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 October 14, 2025.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 1-2, 12, 17, 20-23, 26, 28, 31, 33, 40, 43-44 and 46-48) in the reply filed on October 14, 2025. is acknowledged.
Applicant election of compound XII (Ibiglustat, Venglustat, SAR402671, GZ402671)”
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also known as Compound 2 (see page 50 of the specification) as the species of formula I, is also acknowledged.
Status of Claims
Claims 1-2, 12, 17, 20-23, 26, 28, 31, 33, 36-37, 40, 43-44 and 46-48 are currently pending and are the subject of this office action.
Claims 36-37 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 14, 2025.
Claims 1-2, 12, 17, 20-23, 26, 28, 31, 33, 40, 43-44 and 46-48 are presently under examination.
Due to Applicant’s election of the species:
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as the compound of formula (I), the examination of the instant claims is restricted to the following CORE structure:
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(See Improper Markush Group Rejection below).
All other structures within the claims are not being examined, since they are not considered part of the elected invention, as such it is suggested that Applicant amends the claims accordingly to remove all non-elected inventions (see Improper Markush Group rejection below).
The following species, elected by Applicant, corresponding to the above CORE structure (see above) is under examination:
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Priority
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Claim Rejections – Improper Markush Group.
Claims 1-2, 12, 21-23, 26, 28, 31, 33, 40, 43-44 and 46-48 are rejected under Improper Markush Group.
The improper Markush Group Rejection is based on a judicially approved doctrine when the claim contains an improper grouping of alternatively useable species. A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
In the instant case, claims 1-2, 12, 21-23, 26, 28, 31, 33, 40, 43-44 and 46-48 encompass a very large and diverse set of compounds as depicted by general formula (I):
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The above formula encompasses a wide variety of chemical compounds which are different recognized physical classes and would embrace different chemical compounds that do not share any single structural similarity between the species. For instance: A can be any 5- or 6-membered aryl or heteroaryl group, which will result in an enormous variety of heterocyclic rings, each within its own classification group.
These compounds lack unity of invention since they do not share a common utility and/or they do not share a substantial structural feature essential to that utility: In re Harnisch, 631 F.2d 716, 206 USPQ 300(CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984).
To overcome this rejection, Applicant should amend the above claims according to the following CORE structure:
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Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 12, 17, 20-23, 26, 28, 31, 33, 40, 43-44 and 46-48 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of PD and DLB, does not reasonably provide enablement for the prevention of a PD and DLB. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. This is a scope of enablement rejection.
To be enabling, the specification of the patent application must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fd. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated that:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996). As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is "undue", not "experimentation".
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 wherein, citing Ex parte Forman, 230 USPQ 546 (Bd. Apls. 1986) at 547 the court recited eight factors:
1- the quantity of experimentation necessary,
2- the amount of direction or guidance provided,
3- the presence or absence of working examples,
4- the nature of the invention,
5- the state of the prior art,
6- the relative skill of those in the art,
7- the predictability of the art, and
8- the breadth of the claims
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention
Claims 1-2, 12, 17, 20-23, 26, 28, 31, 33, 40, 43-44 and 46-48 recite:
A method of treating or preventing a neurodegenerative disease in a human subject in need thereof by reducing glycosphingolipid concentration in brain tissue of the subject, whereby the concentration of glucosylceramide (GL-1) in cerebrospinal fluid (CSF) of the subject is reduced by at least 30%, wherein the neurodegenerative disease is selected from Parkinson's disease (PD) and dementia with Lewy Bodies (DLB) and:(a) wherein the subject does not have a lysosomal storage disease; and/or (b) wherein the subject is a heterozygous carrier of one or more glucocerebrosidase 1 gene (GBA1) mutations; the method comprising administering to the subject an effective amount of a compound of formula:
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(see above Improper Markush Rejection)
2. The relative skill of those in the art
The relative skill of those in the art is high, generally that of an M.D. or Ph.D.
The artisan using Applicant’s invention would generally be a physician with a M.D. degree and several years of experience.
3. The state and predictability of the art
First, the term prevention is synonymous with the term curing, and both circumscribe methods of treatment having absolute success (100% success). Humans in need of prevention of PD or DLB do not yet suffer from PD or DLB, and if they were to be administer a compound of formula (VIII) according to the instant claims, they will never ever suffer from a psychiatric disorder. The general knowledge of the prior art clearly indicates that the art of preventing any diseases including PD and DLB, is highly unpredictable.
Second, an extensive search of the prior art reveals that there are no references disclosing any type of prevention of PD or DLB with any drug.
4. The amount of direction or guidance provided and the presence or absence of working examples
MPEP 2164.03 cites: “the amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The “amount of guidance or direction” refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. >See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“Nascent technology, however, must be enabled with a specific and useful teaching.’ The law requires an enabling disclosure for nascent technology because a person of ordinary skill in the art has little or no knowledge independent from the patentee’s instruction. Thus, the public’s end of the bargain struck by the patent system is a full enabling disclosure of the claimed technology.”
The specification teaches some examples (see Examples 1-8) that correlate with the administration of very specific compound of formula VIII (Instant compound XII or compound 2) with the treatment of PD.
