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 .
Applicant’s amendments and remarks, filed on 08/11/2026, are acknowledged. Applicant’s arguments have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn.
Status of Claims
Claims 1-18, 20, 21, 25, 36 are cancelled.
Claims 39-43 are newly added.
Claims 19, 22-24, 26-35, 37, 38-43 are under examination.
Priority
This Application is a 35 U.S.C. 371 National Phase Entry of International Patent Application No. PCT/EP2021/055085 filed March 1, 2021, which designates the U.S. and claims benefit of foreign priority under 35 U.S.C. 119(a) of GB Application Number 2011592.9 filed July 27, 2020 and GB Application Number 2002909.6 filed February 28, 2020.
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.
The following rejections are necessitated by amendment.
Claims 35, 37, 38 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
The United States Patent and Trademark Office published revised guidance on the application of 35 U.S.C. § 101. USPTO’s 2019 Revised Patent Subject Matter Eligibility Guidance (“Guidance”). Under the Guidance, 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) (Guidance Step 2A, Prong 1); and
(2) additional elements that integrate the judicial exception into a practical application (see MPEP § 2106.05(a)-(c), (e)-(h)) (Guidance Step 2A, Prong 2).
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 are not “well-understood, routine and conventional in the field” (see MPEP § 2106.05(d)); or 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50-57 (January 7, 2019).
(4) simply appends well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception.(Guidance Step 2B). See Guidance, 84 Fed. Reg. at 54-56.
Step 1
The instantly claimed invention (claim 35) is directed to a method. Thus, the claim is directed to one of the statutory categories of invention. MPEP 2106.03.
A. Guidance Step 2A, Prong 1
The Revised Guidance instructs us first to determine whether any judicial exception to patent eligibility is recited in the claim. The Revised Guidance identifies three judicially-excepted groupings identified by the courts as abstract ideas: (1) mathematical concepts, (2) certain methods of organizing human behavior such as fundamental economic practices, and (3) mental processes. In this case, the claimed invention includes the following steps:
determining the blood pressure and body mass index (BMI) of a pregnant woman at 13 to 19 weeks of pregnancy; and determining the sex of a foetus carried by the pregnant woman at 13 to 19 weeks of pregnancy.
Mental Processes
Regarding claim(s) 35, the above determining step is limited to any particular acts or operations and thus broadly encompasses observation of data and evaluation. There is nothing in the claim that forecloses this step from being performed by a scientist with a pen and paper. Accordingly, the above steps clearly fall within the mental process groupings of abstract ideas because they cover concepts performed in the human mind, including observation, evaluation, judgment, and opinion. See MPEP 2106.04(a)(2), subsection III [Step 2A, Prong 1: YES].
B. Guidance Step 2A, Prong 2
This part of the eligibility analysis evaluates whether the claim as a whole integrates the recited judicial exception into a practical application of the exception. Having made that determination, under the 2019 Guidance, the examiner next determines whether there are additional elements beyond the recited abstract idea(s) that integrate them into a practical application. In this case, claim 35 does not recite any limitations that integrate the abstract idea into a practical application. Accordingly, the claim as a whole does not integrate the recited judicial exception into a practical application and the claim is directed to the judicial exception. [Step 2A, Prong 2: NO]. For a list of considerations when evaluating whether additional elements integrate a judicial exception into a practical application see MPEP 2106.04(d)(1).
C. Guidance Step 2B:
Under the 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B. In this case, as set forth above, the claims do not include additional steps and/or elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) [Step 2B: NO].
D. Dependent Claims:
Dependent claims 37, 38 have also been considered under the two-part analysis but do not include additional steps/elements appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception(s) for the following reasons. Regarding claim(s) 37, 38, these claims are directed to limitations that further limit the specificity of the abstract idea or the data being used by the abstract idea. As such, these steps are also directed to an abstract idea for the reasons set forth above in Step 2A (prong 1) analysis. Therefore, based on the two-part analysis, the instantly rejected claims as a whole are not drawn to eligible subject matter as they are directed to an abstract idea (and/or natural correlation) without significantly more.
Response to Arguments
Applicant’s arguments, filed 08/11/2026, have been fully considered but are moot in view of the modified rejection set forth above (which is modified in view of applicant’s amendments).
Claim rejections - 35 USC § 112b
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.
The following rejections are necessitated by amendment.
Claims 19, 22-24, 26-35, 37, 38-43 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 pre-AIA the applicant regards as the invention. Claims that depend directly or indirectly from claim(s) 19 is/are also rejected due to said dependency.
Claims 19, 28, and 41 recite “administering…prior to the appearance of pre-clinical symptoms of pre-eclampsia.” In each case, it is unclear as to the metes and bounds of “pre-clinical symptoms of pre-eclampsia” such that the artisan would know how to avoid infringement. A review of the specification does not provide any limiting definition of said “pre-clinical symptoms” that would serve to clarify the scope. As a result, it is unclear as to when the administering step is performed. At best, the specification teaches that "early detection of risk of pre-eclampsia" means detection of risk prior to the appearance of symptoms of the syndrome, for example during the second trimester of pregnancy (or late first trimester or early third trimester), for example from 8 to 24 weeks, or from 10 and 22 weeks, and ideally about 16 weeks (+/- 2 or 3 weeks) gestation [page 20]. However, this does not serve to clarify the above issue with regards to the scope of “pre-clinical symptoms of pre-eclampsia”. Clarification is requested via amendment.
