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 .
Status of the claims
The amendment filed 11/13/25 is acknowledged and has been entered. Claims 1, 3-6, 14, 17-21, 23-24, 26-27 and 29 have been amended. Claims 1, 18-20 and 27 remain withdrawn as being directed to a non-elected invention. Claim 7 has been canceled. Claims 2 and were previously canceled. Accordingly, claims 3-6, 11-17, 21-26 and 28-31 are under examination.
Withdrawn Rejections
All rejections of claims not reiterated herein, have been withdrawn.
Claim Objections
Claim 17 is objected to because of the following informalities: Claim 17 the recitation “wherein said pair of isolated biomarkers comprises Disintegrin and metalloproteinase domain-containing protein 12 (ADA12) and an isolated biomarker selected from the group consisting Mast/stem” should be -- wherein said pair of isolated biomarkers comprises Disintegrin and metalloproteinase domain-containing protein 12 (ADA12) and an isolated biomarker selected from the group consisting of Mast/stem--. Appropriate correction is required.
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 3-6, 11-17, 21-26 and 28-31 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract ideas and/or to laws of nature/natural phenomena without significantly more.
The U.S. Patent and Trademark Office recently revised the MPEP with regard to § 101 (see the MPEP at 2106). Regarding the MPEP at 2106, in determining what concept the claim is “directed to,” we first look to whether the claim recites:
(1) any judicial exceptions, including certain groupings of abstract ideas (i.e., mathematical concepts, certain methods of organizing human activity such as a fundamental economic practice, or mental processes); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)).
Only if a claim (1) recites a judicial exception and (2) does not integrate that exception into a practical application, do we then look to whether the claim contains an “‘inventive concept’ sufficient to ‘transform’” the claimed judicial exception into a patent-eligible application of the judicial exception. Alice, 573 U.S. at 221 (quoting Mayo, 566 U.S. at 82). In so doing, we thus consider whether the claim:
(3) adds a specific limitation beyond the judicial exception that is not “well-understood, routine, conventional” in the field (see MPEP § 2106.05(d)); or
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.
See MPEP 2106.
ELIGIBILITY STEP 2A: WHETHER A CLAIM IS DIRECTED TO A JUDICIAL EXCEPTION
Step 2A, Prong 1
Claim 3 is directed to a naturally occurring correlation between the levels of the recited biomarkers in a pregnant female and estimated due date or time of birth. Claims 3 and 17 are also directed to the abstract idea of a mathematical relationship or calculations in the measurement a reversal value and predictive model.
Step 2A, Prong 2
The additional elements of detecting the presence or amount of a pair of the recited biomarkers by mass spectrometry or an assay that utilizes a capture agent that binds one biomarker of the pair do not apply, rely on, or use the judicial exception/abstract idea in a manner that imposes a meaningful limit on the judicial exception.
Also, with respect to the recitations “determining a reversal value for said pair of isolated biomarkers” and “determining the EDD or TTB for said pregnant human female using the reversal value”. The “determining” statements at best articulates the judicial exception, amounting only to a general instruction to apply or use the judicial exception. This could read on mental activity being performed solely in a practitioner’ head, e.g. A mental appreciation of the reversal value from the detected values and being correlated with EDD or TTB. No active method steps are invoked or clearly required; the “determining” statements do not include any activity that would constitute a practical application, i.e. steps that apply, rely on or use the natural principle in a manner such that the claims amount to significantly more that the natural principal itself.
ELIGIBILITY STEP 2B: WHETHER THE ADDITIONAL ELEMENTS CONTRIBUTE AN "INVENTIVE CONCEPT"
Further, the additional elements of the claims are recited with a high level of generality and do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception. (the active method steps/limitations recited in addition to the judicial exceptions themselves) and do not add significantly more to the judicial exception(s).
As shown by Hickok et al (US 2014/0287950) it is well known, routine and conventional in the art to detect pairs of the recited biomarkers in pregnant female subjects and to use a predictive model for diagnosis (e.g. para’s 0018-0019, 0026, 0030-0032, 0039, 0117, 0174).
Also, as shown by Saade et al (American Journal of Obstetrics & Gynecologty, May 2016, pages 633.e1-633e4) it is well known, routine and conventional in the art to establish a measured reversal value of biomarkers in a pregnant female.
As shown by Chen-Plotkin et al (US 2017/0335395) it is well known, routine and conventional in the art to detect the presence or amount of biomarkers such as IGF1 and ADAM12 (ADA12) (e.g. Table 3, pages 14, 18).
With respect to the “administering an intervention for the pregnant female…” as recited in claim 3. Although the claim invokes administering an intervention to the subject the claim currently recites a intervention step that is generic and allows for anything already known and conventional such as telling the subject to rest or someone to change their diet. Therefore, the claims as currently recited do not recite something significantly more than the judicial exception.
It does not appear to be the case that the active steps recited, which are performed in order to gather the data or perform the assay, are steps recited or performed in an unconventional or non-routine way, such to provide an inventive concept under step 2B.
The claimed limitations as currently presented fail to recite limitations that add a feature that is more than well understood, conventional or routine in the field of diagnostics and biochemical assay methodologies.
