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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/03/2026 has been entered.
Status of the Application
Claims 6-8, 10, 22-25, and 43-45 are currently pending in this case and have been examined and addressed below. This communication is a Non-Final Rejection in response to the Amendment to the Claims and Remarks filed on 07/31/2026.
Claims 1-5, 9, 11-21, 26-42 are currently canceled and not considered at this time.
Claims 6-8, 10, and 22 are currently amended.
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 6-8 are rejected because the claimed invention is directed to an abstract idea without significantly more.
Step 1
Claims 6-8 fall within the statutory category of a process.
Step 2A, Prong One
As per Claim 6, the limitations of detecting in a bodily fluid sample from the pregnant subject at least five anti-herpesvirus antibody features and classifying the pregnant subject as having a high risk for vertical transmission, under its broadest reasonable interpretation, covers managing personal behaviors or personal interactions between people as these are behaviors that a physician carries out in the course of treating a pregnant subject. The physician carries out the activities of obtaining patient data and analyzing the data to determine patient risk of vertical transmission in the normal activities of patient care. Activities performed by a physician in patient care including personal interactions and personal behaviors fall into the “certain methods of organizing human activity” grouping of abstract ideas. The claim also includes the limitations of applying a machine learning algorithm to the anti-herpesvirus antibody features, wherein the machine learning algorithm has importance measures assigned to the anti-herpesvirus antibody features based on data from a plurality of maternal samples and wherein the machine learning algorithm assigns an importance measure to one or more anti-herpesvirus antibody features, which covers mathematical calculations, relationships, formulas or equations. Applying data to a machine learning algorithm to determine an output (in this case a classification of risk for vertical transmission) is a mathematical calculation/relationship which falls into the abstract grouping of mathematical concepts.
Step 2A, Prong Two
The judicial exception is not integrated into a practical application because the additional elements and combination of additional elements do not impose meaningful limits on the judicial exception. In particular, the claims recite the additional element of using a machine learning model to apply the concepts of the abstract idea in the claims, which is recited at a high-level of generality such that it amounts to mere instructions to apply the exception. As per MPEP 2106.05(f), a claim that recites only the idea of a solution or outcome and fails to recite details of how a solution to a problem is accomplished and use of computers as a tool to perform existing processes such as a commonplace mathematical algorithm applied on a general purpose computer, has been found by the courts to amount to mere instructions to apply the exception and does not integrate the abstract idea into a practical application or provide significantly more. Accordingly, this additional element does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim also recites administering an antiviral therapy to the pregnant subject identified in step (c) to reduce risk of vertical transmission, wherein the antiviral therapy is selected from the group consisting of a nucleoside inhibitor, a DNA terminase complex inhibitor, a DNA terminase complex inhibitor, a DNA polymerase inhibitor, and an anti-herpesvirus antibody, wherein the nucleoside inhibitor is ganciclovir, valganciclovir, or valacyclovir, the DNA terminase complex inhibitor is letemovir, wherein the DNA polymerase inhibitor is foscarnet; and the anti-herpesvirus antibody selected from the group consisting of an anti-herpesvirus monoclonal antibody, polyclonal anti-herpesvirus antibodies, or CMV hyperimmune IVG. Although the claim recites administration of a treatment, the treatment recited is not particular. As per MPEP 2106.04(d)(2), a treatment must be specifically identified to be considered a particular treatment. The present claim does not specifically identify what the treatment is because the antiviral therapy can be selected from one of four different treatments including nucleoside inhibitor, a DNA terminase complex inhibitor, a DNA polymerase inhibitor, and an anti-herpesvirus antibody. Where the administration step is not particular, it is instead merely instructions to “apply” the exception in a generic way. Thus the administration step does not integrate the mental analysis step into a practical application. Because the additional elements do not impose meaningful limitations on the judicial exception, the claim is directed to an abstract idea.
