DETAILED ACTION
Applicant’s response received on 3/17/26 has been entered. Claims 1-23 remain pending in this application. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . An action on the merits follows.
Those sections of Title 35, US code, not included in this action can be found in a previous office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/17/26 is in compliance with the provisions of 37 CFR 1.97 and 1.98. Accordingly, the information disclosure statement has been considered by the examiner and an initialed and signed copy of the 1449 is attached to this action.
Claim Rejections - 35 USC § 103
The rejection of claims 1-4, 7-15, and 21-23 under 35 U.S.C. 103 as being unpatentable over Wang et al. (2008) Anal. Chem., Vol. 80, 2118-2124, in view of U.S. Patent 6,103,493 (2000), hereafter referred to as Skerra et al., Saviranta et al. (1998) Bioconjugate Chem., Vol. 9, 725-735, WO 2012/129514 (September, 2012), hereafter referred to as Riddell et al., Milone et al. (2009) Mol. Ther., Vol. 17 (8), 1453-11464. doi.org/10.1038/mt.2009.83, pages 1-20, and U.S. Patent 5,773,224 (1998), hereafter referred to as Grandics et al., is maintained. Applicant’s arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
The applicant argues the claims require simultaneous selection of two distinct cell populations, specifically CD4+ and CD8+ T cells, from the starting sample and none of the cited references teach this limitation. According to applicant, Wang et al. teaches separating two different cell types in parallel or in a series, and that in both of those methods the purification of the two different cell types happens in separate capillaries. The applicant argues that the use of separate categories is not simultaneous co-selection and that Wang does not teach simultaneous contacting of a sample with two distinct targeting agents. The applicant argues that neither Skerra nor Saviranta cure these deficiencies as according to applicant neither reference teaches or suggest using streptavidin muteins or Fab-biotin conjugates to perform simultaneous dual-subset T cell selection from a mixed population.
In response, it is first noted that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). It is further noted that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Also, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In regards to applicant’s argument that Wang et al. does not teach simultaneous co-selection because Wang et al. teaches separating two different cell types in parallel or in a series, which involves the purification of the two different cell types in separate capillaries, it is noted that applicant’s arguments relies on features which are not recited in the rejected claim. 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). Specifically, independent claim 1 recites as step (a), “simultaneously contacting cells of a sample containing primary human T cells with a first immunoaffinity reagent that specifically binds to CD4 and a second immunoaffinity reagent that specifically binds to CD8 in an incubation composition”. Step (b) recites, “recovering cells from the incubation composition bound to the first and the second immunoaffinity reagent, thereby generating a composition enriched in CD4+ T cells and CD8+ T cells relative to the sample”. Independent claim 16 recites similar steps to claim 1. In both independent claims, the only limitation which is “simultaneous” is the step of contacting the cells of the sample with the first and second immunoaffinity reagent. The recovering step, step (b) is not recited as a “simultaneous” recovery step. Step (b) reads on any method of recovering the two labeled cell types from the initial sample which encompasses the use of more than one capillary for separating and collecting the two different labeled cell types either in tandem or in parallel. Thus, applicant’s argument that Wang et al. does not teach “simultaneous co-selection” of the two cell types is not persuasive as the claims under examination do not require simultaneous co-selection, or the use of a single capillary to capture both labeled cell types.
