DETAILED NOTICE
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
Acknowledgement is made of Applicants’ claim for benefit to prior filed US Provisional application 63/112,495 (filed 11/11/2020).
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/112,495, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application: Claims 1-4, 6-9, 14, 27-28, 32, 35-36, 60, 65-67, and 69-70. Therefore, claims 1-4, 6-9, 14, 27-28, 32, 35-36, 60, 65-67, and 69-70 do not receive domestic benefit to the provisional Application No. 63/112,495 filed on 11 November 2020 because it does not disclose a method of obtaining a B cell producing a cross-reactive antibody as recited by the claims. Support for this method can be found in the instant claims and instant Specification (¶0165). For purposes of applying prior art, the filing date for claims 1-4, 6—9, 14, 27-28, 32, 35-36, 60, 65-67, and 69-70 is 21 August 2024.
Claim Status
Claims 1-4, 6-9, 14, 27-28, 32, 35-36, 60, 65-67, and 69-70 are pending, all of which have been considered on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: “thereby obtaining a b cell producing” in line 6 should read “thereby obtaining a B cell producing”.
Claim 8 is objected to because of the following informalities: “viral polypeptides of a different protein types” in lines 2 and 3 should read “viral polypeptides of different protein types”. Appropriate correction is required.
Claim Interpretation
Claim 65 recites “[a]n antibody or fragment thereof derived from a B-cell obtained by the method of claim 1.” Claim 65 was interpreted herein as a product-by-process claim.
“[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-
process claim is the same as or obvious from a product of the prior art, the claim is
unpatentable even though the prior product was made by a different process." In re
Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Here, the claim is drawn to a cross-reactive antibody derived from a B-cell, and not a method for making the same. As such, for purposes of compact prosecution and applying prior art, claim 65 was broadly interpreted to encompass any cross-reactive antibody. As claims 66-67 and 69-70 rely on claim 65, the interpretation carries.
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 27 and 60 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.
The term “about” in claim 28 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The number of days the isolating step is performed after the immunizing step is rendered indefinite by use of the term “about”.
Claim 60 recites the limitation "the plurality of coronavirus antigens" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim because the plurality of coronavirus antigens is not recited previously in the claim or in claim 1 for which claim 60 is dependent and it is unclear what the plurality of coronavirus antigens entails as it is not clearly defined.
For the purposes of compact prosecution and applying prior art, claim 60 is being interpreted as “wherein the first and/or second plurality of antigens are of coronaviruses in the subgenus of Sarbecovirus”.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 65-67 and 69 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
The instant claims are drawn to a cross-reactive antibody derived from a B-cell and nucleic acid molecules encoding and compositions comprising the same. As such, the instant claims are drawn to a composition of matter, which is a statutory category of invention (STEP 1: YES).
The instant claims evidence that cross-reactive antibodies are naturally created in mammals after exposure to an antigen (claim 1). Furthermore, Yang, et al. (Cell Rep. 2023 Mar 28;42(3):112160, hereinafter “Yang”) teaches that upon natural infection or vaccination antibodies are elicited in a process called affinity maturation (pg. 3 ¶2). Yang further teaches that immunization with certain vaccines/antigens leads to the generation of cross-reactive antibodies naturally in the mammal model (pg. 4 ¶2). LabXchange (available at: https://www.labxchange.org/library/items/lb:LabXchange:daa104a3:html:1 accessed: 23 September 2026, published June 18, 2024) teaches that antibodies are created naturally from transcribing the genes to generate mRNAs which are then translated into the heavy chain and light chain units before being assembled to form the Y shaped protein (pg. 2 last paragraph). As such, mammalian B cells would naturally create cross-reactive antibodies, including portions of the antibody, and nucleic acids that encode the antibody. Moreover, the broadest reasonable interpretation of a pharmaceutically acceptable carrier (as required in a pharmaceutical composition by Instant Specification ¶0130) encompasses, e.g. water. Claim 67 requires recombinant expression of the nucleic acid molecule. The recombinant expression of a natural antibody still results in a natural antibody, i.e., the recombination expression of a naturally occurring antibody does not impart any markedly different characteristics with respect to structure, function, or any other property to distinguish the recombinantly expressed antibody from its natural counterpart.
