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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 5, 6, 12, 13, 18-20, 24-27, 29, 31, 37, 48, 49, 52 and 70), drawn to methods of determining gestational age of pregnancy comprising measuring placental proteins, in the reply filed on 01/15/2026 is acknowledged. Applicant has also elected the species of ADAM-12. Upon further consideration, the species of PAPP-A will be rejoined with the elected species of ADAM-12. Claims 42 and 75 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01/15/2026.
Claims 5, 6, 12, 13, 18-20, 24-27, 29, 31, 37, 48, 49, 52 and 70 are under examination.
Effective Filing Date
Applicant’s claim for the domestic benefit of prior-filed applications under 35 USC 119(e) and 120 is acknowledged. No foreign priority claims are made. Under the AIA , the effective filing date of a claimed invention is the earlier of:
The actual filing date of the application;
OR
The filing date to which the application is entitled to a right of foreign priority or domestic benefit as to such claimed invention.
Note that with regard to claiming domestic benefit of prior-filed applications, MPEP 211.05 sets forth the disclosure requirements, noting that the disclosure of the invention in the prior application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph. Based on the information given by Applicant and an inspection of the prior applications and patent, the examiner has concluded that the subject matter defined in the instant claims is supported by the disclosures in 16/893,377 (now US Patent 12,066,432) and provisional application serial no. 62/857,746. The effective filing date of claims 5, 6, 12, 13, 18-20, 24-27, 29, 31, 37, 48, 49, 52 and 70 is 05/05/2019.
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 5, 6, 12, 13, 18-20, 24-27, 29, 31, 37, 48, 49, 52 and 70 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. Claim 5 is drawn to a method for performing prenatal care or clinical treatment on a pregnant subject that has been selected for prenatal care. The selection comprises determining if the patient’s gestational age is less than or greater than a “predetermined GA cut-point”, which is defined in the claim “a timepoint between at or about 5 weeks and at or about 40 weeks”. The “GA” in this context is interpreted as meaning a standard gestational age based upon last known menstrual period or ultrasound, against which the patient’s actual gestational age is determined. The determination is based upon the measured values of one or more placental proteins from the patient’s whole blood or serum and the comparison to a “predetermined threshold level” in which the patient’s gestational age is determined to be less than the predetermined GA cut-point if the measured concentration of each of the one or more placental proteins is lower than the predetermined threshold level. Similarly, the patient’s gestational age is deemed to be greater or equal to the predetermined GA cut-point if the measured concentration of each of the one or more placental proteins is higher than or equal to the predetermined threshold level. Claim 6 recites that the assay for determining the placental protein(s) is an immunoassay, claims 12 and 13 recite the elected placental proteins, ADAM-12 and PAPP-A, respectively.
Claims 19, 24, 25 and 27 recite that the GA cut-points are as follows:
Claim
Cut-point
19 (depends on claim 5)
~5-~20 weeks
24 (depends on claim 5)
~64-~140 days
25 (depends on claim 24)
~70 days
27 (depends on claim 5)
~70-~140 days
Claims 20, 26, 29 and 31 recite that the PAPP-A and ADAM-12 predetermined threshold values are as follows:
Claim
PAPP-A Threshold Value
ADAM-12 Threshold Value
20 (depends on claim 5)
~3ng/mL-~130ng/mL
~0.5ng/mL-~15ng/mL
26 (depends on claim 24)
~3ng/mL-~10ng/mL
~0.5ng/mL-~4ng/mL
29 (depends on claim 27)
~10ng/mL-~70ng/mL
~3.5ng/mL-~8ng/mL
31 (depends on claim 27)
~60ng/mL-~130ng/mL
~8ng/mL-~14ng/mL
Claim 37 recites that the prenatal care or prenatal clinical treatment is selected from:
a medical abortion or early aspiration
a test for a chromosomal abnormality or a test that involves amniocentesis;
a glucose tolerance test;
a decision about the risk of embryotoxicity
Independent claim 48 recites a method for performing a prenatal care or prenatal clinical treatment on a pregnant subject selected based on the gestational age of the pregnancy, wherein the gestational age of the pregnancy is predicted based on a measured concentration of each of one or more placental proteins from a whole blood or serum sample and wherein the predicting comprises providing the concentration of each of the one or more placental proteins from the sample as input to a process that uses the concentration of each of the one or more placental proteins from the sample as a continuous predictor of gestational age. Claim 49 recites that the measurement of the placental proteins is carried out via immunoassay; claim 52 recites that the recited process comprises a regression model using gestational ages and placental protein concentrations and claim 70 recites that the prenatal care or prenatal clinical treatment is selected from:
a medical abortion or early aspiration
a test for a chromosomal abnormality or a test that involves amniocentesis;
a glucose tolerance test;
a decision about the risk of embryotoxicity;
a clinical examination;
a vaccination;
a risk assessment;
a fetal assessment;
a blood assay;
a urine assay;
vitamin supplementation;
a test for disease;
education or counseling
In summary, the claims are drawn to processes (see Step 1 of the Revised Guidelines).
