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 .
Preliminary Amendments
Applicant’s amendments filed 05/19/2023 and preliminary amendments filed 08/29/2022 are acknowledged.
Status of Claims
Claims 19-38 are pending and under examination.
Claims 1-18 are cancelled via amendment.
Drawings
The drawings filed 08/29/2022 are acceptable.
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.
Information Disclosure Statement(s)
The information disclosure statement (IDS) document(s) submitted on 09/22/2022 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS document(s) has/have been fully considered by the examiner.
Objections
Claims 20-27 are objected to because of the following informalities: All of these dependent claims recite “according to Claim 19”. Accordingly, in each case the claims are grammatically incorrect because “Claim” should not be capitalized. Appropriate correction is required.
Claims 29-34 are objected to because of the following informalities: All of these dependent claims recite “according to Claim 28”. Accordingly, in each case the claims are grammatically incorrect because “Claim” should not be capitalized. Appropriate correction is required.
Claims 36-38 are objected to because of the following informalities: All of these dependent claims recite “according to Claim 35”. Accordingly, in each case the claims are grammatically incorrect because “Claim” should not be capitalized. 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 19-38 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 19, 28, 35) is directed to a method for treating a pregnant woman. 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:
…determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than a reference blood pressure and a BMI lower than a reference BMI with a pre-term-pre- eclampsia drug; treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than the reference blood pressure and a BMI higher than the reference BMI with a term-pre- eclampsia drug (claim 19)
…determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than a reference blood pressure, a BMI lower than a reference BMI, and to be carrying a female foetus with a pre-term-pre-eclampsia drug; treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than the reference blood pressure, a BMI higher than the reference BMI, and to be carrying a male foetus with a term-pre-eclampsia drug (claim 28)
determining the blood pressure and body mass index (BMI) of a pregnant woman at 13 to 19 weeks of pregnancy (claim 35)
Mental Processes
Regarding claim(s) 19 and 28, the above past tense ‘determined’ limitations necessarily require comparing blood pressure data and BMI data to reference data (see also rejections under 35 USC 112b). As such, the ‘determined’ limitations are presently being analyzed under Step 2A (prong 1) and broadly encompasses observation and evaluation. There is nothing in the claims themselves that foreclose these steps 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].
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, the claimed steps that are not part of the abstract idea are as follows:
treating a pregnant woman…with a pre-term-pre- eclampsia drug; treating a pregnant woman…with a term-pre- eclampsia drug (claim 19)
treating a pregnant woman…with a pre-term-pre-eclampsia drug; treating a pregnant woman…with a term-pre-eclampsia drug (claim 28)
Regarding claim(s) 19 and 28, the ‘pre-eclampsia’ drugs in the treating steps are generically recited. Applicant is reminded that the treatment or prophylaxis limitation must be particular, i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). See MPEP 2106.04(d)(2). For example, consider a claim that recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” This administration step recites a particular dosage and type of medication and it integrates the mental analysis step into a practical application. The Federal Circuit also has rejected the premise that “claims drafted to include treatment steps are automatically patent eligible.” INO Therapeutics LLC v. Praxair Distribution Inc., 782 F. App’x 1001, 1007 (Fed Cir. 2019). In INO Therapeutics, the court held that the treatment step “is plainly not the focus of the claimed invention” and “is not innovative.” Id. (“Unlike Vanda, claim 1 does not recite a specific method of treating disease using an improved set of doses in light of this discovery [of an underlying condition]”). Therefore, after careful consideration, this limitation amounts to mere instructions to “apply” the exception in a generic way. MPEP 2106.04(d)(2). Thus, the administration step does not integrate the mental analysis step into a practical application.
Regarding claim(s) 35, this claim 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) lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2);
Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
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, 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) for the following reasons:
As discussed above, the non-abstract steps discussed above (including the full limitations and not just the verbs) amount to nothing more than insignificant extra-solution activity. Additionally, there is nothing inventive or unconventional about these limitations for the following reasons. With regards to the treating step, methods for treating pregnant subjects with preeclampsia using aspirin and metformin were routine and conventional in the art, as supported by Alqudah et al. (Diabetic Medicine, 35(2), 160-172). Accordingly, these steps remain insignificant extra-solution activity even upon reconsideration, and do not amount to significantly more. Even when considered in combination, these additional steps/elements represent insignificant extra-solution activity and mere instructions to apply an exception, which cannot provide an inventive concept [Step 2B: NO].
