DETAILED ACTION
Status of the Claims
Claims 51-58 are currently pending and are examined herein.
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 10/12/2023 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities: Figure 8 of the drawings has parts A, B, and C, however, these are not addressed in the Brief Description of the Drawings section. Appropriate correction is required.
Drawings
The drawings are objected to because there are two misspellings in Figure 1 "Catagorization" in the title and "Caner" in the heading of the table in the third column. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as "amended." If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either "Replacement Sheet" or "New Sheet" pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 52 is objected to because of the following informalities: the claim recites the term “lung caner” which appears to be a misspelling for “lung cancer”. Appropriate correction is required.
Claim Rejections - 35 USC § 112, 1st Paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement
Claims 51-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for methods of identifying an asymptomatic human subject with an increased risk for lung cancer, does not reasonably provide enablement for methods of identifying an asymptomatic human subject with an increased risk for all cancers, as presently claimed in claims 51-57 nor for bile duct cancer, bone cancer, breast cancer, pancreatic cancer, cervical cancer, colon cancer, colorectal cancer, gallbladder cancer, liver or hepatocellular cancer, ovarian cancer, testicular cancer, lobular carcinoma, prostate cancer, skin cancer or melanoma, as presently claimed in claim 58. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims.
The standard for determining whether the specification meets the enablement requirement was cast in the Supreme Court decision of Minerals Separation Ltd. v. Hyde, 242 U.S. 261, 270 (1916) which postured the question: is the experimentation needed to practice the invention undue or unreasonable? That standard is still the one to be applied. In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). Accordingly, even though the statute does not use the term "undue experimentation," it has been interpreted to require that the claimed invention be enabled so that any person skilled in the art can make and use the invention without undue experimentation. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404 (Fed. Cir. 1988). See also United States v. Telectronics, Inc., 857 F.2d 778, 785, 8 USPQ2d 1217, 1223 (Fed. Cir. 1988) ("The test of enablement is whether one reasonably skilled in the art could make or use the invention from the disclosures in the patent coupled with information known in the art without undue experimentation.").
Factors to be considered in determining whether undue experimentation is required are summarized in In re Wands (858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988) and MPEP 2164.01(A)) as follows: 1) quantity of experimentation necessary, 2) the amount of direction or guidance presented, 3) the presence and absence of working examples, 4) the nature of the invention, 5) the state of prior art, 6) the relative skill of those in the art, 7) the predictability or unpredictability of the art, and 8) the breath of the claims. While all the above factors have been fully considered and have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, only the most relevant factors are addressed in detail below.
As per MPEP 2164.08, the Federal Circuit has repeatedly held that "the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without ‘undue experimentation’", citing In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Further, the propriety of a rejection based upon the scope of a claim relative to the scope of the enablement concerns (1) how broad the claim is with respect to the disclosure and (2) whether one skilled in the art could make and use the entire scope of the claimed invention without undue experimentation.
The breath of the claims
The type of cancer
Claims 51-57 are presently drawn to methods of “identifying an asymptomatic human subject with an increased risk for cancer and treating the subject” by measuring a panel of markers comprising CEA, CA125, and Cyfra 21-2. While the panel of markers may include other markers, the minimum set consists of the three recited. Notably, these claims encompass any cancer. Claim 58 narrows the cancer to being selected from bile duct cancer, bone cancer, breast cancer, pancreatic cancer, cervical cancer, colon cancer, colorectal cancer, gallbladder cancer, liver or hepatocellular cancer, lung cancer, ovarian cancer, testicular cancer, lobular carcinoma, prostate cancer, skin cancer, and melanoma.
However, the specification enables only some methods of identifying an asymptomatic human subject with an increased risk for lung cancer and treating the subject.
The sample
Claims 51-54 and 56-58 presently encompass “measuring a panel of markers comprising CEA, CA125, and Cyfra 21-1 in the sample”. Claim 55 limits the sample as being “blood, blood serum, or blood plasma”. However, regarding claims 51-54 and 56-58, the specification does not support the full scope of the limitation of "a sample" which is obtained from a human subject. There is no support for the full breadth of sample types one may collect from a human subject. Rather, the specification recites in paras. [00166], [00170], and [00190] working examples involving the collection of blood samples, in para. [00179] a serum sample, and in para. [00192] using plasma.
The amount of direction or guidance presented and the existence of working examples
The specification discloses sufficient guidance and working examples for identifying an asymptomatic human subject with an increased risk for lung cancer and subsequent imaging and surgery using the panel marker of the claims, for example in para 00105-00107 and the Examples. However, the only mention of other cancer-specific markers appears to be two biomarkers for colorectal cancer, namely, miR-92 and aberrantly methylated SEPT9 DNA (e.g., as per para 0092). None of the Examples disclose or suggest any other cancers other than lung cancer.
