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 1-21 are pending.
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-10, in the reply filed on 1-11-26 is acknowledged. The traversal is on the ground(s) that the addition of “by reduction or inhibition or a combination thereof, of gametogenesis, meiosis, gamete function, or gamete fertilization” has been added to the product claim. This is not found persuasive because the phrase added makes the product-by-process claim, but the process does not distinguish the product claimed from the chicken PGCs with a modified DAZL or DDX4 gene described by McGrew (CA 3115886). More importantly, the modified DAZL or DDX4 gene described by McGrew reduces/inhibits gametogenesis, meiosis, gamete function, or gamete fertilization. Therefore, claim 1 is still not a contribution over the art. The requirement is still deemed proper and is therefore made FINAL.
Claims 11-21 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 1-11-26.
Claims 1-10 are under consideration and are only under consideration as they relate to an avian PGC with a genetically modified DDX4 gene capable of producing an infertile living avian.
Claim Objections
Claim 1 uses elliptical, confusing, and repetitive language to describe the avian PGCs and can be written much more succinctly as ---A genetically modified avian primordial germ cell comprising a genetically modified gene that causes sterility in an avian obtained from the PGC---. The concept of the PGC having a modified gene “inducing sterility [produced] by reduction or inhibition or a combination thereof, of gametogenesis, meiosis, gamete function, or gamete fertilization” in claim 1 makes the claim a product-by-process claim. However, it is unclear how that alters the structure or function of the PGC. Use of “gene-edited or genetically modified” is used at least three times in the claim, but the phrase is redundant and should be simplified because they mean the same thing. The phrase “first genetic modification on a chromosome, said modification modifying a trait in the PGC” can be written more clearly as ---a genetically modified gene---. The phrase “the gene edited or genetically modified avian produced by the PGC” is used three times in the claim, but it lacks antecedent basis. The genotype and phenotype of the PGC can be written more simply as --- comprising a genetically modified gene that causes sterility in an avian obtained from the PGC---. The phrase “reducing or inhibiting or a combination thereof” is redundant; pick one because they mean the same thing. The concept of “inducing sterility by reduction or inhibition of gametogenesis, … …, gamete function, or gamete fertilization” applies only to an avian obtained from the PGC. It also appears to be a mechanism of action for “inducing sterility”, so it’s not really helping. The phenotype should be written in context of an avian obtained from the PGC, i.e. ---a genetically modified gene that causes decreased gametogenesis, meiosis, gamete function in an avian obtained from the PGC---. The phrase “gamete fertilization” is a step beyond the features of an avian obtained from the PGCs because it refers to a process that hasn’t happened in the PGC or the avian; it may describe an inability of the gametes of the avian or the inability of the avian to be fertile, but the phrase as written does not make sense.
The phrase “without impairing viability” of an avian produced by the PGC can be written more simply as ---A genetically modified avian primordial germ cell (PGC) comprising a genetically modified gene that causes sterility in a living avian obtained from the PGC---.
Claims 2-10 have similar redundancies, ellipses, and use of phrases without antecedent basis.
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 1-10 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 species of avian PGC capable of making a genetically modified, sterile, living avian with any modification of a DDX4 gene as required in claim 1 or 9 other than an isolated chicken PGC with an inactivated DDX4 gene. Claim 1 or 9 encompasses any species of avian including chicken, duck, turkey, goose, bantam, quail, pheasants, eagles, hummingbirds, parrots, finches, hawks, owl, flamingo, woodpecker, crows, ostrich, emu, etc. The PGCs may be in vitro or in vivo. The DDX4 gene may have any substitution, insertion or deletion and may express functional or partially functional DDX4, have decreased DDX4 expression, or be inactivated.
Example 1 (pg 53) is prophetic and suggests modifying a gene in any avian PGCs to make avian embryos devoid of PGCs (para 190). The specification does not teach the structure of any avian gene or any modified avian gene that makes avian embryos devoid of PGCs. The remaining examples are prophetic and do not disclose any specific species of PGCs or DDX4 genes. The examples do not disclose any specific modification of any specific avian DDX4 gene that causes sterility without impairing viability as required in claim 1 or 9.
McGrew (CA 3115886) taught an isolated chicken PGC with an inactivated DDX4 gene that reduces/inhibits gametogenesis, meiosis, gamete function, or gamete fertilization in a living avian obtained from the PGC (pg 2, lines 26-34; 3, lines 25-34; pg 4-, lines 15-25; pg 19, lines 15-20). This is equivalent to claim 1 or 9 because embryos obtained from the PGCs lack germ cells (claim 1 “causes death of germ cells”; claim 9).