For all of these reasons, the claims fail to include additional elements that are sufficient to either integrate the judicial exception(s) into practical application(s) thereof, or amount to significantly more than the judicial exception(s).
Claim Rejections - 35 USC § 112
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.
Written Description
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 3-6, 11-16, 21-23, 28 and 30-31 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
The instant claims are directed to a method of determining the estimated due date (EDD) or time to birth (TTB) for a pregnant human female and administering an intervention for the pregnant female to prevent preterm birth based on the EDD or TTB.
The specification on page 1, under the section entitled “BACKGROUND” , paragraph 0003 discloses that the information of EDD and/or TTB early in prenatal care is vital for timing of appropriate obstetric care; scheduling and interpretation of certain antepartum tests; determining the appropriateness of fetal growth; and designing interventions to prevent preterm births, postterm births, and related morbidities. However, the specification fails to provide any data, results, tables, or experiments that such intervention prevents preterm birth. The term “prevent” (recited in claim 3) is interpreted as implying an absolute and complete prevention of the appearance/onset of preterm birth, i.e., not any overt symptom or pre-symptomatic marker or damage may be present at any level. The specification fails to reasonable provide written description for prevention of preterm birth in any subject by any means. It is recommended to delete the term from the claims. The applicant has not shown possession of methods of prevention of major adverse events.
NEW MATTER
Claims 3-6, 11-16, 21-23, 28 and 30-31 are rejected under 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the claimed invention. The instant claims recite "Administering an intervention for the pregnant female to prevent preterm birth based on the EDD or TTB”. The specification on page 1, paragraph 0003 discloses that the information of EDD and/or TTB early in prenatal care is vital for timing of appropriate obstetric care; scheduling and interpretation of certain antepartum tests; determining the appropriateness of fetal growth; and designing interventions to prevent preterm births, postterm births, and related morbidities. The specification on page 54, paragraph 00199) discloses the communication informs a subsequent treatment decision. There is no description in the specification disclosing administering any type of treatment, medication etc to the pregnant subject based on the EDD or TTB. The only disclosure of an intervention is that of designing an intervention mentioned in the background of the specification and the specification does not disclose any interventions specifically designed based on the EDD or TTB to prevent preterm birth. The specification mentions a decision about treatment but does not disclose any specific treatments based on the EDD or TTB. Furthermore, none of the originally filed claims recited the limitations in question. Recitation of claim limitations lacking literal or adequate descriptive support in the specification or originally filed claims constitutes new matter.
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.
Claims 3-6, 11-17, 21-26 and 28-31 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.
Claim 3 the recitation “based on the detected presence” is vague and indefinite because it is unclear how one can determine a reversal value from the detected presence of the biomarkers. As disclosed in paragraph 0111 of the current specification “reversal” refers to the ratio of the measured value of an upregulated analyte over that of a down-regulated analyte. Thus, how does one determine a value or if the biomarker is upregulated or downregulated by determining the mere presence of the biomarkers. The presence would appear to be a yes or no that if the biomarkers are there or not. Therefore, how does one calculate a value and ratio from the mere presence or absence of the biomarkers. Please clarify. See also deficiency found in claim 17.
Claim 3, step (b) is indefinite in reciting “determining a reversal value for said pair of isolated biomarkers..” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with –detecting-- or --measuring--.
Claim 17, step (b) is indefinite in reciting “determining a reversal value for said pair of isolated biomarkers..” because the term “determining” appears to intend a mental step; hence, it is unclear if applicant actually intends a positive active method step in the claim. It is suggested but not required to delete the term “determining” and replace it with –detecting-- or --measuring--.
Response to Arguments
Applicant's arguments filed 11/13/25 have been fully considered but they are not persuasive.
101 Rejections:
Applicant argues that the MPEP provides guidance at section 2106.04(d)(2) indicating that one way to demonstrate integration of an abstract idea into a practical application is when the elements of a claim apply or use a recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (e.g. preterm birth) and thus the naturally occurring correlation and abstract idea of claim 3 is incorporated into a practical application.
This argument is not found persuasive because although the claim invokes administering an intervention to the subject the claim currently recites an intervention step that is generic and allows for anything already known and conventional such as telling the subject to rest or someone to change their diet (thus the treatment is not a particular treatment). Therefore, the claims as currently recited do not recite something significantly more than the judicial exception.
Applicant argues that claim 17 is amended to recite specific pairs and Hickok et al does not teach the specific recited pairs.
This argument is not found persuasive because teaches that it is known to detect pairs of biomarkers. Further, As shown by Chen-Plotkin et al (US 2017/0335395) it is well known, routine and conventional in the art to detect the presence or amounts of biomarkers such as IGF1 and ADAM12 (ADA12) (e.g. Table 3, pages 14, 18). Also, the claim now recited an additional abstract idea in reciting “determining a reversal value…”. See 101 supra. Applicant’s remaining arguments filed 11/13/25 have been considered but are moot in view of the new grounds of rejection.
Conclusion
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.
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/GARY COUNTS/ Primary Examiner, Art Unit 1678