Regarding selection of markers, Applicant’s disclosure as originally filed states that “markers are known for cancers and a known panel can be selected … based on measurement of individual markers in retrospective clinical samples wherein a panel is generated based on empirical data for a desired cancer” as per para 0085. That is, other than lung cancer (and perhaps colorectal cancer, as above), the disclosure provides no guidance beyond a conclusory statement that panels of markers are known in the art. See below for discussion of the state of the art at the time of the invention.
The state of prior art, the relative skill of those in the art, and the predictability or unpredictability of the art.
A skilled artisan would reasonably have substantial knowledge of immunoassays, cancer biomarkers, and statistical analysis, including the ability to measure markers and evaluate retrospective data, and likely have or be working toward a post-graduate degree.
The level of unpredictability of the art at the time of the invention for cancer-specific markers useful for diagnosing or assessing the risk level of a human subject is demonstratably high. Admissions of Applicant in the disclosure are instructive here. For example, para 0106 generally offers that “[s]ince the presence of these proteins or their increased expression is directly related to the cancer cells they tend to be specific to cancer, however they may often be found in more than one type of cancer.” The same paragraph evens admits difficulties for even lung cancer itself, stating that “[u]nfortunately, due to the heterogeneity of the cancers we classify as lung cancer and the individual differences in patient immune responses, a large panel of autoantibodies is required to sensitively detect all lung cancers” (emphasis added).
The state of the prior art at the time the invention was made can be deduced from the relevant prior art literature from about that time, with review articles being particularly relevant. Of note, Eleftherios P. Diamandis, Md, PhD, FRCPC writes in “Cancer Biomarkers: Can We Turn Recent Failures Into Success?” (JNCI: Journal of the National Cancer Institute, Volume 102, Issue 19, 6 October 2010, Pages 1462–1467, https://doi.org/10.1093/jnci/djq306) write in the Abstract that “very few biomarkers are useful for cancer diagnosis and monitoring. Over the past 15 years, major investments have been made to discover and validate cancer biomarkers. Despite such investments, no new major cancer biomarkers have been approved for clinical use for at least 25 years.”
Further, Prof. Michael J. Duffy in “USE OF BIOMARKERS IN SCREENING FOR CANCER” (EJIFCC, 2010, Mar 25;21(1):1-12 eCollection) discusses the in the review literature relevant to the use of biomarkers as screening tests for cancer. He concludes that “Although biomarkers have many attractions as screening tests, inadequate sensitivity and specificity, when combined with the low prevalence of cancer in asymptomatic subjects, limit their value for the early detection of malignancy” (e.g., as per p. 1). He further describes the “lack of sensitivity for early invasive disease or premalignant lesions and lack of specificity for malignancy limit the use of existing biomarkers in screening asymptomatic subjects for early malignancy”, as per p.2, and concludes that “Although intuitively appealing, the success of biomarkers in screening for early cancer has been disappointing” (e.g., as per the Conclusion section on p. 8).
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification.
Based on the findings described herein, practicing the broad scope of the claims would require cancer-specific investigation to determine whether the required minimum panel claimed could support increased-risk assessment and classification, absent any known or presented principle predicting successful application. Given this claim broadness, the guidance and working examples almost exclusive to lung cancer, the limited guidance or ability for extrapolating presented data to other cancers and possibly more biomarkers, and the generally high level of unpredictability in the prior art at the time of the invention, it must be concluded that the invention as presently claimed would certainly require an undue amount of experimentation to practice it. This is taking into account the availability of routine assays and statistical techniques available to the public at the time. Note that the subsequent imaging and surgery do not provide the missing risk identification ability based on marker panels.
Written Description – New Matter
Claims 51-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. This rejection concerns “new matter.”
Claim 51 has been amended to broaden the scope of the claims to include a method of identifying an asymptomatic subject with an increased risk for cancer and treating the subject, however, the specification as originally filed does not provide adequate written description support for such a broadening of the claim scope. As discussed supra, while the disclosure as originally filed appears to be enabled for and shows possession of identifying an asymptomatic subject with an increased risk for lung cancer, there is zero indication given that this single species disclosed can constitute a representative number of species sufficient to show possession of the genus of all cancers, or even those listed specifically in claim 58. Given the lack of guidance and high level of unpredictability in the art (detailed above), it is not reasonable that Applicant has provided enough to support the written description requirement as required by 35 U.S.C. 112, first paragraph.
Applicants are reminded, as per 37 C.F.R. 1.121, that no amendment may introduce new matter into the disclosure of an application, and that in accordance with MPEP § 2163(II)(A)(3)(b), when filing an amendment an applicant should show support in the original disclosure for new or amended claims.
