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 .
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.
Priority
The present application, filed 05/21/2020, claims benefit under 35 U.S.C. 119(e) to provisional application No. 62/850,999, filed 05/21/2019.
Status of the Claims
Claims 1, 3-4, 6, 8-9, 11-19, 21-22, 24, 26-29 and 31-32 are pending; claims 5, 7, 10, 20, 23, 25 and 30 are canceled; claims 1, 3, 8-9, 11, 15-19, 21, 28-29 and 32 are amended. No claims are withdrawn. Claims 1, 3-4, 6, 8-9, 11-19, 21-22, 24, 26-29 and 31-32 are pending.
Withdrawn Objections/Rejections
The previous rejection of claims under 35 U.S.C. 112(b) is withdrawn in response to Applicant’s amendments to the claims.
The rejection of under 35 U.S.C. 103 citing Voss et al., in view of Bosteels et al., Burakov et al., Padhan, N, and Bancel et al. is withdrawn in response to Applicant’s amendments to the claims.
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via EFS-Web, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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.
Claim(s) 1, 3-4, 6 and 8-16 are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al., US PG Pub No. 2009/0023156A1 (IDS entered 09/15/2020) in view of Bosteels et al., WO2018/065389A1, Rietveld, L., Polyclonal vs Monoclonal Explained. Stress Marq Biosciences Inc. (2015). https://www.stressmarq.com/blog/polyclonal-vs-monoclonal-antibodies/?srsltid=AfmBOopuJnojrsjzi2jd5Wt2bec5k2buTT_rkKSobzVVvrYjDZjgkEut. [Accessed 10/02/2025]., Burakov et al., WO2018039499A1, Yu et al., US PG Pub No. 2016/0319012A1, and Padhan, N, Highly Sensitive and Quantitative Detection of Proteins and Their Isoforms by Capillary Isoelectric Focusing Method, Journal of Visualized Experiments, 139, (2018), (6 pages).
Voss et al. teach a method of detection performed on a protein containing sample, specifically separating the components (protein components) of the sample by a physical parameter within a capillary (addressing one or more capillaries as claimed, see specifically addressing the elected species, namely resolving by isoelectric focusing, using an ampholyte reagent loaded in the fluid path for separation based on charge (paras [0061] and [0062]), contacting the separated components within the capillary with a primary antibody that binds protein of interest (para [0066], [0067]), and detecting the binding of the antibody (see abstract and paras [0023], [0024], [0042], [0046], [0061], [0062]). See further para [0071] the methods encompass using different detection agents, which bind and detect different types of analytes and standards for simultaneous detection. Voss also encompass embodiments separating by molecular weight (rather than charge), see for example para [0046], and more specifically, para [0060] (see for example separating in a gel (thereby addressing sieving matrix) by molecular weight).
See also para [0063] refers to resolving one or more (thereby addressing at least 2) analytes, detecting with one or more detection agent (paras [0063]-[0066]). Voss teaching resolving one or more analyte to separation the molecules, see para [0065] contacting detection agent with analyte or analytes of interest.
Voss et al. differs from the claimed invention in that Voss fails to teach specifically applying their method of detection in order to detect two or more variants (i.e., different forms) of a host cell protein contaminant of interest in an antibody preparation sample.
Further, although Voss teaching detecting one or more analytes by contact with a detection reagent, since Voss fails to teach detecting two or more variants of at least one host cell protein contaminant of interest, the reference also fails to specifically teach a primary antibody that specifically binds to the two or more variants of the host cell protein.
Bosteels et al. teach host cell proteins such as for example, putative phospholipase B-like 2 (PLBL2 or PLBD2) have been shown to have an increased propensity to co-purify with certain Ig variants (page 2, lines 7-22). PLBL2 is taught as an undesirable contaminant, having the potential to illicit immune response in patients and further has a potential causative agent for the degradation of formulation excipients necessary for stabilization of product protein in final formulation (thereby effecting shelf life and drug safety). Bosteels et al. teach use of anti-PLBL2 antibody for the detection of PLBL2 in an antibody preparation sample by western blot analysis (see for example, Example 2 at page 27).