In regards to applicant’s argument that Wang does not teach simultaneous contacting of a sample with two distinct targeting agents, Wang et al. provides teachings and motivation for contacting the sample of cells with a targeting antibody versus using capillary columns comprising the targeting antibody. In the rejection of record, Wang et al. was cited for teaching multiple cell type purification using open-tubular capillary cell affinity chromatography where multiple capillaries are attached either in parallel or in a series to allow for the isolation of two or more different cell types based on either positive or negative selection of cell surface markers on the target cells from a single peripheral blood sample (Wang et al., pages 2118-2119). Wang et al. teaches two approaches to separating two different cell types. In one approach, Wang et al. teaches that each capillary is coated with a target antibody, and exemplifies the successful separation of two different cell types, CD19+ B cells, and CD4+ T cells from a single sample applied to a series of connected capillaries where the sample is applied to a first column which selects for cells expressing CD19 using an anti-CD19 antibody which is serially connected to a second column which selects for cells expressing CD4 using and anti-CD4 antibody such that cells which are not selected and retained by the first column pass through to the second capillary column for selected by the second antibody (Wang et al., page 2123). As a second approach, Wang et al. teaches an alternative method in which instead of using columns which have been coated with a selection antibody, the sample itself is contacted with selection antibody and the capillary columns are coated with capture protein capable of selectively binding to the antibody which is bound to the cell (Wang et al., page 2124). Wang et al. demonstrated that a capillary column coated with neutravidin could successfully capture cells pre-incubated with an antibody specific for CD14 conjugated to biotin (Wang et al., page 2124). While Wang et al. did not specifically exemplify a series of capillaries which capture different targeting antibodies bound to different cell types pre-incubated with those targeting antibodies, Wang et al. clearly teaches and demonstrates that the pre-incubation method works, and further shows that pre-incubation with antibody allows for the use of antibodies with insufficient affinities to capture cells under flow shear forces when bound to the capillary surface, i.e. suboptimal yield conditions (Wang et al., page 2124). Thus, the skilled artisan reading Wang et al. would have understood that several configurations and types of capillaries could be used separate out two different cell types from the same starting sample, including the use of capillaries for binding cells which have been pre-incubated with a target antibody, and thus would have had ample motivation to pre-incubate a starting cell sample with more than one targeting antibody for the purpose to isolating two different cell types from the starting sample. However, the rejection of record did acknowledge that while Wang et al. teaches that the capillaries coated with biotin and neutravidin can be used in a series to bind cells pre-incubated with a biotin-antibody conjugate, and that the pre-incubation of the sample cells with antibody allows for the use of antibodies with insufficient affinities to capture cells under flow shear forces when bound to the capillary surface, i.e. suboptimal yield conditions, Wang et al. does not teach the specific capillary conditions under which the two different cell types pre-incubated with the two different biotin-antibody conjugates can bind to and then be released from each of the capillaries in the capillary array. The rejection of record therefore cited secondary references to supplement the teachings of Wang et al.
Skerra et al. was cited to supplement Wang et al. by teaching that muteins of streptavidin and short peptide biotin mimics capable of binding to a streptavidin mutein were both known at the time of filing and had been used successfully in affinity column purification (Skerra et al., columns 2-3, 5, and 11). In particular, Skerra et al. teaches that the advantages of using a streptavidin mutein and streptavidin mutein small peptide binding partner over conventional streptavidin-biotin apply in particular to affinity chromatography and isolation of bound proteins and cells (Skerra et al., column 5). Skerra et al. teaches that compared to the elution conditions required for releasing the binding of streptavidin to biotin, very mild conditions for elution can be used (Skerra et al., column 5). Importantly, Skerra et al. teaches that an elution buffer comprising diaminobiotin leads to the elution of a positively selected biotin-fusion molecule from conventional/wt streptavidin, that this buffer does not elute the corresponding binding peptide fusion from the streptavidin muteins. Applicant’s argument that Skerra et al. is only directed to selecting tagged fused protein and not tagged cells is not found persuasive because Wang et al. already provides the relevant teachings for cell separation, including the separation of cells pre-incubated with tagged antibodies using a column comprising the binding partner of the tag, and more specifically where the tag is biotin and the binding partner present in the column is streptavidin.
