DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. Applicant’s election without traverse of Species A and Species D in the reply filed on July 14, 2026, is acknowledged.
Claims 200-204, 208-211, 214, and 215 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Status of the Claims
Claims 192-194, 196, 198, 205-207, 216-218, and 222-231 are under examination.
Claims 200-204, 208-211, 214, and 215 are withdrawn.
Claim Rejections - 35 USC § 112
3. 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 194, 196, and 198 are 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 194, 196, and 198 recites the limitation "said prophylactic intervention" in line 1. There is insufficient antecedent basis for this limitation in the claim. This limitation was not recited previously in the instant claim or in the claim from which it depends. It is unclear to what the limitation is referring.
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.
Claims 192-194, 196, 198, 205-207, 216-218, and 222-231 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exception without significantly more.
Claims 192-194, 196, 198, 205-207, 216-218, and 222-231 are directed to method of predicting the risk of pregnancy-related hypertensive disorder and providing a treatment plan for the pregnancy-related hypertensive disorder. As described in Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 573 U.S._, 134 S. Cr. 2347, 110 U.S.P.Q.2d 1976 (2014), a two-step analysis is required in considering the patent eligibility of the claimed subject matter. The first step requires determining if the claimed subject matter is directed to a judicial exception. The instant claims require the steps of computer processing the expression level of a pregnancy-associated gene against a reference expression level of a pregnancy-associated gene or processing the expression level of a gene with a trained machine learning algorithm, determining that the pregnant subject has an elevated risk of a pregnancy-related hypertensive disorder, and providing a treatment plan to the pregnant subject for an elevated risk of pregnancy-related hypertensive disorder. The steps of processing the expression level against a reference expression level, determining that the pregnant subject has an elevated risk of having the disorder, and providing a treatment plan are mental steps. While the claims recite “computer processing”, these steps remain mental steps as they may be performed in the human mind (MPEP 2106.04(a)(2)(III)). Alternatively, the steps of processing with a trained machine learning algorithm may be interpreted as a mathematical algorithm. Dependent claims 193-194, 196, 198, 205-207, 216-218, and 222-231 recite additional mental or mathematical steps or the data used in the judicial exception. Mental steps are a judicial exception. The courts have found mathematical algorithms to be drawn to the judicial exception of an abstract idea (In re Grams, 888 F.2d 835, 12 U.S.P.Q.2d 1824 (Fed. Cir. 1989)). Thus, the instant claims are drawn to a judicial exception.
This judicial exception is not integrated into a practical application. The instant claims do not recite an element that reflects an improvement in the functioning of a computer or other technology, an element that applies the judicial exception to effect a particular treatment, an element that implements the judicial exception with a particular machine, or an element that effects a transformation of a particular article to a different state or thing. The instant claims recite the steps of assaying a cell-free blood sample for the expression level of a pregnancy related gene. However, assaying a cell-free blood sample for an expression level of a gene is extra solution data gathering. Extra solution data gathering does not integrate the judicial exception into practical application. The instant claims also recite computer processing. However, the instant claims do not recite any structural limitations of the computer, and the computer is not drawn to a particular machine. Thus, the instant claims do not integrate the judicial exception into a practical application.
Instant claims 194-198, 230 and 231 recite various treatments for pregnancy-related hypertensive disorder. However, as it is written, these treatments are included in a treatment plan, but these treatments are not administered to the patient. Since the treatments are not administered to the patient, the instant claims do not recite a particular treatment that integrates the judicial exception into a practical application.
The second part of the analysis requires determining if the claims include additional elements that are sufficient to amount to significantly more than the judicial exception. The instant claims recite the additional elements assaying a cell-free blood sample and a computer. The step of assaying a blood sample is well-understood, conventional and routine (MPEP 2106.05(d)(II)). The element of a computer is a well-understood, conventional, and routine device for processing information (MPEP 2106.05(d)(II)). Reciting such well-understood, routine, and conventional elements do not transform a judicial exception into patent eligible subject matter. In addition, the recitation of the specific types of data to be used in the judicial exception does not transform the abstract idea into a non-abstract idea. (See buySAFE, Inc. v Google, Inc. 765 F.3d 1350, 112 U.S.P.Q.2d 1093 (Fed.Cir.2014)). Furthermore, the elements taken as a combination are also well-understood, routine, and conventional, since the elements are merely specifying a general computer for implementing the judicial exception and gathering data for the judicial exception. Thus, the instant claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
5. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
6. Claims 192-194, 205-207, 216-218, and 230-231 are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al. (US 2004/0203037 A1) in view of Kas et al. (US 2011/0251094 A1).
