DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The instant application is a 35 U.S.C. 371 national phase application filed 09/29/2022, and claims priority to International Application No. PCT/IB21/00206 (filing date 03/30/2021), which claims the benefit of the prior-filed United States
Provisional Patent Application No. 63/002,168 (filing date 03/30/2020).
Status of Application/Claims
The amendment, filed 12/19/2025, is acknowledged. Claims 1-2, 4, 7, 9, 11-14, 16, 18-199, 24-25, 27, 31, 35, and 37-51 are currently amended. Claims 1-51 are currently pending and are examined on the merits herein.
Information Disclosure Statement
No new information disclosure statements (IDSs) are submitted.
Withdrawn Objections & Rejections
Regarding the specification objection for trade names and/or trademark compliance issues, applicant amendment has addressed the issue. Thus, the objection is withdrawn.
Regarding the claim objections for claims 24, 26-27, 29-30, 32, and 45 for minor informalities, applicant amendment has addressed the issue. Thus, the objection is withdrawn. Regarding the claim objection for claim 36 for minor informalities, the objection is maintained.
Regarding the rejections for claims 1-2, 4, 7, 9, 11-14, 16, 18-19, 24-25, 31, 35, and 37-51 under 35 U.S.C. 112(b) for indefiniteness: Applicant amendment has addressed the issues and the rejection for these claims is withdrawn.
Regarding the rejections for claim 29 under 35 U.S.C. 112(d) for failing to further limit the subject matter of the claim upon which it depends: Applicant amendment has addressed the issue and the rejection is withdrawn
Regarding the rejection for claims 1-11, 15-25, and 28-49 under 35 U.S.C. 102 for novelty, applicant has submitted an affidavit (filed 12/19/2026) stating that the prior art of Dinney, WO2019118389 recited in the previous non-final office action (filed 07/23/2025) was commonly owned by applicant Trizell Ltd. Thus, the rejection is withdrawn.
Regarding the rejection for claims 1, 33, and 50-51 under 35 U.S.C. 102 for novelty, applicant has submitted an affidavit (filed 12/19/2026) stating that the prior art of Parker, WO2020146065 recited in the previous non-final office action (filed 07/23/2025) was commonly owned by applicant Trizell Ltd. Thus, the rejection is withdrawn.
Regarding the rejection for claims 12-14 and 26 under 35 U.S.C. 103 for obviousness, applicant has submitted an affidavit (filed 12/19/2026) stating that the primary prior art reference of Dinney, WO2019118389 recited in the previous obviousness rejection of the non-final office action (filed 07/23/2025) was commonly owned by applicant Trizell Ltd. Thus, the rejection is withdrawn.
Regarding the rejection for claim 27 under 35 U.S.C. 103 for obviousness, applicant has submitted an affidavit (filed 12/19/2026) stating that the primary prior art reference of Dinney, WO2019118389 recited in the previous obviousness rejection of the non-final office action (filed 07/23/2025) was commonly owned by applicant Trizell Ltd. Thus, the rejection is withdrawn.
Claim Objections
Claims 23 and 24 are objected to for the following: All "currently amended" claims must include markings to indicate the changes made relative to the immediate prior version of the claims: underlining to indicate additions, strike-through or double brackets for deletions (see 37 CFR 1.121(c) for further details regarding the format of claim amendments). Applicants should note that, in an amendment to the claims filed in a national phase application, the status identifier "original" must be used for claims that had been presented on the international filing date and not modified or canceled. The status identifier "previously presented" must be used in any amendment submitted during the national phase for any claims added or modified under PCT Articles 19 or 34 in the international phase that were subsequently entered in the national phase. The status identifier "canceled" must be used in any amendment submitted during the national phase for any claims canceled under a PCT Article 19 or 34 amendment in the international phase and subsequently entered in the national phase.
