so in utero. The specification does not correlate performing the method in mammalian cells any invertebrates, insects, fish, amphibians, reptiles, or birds zygotes/embryos. The specification does not correlate performing the second “delivery” into any embryo with any number of cells other than two cells. The specification does not correlate Bxb1 to any other “cognate integrase”. The specification does not correlate performing the 2nd “delivery” to a two-cell embryo such that the genome of the embryo contains the sequence encoding the product of interest to performing the delivery into a 4, 8, 16, 32, 64, 128, etc.-cell embryo and obtaining a genome comprising the sequence encoding the product of interest. There is no reason to believe the entire genome of the embryo would contain the genetic modification unless the 2nd delivery happened during the one or two cell stage. There is no reason to believe the entire genome of the embryo would contain the genetic modification when the 2nd delivery happened at the 128 cell stage or right before the embryo became a fetus. The specification does not correlate delivering a 1st sequence comprising a bxb1 site followed by a 2nd sequence comprising a bxb1 site and a sequence of interest and a 3rd sequence encoding Bxb1 to delivering any “integrase attachment site” (attP, attB, attL, attR, bxb1) in combination with any a sequence encoding any “cognate integrase” (unknown metes and bounds). Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to perform the method of claim 1 as broadly written.
The specification does not enable delivering the 1st sequence comprising the 1st integrase attachment site and the 2nd and 3rd sequences as broadly encompassed by claim 1 other than with electroporating a zygote with the 1st sequence comprising the 1st integrase attachment site and a Cas9 ribonucleoprotein followed by microinjecting a two cell blastomere with a 2nd sequence comprising a 2nd integrase attachment site and a coding sequence of interest and a 3rd sequence encoding Bxb1. Claim 1 encompasses delivering the 1st, 2nd and 3rd sequences in the absence of Cas9. However, the specification is limited to electroporating a zygote with the 1st sequence comprising the 1st integrase attachment site and a Cas9 ribonucleoprotein followed by microinjecting a two cell blastomere with a 2nd sequence comprising a 2nd integrase attachment site and a coding sequence of interest and a 3rd sequence encoding Bxb1 (Fig. 1; pg 5, lines 8-14). Pg 18, line 5, says the sequence encoding Cas9 was inserted into a Rosa26 gene of the mouse embryo. The specification does not teach how to integrate the 1st site without Cas9. The specification does not teach how to integrate the Cas9 coding sequence other than the Rosa26 gene, a “safe harbor” gene. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to perform the method as broadly claimed.
The specification does not enable making any “engineered” embryo whose genome comprises the sequence encoding a product of interest as broadly encompassed by claim 1 other than one whose genome comprises a Cas9 coding sequence operably linked to an endogenous Rosa26 promoter. Example 1 (pg 18-19) is limited to inserting a Cas9 coding sequence into an endogenous Rosa26 gene of the embryo (Fig. 1). Pg 5, line 9, says a 1st Bxb1 attP site is inserted into a CD68 gene using a Cas9-mediated repair template. Pg 5, line 10, says a sequence encoding Cas9 containing a Bxb1 attB site is inserted into a CD68 gene using Bxb1 integration. The specification does not correlate this limited embodiment to any other genetic “engineered” state as broadly encompassed by claim 1. Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to do so other than the limited embodiment shown in Fig. 1.
The specification does not enable making/using any 1st integrase attachment site being “operably linked to an endogenous promoter of a gene of interest” as required in claim 11. As written, the claim seems to encompass delivering a 1st nucleic acid sequence comprising an integrase attachment site operably linked to a promoter that is “endogenous” to the zygote. However, this concept is not disclosed in the specification. Moreover, the 1st integrase attachment site cannot be operably linked to an endogenous promoter of the zygote until the 1st nucleic acid sequence has been integrated into the genome of the zygote which is missing from the claim.
The specification does not enable making/using any 1st integrase attachment site being “upstream from (5’) and in frame with a transcriptional start codon or downstream from (5’) and in frame with a transcriptional start codon” as required in claim 12. As written, the claim seems to encompass delivering a 1st nucleic acid sequence comprising an integrase attachment site in frame (upstream or downstream) of a transcriptional start codon. However, this concept is not disclosed in the specification. Moreover, the 1st integrase attachment site cannot be in frame (upstream or downstream) of a transcriptional start codon until the 1st nucleic acid sequence has been integrated into the genome of the zygote which is missing from the claim.