Thus, it is maintained that based on the teachings of Wang et al. that several configurations and types of capillaries can be used separate out two different cell types from the same starting sample, including the use of capillaries for binding cells which have been pre-incubated with a target antibody, the further teachings of Wang et al. for certain advantages associated with the pre-incubation of the sample cells with antibody, including the use of antibodies with insufficient affinities to capture cells under flow shear forces when bound to the capillary surface, and the further advantages of the streptavidin mutein/binding peptide combination taught by Skerra et al. in affinity chromatography, and in particular the fact that the choice of eluant/releasing compound can differentiate between the release of a biotin tagged substance from streptavidin vs. a binding peptide tagged substance and a streptavidin mutein, the skilled artisan would have been motivated to utilize the streptavidin mutein/binding peptide combination taught by Skerra et al. in the methods of multi-capillary isolation of two different cell types taught by Wang et al., particularly where the cell types have been pre-incubated with two different biotin conjugated antibodies prior column loading so as to control the isolation of each of the cell types separately in columns set up in tandem or in a series. As such, it is maintained that it would have been prima facie obvious to the skilled artisan at the time of filing to practice the methods of Wang for the separation of CD4+ T cells and CD19+ B cells or CD14+ cells from a sample obtained from blood where the cells in the sample are pre-incubated with both an anti-CD4 antibody fused or tagged with biotin and an anti-CD19 or anti-CD14 antibody fused or tagged with a small peptide biotin mimic capable of binding to a streptavidin mutein as taught by Skerra et al., or vice versa, and then separated by applying the antibody pre-incubated cells to a multi-affinity column array as taught by Wang et al. where one of the columns in the tandem array of columns or series of columns comprises streptavidin, and the other column comprises a streptavidin mutein such that the elution of CD4+ T cells vs the elution of CD19+ B cells or CD14+ cells can be separately controlled by the selection of eluant to allow either the separate collection of the two different cell types, or the collection of a defined combination of the two different cell types with a reasonable expectation of success.
The applicant can not provided any specific arguments concerning the actual teachings of Saviranta et al., Malone et al., Riddell et al., or Grandics et al., other than stating that the teachings of these references do not overcome the alleged deficiencies of Wang et al. Applicant’s arguments concerning the teachings of Wang et al., and Skerra et al., have not been found persuasive, as discussed in detail above. The teachings of Saviranta et al., Malone et al., Riddell et al., and Grandics et al. are reiterated below for clarity.
The rejection of record states that Wang et al. further differs from the instant methods by not teaching to separate CD4+ and CD8+ lymphocytes using the multiple capillary system, or to specifically use an antibody Fab-biotin conjugate to bind to CD4 or CD8. While Wang et al. generally teaches for example an anti-CD4 antibody-biotin conjugate, Wang et al. does not teach that the antibody is a Fab fragment conjugated to biotin. It is also noted that Wang et al. also teaches to separate the capillaries prior to collection of the different captured cell types, and/or does not teach to combine the isolated CD4+ and CD8+ positive cells together at a desired ratio in the closed system. Saviranta et al. supplements Wang t al. and Skerra et al. by teaching that Fab-biotin conjugates were well known at the time of filing, have the advantage of being 1/3 the size of whole antibodies, and can be easily genetically engineered (Saviranta et al., page 725). Saviranta et al. further demonstrates that the biotinylated Fab was functional and bound to both the target antigen and to streptavidin (Saviranta, page 728). Riddell et al. supplements further supplements Wang et al. and Skerra et al.by teaching the benefits of generating a combined population of isolated CD4+ and CD8+ T lymphocytes for adoptive immunotherapy of cancer. Specifically, Riddell et al. teaches compositions for adoptive immunotherapy of cancer comprising a combination of isolated CD4+ and CD8+ T cells at CD4/CD8 ratios including 2:1, 1:1, and 1:2 (Riddell et al., pages 36-37). Riddell et al. teaches that the CD4 and CD8 cell populations were isolated from human peripheral blood mononuclear cells (PBMC), stimulated with anti-CD3 antibody, and transduced with lentivirus encoding a cancer specific chimeric antigen receptor (CAR) (Riddell et al., pages 30-33). Riddell et al. further teaches to isolate specific subpopulations of CD4+ T cells, and in particular a central memory (CM) CD4+ T cells with the phenotype CD45RA- CD45RO+ CD62L+ and to combine these CM CD4+ T cells with CD8+ T cells at a 1:1 ratio (Riddell et al., pages 37-39). Riddell et al. demonstrates that the combination of CD4+ T cells, either bulk or the CM fraction augments CD8+ CTL activity (Riddell et al., pages 36-37).
