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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on September 8, 2026, has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-16, 27, 29-37, 39, 43, 45-47, 50-53, 55-57, 63-66, 69, 75, and 77) drawn to a method for analyzing for or detecting the presence of enhancers of adeno- associated virus (AAV) vector cell transduction in a biological sample from a subject) in the reply filed on September 11, 2024, is acknowledged.
Applicant further elected Method Species A, corresponding to claims 1 and 69.
Claims 2-16, 27, 29-37, 39, 43, 45-47, 50-53, 55-57, 63-66, 75, and 77 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (Group II and Species B-E), there being no allowable generic or linking claim.
DETAILED ACTION
The amended claims filed on September 8, 2026, have been acknowledged. Claims 17-26, 28, 38, 40-42, 44, 48-49, 54, 58-62, 67-68, 70-74, 76, and 78-85 were cancelled. Claims 1 and 88 were amended. In light of the Applicant’s elected group and species, claims 2-16, 27, 29-37, 39, 43, 45-47, 50-53, 55-57, 63-66, 75, and 77 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1, 69, and 86-88 are pending and examined on the merits.
Priority
The applicant claims domestic priority from U.S. provisional application No. 62/768,665, filed on November 16, 2018. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1, 69. And 86-88 receive domestic benefit from U.S. provisional application No. 62/768,665, filed on November 16, 2018.
Withdrawn Claim Rejections - 35 USC § 101
The prior rejection of claims 1 and 69 under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more is withdrawn in light of Applicant’s amendment to claim 1 as the amendments are considered to integrate the previously identified judicial exception into a practical application (treating the subject).
Claim Rejections - 35 USC § 103
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 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 1, 69, and 88 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Gene Therapy 24: 49-59. 2017) and World Intellectual Property Organization Patent Application No. 2013/078400 (Mingozzi). This rejection is a new rejection made in response to Applicant’s amendments to the claims that is substantially similar to a previous rejection of record. Any aspect of Applicant’s traversal relevant to the new rejection of record is addressed below.
Wang teaches a method for analyzing for or detecting the presence of enhancers of adeno-associated virus (AAV) vector cell transduction in a biological sample from a subject, comprising:
(a) providing infectious recombinant AAV particles comprising a recombinant AAV vector, wherein (Particles of AAV/luc vector (1 × 108) were incubated with PBS for 2 h at 4 °C. The mixture of AAV vector and PBS was used to transduce 1 × 105 Huh7 cells in a 48-well plate in the presence of adenovirus dl309 at MOI of 5 (Figure 1))
(i) said vector comprises a reporter transgene (the AAV/luc vector comprises a luciferase reporter gene (Figure 1)),
(ii) said reporter transgene comprises a single-stranded (AAV vectors comprise single stranded DNA),
(iii) said reporter transgene is operably linked to one or more expression regulatory element (Wang teaches that the AAV transgene plasmid is pTR/CBA-luc. The CBA corresponds to the chicken beta actin promoter (a regulatory element) (page 56, column 2, paragraph 4); and
(iv) said reporter transgene is flanked by one or more flanking element (AAV vectors comprise ITRs that flank the transgene);
(b) providing cells that can be infected with said infectious recombinant AAV particles (The mixture of AAV vector and PBS was used to transduce 1 × 105 Huh7 cells in a 48-well plate in the presence of adenovirus dl309 at MOI of 5 (Figure 1));
(c) contacting said cells of (b) with said infectious recombinant AAV particles of (a) under conditions in which said cells of (b) are transduced by said infectious recombinant AAV particles of (a) and said reporter transgene is expressed by said cells of (b) (The mixture of AAV vector and PBS was used to transduce 1 × 105 Huh7 cells in a 48-well plate in the presence of adenovirus dl309 at MOI of 5 (Figure 1));
(d) measuring expression of said reporter transgene and assigning a value denoted MAX that reflects the amount of reporter transgene expression of (c) (After 24 h, luciferase activity from the cell lysate was analyzed. The fold increase of transgene expression from sera incubation was calculated by comparison with PBS (Figure 1));
(e) providing infectious recombinant AAV particles of (a) (Particles of AAV/luc vector (1 × 108) were incubated with 1:500 diluted human sera for 2 h at 4 °C. The mixture of AAV vector and sera was used to transduce 1 × 105 Huh7 cells in a 48-well plate in the presence of adenovirus dl309 at MOI of 5 (Figure 1);
(f) providing a biological sample from a subject (Particles of AAV/luc vector (1 × 108) were incubated with 1:500 diluted human sera for 2 h at 4 °C. The mixture of AAV vector and sera was used to transduce 1 × 105 Huh7 cells in a 48-well plate in the presence of adenovirus dl309 at MOI of 5 (Figure 1);
(g) providing cells that can be infected with said infectious recombinant AAV particles (Particles of AAV/luc vector (1 × 108) were incubated with 1:500 diluted human sera for 2 h at 4 °C. The mixture of AAV vector and sera was used to transduce 1 × 105 Huh7 cells in a 48-well plate in the presence of adenovirus dl309 at MOI of 5 (Figure 1);
(j) measuring expression of said reporter transgene and assigning a value denoted S.EV that reflects the amount of reporter transgene expression of (i) (After 24 h, luciferase activity from the cell lysate was analyzed. The fold increase of transgene expression from sera incubation was calculated by comparison with PBS (Figure 1));
(k) comparing said S.EV to said MAX, wherein if said S.EV is greater than said MAX the biological sample from said subject contains enhancers of AAV vector cell transduction (After 24 h, luciferase activity from the cell lysate was analyzed. The fold increase of transgene expression from sera incubation was calculated by comparison with PBS (Figure 1)).
