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 .
2nd Non-Final Rejection
The reasons for this 2nd Non-final are described below:
The previous Office Action included a rejection of claims 23 and 28-29 under 35 U.S.C. 103 as being unpatentable over S. Daluge, USPN 5,049,671 A (09/17/1991). According to STN, Patent USPN 5,049,671 A disclosed the compound below with CAS Reg No. 12132-07-0:
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Applicant’s argument filed on 10/10/2025 inquired about the presence of the compound above in USPN 5,049,671 A “Daluge discloses no compounds wherein the methanol on the cyclopentene is functionalized, let alone esterified.”
In response to Applicant’s argument above, an inquiry sent to STN (CAS Customer Center) with respect to locating the compound with CAS Reg No. 12132-07-0 in the U.S. Patent No. 5,049,671 A. CAS Customer Center determined that USPN 5,049,671 A does not include the compound above. Thus, this 2nd non-final office action is being sent to acknowledge that the compound is incorrectly listed by STN as one of the compounds of USPN 5,049,671 A. However, Daluge’s disclosure still reads on claims 23 and 28-29. See the modified 103 Rejection below.
Priority
This application filed on 03/16/2022, is a continuation of U.S. Application No. 15/517,581 filed 04/07/2017, which is a 371 application of PCT/US2015/054826 filed on 10/09/2015, which claims priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application No. 62/061,759, filed 10/09/2014.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/16/2022, 05/23/2022 and 10/10/2025, complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits, except where noted.
DETAILED ACTION
The Applicant Amendments and Arguments filed on 10/10/2025 has been received and has been carefully considered. Claims 1, and 11 were amended, claims 2-5, 7-9, 16-18, and 24-27 were previously cancelled, and claims 30-34 were added. Claims 1, 6, 10-15, 19-23, and 28-34 are pending.
Claim interpretation
Examination requires claim terms first be construed in terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. See MPEP § 2111. Under a broadest reasonable interpretation, words of the claim must be given their plain meaning, unless such meaning is inconsistent with the specification. See MPEP § 2111.01. It is also appropriate to look to how the claim term is used in the prior art, which includes prior art patents, published applications, trade publications, and dictionaries. MPEP § 2111.01 (III). However, specific embodiments of the specification cannot be imported into the claims, particularly where the subject claim limitation is broader than the embodiment. MPEP § 2111.01(II).
Claim interpretation for claim 1 term “amphiphilic”
The instant specification defines the “amphiphilic” as:
the term "amphiphilic" means the ability to dissolve in both water and lipids/a polar environments. Typically, an amphiphilic compound comprises a hydrophilic portion and a hydrophobic portion. "Hydrophobic" designates a preference for a polar environment (e.g., a hydrophobic substance or moiety is more readily dissolved in or wetted by non-polar solvents, such as hydrocarbons, than by water). "Hydrophobic" compounds are, for the most part, insoluble in water. As used herein, the term "hydrophilic" means the ability to dissolve in water. [Pg. 25, ln. 7-14].
As such, under broad reasonable interpretation, the amphiphilic is interpreted consistent with instant specification.
Claim interpretation for claim 1 term “targeting ligand”
The instant specification defines the term “targeting ligand” as:
the term "targeting ligand" refers to any compound which specifically binds to a specific type of tissue or cell type, particularly without substantially binding other types of tissues or cell types. Examples of targeting ligands include, without limitation: proteins, polypeptides, peptides, antibodies, 25IPTS/115, antibody fragments, hormones, ligands, carbohydrates, steroids, nucleic acid molecules, and polynucleotides. [Pg. 25, ln. 30-Pg. 26, ln. 2].
As such, the targeting ligand is interpreted consistent with the instant specification.
Claim interpretation of claim 28 term “aliphatic”
The instant specification defines the term “aliphatic” as:
“term "aliphatic" refers to a non-aromatic hydrocarbon-based moiety. Aliphatic compounds can be acyclic (e.g., linear or branched) or cyclic moieties (e.g., alkyl and cycloalkyl) and can be saturated or unsaturated (e.g., alkyl, alkenyl, and alkynyl). Pg. 26, ln. 3-10].”
As such, the term aliphatic is interpreted consistent with the instant specification.
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.
Claims 23 and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over S. Daluge (USPN 5049671 A, 09/17/1991, “Daluge” cited in the PTO-892 dated 04/11/2025).
