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 .
Election/Restrictions
Applicant’s election without traverse of Group IV in the reply filed on December 18, 2025 is acknowledged.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms Corning Costar®, NCCN®, Percoll®, and drug candidates listed in page 12, line 29 – page 13, line 7 of specification as filed, which are a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 16 is rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (law of nature, natural phenomenon, or an abstract idea) without significantly more.
Claim 16 recites a method of evaluating a drug’s effect on cancer cells obtained from tumor, contacting the cells with a drug, measuring optical density (OD) over time, calculating a kinetic units (KU) value, and correlating the KU value with an ability of the drug to induce apoptosis in the tumor.
Although the claim falls within the statutory category of a process, the claim is directed to a judicial exception. The claim recite a correlation between a measured parameter (KU value derived from OD measurements) and a naturally occurring biological phenomenon (apoptosis). Apoptosis is a natural cellular process and the relationship between changes in OD and occurrence of apoptosis reflects a natural law or natural phenomenon governing biological relationships. The final step of correlating the KU value based on whether it is positive or not positive is a mental process and an abstract idea, as it merely involved reaching a conclusion from gathered data. The claim therefore is directed to a judicial exception.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. The additional claim elements such as obtaining tumor cells from an individual patient, preparing a single-cell suspension, plating cells in a well, contacting the cell with a drug, measuring OD at 600 nm, calculating a value, and correlating the KU value with an ability of drug to induce apoptosis in the tumor, constitute well-understood, routine, and conventional laboratory activities previously known in the field of oncology assays. The microculture kinetic (MiCK) assay is a well-known test method that measures in vitro drug-induced apoptosis in a patient’s tumor cells to determine the most effective chemotherapy as discussed below (Claim Rejections - 35 USC § 103). For example, Perrée and Hallquist (US 2011 0244503; cited on PTO-892) discloses the MiCK assay steps comprising plating a single-cell suspension of viable cancer cells in at least one well of a plate able to be read by a spectrophotometer, wherein the cancer cells are in a concentration sufficient to form a monolayer of cells on a bottom of the well; adding at least one drug candidate to the well in an amount sufficient to achieve a target drug candidate concentration; measuring the OD of the well at a wavelength of approximately 600 nm using a spectrophotometer at selected time intervals for a selected duration of time; determining a KU value from the OD and time measurements; and correlating the KU value with an ability of the anti-cancer drug candidate to induce apoptosis. As written, the claimed steps are routine and customary in the cited art. The claim does not include an inventive concept such as a specific treatment step or a non-conventional improvement over existing assay techniques.
When considered as a whole, the claim amounts to instructions to observe natural biological responses, measure them using routine techniques, and draw a conclusion based on the observed correlation. Such an application of a natural law using conventional techniques does not amount to significantly more than the judicial exception itself. Accordingly, the claim lacks an inventive concept sufficient to transform the judicial exception into patent-eligible subject matter.
Claim Rejections - 35 USC § 112 Indefiniteness
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites use of an assay to determine the effect of a drug candidate on a primary tumor by using cells from a metastatic tumor of the primary tumor. The claim language fails to clearly define how the use of cancer cells from a metastatic tumor of the primary tumor corresponds to the effect on the primary tumor. Terms such as “to determine the efficacy of at least on drug candidate…against a primary tumor”, “obtained from at least one metastatic tumor of said primary tumor”, and “correlating the KU value with an ability of the at least one drug candidate……to induce apoptosis in the primary tumor” create ambiguity (underlined for emphasis). It remains unclear whether the KU values determined using metastatic tumor cells accurately indicate apoptosis activity in the primary tumor. Neither the claim nor the specification provides guidance on how to interpret the relationship between primary and metastatic tumor cells within the context of the claimed assay. Accordingly, the claim is indefinite because it fails to inform a person of ordinary skill in the art of the precise metes and bounds of the invention, particularly regarding the correlation between primary tumor effects and measurements performed on metastatic tumor cells.
Claim 16 recites the limitation "the method" in line 2. The claim lacks an antecedent basis for this limitation as the claim only refers to the “use of an assay” rather than a method. It is suggested that claim 16 be amended to “A method to determine…” to obviate this rejection.
Clarification and/or amendment is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Perrée and Hallquist (US 2011 0244503; cited on PTO-892) in view of Kravtsov and Koury (WO 02 46751, 2002; cited on PTO-892).