Regarding claim 192, Lo et al. teach a method of predicting preeclampsia (abstract) that includes assaying a cell-free blood sample of a pregnant subject (paragraph [0007] and [0047]-[0060]) to determine the expression level of KISS1 (paragraphs [0056]; [0144]; [0152], and claim 1), where the pregnancy-associated gene is differentially expressed in a first population of subject having a pregnancy-related hypertensive disorder as compared to a second population of subjects not having said pregnancy-related hypertensive disorder (claim 1); comparing the expression level of the pregnancy-associated gene against a reference expression level of the pregnancy-associated gene (claim 1); determining that the pregnant subject has an elevated risk of having pregnancy-related hypertensive disorder (claim 1).
However, Lo et al. does not teach providing a treatment plan for the elevated risk of having a pregnancy-related disorder.
Kas et al. teach a method of predicting preeclampsia (abstract) that includes measuring makers to determine if a subject needs a prophylactic treatment (paragraphs [0057]-[0059]) and providing a treatment plan (paragraph [0059]).
It would have been obvious to one of ordinary skill in the art, at the time of filing, to combine the methods of Lo et al. and Kas et al. Both Lo et al. and Kas et al. are drawn to monitoring, diagnosing, and predicting if a patient is at risk for preeclampsia (Lo et al., abstract; Kas et al. abstract). In order to determine if a patient is at risk for preeclampsia, one of ordinary skill in the art would have been motivated to use both methods of Lo et al. and Kas et al. to obtain a more comprehensive evaluation of markers that indicate a risk of preeclampsia. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success, since the methods may be performed sequentially or concurrently to arrive at a prediction or diagnosis.
Regarding claim 193, Kas et al. teach where the treatment plan comprises a prophylactic intervention that reduces the elevated risk of having a pregnancy-related hypertensive disorder (paragraph [0059]).
Regarding claim 194, Lo et al. teach where the treatment plan includes blood pressure monitoring (paragraph [0069]).
Regarding claims 205-207, Kas et al. teach determining if a pregnant subject has an elevated risk of having a pregnancy-related disorder, such as preeclampsia (abstract; paragraphs [0061-0070] and [0073]) and providing a treatment plan for preeclampsia (paragraph [0059]).
Regarding claim 216, Lo et al. teach where the sample is a plasma sample (paragraph [0050]).
Regarding claim 217, Kas et al. teach where the pregnant subject is asymptomatic for a pregnancy-related hypertensive disorder (paragraph [0071]).
Regarding claim 218, Kas et al. teach using a machine learning algorithm to determine is a patient is at an elevated risk of a hypertensive disorder (paragraph [0400]).
Regarding claim 230, Kas et al. teach where the prophylactic intervention includes administering an antihypertensive drug (paragraph [0059]).
Regarding claim 231, Kas et al. teach where the prophylactic intervention includes a calcium channel blocker (paragraph [0059]).
7. Claims 196, 198, and 222 are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al. (US 2004/0203037 A1) in view of Kas et al. (US 2011/0251094 A1) as applied to claims 192-194, 205-207, 216-218, and 230-231 above, and further in view of Cuckle et al. (US 2010/0304412 A1).
Lo et al. and Kas et al. are applied as above.
Lo et al. and Kas et al do not teach where the prophylactic intervention is a nutritional supplement or providing nutrition counselling.
Regarding claim 196, Cuckle et al. teach where the prophylactic intervention is vitamin D or calcium (paragraph [0024]).
Regarding claim 198, Cuckle et al. teach where the prophylactic intervention includes nutrition counseling (providing lifestyle advice that includes dietary supplements) (paragraph [0024]).
Regarding claim 222, Cuckle et al. teach using the biomarker ADAM12 to determine pregnancy induced hypertension (paragraph [0110]).
It would have been obvious to one of ordinary skill in the art, at the time of filing to combine the teachings of Lo et al., Kas et al. and Cuckle et al. Lo et al., Kas et al., and Cuckle et al are drawn to monitoring, diagnosing, and predicting if a patient is at risk for preeclampsia (Lo et al., abstract; Kas et al. abstract; Cuckle et al., abstract). In order to determine if a patient is at risk for preeclampsia, one of ordinary skill in the art would have been motivated to use the methods of Lo et al., Kas et al. and Cuckle et al. to obtain a more comprehensive evaluation of markers that indicate a risk of preeclampsia. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success, since the methods may be performed sequentially or concurrently to arrive at a prediction or diagnosis.
8. Claims 222 and 223 are rejected under 35 U.S.C. 103 as being unpatentable over Lo et al. (US 2004/0203037 A1)(hereinafter Lo et al. ‘037) in view of Kas et al. (US 2011/0251094 A1) as applied to claims 192-194, 205-207, 216-218, and 230-231 above, and further in view of Lo et al. (US 2006/0252068 A1) (hereinafter Lo et al. ‘068).
Lo et al. ‘037 and Kas et al. are applied as above.
While Lo et al. and Kas et al. teach using the marker KISS1 (Lo et al.’ 037, claim 1; Kas et al. paragraph [0040]), Lo et al.’037 and Kas et al. do not teach where the pregnancy associated genes includes two or three of the genes from the group of PAPP2, FABP1, CLDN7, SNORD14A, PLEKHH1, MAGEA10, TLE6, KISS1, ADAM12, SELENOP, APOB, and MUC3A.
