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 Arguments and Amendment filed, 10/10/2025, wherein the Amendment amended claims 1, 12-13, 54, 63, 65-66, and cancelled claims 11, 27-28, 31-39, 62.
Claims 1-2, 5-10, 12-13, 54-59, 61, and 63-66 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
Claim Objections
Applicant’s amendments to claims 13 and 65-66 are sufficient to overcome these objections.
35 U.S.C. § 112(b)
Applicant’s amendment to claim 1 and deletion of claim 27 is sufficient to overcome these rejections.
Double Patenting
Since the patient populations of the claimed methods of Application Nos. 18/253,071 and 18/280,565 are distinct, these rejections are withdrawn.
REJECTIONS-MAINTAINED, MODIFIED, & NEW
Applicant’s amendments to the claims have resulted in the below new and modified rejections.
Regarding the amendment to independent claims 1 and 54, implicit support for these limitations can be found in [0031] of the specification.
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.2 and 103) is incorrect, any correction of the statutory basis 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.
(Modified) Claims 1-2, 5, 10, 13, 54-55, 61, 63, and 65-66 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by US 9,796,672 to Rishton (published 2017, IDS of 03/19/2024).
Regarding claims 1 and 54, Rishton teaches a method of treating Alzheimer’s disease comprising administering to a subject, an effective amount of
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, which inhibits amyloid beta effect on a neuronal cell (Cols. 214-216, Claims 1-15).
Rishton teaches 0.01mg/kg to about 500 mg/kg as the effective amount, wherein these amounts are per day. (Col. 78, line 60-Col. 79, line 44).
Rishton exemplifies orally administering 10 or 30 mg/kg/day of a test compound (Col. 145, Example 16), wherein
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is Test Compound 61 in Table 2 (Col. 128, line 62-Col. 132, line 58; Col. 144, Example 14; Col. 193, lines 46-61).
While Rishton does not explicitly teach “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of Rishton would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts (Rishton teaches 0.01mg/kg to about 500 mg/kg and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Regarding claims 2 and 55, Rishton defines subject as any animal including humans (Col. 72, line 66-Col. 73, line 3).
Regarding claim 5, Rishton teaches Alzheimer’s disease.
Regarding claims 10, 13, 61, 63, and 65-66, MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, these wherein clauses expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, such as an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Response to Arguments
On pgs. 7-8, Remarks, Applicant argues that independent claim 1 has been amended to recite “thereby reducing amyloid beta monomer levels” to the body of the claim, and that “The Examiner’s rejection treated the ‘wherein’ clauses as merely expressing intended results, but amended claim 54 now positively recites that the administration ‘results in a reduction in amyloid beta monomer levels. . .that distinguishes over Rishton’s general teaching of treating Alzheimer’s disease.”
This argument has been fully considered, but is not found persuasive. The above rejections have been modified to address the amendments to independent claims 1 and 54.
While Rishton does not explicitly teach “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of Rishton would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts (Rishton teaches 0.01mg/kg to about 500 mg/kg and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Applicant has provided no evidence that the methods of Rishton would not result in
“a reduction in amyloid beta monomer levels in a subject” or “a reduction in amyloid beta monomer levels in the subject.”
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 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.
(Modified) Claims 6-9 and 56-59 are rejected under 35 U.S.C. 103 as being unpatentable over US 9,796,672 to Rishton (published 2017, IDS of 03/19/2024) as applied to claims 1-2, 5, 10, 13, 54-55, 61, 63, and 65-66 above, and further in view of US 2020/0000822 to Kruse (effectively filed 02/23/2017, PTO-892).
Rishton is applied as discussed above and incorporated herein.
Regarding claims 6-9 and 56-59, while Rishton teaches a method of treating Alzheimer’s disease by administering 0.01mg/kg to about 500 mg/kg
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per day (Col. 78, line 60-Col. 79, line 44), it differs from that of the instantly claimed invention in that it does not teach administration for at least 6 months.
Kruse teaches a method for treating neurological diseases, such as Alzheimer’s disease, by administering therapeutically effective amounts of compounds which modulate the activity of sigma receptors, such as a TMEM97 ligand, wherein CT-1812 is taught as a TMEM97 ligand (abstract, pg. 26, claims 13, 14, 18, 27 18; [0002]; [0019]; [0051]), and CT-1812 is taught as an exemplary sigma-2 receptor agonist/antagonist ([0006], [0032], [0056], pg. 24, claim 3).