Perrée discloses the MiCK assay for evaluating the ability of an anti-cancer drug candidate to induce apoptosis comprising placing a single-cell suspension of viable cancer cells in at least one well of a plate able to be read by a spectrophotometer, wherein the cancer cells are in a concentration sufficient to form a monolayer of cells on a bottom of the well; adding at least one drug candidate to the well in an amount sufficient to achieve a target drug candidate concentration; measuring the OD of the well at a wavelength of approximately 600 nm using a spectrophotometer at selected time intervals for a selected duration of time; determining a KU value from the OD and time measurements; and correlating the KU value with an ability of the anti-cancer drug candidate to induce apoptosis (claim 1). Perrée discloses an ability of the anti-cancer drug candidate to induce apoptosis in the cancer cell line if the KU value is positive, and an inability of the anti-cancer drug candidate to induce apoptosis in the cancer cell line if the kinetic units value is not positive (claim 1).
Perrée does not disclose cancer cells from metastatic tumor of primary tumor of an individual patient.
Kravtsov discloses the MiCK assay for predicting the effect of a drug on a patient suffering from a disease that can be treated by killing certain cells within the patient (claim 1). Kravtsov discloses that examples of cancer can be primary and metastatic cancer isolated from individual patients for the MiCK assay (page 5, lines 7-8; page 5, line 36).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Perrée to use metastatic or primary tumor cells from individual patients as taught by Kravtsov. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Kravtsov teaches that cancer cells from metastatic or primary tumors from an individual patient can be used for the MiCK assay. Further, a person of ordinary skill in the art would have been motivated to select cell types based on the assay’s purpose. Accordingly, applying the teachings of Kravtsov to the method of Perrée constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 16 obvious.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Kravtsov and Koury (WO 02 46751, 2002; cited on PTO-892) in view of Perrée and Hallquist (US 2011 0244503; cited on PTO-892).
In addition to the teachings of Kravtsov discussed above, Kravtsov discloses the MiCK assay for predicting the effect of a drug on a patient suffering from a disease that can be treated by killing certain cells within the patient comprising plating certain cells such as cancer cells obtained from primary and metastatic tumor of individual patients in at least one well of a 96-well microtiter plate suitable to be read by a spectrophotometer; contacting the culture with the drug in an amount sufficient to achieve a target drug concentration; measuring the OD at more than one time point such as every 5 minutes for a period of 24 hours; determining a net slop, wherein a positive net slope indicates that the drug can be effective in the treatment of the disease (claims 1 and 2; page 5, lines 7-8; page 5, line 36; page 10, lines 1-15). Kravtsov discloses that the extent of apoptosis can be determined from the slope of the steepest increase of OD over time and can be expressed as KU (page 10, lines 1-15).
Kravtsov does not disclose a single-cell suspension of cancer cells in a concentration sufficient to form a monolayer of cells on the bottom of the well.
As discussed above, Perrée discloses that a single-cell suspension can be prepared with a cancer cell concentration sufficient to form a monolayer of cells on a bottom of the well for the MiCK assay (claim 1).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Kravtsov to prepare a single-cell suspension with a concentration of cells sufficient to form a monolayer on the bottom of the well as taught by Perrée. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Perrée teaches single-cell suspension can be prepared and the cells can attach to the wells and form monolayer for the MiCK assay. Further, a person of ordinary skill in the art would have been motivated to use a single-cell suspension with a concentration of cells sufficient to form a monolayer on the bottom of the well in order to improve accuracy and reliability of OD measurements in adherent cell-based microplate assays. Accordingly, applying the teachings of Perrée to the method of Kravtsov constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 16 obvious.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Ballard et al. (Journal of Gynecologic Oncology, 2010; cited on PTO-892) in view of Perrée and Hallquist (US 2011 0244503; cited on PTO-892) and Kravtsov and Koury (WO 02 46751, 2002; cited on PTO-892).
Ballard discloses the MiCK assay comprising plating single-cell suspensions of viable cancer cells in at least one well of a 96-well plate suitable to be read by a spectrophotometer; adding chemotherapy drug in an amount sufficient to achieve a target drug concentration to the well; measuring OD at 600 nm every 5 minutes over a period of 48 hours; determining a kinetic representation for the drug responses by plotting OD readings against time (abstract; page 46, ¶¶ 3-4). Ballard discloses that apoptosis can be characterized by a steep increase in OD while necrosis shows a decline in OD values, and the measure of apoptosis can be reported in KU (page 46, ¶4).
Ballard does not disclose cancer cells from metastatic tumor of primary tumor of an individual patient and a monolayer of cells formed on the bottom of the well.