Wang discloses that in their study, they have identified several proteins from human serum, which directly interact with AAV virions and have the potential to impact AAV transduction (page 50, column 1, paragraph 1 and Figure S1).
Wang does not teach wherein the biological sample of (f) is mixed with empty capsid AAV particles to produce a mixture (M) and incubating said M under conditions allowing said empty capsid AAV particles to bind to any AAV binding antibodies present in said biological sample nor (i) simultaneously contacting said cells of (g) with said M and said infectious recombinant AAV particles of (e) under conditions in which said infectious recombinant AAV particles of (e) can transduce said cells of (g) and express said reporter transgene in said cells of (g).
However, Mingozzi teaches a method of measuring anti-AAV antibody-mediated neutralization in vitro wherein a reporter AAV8 vector expressing luciferase was incubated with increasing dilutions of pooled normal plasma alone (0X) or in the presence of increasing amounts of AAV585/8 empty capsids (10X, 100X, 1000X the amount of AAV8-Luciferase vector). After one hour incubation at 37°C, vectors were used to transduce HEK293 cells in vitro. Percent inhibition was measured relative to a control in which the reporter vector was incubated with medium only instead of pooled plasma. The addition of increasing amounts of AAV585/8 empty capsids protects the AAV8-Luciferase vector from antibody-mediated neutralization.
Mingozzi teaches that viral vectors and empty capsids can be administered separately. AAV empty capsids act as vector decoys that are bound by neutralizing antibodies (NAbs) and thus prevent them from neutralizing AAV vectors (containing a transgene), resulting in superior gene transduction efficiency when AAV vectors are delivered to a cell (paragraphs 0012-0032, Figure 7, and Example 5).
Mingozzi teaches that adult human sera has neutralizing antibodies (Nabs) that cause a significant reduction in viral transduction of a target cell. To evaluate individuals more rigorously, a series of sera from hemophilia subjects were screened using an in vitro NAb assay. Among those samples with a low NAb titer (from 1 to 3), a broad range of neutralizing activity in undiluted serum was measured (Table 1). Despite the pre-selection of subjects with low NAb titer, the dot blot analysis showed a marked variation in the amounts of total anti-AAV antibodies (both neutralizing and nonneutralizing) detected. These results indicate that adult human subjects who appear to have low-titer neutralizing antibodies (NAb) to AAV carry significant amounts of anti-AAV IgG not reliably detected by routine assays for NAb. (paragraphs 0006 and 125-127).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the method for analyzing or detecting the presence of enhancers of adeno-associated virus (AAV) vector cell transduction in a biological sample from a subject of Wang with the method step of protecting AAV vectors from antibody-mediated neutralization by including empty AAV vector as taught by Mingozzi to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because Mingozzi teaches that adult human sera is known to have neutralizing antibodies that cause a significant reduction in viral transduction of a target cell. By mixing empty capsids and the human sera, the AAV/Luc vector can be protected from neutralization. Furthermore, as human sera has a wide variation in the levels of neutralizing antibodies, it would also be obvious to use the empty capsids the protect the AAV vectors from neutralization in order to reduce the variability in the data between experiments, allowing for a more accurate assessment of the enhancer qualities of the sera/compounds within the specific type of sera and specific type of AAV vectors used in the method of Wang. In other words, Wang teaches that there are multiple possible enhancers in human serum (e.g. Table S1) that were to be analyzed, as well as other isotypes of AAV that would need to be analyzed in the presence of empty AAV vectors in order to protect from neutralizing antibodies. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding the limitation, mixing the biological sample with the empty capsids to produce a mixture (M) prior to contacting M and said cells of (g) with the infectious recombinant AAV particles, as an initial matter, the “prior to contacting M and said cells of (g)” limitation is broadly interpreted to require that mixing the biological sample with the empty capsids occurs before the mixture (M) and the cells are contacted by the infectious AAV particles, individually. This allows for the mixture of the biological sample and empty capsids to be incubated with the infectious viral vectors prior to administering the combined mixture of the biological sample, empty capsids, and infectious particles to the cells. This interpretation is further backed up by subclaim (i) which has the limitation of “simultaneously contacting said cells of (g) with said M and said infectious recombinant AAV particles” as the simplest and most logical way of simultaneously contacting the cells with the mixture M and the infectious AAV is to mix the mixture M and the infectious AAV prior to administering the combined mixture to the cells.
