DETAILED ACTION
Claim Rejections - 35 USC § 112-2nd paragraph
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 40-54 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 40 and dependent claims thereof are vague and indefinite because of the phrase “an antigenic M. viscosa component, comprising an antigen derived from a variant of M. viscosa.” First, the term “derived” does not provide the character or properties from the source that are to be retained in the final product, e.g., paper is derived from wood but is very different from wood. The phrase “derived from” should be changed to “isolated from”. Second, the name alone “antigen derived from a variant of M. viscosa” is vague and indefinite because it the mere recitation of a name to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the amino acid sequence of the protein or molecular weight, which would allow for one to identify the antigenic component without ambiguity. Lastly, it is noted that the first time an abbreviation appears in the claims, e.g., M. viscosa, the name/term should be spelled out. Appropriate clarification and/or correction is required.
Claims 41, 44 and 45 are also vague and indefinite because it is unclear what structures are considered “variant M. viscosa” versus “classic non-viscous M. viscosa.” Non-viscous seems to be an internal designation not commonly used and simply based on phenotypic analysis and, therefore, the metes and bounds of the invention are not understood. While the specification can be used to provide definitive support, the claims are not read in a vacuum. Rather, the claim must be definite and complete in and of itself. Limitations from the specification will not be read into the claims. Appropriate clarification and/or correction is required.
Claim 49 is vague and indefinite because the mere recitation of a name, e.g., IPNV, ISAV, SPDV, Aeromonas salmonicdia, etc., to describe the invention is not sufficient to satisfy the Statute's requirement of adequately describing and setting forth the inventive concept. The claim should provide any structural properties, such as the amino acid sequence of the protein or molecular weight, which would allow for one to identify the antigenic component without ambiguity. Appropriate clarification and/or correction is required.
Claim Rejections - 35 USC § 112-Written Description
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 40-54 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, for example:
A method of protecting fish in need thereof against infection caused by classic non- viscous M. viscosa, the method comprising administering to said fish a vaccine comprising an antigenic M. viscosa component, said antigenic M. viscosa component comprising an antigen derived from a variant M. viscosa.
The method wherein the vaccine protect fish against infection caused by variant M. viscosa and by classic non-viscous M. viscosa.
The method wherein said vaccine does not include an antigen derived from a classic non-viscous M. viscosa strain.
The method wherein said one or more non M. viscosa antigens are selected from the group consisting of IPNV, ISAV, SPDV, Aeromonas salmonicida, Vibrio anguillarum 01, 02, Vibrio (Aliivibrio) salmonicida, Yersinia ruckeri 01.
The instantly claimed method recites “an antigenic M. viscosa component, comprising an antigen derived from a variant of M. viscosa.” The term “derived” does not provide the character or properties from the source that are to be retained in the final product, e.g., paper is derived from wood but is very different from wood. Additionally, non-viscous seems to be an internal designation not commonly used and simply based on phenotypic analysis. Looking to prior art D1, the gyrB is used to determine the phylogenetic relationship among Moritella (fig.1) but is not the only variant gene present in the different isolates (see tab.2). Additionally, the different variants have different pathogenicity and virulence in different fishes.
Accordingly, the claims do not have adequate written description for the ‘antigens derived from a variant of M. viscosa,” as the variants are not fully defined, nor are the actual antigens to be used in the claimed methods.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession the claimed invention. Applicants have not described the genus of claimed antigenic components derived from a variant M. viscosa such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
With the written description of a genus, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014).
The purpose of the "written description" requirement is broader than tomerely explain how to "make and use"; the applicant must convey with reasonableclarity to those skilled in the art that, as of the filing date sought, he or she was inpossession of the invention. The invention is, for purposes of the "writtendescription" inquiry, whatever is now claimed. See Vas-Cath, Inc. v. Mahurkar,935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Federal Circuit, 1991).Furthermore, the written description provision of 35 USC § 112 is severable fromits enablement provision; and adequate written description requires more than amere statement that it is part of the invention and reference to a potential methodfor isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by 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" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. An objective standard for determining compliance with the written description requirement is, "does the description clearly allow a person of ordinary skill in the art to recognize that he or she invented what is claimed." In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). To satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
While paragraph [0050] on page 7 of the instant specification recites:
[0050] "Variant M. viscosa": as noted previously, it has been determined that classic isolates (both viscous and non-viscous) of M. viscosa have a conserved sequence in their respective gyrB genes. Accordingly, classic isolates are the isolates that contain, in their respective gyrB sequences, a subsequence that is at least 98% identical to SEQ ID NO: 1. Conversely, in variant M. viscosa isolates, the respective subsequences of the gyrB sequences are less than 98% identical to SEQ ID NO: 1. Preferably, in variant M. viscosa isolates, the respective subsequences are 70-98% identical to SEQ ID NO: 1. In addition to the differences in gyrB sequences, for the purpose of this application, variant M. viscosa isolates are not recognized by antibodies raised in salmon against classic viscous M. viscosa strains under conditions described in Example 1. [0051] In certain embodiments, the variant M. viscosa isolates have the subsequence in their gyrB gene sequences that are at least 90% identical to SEQ ID NO: 2, preferably, at least 95% identical to SEQ ID NO: 2, provided that these subsequences are no more than 98% identical to SEQ ID NO: 1.
