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 .
DETAILED ACTION
This office action is in response to applicant’s reply filed on May 21, 2026.
Status of Claims
Amendment of claims 1, 20, 23, 26, 28, 31, 33, 40, 43-44 and 46-48; cancellation of claims 2, 12, 17, and 36-37; and addition of claims 57-60 is acknowledged.
Claims 1, 20-23, 26, 28, 31, 33, 36-37, 40, 43-44, 46-48 and 57-60 are currently pending and are the subject of this office action.
Claims 1, 20-23, 26, 28, 31, 33, 40, 43-44, 46-48 and 57-60 are presently under examination.
Priority
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Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 1, 20-23, 26, 28, 31, 40, 43-44, 46-48 and 57-60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trials. Gov study NCT02906020 (V44 2019-07-12) (https://www.clinicaltrials.gov/study/NCT02906020) in view of Mila (American Academy of Neurology-70th Annual Meeting, Drugs of the Future (2018) 43:457-465).
For claims 1, 20-22, 40 and 59, the NCT02906020 study teaches a method of treating PD comprising the administration of an effective amount of a composition comprising the compound GZ/SAR402671 (Ibiglustat, Venglustat, SAR402671, GZ402671):
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(instant compound 2 or XII), wherein the subject are heterozygous carriers of a GBA mutation such as E326K (see entire document including Inclusion Criteria) and wherein the subject does not have Gaucher Disease (GD, a lysosomal storage disease, see Exclusion criteria).
The NCT02906020 study does not teach the administration of 2 mg to 30 mg of the above compound. However, Mila teaches (see page 261 under “Favorable Phase I safety and tolerability data for Venglustat) that in a Phase I study it was determined that the oral administration of 5 mg, 10 mg or 20 mg Venglustat were well tolerated and glucoseramide (GL-1) reductions were detected in plasma. All three amounts anticipate the claimed range (2 mg to about 30 mg).
At the time of the invention, it would have been prima facie obvious for the skilled in the art to treat PD comprising the oral administration of Venglustat or its salts (as taught by NCT02906020 study) in daily amounts of 5 mg, 10 mg or 20 mg (as taught by Mila).
The prior art is silent regarding:
“in an amount effective to reduce glycosphingolipid concentration in brain tissue (wherein the brain tissue is a neuron of substantia nigra, cerebral cortex, hippocampus, frontal lobes, or temporal lobes of said subject as in claim 59) of the subject, such that the concentration of glucosylceramide (GL-1) in cerebrospinal fluid (CSF) of the subject is reduced by at least 30% (Claim 1).
However, the amounts disclosed by the prior art: 5 mg, 10 mg and 20 mg anticipate the instantly claimed range (2 mg to about 30 mg)..
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the effective amounts used in the method of the prior art (5 mg, 10 mg and 20 mg, etc.) do not possess the same material, structural and functional characteristics of the amounts claimed in the instant application (2 mg to about 30 mg). In the absence of evidence to the contrary, the burden is on the applicant to prove that the amounts used in the claimed method are different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
All this will result in the practice of claims 1, 20-22, 40 and 59 with a reasonable expectation of success.
For claim 23, it is well known that brain tissues comprise neurons, thus resulting in the practice of claim 23 with a reasonable expectation of success.
For claim 26, the prior art is silent regarding: “wherein the method results in a reduction of GL-1 concentration in CSF of at least 40%”
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg ".
MPEP 2111.04 states: “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. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “reduction of GL-1 concentration in CSF of at least 40%” appears to be the result of the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg ", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 26 with a reasonable expectation of success.
For claim 28, the NCT02906020 study teaches that the subject has been diagnosed with PD (see under Inclusion criteria).
The prior art is silent regarding:
“wherein the method prevents, reduces, or reverses motor dysfunction, bradykinesia, rigidity, postural instability, and/or impaired balance”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: ““a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg".
