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
Status of 17/792,766
Claims 61-82 and 84-87 are currently pending.
Priority
Instant application 17/792,766, filed 7/14/2022, claims priority as follows:
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Receipt of the foreign priority application is acknowledged and thus, the effective filing date the instant claims is 2/3/2020.
Information Disclosure Statement
All references from the IDS’s submitted on 8/18/2023 and 7/24/2025 have been considered unless marked with a strikethrough.
Response to Applicants Amendments/Arguments
The amendment entered 1/9/2026 has been entered. Claims 61, 66, 69, 73, and 81 have been amended. Claims 1-5, 8, 11, 14-16, 29, and 48-56 have been cancelled.
Claims 79-80 and 86-87 were objected to in the Non-Final dated 10/17/2025 as they are dependent upon a rejected base claim. Applicant has not overcome the objection by placing the independent claims in allowable form. Thus, the objection is maintained.
In the Non-Final dated 10/17/2025, claims 61-78, 81, and 85 were rejected under 35 U.S.C. 112(b). In response, Applicant has amended the instant claims, which overcome the rejections. Thus, the rejections are withdrawn.
Claims 61-62, 66-68, and 81 were rejected under 35 U.S.C. 102(a)(1) in the Non-Final dated 10/17/2025. In response, Applicant has amended the claims to omit the anticipatory species and amended the definition of R6’, R7’, and R8’, which overcomes the rejection. Thus, the rejection is withdrawn.
However, Applicant’s amendments necessitated the new ground(s) of rejection presented in this Office Action.
Election/Restriction
Applicant’s election of Group II, claims 61-82 and 84-87, drawn to compounds and compositions of Formula (I), with traverse in the reply filed 7/24/2025 is acknowledged. The traversal is on the grounds that the claims of the instant application do not qualify as a “clear case” of lacking unity of invention, and that the benefit of the doubt must be given to the Applicant. This argument has been considered, but is unpersuasive because there are multiple instances of compounds of Formula (I), a unifying feature of Groups I and II of the restriction requirement, in the art. See the Requirement for Restriction/Election of 4/25/2025 and the 102 rejection of the Non-Final 10/17/2025. Additionally, the traversal is on the grounds that a search of Group II would not impose a serious search burden on the Examiner. However, search burden is not a qualifying feature for restriction of applications filed under 35 U.S.C. 371, and the requirement is still deemed proper and is therefore made FINAL.
Applicants’ election of Example 40:
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in the reply filed 7/24/2025, with traverse, is also acknowledged. The traversal is on the grounds that a search of the elected species would likely uncover art of interest to other species recited in the claims. The argument has been considered but is not persuasive because the application was filed under 35 U.S.C. 371, of which search and burden of search is not a requirement. Thus, the requirement is still deemed proper and is made FINAL.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final dated 10/17/2025, the elected species was searched and no prior art was identified. Thus, the Examiner expanded the scope of the search to compounds where variables B and B’ are a fused benzene ring, and prior art was identified. In response, Applicant has amended the claims to omit the anticipatory species and amended the definition of R6’, R7’, and R8’. Subsequent examination in this Office Action is based on additional compounds where variables B and B’ are a fused benzene ring. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claim 61-62, 66-68, 77, 81, and 85 read on the expanded species. Claims 79-80 and 86-87 remain objected to. Claims 63-65, 69-76, 78, 82, and 84 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
Claim Objections
Claims 79-80 and 86-87 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 61-62, 66-68, and 77 are rejected under 35 U.S.C. 102(a)(1) being anticipated by ACS 1 (American Chemical Society. Chemical Abstract Service. RN 1013482-57-9, Entered into STN 10 April 2008, herein after “ACS 1”). This rejection applies to the expanded species.