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements when considered both individually and as an ordered combination do not amount to significantly more than the abstract idea. As discussed above with the respect to integration of the abstract idea into a practical application, the additional element of using a machine learning model to apply the concepts of the abstract idea in the claims amounts to no more than mere instructions to apply the exception. The claim also recites administering an antiviral therapy to the pregnant subject identified in step (c) to reduce risk of vertical transmission, wherein the antiviral therapy is selected from the group consisting of a nucleoside inhibitor, a DNA terminase complex inhibitor, a DNA terminase complex inhibitor, a DNA polymerase inhibitor, and an anti-herpesvirus antibody, wherein the nucleoside inhibitor is ganciclovir, valganciclovir, or valacyclovir, the DNA terminase complex inhibitor is letemovir, wherein the DNA polymerase inhibitor is foscarnet; and the anti-herpesvirus antibody selected from the group consisting of an anti-herpesvirus monoclonal antibody, polyclonal anti-herpesvirus antibodies, or CMV hyperimmune IVG. This does not recite a particular treatment and therefore is merely “apply it”. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of the computer or improves another technology. The claims do not amount to significantly more than the underlying abstract idea.
Dependent Claims
Dependent Claims 7-8 add further limitations which are also directed to an abstract idea. Claims 7-8 include limitations which further specify or limit the elements of the independent claims, and hence are nonetheless directed towards fundamentally the same abstract idea as independent claim 6. Because the additional elements do not impose meaningful limitations on the judicial exception and the additional elements are well-understood, routine and conventional functionalities in the art, the claims are directed to an abstract idea and are not patent eligible.
Eligible Subject Matter
Examiner notes that Claims 10, 22-25 and 43-45 are eligible subject matter because Claim 10 recites administering a particular treatment, specifically antiviral therapy which is CMV hyperimmune IVIG. Claim 22 recites administering a herpesvirus vaccine to the human subject based on the human subject being determined to be a suitable candidate. This is similar to MPEP 2106.04(d)(2) in which the step of “vaccinating a second group of domestic cats in accordance with the lowest-risk vaccination schedule." Was found to apply the exception by using the result of the analysis of the abstract idea to determine the subjects which are to receive the vaccination and type of vaccination. Therefore, this integrates the abstract idea into a practical application. Claims 23-25 and 43-45 depend on Claim 22 and therefore include the same limitations which integrate the abstract idea into a practical application.
Subject Matter Free of the Prior Art
The following is an examiner’s statement of subject matter free of the prior art: The limitations in Claims 6 and 22 stating: detecting in a bodily fluid sample from the human subject at least five anti- herpesvirus antibody features, the at least five anti-herpesvirus antibody features comprising: i. isotype, ii. subclass, iii. Fe receptor binding capacity, iv. viral neutralization, and v. effector function, in combination with the machine learning algorithm to classify a pregnant subject as having a high risk for vertical transmission is free of the prior art. The broadest reasonable interpretation of the claim language requires the detection of all five antibody features in the bodily fluid sample. Because Claims 6 and 22 are free of the prior art, so too are claims 7-8, 10, 23-25 and 43-45 which depend on Claims 6 and 22.
Allowable Subject Matter
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 22-25 and 43-45 are allowed.
Response to Arguments
Applicant’s arguments, see Page 6, “Rejections Under 35 U.S.C. §112(b)”, filed 07/31/2026 with respect to claim 22 have been fully considered and they are persuasive. Therefore, the rejection of 06/03/2026 has been withdrawn.
Applicant’s arguments, see Page 6, “Rejections Under 35 U.S.C. §101”, filed 07/31/2026 with respect to claims 6-10 and 35-40 have been fully considered.
With regard to independent claim 6:
Applicant argues that the claim provides administration of a particular treatment. Examiner respectfully disagrees. Although the claim recites an administration of a treatment, the treatment is not particular because it lists that the treatment can be one of a group of treatments. One of ordinary skill in the art would not know what particular treatment to administer when it can be any of a group of four different treatments to be administered to a patient.
With regard to Claims 9 and 35, the arguments are moot because the claims have been canceled.
With regard to Claim 10, the arguments are persuasive. The claim recites administration of a particular treatment and therefore is not directed to an abstract idea and the rejection is withdrawn.
Applicant’s arguments, see Page 7, “Rejections Under 35 U.S.C. §103”, filed 07/31/2026 with respect to claims 6-10 and 35 have been fully considered and they are persuasive. Therefore, the rejections of 06/03/2026 have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evangeline Barr whose telephone number is (571)272-0369. The examiner can normally be reached Monday to Friday 8:00 am to 4:00 pm.
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/EVANGELINE BARR/Primary Examiner, Art Unit 3682