Isolating the antibodies or nucleic acid and, in some embodiments, formulating with water would not, absent evidence to the contrary, result in any markedly different characteristics with respect to structure, function, or any other property to distinguish the claimed antibody/nucleic acids from their naturally occurring counterparts.
Accordingly, the instant claims recite a natural phenomenon, i.e., naturally occurring antibodies/nucleic acids, which is a judicial exception (JE) (STEP 2A, Prong One: YES).
The instant claims are drawn solely to the JE, and not a method of using the JE for, e.g. a specific treatment or prophylaxis. As such the instant claims do not recite any additional elements that integrate the JE into a practical application (STEP 2A, Prong Two: NO).
Since the instant claims are limited to only the JE, the instant claims do not recite any additional elements that amount to significantly more than the JE (STEP 2B: NO).
In view of the foregoing, the instant claims do not constitute patent eligible subject matter under 35 U.S.C. §101.
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.
Written Description
Claims 65-67 and 69-70 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 65-67 and 69-70 broadly encompass an antibody or fragment thereof. The Specification has failed to sufficiently describe the structural features 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 antibody to bind an antigen.
“An antibody or fragment thereof” encompasses a large pool of proteins when accounting for both the contact and variable region of the antibody and the Specification does not adequately describe the necessary amino acids that must remain for the amino acid sequences that are required for the antibody fragments to able to bind an antigen.
While the instant claims are drawn to a genus that comprises innumerable permutations of sequences, the Specification has only adequately described and successfully reduced to practice complete antibodies, not fragments. As such, the Specification reasonably demonstrates that Applicant was in possession of complete antibodies after mammalian immunization. However, this is not representative of the extremely large genus of protein since only the complete antibody is supported and not the innumerable sequences or fragments contained within a genus of “antibody fragments”.
The data generated for the complete full-length antibodies cannot be reasonably extrapolated and applied to support possession of the entire claimed genus of antibody fragments 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).
Janeway, et al. (Immunobiology: The Immune System in Health and Disease. 5th edition. New York: Garland Science; 2001. The interaction of the antibody molecule with specific antigen., hereinafter “Janeway”) provides a review of the antigen binding site and the necessity of the antigen binding site for antigen binding and the specificity required between the antigen binding site and the antigen to allow for binding of the antigen (¶1). While Applicant may have possession of antibody fragments, as these fragments have not been shown to bind antigen, these fragments would not be considered functional antibodies.
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.
Scope of Enablement
Claim 70 is 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 treating or preventing a disease or disorder caused by a viral infection by administering a pharmaceutical composition comprising an antibody against the same virus or an antibody cross-reactive to the same virus that caused the viral infection, does not reasonably provide enablement for treating or preventing a disease or disorder caused by a viral infection by administering a pharmaceutical composition that comprises an antibody that is not against or cross-reactive to the same virus that caused the viral infection. The Specification does not enable any person skilled in the art to which it is most nearly connected, to use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation in “undue.” These factors include, but are not limited to:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
In re Wands, 858 F.2d 732, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988).
The breadth of the claim 70 broadly encompasses pharmaceutical compositions comprising cross-reactive antibodies derived from B-cells configured for treating or preventing a disease or disorder caused by a viral infection in a subject. When a compound or composition claim is limited by a particular use, enablement of that claim should be evaluated based on that limitation. See MPEP 2164.01(c).
The embodiment of treating or preventing a disease or disorder caused by a viral infection in a subject by administering a pharmaceutical composition that comprises an antibody that is not against or cross-reactive to the same virus that caused the viral infection is not enabled because an antibody that is not against or cross-reactive to a virus/viral antigen will not bind to the virus or viral antigen and therefore not treat or prevent the disorder or disease caused by the viral infection. The level of skill in the art is high, e.g. PhD level scientists.
The Specification does not provide any working examples of a either an antibody against or cross-reactive antibody for the viral infection being treated or prevented or an antibody not against or cross-reactive for the viral infection being treated or prevented.
Janeway provides a review of the state of the art of antibodies binding to antigens with the antigen binding sites. Antibodies only bind to certain antigens though the antigen binding as the antigen binding site is highly specific (¶1) Janeway demonstrates that the ability of an antibody to bind to some viral antigens is not reasonably predictive of the ability of the antibody to bind to all viral antigens and therefore, of its ability to prevent and treat all disease and disorders caused by viral infections.
