DETAILED ACTION
Claims 1-22 are pending and under examination in the instant application. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 6/4/24 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement has been considered by the examiner, and an initialed and signed copy of the 1449 is attached to this action.
Claim Rejections - 35 USC § 112
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 1-22 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.
Independent claim 1 recites a product which is a “transgenic Betta comprising a chromosomally integrated expression cassette encoding a fluorescent protein, wherein the Betta comprises the “Purple Betta 1 transformation event” ”. It is unclear what is encompassed by the “Purple Betta 1 transformation event”, or why this phrase is enclosed by quotation marks. While the specification does refer to a Purple Betta 1 transformation event, the specification does not actually define what is encompassed by the “Purple Betta 1 transformation event”. It is unclear whether this event is meant to refer to a particular chromosomal integration event such as integration into a particular site in one of the fish chromosomes, or to a particular expression cassette which has been integrated into the fish, or both. The specification does not provide any guidance for what is meant by a “Purple Betta 1 transformation event” and further provides no guidance as to the structure of any chromosome which has undergone such an event. It is further noted that while this term includes the word “Purple”, the transgenic Betta is recited as comprising an expression cassette encoding a fluorescent protein not limited to a purple fluorescent protein. As the structure of the “Purple Betta 1 transformation event” cannot be determined, it is unclear whether the fluorescent protein reads broadly on a genus of fluorescent proteins of any color or whether applicant intends the fluorescent protein to a purple fluorescent protein. Thus, the claim as a whole is indefinite as the neither the metes and bounds of the claimed terms, and in particular the phrase “Purple Betta 1 transformation event”, nor the structure of the transgenic Betta can be determined. Claims 2-9, and 13-20 depend on claim 1 and thus are included in this rejection.
In the interests of compact prosecution, claims 1-9 and 13-20 has been given their broadest reasonable interpretation as encompassing any transgenic Betta fish with a chromosomally integrated expression vector encoding any fluorescent protein.
Claims 2 and 13 are further indefinite in that it recites the transgenic Betta of claim 1, or the progeny of claim 1, “wherein cryopreserved sperm cells comprising the Purple Betta 1 transformation event having been deposited at ATCC with Accession No. PTA-127166” (claim 2), or simply “having been deposited at ATCC” (claim 13). It is unclear how this wherein clause relates to the claimed transgenic Betta of claim 1. Claim 1 is drawn to a transgenic Betta fish, not to cryopreserved sperm cells. The wherein clause in claim 2 and claim 13 further recites what appears to be a past active event where the cells “having been deposited” appears to be potentially a method step. However, claim 1 is a product claim drawn to a transgenic Betta fish and not to a method of making such a fish or potentially a method of depositing cryopreserved sperm cells. Thus, the claim is confusing as it unclear what exactly is being claimed, a product which is a transgenic Betta fish, or a composition of products comprising the transgenic Betta fish and the cryopreserved sperm cells. In addition, note that claims 13 does not identify any accession number for the ATCC deposit. As such, the metes and bounds of the elements of the claim cannot be determined.
In the interests of compact prosecution, claims 2 and 13 have been given their broadest reasonable interpretation as reading on a transgenic Betta comprising a chromosomally integrated expression cassette encoding a fluorescent protein.
Independent claim 10 recites a method of making a “transgenic Betta comprising a chromosomally integrated expression cassette encoding a fluorescent protein, wherein the Betta comprises the “Purple Betta 1 transformation event” ”. It is unclear what is encompassed by the “Purple Betta 1 transformation event”, or why this phrase is enclosed by quotation marks. While the specification does refer to a Purple Betta 1 transformation event, the specification does not actually define what is encompassed by the “Purple Betta 1 transformation event”. It is unclear whether this event is meant to refer to a particular chromosomal integration event such as integration into a particular site in one of the fish chromosomes, or to a particular expression cassette which has been integrated into the fish, or both. The specification does not provide any guidance for what is meant by a “Purple Betta 1 transformation event” and further provides no guidance as to the structure of any chromosome which has undergone such an event. It is further noted that while this term includes the word “Purple”, the transgenic Betta is recited as comprising an expression cassette encoding a fluorescent protein not limited to a purple fluorescent protein. As the structure of the “Purple Betta 1 transformation event” cannot be determined, it is unclear whether the fluorescent protein reads broadly on a genus of fluorescent proteins of any color or whether applicant intends the fluorescent protein to a purple fluorescent protein. Thus, the claim as a whole is indefinite as the neither the metes and bounds of the claimed terms, and in particular the phrase “Purple Betta 1 transformation event”, nor the structure of the transgenic Betta can be determined. Claims 11-12 and 21-22 depend on claim 10 and thus are included in this rejection.
