DETAILED ACTION
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 .
Status of the Claims
Claims 1-9, 15, 20-31, 39, and 50 are pending. Acknowledgment is made of the amendment to claims 1 and 2 in the reply filed 11/20/2025. Claims 7-9, 15, 26-31, 39, and 50 are withdrawn.
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/20/2025 has been entered.
Election/Restriction Requirement
Applicant elected without traverse Group I, directed to compounds of formula (I), in the reply filed on 02/21/2025. Applicant further elected the species of compound BAQ13, shown below, which reads on claims 1-6 and 20-25. The search has been limited to the elected species and any 35 U.S.C. 102 prior art found during the search.
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Claims 7-9, 15, 26-31, 39, and 50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species or invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/21/2025.
Withdrawn Rejections
Applicant’s amendment to the claims, filed 11/20/2025, overcomes the rejection of claims 1-4 and 20-23 under 35 U.S.C. 103 as being unpatentable over McAfee et al. (Autophagy inhibitor Lys05 has single-agent antitumor activity and reproduces the phenotype of a genetic autophagy deficiency, PNAS, 2012, Vol. 109(21), pages 8253-8258). The rejection of claims 1-4 and 20-23 has been withdrawn.
Applicant’s amendment to the claims, filed 11/20/2025, overcomes the rejection of claims 1-4 and 20-23 under 35 U.S.C. 103 as being unpatentable over Baker et al. (WO 2016196393 A2). The rejection of claims 1-4 and 20-23 has been withdrawn.
Applicant’s amendment to the claims, filed 11/20/2025, overcomes the rejection of claims 1-4 and 20-23 under 35 U.S.C. 103 as being unpatentable over Moley et al. (US 20180280372 A1). The rejection of claims 1-4 and 20-23 has been withdrawn.
Applicant’s amendment to the claims, filed 11/20/2025, overcomes the rejection of claims 1-4 and 20-23 under 35 U.S.C. 103 as being unpatentable over Amaravadi et al. (US 20180111904 A1). The rejection of claims 1-4 and 20-23 has been withdrawn.
Modified Rejections
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-6 and 20-25 are rejected under 35 U.S.C. 103 as obvious over Amaravadi et al. (US 20170275252 A1), cited by Applicant in the IDS.
Amaravadi et al. teaches, in claim 1, compounds of the following formula IA:
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Amaravadi et al. also teaches the compound Lyso-1, shown below.
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It is taught in formula IA that R1 is F, Cl, Br, or I, as in the instant claims. Additionally, it is taught that R” is C1-C12 alkyl. This overlaps with the requirement of instant claims 1-6 and 20-25 that R1 of formula (I) must be at least C10 – C25 or C12 – C18 alkyl. MPEP 2144.05 I states: “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)”. Therefore, although no specific compounds were synthesized in the prior art reference which contain C10 to C12 alkyl groups on R” of formula IA, the explicit teaching of Formula IA, which contains a genus of compounds that read on instant claims 1-6 and 20-25, renders these claims prima facie obvious.
Applicant Argues:
Applicant argues that there is not sufficient motivation to arrive at an R1 group of C10 or C12 based on the teachings of the prior art. Applicant argues that the compounds of Amaravadi et al. are not taught to form nanoparticles.
Examiner Responds:
Applicant's arguments filed 11/20/2025 have been fully considered but they are not persuasive. Applicant’s argument that there is no motivation to select an R1 group of C10 or C12 in the prior art is not persuasive in view of the explicit teaching that R” may be C1-12 alkyl, as taught in the definition of Formula IA of the prior art. The prior art stating that the preferred embodiment contains an R” group having C1-8 alkyl does not negate that the art teaches that R” can be C10-12 alkyl. It would be prima facie to one of ordinary skill in the art to select a longer alkyl chain in this limited genus which overlaps with the instant compounds, since it is explicitly taught and would not require alternate synthesis methods.
With regards to Applicant’s claim that Amaravadi et al. does not teach the formation nanoparticles, instant claims 1-6 and 20-25, which are currently being rejected, do not teach that the compounds are nanoparticles. Therefore, this reasoning is moot. Additionally, MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Even though the formation of nanoparticles was not known in the prior art, since the compounds of the prior art read on the instant claims, this is not patentably new.