The above does not provide written description for a specific M. viscosa variant, much less an antigenic component ‘derived from’ said M. viscosa variant with the added functionality of protecting fish against infection caused by classic non-viscous M. viscosa.
Factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
With respect to the Examples presented in the specification, it appears only a whole cell bacterium is used in the methods. See page 20 of the instant specification:
Example 2: vaccination with variant M. viscosa cross-protects against classic non-viscous challenge, while vaccination with classic viscous M. viscosa does not Materials and methods
[00101] Bath challenge studies were comparative, investigator-blinded, negative controlled and randomized laboratory experiments. The efficacy of different oil-adjuvanted injectable vaccines in protecting Atlantic salmon against experimental infection with different isolates of M. viscosa were investigated in the study. The experimental vaccines containing field isolates of classic non- viscous M. viscosa and variant M. viscosa adjuvanted with water-in-oil (W/O) emulsion were administered intraperitoneally by co-injection with commercial vaccines according to manufacturers' instructions. Both of these commercial vaccines contained classic viscous strains of M. viscosa. A negative control group was included. The fish was approximately 25 grams in average at vaccination.
Nowhere is an ‘antigen derived from a variant M. viscosa” described in these examples, e.g., only whole cell bacteria are used.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Because the art is unpredictable, in accordance with the Written Description Guidelines, and the scope of the claim includes numerous structural variants and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
There are no drawings or structural formulas disclosed of any of thesefragments or variants. Based on the lack of knowledge and predictability in the art, those of skill in the art would not conclude that the applicant was in possession of the claimed genus of antigens derived from a variant M. viscosa which, when administered, protect fish against infection caused by classic non-viscous M. viscosa.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov
Claim Rejections - 35 USC § 112-Enablement
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 40-54 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, for example:
A method of protecting fish in need thereof against infection caused by classic non- viscous M. viscosa, the method comprising administering to said fish a vaccine comprising an antigenic M. viscosa component, said antigenic M. viscosa component comprising an antigen derived from a variant M. viscosa.
The method wherein the vaccine protect fish against infection caused by variant M. viscosa and by classic non-viscous M. viscosa.
The method wherein said vaccine does not include an antigen derived from a classic non-viscous M. viscosa strain.
The method wherein said one or more non M. viscosa antigens are selected from the group consisting of IPNV, ISAV, SPDV, Aeromonas salmonicida, Vibrio anguillarum 01, 02, Vibrio (Aliivibrio) salmonicida, Yersinia ruckeri 01.
The instant specification does not enable the claimed method.
Paragraph [0050] on page 7 of the instant specification recites:
[0050] "Variant M. viscosa": as noted previously, it has been determined that classic isolates (both viscous and non-viscous) of M. viscosa have a conserved sequence in their respective gyrB genes. Accordingly, classic isolates are the isolates that contain, in their respective gyrB sequences, a subsequence that is at least 98% identical to SEQ ID NO: 1. Conversely, in variant M. viscosa isolates, the respective subsequences of the gyrB sequences are less than 98% identical to SEQ ID NO: 1. Preferably, in variant M. viscosa isolates, the respective subsequences are 70-98% identical to SEQ ID NO: 1. In addition to the differences in gyrB sequences, for the purpose of this application, variant M. viscosa isolates are not recognized by antibodies raised in salmon against classic viscous M. viscosa strains under conditions described in Example 1. [0051] In certain embodiments, the variant M. viscosa isolates have the subsequence in their gyrB gene sequences that are at least 90% identical to SEQ ID NO: 2, preferably, at least 95% identical to SEQ ID NO: 2, provided that these subsequences are no more than 98% identical to SEQ ID NO: 1.