In the interests of compact prosecution, claims 10-12 and 21-22 has been given their broadest reasonable interpretation as encompassing any transgenic Betta fish with a chromosomally integrated expression vector encoding any fluorescent protein.
Claim 11 is further indefinite in that it recites the method of making a transgenic Betta of claim 10, “wherein cryopreserved sperm cells comprising the Purple Betta 1 transformation event having been deposited at ATCC with Accession No. PTA-127166”. It is unclear how this wherein clause relates to the claimed method of making a transgenic Betta of claim 10. Claim 10 does not include a step of using cryopreserved sperm cells to make the transgenic Betta. The wherein clause in claim 11 further recites what appears to be a past active event where the cells “having been deposited” appears to be potentially a method step. However, from the use of the past tense it is not clear whether the activity of depositing the sperm cells is intended to be a step in the method of making a Betta as set forth in claim 10. Thus, the claim is confusing as it unclear how the cryopreserved sperm cells or their deposit with the ATCC relates to the method steps for making a transgenic Betta as set forth in claim 10. As such, the metes and bounds of the elements of the claim cannot be determined.
In the interests of compact prosecution, claim 11 has been given its broadest reasonable interpretation as reading on a method of making a transgenic Betta comprising a chromosomally integrated expression cassette encoding a fluorescent protein.
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.
Claims 1-22 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.
The instant claims recite a transgenic Betta comprising a chromosomally integrated expression cassette encoding a fluorescent protein, wherein the Betta comprises the “Purple Betta 1 transformation event”, or methods of making a transgenic Betta with the “Purple Betta 1 transformation event”. The specification lacks adequate written description for what is encompassed by the “Purple Betta 1 transformation event”. While the specification does refer to a Purple Betta 1 transformation event, with and without the quotes, the specification does not actually define what is encompassed by the “Purple Betta 1 transformation event”. It is unclear whether this event is meant to refer to a particular chromosomal integration event such as integration into a particular site in one of the fish chromosomes, or to a particular expression cassette which has been integrated into the fish, or both. The specification does not provide any definition or description for what is meant by a “Purple Betta 1 transformation event” and further provides no description relating to the structure of any chromosome which has undergone such an event. It is further noted that while this term includes the word “Purple”, the transgenic Betta in the claims is recited as comprising an expression cassette encoding a fluorescent protein not limited to a purple fluorescent protein. The disclosure provided by the instant specification is limited and while an expression cassette is mentioned in the specification, no specifics as to the structure of any such expression cassette is disclosed other than general guidance that the expression cassette encodes a fluorescent protein which can be a purple fluorescent protein (PFP) such as FP635, Katushka2S, mKate2, mCherry2, mCherry, mKate-S158C, eqFP650, mPlum, jRed, and mRFPI (specification, paragraph 22). Note that several of these examples are not actually purple fluorescent proteins. mCherry and mKate2, for example, are both bright red fluorescent proteins. The specification does not actually disclose whether the “Purple Betta 1 transformation event” involves the insertion of an expression cassette encoding a purple fluorescent protein or any other fluorescent protein, or what type of fluorescent protein is actually expressed in the Betta fish following this “event”. The only additional disclosure related to the “Purple Betta 1 transformation event” indicates that cryopreserved sperm cells comprising the Purple Betta 1 transformation event have been deposited at the American Type Culture Collections (ATCC) in Manassas, VA under the provision of the Budapest Treaty as “Purple Betta 1” under Provisional Accession Number PTA-127166 (specification, paragraph 39). Note that while the specification states that the deposit has been made under the provisions of the Budapest Treaty that the Accession Number provided is a provisional Accession Number. The claims, however, are not limited to a transgenic Betta fish which has been generated from the deposited cryopreserved sperm. The claims simply recite that the transgenic Betta comprises the “Purple Betta 1 transformation event”. While claims 2 and 11 do recite a “wherein” clause that refers to cryopreserved sperm with the ATCC provisional accession number PTA-127166, the claims do not actually recite that the transgenic Betta fish have been made using these sperm. See also the discussion of these claims above in the rejection of the claims under 35 U.S.C. 112(b), for indefiniteness.
As set forth in MPEP 2163:
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. However, a showing of possession alone does not cure the lack of a written description. Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 969-70, 63 USPQ2d 1609, 1617 (Fed. Cir. 2002). For example, it is now well accepted that a satisfactory description may be found in originally-filed claims or any other portion of the originally-filed specification. See In re Koller, 613 F.2d 819, 204 USPQ 702 (CCPA 1980); In re Gardner, 475 F.2d 1389, 177 USPQ 396 (CCPA 1973); In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). However, that does not mean that all originally-filed claims have adequate written support. The specification must still be examined to assess whether an originally-filed claim has adequate support in the written disclosure and/or the drawings.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaff v. Wells Elecs., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm., 927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991) (one must define a compound by "whatever characteristics sufficiently distinguish it"). "Compliance with the written description requirement is essentially a fact-based inquiry that will ‘necessarily vary depending on the nature of the invention claimed.’" Enzo Biochem, 323 F.3d at 963, 63 USPQ2d at 1612.
