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 1-34 have been canceled. Claims 35-41 remain pending and are under consideration.
Election/Restrictions
Applicant's election with traverse of Group I, claims 35-39 in the reply filed on 12-29-25 is acknowledged. The traversal is on the ground(s) that while MSTN mutations were known to cause excess muscle mass, enlarged heart, high blood pressure, and decreased life span in cattle, but the MSTN mutation in claim 35 causes excess muscle mass without causing adverse effects. This is not found persuasive because this assertion is unfounded in the specification or the art at the time of filing. More importantly, claim 35 encompasses a cattle with excess muscle mass, enlarged heart, high blood pressure, and decreased life span. The requirement is still deemed proper and is therefore made FINAL.
Claims 40 and 41 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 12-29-25.
Claim Objections
The phrase “wherein the animal is a non-human animal” at end of claim 35 should be in the preamble and the body of the claim, i.e. ---A transgenic non-human animal---.
Use of “artificially” in the phrase “artificially modified” or “artificial” in the phase “artificial modification” in claim 35 makes the claim unclear because the terms “artificially” and “artificial” do not further limit how the gene is genetically modified.
It is unclear whether the endogenous myostatin gene has been modified in claim 35 or if it encompasses introducing an exogenous modified myostatin gene that integrates randomly.
The genetically modified myostatin gene in claim 35 can be written more succinctly.
There is a “the” missing before “amino acid” in line 8 of claim 35.
Saying the nucleic acid sequence of the artificially modified myostatin gene encode a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33 AND saying the animal expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33 is redundant. Just say the animal expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33.
Claim 35 can be written more clearly as ---A transgenic non-human animal whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence leucine, tryptophan, isoleucine, and tyrosine (LWIY) has been deleted from exon 2, wherein the animal expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33---.
There is a “the” missing before “amino acid” in line 2 and in line 4 of claim 39.
Claim 39 can be written more clearly as ---An isolated transgenic [bovine] cell whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence leucine, tryptophan, isoleucine, and tyrosine (LWIY) has been deleted from exon 2, wherein the cell expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33---.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(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.
Written Description
Claims 35-39 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.
A) The specification lacks written description for any transgenic animal comprising an “artificially modified myostatin gene” where the modification is in a second exon of the myostatin gene, is a deletion of 12 base pairs corresponding to a region encoding an amino acid sequence of the order of leucine, tryptophan, isoleucine, and tyrosine (LWIY) in the second exons compared to an amino acid sequence of a wild-type pro-myostatin protein, wherein the nucleic acid sequences of the modified myostatin gene encodes an engineered pro-myostatin protein consisting of amino acid sequence selected from SEQ ID NO: 30-33, wherein the animal expresses the engineered pro-myostatin protein; and wherein the transgenic animal is a non-human animal.
Claim 35 is drawn to “A transgenic animal comprising an artificially modified myostatin gene, wherein the artificial modification is located in a second exon of the myostatin gene, wherein the modification is a deletion of 12 base pairs corresponding to a region encoding an amino acid sequence of the order of leucine, tryptophan, isoleucine and tyrosine (LWIY) in the second exons, compared to an amino acid sequence of a wild-type pro-myostatin protein, wherein a nucleic acid sequence of the artificially modified myostatin gene encodes an engineered pro-myostatin protein consisting of amino acid sequence selected from SEQ ID NOs: 30 to 33,wherein the transgenic animal expresses the engineered pro-myostatin protein and wherein the transgenic animal is a non-human animal.”
Claim 35 encompasses any genetically modified invertebrate, insect, fish, amphibian, reptile, bird or mammal.
Claim 35 encompasses an animal with an exogenous genetically modified myostatin gene in its genome, an episomal exogenous genetically modified myostatin gene, or an endogenous myostatin gene that has been genetically modified.
Claim 35 encompasses an animal with a wild-type phenotype, an animal with excess muscle mass, enlarged heart, high blood pressure, and decreased life span, or an animal with a normal life span that has excess muscle mass but not an enlarged heart or high blood pressure.