Regarding a (singular) primary antibody that specifically binds to the two or more variants of PLBD2, see for example at Example 2 Bosteels et al. (at page 28, lines 5-21), teach an anti-PLBD2 polyclonal antibody as a commercially available antibody (Abcam, Ab138334).
Further, regarding polyclonal antibodies, see Rietveld, a reference comparing polyclonal and monoclonal antibodies, it is known in the art that polyclonal antibodies are a heterogeneous mixture of antibodies that recognize multiple epitopes, making them ideal for detection of modified proteins (see for example, first section “What are Polyclonal and Monoclonal Antibodies?”). See further in Rietveld, under “Polyclonal Antibodies in Multiplex Assays”, teaching polyclonal antibodies are known useful for detection protein isoforms and conformation variants, and further under “Best uses of polyclonal antibodies:”, the first bullet point, a best use is recognized in the art as to detect known or unknown isoforms of antigens with high antigen homology.
See also Burakov et al., Burakov is teaching invention based on a recombinant host cell and cell expression system thereof that decreases expression of two or more endogenous host cell fatty acid hydrolases; disrupting genes encoding at least two for optimized and efficient production and purification of biopharmaceutical produces expressed in these systems (see para [001117]). Burakov teach in addition to PLBD2, other fatty acid hydrolases in protein fractions of certain antibody -producing cells are considered contaminants, see for specifically Burakov teach an example of esterases, namely including PLDB2, lipoprotein lipase, and lysosomal acid lipase (para [00117], see also para [00127]).
Yu et al. teach for recombinant pharmaceutical proteins to be acceptable for administration to humans, it is important that residual impurities resulting from manufacture and purification processes are removed from the final product (para [0006]). Yu recognize that host cell impurities include process-specific host cell proteins (HCPs), which are process related impurities/contaminants, see Yu teaching a need to detect and quantitate HCPs. See further para [0017], consistent with Burakov, Yu teach PLBD2 as a species of CHOP (HCP) (see also para [0019]); at para [0017] Yu et al. teach it is known that PLBD2 exists as N and C terminal fragments (i.e., these variants are known to exist/be present, in addition to the intact form).
Padhan teach cIEF as an automated, capillary-based immunoassay that is highly reproducible and capable of resolving proteins and their modified isoforms rapidly and quantitatively, Padhan teaching cIEF as an alternate to conventional methods such as western blotting (page 1 of 6, at the Introduction, paragraph 1). Padhan teach cIEF as a procedure that provides higher resolution and sensitivity.
It would have been prima facie obvious to one having ordinary skill in the art at the time the claimed invention was effectively filed to have applied the method of Voss for the detection of variants of PLBD2 (intact and variant forms of PLBD2, as taught by Yu et al.) in an antibody preparation sample as in Bosteel et al., Barkov et al. and Yu et al. (namely to have modified Voss in order to perform the method on a sample for the detection of the targeted contaminants such as intact and variant forms of PLBD2). Specifically one motivated to use the technique on samples to detect PLBD2 (intact and truncated forms) because these endogenous host cell fatty acid hydrolases were recognized as undesirable contaminants that should be removed from final biological products (Yu et al.), for example see also Bosteel, teaching such contaminant as PLBD2 can potentially illicit immune response in patients and degrade excipients necessary for stabilization of antibody preparation products, reducing shelf-life and causing safety issues (Burakov and also Yu recognized PLBD2 as a contaminate that should be removed). Further the ordinarily skilled artisan would have been motivated to have used the technique of Voss (the cIEF) because cIEF is recognized as a suitable alternative to other detection techniques, for example western blot immunoassay (Bosteels using western blot), specifically because it is a rapid, quantitative alternative, which provides high resolution and sensitivity.
As a result, one having ordinary skill in the art would have a reasonable expectation of success, particularly since cIEF was recognized applicable for protein containing samples (Voss, Padhan), and see further one having a reasonable expectation of success given antibodies to these targets were known and available (see as cited above, Bosteel).
