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 .
DETAILED ACTION
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-7, 9-19, and 21-27 have an effective filing date of 25 OCT 2019.
Election/Restriction
In the response filed on 11/05/2024, Applicant elected, without traverse:
Group I, claims 1-15
Species
A distinct characteristic determined
Sensitivity with respect to a drug
A distinct drug sensitivity determined
Anthracycline-based drug
A distinct marker gene used to determine
TOP2A
A distinct component the lipid membrane contains
Lipid of Formula (I)
Status of Claims
Claims 1-7, 9-11, and 13-15 are currently pending and presented for examination on the merits.
Claims 12, 16-19, and 21-27 are withdrawn from further consideration by Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1-7, 9, 16, 18, 21, and 24 are amended.
Claims 8 and 20 are canceled.
Claim 27 is new.
Rejections Withdrawn
The rejection filed under 35 U.S.C. 112(b) is withdrawn in view of Applicant’s amendments.
Rejections Maintained
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-7, 9-11, and 13-15 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception an abstract idea without significantly more. The claim(s) recite(s) a judicial exception (abstract idea/natural phenomenon), specifically, a mental process that is a selecting step. The rationale for this determination is explained below:
The 2019 Patent Subject Matter Eligibility Guidance (“Guidance”) provides a means of determining whether a particular claim is patent eligible under 35 U.S.C. 101. The Guidance requires an analysis of multiple steps, Steps 1, 2A, and 2B:
Step 1 - Following a determination of the broadest reasonable interpretation of a claim, is the claim drawn to a process, machine, manufacture, or composition of matter? If the answer to this inquiry is “Yes,” the analysis moves on to step 2A. Step 2A - A two-prong analysis. For prong one, does the claim recite an abstract idea, law of nature, or natural phenomenon? If “Yes,” the analysis proceeds to prong two, which asks whether the claim recites additional elements that integrate the judicial exception into a practical application. If “No,” the analysis moves on to step 2B. Step 2B - Does the claim recite additional elements that amount to significantly more than the judicial exception? If “No,” the claim is not eligible subject matter under 35 U.S.C. 101.
In the instant case, the claims are drawn to a method, so the answer to Step 1 is “Yes.” With respect to prong one of Step 2A, the recited step of determining a characteristic of a tumor cell group is a mental step/abstract idea, which is a judicial exception. Claims are drawn to methods of determining a characteristic of a tumor cell group. With respect to Step 2B, in addition to the recited judicial exception, the claims recite steps of bringing a lipid particle in contact with a tumor cell group, detecting the presence of a signal from a reporter protein, counting the number of tumor cells having said characteristic, and determining the presence or absence or a degree of the characteristic. However, these steps were well-understood, routine, and conventional data gathering steps that were practiced by investigators prior to the effective filing date of this application. Note the art rejection below. These steps do not amount to additional elements that amount to significantly more than the recited judicial exception. Accordingly, the answer to the Step 2B analysis is “No,” and therefore the claims are not eligible subject matter under 35 U.S.C. 101.
In regard to predicting which therapeutic agent and first determining the presence or absence or a degree of the characteristics, it is further noted that merely adding the generic “using the outputs to predict responsiveness” step, does not integrate the exception into a practical application or amount to significantly more than the judicial exception because it is at best the equivalent of merely adding the words “apply it” and “counting data” to a claim is otherwise unpatentable under 35 U.S.C. 101 is insufficient to establish eligibility under the statute. See Alice Corp. v. CLS Bank, 573 U.S. 208, 221, 110 USPQ2d 1976, 1982-83 (2014) (quoting Mayo Collaborative Servs. V. Prometheus Labs., Inc., 566 U.S. 66, 72, 101 USPQ2d 1961, 1965) (claim unpatentable under 35 U.S.C. 101 despite recitation of the step: “more than simply stat[e] the [judicial exception] while adding the words ‘apply it’”). Moreover, “[w]hile preemption may signal patent ineligible subject matter, the absence of complete preemption does not demonstrate patent eligibility…” Ariosa Diagnostics, Inc., v. Sequenom, Inc., 788 F.3d 1371, 1379 (Fed. Cir. 2015), cert. denied, No. 15-1182, 2016 WL 1117246 (U.S. June 27, 2016). Further, “Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the § 101 inquiry.” Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2117 (2013).