Kruse teaches a therapeutically effective amount of from about 0.001mg/kg to about 1000 mg/kg per day, and teaches that the dosage regimen may be determined by the clinical indication being addressed, as well as by various patient variables (e.g. weight, age, sex) and clinical presentation (e.g. extent or severity of disease). Furthermore, Kruse teaches that it is understood that all dosages may be continuously given or divided into dosages given per a given time frame. The composition can be administered, for example, every hour, day, week, month, or year ([0016]-[0019]).
As evidenced by [0026] of the instant specification,
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is CT-1812.
It would have been prima facie obvious to one of ordinary skill in art, prior to the effective filing date of the instantly claimed invention, to modify the method of Rishton by a) administering
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for at least 6 months, b) administering 10mg-2000mg
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for at least 6 months, c) administering about 300 mg
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for at least 6 months, and d) administering 100mg
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for at least 6 months, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Rishton and Kruse are both directed toward methods of treating Alzheimer’s disease by administering
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,
- Rishton teaches administration of 0.01mg/kg to about 500 mg/kg
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per day,
- Kruse teaches administering a therapeutically effective amount of from about 0.001mg/kg to about 1000 mg/kg per day, and teaches that a) the dosage regimen may be determined by the clinical indication being addressed, as well as by various patient variable (e.g. weight, age, sex) and clinical presentation (e.g. extent or severity of disease), b) it is understood that all dosages may be continuously given or dived into dosages given per a given time frame, and c) the composition can be administered, for example, every hour, day, week, month, or year, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II).
As such, an artisan having ordinary skill in the art would have been motivated to make such a modification to predictably arrive at a dosage regimen that is optimized to treat Alzheimer’s disease.
(Modified) Claims 12 and 64 are rejected under 35 U.S.C. 103 as being unpatentable over US 9,796,672 to Rishton (published 2017, IDS of 03/19/2024) as applied to claims 1-2, 5, 10, 13, 54-55, 61, 63, and 65-66 above, and further in view of NCT03522129 (ClinicalTrials.gov, published 01/04/2019, PTO-892).
Rishton is applied as discussed above and incorporated herein.
While Rishton teaches a method of treating Alzheimer’s disease by administering
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, it differs from that of the instantly claimed invention in that it does not teach measuring amyloid ß monomer or oligomer levels.
Rishton teaches that sigma-2 receptor antagonists inhibit deleterious effects on soluble amyloid ß (Col. 1, lines 56-67), and inhibit amyloid ß oligomer binding (Col. 48, lines 29-Col. 49, line 9; Col. 68, lines 46-54).
Rishton teaches that in some embodiments, the sigma 2-antagonist competes with amyloid ß oligomer binding to neurons and specific synapses, or otherwise disrupts the ability of the oligomers to bind to neurons, such as by interfering with oligomer formation (Col. 68, line 63-Col. 69). Rishton teaches that amyloid ß includes peptide-containing components such as amyloid ß monomers, oligomers, or complexes of peptides (Col. 72, lines 27-57). Rishton teaches measuring levels of amyloid ß in assays (Col. 75, line 39-Col. 77 line 14). Any form of amyloid ß may be used in the practice of the screen methods of the assays, including amyloid ß monomers and oligomers (Col. 108, lines 56-65). See Col. 80, line 5-Col. 81, line 25.
NCT03522129 teaches evaluating the effect of CT1812 treatment on Amyloid Beta Oligomer displacement into cerebral spinal fluid (CSF) in subjects with Alzheimer’s disease (pg. 3, title). NCT03522129 teaches that the primary endpoint is the change from the baseline CSF amyloid ß oligomer concentration after dosing with CT1812, wherein the change from baseline is measured (pg. 4, “Detailed Description;” pg. 6, “Primary Outcome Measures”).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add measuring amyloid ß monomer and oligomer levels from the CSF, to the method of Rishton, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Rishton teaches amyloid ß monomers and oligomers as indicators of disease in Alzheimer’s disease,
-Rishton teaches methods of measuring levels of amyloid ß monomer and oligomer levels in assays, and
-NCT03522129 teaches evaluating the effect of CT1812 treatment on amyloid ß displacement as measured in CSF.
As such, an artisan having ordinary skill in the art would have been motivated to make such an addition to predictably arrive at a method that evaluates the effectiveness of CT1812 in the treatment of the Alzheimer’s disease.