MPEP §2163(I) states that to satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. MPEP §2163(I)(B) explains the written description matter as it relates to new and amended claims, stating that the written description requirement prevents an applicant from claiming subject matter that was not adequately described in the specification as filed.
MPEP 2163.06(I) notes “If new matter is added to the claims, the examiner should reject the claims under 35 U.S.C. 112, first paragraph - written description requirement. In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981).”
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
U.S. 11,733,249 B2
Claim 51-56 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 11,733,249 B2 (the ‘249 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding present claim 51, the claims of the ‘249 patent disclose a method of identifying an asymptomatic human subject with an increased risk for cancer and treating the subject comprising obtaining a sample from the asymptomatic human subject; measuring a panel of markers comprising CEA, CA125, and Cyfra 21-1 in the sample; determining a composite score for the human subject based on the measured panel of markers; identifying an increased risk level for the human subject based on the composite score and corresponding retrospective data; administering an imaging scan to the human subject with an identified increased risk for the presence cancer; and, surgically removing one or more cancerous tumors identified on the imaging scan (e.g., as per claims 1 and/or 5 of the ‘249 patent).
Regarding present claim 52, the claims of the ‘249 patent disclose the above, wherein the increased risk level is determined based on a risk categorization of the retrospective data wherein positive predictive scores of the retrospective data are converted to a multiplier indicating increased likelihood of having lung cancer for one or more categories of the risk categorization (e.g., as per claims 2 and/or 6 of the ‘249 patent).
Regarding present claim 53, the claims of the ‘249 patent disclose the above, wherein the one or more categories of the risk categorization further comprises a risk identifier (e.g., as per claims 3 and/or 7 of the ‘249 patent).
Regarding present claim 54, the claims of the ‘249 patent disclose the above, wherein the risk level is selected from low risk, intermediate-low risk, intermediate risk, intermediate-high risk and high risk (e.g., as per claims 4 and/or 8 of the ‘249 patent).
Regarding present claim 55, the claims of the ‘249 patent disclose the above, wherein the sample is blood, blood serum, or blood plasma (e.g., as per claims 1 and/or 5 of the ‘249 patent).
Regarding present claim 56, the claims of the ‘249 patent disclose the above, wherein the panel of markers further comprises one or more autoantibodies.
Regarding present claim 58, the claims of the ‘249 patent disclose the above, wherein the cancer is selected from the group consisting of bile duct cancer, bone cancer, breast cancer, pancreatic cancer, cervical cancer, colon cancer, colorectal cancer, gallbladder cancer, liver or hepatocellular cancer, lung cancer, ovarian cancer, testicular cancer, lobular carcinoma, prostate cancer, and skin cancer or melanoma (e.g., lung cancer as per claims 1 and/or 5 of the ‘249 patent).
U.S. 9,753,043 B2
Claim 51-55 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 9,753,043 B2 (the ‘043 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be rendered obvious by the subject matter in the claims of the reference patent in view of Goldstraw et al. (Lancet, 2011, 378:1727-1740, published online 05/11/2011).
Regarding present claim 51, the claims of the ‘043 patent disclose a method of identifying an asymptomatic human subject with an increased risk for cancer and treating the subject comprising obtaining a sample from the asymptomatic human subject; measuring a panel of markers comprising CEA, CA125, and Cyfra 21-1 in the sample; determining a composite score for the human subject based on the measured panel of markers; identifying an increased risk level for the human subject based on the composite score and corresponding retrospective data; administering an imaging scan to the human subject with an identified increased risk for the presence cancer (e.g., as per claims 1-2 and/or 15-16 of the ‘043 patent).
It is noted that the claims of the ‘043 patent are silent as to the limitation of surgically removing one or more cancerous tumors identified on the imaging scan. However, such was known in the art. For example, Goldstraw et al. disclose the importance of surgical intervention in the treatment of lung cancer in its ability to increase mean survival time (e.g., as per the Advances in surgical treatment section).
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to surgically removing one or more cancerous tumors identified on the imaging scan as per Goldstraw in the methods of the ‘043 patent claims. One of ordinary skill in the art would have been motivated to do so in order to increase the survival time of the patient, as reviewed by Goldstraw. Given the teachings of the prior art and the level of the ordinary skilled artisan at the time of the applicant’s invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Regarding present claim 52, the claims of the ‘043 patent disclose the above, wherein the increased risk level is determined based on a risk categorization of the retrospective data wherein positive predictive scores of the retrospective data are converted to a multiplier indicating increased likelihood of having lung cancer for one or more categories of the risk categorization (e.g., as per claims 7 and/or 21 of the ‘043 patent).
