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 . Applicant’s amendment filed 9/15/2025 is acknowledged. Claims 1 and 3 have been amended. Claims 2 and 4-8 have been canceled. Claims 1 and 3 are pending.
All of the amendment and arguments have been thoroughly reviewed and considered.
Any rejection not reiterated in this action has been withdrawn as being obviated by the amendment of the claims.
This action is made Final.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Previous Rejections
The objection to the specification is withdrawn in view of Applicant’s amendment to the specification.
The claim rejection for improper Markush grouping directed to the claim 6 is withdrawn in view of Applicant’s cancellation of the claim 6.
The claim rejection under 35 USC 101 directed to the claims 1-8 is withdrawn in view of Applicant’s amendment of the claim.
The enablement rejection under 35 USC 112 directed to claims 1-5 is withdrawn in view of Applicant’s amendment of the claims.
The indefiniteness rejection under 35 USC 112(b) directed to the claims 1-5 is withdrawn in view of Applicant’s amendment of the claims.
The prior art rejection under 35 USC 102 directed to the claims 6-8 is withdrawn in view of Applicant’s cancellation of the claims.
New Ground(s) of Rejections
THE NEW GROUND(S) OF REJECTIONS WERE NECESSITATED BY APPLICANT’S AMENDMENT OF THE CLAIMS:
Claim Rejections - 35 USC § 101
4. 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.
5. Claims 1 and 3 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 claim(s) require a natural phenomenon and abstract idea. This judicial exception is not integrated into a practical application as explained below. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception as detailed below.
The unpatentability of laws of nature was confirmed by the U.S. Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150 (March 20, 2012). “[L]aws of nature, natural phenomena, and abstract ideas” are not patentable. Diamond v. Diehr, 450 U. S. 175, 185 (1981); see also Bilski v. Kappos, 561 U. S. 593 (2010) (slip op., at 5). “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).
Additionally, the unpatentability of abstract ideas was confirmed by the U.S. Supreme court in Bilski v. Kappos, No. 08-964, 2010 WL 2555192 (June 28, 2010) and in Alice Corp. v. CLS Bank Inti, 134 S. Ct. 2347, 2354 (2014).
The following inquiries are used to determine whether a claim is drawn to patent-eligible subject matter:
Step 1. Is the claim to a process, machine, manufacture, or composition of matter? Yes- The claims are directed to methods.
Step 2A, prong 1. Does the claim recite a law of nature, a natural phenomenon, or an abstract idea (judicially recognized exceptions)? Yes – Where the claims recite “analytical method for diagnosing recurrent pregnancy loss” (i.e.: the preamble of claim 1 and final step of claim 1 “providing the patient having recurrent pregnancy loss with information about risk of miscarriage in pregnancies”, the claim is directed to an abstract idea which is the evaluation or observation of data to make a judgement (final method step). Additionally, where the claims refer to a measuring an expression level of HtrA4 protein in a subject’s sample “indicative of diagnosing recurrent pregnancy loss”, the claims are directed to a natural phenomenon which is a gene expression: phenotype association.
Step 2A, prong 2. The judicial exception(s) to which the claims are directed are not integrated into a practical application because the rejected claims do not require the performance of any tangible step, process or technique related to the judicial exception(s). There are no additional practical steps based on the detection of determination.
Step 2B. Does the claim recite additional elements that amount to significantly more than the judicial exception? No- In the instant case when considering the steps of the claims, they are directed to methods that encompass the gathering and analysis of data collected by routine and conventional methods that are well-known in the art e.g., Western blotting, such as in the art and are not themselves inventive as evidenced by the prior art of Liu et al (Molecular Medicine Reports 18: 2937-2944, 2018) and which teaches data gathering related to preeclampsia by measuring expression levels of HTRA1 and HTRA4 using RT-PCR, Western Blotting and proliferation assay techniques and Inagaki et al (Placenta, 22 (2012) 919-926) which teaches western blotting analysis of HtrA4 protein expression levels in pregnant patients. Thus, the methods of data collection are not themselves novel, but are routine and conventional in the related art.
In this regard, as set forth in MPEP 2106.05(d) II, relevant activities that have been recognized by the courts as well understood, routine and conventional, include:
ii. Using polymerase chain reaction to amplify and detect DNA, Genetic Techs. V. Merial LLC, 818 F.3d 1369, 1376, 118 USPQ2d 1541, 1546 (Fed. Cir. 2016); Ariosa Diagnostics, Inc. v. Sequenom, Inc., 788 F.3d 1371, 1377, 115 USPQ2d 1152, 1157 (Fed. Cir. 2015);
v. Analyzing DNA to provide sequence information or detect allelic variants, Genetic Techs., 818 F.3d at 1377; 118 USPQ2d at 1546;
vii. Amplifying and sequencing nucleic acid sequences, University of Utah Research Foundation v. Ambry Genetics, 774 F.3d 755, 764, 113 USPQ2d 1241, 1247 (Fed. Cir. 2014); and
viii. Hybridizing a gene probe, Ambry Genetics, 774 F.3d at 764, 113 USPQ2d at 1247.