In view of the breadth of the claims, the limited teachings of the specification and the examples regarding treating and preventing all viral diseases and disorders, the state of the art, and the low predictability with regard to the ability of any antibody to treat or prevent any viral disease or disorder, it would require undue experimentation to practice the claimed methods.
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 65 and 69-70 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mire, et al. (J Infect Dis. 2020 May 11;221(Suppl 4):S471-S479., hereinafter “Mire”).
Regarding claims 65 and 69, Mire discloses a cross-reactive humanized monoclonal antibody that reacts to both the F glycoprotein of Hendra and Nipah (abstract) and is used in a pharmaceutical composition (pg. S475, column 2).
Regarding claim 70, Mire discloses a method of preventing HeV disease in ferrets my administering a pharmaceutical composition comprising a cross-reactive antibody (pg. S476, column 1).
Accordingly, the claimed invention was anticipated by Mire.
Claim Rejections - 35 USC § 103
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 1-4, 6-7, 9, 14, 28, 36, 60, and 65 are rejected under 35 U.S.C. 103 as being unpatentable over Leenaars, et al. (ILAR J. 2005;46(3):269-79., hereinafter “Leenaars”) and further in view of Gao, et al. (CN 118459605 A, hereinafter “Gao”).
Regarding claim 1, Leenaars teaches a method of obtaining B cells that produce antibodies comprising immunizing a mammal with a vaccine composition and then isolating B cells from the spleen of the mammal (pg. 275 column 1). Leenaars does not teach that the vaccine comprises a multivalent carrier displaying a plurality of antigens and that the B cells produce cross reactive antibodies. However, Gao teaches a broad-spectrum nanoparticle vaccine that comprises a plurality of B subgroup beta coronavirus antigens (abstract), immunization with this vaccine lead to antibodies with broad spectrum binding and cross-reactivity (Figure 20).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the vaccine taught by Leenaars for the specific broad-spectrum nanoparticle vaccine that comprises a plurality of B subgroup beta coronavirus antigens taught by Gao. Leenaars teaches that many different vaccines can be used with different antigens and adjuvants to produce polyclonal antibodies (pg. 275 column 1). One of skill in the art would have substituted the vaccine taught by Leenaars with the broad-spectrum nanoparticle vaccine that comprises a plurality of B subgroup beta coronavirus antigens taught by Gao to create B cells that produce cross-reactive antibodies to B subgroup beta coronaviruses. One of skill ion the art would have had a reasonable expectation of success of substituting the vaccines because they are both vaccines comprising antigens that stimulate B cells that produce antibodies.
Regarding claim 2, Gao teaches that a vaccine against LyRa11-RBD, SARS-CoV-2 (Prototype) -RBD, SARS-CoV-2 (Beta) -RBD, RaTG13-RBD, RshSTT182-RBD, RmYN02-RBD creates antibodies against LyRa11-RBD (Figure 20).
Regarding claim 3, Gao teaches that a vaccine against LyRa11-RBD, SARS-CoV-2 (Prototype) -RBD, SARS-CoV-2 (Beta) -RBD, RaTG13-RBD, RshSTT182-RBD, RmYN02-RBD creates antibodies against Pangolin-RBD (Figure 20).
Regarding claim 4, Gao teaches that a vaccine against LyRa11-RBD, SARS-CoV-2 (Prototype) -RBD, SARS-CoV-2 (Beta) -RBD, RaTG13-RBD, RshSTT182-RBD, RmYN02-RBD creates antibodies against a subset of these antigens (Figure 20).
Regarding claims 6 and 60, Gao teaches that the antigens are coronavirus antigens (abstract).
Regarding claim 7, Gao teaches that the antigens in the vaccine LuS-mRBD-B are all RBD antigens (Figure 15).
Regarding claim 9, Gao teaches that the vaccine LuS-mRBD-A comprises antigens from pangolin coronaviruses and SARS-CoV-2 (Figure 15).
Regarding claim 14, Gao teaches that the vaccine is a protein-based nanoparticle formed by the 2, 4-tetrahydro-pteridine synthase (LuS) fusion expression with SpyCatcher (¶0040).
Regarding claim 27, Leenaars teaches administering several booster vaccines before B cell harvesting (pg. 275 column 1).
Regarding claim 36, Gao teaches that the vaccines LuS-mRBD-A and B create cross-neutralizing antibodies (Figure 17).
