DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendments and remarks, filed on 11/25/2025, are acknowledged. Applicant’s arguments have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.
Status of Claims
Claims 13-29 are under examination.
Claims 1-12 are withdrawn.
Priority
This application is a continuation of U.S. Patent Application Serial No. 17/499,284, filed October 12, 2021, which is a continuation of U.S. Patent Application Serial No. 16/691,480, filed November 21, 2019, which is a continuation of U.S. Patent Application Serial No. 14/554,715, filed November 26, 2014, which is a continuation of U.S. Patent Application Serial No. 13/164,499, filed June 20, 2011, which claims priority to U.S. Provisional Application Serial No. 61/356,501 filed June 18, 2010.
After careful consideration, neither the claims nor the specification of Provisional Application No. 61/356,501 provides support for the instantly claimed feature of “not a human X/Y sex chromosome pair”. At best, the ‘501 application merely provides support for a chromosome pair that is “not the pair of human chromosome 17”. For these reasons, applicants are not given benefit of priority to Provisional Application No. 61/356,501.
Withdrawn Rejections
The rejection of claims 13-29 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite is withdrawn in view of applicant’s amendments.
The rejection of claims 13-26 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nannya et al. (Cancer Res, 2005; 65; pp. 6071-79) is withdrawn in view of applicant’s amendments.
The rejection of claims 13-29 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-6, 8-12 of US Application 16/691480 (now US 11,174,519) in view of Nannya et al. (Cancer Res, 2005; 65; pp. 6071-79) is withdrawn in view of applicant’s amendments.
The rejection of claims 13-29 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-13 of US Application 16/576,643 (now US 10,851,425) in view of Nannya et al. (Cancer Res, 2005; 65; pp. 6071-79) is withdrawn in view of applicant’s amendments.
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 13-29 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.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and ‘as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355).
Guidance Step 1: Under the broadest reasonable interpretation, the claimed invention (claim 13 being representative) is directed to a method of detecting an indicator LOH region in genomic DNA. Therefore, the claims fall into one of the four statutory categories. [Step 1: YES]
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. Regarding claim(s) 13, the following steps encompass an abstract idea:
(c) detecting at least one indicator LOH region in the genomic DNA based on homozygosity of the loci genotyped in (b), wherein the indicator LOH region is longer than 1.5 megabases but shorter than the length of the whole chromosome containing the indicator LOH region
Mental Processes
With regards to said detecting, the claim does not provide any details with regards to how the detecting is being performed. Accordingly, the plain meaning of detecting encompasses mental observations or evaluations, e.g., a scientist merely observing/analyzing data and making a decision based on said analysis. In addition, the specification describes computational and/or algorithmic methods for determining LOH regions [0062]. As such, the specification provides sufficient evidence that the claims are directed to an abstract idea since the specific descriptions provided for accomplishing these tasks include only data reception and analysis, which may be performed in the human mind via normal processes of observation and evaluation. For these reasons, but for the recitation of processors, the above step falls within the mental process groupings of abstract ideas. See MPEP 2106.04(a)(2), subsection III. [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
Having made that determination, under the 2019 Guidance, the examiner next determines whether there are additional elements beyond the recited abstract idea(s) that integrate them into a practical application.
In this case, the additional steps/elements that are not part of the abstract idea are as follows:
(a) sequencing genomic DNA from a cancer cell obtained from a subject…and wherein the cancer cell is selected from the group consisting of a breast cancer cells an ovarian cancer cell, a leukemia cancer cell, an esophageal cancer cell, a lung cancer cell, and a prostate cancer cell;
(b) genotyping at least 1000 loci in the DNA sequencing results as having a heterozygous or homozygous genotype, wherein the loci are not in a human X/Y sex chromosome pair;
With regards to the sequencing and genotyping steps, these steps are recited at a high level of generality and require collecting data for use by the abstract idea. Accordingly, these steps amount to insignificant extra-solution activity and are not indicative of an integration into a practical application. See MPEP 2106.05(g). Notably, the claim does not include any specific machines or computer processor for practicing the claimed invention. Even when viewed in combination, these additional elements do not integrate the recited judicial exception into a practical application. [Step 2A, Prong 2: NO].
C. Guidance Step 2B:
This part of the eligibility analysis evaluates whether the claim as a whole amount to significantly more than the recited exception i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim. See MPEP 2106.05.