Applicants fail to correlate the chicken PGCs or DDX4 gene of McGrew to any other avian species of PGCs or DDX4 gene as broadly encompassed by claim 1 or 9. The art is silent in this regard.
Applicants fail to correlate the inactivated DDX4 gene of McGrew to any other “modification”, i.e. insertion, substitution, deletion, as broadly encompassed by claim 1 or 9 that would cause sterility without impairing viability as required in claim 1. The art is silent in this regard.
Applicants fail to correlate the isolated PGCs of McGrew to PGCs with the modification in vivo because embryos obtained from the PGCs with an inactivated DDX4 gene have “death of germ cells”. PGCs with the inactivated DDX4 are not disclosed in vivo.
Accordingly, the concept lacks written description.
Claim 7 has been included because the specification does not teach making or using PGCs or teach the identify of any DDX4 gene from any Galliformes, i.e. chicken, grouse, quail, pheasant, partridge, peafowl, turkey, ; Anseriformes, i.e. ducks, mallards, swans, geese; Otidiformes, i.e. bustard; or Columbiformes, i.e. doves, pigeons, other than chicken.
Claim 8 has been included because the specification does not teach making or using PGCs or teach the identify of any DDX4 gene from any Galliformes Numidia or Phasianidae family, or Gallus or Meleagris genus other than chicken.
B) The specification lacks written description for any “modification” of a DDX4 gene in an avian cell inducing sterility “by reduction [ ] of gametogenesis, meiosis, gamete function, or gamete fertilization” as required in claim 1.
The claim encompasses any number of DDX4 modifications that inhibit any aspect of gametogenesis, inhibits any aspect of meiosis, inhibits any function of any gamete, or inhibits the ability of any gamete to fertilize another gamete.
McGrew (CA 3115886) taught an isolated chicken PGC with an inactivated DDX4 gene that reduces/inhibits gametogenesis, meiosis, gamete function, or gamete fertilization in a living avian obtained from the PGC (pg 2, lines 26-34; 3, lines 25-34; pg 4-, lines 15-25; pg 19, lines 15-20). This is equivalent to claim 1 because embryos obtained from the PGCs lack germ cells (claim 1 “causes death of germ cells”; claim 9).
Example 1 (pg 53) is prophetic and suggests modifying a gene in any avian PGCs to make avian embryos devoid of PGCs (para 190). The remaining examples are prophetic and do not disclose any specific species of DDX4 modifications. The specification does not teach the structure of any specific modification of any avian DDX4 gene that is associated with any of these mechanisms of action. The specification does not teach any specific DDX4 gene modifications that inhibit any aspect of gametogenesis or meiosis, inhibit any function of any gamete, or inhibit the ability of any gamete to fertilize another gamete. The specification does not distinguish any specific DDX4 gene modifications that inhibit gametogenesis from those that inhibit meiosis, any function of any gamete, or the ability of any gamete to fertilize another gamete.
Applicants fail to correlate the inactivation of DDX4 gene that kills PGCs in an embryo described by McGrew to any other DDX4 gene modification that inhibits any aspect of gametogenesis or meiosis, any function of any gamete, or the ability of any gamete to fertilize another gamete as broadly encompassed by claim 1. The art is silent in this regard.
Accordingly, the concept lacks written description.
C) The specification lacks written description for modifying any two genes that cause sterility without impairing viability as required in claim 4. The specification contemplates modifying any of the genes listed in claim 3 “or a combination thereof”; however, the specification does not reduce such a PGC to practice in the Examples. An adequate written description of PGCs with genetic modification of two genes that cause sterility without impairing viability requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it; what is required is a description of the specific modification in two specific genes in one specific avian species that cause sterility without impairing viability. It is not sufficient to define the product solely by its principal biological property, i.e. having modifications in two genes that cause sterility without impairing viability, because disclosure of no more than that, as in the instant case, is simply a wish to know the identity of any modification in any two genes that cause sterility without impairing viability. Also, naming a type of material generically known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Thus, claiming all avian PGCs with modifications in any two genes that cause sterility without impairing viability without defining what means will do is not in compliance with the description requirement. Rather, it is an attempt to preempt the future before it has arrived.
Claim 6 has been included because it requires modifying two genes on the same chromosome.
D) The specification lacks written description for an embryo comprising the genetically modified avian PGC as required in 9 for reasons set forth above.