Applicant’s Arguments:
Applicant traverses.
Claims have been amended to clarify that the method is a method of measuring a characteristic of a tumor cell group, and the characteristic is sensitivity with respect to a drug, prognosis, metastatic properties, or infiltrative properties.
Examiner’s Response:
Applicant’s amendment of claims to change “determining the characteristics”, to “measuring the characteristics”, does not integrate the exception into a practical application or amount to significantly more than the judicial exception because it is at best the equivalent of merely adding the words “apply it” and “counting data” to a claim is otherwise unpatentable under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
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 2 recites, line 3, “a degree of the characteristic”. The metes and bounds of the claim is not clear because it is unclear what would be considered sensitivity with respect to a drug, prognosis, metastatic properties, or infiltrative properties. Clarification is required.
Claim 2 recites, line 3, “a degree of the characteristic”. The metes and bounds of the claim is not clear because it is unclear what would be considered sensitivity with respect to a drug, prognosis, metastatic properties, or infiltrative properties. Clarification 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.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-7, 9-11, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Wirtz et al (US 20040219543 A1, IDS 9/9/2021), Hidekazu (JP 2017127227, IDS 9/9/2021), and further in view of Wang et al (TOP2A amplification in breast cancer is a predictive marker of anthracycline-based neoadjuvant chemotherapy efficacy, Breast Cancer Res Treat, 135:531-537, 2012, IDS 9/9/2021).
Wirtz et al teaches diagnosing tumor cells by transfecting blood samples with nucleic acid constructs comprising a reporter gene [0027]. Wirtz et al further teaches the method if used for detection of any disease-associated cell [0027]. Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050]. Wirtz et al further teaches culturing the target cells [0043]. Wirtz et al further teaches utilizing two separate reporter genes [0057]. Wirtz et al further teaches utilizing this method to make individualized decisions with therapy [0043]. Wirtz et al further teaches the sensitivity of tumor cell detection is very high because of the natural amplification system [0044]. Wirtz et al further teaches the use of cell culture and detection device [0078]. Wirtz et al further teaches using these methods for monitoring changes in drug therapy and testing patient samples for ex vivo therapeutic purposes [0060]. One of ordinary skill in the art would recognize that cells are quantified cancer cells in a sample would include counting. Wirtz et al further teaches the characteristic of a P53 mutation in breast cancer patients is associated with de novo resistance to doxorubicin [0010].
However, Wirtz et al does not specifically teach breast cancer cells. However, this deficiency is made up in the teachings of Hidekazu et al.
Hidekazu et al teaches evaluating cell characteristics of cancer cells [0014]. Hidekazu et al further teaches characteristics of: abnormal or normal, degree of abnormality, or degree of malignancy [0014]. Hidekazu et al further teaches detecting cells using a fluorescent protein gene [0101]. Hidekazu et al further teaches detecting multiple signals [0112]. Hidekazu et al further teaches the carrier a method of introducing the reporter into cells by lipofection [0151].
Wirtz et al does not specifically teach TOP2A amplification and breast cancer. However, this deficiency is made up in the teachings of Wang et al.
Wang et al teaches anthracycline-based chemotherapies [Conclusion, pg. 535]. Wang et al further teaches TOP2A amplification in breast cancer tumor cells is a predictive marker for anthracycline-based neoadjuvant chemotherapy sensitivity [Conclusion, pg. 535].