Claim 23 is labeled with a “previously amended” identifier but is currently amended. Claims 23 and 24 are currently amended (filed 12/19/2025) but do not include proper markings to indicate the changes made relative to the immediate prior version of the claims (filed 05/16/2023). For further examination, claims 23 and 24 are considered to be dependent on instant claim 1 as recited in claims filed 05/16/2023.
Claim 36 is objected to because of the following informality: Claim 24 recites “…diagnosed with one or both of carcinoma in situ (CIS) or high-grade papillary disease.” The term “or” should be corrected to “and/or.”
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 4-5 are rejected under 35 U.S.C. 101 because the claimed
invention is directed to abstract ideas with judicial exceptions without significantly
more. The claim is drawn to a method comprising abstract ideas. The judicial exception is not integrated into practical application because the claim reads on abstract ideas. The claim does not include additional elements that are sufficient to amount to
significantly more than the judicial exceptions.
The claims are evaluated using the “Subject Matter Eligibility Test for Products and Processes” flow chart as shown in MPEP § 2106.III.
Step 1: Is the claim drawn to a process, machine, manufacture or composition of matter?
Yes. Claim 4 is drawn to a method which is one of the four statutory categories. Claim 5 further limits the method of claim 4.
Step 2A, Prong One: Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Yes. With respect to claim 4, the method is drawn to “a method for evaluating or monitoring efficacy of the composition in a subject having or diagnosed with high-grade NMIBC”. The remainder of the claim fails to provide further explanation of how this evaluation or monitoring is being conducted. However, the claim language indicates that these steps are being performed in the method. Because these steps encompass mental steps, the claim recites a judicial exception. Claim 5 includes the mental steps of claim 4 and the additional limitation of administering the composition to the subject; thus, claim 5 also includes the judicial exception.
Step 2A, Prong Two: Does the claim recite additional elements that integrate the judicial exception into an application?
Yes. Claim 4 recites the additional step of “performing an assay on the subject or on a sample from the subject.” And, claim 5 recites the additional step of “administering the composition to the subject.” However, these steps do not integrate the judicial exception into a practical application.
Firstly, claim 4 fails to provide any connection between the judicial exception and the indicated assay. Likewise, claim 5 also fails to provide a connection between the judicial exception of “evaluating and monitoring” and administering the composition. Therefore, the claim broadly reads on a method of evaluating or monitoring efficacy of a composition in a subject along with performing an apparently related method comprising administering a composition and performing some generic assay on the subject. Due to the lack of any connection between the two steps, the additional element fails to integrate the judicial exception into a practical application.
Secondly, even if it is assumed that the evaluation or monitoring is done on the basis of data collected as a result of performing the assay on a subject receiving administration of the composition, that assay fails to integrate the judicial exception into a practical application. In such a case, the assay is merely data gathering necessary for the “method of evaluation or monitoring.” MPEP §2106.05(g) indicates that mere data gathering is generally considered insignificant extra-solution activity which fails to integrate judicial exceptions into a practical application.
It is noted that claim 4 additionally includes two wherein clauses: 1) defining the composition to be evaluated, and 2) defining the subject as having previously received administrations of the composition. These steps merely limit the scope of the evaluation to that of a narrow group of compositions, and fails to change the analysis indicated above.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception?
No. The additional element to the claim is the performance of an assay after administering a composition. Given the high level of generality of the claim, it would appear that this step is relying on assays that are well-understood and routine in the art. Thus, the claim does not amount to significantly more than the judicial exception.
Without any evidence to the contrary, the method does not include any steps other than those listed above, which are mental processes. Because there are no additional steps that integrate the judicial exceptions of abstract ideas into an application that amounts to significantly more than the judicial exceptions, the claimed invention does not pass the “Subject Matter Eligibility Test for Products and Processes” (See, e.g., MPEP 2106).