Furthermore, it is worth noting that as currently written, there is no time frame associated with the incubation of the empty capsid with the biological sample and that this encompasses incubation steps that occur between addition of different components (i.e. seconds/minutes of incubation).
As stated above, Mingozzi teaches a method of measuring anti-AAV antibody-mediated neutralization in vitro wherein a reporter AAV8 vector expressing luciferase was incubated with increasing dilutions of pooled normal plasma alone (0X) or in the presence of increasing amounts of AAV585/8 empty capsids (10X, 100X, 1000X the amount of AAV8-Luciferase vector). After one hour incubation at 37°C, vectors were used to transduce HEK293 cells in vitro. Mingozzi teaches that viral vectors and empty capsids can be administered separately. AAV empty capsids act as vector decoys that are bound by neutralizing antibodies (NAbs) and thus prevent them from neutralizing AAV vectors (containing a transgene), resulting in superior gene transduction efficiency when AAV vectors are delivered to a cell (paragraphs 0012-0032).
Although Mingozzi identifies that the empty capsids and infectious viral vectors can be provided separately and incubated with serum prior to contacting the mixture of the serum, empty capsids, and infectious vector, they do not directly teach mixing empty capsids with the biological sample before contacting the mixture with the infectious particles.
However, it would have been well understood that the empty capsids could be mixed with the serum before adding the infectious vectors to the mixture. Mingozzi already teaches that AAV empty capsids act as vector decoys that are bound by neutralizing antibodies (NAbs) and thus prevent them from neutralizing AAV vectors (containing a transgene), resulting in superior gene transduction efficiency when AAV vectors are delivered to a cell. It would have been obvious that one would want to mix the empty capsids with the serum as this would ensure that any neutralizing antibodies in the serum only bind to the empty capsids. If the infectious particles were added concurrently or before the empty capsids, the neutralizing antibodies would interact with the infectious particles and neutralize them, reducing the effective viral titer of the infectious vectors and increasing the variability between experiments as the number of neutralized infectious vectors would differ between experimental samples. Therefore, it would have been well understood that one of ordinary skill in the would want to incubate the serum sample with the empty capsids prior to adding the infectious vectors to the mixture and incubating the combined mixture of serum, empty capsids, and infectious vectors before administering it to the cells.
Furthermore, it would have been obvious to one of ordinary skill in the art that the empty capsids can be added prior to adding the infectious particles as this would have been a readily known option to choose. Furthermore, changing the order of steps was known to be obvious, see Ex parte Rubin, 128 USPQ 440 (Bd. App. 1959) (Prior art reference disclosing a process of making a laminated sheet wherein a base sheet is first coated with a metallic film and thereafter impregnated with a thermosetting material was held to render prima facie obvious claims directed to a process of making a laminated sheet by reversing the order of the prior art process steps.). See also In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946) (selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results); In re Gibson, 39 F.2d 975, 5 USPQ 230 (CCPA 1930) (Selection of any order of mixing ingredients is prima facie obvious.).
As such, the combined method of Wang and Mingozzi teaches a method of detecting enhancers of AAV in a biological sample corresponding to steps (a)-(k).
Regarding the treatment steps of (l)-(m), although Wang identifies that they performed AAV gene therapy in their mice and identifies the potential for clinical translation of their work, they do not specifically select subjects containing enhancers of AAV vector cells transduction for treatment.
However, Wang does teach that they examined AAV transduction enhancement using 10 human serum samples and found that the interaction of human serum with AAV induced an approximately fourfold increase in transgene activity in an AAV capsid-independent manner in vitro and in vivo. The enhancement of AAV transduction was also demonstrated following incubation of AAV vectors with serum from other species including mouse, dog, primate and fetal bovines (page 50 column 1, paragraph 2, Figure 1, and Supplementary Figures 1 and 2).