New Objections
Claim 2 is objected to because of the following informalities:
Claim 2, in line 4, reads “W is C3-12 cycloalkyl or C6-12 aryl,, …”. This extra comma should be removed.
Appropriate correction is required.
New Rejections
Necessitated by Claim Amendment
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-3, 20, 21, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Amaravadi et al. (WO 2016022956 A1).
Amaravadi et al. teaches, on page 41, compound XX2, shown below, where R2a and R2b are H; R3a and R3b are Cl; X is absent; m is 2; n is 3; R1 is –(L-Y)p-Z; L is C3 alkylene; Y is absent; and Z is -NH2.
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Amaravadi et al. fails to teach this compound where L is C4 alkylene rather than C3 alkylene, as in instant claims 1-3, 20, 21, and 23.
However, The CCPA has defined a homologous series as a family of chemically related compounds, the composition of which varies from member to member by a -CH2 (one atom of carbon and two hydrogen). In re Coes, Jr. (CCPA 1949) 173 F2d 1012, 81 USPQ 369. The Court of Appeals for the District of Columbia applied a broader definition and defined a homolog (homologue) as a member of a series of compounds in which each member differs from the next member by a constant number of atoms. Carr. Pats.v. Deutsche Gold-und-Sllber, etc. (CADC 1968) 397 F2d 656,157 USPQ 549.
The "Hass-Henze Doctrine" evolved from three CCPA cases, viz., In re Hass et al. (CCPA 1944) 141 F2d 122 and 127, 60 USPQ 544 and 548; and In re Henze (CCPA 1950) 181 F2d 198, 85 USPQ 261. In the Henze decision, the Court said:
"The nature of homologues and the close relationship the physical and chemical properties of one member of a series bears to adjacent members is such that a presumption of unpatentability arises against a claim directed to a composition of matter, the adjacent homologue of which is old in the art. The burden is on the applicant to rebut that presumption by a showing that the claimed compound possesses unobvious or unexpected beneficial properties not actually possessed by the prior art homologue. It is immaterial that the prior art homologue may not be recognized or known to be useful for the same purpose or to possess the same properties as the claimed compound. The CCPA concluded that because the characteristics normally possessed by members of a homologous series are principally the same, varying gradually from member to member, chemists knowing the properties of one member of a series would in general know what to expect in adjacent members so that a mere difference in degree is not the marked superiority which will ordinarily remove the unpatentability of adjacent homologues of old substances. Contra, where no use for the prior art compound is known. In m Stemniski (CCPA 1971) 444 F2d 581, 170 USPQ 343, and cases cited therein. Whether a compound is patentable over a prior art homologue or isomer is a question to be decided in each case. In re Hass et al., supra."
The 'Hass-Henze Doctrine" stands for the proposition that, "If that which appears at first blush to be obvious though new is shown by evidence not to be obvious then the evidence prevails over surmise or unsupported contention and rejection based on obviousness must fail." In re Papesch (CCPA 1963) 315 F2d 381, 137 USPQ 43, 48. The presumption that homologues are unpatentably obvious is an inference of fact, viz., that adjacent homologs are expected to have similar properties which places a 'burden of persuasion' on the applicant who asserted a contrary fact. In re Mills (CCPA 1960) 281 F2d 218, 126 USPQ 513.
Compounds that differ only by the presence of an extra methyl group are homologs. Homologs are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homolog. The homolog is expected to be capable of preparation by the same method and to have the same properties. This expectation is then deemed the motivation for preparing homologs. Homologs are obvious even in the absence of a specific teaching to methylate, In re Wood 199 USPQ 137; In re Hoke 195 USPQ 148; In re Lohr 137 USPQ 548; In re Magerlein 202 USPQ 473; In re Wiechert 152 USPQ 249; Ex parte Henkel 130 USPQ 474; In re Fauque 121 USPQ 425; In re Druey 138 USPQ 39. In all of these cases, the close structural similarity of two compounds differing by only one (or two) methyl groups sufficed; no specific teaching to methylate was present or required. None of these cases has been overruled and indeed the examiner is unaware of any post Lohr case in which motivation is required to put a methyl group on an old compound.
Conclusion
Claims 1-6 and 20-25 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 9-5.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624