Regarding the limitation specific to a primary antibody that specifically binds to the two or more variants of the host cell protein, it would have been obvious to have used the specific polyclonal anti-PLDB2 antibody of Bosteel as the antibody to detect the PLDB2 variants because such an antibody would be expected to bind and detect the various forms in the sample because it is known that polyclonal antibodies are a heterogeneous mixture of antibody species capable of targeting various epitopes, usable for different protein isoform detection (see Rietveld). One having ordinary skill in the art would have a reasonable expectation because the polyclonal antibody of Bosteel was commercially available and known to those of ordinary skill in the art before the effective filing date of the claimed invention, and further would reasonably expect success because polyclonal antibodies were specifically recognized as useful for detection of different protein isoforms due to the heterogenous nature of the polyclonal antibodies (Rietveld).
Regarding claim 3-4 and 10, the combination of the cited art above addresses discriminating between proteins (and the variants of said proteins) of interest by a physical parameter, specifically by charge, using a separation matrix that is carrier ampholytes.
Regarding claims 6, see Voss also encompass embodiments separating by molecular weight (rather than charge), see for example para [0046], and more specifically, para [0060] (see for example separating in a gel (thereby addressing sieving matrix) by molecular weight).
Regarding claims 8 and 9, see the method of Voss involves contacting with a primary antibody, and a secondary labeled antibody for the primary antibody (e.g., para [0043]).
Regarding claim 11, see Voss above, the method is a quantitative detection method (detecting relative or absolute amounts).
Regarding claim 12, see Voss teach chemiluminescent or fluorescent label (e.g., para [0046] or [0066]).
Regarding claim 13, see Voss at paras [0035], [0036], particularly [0050], sample including internal standard.
Regarding claim 14, see Voss at paras [0061], [0094] (e.g., photoimmobilization).
Regarding claim 15, see for example Voss at para [0006], antibodies used in the methods can be polyclonal, see further the combination of the cited art teaching primary antibody that is a polyclonal antibody (antibodies which bind multiple epitopes, useable for detection of isoforms).
Regarding claim 16, see as cited in detail above, the combination of Voss and the cited art is addressing at least two variants of the species PLBD2 (Bosteels et al., cited above, see also Yu et al.).
Claim(s) 17-19, 21, 22, 24, 26-29, 31 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Voss et al., US PG Pub No. 2009/0023156A1 (IDS entered 09/15/2020) in view of Bosteels et al., WO2018/065389A1, Rietveld, L., Polyclonal vs Monoclonal Explained. Stress Marq Biosciences Inc. (2015). https://www.stressmarq.com/blog/polyclonal-vs-monoclonal-antibodies/?srsltid=AfmBOopuJnojrsjzi2jd5Wt2bec5k2buTT_rkKSobzVVvrYjDZjgkEut. [Accessed 10/02/2025]., Burakov et al., WO2018039499A1, Yu et al., US PG Pub No. 2016/0319012A1, Padhan, N, Highly Sensitive and Quantitative Detection of Proteins and Their Isoforms by Capillary Isoelectric Focusing Method, Journal of Visualized Experiments, 139, (2018), (6 pages) and Bancel et a.., US 2013/0259924A1, as evidenced by Abcam. Anti-Lysosomal acid lipase/LAL antibody, ab89771. file:///C:/Users/emarcsisin/OneDrive%20-%20US%20Patent%20and%20Trademark%20Office/Documents/e-Red%20Folder/16880736/abcam%20ab89771.pdf . [Accessed: 10/02/2025]. (4 pages).
