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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/16/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c). Specifically, a sequence appears in para. 84 of the instant specification that does not have accompanying sequence identifier.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because of the following informalities: para. 84 of the specification does not have a necessary sequence identifier, as described above.
Appropriate correction is required.
Claim Objections
Claims 2-3 are objected to because of the following identical informality: in line 1 of each claim, “mutant viruses,” should read “mutant virus,” to better align with the single KSHV mutant described in claim 1. Appropriate correction is required.
Claim 3 is objected to because of the following informality: the comma in line 2 should be removed. Appropriate correction is required.
Claims 4-6 are objected to because of the following identical informality: “a KSHV mutant” should read “the KSHV mutant,” as this phrase refers to the mutant generated in claim 1. Appropriate correction is required.
Claim 10 is objected to because of the following informality: the phrase “a gene or gene product” should read “the gene or gene product thereof” to better match the language of claim 9, from which this claim depends. Appropriate correction is required.
Claim 11 is objected to because of the following informalities: “the artificial constructs of claim 9” should read “the artificial gene or gene product thereof of claim 9” to better match the language used in claim 9. Additionally, the comma in line 2 should be removed. Appropriate correction is required.
Claim 12 is objected to because of the following informality: the phrase “a gene or gene product” should read “the gene or gene product thereof” to better match the language of claim 9, from which this claim depends. Appropriate correction is required.
Claim 13 is objected to because of the following informality: “A method for using a mutant according to claim 1” should read “A method for using the KSHV mutant according to claim 1.” Appropriate correction is required.
Claim 14 is objected to because of the following informality: “a viral mutant according to claim 1” should read “the KSHV mutant according to claim 1.” Appropriate correction is required.
Claim 16 is objected to because of the following informality: “a non-essential genes of claim 15” should read “the non-essential gene of claim 15,” though note the 35 USC 112(b) Rejection associated with this phrasing in claim 15 below. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: in lines 1-2, “modulators” and “regulators” should read “modulator” and “regulator,” as these refer to the single opportunistic factor of claim 18. Also, in line 4, “find use” should read “for use.” Appropriate correction is required.
Claim 20 is objected to because of the following informality: “an opportunistic factor of claim 18” should read “the opportunistic factor of claim 18.” Appropriate correction is required.
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 10-12, 14, 16, and 19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims do not fall within at least one of the four categories of patent eligible subject matter because each of these claims is a “use” claim.
In considering “use” claims, MPEP 2173.05(q) is relevant. This section states, "'Use' claims that do not purport to claim a process, machine, manufacture, or composition of matter fail to comply with 35 U.S.C. 101. In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961)("one cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101 "). In Ex parte Dunki, 153 USPQ 678 (Bd. App. 1967), the Board held the following claim to be an improper definition of a process: "The use of a high carbon austenitic iron alloy having a proportion of free carbon as a vehicle brake part subject to stress by sliding friction." In Clinical Products Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966), the district court held the following claim was definite, but that it was not a proper process claim under 35 U.S.C. 101: "The use of a sustained release therapeutic agent in the body of ephedrine absorbed upon polystyrene sulfonic acid."
Each of the rejected claims (10-12, 14, 16, and 19) state the "use of" a component, and so are not directed to a category of patentable inventions. Thus, these claims are rejected under 35 USC 101 and are not further examined on their merits herein.
Claims 1, 4-5, and 9 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claims recite natural products.
Claim 1 is drawn towards a Kaposi sarcoma associated herpesvirus (KSHV) mutant with one or more particular mutations. As mutations to nucleic acid sequences naturally occur and exist in nature, and these mutants are not required to possess any functional differences relative to the naturally occurring mutations, the claim as a whole is directed to a group of products that are not markedly different from their naturally occurring counterparts.
Claims 4-5 are both drawn to a pair of primers. Though it is not clear that oligonucleotides having the features recited in claims 4-5 exist in nature, the claimed oligonucleotides are, nevertheless, judicial exceptions because they are derived from naturally occurring molecules and are not required to possess any structural or functional differences relative to their naturally occurring counterparts. For example, the oligonucleotides of claims 4-5 are not required to include a detectable label. As well, the oligonucleotides do not have a function that differs from that of the naturally occurring counterparts since, like the naturally occurring counterparts, the claimed oligonucleotides hybridize to particular sequences. See also MPEP 2106.04(c) II. Thus, the claims as a whole are directed to a group of products that are not markedly different from their naturally occurring counterparts.