Thus, while the specification provides a procedure for treating PD, the specification appears to be silent on a nexus between:
treating PD and preventing PD.
As such, if there is no correlation then the examples do not constitute working examples.
While it is understood that the absence of working examples should never be the sole reason for rejecting a claim as being broader than an enabling disclosure, the criticality of working examples in an unpredictable art, such as the prevention (100% success) of PD or DLB, is required for practice of the claimed invention.
5. The Quantity of experimentation necessary
Because of the known unpredictability of the art (see section 3) and in the absence of experimental evidence commensurate with the claims (see section 4), the skilled in the art will not accept that the administration of a composition a compound of formula (VIII), can prevent (100% success) psychiatric disorders as inferred by the claims and contemplated by the specification.
7. Conclusion
Accordingly, the inventions of claims 1-2, 12, 17, 20-23, 26, 28, 31, 33, 40, 43-44 and 46-48 do not comply with the scope of enablement requirement of 35 U.S.C 112, first paragraph, since to practice the claimed invention, a person of ordinary skill in the art would have to engage in undue experimentation with no reasonable expectation of success.
NOTE: In order to overcome this rejection, it is suggested that Applicant:
1- amends the above claims according to the CORE structure:
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and within the above CORE structure (see above Improper Markush rejection), and
2- delete the word prevention.
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.
Claim(s) 1-2, 12, 17, 20-23, 26, 28, 31, 43 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by ClinicalTrials. Gov study NCT02906020 (V44 2019-07-12). (https://www.clinicaltrials.gov/study/NCT02906020)
For claims 1-2, 12, 17, 20-23 and 26, 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):
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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 prior art is silent regarding:
“reducing glycosphingolipid concentration in brain tissue of the subject, whereby the concentration of glucosylceramide (GL-1) in cerebrospinal fluid (CSF) of the subject is reduced by at least 30% (Claim 1), wherein the brain tissue is or comprises neurons (claim 23)”
However, the above statement does not require additional steps to be performed and simply expresses the intended result of carrying the process anticipated by the prior art: “a method of treating PD comprising administering to a subject PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease".
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 “reducing glycosphingolipid concentration in brain tissue (wherein the brain tissue is or comprises neurons) of the subject, whereby the concentration of glucosylceramide (GL-1) in cerebrospinal fluid (CSF) of the subject is reduced by at least 30%” appears to be the result of the process anticipated by the prior art: “a method of treating PD comprising administering to a subject PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
Similar reasoning is made for the wherein clause of claims 26.
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 anticipated by the prior art: “a method of treating PD comprising administering to a subject PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease".
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 anticipated by the prior art: “a method of treating PD comprising administering to a subject PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
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).
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 anticipated by the prior art: “a method of treating PD comprising administering to a subject PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease".
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 anticipated by the prior art: “a method of treating PD comprising administering to a subject PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
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.
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) 33, 40 and 46-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over ClinicalTrials. Gov study NCT02906020 (V44 2019-07-12) (https://www.clinicaltrials.gov/study/NCT02906020) in view of Cheng et. al. (US 2018/0036295).
The NCT02906020 trial teaches all the limitations of claim 33 (See 102(a)(1) above) 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.
The NCT02906020 trial teaches all the limitations of claim 40 (See 102(a)(1) above) except for the daily dose of 2 mg to 30 mg. However, Cheng teaches a method of treating PD comprising the administration of formula (I):
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(see [0010] and in particular compound (XII):
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(see [0159]),
The amount administered can vary between 1 mg to about 750 mg or 1 microgram to 1 mg (see [0230]), which either overlap or are very close to the instantly claimed range (2 mg to 30 mg).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 40 with a reasonable expectation of success.
.
The NCT02906020 trial teaches all the limitations of claim 46 (See 102(a)(1) above) except for the daily dose of 15 mg and the malate salt of GZ/SAR402671 (Ibiglustat, Venglustat).
However, Cheng teaches malate salts of the claimed compounds (see [0164], {0167] and [0324]) and the amount administered varies between 1 mg and 750 mg (see [0230]) which overlaps with the instantly claimed amount (15 mg).
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima
facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower
claimed range is sufficient to establish a prima facie case of obviousness." In re
Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also
In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
All this will result 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 PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease".
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 PD a composition comprising an effective amount of GZ/SAR402671 (Ibiglustat, Venglustat), wherein the subject does not have a lysosomal storage disease ", e. g. the intended result of a process step positively recited.
As such, this limitation in the instantly claimed method has not been given any weight.
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.
2) Claim(s) 44 is/are rejected under 35 U.S.C. 103 as being unpatentable over ClinicalTrials. Gov study NCT02906020 (V44 2019-07-12) (https://www.clinicaltrials.gov/study/NCT02906020) in view of Liu et. al. (US 2017/0258828).
The NCT02906020 trial teaches all the limitations of claim 44 (See 102(a)(1) above) except for measuring the trail-making-test (TMT).
However, Liu teaches that TMT is a known cognitive test (see [0120]).
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 measure cognition with a TMT test, thus resulting in the practice of claim 44 with a reasonable expectation of success.
Conclusion
No claims are allowed.
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.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
October 27, 2025.