Mingozzi identifies a protocol for patient treatment studies employing AA V vectors and/or empty capsid AAV to treat a disease or disorder. Serial dilution of serum from the patient will be incubated at 37°C with an AAV vector expressing a luciferase reporter. Increasing quantities of AAV empty capsids will be added to the reaction, from 1x to 1000x. The excess of empty AAV capsids that will result in a NAb titer of <1:1 can be used to produce a formulation with a AAV vector for transgene transfer. Thus, samples such as serum or plasma samples from candidate patients for gene therapy with AAV vectors will be analyzed for anti-AAV neutralizing antibodies using an AAV antibody (e.g., neutralizing antibody or "NAb") assay. Based on the assay results that provide the AAV antibody amount (titer), subjects can optionally be classified prior to treatment (Example 5).
Therefore, it would have been well understood that following the assay steps of (a)-(k), a candidate patient for gene therapy could be selected and administered the AAV vector based gene therapy to treat the patient’s disorder based on the results of the assay as this was successfully reduced to practice by Mingozzi.
Regarding claim 69, Wang teaches that luciferase activity was measured with a Wallac1420 Victor 2 (Marshall Scientific, Hampton, NH, USA) automated plate reader (page 56, column 2, paragraph 6). As such, Wang teaches that steps d and j are automated.
Regarding claim 88, Wang teaches that to study the phenotypic correction using AAV vectors incubated with HSA, they used hemophilia B mice as a disease model and
AAV8/FIX-OPT, which has been used in Phase I clinical trials in patients with hemophilia B. over fivefold higher FIX levels were detected in mice incubated with AAV8/FIX-OPT than those with the same vectors treated with PBS. Similarly, plasma FIX activity was much higher in mice receiving vector treated with HSA (page 53, column 2, paragraph 2-page 54, column 1, paragraph 1).
Mingozzi teaches that their invention is useful in human medical applications and that the subjects can be human (paragraph 0087).
Response to Arguments
Applicant's arguments filed September 8, 2026, are acknowledged.
Applicant argues that Wang and Mingozzi fail to disclose or suggest amended steps (h) and (i) and new steps (l) and (m). Regarding steps (h) and (i), the Applicant argues that Wang allows for incubation of the neutralizing antibodies with the AAV vector prior to contacting the cells, whereas, the instantly claimed method requires simultaneously contacting the cells with the AAV vector and the biological sample comprising the neutralizing antibodies at the same time (page 18, paragraph 2-page 19, paragraph 2).
Applicant's arguments have been fully considered but they are not persuasive.
As an initial matter, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., contacting the cells with the AAV vector and the biological sample comprising the neutralizing antibodies at the same time without a preincubation step of the AAV vector with the biological sample) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The court explained that “reading a claim in light of the specification, to thereby interpret limitations explicitly recited in the claim, is a quite different thing from ‘reading limitations of the specification into a claim,’ to thereby narrow the scope of the claim by implicitly adding disclosed limitations which have no express basis in the claim.” The court found that applicant was advocating the latter, i.e., the impermissible importation of subject matter from the specification into the claim.). See also In re Morris, 127 F.3d 1048, 1054-55, 44 USPQ2d 1023, 1027-28 (Fed. Cir. 1997) (The court held that the PTO is not required, in the course of prosecution, to interpret claims in applications in the same manner as a court would interpret claims in an infringement suit. Rather, the “PTO applies to verbiage of the proposed claims the broadest reasonable meaning of the words in their ordinary usage as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in applicant’s specification.”). See MPEP 2111]
It is worth noting that the present claims do not require that there is no preincubation between the AAV vector and the sample. As identified in the rejection above, the “prior to contacting M and said cells of (g)” limitation is broadly interpreted to require that mixing the biological sample with the empty capsids occurs before the mixture (M) and the cells are contacted by the infectious AAV particles, individually. This allows for the mixture of the biological sample and empty capsids to be incubated with the infectious viral vectors prior to administering the combined mixture of the biological sample, empty capsids, and infectious particles to the cells. This interpretation is further backed up by subclaim (i) which has the limitation of “simultaneously contacting said cells of (g) with said M and said infectious recombinant AAV particles” as the simplest and most logical way of simultaneously contacting the cells with the mixture M and the infectious AAV is to mix the mixture M and the infectious AAV prior to administering the combined mixture to the cells.
