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 .
DETAILED ACTION
Claim Status
This action is in response to the claims filed on 12/12/2024.
Claims 1-10 are pending and are considered on the merits.
Priority
This application is a DIV of 16/980,359 (filed on 09/11/2020), which is a 371 of PCT/US2019/027353 (filed on 04/12/2019), which claims benefit from provisional application 62/663,637 (filed on 04/27/2018). The priority claim of the instant application has been granted and the earliest benefit date is 04/27/2018 from the application 62/663,637.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/12/2024 and 07/08/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner. The corresponding signed and initialed PTO forms 1449 have been mailed with this action.
Claim Objections
Claim 7 is objected to because of the following informalities:
Claim 7 recites “a env polypeptide” in line 5. It is recommended to change to “an env polypeptide”.
Appropriate correction is required.
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 1-10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Specifically, instant claims encompass a genus of method for treating a genus of cancer comprising administering a genus of simian foamy virus (SFV) comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain, while the specification only discloses a method for treating a limited list of cancers comprising administering a single species of chimeric simian foamy virus comprising a first defined genomic fragment comprising a 5’ LTR, a nucleic acid encoding a gag polypeptide and a 5’ portion of a nucleic acid encoding a pol polypeptide of a chimpanzee PAN1 SFV strain and a second defined genomic fragment comprising a 3’ portion of a nucleic acid encoding a pol polypeptide, a nucleic acid encoding an env polypeptide, a nucleic acid encoding a tas polypeptide, a nucleic acid encoding a bel2 polypeptide and a 3’ LTR of a chimpanzee PAN2 SFV strain (see specification, Example 4, p. 28-30 for PAN1/2’s direct antitumoral effect on a cancer model and PAN1/2 armed with a therapeutic suicide gene, and see p. 19, last para. for construction of the chimeric PAN1/2 SFV).
Under the written description guidelines (see MPEP 2163) the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
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. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the 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. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
SCOPE OF THE INVENTION
Independent claim 1 encompasses a genus of method for treating a genus of cancer comprising administering a genus of simian foamy virus (SFV) comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain. Thus, the independent claim encompasses a genus of chimeric SFV that comprises recombination of any genomic fragment of any SFV strain with any genomic fragment of another any SFV strain and this genus of chimeric SFV has oncolytic anti-cancer activity and is used to treat a genus of cancer. However, the specification only discloses a single species of chimeric simian foamy virus comprising a first defined genomic fragment comprising a 5’ LTR, a nucleic acid encoding a gag polypeptide and a 5’ portion of a nucleic acid encoding a pol polypeptide of a chimpanzee PAN1 SFV strain and a second defined genomic fragment comprising a 3’ portion of a nucleic acid encoding a pol polypeptide, a nucleic acid encoding an env polypeptide, a nucleic acid encoding a tas polypeptide, a nucleic acid encoding a bel2 polypeptide and a 3’ LTR of a chimpanzee PAN2 SFV strain and this specific PAN1/2 chimeric SFV has oncolytic anti-cancer activity and is used to treat a defined cancer model (see specification, Example 4, p. 28-30 for PAN1/2’s direct antitumoral effect on a cancer model and see p. 19, last para. for construction of the chimeric PAN1/2 SFV).
Dependent claims 2-10 encompass the species of mammal, the types of cancer, the strains of the SFV strain, the genomic fragments, the linker of the two genomic fragments, the SFV further comprising a transgene encoding a suicide polypeptide. However, the specification only discloses a combination of the limitations (defined genomic fragments of specific SFV strains regarding the chimeric SFV and the defined list of cancers).
ACTUAL REDUCTION TO PRACTICE
Accordingly, Applicant did not demonstrate a reduction to practice of a genus of method for treating a genus of cancer comprising administering a genus of SFV comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain, nor did Applicant adequately set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of method for treating the claimed genus of cancer comprising administering the claimed genus of SFV.