The reference ACS 1 discloses the following compound:
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Which anticipates a compound of instant formula (I’):
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Where B’ is
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, R6’ and R7’ are -ORa, where Ra is C1 alkyl, R8’ is hydrogen, R3 is hydrogen, R3’ is hydrogen, R1 is C2 alkyl, R4 is hydrogen, R4’ is hydrogen, and R2b and R5b together with the nitrogen to which they are attached form a 6-membered heterocyclic ring, which is substituted with C1 alkyl, further substituted with a C6 aryl. Thus, ACS 1 anticipates claims 61-62, 66-68, and 77.
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.
Claims 85 is rejected under 35 U.S.C. 103 as being unpatentable over ACS 1 (American Chemical Society. Chemical Abstract Service. RN 1013482-57-9, Entered into STN 10 April 2008, herein after “ACS 1”), as applied to claims 61-62, 66-68, and 77 above. This rejection applies to the expanded species.
Determining the scope and contents of the prior art
The reference ACS 1 teaches as disclosed above and at least those teachings are incorporated herein. Additionally, ACS 1 teaches in silico mass solubilities at varying pH’s:
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,
indicating a pharmaceutical composition comprising water.
Ascertaining the differences between the prior art and the claims at issue
ACS 1 fails to teach an experimental data point of the solubilities.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of pharmaceutical compositions for treating MPS1. An artisan possesses the technical knowledge necessary to make adjustments to the pharmaceutical compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said pharmaceutical compositions and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
It would be prima facie obvious to experimentally test the solubilities of the compound in water in light of the in silico data, therefore generating a pharmaceutical composition. A skilled artisan would be reasonably motivated to confirm the validity of the in silico data, and arrive at a pharmaceutical composition of the compound in water before the effective filing date of the claimed invention.
Claims 81 is rejected under 35 U.S.C. 103 as being unpatentable over ACS 2 (American Chemical Society. Chemical Abstract Service. RN 1286642-26-9, Entered into STN 27 April 2011, herein after “ACS 2”). This rejection applies to the expanded species.
Determining the scope and contents of the prior art
The reference ACS 2 teaches the following compound:
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Which anticipates a compound of instant formula (I):
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When B is a substituted, fused benzene ring, R3 is hydrogen, R3’ is hydrogen, R1 is C2 alkyl, R4 is hydrogen, R4’ is hydrogen, and R2 and R5 together with the nitrogen to which they are attached forms a 6-membered heterocyclic ring. The Examiner notes the interpretation of substituted, fused benzene ring B includes C1 alkoxy groups in accordance with the definition on page 43, paragraph [0171].
Additionally, ACS 2 teaches in silico mass solubilities at varying pH’s:
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,
indicating a pharmaceutical composition comprising water.
Ascertaining the differences between the prior art and the claims at issue
ACS 1 fails to teach an experimental data point of the solubilities.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of pharmaceutical compositions for treating MPS1. An artisan possesses the technical knowledge necessary to make adjustments to the pharmaceutical compositions to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said pharmaceutical compositions and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
It would be prima facie obvious to experimentally test the solubilities of the compound in water in light of the in silico data, therefore generating a pharmaceutical composition. A skilled artisan would be reasonably motivated to confirm the validity of the in silico data, and arrive at a pharmaceutical composition of the compound in water before the effective filing date of the claimed invention.
Close Prior Art Not Cited
As stated in the Non-Final of 10/17/2025, a prior art search identified ACS 3 (American Chemical Society. Chemical Abstract Service. RN 1037930-65-6, Entered into STN 03 August 2008, herein after “ACS 3”):
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Which overlaps with a compound of formula (I’):
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When B’ is B2’, R3 and R3’ are H, R1 is C1 alkyl, R4 and R4’ are H, and R2b or R5b is a C6 aryl substituted with 2 halogens. The compound of ACS 3 differs from the instant claims because instant formula (I’) requires B2’ to be substituted with a substituent of R9’, and R2b or R5b are not allowed to be H.
Conclusion
Claims 61-62, 66-68, 77, 81, and 85 are rejected. Claims 79-80 and 86-87 remain objected to. Claims 63-65, 69-76, 78, 82, and 84 are withdrawn.
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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621