Milone et al. further supplements Wang et al. and Riddell et al. by teaching alternative methods of genetically modifying a combined population of CD4+ T cells and CD8+ T cells in which CD4+ T cells and CD8+ T cells are mixed at a 1:1 ratio and then stimulated with alpha CD3/alphaCD28 aAPCs followed by transduction with a lentiviral vector encoding a gene of interest, where the genetically modified mixed population of CD4+ T cells and CD8+ T cells are cultured for at least 6 days (Milone et al., pages 2-3, 14 and Figures 1 and S1). In particular, Milone et al. teaches expressing a CAR in a mixed population of CD4 and CD8 T cells (Milone et al., pages 2-3). Milone et al. teaches substantial expansion of the transduced mixed population and anti-tumor activity in vitro and in vivo (Milone et al., pages 5-6).
Therefore, in view of the specific motivation provided Saviranta et al. for using biotinylated Fab fragment antibodies over complete antibodies, the specific motivation provided by both Riddell et al. and Milone et al. for making a mixed population of CAR expressing transduced CD4+ T cells and CD8+ T cells using isolated CD4+ T cells and CD8+ T cells for use in cancer immunotherapy, and the further specific teachings of Milone et al. for a successful method of transducing a mixed population of CD4+ T cell and CD8+ T cells, which includes mixing untransduced isolated CD4+ T cells and CD8+ T cells at a 1:1 ratio, stimulating the mixed population, and transducing the mixed population with a vector encoding a gene such as a CAR, it would have been prima facie obvious to the skilled artisan at the time of filing to utilize the multiple capillary affinity chromatography method taught by Wang et al. in view of Skerra using a biotinylated or biotin mimic peptide tagged Fab to isolate CD4+ and CD8+ T cells for use in generating a mixed population of CAR transduced CD4+ T cells and CD8+ T cells according to the methods of Milone et al. with a reasonable expectation of success.
Grandics et al. was cited to further supplement Wang et al., Skerra et al., Saviranta et al., Riddell et al., and Milone et al. by teaching an improved biotin-avidin immunoaffinity column chromatography method for positive or negative cell selection of cells such as lymphocytes for use in gene therapy and the treatment of malignancies (Grandics et al., columns 1-3, 5, and 9, and claims). Grandics et al. further provides motivation to set up and utilize a fully closed system comprising immunoaffinity columns by teaching that potential clinical use of cell separation systems requires a sterile, closed apparatus in which large quantities of viable, specific cell populations can be obtained rapidly from crude cell suspension or directly from blood, and that their improved immunoaffinity column method allows for set up as a closed system without the need for clean room operation (Grandics et al., columns 1 and 9).
Therefore, in view of the motivation provided by Milone et al. to isolate CD4+ T cells and CD8+ T cells and to combine the two separated cells at a ratio of 1:1 prior to stimulation and transduction with a vector encoding a CAR useful for immunotherapy of cancer, and the benefits of setting up an immunoaffinity column separation system for the separation of large quantities of cells useful for gene therapy and cancer therapy as a closed system provided by Grandics et al., it would have been prima facie obvious to the skilled artisan at the time of filing to set up the immunoaffinity column system in parallel or in tandem as taught by Wang et al. in view of Skerra et al. as a closed system, to pre-incubate a sample derived from blood comprising a large quantity of CD3+ T cells, such as 1X10-9 CD3+ T cells, and to further elute a specific ratio of CD4+ T cells and CD8+ T cells from such a closed system for use in generating a mixture of CAR transduced CD4+ T cells and CD8+ T cells as taught by Milone et al. for clinical use in cancer immunotherapy with a reasonable expectation of success.