DISCLOSURE OF STRUCTURE
The Applicant claims a genus of method for treating a genus of cancer comprising administering the claimed genus of chimeric SFV, but has provided no other chimeric SFV strains other than the specific PAN1/2 SFV to treat a specific cancer model. Certainly, with sequences of SFV strains and recombination techniques available, a skilled artisan could make a chimeric SFV comprising any genomic fragments from any two SFV strains. However, the prior art is silent on the genus of resulted chimeric SFV having oncolytic anti-cancer activity on a genus of cancer. Furthermore, neither the specification nor the art indicates a relationship between the structure of the claimed genus of chimeric SFV and the oncolytic anti-cancer activity on the claimed genus of cancer.
SUFFICIENT RELEVANT IDENTIFYING CHARACTERISTICS
As mentioned above, the sequences of SFV strains were known in the art field, and the skilled artisan could make a chimeric SFV comprising any genomic fragments from any two SFV strains. However, the prior art is silent on the resulted chimeric SFV having oncolytic anti-cancer activity on a genus of cancer.
The breadth of the claims encompasses a genus of method for treating a genus of cancer comprising administering a genus of SFV comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain, yet the present specification provides no guidance nor description what genomic fragments of which SFV strains, other than the defined genomic fragments of the specific chimpanzee PAN1 and PAN2 SFV strains, to make a chimeric SFV to treat what cancers, other than a limited list of cancers. Therefore, the skilled artisan would not know what rational approach to take to make the genus of chimeric SFV comprising genomic fragments of two SFV strains, with any predictable outcome on its possession of oncolytic anti-cancer activity on a genus of cancer. Therefore, it is incumbent on the applicant to provide this nexus between structure and function, in order to be given credit for possession of the claimed genus of method for treating a genus of cancer comprising administering a genus of SFV comprising genus of any genomic fragments of two SFV strains.
An applicant may show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics. Enzo Biochem, 323 F.3d at 964, 63 USPQ2d at 1613.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
The method of using the claimed invention is not well established. Although the making of a chimeric SFV was known in the state of the art, one of skill in the art would neither expect nor predict the appropriate oncolytic anti-cancer activity on a genus of cancer produced according to the claimed genus of chimeric SFV comprising genus of any genomic fragments of two SFV strains.
Prior art Heinkelein et al., (Cancer Gene Therapy. 2005; 12: 947-953. Cited in IDS 12/12/2024) discloses a replication-competent foamy virus vector based on prototypic FV (HSRV2, a type of SFV) that has oncolytic anti-cancer activity (see e.g., p. 951, left col, section “Inhibition of tumor growth by wild-type FV” and Fig 3). Heinkelein teaches FVs belong to a poorly characterized subfamily of retroviruses and their receptor is unknown (p. 952, right col., para 1), and slight differences in the replication competence between the HSRV2 and the vector viruses may be responsible for the reduced capacity of HSRV2 to cure tumor-bearing mice (p. 952, right col., para 5). Thus, Heinkelein discloses that even based on the same prototypic FV strain (a type of SFV strain) and further, the same clone pHSRV2 (see Fig 1 legend), the vector virus variants have different replication competence that leads to different anti-cancer activities on a specific cancer model. Accordingly, Heinkelein evidences that using the claimed method for treating a genus of cancer by administering a genus of chimeric SFV that comprises a genus of any genomic fragments of any two SFV strains, with the possession of oncolytic anti-cancer activity on the claimed genus of cancer, was not well established.
Applicant has claimed a genus of method for treating a genus of cancer comprising administering a genus of SFV comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain, yet the present specification has not disclosed such SFV strains other than the specific PAN1/2 chimeric SFV comprising defined genomic fragments of chimpanzee PAN1 and PAN2 strains that has oncolytic anti-cancer activity on a specific cancer model, has not set forth in terms of distinguishing identifying characteristics as evidenced by other descriptions of the invention that are sufficiently detailed to show that Applicant was in possession of the claimed genus of method for treating the claimed genus of cancer comprising administering the claimed genus of chimeric SFV. Furthermore, the state of the art indicated that using the claimed genus of chimeric SFV for treating the claimed genus of cancer is not well established and would require undue experimentation, and one of skill in the art would neither expect nor predict the claimed function of having oncolytic anti-cancer activity on a genus of cancer produced according to the claimed genus of chimeric SFV comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain.