Lo et al. ‘068 teach using the markers ADAM12 and PAPP2 to predict the risk of preeclampsia (paragraph [0007]; claim 1).
It would have been obvious to one of ordinary skill in the art, at the time of filing to combine the teachings of Lo et al.’037, Kas et al. and Lo et al. ‘068. Lo et al.’037, Kas et al., and Lo et al. ‘068 are drawn to monitoring, diagnosing, and predicting if a patient is at risk for preeclampsia (Lo et al.’037, abstract; Kas et al. abstract; Lo et al. ‘068, abstract). In order to determine if a patient is at risk for preeclampsia, one of ordinary skill in the art would have been motivated to use the methods of Lo et al.’037, Kas et al. and Lo et al. ‘068 to obtain a more comprehensive evaluation of markers that indicate a risk of preeclampsia. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success, since the methods may be performed sequentially or concurrently to arrive at a prediction or diagnosis.
9. Claim 224 is rejected under 35 U.S.C. 103 as being unpatentable over Lo et al. (US 2004/0203037 A1)(hereinafter Lo et al. ‘037) in view of Kas et al. (US 2011/0251094 A1) in view of Lo et al. (US 2006/0252068 A1) (hereinafter Lo et al. ‘068) as applied to claims 192-194, 205-207, 216-218, 222-223 and 230-231 above, and further in view of Boniface et al. (US 2014/0287947 A1).
Lo et al. ‘037, Kas et al., and Lo et al. ‘068 are applied as above.
While Lo et al. and Kas et al. teach using the marker KISS1 (Lo et al.’ 037, claim 1; Kas et al. paragraph [0040]) and Lo et al. ‘068 teach using the markers ADAM12 and PAPP2 (paragraph [0007]; claim 1), Lo et al. ‘037, Kas et al., and Lo et al. ‘068 do not teach where the pregnancy associated genes includes four of the genes from the group of PAPP2, FABP1, CLDN7, SNORD14A, PLEKHH1, MAGEA10, TLE6, KISS1, ADAM12, SELENOP, APOB, and MUC3A.
Boniface et al. teach using the marker APOB to predict the risk of preeclampsia (paragraph [0014]).
It would have been obvious to one of ordinary skill in the art, at the time of filing to combine the teachings of Lo et al.’037, Kas et al., Lo et al. ‘068, and Boniface et al. Lo et al.’037, Kas et al., Lo et al. ‘068 and Boniface et al. are drawn to monitoring, diagnosing, and predicting if a patient is at risk for preeclampsia (Lo et al.’037, abstract; Kas et al. abstract; Lo et al. ‘068, abstract; Boniface et al. abstract). In order to determine if a patient is at risk for preeclampsia, one of ordinary skill in the art would have been motivated to use the methods of Lo et al.’037, Kas et al., Lo et al. ‘068, and Boniface et al. to obtain a more comprehensive evaluation of markers that indicate a risk of preeclampsia. Furthermore, one of ordinary skill in the art would have had a reasonable expectation of success, since the methods may be performed sequentially or concurrently to arrive at a prediction or diagnosis.
Double Patenting
10. 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.
11. Claims 192-198, 205-207, 216-218, 222, and 230-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 5, 6, 8, 11, 22, 29, and 30 of U.S. Patent No. 11,845,988. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims and claim recite similar limitations. The claims differ in that they recite different panels of genes. However, the panels of genes for the instant application and the U.S. Patent share the genes PAPPA2 and FABP1. Given that he instant claims require only one or two genes from the recited panel, the claims of the U.S. Patent encompasses the same subject matter as the instant claims. Thus, the claims at issue are not patentably distinct.
12. Claims 192-198, 205-207, 216-218, 222, and 230-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-7 and 14-15 of U.S. Patent No. 11,441,183. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims and claim recite similar limitations. The claims differ in that they recite different panels of genes. However, the panels of genes for the instant application and the U.S. Patent share the genes PAPPA2 and FABP1. Given that he instant claims require only one or two genes from the recited panel, the claims of the U.S. Patent encompasses the same subject matter as the instant claims. Thus, the claims at issue are not patentably distinct.
13. Claims 192-198, 205-207, 216-218, 222, and 230-231 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-6, 8-11, and 18-22 of U.S. Patent No. 11,208,693. Although the claims at issue are not identical, they are not patentably distinct from each other.
The instant claims and claim recite similar limitations. The claims differ in that they recite different panels of genes. However, the panels of genes for the instant application and the U.S. Patent share the genes PAPPA2 and FABP1. Given that he instant claims require only one or two genes from the recited panel, the claims of the U.S. Patent encompasses the same subject matter as the instant claims. Thus, the claims at issue are not patentably distinct.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JERRY LIN whose telephone number is (571)272-2561. The examiner can normally be reached T-F 7am-5pm.
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/JERRY LIN/ Primary Examiner, Art Unit 1685