One of ordinary skill, before the effective filing date, would have been motivated to apply Wirtz’s method of identifying and characterizing tumor cells comprising transfecting a patient sample with nucleic acid construct comprising a reporter gene and detecting the expression level, with Hidekazu’s method of characterizing cells from tumor cells and characterizing the tumor cells by degree of abnormality and malignancy, with Wang’s method of identifying breast cancer tumor cells that overexpress TOP2A are sensitive to anthracycline-based therapies. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine the teachings of Wirtz, Hidekazu, and Wang to arrive at a method of determining characteristics of a tumor cell comprising a lipid particle including a lipid membrane and a first nucleic acid including a promoter sequence of a marker gene reporter gene, culturing the cells, and detecting and counting the presence or absence of said signal based on a signal expressed from the reporter gene. Motivation to adapt Wirtz’s method of diagnosing tumor cells to breast cancer because Hidekazu teaches the detection of breast cancer cells and Wang teaches TOP2A is an obvious predictive marker of a patient that is sensitive to anthracycline-based neoadjuvant chemotherapies.
Applicant’s Arguments:
Applicant traverses
The "lipid particle" of the present invention is a roughly spherical hollow body constructed from a lipid membrane arranged by lipid molecules in a non-covalent bond, as shown in [0021] and [0022] of the specification and in Fig. 2. Furthermore, in the present claims, the first nucleic acid is encapsulated in the hollow space of such lipid particles.
Hidekazu does not use the technology that employs the "lipid particle" of the present invention described above, nor does Hidekazu use or form the lipid membrane that forms this lipid particle.
“..the present disclosure, by using liposome-shaped lipid particles, it is possible to measure the drug sensitivity of each breast cancer cell in a breast cancer cell population in a manner that is safer, without unnecessarily damaging breast cancer cells, and under conditions similar to those in vivo” [pg. 13 of Applicant’s Arguments].
In such beast cancer cells, it is extremely important to measure the characteristics of each individual cell in the breast cancer population, i.e., drug sensitivity, for treatment.
Examiner’s Response:
Applicant states, “Hidekazu does not use the technology that employs the "lipid particle" of the present invention described above, nor does Hidekazu use or form the lipid membrane that forms this lipid particle”.
Applicant teaches in [0045] of the specification “the lipid particle” will be as illustrated in FIG 2., a lipid particle includes, for example, a lipid membrane, a nucleic acid included in the inner cavity of the lipid membrane.
Wirtz et al teaches the detection and identification of cells in a blood sample [0027]. One of ordinary skill in the art would recognize that a cell comprises a lipid membrane, and a nucleic acid included in the inner cavity of the lipid membrane.
In reference to Applicant’s Argument that Hidekazu et al does not use the technology that employs the “lipid particle”. Hidekazu et al does not criticize, discredit, or otherwise discourage the use of a lipid particle.
MPEP 2143.01 (I) states that,
The disclosure of desirable alternatives does not necessarily negate a suggestion for modifying the prior art to arrive at the claimed invention. In In re Fulton, 391 F.3d 1195, 73 USPQ2d 1141 (Fed. Cir. 2004), the claims of a utility patent application were directed to a shoe sole with increased traction having hexagonal projections in a "facing orientation." 391 F.3d at 1196-97, 73 USPQ2d at 1142. The Board combined a design patent having hexagonal projections in a facing orientation with a utility patent having other limitations of the independent claim. 391 F.3d at 1199, 73 USPQ2d at 1144. Applicant argued that the combination was improper because (1) the prior art did not suggest having the hexagonal projections in a facing (as opposed to a "pointing") orientation was the "most desirable" configuration for the projections, and (2) the prior art "taught away" by showing desirability of the "pointing orientation." 391 F.3d at 1200-01, 73 USPQ2d at 1145-46. The court stated that "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." Id. In affirming the Board’s obviousness rejection, the court held that the prior art as a whole suggested the desirability of the combination of shoe sole limitations claimed, thus providing a motivation to combine, which need not be supported by a finding that the prior art suggested that the combination claimed by the applicant was the preferred, or most desirable combination over the other alternatives. Id. See also In re Urbanski, 809 F.3d 1237, 1244, 117 USPQ2d 1499, 1504 (Fed. Cir. 2016).