CONCLUSION
The Examiner concludes that there is insufficient written description of the instantly claimed genus of method for treating a genus of cancer comprising administering a genus of SFV comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain. Specifically, Applicant has only provided one single species of method for treating a limited species of cancer comprising administering a single species of chimeric SFV comprising defined genomic fragments of two specific SFV strains, thus does not provide sufficient number of species to represent the entire scope of the claimed extremely broad genus of methods. Therefore, the Examiner concludes that there is insufficient written description to show that Applicant was in possession of the claimed genus of method for treating the claimed genus of cancer comprising administering a genus of SFV comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain.
(Scope of Enablement)
Claims 1-10 are 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 a method for treating a mammal having cancer, wherein the method comprises administering, to said mammal, a simian foamy virus (SFV) having oncolytic anti-cancer activity, wherein said SFV comprises a first genomic fragment comprising a 5’ LTR, a nucleic acid encoding a gag polypeptide and a 5’ portion of a nucleic acid encoding a pol polypeptide of a chimpanzee PAN1 SFV strain and a second genomic fragment comprising a 3’ portion of a nucleic acid encoding a pol polypeptide, a nucleic acid encoding an env polypeptide, a nucleic acid encoding a tas polypeptide, a nucleic acid encoding a bel2 polypeptide and a 3’ LTR of a chimpanzee PAN2 SFV strain, wherein the cancer is selected from the group consisting of glioblastoma, pancreatic adenocarcinoma, cholangiocarcinoma, mesothelioma, melanoma, prostate cancer, breast cancer, ovarian cancer, liver cancer, and colorectal cancer (see specification, Example 4, p. 28-30 for PAN1/2’s direct antitumoral effect on a specific cancer model and PAN1/2 armed with a therapeutic suicide gene, and see p. 19, last para. for construction of the chimeric PAN1/2 SFV), does not reasonably provide enablement for a method for treating a mammal having any cancer, wherein the method comprises administering, to said mammal, a simian foamy virus (SFV) having oncolytic anti-cancer activity, wherein said SFV comprises a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The factors to be considered in determining whether undue experimentation is required are summarized In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988). The Court in Wands states: “Enablement is not precluded by the necessity for some 'experimentation.'” Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single simple factual determination, but rather is a conclusion reached by weighing many factual considerations.” (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case is discussed below.
The office has analyzed the specification in direct accordance to the factors outlined in In re Wands. MPEP 2164.04 states: "[W]hile the analysis and conclusion of a lack of enablement are based on factors discussed in MPEP 2164.01(a) and the evidence as whole, it is not necessary to discuss each factor in written enablement rejection." These factors will be analyzed, in turn, to demonstrate that one of ordinary skill in the art would have had to perform "undue experimentation" to make and/or use the invention and therefore, Applicant's claims are not enabled commensurate with the scope of the invention.
SCOPE OF THE INVENTION
The breadth of the claims encompasses a genus of method for treating a genus of cancer comprising administering a genus of simian foamy virus (SFV) comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain. Thus, the claims encompass a genus of chimeric SFV that comprises recombination of any genomic fragment of any SFV strain with any genomic fragment of another any SFV strain and this genus of chimeric SFV has oncolytic anti-cancer activity and is used to treat a genus of cancer. However, the specification only discloses and provides guidance for a single species of chimeric simian foamy virus comprising a first defined genomic fragment comprising a 5’ LTR, a nucleic acid encoding a gag polypeptide and a 5’ portion of a nucleic acid encoding a pol polypeptide of a chimpanzee PAN1 SFV strain and a second defined genomic fragment comprising a 3’ portion of a nucleic acid encoding a pol polypeptide, a nucleic acid encoding an env polypeptide, a nucleic acid encoding a tas polypeptide, a nucleic acid encoding a bel2 polypeptide and a 3’ LTR of a chimpanzee PAN2 SFV strain and this specific PAN1/2 chimeric SFV has oncolytic anti-cancer activity and is used to treat a specific cancer model (see specification, Example 4, p. 28-30 for PAN1/2’s direct antitumoral effect on a cancer model and see p. 19, last para. for construction of the chimeric PAN1/2 SFV). Thus, the specification fails to describe the genus of methods.