The specification does not enable making/using any 1st integrase attachment site being “flanked by nucleotide sequences homologous to nucleotide sequences in the genome of the zygote” as required in claim 14. As written, the claim seems to encompass delivering a 1st nucleic acid sequence comprising an integrase attachment site flanked by nucleotide sequences homologous to nucleotide sequences in the genome of the zygote. However, this concept is not disclosed in the specification. Moreover, the 1st integrase attachment site cannot be flanked by nucleotide sequences homologous to nucleotide sequences in the genome of the zygote until the 1st nucleic acid sequence has been integrated into the genome of the zygote which is missing from the claim.
Given the lack of guidance in the specification taken with the art at the time of filing, it would have required those of skill undue experimentation to determine how to perform the methods of claims 11, 12, 14 as broadly claimed.
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 1, 4, 5, 7-9, 11, 12, 14-21, 23, 47-49 as newly amended 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.
The metes and bounds of “cognate integrase” in claim 1 cannot be determined. The specification uses the phrase on pg 2, lines 13-17; pg 6, lines 25, 26; and pg 8, line 5, and gives an example as Bxb1 (pg 6, line 25). However, the specification and the art at the time of filing do not define when an integrase is “cognate”. Integrases include retroviral integrases, serine integrases (φC31, TP901-1 and Bxb1), tyrosine integrases (Cre, Flp, XerDC), phage integrases (e.g. φC31 and λ integrases). It is unclear when an integrase is “cognate” as claimed. Therefore, those of skill would not be able to determine when they were infringing on the claim.
Claim 5 is indefinite because it limits the “delivering to a single cell zygote” via electroporation or “via microinjection into each cell of the embryo”. The phrase “each cell of the embryo” does not make sense and does not further limit the delivery because the zygote is a single cell.
Claim 12 is indefinite because it says the attachment site is “downstream from (5’)”; however, downstream is 3’ relative to the insertion point. Use of “(5’)” to refer to both “upstream” and “downstream” regions is scientifically and logically incorrect. This makes the claim indefinite.
35 USC § 102
The rejection of claims 1, 4, 5, 7, 9, 11, 12, 14-16, 23 under 35 U.S.C. 102(a)(2) as being anticipated by Luo (20120124686) has been withdrawn. Luo introduced an attP, attB, attR site and a nucleic acid encoding a protein of interest into an embryo and cultured the embryo such that a multi-celled embryo was obtained. The genome of the cell contains a second recombination site (abstract; para 5, 13, 59, 60-62, 75, 78; claims 1, 3, 4, 8, 18) as required in claim 1. The exogenous sequence is in para 99, 202, and throughout, e.g. encoding GFP. Luo did not teach the embryo was a [single-cell] zygote or delivering an att site to a zygote followed by culturing the zygote such that a multi-cell embryo is obtained followed by delivering a 2nd nucleic acid comprising a second att site and a “sequence encoding a product of interest” and a 3rd nucleic acid encoding an integrase to the embryo as newly required in claim 1.
The rejection of claims 1-3, 5, 8, 9, 11, 12, 14-21, 23 under 35 U.S.C. 102(a)(2) as being anticipated by Farruggio (20200385710) has been withdrawn.
Farruggio introduced Bxb1 integrase attP and attB sites into a [single-cell] zygote along with a sequence encoding a product of interest and maintained the cells (claim 1; para 43). Delivery of the DNA was by microinjection or electroporation (para 47, 62, 97) as required in claim 5. Bxb1 integrase is the integrase in claim 8. Farruggio taught using attP and attB sites for Bxb1 (see above) as required in claim 9. Farruggio inserted the attP or attB site into a Hipp11 (H11) or Rosa26 (R26) gene which means they are “operably linked to an endogenous [H11 or R26] promoter” (para 46, 68, 100, 101, 103, et al.) as required in claim 11. Farruggio inserted the attP or attB site into a Hipp11 (H11) or Rosa26 (R26) gene which means they are “operably linked to an endogenous [H11 or R26] promoter” (para 46, 68, 100, 101, 103 et al.) and downstream and in frame with the H11 or R26 start codon as required in claim 12. The sites are in a targeting construct that contains 5’ and 3’ homology arms that bind genomic (H11 or R26) sequences within the cells as required in claim 14. The sequence is in a “minicircle” as required in claim 15 because it is in a small plasmid. The nucleic acid encoding integrase is mRNA (para 44, 51, 61) as required in claim 16. Farruggio taught using the technology in combination with a “programmable nuclease” (4, 5, 78, 92) such as an RNA guided nuclease (4, 5, 78, 92), e.g. Cas9 (4), or ZFN or TALEN (78) as required in claims 17-21. Farruggio taught the cells were from a mammal, rodent, rat or mouse (end of para 43) as required in claims 23, 47-49.