Crawford (WO 2008033042) taught a genetically modified cattle whose genome comprised a mutant myostatin gene, wherein the cattle exhibited increased muscle mass as compared to a wild-type cattle. The mutation was in exon 2 (nt419(del7-ins10)) which occurs in Maine-Anjou cattle (Grobet 1998) (pg 24, lines 5-11).
The specification is limited to a genetically modified cattle whose genome comprised a mutant myostatin gene, wherein the cattle exhibited increased muscle mass as compared to a wild-type cattle (Examples 1-11). sgRNAs were created to target exon 2 of an endogenous myostatin gene and make a 12 nucleotide deletion encoding leucine, tryptophan, isoleucine, and tyrosine (LWIY) (pg 3, lines 19-25; pg 9, lines 3-6; Fig. 4, SEQ ID NO: 7 that is -12 bp). Amino acids 156-159 of bovine or pig myostatin are LWIY; amino acids 157-159 of mouse myostatin are LWIY (pg 27, Table 3). The target sequence may be any of the nucleic acid sequences of SEQ ID NO: 38-60 (pg 28, para 249, through pg 30, para 256; Table 4).
Pg 21, para 187, through pg 22, para 192, and Table 2, show the wild-type mature myostatin amino acid sequence.
Pg 31, para 271, says the sgRNAs in Table 5 (pg 32) target a sequence in Table 2, but actually they target wild-type nucleic acid sequences encoding wild-type myostatin.
Example 1 describes making sgRNA in Table 2 that target myostatin coding sequences.
Examples 2 and 3 describe isolating bovine oocytes and fertilizing them (pg 45-46).
Example 4 (pg 47) describes microinjecting fertilized bovine zygotes with mRNA encoding Cas9 and sgRNAs.
Example 5 (pg 48) describes implanting microinjected zygotes into recipient females such that calves were obtained.
Example 6-7 (pg 49) describe an assay for identifying the desired 12 base deletion in exon 2.
Example 8 (pg 50) describes off target assays.
Example 9 (pg 51) describes “targeted deep sequening”.
Example 10 (pg 53) describes performing the assay to identify the desired 12 base deletion and any off target effects.
Example 11 – part 1 (pg 54) describes assay the female offspring obtained to determine germline transmission. Eggs were collected from the offspring, fertilized, and transferred to a recipient female. The mutation was successfully transmitted to F1 offspring (pg 57, line 20). Pg 58, para 482, describes Fig. 17 which shows sequencing data from offspring with 12 nucleotides deleted.
Example 11 – part 2 (pg 58) describes assay the male offspring obtained to determine germline transmission. Sperm was collected from the offspring, used to fertilize eggs, and transferred to a recipient female. The mutation was successfully transmitted to F1 offspring (pg 57, line 20). Pg 59, para 487, describes Fig. 21 which shows sequencing data from offspring with 12 nucleotides deleted.
The Examples do not teach the phenotype of the cattle obtained.
The specification fails to correlate the cattle embodiments to any invertebrate, insect, fish, amphibian, reptile, bird or non-human mammal other than bovine.
The specification fails to correlate genetically modifying an endogenous myostatin gene to any exogenous genetically modified myostatin gene integrated randomly into the genome of the animal. Or to any episomal exogenous genetically modified myostatin gene. It must be an endogenous myostatin gene that has been genetically modified.
Claim 35 encompasses an animal with a wild-type phenotype, an animal with excess muscle mass, enlarged heart, high blood pressure, and decreased life span, or an animal with a normal life span that has excess muscle mass but not an enlarged heart or high blood pressure. The specification does not teach the deletion of 12 nucleotides encoding LWIY in exon 2 WILL definitely cause any desired phenotype including increased muscle mass. It is unclear whether the deletion of 12 nucleotides encoding LWIY in exon 2 will cause enlarged heart, high blood pressure, and decreased life span in cattle.
Accordingly, these concepts lack written description.