Claim 9 is drawn to “an artificial gene,” where the gene comprises one of the KSHV essential or non-essential genes. No other component for the artificial gene appears to be required. Thus, the artificial gene can simply be the same exact sequence as a naturally occurring KSHV gene, with no structural or functional differences between the two. Thus, the claim as a whole is directed to a group of products that are not markedly different from their naturally occurring counterparts.
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 1-9, 13-15, 17-18, and 20 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.
Regarding claim 1, MPEP 2173.05(s) states, “Where possible, claims are to be complete in themselves…Reference characters corresponding to elements recited in the detailed description and the drawings may be used in conjunction with the recitation of the same element or group of elements in the claims.” Claim 1 recites Table 1 of the specification without also reciting the elements within the table, and so this claim is indefinite.
Claims 2-8, 13, and 17 are rejected due to their direct or indirect dependence on rejected claim 1.
Regarding claim 2, MPEP 2173.05(q) states "Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986)." Claim 2 recites a “method of using the mutant viruses of claim 1 for analyzing the molecular, cellular, and immunological response to mutant virus infections,” but does not provide any actual method steps for performing these analyses. Therefore, the claim is indefinite, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method.
A similar problem is presented in claim 3, which recites a method of using mutant viruses “in the production of other viral vectors, and/or the generation of live-attenuated vaccines.” This is merely a statement of use with no concrete method steps provided for how to accomplish said use. Therefore, the claim is indefinite, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method.
Additionally regarding claim 5, this claim recites Table S1 without also reciting the elements within the table, and so this claim is indefinite for the same reasons described above in the rejection of claim 1.
Additionally regarding claim 6, this method is for “constructing a KSHV mutant,” using primers without explaining any steps involved in the mutant creation or how the primers are to be used. Therefore, the claim is indefinite for the reasons related to MPEP 2173.05(q) as recited above, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method.
Additionally regarding claim 7, the method is drawn to “using the primers for mutagenesis,” without explaining any steps involved in performing mutagenesis or how the primers are to be used. Therefore, the claim is indefinite for the reasons related to MPEP 2173.05(q) as recited above, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method.
Claim 7 is also rejected for using the phrase “e.g.,”, as this renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). The claim will be interpreted as though this example is not required of the claim. Similarly, at the end of the claim, the term “like” in “like CRISPR” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. The claim will be interpreted as though a teaching regarding CRISPR is not required.
Claim 7 is also rejected because of the phrasing “having high fidelity…superior to other mutagenesis approaches.” The terms “high fidelity” and “superior to” are 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. These terms are thus considered relative terms, as it is unclear how prior art would be evaluated to have “high fidelity,” or how much better a method would have to be to be “superior to other mutagenesis approaches.”
Additionally regarding claim 8, the method is drawn to “using the primers…using transfection, induction, and/or tittering,” without explaining how these methods would be used, or where the primers would come into play. The claim later states, “the methods comprising a tractable workflow,” but this does not further elucidate any particular steps or incorporate the primers, transfection, induction, and/or tittering into the workflow. Therefore, the claim is indefinite for the reasons related to MPEP 2173.05(q) as recited above, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method, other than the presence of a “tractable workflow.”
Additionally regarding claim 9, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). A similar issue is presented with the phrase “particularly the 27 new identified essential genes,” as it is unknown if one of these genes is required to be used, or if the use of such genes is merely preferred.
Also in claim 9, this claim recites Table 1 without also reciting the elements within the table, and so this claim is indefinite for the same reasons described above in the rejection of claims 1 and 5.
Finally regarding claim 9, the use of the phrase “as disclosed” in the final line of the claim is unclear, as it is unclear what particular disclosure this is referring to, and if this is referring to the 27 genes, or the artificial gene itself.