Accordingly, claims 4 and 5 are directed to a judicial exception. Because the claim
does not include any additional features that could add significantly more to the
exception, the claim does not qualify as eligible subject matter under 35 U.S.C §101.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11, 15-25, 28-51 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Shore, et al. Intravesical rAd-IFNα/Syn3 for Patients with High-Grade Bacillus Calmette-Guerin-Refractory or Relapsed Non-Muscle-Invasive Bladder Cancer: A Phase II Randomized Study. Journal of Clinical Oncology (2017), 35:30, p.3410-3416 (published 10/20/2017; herein referred to as Shore),
as evidenced by De Wit and Goldberg. Pembrolizumab for Patients with High-Risk Non–Muscle Invasive Bladder Cancer Unresponsive to Bacillus Calmette-Guérin: Updated Follow-Up from KEYNOTE-057. ASCO 2019 Annual Meeting #ASCO19, 05/31/2019 – 06/04/2019, Chicago, IL, USA (herein referred to as Goldberg).
Shore teaches a method of treating a population of subjects with high-grade non-muscle-invasive bladder cancer (NMIBC) in a subject by intravesically administering a non-replicating serotype 5 (i.e., “type 5”) recombinant adenoviral vector that encodes interferon a-2b (IFN a-2b; i.e., IFNα-2b) and SYN3 (title; abstract; p.3411, col.1, para.5; Supplemental Methods, para.2). Shore teaches that NMIBC includes papillary disease (i.e., Ta or T1) and carcinoma in situ (i.e., CIS) (p.3411, col.1, para.5). Shore teaches administration of the treatment every 3 months with evaluations and an end point of 12 months (i.e., at least one year; p.3411, col.2, para.3).
Shore teaches performing evaluative assays on the subject and samples from the subject at 12 months (i.e., at about one year or longer after administration of the composition; p.3411, col.2, para.3). Shore teaches assays that assess response to treatment (i.e., efficacy), including assessment of the concentration of IFNα-2b (applicant “IFN a-2b”) in urine samples (p.3411, col.2, para.5; p.3414, Table 3) and determination of high-grade (HG) recurrence-free survival (RFS) (i.e., HG RFS; p.3412, section—Primary End Point: HG RFS). Shore, thus, teaches acquiring samples from subjects in order to perform efficacy and safety assessments, which included hematology and urinalysis assessments (i.e., blood samples, serum samples, and urine samples; p.3411, col.2, para.5; p.3412, Fig.1). Shore further teaches evaluation using cytology, cystoscopy, and biopsy (i.e., assays using cytology/cystoscopy and assays that are not cytology or cystoscopy; p.3411, col.2, para.3).
Shore also teaches the method wherein subjects also are treated a combination therapy that also comprises a cancer checkpoint inhibitor that is an anti-programmed death 1 inhibitor (i.e., an additional therapeutic agent that is a PD-1 inhibitor; p.p.3415, col.1, para.1).
Shore teaches that subjects have complete responses (CR), partial responses (i.e., varied durations of HG RFS), and non-responses to treatment (i.e., in the population of subjects; Tables 2 and 4) including subjects that do not exhibit high-grade recurrence after treatment (i.e., for at least one year after administration; (see Table 4 Durability for patients exhibiting HG RFS ~12 months; p.3412, col.1, para.4). Shore teaches that the subjects have an Eastern Cooperative Oncology Group status of 2 or less than 2 (see p.3413, ECOG PS 0 and 1 in Table 1). Shore teaches that the subjects have high-risk NMIBC (i.e., papillary = Ta and T1, and CIS; p.3411, col.1, para.5; Table 1) as evidenced by Goldberg, which defines “high-risk NMIBC” as “any carcinoma in situ (CIS), T1 tumor, or high-grade Ta tumor” (p.1, para.1). Shore teaches that subjects include those which have not been responsive to at least one prior treatment comprising Bacillus Calmette-Guerin (BCG; see Table 1 BCG failure classification: relapsed (i.e., recurring) and refractory) and subjects with recurring NMIBC (p.3413, col.2, para.3) and subjects have received more than one treatment with BCG (p.3411, col.1, para.5; Table 1, see No. of previous BCG courses: 1, 2, and ≥ 3).
