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 with traverse of group I in the reply filed on August 25, 2025 is acknowledged. The traversal is on the ground(s) that Sullivan does not teach cancer. This is not found persuasive because Clarke et al. (US 2007/0105133) anticipate or make obvious claim 54 (see rejections below).
The requirement is still deemed proper and is therefore made FINAL.
Claims 54-100 are pending. Claims 1-53 are canceled. Claims 64-71 and 80-100 are withdrawn. Claims 54-63 and 72-79 are examined.
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 54-63 and 72-79 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim(s) is/are directed to a law of nature. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
The rationale for this determination is explained below and is based on USPTO’s 2014 Interim Guidance on Patent Subject Matter Eligibility, called ‘‘Interim Eligibility Guidance’’ (published in Federal Register /Vol. 79, No. 241 /Tuesday, December 16, 2014) and Interim Guidance published May 4, 2016 for use by USPTO personnel in determining subject matter eligibility under 35 U.S.C. 101 in view of recent decisions by the U.S. Supreme Court (Supreme Court). In Mayo Collaborative Services v. Prometheus Laboratories, Inc. (Mayo) 101 USPQ2d 1961, 1965-1966 (SC 2012) it was stated:
“Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U. S. 63, 67 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it. (Emphasis added).
Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words “apply it.”
Our conclusion rests upon an examination of the particular claims before us in light of the Court’s precedents. Those cases warn us against interpreting patent statutes in ways that make patent eligibility “depend simply on the draftsman’s art” without reference to the “principles underlying the prohibition against patents for [natural laws].” Flook, supra, at 593. They warn us against upholding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112– 120; Benson, supra, at 71–72.
And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an “inventive concept,” sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. Flook, supra, at 594; see also Bilski, supra, at ___ (slip op., at 14) (“[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant post solution activity’” (quoting Diehr, supra, at 191–192)). (Emphasis added).
We find that the process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries. (Emphasis added)
1. Is the claimed invention directed to one of the four statutory categories, i.e. a process, machine, manufacture, or composition of matter?
2. Does the claim recite or involve judicial exception(s), i.e. abstract ideas, laws of nature/natural principles, natural phenomena, and natural products?
3. Does the claim as a whole recite something significantly different than the judicial exception(s)?
In the present case, the claims are directed to an abstract idea and a correlation of IL4I1 and AHR expression or activity and cancer detection.
The answers to the first two questions of the claim eligibility chart is yes because the claim is to a method and the claim recites judicial exceptions of a conditional “if” clause of mental step and a correlation of natural law of presence of IL4I1 and ARH with cancer detection.
The answers to the question three is no because the claims as a whole does not recite something significantly different than the abstract idea and natural law of correlation of marker diagnostic with cancer detection.
The abstract idea steps recited in claims do not contain any additional elements or steps beyond the observation of abstract idea in a conditional phrase, and as a result, these claims do not satisfy the third inquiry. The method of claims involve instructions that are well-understood, routine, and conventionally practiced by those in the field. Thus, the claim also fails to satisfy the third inquiry. Since the claim satisfies all three inquiries, it is rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter.
In the present case, the claims are directed to an abstract idea which is dependent on a conditional phrase. Claim 79 recite generic treatment of IL4I1 inhibitor but is not sufficient as just “apply it” generic treatment. The claims as a whole does not recite something significantly different than the abstract idea for patients not treated. Thus, the claim also fails to satisfy the third inquiry. Since the claim satisfies all three inquiries, it is rejected under 35 U.S.C. 101 as not being drawn to patent-eligible subject matter.
In sum, when the relevant factors are analyzed, they weigh against significant difference from naturally occurring principle and thus claims do not qualify as eligible subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 54-56 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Clarke et al. (US 2007/0105133).
Clarke teach the method of detection of solid tumor by detection of cancer markers of IL4I1 and ARH compared to control expression from sample from patients (paragraph 39, 101-104, 114, 117, 149, 170-173, 262; Table 5-6). The term “housekeeping gene” is not defined and encompass any control genes since all cells are essentially housekeeping to maintain the homeostasis of the cell.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 54-62, 72-79 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clarke et al. (US 2007/0105133) in view of Molinier-Frankel (WO 2010/066858), Vacher (PLOS One, 2018) and Sherr et al. (US 2013/0281525).
Clarke teach the method of detection of solid tumor by detection of cancer markers of IL4I1 and ARH compared to control expression from sample from patients (paragraph 39, 101-104, 114, 117, 149, 170-173, 262; Table 5-6). The term “housekeeping gene” is not defined and encompass any control genes since all cells are essentially housekeeping to maintain the homeostasis of the cell. Clarke does not teach the enzymatic assay with IL4I1. Clarke does not teach the increase in ARH.
Molinier-Frankel teach the method of detection of cancer using the IL4I1 increased enzymatic assay detecting H2O2 fluorimetric quantification from phenylalanine oxidative deamination and high expression IL4I1 immunochemistry with antibody and compared to control from sample from human (page 3, 7, 8, 9,12-14, 17, 23, 24, 26, 31-36, 38-39). Molinier teach the method of using enzyme inhibitor of IL4I1 (page 3). Molinier teach the different cancer (page 10). Molinier teach the enzymatic assay measurement of phenylalanine and phenylpyruvate in biological fluids (page 17).
Vacher teach the high expression of AHR in breast tumors.
Sherr teach the method of detecting and treating cancer cells with AHR modulation activity (paragraph 104-105, 293, 295, 306, 311).
It would have been obvious to one of ordinary skill in the art at the time of the invention to incorporate the detection methods of Molinier-Frankel, Vacher and Sherr to detect cancer method of Clarke. One of ordinary skill in the art would have been motivated by the extra detail methods available in the state of the art of Molinier-Frankel, Vacher and Sherr to perform the detection of cancer with IL4I1 and AHR of Clarke.
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 54-63, 72-79 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 3-6, 13-14, 17-24 of copending Application No. 17/602,361 in view of Clarke et al. (US 2007/0105133), Molinier-Frankel (WO 2010/066858), Vacher (PLOS One, 2018) and Sherr et al. (US 2013/0281525).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3-6, 13-14, 17-24 of copending Application No. 17/602,361 anticipates the claims because the ‘361 teach the detection of IL4I1 and ARH for detection of cancer and treatment of cancer with inhibitors.
Clarke et al. (US 2007/0105133), Molinier-Frankel (WO 2010/066858), Vacher (PLOS One, 2018) and Sherr et al. (US 2013/0281525) provides supporting details of the methods claimed.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL D PAK whose telephone number is (571)272-0879. The examiner can normally be reached on flexible time.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached on 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL D PAK/Primary Examiner, Art Unit 1674
Prosecution Insights