DETAILED ACTION
This Office Action is in response to Applicant’s Amendment and Remarks filed on 12 November 2025 in which claims 31 and 34 were amended to change the scope and breadth of the claims.
Claims 31, 32 and 34-50 are pending in the current application and are examined on the merits herein.
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 .
Withdrawn Rejections
Applicant’s amendment, filed 12 November 2025, with respect to the rejections of claims 32 and 34 under 35 U.S.C. § 112(b), second paragraph, for indefiniteness, has been fully considered and is persuasive because the claim as amended more specifically claims the subject matter disclosed and supported in Applicant’s Specification.
Applicant’s amendment, filed 12 November 2025, with respect to the rejections of claims 31-37 and 40-50 under 35 U.S.C. § 102(a)(1) as being anticipated by Hughes et al. as evidenced by NCT01218659 Clinical Trials Register (ATTRACT study), has been fully considered and is persuasive because claim 31 has been amended to recite “without instructing the patient before the treatment is initiated to use effective birth control during the treatment”. The rejection is hereby withdrawn.
Applicant’s amendment, filed 12 November 2025, with respect to the rejections of claims 31, 32, 34-37 and 40-50 under 35 U.S.C. § 103 as being unpatentable over Hughes et al. in view of Holmes et al. and further in view of Galafold Summary of Product Characteristics, has been fully considered and is persuasive because claim 31 has been amended to recite “without instructing the patient before the treatment is initiated to use effective birth control during the treatment”. The rejection is hereby withdrawn.
Applicant’s amendment, filed 12 November 2025, with respect to the rejections of claims 31, 32, and 34-50 under 35 U.S.C. § 103 as being unpatentable over Hughes et al. in view of Castelli et al., has been fully considered and is persuasive because claim 31 has been amended to recite “without instructing the patient before the treatment is initiated to use effective birth control during the treatment”. The rejection is hereby withdrawn.
Claim Interpretation
The recitation “wherein the patient becomes pregnant during the treatment” in newly amended claim 32 does not change the patient population treated in the active step. According to the Specification “becomes pregnant” is defined where a patient may or may not be aware that they have become pregnant. There is no active step of testing for pregnancy, etc. Thus, this wherein limitation has no effect on the active steps performed.
The recitation “wherein the patient’s pregnancy results in a birth of a child having a gestational age of at least 37 weeks” in present claim 35 does not affect the positively recited steps. The same rational applies to present claims 36 and 37.
Response to Arguments
Applicant’s amendment, see pages 6-8, filed 12 November 2025, with respect to the rejection of the claims over Hughes et al. as noted above have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Castelli et al.
New Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on 12 November 2025, where the limitations in pending claims 31 and 34 as amended now have been changed. Therefore, rejections from the previous Office Action, dated 12 May 2025, have been modified and are listed below.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 31-32 and 35-44 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Castelli et al. (US Patent Application Publication No. 2016/0324839, cited in previous Office Action).
Castelli et al. disclose a method of treating Fabry disease in a patient in need thereof, the method comprising administering to the patient a formulation comprising an effective amount of 1-deoxy-galactonojirimycin (i.e. migalastat) or salt thereof every other day, wherein the effective amount is about 123 mg free base equivalent (claim 14). The patient is administered about 150 mg migalastat hydrochloride every other day (claim 17). The migalastat enhances α-galactosidase A activity (hereinafter: α-GAL).
In an in vitro study, Castelli et al. found cells corresponding to late-onset Fabry disease exhibited an increase in α-GAL enzymatic activity following treatment (para [0383]). “20 of the 75 cell lines expressed a missense mutation corresponding to later-onset Fabry disease. Of these 20 cell lines, 19 (95%) displayed an increase in α-GAL activity following treatment.”.
In example 6, nine female patients with Fabry disease were administered migalastat hydrochloride (para [0334]-[0380]). The female patients were randomized to receive one of three dosages: 50, 150 or 250 mg Q.O.D. for 12 weeks (Group D)(Fig.8). Some male patients were treated for 24 weeks (fig. 8). The patients treated displayed classic and late-stage Fabry disease, and are 17-65 years in age (i.e. female patient of childbearing potential), (fig. 8).
In example 6, Castelli et al. is silent with respect to whether the patient is pregnant when treatment is initiated. Thus, it can be assumed the patient is not pregnant. Or, alternatively, the disclosure of Castelli et al. encompasses both pregnant and non-pregnant females. One of ordinary skill in the art could at once envisage both patients.
The recitation “wherein the patient becomes pregnant during the treatment” in present claim 32 is not an active method step, and is not a result of performing the active step of claim 31. It also does not further limit the patient population recited in claim 31 where the active step was performed.
Thus, the disclosure of Castelli et al. anticipates claims 31-32 and 35-44 of the present application.
Claim Rejections - 35 USC § 103
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.
Claim(s) 31-32 and 34-44 are rejected under 35 U.S.C. 103 as being unpatentable over Castelli et al. (US Patent Application Publication No. 2016/0324839, cited in previous Office Action) in view of Holmes et al. (JMID Reports, 2015, pp. 57-63, cited in previous Office Action)
Castelli et al. teach as discussed above.
Castelli et al. do not expressly disclose “and the patient becomes pregnant during the treatment” (present claim 32). Castelli et al. do not expressly disclose discontinuing treatment upon identification of the patient’s pregnancy (present claim 34).
Holmes et al. teach Fabry-related symptoms and features may worsen during pregnancy, including gastrointestinal symptoms, arcoparesthesias, proteinuria, headaches, and postpartum depression (abstract). Based on the retrospective review, Holmes et al. conclude pregnant women affected by Fabry disease do not have life-threatening complications but may experience worsening of specific disease symptoms (p.63, Synopsis). Holmes et al. teach “Of course, these women may require a change in therapeutic regime and consultation with a genetic counselor or teratogen service as some medications used to treat symptoms may have a teratogenic effect” (p.62, , third para). With respect to enzyme replacement therapy (ERT), Holmes et al. teach “the decision to continue therapy must be made on an individual basis in cooperation with a team experienced with treatment of FD” (p.62, fourth para).
From Holmes et al., the ordinary artisan would have known women having Fabry disease are capable of becoming pregnant. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to discontinue migalastat treatment if the patient becomes pregnant because Holmes et al. teach pregnant women may need to change therapies, continue therapy and/or stop any ongoing treatment, since some medications may cause birth defects.
Neither Castelli et al. nor Holmes et al. teach instructing women to use effective birth control during treatment.
The duration of treatment taught by Castelli et al. of 12-24 weeks overlaps with the lengths of time recited in present claims 42-50.
The recitation “wherein the patient’s pregnancy results in a birth of a child having a gestational age of at least 37 weeks” in present claim 35 does not affect the positively recited steps. The same rational applies to present claims 36 and 37.
Thus, the claimed invention as a whole is prima facie obvious over the combined teaching of the prior art.
Conclusion
In view of the rejections to the pending claims set forth above, no claim is 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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/BAHAR CRAIGO/
Primary Examiner
Art Unit 1699