Daluge teaches 6-substituted purine carbocyclic nucleosides of formula I and formula Ia and a pharmaceutically acceptable derivative thereof, for the treatment of HIV and HBV infections [Pg. 3, col. 2 and 3], for example Daluge teaches species of formula I, [Pg. 15, col. 28, Example 47]:
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Daluge teaches that by “a pharmaceutically acceptable derivative” is meant pharmaceutically or pharmacologically acceptable salt, ester or salt of such ester of a compound according to the invention which, upon administration to the recipient, is capable of providing (directly or indirectly) a compound according to the invention, or an antivirally active metabolite or residue thereof, wherein preferred esters of the compounds of the invention include carboxylic acid esters in which the non-carbonyl moiety of the ester grouping is selected from straight or branched chain alkyl, e.g., n-propyl, t-butyl, n-butyl, etc., wherein any alkyl moiety present advantageously contains 1-18 carbon atoms. [Pg. 4, col. 5, ln. 21-47].
Daluge teaches that the compounds are used in the manufacture of a medicament for the treatment HIV infections or conditions. [Pg. 4, col. 5, ln. 19-21].
While Daluge does not explicitly provide a compound where the above OH group of the compound of Example 47 is esterified to form an alkyl ester e.g., C1-18 alkyl ester, Daluge provides the requisite teachings and guidance to one of ordinary skill in the art to envisage the claimed compound as described below:
Daluge teaches the compound of Ex. 47 above, wherein the compound is represented by “a pharmaceutically acceptable derivative” preferably ester derivative, wherein the ester is preferred for its capability to provide the compound upon administration to the recipient; Daluge teaches that the ester provides an antivirally active metabolite [Col. 5, 22-29]; Daluge teaches that the preferred esters of the above compound are advantageously contains 1-18 carbon atoms [Pg. 4, col. 5, ln. 21-47]; and Daluge specifically listed n-butyl as one of the preferred esters. Therefore, one of ordinary skill in the art would have been reasonably envisaged the ester i.e., C4 ester of the above Daluge compound. Moreover, As provided in MPEP 2144.09, a prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963). In the instant case, the claimed compound is directed toward the treatment of HIV, and Daluge teaches that the compounds are used in the manufacture of a medicament for the treatment HIV infections or conditions. [Pg. 4, col. 5, ln. 19-21]. Furthermore, Prior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979). A claimed compound may be obvious because it was suggested by, or structurally similar to, a prior art compound even though a particular benefit of the claimed compound asserted by patentee is not expressly disclosed in the prior art. In re Dillon, 919 F.2d 688, 693, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc). Therefore, in view of Daluge disclosure and MPEP 2144.09 guidance, claims 23, 28, and 29 are obvious over Daluge.
Allowable Subject Matter
Claims 1, 6, 10-15, 19-22, and 30-34 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art is considered to be S. Daluge (USPN 5,049,671 A, 09/17/1991, “Daluge” cited in the PTO-892 dated 04/11/2025).
Instant claim 1 recites “A nanoparticle comprising an amphiphilic block copolymer comprising at least one block of poly(oxyethylene) and at least one block of poly(oxypropylene) coating a crystal of a compound having the formula:
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wherein R is a C4-C22 unsaturated or saturated aliphatic or alkyl chain.
As discussed in the 103 Rejection above, the instant compounds of claims 1 and 23 are obvious over Daluge. However, Daluge does not teach a crystal of the compound that is coated in a nanoparticle comprising an amphiphilic block copolymer comprising at least one block of poly(oxyethylene) and at least one block of poly(oxypropylene). To arrive at the instantly claimed invention, one of ordinary skill in the art would have to prepare a nanoparticle comprising the above amphiphilic copolymer of the Daluge’s compound. However, Daluge’s disclosure does not provide sufficient guidance and motivation to one of ordinary skill in the art to prepare such nanoparticle. Therefore, Daluge’s disclosure does not anticipate or render the instant claims 1, 6, 10-15, and 19-22 as obvious.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1, 6, 10-15, 19-22, and 30-34 are allowed. Claims 23 and 28-29 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MANAHIL MIRGHANI ALI ABDALHAMEED whose telephone number is (571)272-1242. The examiner can normally be reached M-F 7:30 am - 5:00 pm.
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/M.M.A./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/
Supervisory Patent Examiner, Art Unit 1622