The rejection of claims 5-6 and 16-20 under 35 U.S.C. 103 as being unpatentable over Wang et al. (2008) Anal. Chem., Vol. 80, 2118-2124, in view of U.S. Patent 6,103,493 (2000), hereafter referred to as Skerra et al., Saviranta et al. (1998) Bioconjugate Chem., Vol. 9, 725-735, WO 2012/129514 (September, 2012), hereafter referred to as Riddell et al., Milone et al. (2009) Mol. Ther., Vol. 17 (8), 1453-11464. doi.org/10.1038/mt.2009.83, pages 1-20, and U.S. Patent 5,773,224 (1998), hereafter referred to as Grandics et al., as applied to claims 1-4, 7-15, and 21-23 above, and further in view of Stemberger et al. (2012) PloS One, Vol. 7(4), e35798, pages 1-11, is maintained. Applicant’s arguments have been fully considered but have not been found persuasive in overcoming the rejection for reasons of record as discussed in detail below.
The applicant refers to their arguments concerning the alleged lack of teachings for simultaneous separation in Wang et al., and further argues that Stemberger et al. does not overcome the deficiencies of Wang et al. because Stemberger teaches serial separation and not simultaneous selection.
In response, applicant’s arguments concerning Wang et al. have been fully considered and have not been found persuasive as discussed in detail above. In particular, it is reiterated that applicant is arguing limitations which are not present in the methods as claimed. As discussed above, the recovering step, step (b), recited in the independent claims is not recited as a “simultaneous” recovery step. Step (b) reads on any method of recovering the two labeled cell types from the initial sample which encompasses the use of more than one capillary for separating and collecting the two different labeled cell types either in tandem or in parallel. Thus, applicant’s argument that Wang et al. does not teach “simultaneous co-selection” of the two cell types is not persuasive as the claims under examination do not require simultaneous co-selection, or the use of a single capillary to capture both labeled cell types. Likewise, for the same reasons, applicant’s argument that Stemberger et al. teaches serial and not simultaneous selection is also not persuasive.
In regards to the teachings of Stemberger et al., the rejection of record noted that all of Wang et al., Skerra et al., and Saviranta et al. teach the separation of the cells bound by the antibodies where the antibodies or Fab are conjugated to biotin or a small peptide biotin mimic, using columns comprising a reagent or beads conjugated to streptavidin or a streptavidin mutein. Stemberger et al. was cited for teaching that alternative means for selection of antibody bound cells were well known, including the use of antibodies conjugated to magnetic beads. Stemberger et al. teaches a method for serial selection of cells expressing more than one different marker where the cells are first incubated with anti-CD4 Fab-strep-tag coated stret-Tactin functionalized magnetic beads and the bound cells then separated from non-bound cells using a magnet and the cells released from the antibody-strep-tag -stret-Tactin magnetic beads using D-biotin (Stemberger et al., page 3). Stemberger et al. further teaches that additional serial anti-Fab magnetic bead separations can be performed using different anti-Fab antibodies- see the diagram in Figure 1A on page 4 of Stemberger et al. Stemberger et al. teaches that the advantage of this method which uses magnetic separation of reversibly bound strep-tag conjugated antibodies and strep-Tactin functionalized magnetic beads results in removal of the bead and spontaneous removal of the antibody marker resulting in extremely high levels of purity in the selected cells with over 90% and up to 98 or more percent purity (Stemberger et al, page 8, Figure 4D). Note that strep-tag and strep-Tactin are a small peptide biotin mimic and a streptavidin mutein reversible binding partner as disclosed by Skerra et al.
