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 .
This Office Action is in reply to Applicants’ correspondence of 10/31/2025
Applicants’ remarks and amendments have been fully and carefully considered but are not found to be sufficient to put the application in condition for allowance. Any new grounds of rejection presented in this Office Action are necessitated by Applicants’ amendments. Any rejections or objections not reiterated herein have been withdrawn in light of the amendments to the claims or as discussed in this Office Action.
This Action is made FINAL.
Please Note: The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. under 35 U.S.C. 120, 121, 365(c), or 386(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 16/923.005, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Claim 32 recites “… selecting a recommendation of a treatment regimen for the pregnant woman subject comprises selecting a recommendation of …”. But the prior filed application does not set forth any step of making any “recommendation” or the “selecting” of any such recommendation. As such the effective filing date of the subject matter of claim 32 is the filing date of the instant application, which is 03/01/2024.
New Claim Rejections - 35 USC § 112 – Indefiniteness
Necessitated by Claim Amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 32 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 32 is unclear over recitation of the phrase “… wherein selecting a recommendation of a treatment regimen for the pregnant woman subject comprises selecting a recommendation of …” because there is no antecedent basis for any “selecting a recommendation of a treatment regimen for the pregnant woman subject” in either claim 32 or in claim 1 from which claim 32 depends.
Maintained Objection to the Specification
Modified as Necessitated by Claim Amendments
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required: The specification does not provide antecedent basis for the step recited in claim 32 as “selecting a recommendation of a treatment regimen”.
Maintained Claim Rejections - 35 USC § 101
Modified as Necessitated by Claim Amendments
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 1-2, 4-6, 8, 9, and 30-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas without significantly more.
The claim(s) recite(s) several abstract ideas that encompass mental process (see MPEP 21106.04(a)(2) II)I. Steps in the claims such as (e.g.: as recited in claim 1) “choosing”, “identifying” and “selecting” are concepts that may be performed in the human mind e.g.: observations, evaluations, judgments, and opinions). Additionally, the steps of data manipulation such as “averaging”, “multiplying” and “combining” are mathematical calculations that also are interpreted as being abstract ideas (e.g.: see MPEP 21106.04(a)(2) I).
This judicial exception is not integrated into a practical application because the claims do not require any active process step that is performed based on a particular result of the abstract ideas of the claims. The claims are directed to the analysis of alleles amplified from a cell-free blood sample, but the methods end with the abstract idea of “selecting a recommendation”, which is itself an abstract idea.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the data collection of the claims uses well understood, routine and conventional methods that are properly considered insignificant extra-solution activity (e.g.: see MPEP 2106.05(g). The data gathering steps themselves (e.g.: amplification of alleles from nucleic acids obtained from the blood of a pregnant woman) were known in the art as evidenced by Oeth (2012) (cited on the IDS of 03/15/2024), including subject at week 20 or earlier of pregnancy (e.g.: para 0035).
Response to Remarks
Applicants have traversed the rejection of claims under 35 USC 101 as directed to judicial exception to patentability without significantly more. Applicants’ arguments (p.4-5 of the Remarks of 10/31/2025) have been considered but are not persuasive to withdrawn the rejection. Applicants have argued that the claimed methods recite several steps that are not abstract. This aspect of the claims has been addressed in the rejection, where the additional elements well understood, routine and conventional methods that are properly considered insignificant extra-solution activity. Applicants have further argued that the claims are directed specifically to samples take from a subject at week 20 or earlier of pregnancy. Initially it is noted that while the preamble of claim 1 states that the method is for determination in one assay at week 20 or earlier of pregnancy, the practical step of the claim recites “collecting a blood sample from a pregnant woman subject”, which does not recite any particular gestational period, and uses the indefinite article ‘a’ in the phrase “sample from a pregnant woman” which does not specify the pregnancy of the preamble. Nonetheless, the examiner maintains that Oeth (2012), as cited in the rejection, demonstrates the routine nature of the practical steps of the claims, including the analysis of samples from subject with less than 20 weeks of pregnancy (e.g.: para 0035 of Oeth). The analysis of samples from subject with less than 20 weeks of pregnancy was known in additional prior art, such as Lau et al (2013).
Withdrawn Claim Rejections - 35 USC § 103
Any rejections of claims made under 35 USC 103 as set forth on pages 5-9 of the Office Action of 07/01/2025, which are not reiterated below, are withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 103
Claim(s) 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landry et al (US PG Pub 2022/0010379) in view of Ziza et al (2017) cited on the IDS of 03/15/2024 and Avent (2008) cited on the IDS of 03/15/2024.
Landry et al (US PG Pub 2022/0010379) is available as prior art based on the effective filing date of the rejected claim, as set forth earlier in this Office Action.
Relevant to the limitations of claim 1, from which claim 32 depends, Landry et al teaches methods of fetal Rhesus D genotype determination and fetal fraction determination in an assay preformed on blood from a pregnant woman subject comprising the steps recited in parts i.-x. of claim 1. Landry et al further teaches the limitations relevant to claims 2-6, 8, 9 and 30-32 (see for example pages 7-8, and paras 0070-0072).
Landry et al does not teach selecting a recommendation of a treatment for the pregnant woman subject, relevant to step the limitations of claim 32.
However the detection of such RhD genotypes in pregnant human subjects and treatment of subjects with anti-D immunoglobulin was known in the prior art. Both Ziza et al and Avent teach that it is routine for pregnant women with a RhD-negative genotype to undergo RhD fetal typing and that the RnhD negative genotype can determined by detecting various genetic elements (e.g.: complete deletion of RhD (RhD-negative); 37bp duplication in intron 3 and exon 4 (RhD pseudogene, known as RhD-psi); and hybrid alleles (RhD-CE-D)). Additionally, both Ziza et al and Avent teach treatment of appropriate pregnant subjects (i.e.: based on a maternal Rh-D-negative blood type and a fetal Rh-D-positive blood type) with administration of anti-D immunoglobulin (e.g.: Ziza et al at page 1; Avent at p.189).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have modified the methods of fetal fraction determination and RhD genotype analysis taught by Landry et al to include a selection and recommendation of a suitable treatment such as administering and anti-D-immunoglobulin to a pregnant woman with an Rh-D-negative blood type and a fetal Rh-D-positive blood type. The skilled artisan would have been motivated to recommend and select a suitable treatment based on the expressed teachings of Avent and Ziza et al which provide that such treatment is a standard of care treatment for women at risk of hemolytic disease of the fetus and newborn (HDFN).
Withdrawn Double Patenting
The rejection of claims for issues of double patenting, as set forth on pages 9-10 of the Office Action of 07/01/2025, is withdrawn in light of the terminal disclaimer filed on 10/31/2025, which is approved.
Requirement for Information
The Examiner thanks the Applicant for providing the requested information as set forth on pages 10-12 of the Office Action of 07/01/2025.
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683