B) The specification lacks written description for “myostatin mRNA expression” in the transgenic animal being “less than that of a wild-type animal” as required in claim 36. The concept cannot be found in the specification or any of the examples. It is unclear how/why the transgenic animal would have less mRNA expression than a wild-type animal because the transgenic animal still expresses mutant myostatin mRNA and uses the same cell machinery to do so as compared to a wild-type animal. While the mRNA may encode mutant myostatin in a transgenic animal, the amount of mRNA MUST be the same as in a wild-type animal because the cell machinery is the same. Accordingly claim 36 lacks written description.
C) The specification does not enable a transgenic non-human animal whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence LWIY has been deleted from exon 2, wherein the animal expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33 and has higher muscle mass than a wild-type animal as required in claim 38. Crawford (WO 2008033042) taught a genetically modified cattle whose genome comprised a mutant myostatin gene, wherein the cattle exhibited increased muscle mass as compared to a wild-type cattle. The mutation was in exon 2 (nt419(del7-ins10)) which occurs in Maine-Anjou cattle (Grobet 1998) (pg 24, lines 5-11).
Claim 35 encompasses an animal with excess muscle mass, enlarged heart, high blood pressure, and decreased life span.
Claim 35 also encompasses an animal with a normal life span that has excess muscle mass but not an enlarged heart or high blood pressure.
The specification and Examples are summarized above.
The specification does not teach the deletion of 12 nucleotides encoding LWIY in exon 2 of a myostatin gene WILL definitely cause any desired phenotype including increased muscle mass. It is unclear whether the deletion of 12 nucleotides encoding LWIY in exon 2 will cause enlarged heart, high blood pressure, and decreased life span in cattle.
Accordingly, claim 38 lacks written description.
D) The specification lacks written description for an engineered cell comprising a nucleic acid encoding an engineered pro-myostatin consisting of the amino acid sequence of SEQ ID NO: 30-33 as required in claim 39 other than an isolated transgenic bovine cell whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence LWIY has been deleted from exon 2, wherein the cell expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33.
Claim 35 encompasses any genetically modified plant or animal cell. Animal cells encompass invertebrate, insect, fish, amphibian, reptile, bird or mammalian cells.
Claim 35 encompasses a plant or animal cell with an exogenous genetically modified myostatin gene in its genome, an episomal exogenous genetically modified myostatin gene, or an endogenous myostatin gene that has been genetically modified.
Crawford (WO 2008033042) is summarized above.
The specification and the Examples are discussed above.
The specification fails to correlate the cattle embodiments to any plant cells. The specification fails to correlate the cattle embodiments to any invertebrate, insect, fish, amphibian, reptile, bird or non-human mammal cell other than bovine cells.
The specification fails to correlate genetically modifying an endogenous myostatin gene in a bovine cell to any exogenous genetically modified myostatin gene integrated randomly into the genome of the animal as broadly encompassed by claim 39. Or to any episomal exogenous genetically modified myostatin gene as broadly encompassed by claim 39. It must be an endogenous myostatin gene that has been genetically modified.
Accordingly, claim 39 lacks written description other than an isolated transgenic bovine cell whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence LWIY has been deleted from exon 2, wherein the cell expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33.
Enablement
Claims 35-39 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 a transgenic non-human mammal whose genome comprises a genetically modified myostatin gene comprising a deletion of 12 nucleotides in exon 2 encoding the amino acid sequence leucine, tryptophan, isoleucine, and tyrosine (LWIY), does not reasonably provide enablement for any species of non-human animal, a modified myostatin gene other than one in the genome comprising a genetically modified myostatin gene comprising a deletion of 12 nucleotides in exon 2 encoding the amino acid sequence LWIY. 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.
The specification does not enable any transgenic animal comprising an “artificially modified myostatin gene” where the modification is in a second exon of the myostatin gene, is a deletion of 12 base pairs corresponding to a region encoding an amino acid sequence of the order of leucine, tryptophan, isoleucine, and tyrosine (LWIY) in the second exons compared to an amino acid sequence of a wild-type pro-myostatin protein, wherein the nucleic acid sequences of the modified myostatin gene encodes an engineered pro-myostatin protein consisting of amino acid sequence selected from SEQ ID NO: 30-33, wherein the animal expresses the engineered pro-myostatin protein; and wherein the transgenic animal is a non-human animal.