One of ordinary skill, before the effective filing date, would have been motivated to apply Wirtz’s method of identifying and characterizing tumor cells comprising transfecting a patient sample with nucleic acid construct comprising a reporter gene and detecting the expression level, with Hidekazu’s method of characterizing cells from tumor cells and characterizing the tumor cells by degree of abnormality and malignancy. The idea of combining them flows logically from their having been individually taught in the prior art (MPEP 2144.06). Combining prior art elements according to known methods to yield predictable results is an exemplary rationale for a prima facie case of obviousness. MPEP2143. It would have been prima facie obvious to combine the teachings of Wirtz and Hidekazu, to arrive at a method of determining characteristics of a tumor cell comprising a lipid particle including a lipid membrane and a first nucleic acid including a promoter sequence of a marker gene reporter gene, culturing the cells, and detecting and counting the presence or absence of said signal based on a signal expressed from the reporter gene. As such the invention of Wirtz, Hidekazu, and Wang would reasonably be expected to detect and characterize a tumor cell group by a method of determining characteristics of a tumor cell comprising a lipid particle including a lipid membrane and a first nucleic acid including a promoter sequence of a marker gene reporter gene, culturing the cells, and detecting and counting the presence or absence of said signal based on a signal expressed from the reporter gene, by combining parameters to search by, each of which was shown as parameters to detect diseases including cancer.
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.
Claims 1-7, 9-11, and 14-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12, 14-15, and 17 of U.S. Patent No. 10765761 ('761) in view of Wirtz et al (US 20040219543 A1, IDS 9/9/2021), Hidekazu (JP 2017127227, IDS 9/9/2021), and Wang et al (TOP2A amplification in breast cancer is a predictive marker of anthracycline-based neoadjuvant chemotherapy efficacy, Breast Cancer Res Treat, 135:531-537, 2012, IDS 9/9/2021).
The teachings of Wirtz et al, Hidekazu et al, and Wang et al are discussed above.
Claims 1 and 7 are directed to an invention not patentably distinct from claims 1, 12, 14-15, and 17 of ‘761. Specifically, a liposome comprising nucleic acid, a reporter gene, a promoter, and detecting a signal from the reporter gene.
In regards to claim 2, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050].
In regards to claims 3 and 4, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050]. Wirtz et al teaches diagnosing tumor cells by transfecting blood samples with nucleic acid constructs comprising a reporter gene [0027].
In regards to claims 5-6 and 14, Wirtz et al further teaches utilizing this method to make individualized decisions with therapy [0043]. Wirtz et al further teaches using these methods for monitoring changes in drug therapy and testing patient samples for ex vivo therapeutic purposes [0060].
In regards to claims 9-11, Wang et al teaches TOP2A amplification in breast cancer tumor cells is a predictive marker for anthracycline-based neoadjuvant chemotherapy sensitivity [Conclusion, pg. 535].
In regards to claim 15, Wirtz et al further teaches the use of cell culture and detection device [0078].
Claims 1-7, 9-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 10-11, 14, 18, and 21-23 of copending Application No. 17/552,652 ('652) in view of Wirtz et al (US 20040219543 A1, IDS 9/9/2021), Hidekazu (JP 2017127227, IDS 9/9/2021), and Wang et al (TOP2A amplification in breast cancer is a predictive marker of anthracycline-based neoadjuvant chemotherapy efficacy, Breast Cancer Res Treat, 135:531-537, 2012, IDS 9/9/2021).
The teachings of Wirtz et al, Hidekazu et al, and Wang et al are discussed above.
Claims 1 and 7 are directed to an invention not patentably distinct from claims 10, 14, 18, 21-22 of ‘652. Specifically, a liposome comprising nucleic acid, a reporter gene, a promoter, and detecting a signal from the reporter gene.
In regards to claim 2, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050].
