DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
The present application was filed on 02/15/2024 and is a CON of 17/402,262, filed 08/13/2021, which is a CON of 16/544,357, filed 08/19/2019, which is a CON of 15/890,048, filed on 02/06/2018, which is a CON of 15/069,258, filed on 03/14/2016, which is a CON of 14/264,568, filed on 04/29/2014, which is a CON of 13/012,063, filed on 01/24/2011, which is a CON of 11/245,713, filed in 10/6/2005. Acknowledgment is made of applicant’s claim for domestic benefit under 35 U.S.C. 119(e) to provisional application No. 60/642,794, filed 01/11/2005 and provisional application No. 60/616,590, filed 10/06/2004.
Information Disclosure Statement
The information disclosure statement filed on 1/7/2025 is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1 line 5, Applicant uses the abbreviation "B7-H1", it is recommended that abbreviations be accompanied by their full meaning at least at the first instance that the abbreviation is used in order to improve clarity and avoid confusion.
In claim 1 line 5, “(b) assessing whether the test cells express B7-H1, wherein expression” appears to be a typographical error, namely it is suggested that “(b) assessing whether the test cells express B7-H1, wherein expression” read as “(b) assessing whether the test cells express B7-H1, wherein B7-H1 expression” (annotations added) as per the specification page 2 line 12.
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 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to at least one judicial exception (e.g. a law of nature) without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
The claim recites “A method of diagnosis, the method comprising: (a) providing a tissue sample from a subject suspected of having; or likely to develop, cancer of the tissue, wherein the sample comprises test cells, the test cells being cells of the tissue or leukocytes infiltrating the tissue; and (b) assessing whether the test cells express B7-H1, wherein expression by some or all of the test cells is an indication that the subject has cancer”.
The natural relationship to which the claims are directed (i.e., the relation between B7-H1 expression of test cells and cancer) is a law of nature. Similar concepts have been held by the courts to constitute law of nature/natural phenomena, as in the identification of a correlation between the presence of myeloperoxidase in a bodily sample (such as blood or plasma) and cardiovascular disease risk in Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1361, 123 USPQ2d 1081, 1087 (Fed. Cir. 2017). In Mayo, the Supreme Court found that a claim was directed to a natural law, where the claim required administering a drug and determining the levels of a metabolite following administration, where the level of metabolite was indicative of a need to increase or decrease the dosage of the drug. See Mayo Collaborative Services v. Prometheus Labs., Inc., 566 U.S. 66, 74 (2012).
The instant claims are similar to those in Mayo as they involve a "relation itself [which] exists in principle apart from any human action" (id. at 77), namely the relationship between the naturally occurring B7-H1 expression in test cells and the presence of cancer.
The correlation between B7-H1 expression and cancer is a judicial exception as it exists in principle apart from any human action; the correlation itself therefore cannot form the basis for eligibility.
Furthermore, the step of “(b) assessing whether the test cells express B7-Hl…” may also be categorized as abstract ideas, namely mental processes/ concepts performed in the human mind (such as a doctor simply thinking about the measured level of B7-H1 in relation to a cutoff value and making an evaluation, judgment, or opinion). The claims, under their broadest reasonable interpretation, cover performance of step (b) solely within the human mind, or by a human using pen and paper.
Step 2A, Prong 2
The claim recites “(a) providing a tissue sample from a subject suspected of having; or likely to develop, cancer of the tissue, wherein the sample comprises test cells, the test cells being cells of the tissue or leukocytes infiltrating the tissue; and (b) assessing whether the test cells express B7-H1”. Such steps of providing a sample of test cells and assessing the B7-H1 expression therein are insufficient to integrate the judicial exception(s) because the purpose is merely to obtain data. This does not go beyond insignificant presolution activity, i.e., a mere data gathering step necessary to use the correlation, similar to the fact pattern in In re Grams, 888 F.2d 835 (Fed. Cir. 1989) and Ariosa Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir. 2015). Furthermore, the step of assessing expression is recited at a high level of generality and is not tied, for example, to any particular machine or apparatus.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
The additional elements of the claims, including the steps of providing a tissue sample and assessing the expression of B7-H1 therein, do not add significantly more to the judicial exception(s). The step of assessing B7-H1 is recited at a high level of generality and is not limited, for example, to any specific testing technique.
Furthermore, the specification indicates that “[t]he assessment of B7-Hl can be performed by detecting B7-Hl polypeptide or B7-H1 mRNA using any of a variety of methods known in the art, including, for example, those listed above for methods of diagnosis” (page 3 lines 17-20). The specification further discloses that “[m]ethods of detecting a polypeptide in a tissue sample are known in the art. For example, antibodies (or fragments thereof) that bind to an epitope specific for B7-Hl can be used to assess whether test cells from the tissue sample express B7-H1” (page 10 lines 7-9). The specification further discloses that “[m]ethods of detecting an mRNA in a tissue sample are known in the art” (page 10 lines 23-28). See also the disclosure on page 11 lines 10-12, “Alternatively, the level of B7-H1 expression can be assessed using any of a variety of semi-quantitative/qualitative systems known in the art”. Given that expression measurements were predominant in the clinical assay art and were also in routine use for B7-H1 expression assessment, this limitation does not go beyond routine/conventional activity and fails to impose meaningful limits on the claim scope.
