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 .
Priority
Acknowledgment is made of Applicants’ claim for benefit to prior filed US Provisional application 63/238,812 (filed 08/31/2021).
Claim Status
Claims 1-40 are pending, all of which have been considered on the merits.
Claim Interpretation
In claims 9 and 10 “or conservative substitutes thereof” is interpreted in light of ¶0037 of the instant specification. The conservative substitutions for serine include, alanine and threonine and the conservative substitutions for alanine and threonine.
Claim Objections
Claim 6 is objected to because of the following informalities: “further amino acid at” should read “further, an amino acid at”.
Claim 29 is objected to because of the following informalities: “The method of according to claim 27” should read “The method according to claim 27”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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 1-27 and 29-40 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.
Claim 1 is rendered indefinite because it is unclear what position 233 is referring to and how position 233 could be absent. For the purposes of compact prosecution and applying prior art, claim 1 is being interpreted as: An amino acid sequence at least 94% identical to SEQ ID NO: 1, with a substitution or deletion of the amino acid at position 233 relative to SEQ ID NO: 1. The dependent claims do not add additional clarity and, therefore, are also indefinite.
Claims 9 and 10 are rendered indefinite because the claim and the specification do not define a conservative substitution of proline and one of ordinary skill in the art would not know a conservative substitute of proline due to its unique ring structure.
Claim 30 is rendered indefinite because it is unclear if a) and b) are separate primers and probes (a or b) or the same primers and probes (a and b). For the purposes of compact prosecution and applying prior art claim 30 was interpreted as a) or b). The dependent claims do not add additional clarity and, therefore, are also indefinite.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 29 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The limitation “the use according to claim 28” are intended uses that do not further limit the claims as they do not provide further structure to the amino acid sequence. Claim 28 has also been cancelled, a claim cannot depend on a cancelled claim.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
For the purposes of compact prosecution and applying prior art, claim 29 was interpreted as “the method according to claim 27”.
Claim Rejections - 35 USC § 112(a)
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 23-27 and 29 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 written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, 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 inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
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). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
The Federal Circuit has clarified the application of the written description requirement to inventions in the field of biotechnology. See University of California v. Eli Lilly and Co., 119 F.3d 1559, 1568,43 USPQ2d l398, 1406 (Fed. Cir. 1997). The Court stated that a written description of an invention requires a precise definition, one that defines the structural features of the chemical genus that distinguishes it from other chemical structures. A definition by function does not suffice to define the genus because it is only an indication of what the genus does, rather than what it is. Further, the Court held that to adequately describe a claimed genus, an applicant must describe a representative number of species of the claimed genus, and that one of skill in the art should be able to “visualize or recognize the identity of the members of the genus.”
Instant claims 23-27 and 29 are drawn to a vaccine comprising a salmonid alphavirus comprising an amino acid sequence comprising instant SEQ ID NO: 1, wherein position 233 is absent or not threonine, which has written description support. However, the instant claims also broadly encompass a vaccine comprising a salmonid alphavirus comprising an amino acid sequence comprising a sequence 94% identical to instant SEQ ID NO: 1, wherein position 233 is absent or not threonine.
The Specification has failed to sufficiently describe the amino acids that must be retained by the members of the claimed genus as to establish a structure-function relationship with respect to the ability of the proteins to elicit an immune response to the salmonid alphavirus.
94% or more identical amino acid sequences encompasses a vast genus of proteins and the Specification does not adequately describe the necessary amino acids that must remain for the protein to be able to elicit an immune response.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successfully rendered to practice vaccines with the full amino acid sequence. As such, the Specification reasonably demonstrates that Applicant was in possession of the full-length amino acid sequence. However, this is not representative of the extremely large genus of proteins since of the full-length amino acid sequence is supported and not the innumerable sequences or proteins contained within a genus of sequences 94% identical to instant SEQ ID NO: 1.
The data generate for the vaccine comprising the full-length protein cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of proteins because no one species, combination, or variant accounts for the variability among the claimed genus. As in Ariad, merely drawing a fence around the outer limits of a purported genus is not an adequate substitute for describing a variety of materials consisting the genus and showing that one has invented a genus and not just a species. “A patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.” Brenner v. Manson, 383 U.S. 519, 536 (1966).
Solbakk, et al. (GB 2457158 A, hereinafter “Solbakk”) provides a review of salmonid alphavirus vaccines, the full-length amino acid sequences are used, not fragments or similar sequences. While Applicant may have possession of the amino acid sequences that are 94% similar to instant SEQ ID NO: 1, but as these have not been shown to elicit an immune response, these sequences would not be considered vaccines.
Accordingly, the claims as currently written are not adequately described and one of skill in the art would readily appreciate that Applicant was not in possession of the claimed genus at the time of filing.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cassandra Senn Grizer whose telephone number is (571)272-2292. The examiner can normally be reached M-Th 0630 - 1700 ET.
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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