ACTUAL REDUCTION TO PRACTICE
Accordingly, Applicant did not demonstrate a reduction to practice of a genus of method for treating a genus of cancer comprising administering a genus of SFV comprising a first any genomic fragment of a first any SFV strain and a second any genomic fragment of a second any SFV strain. Since the specification only discloses and provides guidance for a single species of method for treating a limited species of cancer by administering a single species of chimeric simian foamy virus, the absence of working examples necessitates further experimentation. Therefore, the specification does not provide sufficient guidance on how to use the claimed genus of methods.
STATE OF THE ART & QUANTITY OF EXPERIMENTATION
In fact, the state of the art teaches that a method for treating any cancer by administering any SFV is not a highly successful technique or has highly variable results.
Prior art Heinkelein et al., (Cancer Gene Therapy. 2005; 12: 947-953. Cited in IDS 12/12/2024) discloses a replication-competent foamy virus vector based on prototypic FV (HSRV2, a type of SFV) that has oncolytic anti-cancer activity (see e.g., p. 951, left col, section “Inhibition of tumor growth by wild-type FV” and Fig 3). Heinkelein teaches FVs belong to a poorly characterized subfamily of retroviruses and their receptor is unknown (p. 952, right col., para 1), and slight differences in the replication competence between the HSRV2 and the vector viruses may be responsible for the reduced capacity of HSRV2 to cure tumor-bearing mice (p. 952, right col., para 5). Thus, Heinkelein discloses that even based on the same prototypic FV strain (a type of SFV strain) and further, the same clone pHSRV2 (see Fig 1 legend), the vector virus variants have different replication competence that leads to different anti-cancer activities on a specific cancer model. Accordingly, Heinkelein evidences that using the claimed method for treating a genus of cancer by administering a genus of chimeric SFV that comprises a genus of any genomic fragments of any two SFV strains, with the possession of oncolytic anti-cancer activity on the claimed genus of cancer, was not well established.
Moreover, not all cancers are created equal. Specifically, Heinkelein teaches FVs belong to a poorly characterized subfamily of retroviruses and their receptor is unknown (see above). Thus, even if (assuming arguendo) treatment could be established for one cancer initially, it would not be expected to work for another (e.g., not expressing the receptor) or for relapse (e.g., the receptor being lost) (i.e., the art is highly unpredictable). Accordingly, a person of ordinary skill would not expect treatment to work safely for every type of cancer since the SFV might not predictably infect each and every type of cancer (especially with the SFV’s receptor unknown), let alone replicate in and kill the cancer cells.
Finally, Applicants are broadly claiming the treatment of all cancers, not just one or two specific cancers. However, "the more one claims, the more one must enable." See Amgen v. Sanofi, 143 S.Ct. 1243 (2023). Accordingly, the claims are not enabled for the full breadth of what is being claimed. See Automotive Technologies Int'I, Inc. v. BMW of North America, Inc., 501 F.3d 1274, 185 (Fed. Cir. 2007) (because 'claims must be enabled to correspond to their scope,' a patent on a side-impact crash sensor claiming mechanical and electronic sensors, but enabling only the former, was invalid).
Since the state of the art did not provide guidance for treating all cancers encompassed by the instant invention, it is incumbent upon the instant specification to do so. The physiological art is recognized as unpredictable (MPEP 2164.03). As set forth in In re Fisher, 166 USPQ 18 (CCPA 1970), compliance with 35 USC 112, first paragraph requires: “That scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; … in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved.” Moreover, the courts have also stated that reasonable correlation must exist between scope of exclusive right to patent application and scope of enablement set forth in the patent application (27 USPQ2d 1662 Ex parte Maize!.). In view of the foregoing, due to the lack of sufficient guidance provided by the specification regarding the issues set forth above, the state of the relevant art, and the breadth of the claims, it would have required undue experimentation for one skilled in the art to use the instant broadly claimed invention.
CONCLUSION
In conclusion, since the art teaches that the method for treating a mammal having any cancer by administering a SFV comprising any genomic fragments of any two SFV strains is prone to influence by multiple factors, and is highly unpredictable, and the specification does not provide ample guidance, one would be burdened with undue experimentation to use the claimed invention for treating any cancer by administering the claimed genus of SFV.
