DETAILED ACTION
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 .
Priority
This application is a national stage entry of PCT/JP2022/025309 filed on 06/24/2022.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in JAPAN on 06/25/2021. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group III (claim 7) drawn to a screening method for a pharmaceutical composition for treating osteosarcoma or glioma in the reply filed on April 13, 2026 is acknowledged. Applicant’s election without traverse of BMS-986278 as a species of a compound that suppresses LPAR1 expression as an active ingredient in the reply filed on April 13, 2026 is also acknowledged. It is noted that as indicated on pages 4-5 of the restriction requirement, claims 1-4 are generic to a species of a compound that suppresses LPAR1 expression as an active ingredient, and since Applicant elected Group III (claim 7), a species election was not required.
Claims 1-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim 7 is currently presented for examination.
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 7 is rejected under 35 U.S.C. 101 because the claimed invention is directed to the judicial exception of a natural phenomenon or an abstract idea without significantly more.
The claim recites a screening method for a pharmaceutical composition for treating osteosarcoma or glioma, the screening method including the steps of: bringing a candidate substance into contact with a cell with appreciable LPAR1 expression; and
measuring the change of LPAR1 expression. The steps of the method claim include two steps which are contacting a cell with a candidate substance and measuring LPAR1 expression. Thus the claims involves measuring the natural action of a substance on the levels of a natural protein expressed in a cell and observing the change in the level of the protein expressed in the cell. Thus the claim involves two judicial exceptions which are the natural phenomenon of what happens when the candidate substance contacts a cell and an abstract idea of observing the changes in expression level of the protein.
This judicial exception is not integrated into a practical application because the claim of the instant application is directed to non-statutory subject matter because it is not a patent-eligible practical application of a law of nature.
With respect to the natural phenomenon of determining the level of LPAR1 expression in a cell when contacted with a candidate substance, even though Applicant has discovered the correlation between LPAR1 expression change and a cancer cell that is responsive to a certain substance, and thus takes a human action to trigger the manifestation of the correlation, the correlation exists in principle apart from any human action. Thus, the LPAR1 levels in a cancer cell and a cancer cell that is responsive to a candidate substance is a natural phenomenon or a naturally occurring correlation.
With respect to the abstract idea of observing the changes in expression level of the protein, an abstract idea may be defined as mental processes – concepts performed in the human mind (including an observation, evaluation, judgment, opinion). The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 1372, 99 USPQ2d 1690, 1695 (Fed. Cir. 2011). As the Federal Circuit explained, "methods which can be performed mentally, or which are the equivalent of human mental work, are unpatentable abstract ideas the ‘basic tools of scientific and technological work’ that are open to all.’" 654 F.3d at 1371, 99 USPQ2d at 1694 (citing Gottschalk v. Benson, 409 U.S. 63, 175 USPQ 673 (1972)). See also Mayo Collaborative Servs. v. Prometheus Labs. Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012) ("‘[M]ental processes and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work’" (quoting Benson, 409 U.S. at 67, 175 USPQ at 675)); Parker v. Flook, 437 U.S. 584, 589, 198 USPQ 193, 197 (1978).
Examples of claims that recite mental processes include: a claim to "collecting information, analyzing it, and displaying certain results of the collection and analysis," where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016); claims to "comparing BRCA sequences and determining the existence of alterations," where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 763, 113 USPQ2d 1241, 1246 (Fed. Cir. 2014); and a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1067, 100 USPQ2d 1492, 1500 (Fed. Cir. 2011).
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied to ensure that the claims amount to significantly more than the natural principle itself.
A natural principle is the handiwork of nature and occurs without the hand of man. For example, the disinfecting property of sunlight is a natural principle. The relationship between blood glucose levels and diabetes is a natural principle. A correlation that occurs naturally when a man-made product, such as a drug, interacts with a naturally occurring substance, such as blood, is also considered a natural principle because, while it takes a human action to trigger a manifestation of the correlation, the correlation exists in principle apart from any human action. These are illustrative examples and are not intended to be limiting or exclusive.
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For this analysis, the claim focuses on a natural principle since the natural principle is a limiting element or step. Thus, the claim is not directed to a practical application of the natural principle that amounts to substantially more than the natural principle itself.
Eligibility Step 2B: Whether a claim amounts to significantly more.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claim does not include additional elements/steps or a combination of elements/steps that integrate the natural principle into the claimed invention such that the natural principle is practically applied to ensure that the claims amount to significantly more than the natural principle itself.
A claim that focuses on the use of a natural principle must also include additional elements or steps to show that the inventor has practically applied, or added something significant to, the natural principle itself. See Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71-72, 101 USPQ2d 1961, 1966 (2012)). To show integration, the additional elements or steps must relate to the natural principle in a significant way to impose a meaningful limit on the claim scope. The analysis turns on whether the claim has added enough to show a practical application. See id. at 1968. In other words, the claim cannot cover the natural principle itself such that it is effectively standing alone. A bare statement of a naturally occurring correlation, albeit a newly discovered natural correlation or very narrowly confined correlation, is not sufficient. See id. at 1965, 1971.
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A claim with steps that add something of significance to the natural laws themselves would be eligible because it would confine its reach to particular patent-eligible applications of those laws, such as a typical patent on a new drug (including associated method claims) or a new way of using an existing drug. See id. at 1971; see also 35 U.S.C. 100(b). In other words, the claim must be limited so that it does not preempt the natural principle being recited by covering every substantial practical application of that principle. The process must have additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. See id. at 1968.
In the instant case, the claim is only drawn to the natural correlation between LPAR1 expression levels and a cancer cell that is responsive to a candidate substance and the abstract mental process of observing the change of LPAR1 expression, and the claims do not require any further steps that integrate the recited judicial exceptions into a practical application of the exceptions. The claim is drawn to only a screening method which involves determining what happens to LPAR1 levels in a cell when contacted with a candidate substance and no further limitations are present in the claim reciting the next steps once the identification of the responsive cell is confirmed and what happens if the cell is not responsive. For example, the claim does not recite a step that includes the administration of any compound for the treatment of any cancer.
For these reasons, when the claims are considered as a whole, the claims do not recite anything significantly more than judicial exceptions and therefore are not directed to patent eligible subject matter.
Prior art considered to be pertinent to the instant invention:
Arpine Khudanyan;David Dadey;Rowan Karvas;Rama Kotipatruni;Dennis Hallahan;Dinesh Thotala, Abstract 3326: Targeting lysophosphatidic acid receptor 1 (LPAR1) radiosensitizes poor prognosis cancers, Cancer Res (2015) Volume 75 Issue 15 Supplement: 3326.
W. Windischhofer et al. “LPA-induced suppression of periostin in human osteosarcoma cells is mediated by the LPA1/Egr-1 axis.” Biochimie 94 (2012) pages 1997-2005.
Conclusion
Claims 1-5 are withdrawn. Claim 6 is canceled. Claim 7 is rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA R. MCMILLIAN whose telephone number is (571)270-5236. The examiner can normally be reached Tuesday-Friday 12:00 PM-6:00 PM.
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/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
KRM
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