Response to Arguments
On pg. 9, Remarks, Applicant argues that “the amendments. . .to the claims overcome the obviousness rejection based on the unexpected properties of the claimed compound” and “The reduction of amyloid beta monomer levels by CT1812 administration is surprising and unexpected.”
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that Applicant has not provided any evidence of unexpected or surprising results.
Regarding unexpected results, MPEP 716.02 states that such results a) are greater than expected results, b) show superiority of a property shared with the prior art, c) exhibit the presence of an unexpected property, and/or d) exhibit the absence of an expected property. MPEP 716.02 additionally states that unexpected results must be commensurate in scope with the claimed invention and provide a comparison with the closest prior art.
On pgs. 9-10, Remarks, Applicant argues that “Rishton does not disclose or teach “a reduction in amyloid beta monomer levels in the subject” and “the Examiner has failed to establish a prima facie case of obviousness over Rishton because the cited reference does not teach or suggest the specific functional result now positively recited in the amended claims—namely, the reduction of amyloid beta monomer levels in the subject.”
This argument has been fully considered, but is not found persuasive. The above prior art rejections have been modified to meet these new limitations.
On pg. 10, Remarks, Applicant argues that “The Examiner’s rejection appears to assume that any method of treating Alzheimer’s disease would inherently result in reduced amyloid beta monomer levels, but this assumption is not supported by the prior art. Rishton’s disclosure focuses on blocking the binding of amyloid beta oligomers to sigma-2 receptors and preventing downstream toxic effects, which is mechanistically distinct from reducing the levels of amyloid beta monomers themselves.”
This argument has been fully considered, but is not found persuasive. It is respectfully pointed out that the rejection does not assume that any method of treating Alzheimer’s disease would inherently result in reduced amyloid beta monomer levels. As discussed in the above rejection, Rishton teaches administering the same compound in the same effective amounts to the same patient population, i.e., Alzheimer’s patients. As such, absent evidence to the contrary, since Rishton teaches the same method, it is reasonable to assume, that it would have the same effects, i.e., reducing amyloid beta monomer levels. See the above rejection for a more detailed explanation of how the teachings of Rishton meet these limitations.
On pgs. 10-11, Remarks, Applicant argues that Kruse and NCT03522129 do not cure the deficiency in Rishton regarding the reduction of amyloid beta monomer levels.
This argument has been fully considered, but is not found persuasive. Kruse is a secondary reference relied upon to teach administration of CT-1812, the instantly claimed compound, for at least 6 months. And NCT03522129 is also a secondary reference relied upon to teach measuring amyloid beta monomer and oligomer levels.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
(Modified) Claims 1-2, 5, 10, 13, 54-55, 61, 63, and 65-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44, 48, 57-61, 67, 75-78, and 92-94 of copending Application No. 16/758,368 (reference application, claim set dated 12/20/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘368 claims a method of treating a subject having Alzheimer’s disease comprising administering
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(claims 44, 60, 78).
‘368 claims administration of about 90mg, 280 mg or 560mg (claims 59, 77, 94) and teaches administration of from about 0.001mg to about 1120mg (claims 58, 76, 93). In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
Regarding claims 1 and 54, while ‘368 does not explicitly claim “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of ‘368 would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts (‘368 teaches 0.001mg/kg to about 1120 mg/kg and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Regarding claims 2, and 55, the specification of ‘368 teaches “subject” as any animal including humans ([0040]).
Regarding claims 10, 13, 61, 63, and 65-66, MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, such as an Alzheimer’s disease patient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(Modified) Claims 1-2, 5, 10, 13, 54-55, 61, 63, and 65-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 38-45 of copending Application No. 18/308,037 (reference application, claim set dated 05/21/2025).
Note: A Notice of Allowance for this application was mailed on 07/08/2025. Once this patent is published, this provisional rejection, will be converted to a non-provisional rejection over the patent.
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘037 claims a pharmaceutical composition comprising 10-2000mg of
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and a pharmaceutically acceptable carrier (claims 38-41). In the case where the claimed ranges “overlap or lie inside ranges disclosed in the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
‘037 claims a composition formulated for oral delivery (claims 44-45).
‘037 teaches it compounds for inhibiting deleterious effects of soluble amyloid-beta peptides and oligomers to treat conditions such as Alzheimer’s disease ([006]-[007]) and teaches its compositions for administration to humans ([072]).