The first prong of the two-prong inquiry for determining whether a claim recites an abstract idea is to consider whether it is directed to a law of nature, a natural phenomenon or an abstract idea (judicially recognized exceptions—see Prong One of Step 2A of the Revised Guidelines). The mental process recited in claim 5 and its dependents is the step involving a decision about whether the measured concentration of the placental proteins (ADAM-12 and PAPP-A) is less than or greater than/equal to the predetermined threshold level, which encompasses looking at and evaluating data (a determining step). The determining step represents a decision or mental step, similar to comparing information regarding a sample or test subject to a control or target data (see Univ. of Utah Research Found, v. Ambry Genetics Corp., 113 USPQ2d 1241 (Fed. Cir. 2014), or diagnosing an abnormal condition by performing clinical tests and thinking about the results (see In re Grams, 12 USPQ2d 1824 (Fed. Cir. 1989). Similarly, claim 48 and its dependents recite a decision step in which the prediction is carried out using a process comprising a regression model, in other words an algorithm. In summary, the judicial exceptions are the steps of determining the patient’s gestational age and performing an algorithm and the answer to prong one Step 2A is yes.
The second prong of Step 2A is to consider whether the claim recites additional elements that integrate the judicial exception into a practical application. Claim 5 and its dependents recite the “measured concentration of each of one or more placental proteins”, which suggests that the measurement took place sometime in the past and that the skilled artisan is merely reading the results and deciding whether the patient’s gestational age is less than or greater than/equal to a predetermined GA cut-point. Claim 48 and its dependents recite that the process of making this decision about the patient’s gestational age involves a regression model or algorithm. These steps encompass data gathering. See Fair Warning IP, LLC v. Iatric Systems (paragraph bridging pages 5-6):
We have explained that the “realm of abstract ideas” includes “collecting information, including when limited to particular content.” Elec. Power Grp., LLC v. Alstrom S.A., No. 15-1778, 2016 WL 4073318, at *3 (Fed. Cir. Aug. 6 1, 2016) (collecting cases). We have also “treated analyzing information by steps people go through in their minds, or by mathematical algorithms, without more, as essentially mental processes within the abstract-idea category.” Id. And we have found that “merely presenting the results of abstract processes of collecting and analyzing information, without more (such as identifying a particular tool for presentation), is abstract as an ancillary part of such collection and analysis.” Id.
In the instant case, the claims are directed to a combination of abstract-idea categories. As noted above, the determining step reads upon deciding the patient’s gestational age from already gathered data. The further step of analyzing the information gathered to perform a selection for treatment is still just analyzing data by steps akin to mental processes and by mathematical algorithms and then presenting the results of the analysis. Finally, the claims recite treatment, however, in the case of claim 5 and its dependents, treatment is only required in the case where the patient’s gestational age is determined to be less than a predetermined GA cut-point. Since claim 48 recites treatment is selected for the pregnant subject based on the gestational age followed by the step for predicting gestational age based on a measured concentration of placental proteins, treatment is correlated to a particular measured concentration. Further, all of the claims encompass treatments that are not particular and do not integrate the mental steps into a practical application. For example, making a decision about embryotoxicity, conducting a risk or fetal assessment, vaccination, vitamin supplementation, testing, education or counseling, etc. are general treatments common to all pregnancies. The answer to prong two of Step 2A is no.