MPEP 2111.04 states: “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. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the method prevents, reduces, or reverses motor dysfunction, bradykinesia, rigidity, postural instability, and/or impaired balance” appears to be the result of the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 28 with a reasonable expectation of success.
For claim 31, the NCT02906020 study teaches that the subject has been diagnosed with PD (see under Inclusion criteria) and the subject has a PD diagnosis of >= 2 years (see under inclusion criteria), thus resulting in the practice of claim 31 with a reasonable expectation of success.
For claim 43,
The prior art is silent regarding:
“wherein the method prevents, reduces, or reverses deterioration in attention concentration, executive functions, memory, language, etc.”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg".
MPEP 2111.04 states: “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. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the method prevents, reduces, or reverses deterioration in attention concentration, executive functions, memory, language, etc.” appears to be the result of the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 43 with a reasonable expectation of success.
For claim 44,
The prior art is silent regarding:
“wherein the method is effective to improve cognitive ability or reduce cognitive deficits in the subject as measured by a reduction in the time taken to complete a trail-making test (TMT), a trail making test part A (TMT-A) or a trail-making test part B(TMT-B), or a reduction in the difference between the time taken to complete the TMT-A and the time taken to complete TMT-B.”
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg".
MPEP 2111.04 states: “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. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the method is effective to improve cognitive ability or reduce cognitive deficits in the subject as measured by a reduction in the time taken to complete a trail-making test (TMT), a trail making test part A (TMT-A) or a trail-making test part B(TMT-B), or a reduction in the difference between the time taken to complete the TMT-A and the time taken to complete TMT-B” appears to be the result of the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 44 with a reasonable expectation of success.
For claim 46, Mila teaches the administration of 15 mf of Venglustat, thus resulting in the practice of claim 46 with a reasonable expectation of success.
For claim 47,
The prior art is silent regarding:
“wherein the concentration of the compound in the CSF of the subject is at least 4 mg/ml within 3 months of commencing treatment”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg".
MPEP 2111.04 states: “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. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the concentration of the compound in the CSF of the subject is at least 4 mg/ml within 3 months of commencing treatment” appears to be the result of the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 47 with a reasonable expectation of success.
Similar arguments can be made for the wherein clause of claim 48 and 58.
For claim 57, Mila teaches the administration of 15 mf of Venglustat, thus resulting in the practice of claim 57 with a reasonable expectation of success.
For claim 60,
The prior art is silent regarding:
“wherein the method results in the reduction of GL-1 concentration in the CSF within 3 months of commencing treatment”.
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg".
MPEP 2111.04 states: “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. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “the method results in the reduction of GL-1 concentration in the CSF within 3 months of commencing treatment” appears to be the result of the process made obvious by the prior art: “a method of treating PD comprising administering to a subject in need thereof a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease, and wherein the effective amount is 5 mg, 10 mg or 20 mg", e. g. the intended result of a process step positively recited.
All this will result in the practice of claim 60 with a reasonable expectation of success.
2) Claim(s) 33, is/are rejected under 35 U.S.C. 103 as being unpatentable over Clinical Trials. Gov study NCT02906020 (V44 2019-07-12) (https://www.clinicaltrials.gov/study/NCT02906020) in view of Mila (American Academy of Neurology-70th Annual Meeting, Drugs of the Future (2018) 43:457-465), as applied to claims 1, 20-23, 26, 28, 31, 40, 43-44, 46-48 and 57-60 above, further in view of Cheng et. al. (US 2018/0036295).
The NCT02906020 trial in view of Mila teaches all the limitations of claim 33 except for the subject has been treated with DOPA. However, Cheng teaches that L-DOPA is normally used to treat PD (see for example [0209]).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat a subject that has been already treated with other PD medications including DOPA, thus resulting in the practice of claim 33 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above rejection
Applicant's arguments have been fully considered but are not persuasive.
Since a new rejection necessitated by amendment was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant have been considered/answered in the rejection itself.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
June 1, 2026.
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