In regards to claims 3 and 4, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050]. Wirtz et al teaches diagnosing tumor cells by transfecting blood samples with nucleic acid constructs comprising a reporter gene [0027].
In regards to claims 5-6 and 14, Wirtz et al further teaches utilizing this method to make individualized decisions with therapy [0043]. Wirtz et al further teaches using these methods for monitoring changes in drug therapy and testing patient samples for ex vivo therapeutic purposes [0060].
In regards to claims 9-11, Wang et al teaches TOP2A amplification in breast cancer tumor cells is a predictive marker for anthracycline-based neoadjuvant chemotherapy sensitivity [Conclusion, pg. 535].
In regards to claim 13, is directed to an invention not patentably distinct from claim 11 of ‘652.
In regards to claim 15, Wirtz et al further teaches the use of cell culture and detection device [0078].
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 9-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 7, 10-13, and 16-17 of copending Application No. 17/930,890 ('890) in view of Wirtz et al (US 20040219543 A1, IDS 9/9/2021), Hidekazu (JP 2017127227, IDS 9/9/2021), and Wang et al (TOP2A amplification in breast cancer is a predictive marker of anthracycline-based neoadjuvant chemotherapy efficacy, Breast Cancer Res Treat, 135:531-537, 2012, IDS 9/9/2021).
The teachings of Wirtz et al, Hidekazu et al, and Wang et al are discussed above.
Claims 1, 7, and 13 are directed to an invention not patentably distinct from claims 7, 10-13, and 16-17 of ‘890. Specifically, a liposome comprising nucleic acid, a reporter gene, a promoter, and detecting a signal from the reporter gene.
In regards to claim 2, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050].
In regards to claims 3 and 4, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050]. Wirtz et al teaches diagnosing tumor cells by transfecting blood samples with nucleic acid constructs comprising a reporter gene [0027].
In regards to claims 5-6 and 14, Wirtz et al further teaches utilizing this method to make individualized decisions with therapy [0043]. Wirtz et al further teaches using these methods for monitoring changes in drug therapy and testing patient samples for ex vivo therapeutic purposes [0060].
In regards to claims 9-11, Wang et al teaches TOP2A amplification in breast cancer tumor cells is a predictive marker for anthracycline-based neoadjuvant chemotherapy sensitivity [Conclusion, pg. 535].
In regards to claim 15, Wirtz et al further teaches the use of cell culture and detection device [0078].
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 9-11, and 14-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21-23, and 25-26 of copending Application No. 17/930,961 ('961) in view of Wirtz et al (US 20040219543 A1, IDS 9/9/2021), Hidekazu (JP 2017127227, IDS 9/9/2021), and Wang et al (TOP2A amplification in breast cancer is a predictive marker of anthracycline-based neoadjuvant chemotherapy efficacy, Breast Cancer Res Treat, 135:531-537, 2012, IDS 9/9/2021).
The teachings of Wirtz et al, Hidekazu et al, and Wang et al are discussed above.
Claims 1, 7, and 13 are directed to an invention not patentably distinct from claims 21-23, and 25-26 of ‘961. Specifically, a liposome comprising nucleic acid, a reporter gene, a promoter, and detecting a signal from the reporter gene.
In regards to claim 2, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050].
In regards to claims 3 and 4, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050]. Wirtz et al teaches diagnosing tumor cells by transfecting blood samples with nucleic acid constructs comprising a reporter gene [0027].
In regards to claims 5-6 and 14, Wirtz et al further teaches utilizing this method to make individualized decisions with therapy [0043]. Wirtz et al further teaches using these methods for monitoring changes in drug therapy and testing patient samples for ex vivo therapeutic purposes [0060].
In regards to claims 9-11, Wang et al teaches TOP2A amplification in breast cancer tumor cells is a predictive marker for anthracycline-based neoadjuvant chemotherapy sensitivity [Conclusion, pg. 535].
In regards to claim 15, Wirtz et al further teaches the use of cell culture and detection device [0078].