Claim 15 is rejected due to its dependence on rejected claim 9.
Additionally regarding claim 13, the method is drawn to “construction of a gene-inactivation or rescued mutant or for tagging or introducing foreign genes into the KSHV genome,” without explaining any steps involved in this construction. Therefore, the claim is indefinite for the reasons related to MPEP 2173.05(q) as recited above, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method.
Claim 13 is also rejected due to the phrase “particularly for use” because it is unclear whether the limitations following the phrase are part of the claimed invention, or is merely reciting a preferred use for the invention. See MPEP § 2173.05(d).
Additionally regarding claim 15, the method is drawn to “using a non-essential gene of claim 9 in a live-attenuated vaccine to impart attenuated growth,” without explaining any steps involved in using the gene or creating the vaccine. Therefore, the claim is indefinite for the reasons related to MPEP 2173.05(q) as recited above, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method.
Claim 15 also recites “using a non-essential gene of claim 9,” but it is unclear what this is referring to. Claim 9 describes an artificial gene that can comprise a KSHV non-essential gene, but is not required to. Thus, it is unknown if the “non-essential gene” recited by claim 15 should read “the artificial gene of claim 9,” or if claim 15 is referring to one of the non-essential genes that may be used in the artificial gene of claim 9.
Additionally regarding claim 17, the method is drawn to “screening KSHV mutants of claim 1 in human cell lines,” without explaining any steps involved in this screening. Therefore, the claim is indefinite for the reasons related to MPEP 2173.05(q) as recited above, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method. The claim states that the method is “as disclosed,” but this is not a specific step, and further compounds the indefiniteness issue, as it is unclear what particular disclosure this is referring to.
Regarding claim 18, an opportunistic factor is described “for use in the treatment of KSHV infection, as disclosed.” It is unclear if “as disclosed” is referring to the claimed opportunistic factor or the use described by the claim. This lack of clarity renders the claim indefinite.
Claim 20 is rejected due to its dependence on rejected claim 18.
Additionally regarding claim 20, the method is drawn to “A method of expressing an opportunistic factor of claim 18, that functions to suppress KSHV spontaneous reactivation, for use in the treatment of KSHV infection,” without explaining any steps involved in this expression, suppression, or treatment. Therefore, the claim is indefinite for the reasons related to MPEP 2173.05(q) as recited above, as the scope of the claim is unclear with regard to what is actually required to perform the claimed method.
Claim Interpretation
MPEP 2111.02 discusses the effects of preamble. Specifically, this section notes that a preamble is only considered to be a claim limitation if it limits the structure of the claimed invention. If the preamble does not limit the structure of a claim, then it is generally considered to recite purpose or intended use, which is non-limiting. This reasoning is used in conjunction with the broadest reasonable interpretation of each claim in light of the 35 USC 112(b) Rejections stated above to interpret each claim, and prior art recited below is considered consistent with these interpretations.
Regarding claim 18 and the term "opportunistic factor," in the instant specification, this term is not specifically defined. Para. 9 states that such factors may have "dual functions of regulating both the immune environment/responses and viral reactivation/replication," and are also referred to as viral factors. Para. 11 states that inactivated open reading frames "with immunomodulatory functions encode factors that regulate viral reactivation and replication in connection with the host immune environment/status and responses." Para. 12 states, "The invention provides methods for developing drugs mimicking or activating opportunistic factors that inhibit viral reactivation/replication and enhance host immune responses." These teachings do not provide specific types or examples of opportunistic factors. Para. 75 describes K6 and K11 as immunomodulatory factors, and these elements appear to be ORFs (see it listed in Table 1). All claim terms must be given their broadest reasonable interpretation in light of the specification, and the broadest reasonable interpretation includes the plain meaning of a term, which is "the ordinary and customary meaning given to the term by those of ordinary skill in the art at the relevant time," (see MPEP 2111). While "opportunistic factor" does not appear to be a particularly common term used in the art, it has been used to refer to broad categories of elements, including enzymes (Martini et al. (Infection and Immunity, 2015), page 370, column 2, para. 2), environmental conditions (Achenbach et al. (Hydrobiologia, 2014), page 18, column 1, para. 1 and page 21, column 2, para. 1), and genes (Jung et al. (Ir. Vet J, 2021), page 7, column 2, para. 2). Thus, this term does not have a particular definition in the prior art either, and is not used to refer to a particular type of element. Therefore, the "opportunistic factor" of the claim will be interpreted as any element that could be used to suppress KSHV spontaneous reactivation, with no particular limit to the type of element that may be used (e.g. genetic or protein component, an organism, an environmental condition, etc.).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 6-9, 13, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al. (Virology, 2008; cited in Applicant's IDS).