Farruggio did not teach delivering an att site to a [single-cell] zygote followed by culturing the zygote such that a multi-cell embryo is obtained followed by delivering a 2nd nucleic acid comprising a second att site and a “sequence encoding a product of interest” and a 3rd nucleic acid encoding an integrase to the embryo as newly required in claim 1.
The rejection of claims 1-5, 8, 14, 15, 17-20, 23 under 35 U.S.C. 102(a)(2) as being anticipated by Yu (Scientific Reports, 2019, Vol. 9, No. 1971, pg 1-13) has been withdrawn.
Yu introduced a pair of Bxb1 integrase attP sites into a zygote along with a sequence encoding a product of interest and maintained the cells (pg 2-3, “Strategy…”; pg 10-11, “Animals and microinjection of zygotes”). Bxb1 integrase is a “cognate” integrase as required in claim 1. Yu implanted the zygote into a recipient female (pg 10-11, “Animals and microinjection of zygotes”). Delivery of the DNA is by microinjection (pg 10-11, “Animals and microinjection of zygotes”) as required in claim 5. Bxb1 integrase is the integrase in claim 8. Yu is limited to using a pair of attP sites and did not teach using i) attP and attB; or ii) attB and attP as the 1st and 2nd “integrase attachment sites”, respectively, as required in claims 9, 11, 12. The sites are in a targeting construct that contains 5’ and 3’ homology arms that bind genomic (H11 or R26) sequences within the cells as required in claim 14. The sequence is in a “minicircle” as required in claim 15 because it is in a small plasmid. Yu did NOT teach a nucleic acid encoding integrase that mRNA as required in claim 16. Yu taught using the technology in combination with a Cas9 (pg 2-3, “Strategy…”; pg 10, “crRNA design…”) as required in claims 17-20. Yu is limited to using Cas9 and did not teach using the technology in combination with ZFN or TALEN as required in claim 21. Yu taught the cells were from a rodent, which is a mammal as required in claim 23. Yu taught the cells were from a rodent as required in claim 47.
Yu did not teach delivering an att site to a [single-cell] zygote followed by culturing the zygote such that a multi-cell embryo is obtained followed by delivering a 2nd nucleic acid comprising a second att site and a “sequence encoding a product of interest” and a 3rd nucleic acid encoding an integrase to the embryo as newly required in claim 1.
35 USC § 103
The rejection of claims 1-5, 7, 9, 11, 12, 14-16, 23, 30 under 35 U.S.C. 103 as being unpatentable over Luo (20120124686) in view of Oudit (Cardiovascular Res., 2007, Vol. 75, pg 29-39) has been withdrawn for reasons set for above under Luo. This rejection was made to address the limitation of targeting a mouse angiotensin-converting enzyme 2 (ACE2) gene in claim 30 which has been canceled.
The rejection of claims 1-3, 5, 8, 9, 11, 12, 14-21, 23, 30 under 35 U.S.C. 103 as being unpatentable over Farruggio (20200385710) in view of Oudit (Cardiovascular Res., 2007, Vol. 75, pg 29-39) has been withdrawn for reasons set for above under Farruggio. This rejection was made to address the limitation of targeting a mouse angiotensin-converting enzyme 2 (ACE2) gene in claim 30 which has been canceled.
The rejection of claims 1-5, 8, 14, 15, 17-20, 23, 30 under 35 U.S.C. 103 as being unpatentable over Yu (Scientific Reports, 2019, Vol. 9, No. 1971, pg 1-13) in view of Oudit (Cardiovascular Res., 2007, Vol. 75, pg 29-39) has been withdrawn for reasons set for above under Yu. This rejection was made to address the limitation of targeting a mouse angiotensin-converting enzyme 2 (ACE2) gene in claim 30 which has been canceled.
The art at the time of filing did not reasonably teach or suggest delivering a 1st integrase attachment site to a [single-cell] zygote, culturing the zygote such that a multi-cell embryo is obtained, delivering a 2nd nucleic acid comprising a 2nd integrase attachment site and a “sequence encoding a product of interest” and a 3rd nucleic acid encoding an integrase to the embryo as newly required in claim 1.
Applicants are reminded that if they are aware of any references that teach or suggest delivering a nucleic acid to a [single-cell] zygote, culturing the zygote such that a multi-cell embryo is obtained, and delivering a 2nd nucleic acid to the embryo, then it is incumbent upon them to specifically point to such references.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638