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 17/770,264
Claims 1-10, 12-13, 21-22, 24, and 26-29 are currently pending.
Priority
Instant application 17/770,264, filed 4/19/2022, claims priority as follows:
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Support for the instant claims is found in the provisional application.
Response to Applicant’s Arguments/Amendments
The amendment filed 9/11/2025 has been entered. Claims 8-10, 12-13, and 26-27 have been amended. Claim 11 has been cancelled.
In the Non-Final dated 6/12/2025, the specification was objected to for containing embedded hyperlinks and/or other form of browser-executable code in paras [0361] and [0374]. In response, Applicant has struck through the hyperlinks in the specification to overcome the objection. Thus, the objection is withdrawn.
Claim 8 was objected to in the Non-Final dated 9/11/2025 because it did not stand alone. In response, Applicant amended the claim to bring the limitations of claim 1 into the claim and be independent. Thus, the objection is overcome and withdrawn.
Claims 8-9, 11, 26-27, and 29 were rejected under 35 U.S.C. 112(b) in the Non-Final dated 9/11/2025. Upon amendment of the claims to omit the parentheses and the terms “i.e.” and “e.g.” and the cancellation of claim 11, the rejection has been overcome. The rejection has been withdrawn.
In the Non-Final dated 9/11/2025, claims 8-13, 26-27, and 29 were rejected under 35 U.S.C. 112(a) for the limitation “prodrug”. In response, Applicant has amended the claims to omit the limitation “prodrug” and cancelled claim 11. Thus, the rejection has been overcome and withdrawn.
Claims 8-13, 26-27, and 29 were rejected under 35 U.S.C. 103 in the Non-Final dated 6/12/2025. This rejection applied to the elected species. In response, Applicant argues the rejection is deficient because the reference Broad does not teach “other compounds of the same genus”, and specifically because compounds of the instant claims require,
“a)-L3-R3 and -L4-R4 are each not hydrogen; and/or
b) R7 is-CH2OR8; wherein R8 is alkyl having one or more optional points of substitution.”
Which is not taught or suggested by Broad. Further, Applicant has amended the instant claims to specify that the diazocane moiety is saturated and that the backbone of the chemical scaffold is unsubstituted. Applicants amendments and arguments have been considered, but are not persuasive because the instant elected species is nevertheless anticipated by formula (I) of Broad. The Examiner notes compound E4 was merely used as an example to explain why a skilled artisan would choose the specific variables of the elected species from the genus to arrive at the instant elected species. The rejection is not overcome and thus, the rejection is maintained.
In the Non-Final dated 6/12/2025, claims 8-9, 11, 26-27, and 29 were rejected under 35 U.S.C. 102(a)(1). In response, Applicant has amended the claims to specify that R5 is hydrogen. Therefore, the rejection is overcome and withdrawn.
Claims 8-11 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 19 of U.S. Patent No. 11,174,260 and over claims 1 and 16 of U.S. Patent No. 11,866,441 in the Non-Final dated 6/12/2025. In response, Applicant has amended the claims to omit the compounds of the ‘732 application and specify that R5 and R6 are hydrogen. Therefore, the rejections are overcome and withdrawn.
Election/Restriction
Applicant’s election of Group II, claims 8-13 and 26-29, drawn to methods of treating a parasitic disease caused by a parasite from the genus Cryptosporidium, in the reply filed 5/14/2025 is acknowledged. Applicant’s election of compound 16:
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in the reply filed 5/14/2025, is also acknowledged. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 Rejection dated 6/12/2025, the elected species was searched and prior art was identified. During the search, the scope of the elected species search was expanded to include additional variables of instant R4 and R5 and an additional 102 rejection was identified. The elected species rejection was not overcome; however expanded species 102 rejection was overcome in Applicant’s reply of 9/11/2025. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 8-13, 26-27, and 29 read on the elected species. Claims 1-7, 21-22, 24, and 28 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.
MAINTAINED REJECTIONS
Claim Rejections - 35 USC § 103 – Elected Species
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 8-13, 26-27, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over The Broad Institute, Inc. (WO 2018/175385 A1, cited in the IDS of 4/19/2022, herein after “Broad”). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The reference Broad teaches compounds useful for the treatment of parasitic diseases (abstract), and specifically teaches compounds of formula (I) (page 143, claim 1):
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And when R1 is aryl, Z5-Z8 are CH, R3 is -CH2-X, X is -N(R)-C(O)-R, where both R’s are C1 alkyl, R4-R7 are H, Z1-Z4 are CH and R2 is alkoxy, the genus of formula (I) anticipates the elected species. Additionally, preferred embodiments are encompassed in examples such as compound E4 (page 21, Table 1):
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Which contains the same limitations as the elected species when R1 as aryl, Z5-Z8 as CH, R3 as -CH2-X, R4-R7 as H, Z1-Z4 as CH and R2 as alkoxy. Compounds E34 and E35 depict R4 and R5 as H, which are active in, and thus one of ordinary skill in the art would be motivated to synthesize a compound where R4 and R5 are both H.
Further, with respect to the method limitations of claims 8-13, Broad teaches the administration of compounds of formula (I) to mice to treat the parasitic infection caused by C. parvum (page 140, Example 51).
Regarding claim 26-27 and 29, Broad teaches the treatment of HCT-8 cells infected with C. parvum with compounds of formula (I) (page 140-141, Example 52). The limitation “medium” in claim 26 is interpreted in accordance with para [0010] of the specification, and in this embodiment, “medium” is interpreted to mean the parasite population has infected a cultured cell. Additionally, it is noted that compound E4, shown above, has an EC50 of 68 nm in this assay.
Ascertaining the differences between the prior art and the claims at issue
The reference Broad fails to teach the elected species in the methods of treatment, though Broad teaches other compounds of the same genus in said methods.
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 Cryptosporidium treatment methods with azetidine-based compounds. An artisan possess the technical knowledge necessary to make adjustments to the azetidine-based compounds to enhance their effectiveness in the treatment methods. Said artisan has also reviewed the problems in the art as regards to use of said Cryptosporidium treatment methods with azetidine-based compounds and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
It would have been prima facie obvious to arrive at the limitations of the instant claims because Broad teaches the genus formula (I), which anticipates the elected species, and Cryptosporidium treatment methods with compounds of formula (I). Additionally, Broad teaches specific compounds with overlapping variables of the elected species, thus guiding a skilled artisan to the limitations of the instant compounds even though Broad fails to teach the anticipatory elected species in the methods of treatment. The elected species is a compound of formula (I) and a skilled artisan would be motivated to synthesize it because structurally similar compounds have structurally similar properties. According to MPEP § 2144.08:
In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
One of ordinary skill in the art would have reasonably predicted that the elected species would result in a compound capable of treating a parasitic disease caused by a parasite of the genus Cryptosporidium and inhibiting the growth of a population of parasites from the genus Cryptosporidium in view of the teachings of Broad.
Conclusion
Claims 8-13, 26-27, and 29 are rejected. Claims 1-7, 21-22, 24, and 28 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