In this case, it was well-understood, routine and conventional to assess the expression of B7-H1 in tissue samples. See for example Konishi et al. Clinical Cancer Research, Vol. 10, 5094–5100, August 1, 2004-Cite No. 478 of IDS 1/7/2025 (“Konishi”). Konishi teaches “B7-H1 Expression on Non-Small Cell Lung Cancer Cells and Its Relationship with Tumor-Infiltrating Lymphocytes and Their PD-1 Expression” (Title). Konishi further teaches that “[t]he expression of B7-H1 and B7-DC in 52 surgically resected specimens of non-small cell lung cancer was evaluated immunohistochemically” (Abstract). Also, Dong et al. NATURE MEDICINE • VOLUME 8 • NUMBER 8 • AUGUST 2002-Cite No. 356 of IDS 1/7/2025 (“Dong”) teaches that “Immunohistochemical analysis showed B7-H1 immunoreactivity in a majority of freshly isolated human lung carcinomas (20/21 patients), ovarian carcinomas (20/23 patients), colon carcinomas (10/19 patients) and melanomas (22/22 patients) (Table 1). We found B7-H1 immunoreactivity in the plasma membrane, cytoplasm or both. In most cases B7-H1 expression was focal, with no expression in adjacent normal tissues (Fig. 1b). B7-H1 was expressed on metastatic melanoma cells in the lymph nodes but not on adjacent lymphocytes (Fig. 1b)” (page 794 col. 1 para. 2).
Dong and Chen J Mol Med (2003) 81:281–287 DOI 10.1007/s00109-003-0430-2-Cite No. 352 of IDS 1/7/2025 teach that “Immunohistochemistry analysis demonstrated B7-H1 immunoreactivity in a majority of freshly isolated carcinomas of human lung, ovarian, colon, melanoma, head and neck cancers, and breast cancers. We noticed that some tumor-infiltrating macrophages or dendritic-like cells also expressed B7-H1 on their membrane (Fig. 1)” (page 284 col. 1 para. 2).
Finally, Chen and Strome (WO 02/086083 A2)-Cite No. 234 of IDS 1/7/2025 teach that “[i]mmunohistochemical analysis demonstrated hB7-H1 expression in a majority of freshly isolated human lung carcinomas (20/21 patients), ovarian carcinomas (20/23 patients), colon carcinomas (10/19 patients) and melanomas (22/22 patients) (summarized in Table 2). B7-Hl expression was observed in the plasma membrane, cytoplasm or both. hB7-Hl expression was usually focal with adjacent normal tissues negative” (page 35 lines 8-10 and page 36 lines 1-3).
In view of the above evidence, the claimed steps of determining the expression of B7-H1 in a tissue sample does not add any feature that is more than well-understood, purely conventional, or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim 1 is rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Chen and Strome (WO 02/086083 A2)-Cite No. 234 of IDS 1/7/2025 (“Chen”).
Chen teaches a method of diagnosis (“the methods of the invention can be used as diagnostic assays for cancers” page 22 lines 4-5, “Example 3. Human Cancers but not Normal Tissues Express hB7-Hl” page 34 line 10), the method comprising: (a) providing a tissue sample from a subject suspected of having; or likely to develop, cancer of the tissue, wherein the sample comprises test cells, the test cells being cells of the tissue or leukocytes infiltrating the tissue (“Human cancer or normal tissue samples were obtained from Mayo Clinic's Department of Pathology with Internal Review Board approval” page 30 lines 4-6); and (b) assessing whether the test cells express B7-Hl, wherein expression by some or all of the test cells is an indication that the subject has cancer (“[i]mmunohistochemical analysis demonstrated hB7-H1 expression in a majority of freshly isolated human lung carcinomas (20/21 patients), ovarian carcinomas (20/23 patients), colon carcinomas (10/19 patients) and melanomas (22/22 patients) (summarized in Table 2). B7-Hl expression was observed in the plasma membrane, cytoplasm or both. hB7-Hl expression was usually focal with adjacent normal tissues negative” page 35 lines 8-10 and page 36 lines 1-3).
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 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. US 11504376 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because U.S. Patent No. US 11504376 B2 recites subject matter that is patentably indistinct to the instant case.
U.S. Patent No. US 11504376 B2 recites a method of diagnosis, the method comprising: (a) providing a tissue sample from a subject suspected of having; or likely to develop, cancer of the tissue, wherein the sample comprises test cells, the test cells being cells of the tissue or leukocytes infiltrating the tissue (“a sample obtained from the tumor” claims 3-4); and (b) assessing whether the test cells express B7-Hl, wherein expression by some or all of the test cells is an indication that the subject has cancer (“A method for treating a cancer patient, comprising administering, to a patient identified as having a tumor with cells that express B7-H1, a DNA-PKcs inhibitor and an anti-B7-H1 blocking antibody” claim 1, “wherein the cancer patient is identified based on the level of B7-H1 protein in a sample obtained from the tumor” claim 3, “wherein the cancer patient is identified based on the level of B7-H1 mRNA in a sample obtained from the tumor” claim 4). Note that although U.S. Patent No. US 11504376 B2 fails to use the language “a method of diagnosis…comprising…assessing whether the test cells express B7-Hl, wherein expression by some or all of the test cells is an indication that the subject has cancer”, the recitation of “the cancer patient is identified based on the level of B7-H1…in a sample obtained from the tumor” inherently provides a method of diagnosis comprising assessing B7-H1 in the test cells because the expression level of B7-H1 from the tumor is used to identify cancer in the patient, which is effectively a method of diagnosis comprising the claimed steps (a)-(b).
Conclusion
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/Fernando Ivich/Examiner, Art Unit 1678
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677
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