Regarding claim 1, Li teaches the genetic disruption of KSHV major latent nuclear antigen LANA (Title). Specifically, this disruption involves a deletion of ORF73 (see Figure 1 and the creation of BAC3ΔLANA-Kan and BAC3ΔLANA). ORF73 is contained within instant Table 1.
Regarding claim 2, Li shows various uses for their LANA mutants. Specifically, Figure 2A shows the cellular response to infection with BAC3ΔLANA mutants, showing that these viruses are capable of existing within cells. Figure 2B and Figure 3 show particular gene responses to BAC3ΔLANA infection in cells, corresponding to the claimed molecular analyses. Figure 6 shows viral infection of cells with BAC3ΔLANA, corresponding to an analysis of immunological response, as immune response to each mutant would impact the viral titers measured in the figure.
Regarding claim 4, Li teaches that the BAC3ΔLANA-Kan mutant was created by first using PCR primers LANAK-F and LANAK-R on a Kanr flanked by loxP sites (page 241, column 2. para. 3).
Regarding claim 6, Li teaches that the LANAK-F and LANAK-R primers were used in the method for constructing BAC3ΔLANA-Kan as described on page 241, column 2. para. 3.
Regarding claim 7, the mutagenesis methods of Li are shown to be incredibly precise, as evidenced by the workflow shown in Figure 1A. Figure 1 also shows that the created mutant operates exactly as intended – with BAC3ΔLANA not showing any LANA expression. Similar results are also shown in Figure 2B. BAC3ΔLANA-Kan also is the only created mutant that shows Kanr probe hybridization (Figure 1D). These results are considered to meet the limitations of the claim as interpreted in light of the 35 USC 112(b) Rejections above.
Regarding claim 8, the instant specification does not provide a specific definition for what constitutes a "tractable workflow," and only uses the term "tractable" in para. 24 in a statement of embodiments of the invention. Thus, the plain meaning of the phrase will be used. A "tractable workflow" will be considered any method involving multiple steps that is controlled. After creating BAC3ΔLANA-Kan (using primers as described above in the rejection of claim 4), BAC3ΔLANA is created, which is then used to create reconstituted BAC3ΔLANArt-Zeo and BAC3ΔLANArt (Figure 1). This creation is considered a tractable workflow as encompassed by the instant claims. In describing this mutant reconstitution process, Li notes that transfection is used (“The Kanr was removed from the intermediate mutant by Cre-mediated recombination upon transfection of the plasmid pCTP-T expressing the Cre recombinase into the BAC36ΔLANA-Kan E. coli…”; page 241, column 2, para. 3).
Regarding claim 9, Li teaches various mutants, including recombinant mutants such as BAC3ΔLANA-Kan (page 241, column 2, para. 3) and BAC36ΔLANArt-Zeo (page 241, column 2, para. 4). BAC36ΔLANArt-Zeo specifically includes a recombinant fragment that contains ORF73, which is contained within instant Table 1 (Figure 1 of Li).
Regarding claim 13, the term "rescued mutant" is not specifically defined by the instant specification, but appears to encompass instances in which ORFs are returned to a sequence (see paras. 39 and 66), as well as a general restoration of a wild-type sequence (para. 83). BAC3ΔLANA-Kan mutant is then used to create BAC3ΔLANA, and then a BAC3ΔLANA revertant is created, termed BAC36ΔLANArt (page 241, column 2, para. 4 and Figure 1). BAC36ΔLANArt returns ORF73 to the KSHV sequence, and so is considered to be a rescued mutant as is used in the instant invention.