D. Dependent Claims:
Dependent claims 20-27, 29-34, 36-38 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) 20, 21, 22, 29, 30, these claims further limit the type of drug being administered (e.g. aspirin and metformin). However, these limitations do not amount to a particular treatment for reasons set forth above (Step 2A, prong 2, and Step 2B). For example, consider a claim that recites “administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype.” Applicant is reminded that the treatment or prophylaxis limitation must be particular, i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). See MPEP 2106.04(d)(2). Regarding claim(s) 23-27, 31-34, 36-38, 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.
Claim rejections - 35 USC § 112, 2nd Paragraph
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 19-38 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, 28, 35 are also rejected due to said dependency.
Claim 19 recites “treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than a reference blood pressure and a BMI lower than a reference BMI with a pre-term-pre- eclampsia drug; treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than the reference blood pressure and a BMI higher than the reference BMI with a term-pre- eclampsia drug”. This limitation is problematic for the following reasons:
Firstly, the use of past-tense “determined” phrase renders the claim indefinite because it suggests active steps for comparing data, i.e. “determining” blood pressure and BMI as being higher (or lower) compared to a reference, without explicitly requiring any such limitations. Applicant is reminded that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. MPEP 2111.04. Notably, the specification teaches receiving blood pressure and BMI, comparing calculated and reference BMI, and providing an output based on said comparison [page 4]. However, this is not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Therefore, the claim is indefinite as it is unclear in what way this information is being obtained. Clarification is requested via amendment. The examiner suggests (1) removing past-tense/suggestive language and adding an active method steps (such as those disclosed in the specification) prior to the treating steps or, if applicant merely intends to further limit the type of woman being treated, (2) removing past-tense/suggestive language and adding “wherein” clauses, e.g. treating a pregnant woman with a term pre-eclampsia drug, wherein the woman is 13 to 19 months pregnant and has blood pressure higher than a reference blood pressure and a BMI lower than a reference BMI.
Secondly, because the past-tense “determined” phrase also recites conditional statements relating to blood pressure and BMI, it is also unclear what positive process limitation is performed in the event that the condition is not met, e.g. blood pressure is lower than a reference threshold. Clarification is requested via amendment.
Claim 28 recites “treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than a reference blood pressure, a BMI lower than a reference BMI, and to be carrying a female foetus with a pre-term-pre-eclampsia drug; treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than the reference blood pressure, a BMI higher than the reference BMI, and to be carrying a male foetus with a term-pre-eclampsia drug.” This limitation is problematic for the following reasons:
Firstly, the use of past-tense “determined” phrase renders the claim indefinite because it suggests active steps for comparing data, i.e. “determining” blood pressure and BMI as being higher (or lower) compared to a reference, without explicitly requiring any such limitations. Applicant is reminded that claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed. MPEP 2111.04. Notably, the specification teaches receiving blood pressure and BMI, comparing calculated and reference BMI, and providing an output based on said comparison [page 4]. However, this is not commensurate in scope with what is claimed and it is improper to import narrowing limitations into the claims. MPEP 2111.01. Therefore, the claim is indefinite as it is unclear in what way this information is being obtained. Clarification is requested via amendment. The examiner suggests (1) removing past-tense/suggestive language and adding an active method steps (such as those disclosed in the specification) prior to the treating steps or, if applicant merely intends to further limit the type of woman being treated, (2) removing past-tense/suggestive language and adding “wherein” clauses, e.g. treating a pregnant woman with a term pre-eclampsia drug, wherein the woman is 13 to 19 months pregnant and has blood pressure higher than a reference blood pressure and a BMI lower than a reference BMI.
Secondly, because the past-tense “determined” phrase also recites conditional statements relating to blood pressure and BMI, it is unclear what positive process limitation is performed in the event that the condition is not met, e.g. blood pressure is lower than a reference threshold. Clarification is requested via amendment.