Regarding claim 65, as discussed above in claim 1, Leenaars and Gao teach the method of obtaining a B cell producing cross-reactive antibodies. Therefore, Leenaars and Gao also teach the antibody that naturally flows from the method.
Accordingly, the invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Leenaars and Gao as applied to claims 1-4, 6-7, 9, 14, 28, 36, 60, and 65 above, and further in view of Burt, et al. (US 20060286124, US-IDS, filed, 12/04/2024, hereinafter “Burt”).
As discussed above, claims 1-4, 6-7, 9, 14, 28, 36, 60, and 65 were rendered prima facie obvious over Leenaars and Gao.
Regarding claim 8, Leenaars and Gao do not teach that the first or second plurality of antigens comprises viral polypeptides of different protein types. However, Burt teaches vaccine comprising a multivalent carrier displaying both coronavirus S and N proteins (¶0019).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the vaccine taught by Leenaars for the vaccine taught by Burt. Leenaars teaches that many different vaccines can be used with different antigens and adjuvants to produce polyclonal antibodies (pg. 275 column 1). Burt also teaches that vaccines with different protein immunogens induces an immune response against each of the protein immunogens, giving a broader antibody response (¶0128). One of skill in the art would have substituted the vaccine taught by Leenaars with the vaccine taught by Burt to create B cells that produce cross-reactive antibodies to both S and N proteins of coronavirus. One of skill ion the art would have had a reasonable expectation of success of substituting the vaccines because they are both vaccines comprising antigens that stimulate B cells that produce antibodies.
Accordingly, the invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 28, 32, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Leenaars and Gao as applied to claims 1-4, 6-7, 9, 14, 28, 36, 60, and 65 above, and further in view of Ranezani-Rad and Rickert (STAR Protoc. 2021 Mar 2;2(1):100369, hereinafter “Rickert”).
As described above, claims 1-4, 6-7, 9, 14, 28, 36, 60, and 65 were rendered prima facie obvious over Leenaars and Gao.
Regarding claim 28, Leenaars teaches that the isolating step occurs after the immunization step (pg. 275 column 1). Leenaars and Gao do not teach that the isolating step is performed between 1 day and 10 weeks after the immunizing step. However, Rickert teaches that after immunizing mice, you need at least 7 days before isolation to allow for germinal center reaction (pg. 2, immunization of mice).
Regarding claim 32, Rickert teaches negative selection using MACS to isolate B cells (Summary).
Regarding claim 37, Ricket teaches isolating splenocytes to isolate B cells (pg. 8, Purity analysis by flow cytometry).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention have to have combined the teachings of Leenaars and Gao for producing B cells that produce cross-reactive antibodies with the teachings of Rickert for a method of isolating B cells. Leenaars teaches that B cells need to be isolated after immunization to be able to continue to produce antibodies (pg. 275 column 1) but does not teach the exact steps required to isolate the B cells. Rickert teaches the steps required to isolate the B cells including when to harvest the mammalian spleen (pg. 2) and how to isolate using MACS for negative selection (summary). One of skill in the art would have a reasonable expectation of success in combining Leenaars, Gao, and Rickert because they all teach immunizing mammals to produce antibodies.
Accordingly, the invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 66-67 are rejected under 35 U.S.C. 103 as being unpatentable over Mire as applied to claims 65 and 69-70 above, and further in view of Presnell, et al. (Nucleic Acids Res. 1988 Mar 11;16(5):1693-702., hereinafter “Presnell”).
As described above, claims 65-69 and 70 were anticipated by Mire.
Regarding claims 66-67, Mire does not teach a nucleic acid that encodes a cross-reactive antibody or a cross-reactive antibody that is encoded by a nucleic acid. However, Presnell teaches reverse translation, wherein a nucleic acid sequences can be determined from an amino acid sequence (Abstract). These nucleic acid sequences that can be used to create proteins (Pg. 1700, Discussion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the teachings of Mire for an isolated cross-reactive antibody produced by a B cell with the teachings of Presnell for reverse translation. Presnell provides motivation by teaching that reverse translation facilitates the use of modular mutagenesis (Abstract). One of skill in the art would have had a reasonable expectation of success at combining Mire and Presnell because they both teach proteins.
Accordingly, the invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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