Claim 35 and its breadth are cited above.
Crawford (WO 2008033042) taught a genetically modified cattle whose genome comprised a mutant myostatin gene, wherein the cattle exhibited increased muscle mass as compared to a wild-type cattle. The mutation was in exon 2 (nt419(del7-ins10)) which occurs in Maine-Anjou cattle (Grobet 1998) (pg 24, lines 5-11).
The specification is limited to a genetically modified cattle whose genome comprised a mutant myostatin gene, wherein the cattle exhibited increased muscle mass as compared to a wild-type cattle (Examples 1-11). sgRNAs were created to target exon 2 of an endogenous myostatin gene and make a 12 nucleotide deletion encoding leucine, tryptophan, isoleucine, and tyrosine (LWIY) (pg 3, lines 19-25; pg 9, lines 3-6; Fig. 4, SEQ ID NO: 7 that is -12 bp). Amino acids 156-159 of bovine or pig myostatin are LWIY; amino acids 157-159 of mouse myostatin are LWIY (pg 27, Table 3). The target sequence may be any of the nucleic acid sequences of SEQ ID NO: 38-60 (pg 28, para 249, through pg 30, para 256; Table 4).
Pg 21, para 187, through pg 22, para 192, and Table 2, show the wild-type mature myostatin amino acid sequence.
Pg 31, para 271, says the sgRNAs in Table 5 (pg 32) target a sequence in Table 2, but actually they target wild-type nucleic acid sequences encoding wild-type myostatin.
The Examples are summarized above and do not teach the phenotype of the cattle obtained.
The specification fails to correlate the cattle embodiments to any invertebrate, insect, fish, amphibian, reptile, bird or non-human mammal other than bovine.
The specification fails to correlate genetically modifying an endogenous myostatin gene to any exogenous genetically modified myostatin gene integrated randomly into the genome of the animal. Or to any episomal exogenous genetically modified myostatin gene. It must be an endogenous myostatin gene that has been genetically modified.
Claim 35 encompasses an animal with a wild-type phenotype, an animal with excess muscle mass, enlarged heart, high blood pressure, and decreased life span, or an animal with a normal life span that has excess muscle mass but not an enlarged heart or high blood pressure. The specification does not teach the deletion of 12 nucleotides encoding LWIY in exon 2 WILL definitely cause any desired phenotype including increased muscle mass. It is unclear whether the deletion of 12 nucleotides encoding LWIY in exon 2 will cause enlarged heart, high blood pressure, and decreased life span in cattle.
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 make/use any transgenic non-human animal as broadly encompassed by claim 35.
B) The specification does not enable “myostatin mRNA expression” in the transgenic animal being “less than that of a wild-type animal” as required in claim 36. The concept cannot be found in the specification or any of the examples. It is unclear how/why the transgenic animal would have less mRNA expression than a wild-type animal because the transgenic animal still expresses mutant myostatin mRNA and uses the same cell machinery to do so as compared to a wild-type animal. While the mRNA may encode mutant myostatin in a transgenic animal, the amount of mRNA MUST be the same as in a wild-type animal because the cell machinery is the same. 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.
C) The specification does not enable a transgenic non-human animal whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence LWIY has been deleted from exon 2, wherein the animal expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33 and has higher muscle mass than a wild-type animal as required in claim 38.
Crawford (WO 2008033042) taught a genetically modified cattle whose genome comprised a mutant myostatin gene, wherein the cattle exhibited increased muscle mass as compared to a wild-type cattle. The mutation was in exon 2 (nt419(del7-ins10)) which occurs in Maine-Anjou cattle (Grobet 1998) (pg 24, lines 5-11).
Claim 35 encompasses an animal with excess muscle mass, enlarged heart, high blood pressure, and decreased life span.
Claim 35 also encompasses an animal with a normal life span that has excess muscle mass but not an enlarged heart or high blood pressure.