Consistent with Sun Pharmaceutical Industries v. Eli Lilly and Col, 611 F. 3d 1381, 1387 (CAFC 2010), it is permissible to use a compound claim to reject a method of use claim where that method of use is disclosed in the specification of the application claiming the compound. According to the Sun Pharma. Court, “[i]t would shock one’s sense of justice if an inventor could receive a patent upon a composition of matter, setting out at length in the specification the useful purposes of such composition, . . .and then prevent the public from making any beneficial use of such product by securing patents upon each of the uses to which it may be adapted. . .”.
Regarding claims 1 and 54, while ‘037 does not explicitly claim “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of ‘037 would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts (‘037 teaches 0.01mg/kg to about 300 mg/kg ([0105]) and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Regarding claims 2 and 55, the specification of ‘037 teaches “subject” as any animal including humans ([0072]).
Regarding claims 10, 13, 61, 63, and 65-66, MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a patient in need thereof, such as an Alzheimer’s disease patient.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(New) Claims 1-2, 5, 10, 13, 54-55, 61, 63, and 65-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-37 of copending Application No. 19/350,487 (reference application, claims dated 10/06/2025).
Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding claims 1 and 54, ‘487 claims a method for inhibiting an amyloid beta effect on a neural cell comprising administering to a subject a compound of:
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, and specifically claims
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as the compound (claims 18, 29, 32), and specifically teaches treating cognitive decline in Alzheimer’s disease (claim 37).
Regarding claims 2 and 55, ‘487 teaches the subject as human ([072]).
Regarding claims 10, 13, 61, 63, and 65-66 MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a patient in need thereof, such as an Alzheimer’s disease patient, or a patient in need of inhibiting amyloid beta.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
(Modified) Claims 1-2, 5, 10, 12, 13, 54-55, 61, and 63-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,796,672 to Rishton (published 2017, IDS of 03/19/2024).
*Since US 9.796,672 to Rishton also applies as prior art under 102(a)(1) and 102(a)(2), the teachings of Rishton are also applied.
Although the claims at issue are not identical, they are not patentably distinct from each other.
Rishton claims a method for inhibiting amyloid beta effect on a neuronal cell and a method of treating Alzheimer’s disease by administering to a subject, a therapeutically effective amount of
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(claims 1-15).
Rishton teaches 0.01mg/kg to about 500 mg/kg as the effective amount, wherein these amounts are per day. (Col. 78, line 60-Col. 79, line 44 In a 70 kg patient, 0.01mg/kg to about 500 mg/kg
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, is 0.7mg to 35,000 mg; in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05.
The optimization of known amounts for known active agents is considered well within the competence level of an artisan of ordinary skill in the pharmaceutical sciences; it has been held that the selection of optimal parameters, such as amounts of active agents, to achieve a beneficial effect, is within the skill in the art of an ordinary artisan. See In re Boesch, 205 USPT 215 (CCPA 1980) and MPEP 2144.05.
Regarding claims 1 and 54, while Rishton does not explicitly claim “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of Rishton would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts (Rishton teaches 0.01mg/kg to about 500 mg/kg and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Regarding claims 2 and 55, Rishton teaches “subject” and Rishton defines subject as any animal including humans (Col. 72, line 66-Col. 73, line 3).
Regarding claim 5, Rishton claims Alzheimer’s disease.
Regarding claims 10, 13, 61, 63, and 65-66, MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, such as an Alzheimer’s disease patient.
Regarding claims 12 and 64 while Rishton does not claim measuring amyloid ß beta monomer and oligomer levels, Rishton teaches that sigma-2 receptor antagonists inhibit deleterious effects of soluble amyloid ß (Col. 1, lines 56-67), and inhibit amyloid ß oligomer binding (Col. 48, lines 29-Col. 49, line 9; Col. 68, lines 46-54).
Rishton further teaches that in some embodiments, the sigma 2-antagonist competes with amyloid ß oligomer binding to neurons and specifically synapses, or otherwise disrupts the ability of the oligomers to bind to neurons, such as by interfering with oligomer formation (Col. 68, line 63-Col. 69). Rishton teaches that amyloid ß includes peptide-containing components such as amyloid ß monomers, oligomers, or complexes of peptides (Col. 72, lines 27-57). Rishton teaches measuring levels of amyloid ß is assays (Col. 75, line 39-Col. 77 line 14). Any form of amyloid ß may be used in the practice of the screen methods of the assays, including amyloid ß monomers and oligomers (Col. 108, lines 56-65). See Col. 80, line 5-Col. 81, line 25.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to add measuring amyloid ß monomer and oligomer levels in the CSF, hippocampal interstitial fluid, or plasma, to the method of Rishton, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such an addition, with a reasonable expectation of success, because:
-Rishton teaches amyloid ß monomers and oligomers as indicators of disease in Alzheimer’s disease, and
-Rishton teaches measuring amyloid ß monomers and oligomers in assays.