Shore teaches that the vector is administered to patients at a “low” dose of 1 x 1011 viral particles/mL (i.e., vp/mL) or a “high” dose of 3 x 1011 vp/mL; and, that the total dose for each of these groups was 7.5 x 1012 vp or 2.25 x 1013 vp (p.3411, col.2, para.2; Table 1); thus, the total volume for each group was 75 mL.
Shore teaches monitoring of durability of CR (p.11, Table 4), high-grade recurrence-free survival (i.e., 11 of 14 patients monitored after one year remained disease free), radical cystectomy free survival (i.e., only 1 of 14 patients underwent cystectomy; Table 4, patient 2), and overall survival (i.e., 9 of 11 patients who remained in the study for follow-up after one year were still alive).
Shore teaches that 28.6% of CIS-only patients receiving low dose treatment exhibited HG RFS at 12 months (i.e., about 24.3%; i.e., did not exhibit high grade recurrence; p.3414, Table 2). Shore teaches the ability of the method of treatment to result in HG RFS (as it pertains to claims 37 and 39) in CIS subjects, which is attributed to vector-mediated administration of the composition of IFNα-2a in combination with SYN3. This describes an inherent property of the known IFNα-2b and SYN3 structures that does not render the claim patentably new (see MPEP §2112). As Shore teaches that the treatment can result in about 24.3% of subjects (as recited in claim 37) that exhibit HG RFS (i.e., “do not exhibit high grade recurrence” as recited in instant claim 39), applicant’s composition would necessarily possess the same property of resulting in 45.5% HG RFS as recited in instant claim 39 given that one skilled in the art would expect some variability the level of success in achieving HG RFS based on subject/patient characteristics such as health history and disease status. Thus, Shore teaches instant claim 39 based on inherent structure/function properties.
Shore teaches the (absolute) durability of CR for 14 patients based on yearly reporting, including 9 CIS patients of the 14 patients exhibiting HG RFS at one year, which ranged from 15 months – 38 months. One skilled in the art would also understand how to calculate the mean durability of CR for these 9 patients, which is 27.89 months (i.e., better than 9.69 months as recited in instant claim 38; p.10, Table 4).
Shore teaches that 50.0% of papillary disease-only patients exhibited HG RFS at 12 months (i.e., about 43.8%; i.e., did not exhibit high grade recurrence; p.3414, Table 2). Regarding instant claim 42, Shore teaches the ability of the method of treatment to result in HG RFS (as it pertains to claims 40 and 42) in papillary disease subjects, which is attributed to vector-mediated administration of the composition of IFNα-2a in combination with SYN3. This describes an inherent property of the known IFNα-2b and SYN3 structures that does not render the claim patentably new (see MPEP §2112). As Shore teaches that the treatment can result in about 43.8% of subjects (as recited in claim 40) that exhibit HG RFS (i.e., “do not exhibit high grade recurrence” as recited in instant claim 42), applicant’s composition would necessarily possess the same property of resulting in 60% HG RFS as recited in instant claim 42 given that one skilled in the art would expect some variability the level of success in achieving HG RFS based on subject/patient characteristics such as health history and disease status. Thus, Shore teaches instant claim 42 based on inherent structure/function properties.
Shore teaches the (absolute) durability of CR for 14 patients based on yearly reporting, including 9 papillary disease patients (i.e., having Ta or T1 NMIBC) of the 14 patients exhibiting HG RFS at one year, which ranged from 13 months – 36 months. One skilled in the art would also understand how to calculate the mean durability of CR for these 9 patients, which is 24.11 months (i.e., better than 12.35 months; p.3415, Table 4).
Shore teaches the (absolute) durability of CR for 14 patients having CIS and papillary disease (i.e., Ta or T1) exhibiting HG RFS at one year, based on yearly reporting, which ranged from 13 months – 38 months. One skilled in the art would understand how to calculate the mean durability of CR for these 14 patients, which is 26.71 months (i.e., better than 7.31 months; p.3415, Table 4).