Amended claim 19 recites “a) administering aspirin to a pregnant woman prior to the appearance of pre-clinical symptoms of pre-eclampsia, wherein the pregnant woman: i) is 13 to 19 weeks pregnant, ii) has a low risk of developing pre-eclampsia, iii) has a blood pressure higher than a reference blood pressure, and iv) has a Body Mass Index (BMI) lower than a reference BMI; or b) administering metformin to a pregnant woman prior to the appearance of pre-clinical symptoms of pre-eclampsia, wherein the pregnant woman: i) is 13 to 19 weeks pregnant, ii) has a low risk of developing pre-eclampsia, iii) has a blood pressure higher than a reference blood pressure, and iv) has a Body Mass Index (BMI) higher than a reference BMI.” In this case, the above “wherein” clauses appear to recite “conditional” limitations directed to properties and/or characteristics of the pregnant woman and also suggest product-by-process type limitations without positively reciting them (e.g. determining blood pressure, determining risk of developing pre-eclampsia, calculating BMI). As a result, it is unclear what limiting effect of the claimed method is/are intended since limitations directed to the nature of the patient, per se, do not change the function of the claimed administering steps or drugs and since claim scope is not limited by claim language that suggests but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04. Stated differently, it is unclear if the “wherein” clause is further limiting the structure of the subject being treated, how to decide whether to administer the drug, or otherwise. As a result, it is also unclear what positive process limitation is performed when one or more of the “conditions” are NOT met. Clarification is requested via amendment.
Claim 19 (steps a and b), 35, and 41 recite “has a low risk of developing pre-eclampsia”. The term “low risk” is relative term and specification does not provide any limiting definitions, specific properties, or criteria that would serve to clarify the scope, i.e. the result is subjective and imperceptible. As a result, it is also unclear in what way this “risk” is being determined, e.g. through observation of information, a calculation, or otherwise. As a result, it is also unclear in what way this risk is actually being determined. A review of the specification does not provide any equations, algorithms, or computational techniques that would serve to clarify the issue. Notably, the specification does teach “when the woman exhibits blood pressure higher than the reference blood pressure and a BMI lower than the reference BMI, the woman is predicted to be at risk of developing pre-term pre-eclampsia” [page 12]. However, these limitations merely reiterate the language currently in the claim and do not clarify in what way the risk is actually being predicted and/or determined. MPEP 2111.01. Clarification is requested via amendment.
Claim 28 recites “a) administering a pre-term-pre-eclampsia drug to a pregnant woman, wherein the pregnant woman: i) is 13 to 19 weeks pregnant, ii) has a blood pressure higher than a reference blood pressure, iii) has a Body Mass Index (BMI) lower than a reference BMI, and iv) carries a female fetus; or b) administering a term-pre-eclampsia drug to a pregnant woman prior to the appearance of pre-clinical symptoms of pre-eclampsia, wherein the pregnant woman: i) is 13 to 19 weeks pregnant, ii) has a blood pressure higher than a reference blood pressure, iii) has a Body Mass Index (BMI) higher than a reference BMI, and iv) carries a male fetus.” In this case, the above “wherein” clauses appear to recite “conditional” limitations directed to properties and/or characteristics of the pregnant woman and also suggest product-by-process type limitations without positively reciting them (e.g. determining blood pressure, determining risk of developing pre-eclampsia, calculating BMI). As a result, it is unclear what limiting effect of the claimed method is/are intended since limitations directed to the nature of the patient, per se, do not change the function of the claimed administering steps or drugs and since claim scope is not limited by claim language that suggests but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04. Stated differently, it is unclear if the “wherein” clause is further limiting the structure of the subject being treated, how to decide whether to administer the drug, or otherwise. As a result, it is also unclear what positive process limitation is performed when one or more of the “conditions” are NOT met. Clarification is requested via amendment.
Claim 22 recites “wherein b) further comprises administering a second drug in combination with the metformin.” However, parent claim 19 only requires administering aspirin OR metformin (i.e. using alternative language). Accordingly, in the embodiment wherein the practitioner is administering aspirin (i.e. the administering of metformin is not required by the claim) it is unclear what limiting effect of parent claim 19 is intended, i.e. in what way is the second drug administered “combination with the metformin”. Clarification is requested via amendment.
