DETAILED ACTION
Claims 1, 6, 8-9, 11, 14, 19, 22-25, 27-33, and 39-51 were pending. Applicant has amended claims 1, 14, 22, 24-25, and 27; canceled claims 6, 19, 29-33, and 39-51; and has added new claims 52-58 per the Reply of 6/23/2026.
Claims 1, 8-9, 11, 14, 22-25, 27-28, 39-40, and 52-58 are pending, and claims 39-40 stand withdrawn.
Claims 1, 8-9, 11, 14, 22-25, 27-28, and 52-58 are the Subject of the Office Action below.
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 .
Priority
The instant application filed 6/8/2023 is a National Stage entry of PCT/GB2021/053382, with an International Filing Date of 12/21/2021, and claims foreign priority to 2020285.9, filed 12/21/2020 and to 2108231.8, filed 6/9/2021.
Information Disclosure Statement
The Information Disclosure Statement (IDS) submitted on 9/2/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statement is being considered by the Examiner.
Claim Rejections - 35 USC § 102
(Maintained)
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 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 8-9, 11, 14, 22-25, 27-28 and 52-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bailey, WO 2008/137043 A1 published 11/13/2008.
Instant claim 1 a method of preventing or treating pre-eclampsia in a subject, the method comprising administering to the subject a reduced folate; wherein the reduced folate is the sole active pharmaceutical agent.
Bailey teaches in claim 1, a method for treating hypertension in a subject, said method comprising: administering to the subject an effective amount of at least one reduced folate.
Bailey teaches on Page 12, lines 25-34, “subjects who may benefit from such prophylactic treatment include individuals who suffer from diseases, disorders, syndromes, or other conditions which are known to cause a blood pressure increase; women who have previously suffered from pre-eclampsia; women who have previously suffered from pre-eclampsia and who are not presently pregnant; women who have previously suffered from pre-eclampsia and who are pregnant again; women who have previously suffered from pregnancy-induced hypertension…”
Bailey teaches in claim 3, wherein the reduced folate is 5-methyl-(6S)-tetrahydrofolic acid (5-MTHF), this meets the limitations of instant claim 11.
Bailey teaches, “The reduced folates can be administered on a regular basis, for example, once per day,” see page 15 line 10.
Bailey teaches, “[s]uitable daily dosage ranges of reduced folates include: from about 0.45 micromoles to about 15 micromoles.” 5-MTHF has a mass of 459.463 g·mol−1, therefore this equates to 206 to 6892 micrograms (.2 to 6.9 mg), see Page 32, line 15. In Example 1 Bailey teaches a 5 mg dose of 5-MTHF. This meets instant claims 27-28 and 50-51.
Instant claim 8, to the natural stereoisomer is anticipated.
Instant claim 9 to the effect of administration is anticipated as this is a property of the compound given.
Instant claim 14 requires the patient has pre-eclampsia caused by a impaired activity, this is taught as the teaching of Baily is directed to improving BH4 levels.
Instant claim 22 wherein the reduced folate is for administration to a subject after having been diagnosed with a pregnancy-related vascular disorder. This is at once envisaged as doctor’s treat patients based on diagnosis.
Instant claim 23 wherein the reduced folate, combination or composition is effective in the prevention of a disorder associated with insufficient BH4 levels in subsequent generations. This is simply a recitation of the result of the method step positively recited, this flows naturally from the administration step and does not lend to patentability.
Instant claim 24 wherein the prevention or treatment is in a subject who has previously suffered with a disorder associated with insufficient BH4 levels. This is covered by the patient discussed above.
Instant claim 25, wherein the prevention or treatment is in a subject who has previously suffered with hypertension in pregnancy or is in a subject who has previously suffered with pre-eclampsia. This is covered by the patient discussed above.
Bailey teaches, “10 weeks of treatment with 2.5 mg/d or 5.0 mg/d of folic acid or "5.0 mg/d" (actually 11.3 micromoles) of 5- methyl-6S-tetrahydrofolate ("5-MTHF"). This anticipates claims 27 and 54-57 to dosing, which the species of 5 mg anticipates these claims.
Instant claim 58 states wherein the method is a method of treating pre-eclampsia. Applicant defines treatment in the Specification: “As used herein, the terms "treat" or "treatment" refer to both therapeutic treatment and prophylactic or preventative measures, wherein the object is to prevent or slow down (lessen) an undesired physiological change or disorder. Beneficial or desired clinical results include, but are not limited to, alleviation of symptoms, diminishment of extent of disease, stabilized (i.e. , not worsening) state of disease, delay or slowing of disease progression, amelioration or palliation of the disease state, and remission (whether partial or total), whether detectable or undetectable. "Treatment" can also mean prolonging survival as compared to expected survival if not receiving treatment. Those in need of treatment include those already with the condition or disorder as well as those prone to have the condition or disorder or those in which the condition or disorder is to be prevented.”
As such Bailey anticipates this claim as well.
Claims 1, 6, 8-9, 11, 14, and 41-44 are anticipated.
Applicant Arguments: Applicants argue there is no teaching of treating pre-eclampsia and as a sole agent. This is taught by the art, as such the argument is not persuasive.
Conclusion
No claims allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/ Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/ Supervisory Patent Examiner, Art Unit 1629
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