In conclusion, given the breadth of the claims and the limited scope of the specification, an undue quantity of experimentation is required to use the invention beyond the scope of a method for treating a mammal having cancer, wherein the method comprises administering, to said mammal, a simian foamy virus (SFV) having oncolytic anti-cancer activity, wherein said SFV comprises a first genomic fragment comprising a 5’ LTR, a nucleic acid encoding a gag polypeptide and a 5’ portion of a nucleic acid encoding a pol polypeptide of a chimpanzee PAN1 SFV strain and a second genomic fragment comprising a 3’ portion of a nucleic acid encoding a pol polypeptide, a nucleic acid encoding an env polypeptide, a nucleic acid encoding a tas polypeptide, a nucleic acid encoding a bel2 polypeptide and a 3’ LTR of a chimpanzee PAN2 SFV strain, wherein the cancer is selected from the group consisting of glioblastoma, pancreatic adenocarcinoma, cholangiocarcinoma, mesothelioma, melanoma, prostate cancer, breast cancer, ovarian cancer, liver cancer, and colorectal cancer.
Pertinent Reference
Prior art that is considered relevant to Applicant’s invention but not relied upon for rejection:
Prior art Heinkelein et al., (Cancer Gene Therapy. 2005; 12: 947-953. Cited in IDS 12/12/2024. It is noted that this prior art is relied upon for 112a written description and scope of enablement rejections above) disclose a method for treating a mammal having glioma by administering a replication-competent foamy virus vector based on prototypic FV (HSRV2, a type of simian foamy virus) having oncolytic anti-cancer activity (see e.g., p. 951, left col, section “Inhibition of tumor growth by wild-type FV” and Fig 3), and the SFV further comprises a transgene encoding a suicide polypeptide such as a thymidine kinase or a nitroreductase (see e.g., abstract).
Prior art Liu et al., (PLoS Pathog. 2008; 4(7): e1000097, p. 1-22. Cited in IDS 12/12/2024) disclose identification of simian foamy virus (SFV) samples from free-ranging chimpanzees (title, abstract). Liu teaches two SFV samples, MF1269 and CP470, are recombinant SFVs (e.g., p. 13, left col, last para to p. 13, right col, para 1), in which “MF1269 was most closely related to other MF strains in gag and pol-RT regions (Figures 7 and 8), but clustered with MP and WE viruses in the pol-IN region (Figure 6)” (p. 13, left col, para 2). In conclusion, Liu teaches a chimeric SFV (MF1269) comprising a first genomic fragment comprising a 5’ LTR, a nucleic acid encoding a gag, and a 5’ portion of a nucleic acid encoding a pol polypeptide (pol-RT) of a first chimpanzee SFV strain (MF strain) and a second genomic fragment comprising a 3’ portion of a nucleic acid encoding a pol polypeptide (pol-IN), a nucleic acid encoding an env polypeptide, a nucleic acid encoding a tas polypeptide, a nucleic acid encoding a bel-2 polypeptide (note that the orf-2 is the bel-2 in Fig 3) and a 3’ LTR (see Fig 3) of a second chimpanzee SFV strain (MP/WE strain).
Prior art Richard et al., (J Virol. 2015;89(24):12480-12491. Cited in IDS 12/12/2024) disclose the variability of the env genes of zoonotic SFV strains and search for possible recombinants (see e.g., abstract). Richard teaches that the chimpanzee SFV-CpzI and SFV-CpzII subgroups probably recombined (P value of 2.074 x 10-12). Thus, Richard teaches a chimeric SFV comprising a first genomic fragment in the env gene of a first chimpanzee SFV-cpzI strain and a second genomic fragment in the env gene of a second chimpanzee SFV-cpzII strain (it is noted that these chimpanzee SFV-cpzI strain and chimpanzee SFV-cpzII strain are likely to be the chimpanzee PAN1 and PAN2 SFV strains).
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jianjian Zhu whose telephone number is (571)272-0956. The examiner can normally be reached M - F 8:30AM - 4PM (EST).
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/JIANJIAN ZHU/Examiner, Art Unit 1631
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