Regarding claim 17, Lu teaches that BAC3ΔLANA was tested in HEK293 cells for expression of LANA (Figure 2, page 241, column 2, para. 4, and page 242, column 1, para. 2).
Claims 1, 3, 9, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brar (Dissertation, 2018).
Brar discusses means of making live-attenuated vaccines for gammaherpesviruses, specifically including KSHV (Abstract, pages ii-iii). In creating the vaccine, ORF10, ORF11, ORF36, and ORF54 were inactivated (page 11; instant claims 1 and 9). Page 12 states that the use of this mutant, along with other components, resulted in the creation of a live-attenuated gammaherpesvirus vaccine called DIP (instant claim 3). The abstract on page 28 states that DIP cannot establish latent infection and does not persist in the host. Figure 3-1 shows attenuated growth with DIP, and see also page 31 (instant claim 15).
Claims 18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (PLoS Pathogens, 2007).
Yu teaches the evaluation of spontaneous reactivation in KHSV, particularly with regard to the associated cellular signaling pathways (Abstract). On pages 0448-0449, KSHV spontaneous reactivation is discussed, and the Raf/MEK/ERK pathway was considered to result in KSHV spontaneous reactivation. This activation was successfully suppressed by U0126 drug treatment (see also Figure 6). U0126 is a specific inhibitor to the Raf/MEK/ERK pathway (pages 0447-0448, joining para.), and is encompassed by the claimed term “opportunistic factor” as discussed in the “Claim Interpretation” section above. This thus meets the limitations of instant claim 18. As the U0126 treatment is shown in KSHV infected BC-3-G cells (see Figure 6 caption and pages 0448-0449), this is also considered to read on the limitations of instant claim 20.
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.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Li et al. (Virology, 2008; cited in Applicant's IDS), in view of GenBank (Accession #GQ994935.1), and in view of Ye et al. (BMC Bioinformatics, 2012).
Li teaches the methods of claims 1-2, 4, 6-9, 13, and 17, as described above. Though Li teaches the use of primer sequences, the reference does not teach any of the sequences associated with instant Table S1.
GenBank teaches the complete genome of KSHV (see source notation). Within this genome, there are sequences that 100% match instant SEQ ID NOs: 267-268, which are the primers associated with ORF73, the deleted ORF of note in Li. See the alignments below:
Alignment for SEQ ID NO: 267
PNG
media_image1.png
129
719
media_image1.png
Greyscale
Alignment for SEQ ID NO: 268
PNG
media_image2.png
125
726
media_image2.png
Greyscale
Ye teaches the use of the publicly available tool Primer-BLAST, which is able to design target-specific PCR primers (Abstract). This method is flexible, user-friendly, and fast compared to other design tools (pages 9-10, “Conclusions”).
Prior to the effective filing date of the claimed invention, it would have been prima facie obvious to create a primer pair consisting of instant SEQ ID NOs: 267-267 using the teachings of Li, GenBank, and Ye, and to use these primers to aid in the construction and detection of the ORF73 mutants (e.g. BAC3ΔLANA-Kan, BAC3ΔLANA, etc.) in the method of Li. The teachings of Ye indicate that software for PCR primer design is available and can be used by the ordinary artisan to obtain primers suitable for amplifying a known target sequence (page 2, column 2, para. 2). In view of the above, the ordinary artisan would have been motivated to use the publicly available software disclosed in Ye and the known ORF73 sequences described by GenBank to design primers for use in the method of Li, and in the absence of unexpected results, the claimed primers (instant SEQ ID NOs: 267-268) simply represent the result of an obvious series of steps. In other words, the claimed primers, and many other related primer sequences, could have been developed to serve the purposes described by Li utilizing tools and methodologies that would have been within the knowledge and capabilities of the ordinary artisan.
Thus, claim 5 is prima facie obvious over Li, in view of GenBank, and in view of Ye.
Conclusion
No claims are currently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRANCESCA F GIAMMONA whose telephone number is (571)270-0595. The examiner can normally be reached M-Th, 7-5pm.
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/F.F.G./Examiner, Art Unit 1681 /SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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