Voss et al. is as cited in detail previously above teaching a method of detection performed on a protein containing sample, specifically separating the components (protein components) of the sample by a physical parameter within a capillary (addressing one or more capillaries as claimed, see specifically addressing the elected species, namely resolving by isoelectric focusing, using an ampholyte reagent loaded in the fluid path for separation based on charge (paras [0061] and [0062]), contacting the separated components within the capillary with a primary antibody that binds protein of interest (para [0066], [0067]), and detecting the binding of the antibody (see abstract and paras [0023], [0024], [0042], [0046], [0061], [0062]). See further para [0071] the methods encompass using different detection agents, which bind and detect different types of analytes and standards for simultaneous detection. Voss also encompass embodiments separating by molecular weight (rather than charge), see for example para [0046], and more specifically, para [0060] (see for example separating in a gel (thereby addressing sieving matrix) by molecular weight).
As further cited above, Voss at paras [0043]-[0044] teaching a plurality of capillaries in order to analyze multiple samples simultaneously (i.e., detecting two or more proteins), splitting sample (capillaries loaded with the sample, singular, para [0043]). See also para [0063] refers to resolving one or more (thereby addressing at least 2) analytes (para [0063]).
Voss et al. differs from the claimed invention in that Voss fails to teach specifically applying their method of detection in order to detect two or more variants (i.e., different forms) of at least two or more host cell protein contaminants of interest in an antibody preparation sample (separate capillary for each host cell protein, detecting variants of one in one capillary, detected variants of the other in the other capillary), fails to teach first primary antibody specific for the two or more variants of the first host cell protein, second primary antibody specific for two or more variants of the second host cell protein.
Bosteels et al. is as cited previously above, teaching host cell proteins such as for example, putative phospholipase B-like 2 (PLBL2 or PLBD2) have been shown to have an increased propensity to co-purify with certain Ig variants (page 2, lines 7-22). PLBL2 is taught as an undesirable contaminant, having the potential to illicit immune response in patients and further has a potential causative agent for the degradation of formulation excipients necessary for stabilization of product protein in final formulation (thereby effecting shelf life and drug safety). Bosteels et al. teach use of anti-PLBL2 antibody for the detection of PLBL2 in an antibody preparation sample by western blot analysis (see for example, Example 2 at page 27).
Regarding a (singular) primary antibody that specifically binds to the two or more variants of PLBD2, see for example at Example 2 Bosteels et al. (at page 28, lines 5-21), teach an anti-PLBD2 polyclonal antibody as a commercially available antibody (Abcam, Ab138334).
Further, regarding polyclonal antibodies, see Rietveld, a reference comparing polyclonal and monoclonal antibodies, it is known in the art that polyclonal antibodies are a heterogeneous mixture of antibodies that recognize multiple epitopes, making them ideal for detection of modified proteins (see for example, first section “What are Polyclonal and Monoclonal Antibodies?”). See further in Rietveld, under “Polyclonal Antibodies in Multiplex Assays”, teaching polyclonal antibodies are known useful for detection protein isoforms and conformation variants, and further under “Best uses of polyclonal antibodies:”, the first bullet point, a best use is recognized in the art as to detect known or unknown isoforms of antigens with high antigen homology.
See also Burakov et al., Burakov is teaching invention based on a recombinant host cell and cell expression system thereof that decreases expression of two or more endogenous host cell fatty acid hydrolases; disrupting genes encoding at least two for optimized and efficient production and purification of biopharmaceutical produces expressed in these systems (see para [001117]).
Regarding claim 17, see further Burakov teach in addition to PLBD2, other fatty acid hydrolases in protein fractions of certain antibody -producing cells are considered contaminants, see for specifically Burakov teach an example of esterases, namely including PLDB2, lipoprotein lipase, and lysosomal acid lipase (LIPA/LAL) (para [00117], see also para [00127]). The reference further acknowledging variants of LIPA (see para [0049] and [0145]).
Yu et al. teach for recombinant pharmaceutical proteins to be acceptable for administration to humans, it is important that residual impurities resulting from manufacture and purification processes are removed from the final product (para [0006]). Yu recognize that host cell impurities include process-specific host cell proteins (HCPs), which are process related impurities/contaminants, see Yu teaching a need to detect and quantitate HCPs. See further para [0017], consistent with Burakov, Yu teach PLBD2 as a species of CHOP (HCP) (see also para [0019]); at para [0017] Yu et al. teach it is known that PLBD2 exists as N and C terminal fragments (i.e., these variants are known to exist/be present, in addition to the intact form)
Padhan teach cIEF as an automated, capillary-based immunoassay that is highly reproducible and capable of resolving proteins and their modified isoforms rapidly and quantitatively, Padhan teaching cIEF as an alternate to conventional methods such as western blotting (page 1 of 6, at the Introduction, paragraph 1). Padhan teach cIEF as a procedure that provides higher resolution and sensitivity.