In regards to the written description requirement for genuses, MPEP 2163 states:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014).
While the claims recite transgenic Betta comprising the “Purple Betta 1 transformation event”, the applicant has not provided any description or reduction to practice of any specific “Purple Betta 1 transformation event” in a Betta fish. Further, while the specification does disclose cryopreserved sperm with a provisional accession number deposited with the ATCC, the claims are not limited to transgenic Betta fish generated from these deposited sperm.
Therefore, based on the limited description provided in applicant's specification as discussed in detail above as to what structure/structures is/are encompassed by a “Purple Betta 1 transformation event” in a Betta fish, the skilled artisan cannot envision the detailed chemical structure of the transgenic Betta fish or progeny thereof as claimed. As such, the specification does not demonstrate that applicant was in possession of and/or had reduced to practice the generic invention as claimed. Applicant is reminded that adequate written description requires more than a mere statement that it is part of the invention. See Fiers v. Revel, 25 USPQ2d 1602 at 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Thus, for the reasons outlined above, claims 1-22 do not meet the requirements for written description under 35 U.S.C. 112, first paragraph.
Claims 1-22 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 enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The instant claims recite a transgenic Betta comprising a chromosomally integrated expression cassette encoding a fluorescent protein, wherein the Betta comprises the “Purple Betta 1 transformation event”, or methods of making a transgenic Betta with the “Purple Betta 1 transformation event”. The specification lacks adequate guidance for introducing a “Purple Betta 1 transformation event” into a transgenic Betta fish. While the specification does refer to a Purple Betta 1 transformation event, with and without the quotes, the specification does not actually define what is encompassed by the “Purple Betta 1 transformation event”. It is unclear whether this event is meant to refer to a particular chromosomal integration event such as integration into a particular site in one of the fish chromosomes, or to a particular expression cassette which has been integrated into the fish, or both. The specification does not provide any definition or description for what is meant by a “Purple Betta 1 transformation event” and further provides no disclosure relating to the structure of any chromosome which has undergone such an event. It is further noted that while this term includes the word “Purple”, the transgenic Betta in the claims is recited as comprising an expression cassette encoding a fluorescent protein not limited to a purple fluorescent protein. The disclosure provided by the instant specification is limited, and while an expression cassette is mentioned in the specification, no specifics as to the structure of any such expression cassette is disclosed other than general guidance that the expression cassette encodes a fluorescent protein which can be a purple fluorescent protein (PFP) such as FP635, Katushka2S, mKate2, mCherry2, mCherry, mKate-S158C, eqFP650, mPlum, jRed, and mRFPI (specification, paragraph 22). Note that several of these examples are not actually purple fluorescent proteins. mCherry and mKate2, for example, are both bright red fluorescent proteins. The specification further does not actually disclose whether the “Purple Betta 1 transformation event” involves the insertion of an expression cassette encoding a purple fluorescent protein or any other fluorescent protein, or what type of fluorescent protein is actually expressed in the Betta fish following this “event”.
The only additional disclosure related to the “Purple Betta 1 transformation event” indicates that cryopreserved sperm cells comprising the Purple Betta 1 transformation event have been deposited at the American Type Culture Collections (ATCC) in Manassas, VA under the provision of the Budapest Treaty as “Purple Betta 1” under Provisional Accession Number PTA-127166 (specification, paragraph 39). However, note that while the specification states that the deposit has been made under the provisions of the Budapest Treaty, the Accession Number provided is a provisional Accession Number. Provisional Accession Numbers are assigned immediately following deposit pending viability testing. The specification does not state that a non-provisional Accession Number has been granted which would complete the requirement of the Budapest Treaty. If applicant’s deposit to the ATCC under the provisional Accession Number PTA-127166 has been shown to be viable under the terms of the Budapest Treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the deposit has been made under the terms of the Budapest Treaty, and that all restrictions imposed by the depositor on the availability to the public of the deposited material will be irrevocably removed upon the granting of a patent, would satisfy the deposit requirement. See 37 CFR 1.808. If the deposit made was not viable under the Budapest Treaty, then in order to certify that the deposit meets the criteria set forth in 37 CFR 1.808, applicants may provide assurance of compliance by an affidavit or declaration, or by a statement by an attorney of record over his or her signature and registration number, showing that (a) during the pendency of this application, access to the invention will be afforded to the commissioner upon request: (b) all restrictions upon availability to the public will be irrevocably removed upon granting of the patent: (c) the deposit will be maintained in a public depository for a period of 30 years or 5 years after the last request or for the effective life of the patent, whichever is longer: (d) a viability statement in accordance with the provisions of 37 CFR 1.807; and (e) the deposit will be replaced if it should ever become inviable. As required under 37 CFR 1.809 (d), the specification shall contain: (1) the accession number for the deposit; (2) the date of deposit; (3) a description of the deposited biological material sufficient to identify it and to permit its examination; and (4) the name and address of the depository.