The final step in the consideration of whether a clam is patent eligible is to consider whether there are additional elements in the claims that amount to significantly more than the judicial exception (see Step 2B of the Revised Guidelines). The issue regarding the lack of particularity of treating the subjects was discussed in the preceding paragraph and is applicable herein. Insomuch as the claims may require measurement of placental proteins, the claims merely recite “an immunoassay”. Immunoassays for measuring proteins were well-understood, routine and conventional in the art. For example, the instant specification discloses that PAPP-A and ADAM-12 immunoassays were well-known in the art and include commercial assays and kits (see pages 32-33, paragraphs [0107]-[0108]). The immunoassays are not sufficient to transform the claims because they are simply appending well-understood, routine and conventional activities previously known to the industry and specified at a high level of generality to the judicial exception. The answer to Step 2B is no.
For the reasons outlined above with respect to Steps 2A (Prongs One and Two) and 2B, the judicial exceptions are not integrated into a practical application and the claims do not patent-eligible subject matter.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 5, 6, 12, 13, 18-20, 24-27, 29, 31, 37, 48, 49, 52 and 70 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method for performing a prenatal care or prenatal clinical treatment on a pregnant subject, wherein the prenatal care or prenatal clinical treatment is a medical abortion or early aspiration, the method comprising:
(a) measuring the concentrations of ADAM-12 and PAPP-A from a sample from a pregnant subject seeking the medical abortion or early aspiration, wherein:
the concentrations of ADAM-12 and PAPP-A is measured by an immunoassay; and
the sample is a whole blood or serum sample;
(b) determining the gestational age (GA) of the pregnancy as less than 140 days, wherein the subject is determined to have a GA of less than 140 days if the measured concentration of ADAM-12 is lower than a predetermined threshold level for PAPP-A; and the measured concentration of PAPP-A is lower than a predetermined threshold level for PAPP-A; and the pregnant subject with GA classified as less than 140 days is eligible for a medical abortion or early aspiration; and
(c) performing the medical abortion or early aspiration on the pregnant subject, does not reasonably provide enablement for the claims as broadly recited.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make or use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.” (See In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 Fed. Cir. 1988). These factors include, but are not limited to: (a) the breadth of the claims; (b) the nature of the invention; (c) the state of the prior art; (d) the level of one of ordinary skill; (e) the level of predictability in the art; (f) the amount of direction provided by the inventor; (g) the existence of working examples; and (h) the quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The claims are drawn to a method for performing a prenatal care or prenatal clinical treatment on a pregnant subject, wherein the prenatal care or clinical treatment is selected from a medical abortion or early aspiration; a test for a chromosomal abnormality or amniocentesis; a glucose tolerance test; and a decision about the risk of embryotoxicity, comprising performing said care or treatment on a pregnant subject selected as eligible, wherein eligibility is determined if the classified gestational age of the pregnancy is less than a predetermined gestational age (GA) cut-point, wherein: the predetermined GA cut-point is a timepoint between at or about 5 weeks and at or about 40 weeks; the GA of the pregnancy is determined to be less than the predetermined GA cut-point if the measured concentration of each of one or more placental proteins (ADAM-12, PAPP-A) from a sample (whole blood or serum) from the pregnant subject is lower than a predetermined threshold level and the GA of the pregnancy is determined to be greater than or equal to the predetermined GA cut-point if the concentration of any of the one or more placental proteins from the sample is higher than or equal to the predetermined threshold level.