Therefore, it is maintained that based on the benefits of the Fab-strep-tag- strep-Tactin-magnetic microbead approach taught by Stemberger et al., the advantages of the streptavidin mutein/binding peptide combination taught by Skerra et al. in affinity chromatography separation of cells, and in particular the fact that the choice of eluant/releasing compound can differentiate between the release of a biotin tagged substance from streptavidin vs. a binding peptide tagged substance and a streptavidin mutein, the specific motivation provided by both Riddell et al. and Milone et al. for making a mixed population of CAR expressing transduced CD4+ T cells and CD8+ T cells using isolated CD4+ T cells and CD8+ T cells for use in cancer immunotherapy, and the further specific teachings of Milone et al. for a successful method of transducing a mixed population of CD4+ T cell and CD8+ T cells, which includes mixing untransduced isolated CD4+ T cells and CD8+ T cells at a 1:1 ratio, stimulating the mixed population, and transducing the mixed population with a vector encoding a gene such as a CAR, it would have been prima facie obvious to the skilled artisan at the time of filing to modify the multiple serial affinity column set up taught by Wang et al. in view of Skerra et al., Riddell et al. and Milone et al. to comprise sequential purification of CD4 and CD8 T cells from a starting sample population pre-incubated with anti-CD4 Fab-biotin -streptavidin functionalized magnetic microbeads and anti-CD8-Fab-strep-tag- strep-Tactin functionalized magnetic microbeads, or vice versa, using magnetic separation of antibody bound cells followed by release of the magnetic microbeads specific for releasing either the streptavidin-biotin binding between the antibody and the microbead or the strep-tag- strep-Tactin binding between the antibody and microbead to allow either the separate collection of the two different cell types, or the collection of a defined combination of the two different cell types with a reasonable expectation of success.
Double Patenting
The rejection of claims 1-23 on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No.11,400,115, hereafter referred to as the ‘115 patent, in view of Wang et al. (2008) Anal. Chem., Vol. 80, 2118-2124, and Stemberger et al. (2012) PloS One, Vol. 7(4), e35798, pages 1-11, is maintained. Applicant’s arguments concerning an alleged lack of teaching in Wang et al. for simultaneous contacting of the sample with two different antibodies has been fully considered but have not been found persuasive.
In regards to applicant’s argument that Wang does not teach simultaneous contacting of a sample with two distinct targeting agents, Wang et al. provides teachings and motivation for directly contacting a sample of cells with a targeting antibody prior to column separation versus using capillary columns comprising the targeting antibody. In the rejection of record, Wang et al. was cited for teaching multiple cell type purification using open-tubular capillary cell affinity chromatography where multiple capillaries are attached either in parallel or in a series to allow for the isolation of two or more different cell types based on either positive or negative selection of cell surface markers on the target cells from a single peripheral blood sample (Wang et al., pages 2118-2119). Wang et al. teaches two approaches to separating two different cell types. In one approach, Wang et al. teaches that each capillary is coated with a target antibody, and exemplifies the successful separation of two different cell types, CD19+ B cells, and CD4+ T cells from a single sample applied to a series of connected capillaries where the sample is applied to a first column which selects for cells expressing CD19 using an anti-CD19 antibody which is serially connected to a second column which selects for cells expressing CD4 using and anti-CD4 antibody such that cells which are not selected and retained by the first column pass through to the second capillary column for selected by the second antibody (Wang et al., page 2123). As a second approach, Wang et al. teaches an alternative method in which instead of using columns which have been coated with a selection antibody, the sample itself is contacted with selection antibody and the capillary columns are coated with capture protein capable of selectively binding to the antibody which is bound to the cell (Wang et al., page 2124). Wang et al. demonstrated that a capillary column coated with neutravidin could successfully capture cells pre-incubated with an antibody specific for CD14 conjugated to biotin (Wang et al., page 2124). While Wang et al. did not specifically exemplify a series of capillaries which capture different targeting antibodies bound to different cell types pre-incubated with those targeting antibodies, Wang et al. clearly teaches and demonstrates that the pre-incubation method works, and further shows that pre-incubation with antibody allows for the use of antibodies with insufficient affinities to capture cells under flow shear forces when bound to the capillary surface, i.e. suboptimal yield conditions (Wang et al., page 2124). Thus, the skilled artisan reading Wang et al. would have understood that several configurations and types of capillaries could be used to separate out two different cell types from the same starting sample, including the use of capillaries for binding cells which have been pre-incubated with a target antibody, and thus would have had ample motivation to pre-incubate a starting cell sample with more than one targeting antibody for the purpose to isolating two different cell types from the starting sample. As such, it is maintained that the ‘115 patent claims in view of Wang et al. and Stemberger et al. render obvious instant claims 1-23.
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Dr. A.M.S. Wehbé
/ANNE MARIE S WEHBE/Primary Examiner, Art Unit 1634
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