As such, an artisan of ordinary skill in the art would have been motivated to make such an addition to predictably arrive at a method that evaluates the effectiveness of CT1812 in the treatment of the Alzheimer’s disease.
Though Rishton does not explicitly teach the place from which the amyloid ß monomers and oligomers are extracted (i.e., CSF, hippocampal interstitial fluid, or plasma), an artisan having ordinary skill in the art would predictably arrive at extracting the amyloid ß monomers and oligomers from CSF, hippocampal interstitial fluid, or plasma, as an ordinary skilled artisan would know which body fluids comprise these amyloid ß monomers and oligomers.
(Modified) Claims 6-9 and 56-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9,796,672 to Rishton (published 2017, IDS of 03/19/2024), as applied to claims 1-2, 5, 10, 12, 13, 54-55, 61, and 63-66, above, and further in view of US 2020/0000822 to Kruse (effectively filed 02/23/2017, PTO-892).
Rishton is applied as discussed above and incorporated herein.
Regarding claims 6-9 and 56-59, while Rishton claims a method of treating Alzheimer’s disease by administering 0.01mg/kg to about 500 mg/kg
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per day. (Col. 78, line 60-Col. 79, line 44), it differs from that of the instantly claimed invention in that it does not teach administration for at least 6 months.
Kruse teaches a method for treating neurological diseases, such as Alzheimer’s disease, using compounds which modulate the activity of sigma receptors, such as a TMEM97 ligand, wherein CT-1812 is taught as a TMEM97 ligand (abstract, pg. 26, claims 13, 14, 18, 27 18; [0002]; [0019]; [0051]), and CT-1812 is taught as an exemplary sigma-2 receptor agonist/antagonist ([0006], [0032], [0056], pg. 24, claim 3).
Kruse teaches a therapeutically effective amount of from about 0.001mg/kg to about 1000 mg/kg per day, and teaches that the dosage regimen may be determined by the clinical indication being addressed, as well as by various patient variable (e.g. weight, age, sex) and clinical presentation (e.g. extent or severity of disease). Furthermore, it is understood that all dosages may be continuously given or dived into dosages given per a given time frame. The composition can be administered, for example, every hour, day, week, month, or year ([0016]-[0019]).
As evidenced by [0026] of the instant specification,
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is CT-1812.
It would have been prima facie obvious to one of ordinary skill in art, prior to the effective filing date of the instantly claimed invention, to modify the method of Rishton by a) administering
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for 6 months, b) by administering 10mg-2000mg
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for 6 months, c) administering about 300 mg
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for 6 months, and d) administering 100mg
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for 6 months, to arrive at the instantly claimed invention. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
-Rishton and Kruse are both directed toward methods of treating Alzheimer’s disease by administering
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,
- Rishton teaches administration of 0.01mg/kg to about 500 mg/kg
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per day,
- Kruse teaches administering a therapeutically effective amount of from about 0.001mg/kg to about 1000 mg/kg per day, and teaches that the dosage regimen may be determined by the clinical indication being addressed, as well as by various patient variable (e.g. weight, age, sex) and clinical presentation (e.g. extent or severity of disease). Furthermore, it is understood that all dosages may be continuously given or dived into dosages given per a given time frame. The composition can be administered, for example, every hour, day, week, month, or year, and
-"[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II).
As such, an artisan of ordinary skill in the art would have been motivated to make such a modification to predictably arrive at dosage regimen that is optimized to treat Alzheimer’s disease.
(Modified) Claims 1-2, 5, 10, 13, 54-55, 61, 63 and 65-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 9-17, 19, and 21-22 of U.S. Patent No. 10,207,991 (IDS of 03/19/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘991 claims a method for inhibiting amyloid beta effect on a neuronal cell and a method of treating Alzheimer’s disease comprising administering an effective amount to a subject a compound of
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and pharmaceutically acceptable salts, or compositions thereof (claims 1-6, 9-17, 19, 21 and 22).