Furthermore, MPEP 2106.05(g) addresses insignificant extra-solution activity, and indicates that determining the level of a biomarker in blood (akin to the analysis of the instant claims), Mayo, 566 U.S. at 79, 101 USPQ2d at 1968, can be considered mere data gathering, and is not an element that is significantly more than a judicial exception to which the claims are directed.
So even where a practical step of the claim may require collecting data using conventional methods that have been practiced in the art, in University of Utah Res. Foundation v. Ambry Genetics Corp. (Fed Cir, 2014), the Court addressed claims that recite known methodological steps used in the application of a judicial exception, and held that:
Regarding the data gathering steps recited in the claims , Alice dictates that we ask whether the remaining elements, either in isolation or combination with the other non-patent-ineligible elements, are sufficient to “transform the nature of the claim’ into a patent-eligible application.” Alice, 134 S. Ct. at 2355 (quoting Mayo, 132 S. Ct. at 1297). There must be a further inventive concept to take the claim into the realm of patent-eligibility. Id. At 2355. In this case, the claims merely recite measuring expression level using western blotting techniques which we have established are well-known and routine in the art and data gathering steps. The recitation of the limitations “the diagnosis is based on a filing that the expression level of HTR4 protein is 4 or more times lower in the subject compared to that of a normal person without recurrent pregnancy loss and providing the patient having recurrent pregnancy loss with information about risk of miscarriage in pregnancies” could additionally be interpreted as steps encompassing mental analysis, reading data on paper or looking at data on a general computer screen. The Court has made clear if a claim is directed essentially to a method of calculating, using a mathematical formula, even if the solution is for a specific purpose, the claimed method is non-statutory. In other words, patenting abstract ideas cannot be circumvented by attempting to limit the use [the idea] to a particular technological environment.
Finally, the Courts have made clear “essentially, appending conventional steps or elements, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patent-eligible. The Supreme Court also indicated that any additional steps that simply are routine and conventional in the art are insufficient to transform an otherwise patent-ineligible process. Thus, the claims 1 and 3 are rejected as ineligible subject matter under 35 USC 101.
Response to Arguments
6. Applicant traverses the claims based on the amended limitations recited therein. Applicant states that the claims have been amended to “wherein the diagnosis is based on a filing that the expression level of HtR4 protein is 4 or more times lower in the subject compared to that of a normal person without recurrent pregnancy and loss and providing the patient having recurrent pregnancy loss with information about risk of miscarriage in pregnancies. Applicant states that the limitation on the expression level of HTR4 protein is not a natural law or phenomenon itself; it’s a man-made finding to diagnose recurrent pregnancy loss in a subject having a lower expression level of HTR4 protein and it should be considered as one making the invention significant more than the judicial exception, integrating into a practice application. Applicant likewise further step of providing information about the risk of miscarriage in pregnancies to the patient is a tangible step and according the claims are patent eligible.
7. All of the arguments have been thoroughly reviewed and considered but are not found persuasive for the reasons that follow:
The examiner acknowledges Applicant’s arguments but notes that the claims recite a naturally occurring relationship between the naturally-occurring HTR4 protein levels and the natural process of pregnancy. Changes in the level of the HTR4 protein level in pregnancy is a natural phenomenon and discovering or observing it, even if new, does not itself constitute patent eligible subject matter under 101. Likewise using western blotting techniques which are well known in the art does not constitute something that is significantly more than the natural correlation itself because these techniques were well known in the art for measuring expression levels of protein including the HTR4 protein. Finally, in response to Applicant’s arguments that the method steps are not abstract but tangible, the examiner respectfully disagree because the claims recite limitation that can practically be performed in the human mind in the “diagnosing step (step b)” and final “providing step (step c), including for example, observations, evaluations, judgments and opinions or claims encompassing a human performing the step(s) mentally with the aid of a pen and paper or general computer processes. According to the October 2019 updates, 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, LLC v. Alstom, S.A.;
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 Corp.;
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; and
a claim to identifying head shape and applying hair designs, which is a process that can be practically performed in the human mind, In re Brown.
Claims recited a mathematical concept grouping when they recite a mathematical relationships, mathematical formulas or equations, mathematical calculations such as e.g., probability and statistical analysis.
The eligibility guidelines note some considerations indicative that the judicial exception has been integrated into a practical application. These includes:
an additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
an additional element that applies or uses a judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition;
an additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
an additional element effects a transformation or reduction of a particular article to a different state or thing; and
an additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
Applicant claims as currently written are not found to be patent eligible under 35 USC 101 and revised guidelines for patent eligibility.
Conclusion
8. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
9. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/Primary Examiner, Art Unit 1681