E) The specification lacks written description for an avian comprising the genetically modified avian PGC as required in 10 because McGrew taught the inactivated DDX4 gene killed the PGCs by the time the chickens were born. Therefore, the avians didn’t have any genetically modified PGCs anymore because they had all been killed. See above.
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.
Claims 1-10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A) Claim 1 uses elliptical, confusing, and repetitive language to describe the avian PGCs which makes the claim indefinite. The concept of the PGC having a modified gene “inducing sterility [produced] by reduction or inhibition or a combination thereof, of gametogenesis, meiosis, gamete function, or gamete fertilization” in claim 1 makes the claim a product-by-process claim. However, it is unclear how the mechanism of action alters the structure or function of the PGC or the modified DDX4 gene. Use of “gene-edited or genetically modified” is used at least three times in the claim, but the phrase is redundant and should be simplified because they mean the same thing. If they are intended to mean different things, then the distinction cannot be determined.
The phrase “the gene edited or genetically modified avian produced by the PGC” is used three times in the claim, but it lacks antecedent basis.
The phrase “reducing or inhibiting or a combination thereof” is redundant; pick one because they mean the same thing. If they are intended to mean different things, then the distinction cannot be determined.
The concept of “inducing sterility by reduction or inhibition of gametogenesis, … …, gamete function, or gamete fertilization” applies only to an avian obtained from the PGC; however, there is no avian in the claim.
The phrase “gamete fertilization” is a step beyond the features of the PGC claimed or even an avian obtained from the PGCs because it refers to a process that hasn’t happened in the PGC or the avian. It may describe an inability of the gametes of the avian or the inability of the avian to be fertile, but the phrase as written does not make sense.
Accordingly, those of skill would not be able to determine when they were infringing on the claim.
Claims 2-10 use similar language and are indefinite for the reasons cited above.
B) Claim 10 is indefinite because it requires an avian comprising PGCs with a genetically modified DDX4 gene; however, McGrew taught germ cells are killed in an avian made with PGCs containing a genetically modified DDX4 gene. Therefore, the avian cannot contain the genetically modified PGCs as claimed.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-10 are rejected under 35 U.S.C. 102a1 as being anticipated by McGrew (CA 3115886).
The concept of the avian PGC having a modified chromosome and “inducing sterility [produced] by reduction or inhibition or a combination thereof, of gametogenesis, meiosis, gamete function, or gamete fertilization” in claim 1 makes the claim a product-by-process claim.
McGrew taught an isolated chicken PGC with a modified DDX4 gene that reduces/inhibits gametogenesis, meiosis, gamete function, or gamete fertilization in a living avian obtained from the PGC (pg 2, lines 26-34; 3, lines 25-34; pg 4-, lines 15-25; pg 19, lines 15-20). This is equivalent to claim 1.
The DDX4 modifications have a “function specific to gametogenesis, gamete maturation, or gamete function” and “reduce or inhibit survival, maturation, or differentiation of a PGC derived from the gene-edited or genetically modified avian” [that doesn’t exist] because PGCs containing the mutation were killed (claim 1 “causes death of germ cells”; claim 9). This is equivalent to claim 2.
McGrew taught DDX4 as required in claim 3.
McGrew taught two modifications in two genes (“(i) a first nucleotide” and “(ii) a second nucleotide” (claim 1). This is equivalent to claim 4.
McGrew taught both males and females obtained from the PGCs were fertile as required in claim 5 (Examples). This is equivalent to claim 5.
McGrew used a GFP coding sequence in the targeted gene (Examples) which is equivalent to claim 6.
McGrew taught “ the avian may be of the order Galliformes,…otidiformes, columbiformes” as required in claim 7 (pg 3, line 18-20).
Claim 8 has been included because it further limits the Galliformes without excluding the “otidiformes, columbiformes”. Claim 8 has been included because it encompasses “otidiformes, columbiformes” taught by McGrew.
Claim 9 has been included because McGraw taught a living sterile avian obtained from an embryo obtained from the genetically modified PGC. The embryo and adult avian have a genetically modified DDX4 gene that causes sterility in the avian. The mechanism of action of sterility in claim 9 has been included because McGrew taught the germ cells of the avian were killed (Examples).
Claim 10 has been included because McGraw taught a living sterile avian obtained from the genetically modified PGC. The adult avian had a genetically modified DDX4 gene that causes sterility in the avian. The mechanism of action of sterility in claim 10 has been included because McGrew taught the germ cells of the avian were killed (Examples).
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