‘991 teaches human as the subject (Col. 71, line 49-53).
‘991 teaches an effective amount as 0.01mg/kg to about 500 mg/kg (Col. 77, line 42-Col. 78, line 24). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05
Regarding claims 1 and 54, while ‘991 does not explicitly teach “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of ‘991 would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts (‘991 teaches 0.01mg/kg to about 500 mg/kg and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Regarding claims 10, 13, 61, 63, and 65-66, MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, such as an Alzheimer’s disease patient.
(Modified) Claims 1-2, 5-10, 13, 54-59, 61, 63 and 65-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10,611,728 (IDS of 03/19/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘728 claims a method f of treating Alzheimer’s disease comprising administering a daily dose of 10-2000mg, to a subject a compound of
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and pharmaceutically acceptable salts, (claims 1-2, 12). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05
‘728 further claims narrower dosage amounts (claims 3-4, 8-10, 14-16, 19-21).
‘728 claims oral administration (claims 7, 11, 18, 22).
‘728 teaches human as the subject (Col. 71, line 65-Col. 72, line 3).
Regarding claims 1 and 54, while ‘728 does not explicitly teach “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of ‘728 would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts (‘728 claims 10-2000mg, and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Regarding claims 10, 13, 61, 63, and 65-66, MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, such as an Alzheimer’s disease patient.
Though ‘728 does not teach administration for at least 6 months, 728 claims daily dosages (claims 3-6, 15-17, 20-22). As such, an artisan having ordinary skill in the art would have been motivated to modify the claims of ‘728 to teach administration for at least 6 months to predictably arrive at a method of treating Alzheimer’s disease that is effective over a long period of time, and "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II)
(Modified) Claims 1-2, 5-10, 13, 54-59, 61, 63 and 65-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,691,947 (IDS of 03/19/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘947 claims a method f of treating Alzheimer’s disease comprising administering a dose of 0.01mg/kg/day to about 25 mg/kg/day, to a subject a compound of
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and pharmaceutically acceptable salts, (claims 1-2, 11-12). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05
‘947 further claims narrower dosage amounts (claims 3-4, 8-9, 13-14, 18-19).
‘947 claims oral administration (claims 7, 10, 17, 20).
‘947 teaches human as the subject (Col. 72, lines 33-37).
Regarding claims 1 and 54, while ‘947 does not explicitly teach “wherein administration results in a reduction in amyloid beta monomer levels in the subject, wherein the reduction of the amyloid beta monomer levels is relative to amyloid beta monomer levels prior to administration of the compound” in claim 1, or “wherein administering a therapeutically effective amount of the compound results in a reduction in amyloid beta monomer levels in the subject” in claim 54, it is reasonable to assume that administering the
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of ‘947 would have the same properties since it is administered for the same purpose (treating Alzheimer’s disease) in the same dosage amounts ((‘947 claims 0.01-25mg/kg/day, and the instant invention teaches 10mg to 2000mg ([0029] of the instant specification)), to the same patient population (patients with Alzheimer’s disease), as that taught by the instant specification and claims. Thus, while the prior art does not explicitly teach these properties, burden is on Applicant to show that the prior art does not have these properties.
Applicants are reminded that the office does not have the facilities and resources to provide the factual evidence needed in order to establish that the product of the prior art does not possess the same material, structural and functional characteristics of the claimed product. In the absence of evidence to the contrary, the burden is on the applicant to prove that the claimed product is 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).
Moreover, MPEP 2111.04 states 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.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, i.e., an Alzheimer’s disease patient.
See also MPEP 2112.02(I), “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986).”
Regarding claims 10, 13, 61, 63, and 65-66, MPEP 2111.04 states the following regarding wherein clauses: a “‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’” Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In this case, the wherein clause expresses the desired result of the positive step of administering a therapeutically effective amount of
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, to a subject, such as an Alzheimer’s disease patient.
Though ‘947 does not teach administration for at least 6 months, ‘947 claims daily dosages (claims 5-6, 15-16). As such, an artisan having ordinary skill in the art would have been motivated to modify the claims of ‘947 to teach administration for at least 6 months to predictably arrive at a method of treating Alzheimer’s disease that is effective over a long period of time, and "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." MPEP 2144.05(II).
Response to Arguments
Applicant’s arguments mirror the arguments to the 35 USC 102 and 103 rejections. These arguments are fully addressed above.
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 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 LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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/LAUREN WELLS/Examiner, Art Unit 1622