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 9-11, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17 and 20 of copending Application No. 18/468,102 ('102) in view of Wirtz et al (US 20040219543 A1, IDS 9/9/2021), Hidekazu (JP 2017127227, IDS 9/9/2021), and Wang et al (TOP2A amplification in breast cancer is a predictive marker of anthracycline-based neoadjuvant chemotherapy efficacy, Breast Cancer Res Treat, 135:531-537, 2012, IDS 9/9/2021).
The teachings of Wirtz et al, Hidekazu et al, and Wang et al are discussed above.
Claims 1, 7, and 13 are directed to an invention not patentably distinct from claims 17 and 20 of ‘102. Specifically, a liposome comprising nucleic acid, a reporter gene, a promoter, and detecting a signal from the reporter gene.
In regards to claim 2, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050].
In regards to claims 3 and 4, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050]. Wirtz et al teaches diagnosing tumor cells by transfecting blood samples with nucleic acid constructs comprising a reporter gene [0027].
In regards to claims 5-6 and 14, Wirtz et al further teaches utilizing this method to make individualized decisions with therapy [0043]. Wirtz et al further teaches using these methods for monitoring changes in drug therapy and testing patient samples for ex vivo therapeutic purposes [0060].
In regards to claims 9-11,Wang et al teaches TOP2A amplification in breast cancer tumor cells is a predictive marker for anthracycline-based neoadjuvant chemotherapy sensitivity [Conclusion, pg. 535].
In regards to claim 15, Wirtz et al further teaches the use of cell culture and detection device [0078].
This is a provisional nonstatutory double patenting rejection.
Claims 1-7, 9-11, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 7-9, and 31-33 of U.S. Patent No. 11548857 ('857) in view of Wirtz et al (US 20040219543 A1, IDS 9/9/2021), Hidekazu (JP 2017127227, IDS 9/9/2021), and Wang et al (TOP2A amplification in breast cancer is a predictive marker of anthracycline-based neoadjuvant chemotherapy efficacy, Breast Cancer Res Treat, 135:531-537, 2012, IDS 9/9/2021).
The teachings of Wirtz et al, Hidekazu et al, and Wang et al are discussed above.
Claims 1, 7, and 13 are directed to an invention not patentably distinct from claims 1, 7-9, and 31-33 of ‘857. Specifically, a liposome comprising nucleic acid, a reporter gene, a promoter, and detecting a signal from the reporter gene.
In regards to claim 2, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050].
In regards to claims 3 and 4, Wirtz et al further teaches detecting the presence of the downstream reporter gene products [0050]. Wirtz et al teaches diagnosing tumor cells by transfecting blood samples with nucleic acid constructs comprising a reporter gene [0027].
In regards to claims 5-6 and 14, Wirtz et al further teaches utilizing this method to make individualized decisions with therapy [0043]. Wirtz et al further teaches using these methods for monitoring changes in drug therapy and testing patient samples for ex vivo therapeutic purposes [0060].
In regards to claims 9-11, Wang et al teaches TOP2A amplification in breast cancer tumor cells is a predictive marker for anthracycline-based neoadjuvant chemotherapy sensitivity [Conclusion, pg. 535].
In regards to claim 15, Wirtz et al further teaches the use of cell culture and detection device [0078].
Applicant’s Arguments:
Wirtz, Hidekazu, and Wang do not teach or suggest the method of claim 1 of measuring a characteristic of a tumor cell group of sensitivity with respect to a drug, prognosis, metastatic properties, or infiltrative properties.
Examiner’s Response:
Applicant is informed that the amendment to claim 1, “wherein the characteristic is sensitivity with respect to a drug, prognosis, metastatic properties, or infiltrative properties”. A whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DENNIS JOHN SULLIVAN whose telephone number is (571)272-0509. The examiner can normally be reached Mon - Fri: 7:30AM - 4:30PM.
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/DENNIS J SULLIVAN/ Examiner, Art Unit 1642
/NELSON B MOSELEY II/ Primary Examiner, Art Unit 1642
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