The above does not provide enablement for a method of protecting fish in need thereof against infection caused by classic non-viscous M. viscosa using a specific M. viscosa variant, much less an antigenic component ‘derived from’ said M. viscosa variant.
Factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification for use of an antigen derived from a variant M. viscosa to sufficiently protect fish against classic non-viscous M. viscosa; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
With respect to the Examples presented in the specification, it appears only a whole cell bacterium is used in the methods. See page 20 of the instant specification:
Example 2: vaccination with variant M. viscosa cross-protects against classic non-viscous challenge, while vaccination with classic viscous M. viscosa does not Materials and methods
[00101] Bath challenge studies were comparative, investigator-blinded, negative controlled and randomized laboratory experiments. The efficacy of different oil-adjuvanted injectable vaccines in protecting Atlantic salmon against experimental infection with different isolates of M. viscosa were investigated in the study. The experimental vaccines containing field isolates of classic non- viscous M. viscosa and variant M. viscosa adjuvanted with water-in-oil (W/O) emulsion were administered intraperitoneally by co-injection with commercial vaccines according to manufacturers' instructions. Both of these commercial vaccines contained classic viscous strains of M. viscosa. A negative control group was included. The fish was approximately 25 grams in average at vaccination.
Nowhere is an ‘antigen derived from a variant M. viscosa” described in these examples, e.g., only whole cell bacteria are used. Furthermore, the specification does not enable a cross- protective vaccine over the whole scope claimed.
None of the examples in the instant specification specify the type of vaccine used i.e. if e.g. the variant M. viscosa is killed, attenuated, subunit etc. and which type of variant it is. The description refers to gyrB or non-viscous variants. However non-viscous seems to be an internal designation not commonly used and simply based on phenotypic analysis. Looking to prior art Thorburg et al (2018. J. of Fish Diseases. 41(11): 1751-1758; provided by Applicants), the gyrB is used to determine the phylogenetic relationship among Moritella (fig.1) but is not the only variant gene present in the different isolates (see tab.2). Additionally, the different variants have different pathogenicity and virulence in different fishes.
This finding is also confirmed by Karlsen et a (Microbial pathogenesis. Sept. 2014. Vol 77: 53-65; provided by Applicants). The present set of claims refers to "a vaccine comprising an antigenic M.viscosa component" for cross-protection for any fish. The application fails to show that "a component" is enough to protect "any fish". On one side said component is nowhere identified in the application, on the other side the "vaccine" referred to in the application is poorly characterized. Therefore, it is not clear which component is able to raise protective immunity.
As it appears from fig. 1 in the application, polyclonal antibodies from classic and variant Moritella show cross- binding of some proteins. The data show protection in Salmon, but Thorburg (cited above) (see abs) shows that a vaccine of Moritella isolated from Salm did not confer protection to infection with Moritella infected by lumpfish. Karlsen et al (Aquaculture, Feb. 2017. Vol. 473: 538-544; provided by Applicants) also reports different protections from different vaccines, independently if they are variant or classic. Additionally, Furevik et al (Fish & Shellfish Immunology. Vo. 137, May 2023; provided by Applicants), published after the priority date of the application, concludes that variant and classic vaccine show poor cross-protection and therefore a combination of the strains in the vaccine may be necessary for full protection. Therefore, a vaccine comprising component(s) of only variant or classic strain may be not enough for cross-protection. Thus the available prior art cast doubt that any antigenic M. viscosa component cross-protect any fish.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.” That requirement has not been met.
Relevant prior art, not presently relied upon:
GREGER E ET AL: (J. Fish Diseases. May 1999. 22(3): 193-199; provided by Applicants) tests the protection conferred by different isolates of formalin inactivated strains (see pg.196 col.1 1.10-14) and shows protection (see tab.2 and pg.197 "vaccination and challenge experiments")
Correspondence regarding this application should be directed to Group Art Unit 1645. Papers related to this application may be submitted to Group 1600 by facsimile transmission. Papers should be faxed to Group 1600 via the PTO Fax Center located in Remsen. The faxing of such papers must conform with the notice published in the Official Gazette, 1096 OG 30 (November 15,1989). The Group 1645 Fax number is 571-273-8300 which is able to receive transmissions 24 hours/day, 7 days/week.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jennifer E. Graser whose telephone number is (571) 272-0858. The examiner can normally be reached on Monday-Friday from 8:00 AM-4 PM.
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/JENNIFER E GRASER/Primary Examiner, Art Unit 1645 7/29/25
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