As stated in the rejection above, the combined teachings of Wang and Mingozzi teach and/or suggest steps (l) and (m).
Therefore, Applicant’s arguments are considered unpersuasive as steps (h)-(i) and (l)-(m) are considered to be taught by the combined teachings of Wang and Mingozzi, as outlined in the rejection above.
Claims 1, 69, and 86-87 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al. (Gene Therapy 24: 49-59. 2017) and World Intellectual Property Organization Patent Application No. 2013/078400 (Mingozzi) as applied to claims 1 and 69 above, and in further view of Bradley et al. (Journal of Biomolecular Screening 9: 514-524. 2004), as evidenced by LabExchange (Tecan SpectraFluor Plus). This rejection is repeated with regards to the rejection in the Final Office action mailed on April 9, 2026. Applicant’s traversal was addressed above.
The teachings of Wang and Mingozzi are as discussed above.
The combined teachings of Wang and Mingozzi do not teach using an automated system as claimed in claim 86.
However, Bradley teaches an automated system for in vitro determination of inhibitors of HIV entry into cells. The automated system comprises:
Contacting components: Bradley teaches that their automated system dispenses CHO-Tat10 cells and HeLa-P4 cells (transfected with HIV-1 LTR) separately using 2 Multidrops for contactingat a 1:1 ratio and fusion to generate a fluorescent signal from the LacZ transgene
Measuring components: Bradley teaches that they added β-galactosidase quantification substrate using a Robolab Reagent addition stations and plates were read on a Tecan Spectrafluor Plus. Although Bradley does not specifically identify that the Tecan Spectrafluor Plus is connected to a computer for storing the data, LabExachange (page 2) evidences that the Tecan Spectrafluor Plus is a computer controlled fluorometer for measuring samples in a microplate and would store the fluorescent signal in a non-transitory electronic storage.
Mixing and incubating components: Bradley teaches that test compounds were transferred to the assay plates with a CyBiWell with a 384-tip head and control samples for max, min, and standard were added using Tecan Genesis to mix compounds with cells and then plates were incubated at 37°C in a Heraeus Cytomat.
Comparing components: Bradley teaches that to determine the effects of test compounds in the fusion assay, data were normalized to the controls on a per plate basis, and percentage activity values were calculated. Compounds tested at 10μM were considered “active” when they demonstrated > 30% inhibition compared to controls. For IC50 determinations, data were normalized to controls on a per plate basis and the percentage activity at each dose was calculated. Both sets of analyses were carried out using a software package (i.e. using the computer processor) (page 517, column 1, paragraph 2-page 522, column 2, paragraph 1 and Figures 1-8).
Bradley teaches that their fully automated system was employed in a high-throughput screen of ~ 650,000 compounds and a throughput of 40,000 data points per day was achieved which is considerably higher than that achievable with the previously described methods while maintaining high quality data (page 523, column 1, paragraph 3-column 2, paragraph 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method for detecting the presence of enhancers of adeno-associated virus (AAV) vector cell transduction in a biological sample from a subject of Wang and Mingozzi by using an automated system similar to Bradley to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Bradley teaches that their automated system allowed them to greatly increase the number of compounds tested which would also be useful in testing a multitude of biological samples from patients in an automated rather than manual method. Furthermore, although the method of using the automated system of Bradley is different than the method used by Wang and Mingozzi, the automated system of Bradley has all of the components necessary as recited by claim 86 and they can be modified to provide the specific components in the method of Wang and Mingozzi. For example, the 2 multidrops can be used to provide the cells for transduction and a solution comprising the AAV vectors, allowing for the concentration of cells or vectors to be adjusted to the ideal ratio. Furthermore, the CyBiWell can be used to deliver the biological sample to the plate while the Tecan Genesis can be used to deliver the empty AAV capsids. Additionally, the software for comparing the control and test compounds could be modified to use the MAX signal as a control and the S.EV signal as the test compound signal. Therefore, it would have been obvious that the method of Wang and Mingozzi could be modified to automate the process as shown by Bradley. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claim 87, as stated supra, Bradley teaches that the compounds tested at 10 μM were considered “active” when they demonstrated > 30% inhibition compared to controls (page 518, column 1, paragraph 2). As this would be an indication (i.e. > 30% inhibition) of suitability, it would have been obvious that a similar calculation could have been made based on the MAX and S.EV signals to give a readout that provides an indication of enhancers.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KEENAN A BATES whose telephone number is (571)270-0727. The examiner can normally be reached M-F 7:30-5:00.
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/KEENAN A BATES/Examiner, Art Unit 1631