The specification and Examples are summarized above.
The specification does not teach the deletion of 12 nucleotides encoding LWIY in exon 2 of a myostatin gene WILL definitely cause any desired phenotype including increased muscle mass. It is unclear whether the deletion of 12 nucleotides encoding LWIY in exon 2 will cause enlarged heart, high blood pressure, and decreased life span in cattle.
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 make a transgenic animal whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence LWIY has been deleted from exon 2, wherein the animal expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33 and has higher muscle mass than a wild-type animal as required in claim 38.
D) The specification does not enable making/using any engineered cell comprising a nucleic acid encoding an engineered pro-myostatin consisting of the amino acid sequence of SEQ ID NO: 30-33 as broadly encompassed by claim 39 other than an isolated transgenic bovine cell whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence LWIY has been deleted from exon 2, wherein the cell expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33.
Claim 35 encompasses any genetically modified plant or animal cell. Animal cells encompass invertebrate, insect, fish, amphibian, reptile, bird or mammalian cells.
Claim 35 encompasses a plant or animal cell with an exogenous genetically modified myostatin gene in its genome, an episomal exogenous genetically modified myostatin gene, or an endogenous myostatin gene that has been genetically modified.
Crawford (WO 2008033042) is summarized above.
The specification and the Examples are discussed above.
The specification fails to correlate the cattle embodiments to any plant cells. The specification fails to correlate the cattle embodiments to any invertebrate, insect, fish, amphibian, reptile, bird or non-human mammal cell other than bovine cells.
The specification fails to correlate genetically modifying an endogenous myostatin gene in a bovine cell to any exogenous genetically modified myostatin gene integrated randomly into the genome of the animal as broadly encompassed by claim 39. Or to any episomal exogenous genetically modified myostatin gene as broadly encompassed by claim 39. It must be an endogenous myostatin gene that has been genetically modified.
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 make/use any cell as broadly encompassed by claim 39 other than an isolated transgenic bovine cell whose genome comprises a genetically modified endogenous myostatin gene in which 12 nucleotides encoding the amino acid sequence LWIY has been deleted from exon 2, wherein the cell expresses a pro-myostatin protein consisting of the amino acid sequence of SEQ ID NO: 30, 31, 32, or 33.
Indefiniteness
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 37 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.
The concept of the “amino acid sequence of the engineered pro-myostatin protein lack[ing] an amino acid sequence of LWIY compared to amino acid sequence of wild-type pro-myostatin protein” in claim 37 fails to further limit claim 35 because claim 35 is already limited to SEQ ID NO: 30, 31, 32, or 33, each of which lacks LWIY.
Claim Rejections - 35 USC § 103In 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 35, 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over XM_061432883.1 and NP_001277896.1 in view of Crawford (WO 2008033042).
XM_061432883.1 encodes NP_001277896.1 is identical to SEQ ID NO: 30 except for a 4 amino acid deletion at positions 153-156:
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394
488
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390
470
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However, making a deletion in exon 2 of the myostatin gene was well known in the art as described by Crawford (pg 24, lines 5-11). Thus, it would have been obvious to those of ordinary skill in the art at the time of filing to delete amino acids LWIY from the MSTN gene to obtain a double muscle phenotype (pg 24, lines 12-17) to obtain more meat product. This is equivalent to claim 35.
Claim 37 has been included because it does not further limit claim 35.
Claim 38 has been included because mutations in exon 2 of the myostatin gene cause increased muscle mass.
Claim 39 has been included because the bovine is made of cells expressing a protein that consists of the amino acid sequence of SEQ ID NO: 30.
Thus, Applicants' claimed invention as a whole is prima facie obvious in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
Inquiry concerning this communication or earlier communications from the examiner should be directed to Michael C. Wilson who can normally be reached at the office on Monday through Friday from 9:30 am to 6:00 pm at 571-272-0738.
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Michael C. Wilson
/MICHAEL C WILSON/
Primary Examiner, Art Unit 1638
Prosecution Insights