As discussed above, Perrée discloses the a single-cell suspension can be prepared with a cancer cell concentration sufficient to form a monolayer of cells on a bottom of the well for the MiCK assay (claim 1).
As discussed above, Kravtsov discloses that examples of cancer can be primary and metastatic cancer isolated from individual patients for the MiCK assay (page 5, lines 7-8; page 5, line 36).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of Ballard to use a cell concentration sufficient to form a monolayer on the bottom of the well as taught by Perrée while using metastatic or primary tumor cells from individual patients as taught by Kravtsov. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Perrée teaches cells can attach to the wells and form monolayer for the MiCK assay, and Kravtsov teaches that cancer cells from metastatic or primary tumors from an individual patient can be used for the MiCK assay. Further, a person of ordinary skill in the art would have been motivated to select cell types based on the assay’s purpose, and to use a concentration of cells sufficient to form a monolayer on the bottom of the well in order to improve accuracy and reliability of OD measurements in adherent cell-based microplate assays. Accordingly, applying the teachings of Perrée and Kravtsov to the method of Ballard constitutes no more than the predictable use of prior art elements according to their established functions, thus rendering claim 16 obvious.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. US 9,476,871 (cited on PTO-892) in view of Perrée and Hallquist (US 2011 0244503; cited on PTO-892) and Kravtsov and Koury (WO 02 46751, 2002; cited on PTO-892).
Claim 1 of the ‘871 recites a system for determining the relative effectiveness of anti-cancer drugs comprising spectrophotometer, well plate containing cancer cells and drug candidate, recording OD at selected time intervals for a selected duration of time, and calculating an activity value corresponds to a change in OD measurements over time. Claim 2 of the ‘871 recites the activity value is a KU value calculated based on changes in the OD measurements corresponding to the test well as a function of time.
The claims of the ‘091 does not disclose a single-cell suspension of cancer cells obtained from metastatic tumor of primary tumor of an individual patient, a monolayer of cells formed on the bottom of the well, and OD measured at 600 nm.
As discusses above, Perrée discloses that a single-cell suspension can be prepared with a cancer cell concentration sufficient to form a monolayer of cells on a bottom of the well, and OD can be measured at 600 nm in the MiCK assay (claim 1).
As discussed above, Kravtsov discloses that examples of cancer can be primary and metastatic cancer isolated from individual patients in the MiCK assay (page 5, lines 7-8; page 5, line 36).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of the ‘091 to use a single-cell suspension with a cell concentration sufficient to form a monolayer on the bottom of the well and to measure OD at 600 nm as taught by Perrée, while using metastatic or primary tumor cells from individual patients as taught by Kravtsov. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Perrée teaches that a single-cell suspension with a cell concentration sufficient to form a monolayer can be used and OD can be measured at 600 nm in the MiCK assay, and Kravtsov teaches that cancer cells from metastatic or primary tumors from an individual patient can be used in the MiCK assay.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 10,488,402 (cited on PTO-892) in view of Perrée and Hallquist (US 2011 0244503; cited on PTO-892) and Kravtsov and Koury (WO 02 46751, 2002; cited on PTO-892).
Claim 1 of the ‘402 recites a system for determining the relative effectiveness of anti-cancer drugs comprising controlling multi-well plate reader with well plate containing cancer cells and drug candidate, acquiring test data at selected time intervals for a selected duration of time, and calculating an activity value corresponds to a change in the test data over time.
The claims of the ‘402 does not disclose a single-cell suspension of cancer cells from metastatic tumor of primary tumor of an individual patient, a monolayer of cells formed on the bottom of the well, OD measured at 600 nm using a spectrophotometer, and KU value determined to correlate the KU value with an ability of the drug candidate.
As discusses above, Perrée discloses that a single-cell suspension can be prepared with a cancer cell concentration sufficient to form a monolayer of cells on a bottom of the well, OD can be measured at 600 nm using a spectrophotometer, and KU value can be determined to correlate the KU value with an ability of the drug candidate in the MiCK assay (claim 1).
As discussed above, Kravtsov discloses that examples of cancer can be primary and metastatic cancer isolated from individual patients in the MiCK assay (page 5, lines 7-8; page 5, line 36).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of the ‘402 to use a single-cell suspension with a cell concentration sufficient to form a monolayer on the bottom of the well, to measure OD at 600 nm using a spectrophotometer, and to determine KU value for analyzing activity of drug candidate as taught by Perrée, while using metastatic or primary tumor cells from individual patients as taught by Kravtsov. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Perrée teaches that a single-cell suspension with a cell concentration sufficient to form a monolayer can be used, OD can be measured at 600 nm using a spectrophotometer, and KU value can be determined for analyzing drug activity in the MiCK assay, and Kravtsov teaches that cancer cells from metastatic or primary tumors from an individual patient can be used in the MiCK assay.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. US 12,066,427 (cited on PTO-892) in view of Perrée and Hallquist (US 2011 0244503; cited on PTO-892) and Kravtsov and Koury (WO 02 46751, 2002; cited on PTO-892).