The specification discloses the concentration thresholds of PAPP-A and ADAM-12 that predict gestational age (GA) cutoffs with 100% sensitivity (i.e., “the lowest concentration among specimens obtained at GA” greater than a particular cutoff—see paragraph [0187] of the instant specification). The data are depicted in Tables 3-5 of the specification (see also paragraph [0190]):
5.591 ng/mL PAPP-A and 2.33 ng/mL ADAM-12 predicted GA ≤ 70 days (10 weeks) in 90% and 60% of the patients tested, respectively;
41.053 ng/mL PAPP-A and 4.82 ng/mL ADAM-12 predicted GA ≤ 104 days (~15 weeks) in 91% and 61% of patients tested, respectively; and
80.256 ng/mL PAPP-A and 9.135 ng/mL ADAM-12 predicted GA ≤ 140 days (20 weeks) in 96% and 94% of the patients tested, respectively.
The specification also discloses that “[f]or ADAM-12, the perfectly sensitive threshold for identifying GAs >70 days provided a specificity of only 60%; however, reducing that threshold to a concentration that provided a sensitivity of 98.5% (3.11 ng/ml) increased the specificity to 77%” (see paragraph [0190]). The specification does not provide cut-points for determining gestational age before 10 weeks or after 20 weeks.
The art underscores the complexity of using biomarkers to estimate gestational age. The post-filing date art of Raymond et al. (Contraception 101 (2020) 309-314—on IDS filed 09/23/2024) supports the findings in the specification for a cut-point of 70 days, and suggests PAPP-A and ADAM-12 could also be useful for distinguishing pregnancies “above and below 15 weeks” (i.e., 105 days), but it does not suggest the range of dates recited in the claims. See also the Letter to Editor by Johnson et al. (The Journal of Applied Laboratory Medicine, Volume 7, July 2022; 1000-1002—on IDS filed 09/23/2024) states (see p. 1001 and accompanying Figure 1):
The large inter-individual variability of PAPP-A results across GAs [gestational ages] demonstrates that it is impossible to accurately determine GA based on PAPP-A results alone, and equally impossible to accurately establish a single PAPP-A cutoff for a given GA. These data demonstrate that large numbers of patient results are required to observe the degree of variability in PAPP-A concentrations across GA.
In summary, the evidence is not commensurate in scope with the breadth of the claims.
Due to the large quantity of experimentation necessary to determine the cut-points and threshold values for placental proteins across the range of pregnancy, the lack of direction/guidance presented in the specification regarding and the absence of working examples directed to the same, the complex and unpredictable nature of the invention and the breadth of the claims that fail to recite limitations on the timepoint of gestational age that can be determined using PAPP-A and ADAM-12, undue experimentation would be required of the skilled artisan to make and/or use the claimed invention in its full scope.
Double Patenting
The nonstatutory 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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 5, 6, 13, 19, 20, 24-27, 29, 31, 37, 48, 49, 52 and 70 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,066,432 in view of Liu et al. (Statist. Med. 2017, 36 2363-2377). Applicant elected the placental protein species of ADAM-12, however, instant claims 5, 6, 13, 19, 20, 24-27, 29, 31, 37, 48, 49, 52 and 70 recite “one or more placental proteins”, therefore, the broadest reasonable interpretation is that a single placental protein is contemplated, and therefore, the claims as currently construed read upon selecting only PAPP-A.