Shore teaches that, overall, 35.0% of patients remained free of HG recurrence 12 months after the initiation of treatment (i.e., exhibited HG RFS; i.e., about 30.5%; Supplemental Results, para.1). Shore teaches that 11 patients were monitored after the first 12 months, up to 3 years. Shore teaches that 9 of the 11 patients were still alive (3 patients withdrew after 1 year; p.3412, col.2, para.4—p.3413, col.1, para.1). Thus, the overall survival was 81.8% (i.e., about 91.9%, instant claim 46; i.e., about 93.5%, instant claim 47). Regarding instant claims 46 and 47, Shore teaches the ability of the method of treatment to result in overall survival (as it pertains to claims 46 and 47) in CIS and papillary disease subjects, which is attributed to vector-mediated administration of the composition of IFNα-2a in combination with SYN3. This describes an inherent property of the known IFNα-2b and SYN3 structures that does not render the claim patentably new (see MPEP §2112). As Shore teaches that the treatment can result in about 81.8% overall survival, applicant’s composition would necessarily possess the same property of resulting in 91.9% and 93.5% overall survival for CIS and papillary disease subjects, respectively, given that one skilled in the art would expect some variability the level of success in achieving overall survival based on subject/patient characteristics such as health history and disease status. Thus, Shore teaches instant claims 46-47 based on inherent structure/function properties.
Shore also teaches that, of the 14 patients evaluated, only 1 patient experienced progression to muscle invasion and underwent a radical cystectomy (p.3412, col.2, para.4—p.3413, col.1, para.1). This patient had papillary disease (i.e., Ta; Table 4). One skilled in the art would be able to calculate the percentage of CIS patients that exhibited muscle invasion (0 of 14 = 0%, which is better than 4.9% as recited in instant claim 48) and papillary disease patients that exhibited muscle invasion (1 of 14 = 7.1%; i.e., about 6.3%; instant claim 49). Additionally, Shore teaches that 10 of 14 patients who did not withdraw from the study before 2 years and who remained alive (i.e., survived), only 1 patient underwent a radical cystectomy (1 of 10 = 10%; Table 4). One skilled in the art would understand that this would mean 9 of the 10 exhibited “cystectomy-free survival” (i.e., 90%, which is better than 64.5%). Additionally, Shore teaches that of 13 patients that were monitored for 15 months or more, 9 of them still exhibited a complete response (i.e., HG-RFS with no recurrence; p.3415, Table 4). Thus, 9 of 13 (i.e., 69.2%) exhibited HG-RFS at ≥15 months.
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.
Claims 12-14 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Shore as applied to claims 1, 2-3, 8, 10-11 above, and further in view of Keegan. KEYTRUDA – Medication Guide. U.S. Food and Drug Administration, 2019; p.1-67 (herein referred to as FDA).
Shore teaches the method of treating subjects with high-grade non-muscle-invasive bladder cancer (NMIBC) in a subject by intravesically administering a non-replicating serotype 5 (i.e., “type 5”) recombinant adenoviral vector that encodes interferon a-2b (IFN a-2b; i.e., IFNα-2b) and SYN3, as applied to instant claim 1 above (title; abstract). Shore also teaches that NMIBC includes papillary disease (i.e., Ta or T1) and carcinoma in situ (i.e., CIS). Shore teaches administration of the treatment every 3 months with evaluations and an end point of 12 months, as applied to instant claim 1 above (i.e., at least one year). Shore also teaches evaluation using assays that include cytology, cystoscopy, and biopsy, as applied to instant claims 2 and 8 above. Shore also teaches the method wherein subjects also are treated with a cancer checkpoint inhibitor as an additional therapeutic agent, as applied to instant claims 10-11 above.