As discussed above, the non-abstract steps/elements amount to nothing more than insignificant extra-solution activity. Notably, applicant’s own specification teaches routine and conventional means for sequencing and genotyping DNA [0060, 0064]. Moreover, Nannya et al. (Cancer Res, 2005; 65; pp. 6071-79) teaches methods of sequencing and genotyping a patient tumor sample using an SNP array with over 116,000 SNPs to detect LOH regions (Abstract, p.6071, col. 2, p.6072, col. 1), wherein the LOH regions are associated with at least 15 chromosomes that are shorter than the whole chromosome (Table 1). Therefore, even upon reconsideration, there is nothing unconventional with regards to the above non-abstract elements/steps. See MPEP 2106.05(d)(Part II). In sum, “the claims do not add anything beyond conventional technology, and thus do not transform the claims to something more than the abstract idea.” Mortg. Application Techs., LLC v. MeridianLink, Inc., 839 Fed. App’x 520, 526 (Fed. Cir. 2021). Therefore, the claim(s) is/are not patent eligible. [Step 2B: NO].
Dependent Claims
Dependent claims 14-29 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Claims 14-26 further limit the nature of the data used by the abstract idea and data is not patentable. Therefore, these claims also encompass mental processes and are not patent eligible for reasons discussed above. Claims 27-29 further limit the response of the subject to various treatments. However, these claims do not require any positive steps for actually administering any agents so it is unclear what limiting effect this claim has on the method (see also rejection under 35 USC 112(b) below). That being said, these limitations are nothing more than a tangential addition to the claim using routine and convention agents. Accordingly, these claims are broadly interpreted as insignificant extra-solution activity and generically adding the words ‘apply it’ to the judicial exception.
Therefore, these claims are not indicative of an integration into a practical application. See also MPEP 2106.05(g).
Response to Arguments
Applicant’s arguments, filed 11/25/2025, have been fully considered but are not persuasive for the following reasons.
Applicant argues that the claimed invention does not recite any mental steps because the human mind cannot practically perform the step of “genotyping at least 1,000 loci”, nor detecting at least one indicator LOH region (citing the USPTO August 2025 Memo). In response, it is noted at the outset that the August 2025 Memo does not change two-part examination process under 35 USC 101. That being said, the “genotyping” step has not been interpreted as part of the abstract idea. Therefore, this argument is not persuasive. With regards to the ‘detecting’ step, applicant is reminded that the Office's eligibility guidance does not set limit on the number of calculations that can or cannot be performed mentally. MPEP § 2106.04(a)(2)III. In addition, the claimed “detecting” step requires detecting at least LOH region. Accordingly, this step is properly classified under the “mental process” category for reasons discussed above (Step 2A, prong 1). See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
For at least these reasons, and absent any evidence to the contrary, the rejection is maintained. In the interest of advancing prosecution, applicant is encouraged to amend the independent claim to add a step of administering a particular treatment based on the information generated by the abstract idea. See also claims 27 and 28 (which appear to recite particular agents but do not recite an administering step).
Double Patenting
The non-statutory 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. See 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); ln 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 C.F.R. 1.321 (c) may be used to overcome an actual or provisional rejection based on a non-statutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 C.F.R. 1.130(b). 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 C.F.R. 3.73(b). [See also MPEP 804.02].
The conclusion of obviousness-type double patenting is made in light of these factual determinations. Any obviousness-type double patenting rejection should make clear: (A) The differences between the inventions defined by the conflicting claims; and (B) The reasons why a person of ordinary skill in the art would conclude that the invention defined in the claim at issue is anticipated by, or would have been an obvious variation of the invention defined in a claim in the patent.
Claims 13-29 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 14-20 of US Application 17/499,284.
The differences between the inventions defined by the conflicting claims are as follows: Reference claim(s) 14 of the ‘284 application teaches all aspects of the instant claim 13 plus additional features and/or limitations. Therefore, instant claim(s) 13 is/are anticipated by the narrower claims (i.e. species anticipates the genus). Moreover, dependent reference claims 15-20 teach or suggest all aspects of instant claims 14-29. Therefore, the instantly rejected claims 13-29 are made obvious over the combination of reference dependent claims because it would have been obvious to combine all limitations taught in the reference claims. This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Response to Arguments
This rejection is maintained as applicant has not argued the merits of this rejection and no terminal disclaimer(s) in compliance with 37 C.F.R. 1.321 (c) has been filed to overcome this rejection, as required by 37 C.F.R. 1.130(b).
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619