Claim 1 of the ‘427 recites a system for determining the relative effectiveness of anti-cancer drugs comprising controlling multi-well plate reader wherein well plate contains cancer cells and drug candidate, acquiring test data at a plurality of times, and calculating an activity value corresponds to a change in the test data over time.
The claims of the ‘427 does not disclose a single-cell suspension of cancer cells from metastatic tumor of primary tumor of an individual patient, a monolayer of cells formed on the bottom of the well, OD measured at 600 nm using a spectrophotometer, and KU value determined to correlate the KU value with an ability of the drug candidate.
As discusses above, Perrée discloses that a single-cell suspension can be prepared with a cancer cell concentration sufficient to form a monolayer of cells on a bottom of the well, OD can be measured at 600 nm using a spectrophotometer, and KU value can be determined to correlate the KU value with an ability of the drug candidate in the MiCK assay (claim 1).
As discussed above, Kravtsov discloses that examples of cancer can be primary and metastatic cancer isolated from individual patients in the MiCK assay (page 5, lines 7-8; page 5, line 36).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of the ‘427 to use a single-cell suspension with a cell concentration sufficient to form a monolayer on the bottom of the well, to measure OD at 600 nm using a spectrophotometer, and to determine KU value for analyzing activity of drug candidate as taught by Perrée, while using metastatic or primary tumor cells from individual patients as taught by Kravtsov. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Perrée teaches that a single-cell suspension with a cell concentration sufficient to form a monolayer can be used, OD can be measured at 600 nm using a spectrophotometer, and KU value can be determined for analyzing drug activity in the MiCK assay, and Kravtsov teaches that cancer cells from metastatic or primary tumors from an individual patient can be used in the MiCK assay.
Claim 16 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 43 of copending Application No. 18/778,724 (US 2025 0198988; cited on PTO-892) in view of Perrée and Hallquist (US 2011 0244503; cited on PTO-892) and Kravtsov and Koury (WO 02 46751, 2002; cited on PTO-892).
Claim 43 of the ‘724 recites a system for determining the relative effectiveness of anti-cancer drugs comprising controlling multi-well plate reader with well plate containing cancer cells and drug candidate, acquiring test data at selected time intervals for a selected duration of time, and calculating an activity value corresponds to a change in the test data over time.
The claims of the ‘724 does not disclose a single-cell suspension of cancer cells from metastatic tumor of primary tumor of an individual patient, a monolayer of cells formed on the bottom of the well, OD measured at 600 nm using a spectrophotometer, and KU value determined to correlate the KU value with an ability of the drug candidate.
As discusses above, Perrée discloses that a single-cell suspension can be prepared with a cancer cell concentration sufficient to form a monolayer of cells on a bottom of the well, OD can be measured at 600 nm using a spectrophotometer, and KU value can be determined to correlate the KU value with an ability of the drug candidate in the MiCK assay (claim 1).
As discussed above, Kravtsov discloses that examples of cancer can be primary and metastatic cancer isolated from individual patients in the MiCK assay (page 5, lines 7-8; page 5, line 36).
It would have been obvious to a person of ordinary skill in the art before the effective
filing date of the claimed invention to modify the method of the ‘724 to use a single-cell suspension with a cell concentration sufficient to form a monolayer on the bottom of the well, to measure OD at 600 nm using a spectrophotometer, and to determine KU value for analyzing activity of drug candidate as taught by Perrée, while using metastatic or primary tumor cells from individual patients as taught by Kravtsov. A person of ordinary skill in the art would have been motivated to make these modifications and reasonably would have expected success because Perrée teaches that a single-cell suspension with a cell concentration sufficient to form a monolayer can be used, OD can be measured at 600 nm using a spectrophotometer, and KU value can be determined for analyzing drug activity in the MiCK assay, and Kravtsov teaches that cancer cells from metastatic or primary tumors from an individual patient can be used in the MiCK assay.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONG HWAN BAEK whose telephone number is (571)272-0670. The examiner can normally be reached Mon - Thu, 9 am - 3 pm ET.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JONG HWAN BAEK/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618