See also Bancel et al., teaching anti-lysosomal acid lipase antibody (Abcam, ab89771) is known and commercially available/obtainable to those of ordinary skill in the art (para [1958]). See the cited Abcam datasheet which is cited as evidentiary reference, Abcam shows that Abcam Antibody Ab897771 is a polyclonal antibody.
Regarding claim 17, as noted above, the claim recites detecting “two or more variants of two or more host cell protein contaminants of interest”, claim 32 further limiting “the host cell protein contaminants of interest” to those listed at the group recited at claim 32.
It would have been prima facie obvious to one having ordinary skill in the art at the time the claimed invention was effectively filed to have applied the method of Voss for the detection of variants of PLBD2 (intact and variant forms of PLBD2, as taught by Yu et al.) in a first capillary and for LIPA (intact and variant forms of LIPA, see Burakov et al.) in a second antibody, in an antibody preparation sample as in Bosteel et al., Barkov et al. and Yu et al. (namely to have modified Voss in order to perform the method on a sample for the detection of the targeted contaminants such as intact and variant forms of PLBD2, and possible variants of HCP LAL).
Specifically one having ordinary skill would have been motivated to use the technique of Voss to detect HCP contaminants detect such as PLBD2 and LIPA/LAL, including variants (intact and truncated forms) of these HCPs because these endogenous host cell fatty acid hydrolases were recognized as undesirable contaminants that should be removed from final biological products (Burakov et al. and Yu et al.), for example see also Bosteel, teaching such contaminant can potentially illicit immune response in patients and degrade excipients necessary for stabilization of antibody preparation products, reducing shelf-life and causing safety issues (Burakov and also Yu recognized PLBD2 as a contaminate that should be removed). Further the ordinarily skilled artisan would have been motivated to have used the technique of Voss (the cIEF) because cIEF is recognized as a suitable alternative to other detection techniques, for example western blot immunoassay (Bosteels using western blot), specifically because it is a rapid, quantitative alternative, which provides high resolution and sensitivity.
As a result, one having ordinary skill in the art would have a reasonable expectation of success, particularly since cIEF was recognized applicable for protein containing samples (Voss, Padhan), and see further one having a reasonable expectation of success given antibodies to these targets were known and available (see as cited above, Bosteel and Bancel).
Regarding the limitation specific to a primary antibody that specifically binds to the two or more variants of each of the host cell proteins, it would have been prima facie obvious to have used the specific polyclonal anti-PLDB2 antibody of Bosteel as the antibody to detect the PLDB2 variants because such an antibody would be expected to bind and detect the various forms in the sample because it is known that polyclonal antibodies are a heterogeneous mixture of antibody species capable of targeting various epitopes, usable for different protein isoform detection (see Rietveld). One having ordinary skill in the art would have a reasonable expectation because the polyclonal antibody of Bosteel was commercially available and known to those of ordinary skill in the art before the effective filing date of the claimed invention, and further would reasonably expect success because polyclonal antibodies were specifically recognized as useful for detection of different protein isoforms due to the heterogenous nature of the polyclonal antibodies (Rietveld).
Similarly, it would have been prima facie obvious to have used the polyclonal antibody of Bancel (see as evidenced by Abcam) to detect LAL, for the same reasons, namely because such polyclonal antibodies were known as heterogenous antibody mixtures capable of detecting multiple different epitopes, capturing various isoforms. As indicated, one would have been motivated to target LAL, considering this recognized as a host cell species contaminant. One having ordinary skill in the art would have a reasonable expectation of success because polyclonal antibodies to LAL were also known and available to those hving ordinary skill in the art, and because Voss’s device and method are specifically taught as able to/for performing assay on multiple different capillaries for detecting different targeted proteins and host cell proteins are (as discussed in detail above) recognized as a type of protein that would benefit from this type of detection (e.g., Padhan).