Claims 19 and 28 recite the term “BMI”. In this case, it is unclear as to the metes and bounds of this term. The specification does not provide any limiting definition for this term but does teach body mass index [page 2]. However, it is improper to import this limitation into the claims. MPEP 2111.01. Clarification is requested via amendment. The examiner suggests amending the claims to recite “body mass index (BMI)” as the first recitation (at which point BMI will be well defined).
Claims 19 and 28 recite “treating a pregnant woman determined at 13 to 19 weeks of pregnancy…with a pre-term-pre-eclampsia drug”. In this case it is unclear as to the metes and bounds of a “pre-term-pre-eclampsia drug”. A review of the specification does not provide any limiting definition for this term that would serve to clarify what drug(s) is/are encompassed by this term. Clarification is requested via amendment.
Claims 19 and 28 recite “treating a pregnant woman determined at 13 to 19 weeks of pregnancy…with a term-pre-eclampsia drug”. In this case it is unclear as to the metes and bounds of a “term-pre-eclampsia drug”. Clarification is requested via amendment.
Claim 27 recites “The method according to Claim 19, wherein the reference blood pressure for the pregnant woman determined to have a blood pressure higher than a reference blood pressure and a BMI lower than a reference BMI is a reference blood pressure in a low BMI pregnant woman (low BMI reference blood pressure), and wherein the reference blood pressure for the pregnant woman determined to have a blood pressure higher than a reference blood pressure and a BMI higher than a reference BMI is a reference blood pressure in a high BMI pregnant woman (high BMI reference blood pressure).” Firstly, it is unclear what limiting effect of the claimed “reference blood pressure” is intended such that the artisan would know how to avoid infringement. More specifically, the terms “low BMI reference blood pressure” and “high BMI reference blood pressure” are relative terms and the specification does not provide any limiting definitions, specific properties, or scoring criteria indicating the scope of this term, i.e. the result is subjective and imperceptible. 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.
Claims 19, 20, 23-29, 31-34 are rejected under 35 U.S.C. 103(a) as being obvious over Villa et al. (BJOG 2013;120:64–74).
For purposes of applying prior art, the claimed invention is broadly interpreted as being directed to a method for:
treating a pregnant woman with a term-pre- eclampsia drug, wherein the woman is 13 to 19 pregnant and has blood pressure higher than a reference blood pressure and a BMI lower than a reference BMI; treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than the reference blood pressure and a BMI higher than the reference BMI (claim 19)
treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than a reference blood pressure, a BMI lower than a reference BMI, and to be carrying a female foetus with a pre-term-pre-eclampsia drug; treating a pregnant woman determined at 13 to 19 weeks of pregnancy to have a blood pressure higher than the reference blood pressure, a BMI higher than the reference BMI, and to be carrying a male foetus with a term-pre-eclampsia drug (claim 28)
Regarding claims 19 and 28, Villa teaches a drug trial for investigating pre-eclampsia in high-risk pregnant women using aspirin. [Abstract]. In particular, Villa teaches administering aspirin or a placebo to pregnant women at 12 to 19 weeks of gestation who meet specific criteria and pregnant women without known risk factors as a comparison group [page 65, col. 2 and Figure 1]. In this case, the aspirin is broadly interpreted as a pre-term pre-eclampsia drug and the placebo as a term pre-eclampsia drug absent any limiting definition to the contrary.
Villa is silent with regards to the conditional limitations of the woman being treated with a pre-term pre-eclampsia drug having blood pressure higher than a reference blood pressure and a BMI lower than a reference BMI, and to the conditional limitations of the woman being treated with a term pre-eclampsia drug having blood pressure higher than the reference blood pressure and a BMI higher than the reference BMI, as in claims 19 and 28.
However, Villa teaches evaluating woman for inclusion into the drug trial based on specific criteria [Table 1 and 2], wherein the criteria include obesity (BMI over 30kg/m2) and chronic hypertension (blood pressure >140/90 mmHg) and since one of ordinary skill in the art would recognize that these clinical conditions necessarily require a comparison to reference values in order to be determined. Therefore, Villa at a minimum suggests treating a pregnant woman under the various claimed conditions. 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.