However, even should the deposit be found to meet all the requirements of the Budapest Treaty, it is noted that the claims are not limited to a transgenic Betta fish which has been generated from the aforementioned deposited cryopreserved sperm. The claims simply recite that the transgenic Betta comprises the “Purple Betta 1 transformation event”. While claims 2 and 11 do recite a “wherein” clause that refers to cryopreserved sperm deposited with the ATCC provisional accession number PTA-127166, the claims do not actually recite that the transgenic Betta fish have been made using these sperm. See also the discussion of these claims above in the rejection of the claims under 35 U.S.C. 112(b), for indefiniteness.
Therefore, as the exact structure of the “Purple Betta 1 transformation event” is not clearly disclosed, the skilled artisan could not readily make any transgenic Betta fish with this “event” without undue experimentation. Since the “Purple Betta 1 transformation event” is essential to the claimed invention, it must be obtainable by a repeatable method set forth in the specification or otherwise be readily available to the public. For the reasons discussed above, the specification does not provide sufficient guidance for generating a “Purple Betta 1 transformation event” due to a complete lack of disclosure as to any physical components which result in a “Purple Betta 1 transformation event”. Thus, based on the lack of guidance in the specification including the working examples, as to what structure(s) and/or event(s) is/are encompassed by a “Purple Betta 1 transformation event” and how those structures or events relate to the transgenic Betta whose chromosome comprises an expression cassette encoding a fluorescent protein, it would have required undue experimentation to make and use a transgenic Betta fish as claimed.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2020/102333 A1 (May 20, 2020), hereafter referred to as Blake et al..
Regarding claim 1, Blake et al. teaches the same transgenic Betta comprising a chromosomally integrated expression cassette encoding a fluorescent protein, wherein the Betta comprises the "Purple Betta 1 transformation event" as recited in the instant claims (Blake et al., paragraphs 21-24 and claims 61-80). Claims 61-80 recited on pages 25-27 of Blake et al. correspond to instant claims 1-22 as follows:
Instant claim Blake Claim
1 61
2 61
3 62
4 63
5 64
6 65
7 66
8 67
9 68
10 69
11 69
12 70
13 71
14 72
15 73
16 74
17 75
18 76
19 77
20 78
21 79
22 80
Note that claims 61 and 69 of Blake refer to an ECACC deposit of cryopreserved testes, which comprise sperm, rather than a deposit of cryopreserved sperm to the ATCC. However, the Blake et al. reference is an earlier work naming the instant inventor and provides the exact same disclosure regarding transgenic Betta fish comprising a chromosomally integrated expression cassette encoding a fluorescent protein, wherein the Betta comprises a "Purple Betta 1 transformation event" which appears to be, in the absence of evidence to the contrary, the exact same transgenic Betta fish with the exact same "Purple Betta 1 transformation event" as claimed. Further, as noted in the rejection of the instant claims under 35 U.S.C. 112(b) above, the recitation of the wherein clause in instant claims 2 and 11 regarding cryopreserved sperm deposited with the ATCC is not recited as having been used to make the transgenic Betta as claimed nor are they are part of the method of making the transgenic Betta as claimed. Thus, by teaching transgenic Betta with the exact same genetic modifications and transformation events as claimed, and methods of making and using the transgenic Betta and progeny thereof as instantly claimed, Blake et al. anticipates the instant invention as claimed.
Additional Comments
It is noted that obviousness type double patenting does not apply between the claims of the 12,290,055 patent and the instant application as the 12,290,055 patent claims are drawn to transgenic Betta comprising a green, orange, or red transformation event that does not encompass the purple transformation event as claimed.
No claims are allowed.
Any inquiry concerning this communication from the examiner should be directed to Anne Marie S. Wehbé, Ph.D., whose telephone number is (571) 272-0737. If the examiner is not available, the examiner’s supervisor, Maria Leavitt, can be reached at (571) 272-1085. For all official communications, the technology center fax number is (571) 273-8300. Please note that all official communications and responses sent by fax must be directed to the technology center fax number. For informal, non-official communications only, the examiner’s direct fax number is (571) 273-0737. For any inquiry of a general nature, please call (571) 272-0547.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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