Regarding present claim 53, the claims of the ‘043 patent disclose the above, wherein the one or more categories of the risk categorization further comprises a risk identifier (e.g., as per claims 5-6 of the ‘043 patent).
Regarding present claim 54, the claims of the ‘043 patent disclose the above, wherein the risk level is selected from low risk, intermediate-low risk, intermediate risk, intermediate-high risk and high risk (e.g., as per claims 6 and/or 18-19 of the ‘043 patent).
Regarding present claim 55, the claims of the ‘043 patent disclose the above, wherein the sample is blood, blood serum, or blood plasma (e.g., as per claims 1 and/or 15 of the ‘043 patent).
Regarding present claim 56, the claims of the ‘043 patent disclose the above, wherein the panel of markers further comprises one or more autoantibodies (e.g., as per claims 2 and/or 16 of the ‘043 patent).
Regarding present claim 58, the claims of the ‘043 patent disclose the above, wherein the cancer is selected from the group consisting of bile duct cancer, bone cancer, breast cancer, pancreatic cancer, cervical cancer, colon cancer, colorectal cancer, gallbladder cancer, liver or hepatocellular cancer, lung cancer, ovarian cancer, testicular cancer, lobular carcinoma, prostate cancer, and skin cancer or melanoma (e.g., lung cancer as per claims 1 and/or 15 of the ‘043 patent).
U.S. 10,156,575 B2
Claim 51-55 and 58 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 10,156,575 B2 (the ‘575 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be rendered obvious by the subject matter in the claims of the reference patent in view of Goldstraw et al. (Lancet, 2011, 378:1727-1740, published online 05/11/2011).
Regarding present claim 51, the claims of the ‘575 patent disclose a method of identifying an asymptomatic human subject with an increased risk for cancer and treating the subject comprising obtaining a sample from the asymptomatic human subject; measuring a panel of markers comprising CEA, CA125, and Cyfra 21-1 in the sample; determining a composite score for the human subject based on the measured panel of markers; identifying an increased risk level for the human subject based on the composite score and corresponding retrospective data; administering an imaging scan to the human subject with an identified increased risk for the presence cancer (e.g., as per claims 1 and/or 8 of the ‘575 patent).
It is noted that the claims of the ‘575 patent are silent as to the limitation of surgically removing one or more cancerous tumors identified on the imaging scan. However, such was known in the art. For example, Goldstraw et al. disclose the importance of surgical intervention in the treatment of lung cancer in its ability to increase mean survival time (e.g., as per the Advances in surgical treatment section).
It would have been prima facie obvious to a person of ordinary skill in the art at the time the invention was made to surgically removing one or more cancerous tumors identified on the imaging scan as per Goldstraw in the methods of the ‘575 patent claims. One of ordinary skill in the art would have been motivated to do so in order to increase the survival time of the patient, as reviewed by Goldstraw. Given the teachings of the prior art and the level of the ordinary skilled artisan at the time of the applicant’s invention, it must be considered, absent evidence to the contrary, that said skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Regarding present claim 52, the claims of the ‘575 patent disclose the above, wherein the increased risk level is determined based on a risk categorization of the retrospective data wherein positive predictive scores of the retrospective data are converted to a multiplier indicating increased likelihood of having lung cancer for one or more categories of the risk categorization (e.g., as per claims 1 and/or 8 of the ‘575 patent).
Regarding present claim 53, the claims of the ‘575 patent disclose the above, wherein the one or more categories of the risk categorization further comprises a risk identifier (e.g., as per claims 4 and/or 11 of the ‘575 patent).
Regarding present claim 54, the claims of the ‘575 patent disclose the above, wherein the risk level is selected from low risk, intermediate-low risk, intermediate risk, intermediate-high risk and high risk (e.g., as per claims 5 and/or 12 of the ‘575 patent).
Regarding present claim 55, the claims of the ‘575 patent disclose the above, wherein the sample is blood, blood serum, or blood plasma (e.g., as per claims 1 and/or 8 of the ‘575 patent).
Regarding present claim 56, the claims of the ‘575 patent disclose the above, wherein the panel of markers further comprises one or more autoantibodies (e.g., as per claims 1 and/or 8 of the ‘575 patent).
Regarding present claim 58, the claims of the ‘575 patent disclose the above, wherein the cancer is selected from the group consisting of bile duct cancer, bone cancer, breast cancer, pancreatic cancer, cervical cancer, colon cancer, colorectal cancer, gallbladder cancer, liver or hepatocellular cancer, lung cancer, ovarian cancer, testicular cancer, lobular carcinoma, prostate cancer, and skin cancer or melanoma (e.g., lung cancer as per claims 1 and/or 8 of the ‘575 patent).
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