Villa is additionally silent with regards to the conditional limitations of the woman being treated with a pre-term pre-eclampsia drug, wherein the woman is carrying a female fetus, and to the conditional limitations of the woman being treated with a term pre-eclampsia drug, wherein the woman is carrying a male fetus, as in claim 28.
However, Villa teaches evaluating woman for inclusion into the drug trial based on specific criteria [Table 1 and 2], wherein the criteria accounts for the fetus mortality and since one of ordinary skill in the art would recognize the sex of the fetus in the woman appears to be nothing more than an arbitrary condition that does not change the function of the claimed treatment steps or drugs, and Applicant has not disclosed that this particular feature provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, Villa at a minimum suggests treating a pregnant woman under the various claimed conditions.
Regarding dependent claims 20, 23, 24, 25, 26, 27, 29, 31, 32, 33, 34, Villa teaches or suggests all aspects of these claims for the following reasons. Regarding claim(s) 20, 29, Villa teaches administering aspirin, as set forth above. Regarding claim(s) 23, 31, 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) 24, 32, Villa does not specifically teach a reference BMI of 25. However, one of ordinary skill in the art would recognize that the choice of reference BMI is a results-effective variable that does not change the function of the claimed method, and Applicant has not disclosed that this particular feature provides an advantage, is used for a particular purpose, or solves a stated problem. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the teachings of Villa by using a reference BMI as claimed since Villa already teaches an average reference BMI before pregnancy of 27 [Table 2] and since one of skill in the art would recognize that such references are variable and could easily be optimized based on the patient or drug under investigation.
Regarding claim(s) 25, 33, Villa teaches the use of a placebo group (as set forth above), which reads on woman at low risk for developing pre-eclampsia. Regarding claim(s) 26, 34, Villa teaches baseline values for women before they were pregnant [Table 2], which broadly reads on nulliparous absent any limiting definition to the contrary. Regarding claim(s) 27, Villa at a minimum suggests this limitation by teaching women that meet the criteria for both low BMI and high BMI [Tables 1 and 2] as well as low and high blood pressure [Table 1 and 3]. 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.
Claims 21, 22, 30 are rejected under 35 U.S.C. 103(a) as being obvious over Villa et al. (BJOG 2013;120:64–74), as applied to claims 19, 20, 23-29, 31-34, in view of Alqudah et al. (Diabetic Medicine, 2018, 35(2), 160-172).
Villa makes obvious a method for treating pregnant woman, as set forth above. Villa does not specifically teach treating using metformin or metformin in combination with another drug, as in claims 21, 22, 30. However, Villa teaches treating using other antiplatelet agents as well as hypertension medication [page 69, col. 2, and Table 3].
However, Alqudah teaches methods for treating pregnant subjects with preeclampsia [Abstract]. In particular, Alqudah teaches administering aspirin (pre-term pre-eclampsia drug) to pregnant women before 16 weeks gestation to reduce the incidence of pre-eclampsia [pages 2, 4] and administering metformin (term pre-eclampsia drug) to pregnant women who are at higher risk [pages 4, 7].
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 treating pregnant woman with metformin or metformin in combination with a second drug as claimed, since the use metformin (in combination with other drugs) was well known in the art as taught Alqudah. The rationale would have been the predictable use of prior art elements according to their established functions. KSR, 550, U.S. at 417. 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.
Claim Rejections - 35 USC § 102 or 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
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.
Claims 35-38 are rejected under 35 U.S.C. 102(b) as being anticipated by or, in the alternative, under 35 U.S.C. 103(a) as being obvious over Villa et al. (BJOG 2013;120:64–74).
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.
Regarding claim(s) 36, Villa teaches pregnant woman at 12-19 weeks of gestation, as set forth above. Villa does not specifically teach determining the sex of the fetus, as claimed. However, given the breadth of what is claimed, this limitation would have been obvious to one of ordinary skill in the art since Villa additionally teaches determining the birthweight of the newborn [Table 3] and the sex of the newborn would be readily apparent to one of ordinary skill in the art. 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.
Citation of Relevant Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Omu et al. (Med Princ Pract 2008;17:227–232), which teaches methods for treating pregnant subjects with preeclampsia using Magnesium Sulphate Therapy (see abstract).
Conclusion
No claims are allowed.
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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