The claims of the reference patent recite a method for performing a prenatal care or prenatal clinical treatment on a pregnant subject, wherein the prenatal care or prenatal clinical treatment is a medical abortion or early aspiration comprising: (a) measuring the concentration of PAPP-A from a blood or serum sample from a pregnant subject seeking the medical abortion or early aspiration, wherein: the concentration of PAPP-A is measured by an immunoassay, (b) determining the gestational age (GA) of the pregnancy as less than 70 days, wherein the subject is determined to have a GA of less than 70 days if the measured concentration of PAPP-A is lower than a predetermined threshold level for PAPP-A, wherein the predetermined threshold level of PAPP-A is a value between at or about 3 ng/mL and at or about 10 ng/mL, inclusive; and the pregnant subject with GA classified as less than 70 days is eligible for a medical abortion or early aspiration; and (c) performing the medical abortion (i.e., administering mifepristone and misoprostol) or early aspiration on the pregnant subject, wherein the predetermined threshold level for PAPP-A is determined using GAs (determined via ultrasound) and measured concentrations of PAPP-A from a plurality of pregnant subjects.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference patent are more specific with respect to cut-points of PAPP-A. In addition, the claims of the reference patent do not recite a process comprising a trained regression model as recited in instant claim 52. Nevertheless, it would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention that the regression model that was trained using gestational ages and concentrations could be used to aid in diagnosis because Liu et al. teach that pooled data collection of this type reduces costs, preserves specimens and increases efficiency (see p. 2363, 1st paragraph). The person of ordinary skill in the art would have been motivated to use regression analysis because it reduces costs. Furthermore, the person of ordinary skill in the art could have reasonably expected success because such models were well-established in the prior art.
Thus, the instant claims are not patentably distinct over those of the ‘432 patent, especially in light of the teachings of Liu and colleagues.
Claims 5, 6, 13, 48, 49, 52 and 70 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 9, 11, 71, 72, 74 and 92-95 of copending Application No. 18/266,149 in view of Liu et al. (Statist. Med. 2017, 36 2363-2377). Applicant elected the placental protein species of ADAM-12, however, instant claims 5, 6, 13, 48, 49, 52 and 70 recite “one or more placental proteins”, therefore, the broadest reasonable interpretation is that a single placental protein is contemplated, and therefore, the claims as currently construed read upon selecting only PAPP-A.
The claims of the reference application are drawn to classifying the gestational age (GA) of a pregnancy in order to screen a pregnant subject for a prenatal care or prenatal clinical treatment, comprising: (a) detecting PAPP-A in a biological sample (whole blood, serum or plasma) obtained from a pregnant female subject; (b) comparing the degree of the detectable signal assessed from the test sample to the degree of a detectable signal assessed using the immunoassay from a reference PAPP-A sample, wherein the concentration of the reference PAPP-A sample is a predetermined concentration associated with a predetermined GA cut-point; and (c) classifying: the GA of the pregnancy as less than the predetermined GA cut-point if the degree of the detectable signal assessed from the test sample is lower than the degree of the detectable signal assessed from the reference sample; or the GA of the pregnancy as greater than or equal to the predetermined GA cut-point if the degree of the detectable signal assessed from the test sample is higher than or equal to the degree of the detectable signal assessed from the reference sample, and wherein the prenatal care or prenatal clinical treatment is a medical abortion or early aspiration; a decision about a medical abortion regimen; a decision about the risk of embryotoxicity; a clinical examination; a vaccination; a risk assessment; a fetal assessment; a blood assay; a urine assay; vitamin supplementation; a test for disease; education; counseling; or any combination of any of the foregoing.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the reference application do not recite the predetermined GA cut-point is between ~5-40 weeks of gestation. Nevertheless, gestation is ordinarily first detected around 6 weeks and ends around 40 weeks, thus, the instant claims encompass nearly the entire pregnancy. In addition, the claims of the reference application do not recite a process comprising a trained regression model as recited in instant claim 52. Nevertheless, it would have been obvious to the person of ordinary skill in the art at the time of the filing of the invention that the regression model that was trained using gestational ages and concentrations could be used to aid in diagnosis because Liu et al. teach that pooled data collection of this type reduces costs, preserves specimens and increases efficiency (see p. 2363, 1st paragraph). The person of ordinary skill in the art would have been motivated to use regression analysis because it reduces costs. Furthermore, the person of ordinary skill in the art could have reasonably expected success because such models were well-established in the prior art.
Thus, the instant claims are not patentably distinct over those of the ‘149 application, especially in light of the teachings of Liu and colleagues. This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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/CHRISTINA M BORGEEST/Primary Examiner, Art Unit 1675
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