Claims 23, 24, 25, 26, 27, 31, 32, 33, 34, 39, 40 further limit the properties and/or characteristics of the pregnant woman recited in parent claim 19 as discussed above. Therefore, it is unclear in what way these claims further limit the process of parent claim 19 since (i) limitations directed to the nature of the patient, per se, have no limiting effect on how the structure or type of drug and how it is being administered and (ii) claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04. Stated differently, it is unclear if the “wherein” clauses are further limiting the structure of the subject being treated, how to decide whether to administer the drug, or otherwise. Clarification is requested via amendment.
Claim 41 recites “a) administering a pre-term pre-eclampsia drug to a pregnant woman prior to the appearance of pre-clinical symptoms of pre-eclampsia, wherein the pregnant woman: i) is 13 to 19 weeks pregnant, ii) has a low risk of developing pre-eclampsia, iii) has a blood pressure higher than a reference blood pressure, and iv) has a Body Mass Index (BMI) lower than a reference BMI; or b) administering a term-pre-eclampsia drug to a pregnant woman prior to the appearance of pre-clinical symptoms of pre-eclampsia, wherein the pregnant woman: i) is 13 to 19 weeks pregnant, ii) has a low risk of developing pre-eclampsia, iii) has a blood pressure higher than a reference blood pressure, and iv) has a Body Mass Index (BMI) higher than a reference BMI.” In this case, the above “wherein” clauses appear to recite “conditional” limitations directed to properties and/or characteristics of the pregnant woman and also suggest product-by-process type limitations without positively reciting them (e.g. determining blood pressure, determining risk of developing pre-eclampsia, calculating BMI). As a result, it is unclear what limiting effect of the claimed method is/are intended since limitations directed to the nature of the patient, per se, do not change the function of the claimed administering steps or drugs and since claim scope is not limited by claim language that suggests but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. See MPEP 2111.04. Stated differently, it is unclear if the “wherein” clause is further limiting the structure of the subject being treated, how to decide whether to administer the drug, or otherwise. As a result, it is also unclear what positive process limitation is performed when one or more of the “conditions” are NOT met. Clarification is requested via amendment.
Claims 19, 28, 41 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. In this case, the above “wherein” clauses appear to recite “conditional” limitations directed to properties and/or characteristics of the pregnant woman and also suggest product-by-process type limitations without positively reciting them (e.g. determining blood pressure, determining risk of developing pre-eclampsia, calculating BMI). As a result, it is unclear in what way this conditional information is being obtained such that the practitioner would be able to practice said administering. Notably, the specification teaches diagnostic process limitations directed to receiving blood pressure and BMI, comparing calculated and reference BMI, and providing an output based on said comparison, etc. [pages 4, 20, Table 1]. However, these limitations are not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. The omitted steps appear to be positive process limitations for determining each of the conditional information statements (prior to performing said administering steps). Clarification is requested via amendment.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The following rejections are modified in view of applicant’s amendments.
Claims 35, 37, 38 are rejected under 35 U.S.C. 103(a) as being obvious over Villa et al. (BJOG 2013;120:64–74) in view of Efrat et al. (Ultrasound in Obstetrics and Gynecology, 2006, Volume 27, Issue 6, pp. 619-621; Abstract, pages 1-5).
Regarding claim 35, Villa teaches a drug trial for investigating pre-eclampsia in high-risk pregnant women using aspirin. [Abstract]. In particular, Villa teaches evaluating woman are pregnant women at 12 to 19 weeks of gestation for inclusion into the drug trial by determining if they meet specific criteria [Table 1 and 2], wherein the criteria includes obesity (BMI over 30kg/m2) and chronic hypertension (blood pressure >140/90 mmHg) [Figure 1, Tables 1-3, and page 65, col. 2], which broadly reads on determining blood pressure and BMI as claimed. Villa does not specifically teach determining the sex of a foetus carried by the pregnant woman at 13 to 19 weeks of pregnancy, as claimed. However, Efrat teaches methods for determining fetal gender using ultrasound [See entire]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to alter the method of Villa by additionally determining fetal gender, as taught by Alqudah, since Villa already teaches the use of ultrasound [page 69, col. 1]. The rationale would have been the predictable use of prior art elements according to their established functions. KSR, 550, U.S. at 417.
Regarding claim(s) 37, Villa does not specifically teach MAP. However, Villa makes obvious this limitation because Villa teaches measuring systolic/diastolic blood pressure values [Table 1] and one of ordinary sill in the art would recognize that MAP is simply an average pressure in your arteries derived from systolic and diastolic blood pressure readings. Regarding claim(s) 38, Villa teaches the use of a placebo group (as set forth above), which reads on woman at low risk for developing pre-eclampsia. For these reasons, the claimed invention as a whole does not recite any new element, new function, or unpredictable result, and would have been prima facie obvious at the time it was made.
Response to Arguments
Applicant’s arguments, filed 08/11/2026, have been fully considered but are moot in view of the modified and newly applied rejections set forth above (which are necessitated by applicant’s amendments).
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PABLO S WHALEY whose telephone number is (571)272-4425. The examiner can normally be reached between 1pm-9pm EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Anita Coope can be reached at 571-270-3614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PABLO S WHALEY/Primary Examiner, Art Unit 3619
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