Regarding claims 18 and 19, see Voss as cited previously above detecting with more than one (plurality of) antibodies, and see for example paras [0023], [0024], and further see as cited above, Voss teaching multiple capillary detection).
Regarding claims 21-22, the combination of the cited art above addresses discriminating between proteins (and their variants) of interest by a physical parameter, specifically by charge, using a separation matrix that is carrier ampholytes.
Regarding claim 24, Voss also encompass embodiments separating by molecular weight (rather than charge), see for example para [0046], and more specifically, para [0060] (see for example separating in a gel (thereby addressing sieving matrix) by molecular weight).
Regarding claims 26 and 27, see the method of Voss involves contacting with a primary antibody, and a secondary labeled antibody for the primary antibody (e.g., para [0043]).
Regarding claim 28, see Voss above, the method is a quantitative detection method (detecting relative or absolute amounts).
Regarding claim 29, see Voss teach chemiluminescent or fluorescent label (e.g., para [0046] or [0066]).
Regarding claim 31, see Voss at paras [0061], [0094] (e.g., photoimmobilization).
Regarding claim 32, see the combination taught by the cited art include host cell proteins that are PLBD2 and LAL.
Response to Arguments
Applicant's arguments filed 08/11/2025 have been fully considered but they are not persuasive for the following reasons.
Regarding remarks at pages 6-9, Applicant’s amendments to the claims are acknowledged, and the previous rejection of claims under 35 U.S.C. 112(b) and the rejection of under 35 U.S.C. 103 (citing Voss et al., in view of Bosteels et al., Burakov et al., Padhan, N, and Bancel et al.) are withdrawn in response to Applicant’s amendments to the claims.
Regarding Voss et al., Applicant argues Voss teach analytes that are proteins such as ERK1 and ERK2, remarking these proteins are not considered variants and arguing that the Examiner has maintained that these are variants. This argument is not relevant regarding the pending grounds of rejection set forth previously and above, in that the pending grounds of rejection acknowledges that the primary reference, Voss et al., does not teach variants of a host cell protein as claimed. There is motivation to modify Voss to detect host cell protein variants, see as set forth in the pending grounds of rejection detailed above.
Regarding remarks at page 10, Applicant’s amendments to the claims are acknowledged, and the additional grounds of rejection (addressing the alternative possible interpretation of the claims) is withdrawn for the reasons as indicated above.
Regarding remarks pages 11-12, Applicant argues Voss fails to teach or suggest using one primary antibody that specifically binds to two or more variants. However, see the amended grounds of rejection set forth above in response to Applicant’s amendments to the claims. Applicant argues none of the additionally cited references teach or suggest motivation toward detecting variants of a host cell protein contaminant. However, the Examiner disagrees for the reasons of record as set forth in the rejection pending above.
Regarding the motivation (in part see from above), one having ordinary skill would have been motivated to use the technique on samples to detect HCPs, such as for example PLBD2 (intact and truncated forms, because these endogenous host cell fatty acid hydrolases were recognized as undesirable contaminants that should be removed from final biological products (Yu et al.), for example see also Bosteel, teaching such contaminant as PLBD2 can potentially illicit immune response in patients and degrade excipients necessary for stabilization of antibody preparation products, reducing shelf-life and causing safety issues (Burakov and also Yu recognized PLBD2 as a contaminate that should be removed). Further the ordinarily skilled artisan would have been motivated
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
to have used the technique of Voss (the cIEF) because cIEF is recognized as a suitable alternative to other detection techniques, for example western blot immunoassay (Bosteels using western blot), specifically because it is a rapid, quantitative alternative, which provides high resolution and sensitivity.
For these reasons, Applicant’s arguments are not persuasive.
Correspondence
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/ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677