Shore further teaches that second-line treatment agents after BCG for subjects with NMIBC, include valrubicin and gemcitabine (i.e., agents that serve as chemotherapeutic agents) and checkpoint inhibitors used to treat cancer (p3413, col.2, para.4). Regarding instant claim 26, it would have been obvious to one of ordinary skill in the art to use the method of treatment, as taught by Shore, on subjects who have previously received at least one treatment comprising valrubicin, as this population would include BCG-refractory subjects.
Shore does not teach that the checkpoint inhibitor is a checkpoint inhibitor that targets PD-1 or PD-L1 (instant claim 12); that the checkpoint inhibitor is specifically the PD-1 antibody Pembrolizumab (instant claim 13); or that Pembrolizumab is administered intravenously about every three weeks or longer than every three weeks (instant claim 14).
FDA teaches that KEYTRUDA (i.e., pembrolizumab) is a programmed death receptor-1 (PD-1)-blocking antibody, formulated for intravenous injection, that is indicated for urothelial carcinoma, including patients not eligible for cisplatin-containing chemotherapy and whose tumors express PD-L1 (p.1, Indications and Usage; instant claims 12-13, and 26). FDA also teaches that a dosage of 200 mg every three weeks is recommended for urothelial carcinoma patients (p.1, Dosage and Administration; instant claim 14). FDA also teaches that pembrolizumab is approved based on tumor response rate and duration of response (p.4, para.2).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Shore by using the Pembrolizumab PD-1 antibody as the additional therapeutic agent. The motivation for doing so would be that intravenous Pembrolizumab is indicated for urothelial carcinomas, can be used in patients not eligible for cisplatin-containing chemotherapy, and because pembrolizumab has been approved based on tumor response rate and duration of response (as taught by FDA). Therefore, it would have been obvious to one of ordinary skill in the art to modify the method of Shore to include intravenous administration of Pembrolizumab antibody as the additional therapeutic agent in order to treat urothelial carcinoma, especially in patients not eligible for cisplatin-containing chemotherapy. One skilled in the art would have a reasonable expectation of success because KEYTRUDA, which is a pembrolizumab antibody has been approved by the FDA based on tumor response rate and duration of response (as taught by FDA above).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Shore as applied to claim 1 above, and further in view of Narayan and Shore. Intravesical gene therapy. (Feb. 2020) Urol. Clin. North Am., 47:1, p.1-15 (herein referred to as Narayan).
Shore teaches the method of treating subjects with high-grade non-muscle-invasive bladder cancer (NMIBC) in a subject by intravesically administering a non-replicating serotype 5 (i.e., “type 5”) recombinant adenoviral vector that encodes interferon a-2b (IFN a-2b; i.e., IFNα-2b) and SYN3, as applied to instant claim 1 above. Shore also teaches that NMIBC includes papillary disease (i.e., Ta or T1) and carcinoma in situ (i.e., CIS). Shore teaches administration of the treatment every 3 months with evaluations and an end point of 12 months, as applied to instant claim 1 above (i.e., at least one year).
Shore does not teach that the vector is targeted to the epithelium of the bladder tissue.
Narayan teaches that human epithelial cells, including urothelial cell carcinoma cells, are uniquely susceptible to an adenoviral infection due to the presence of the coxsackie/adenovirus receptor (CAR; p.3, para.2).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to use the adenoviral delivery treatment method of Shore to target epithelial cells of the bladder for treatment of NMIBC (as taught by Narayan). One of ordinary skill would have a reasonable expectation of success because urothelial carcinoma cells are uniquely susceptible to adenoviral infection (as taught by Narayan). Therefore, it would have been obvious to one skilled in the that using the adenoviral vector of Shore would target bladder epithelium tissue (as taught by Narayan).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jami M Gurley whose telephone number is (571)272-0117. The examiner can normally be reached Monday - Friday, 8am - 4pm.
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/JAMI MICHELLE GURLEY/Examiner, Art Unit 1647
/JOANNE HAMA/Supervisory Patent Examiner, Art Unit 1647