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
Claims 19-34 are currently pending and a preliminary amendment to the claims filed on 02/10/2026 is acknowledged.
Election/Restriction
Applicant's election with traverse of Group I, claims 19-23 and 30-32 in the Reply filed on 02/10/2026 is acknowledged. Since applicant’s arguments are partially persuasive, restriction to Group III drawn to claims 33-34 (method of use) is withdrawn. Consequently, only claims 24-29 (Group II) have been withdrawn from further consideration. Therefore, claims 19-23 and 30-34 are examined on the merits to which the following grounds of rejections are applicable.
Response to Arguments
Applicant argues that examining Groups I (product), II (a process for preparing) and III (method of use) together does not cause serious burden on examiner.
The Examiner responds that the instant application is a national stage entry of a PCT, which follows Unity of Invention rules. See MPEP § 823. There is no requirement for a showing of undue burden in searching the groups together under the Unity of Invention rules. See MPEP §1893.03(d).
For those reasons, the restriction requirement is deemed proper and made it FINAL.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/02/2023 was filed before the mailing date of the instant first action on the merits. The submission thereof is in compliance with the provisions of 37 CFR 1.97. It is noted that the foreign references have only been considered to the extent that an English language abstract, translation or statement of relevance has been provided to the examiner. Accordingly, the information disclosure statement has been considered by the examiner, and signed and initialed copy is enclosed herewith.
Claim Objections
Claim 30 is objected to because of the below minor informality:
Claim 30 recites “having a nanoformulation as claimed in claim 19”, but which would be better to recite “having the nanoformulation as claimed in claim 19” because claim 30 requires all the limitation of instant claim 19.
Appropriate correction is requested
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19, 22 and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 19, 22 and 30 recites the limitation “sigma receptor targeting ligand (H8)” recited in claims 19 and 30 and “nanoformulation (CSP-H8)” recited in claim 22, however they are vague and indefinite because those claims use parentheses to comment on or quality of the ligand. It is unclear whether the limitations in the parenthesis are meant to be limitations in the claims or whether they are only suggestions/examples. As such, the metes and bounds of the claim cannot be determined. In this respect, please see “parenthetical expressions are not permissible which do not contribute to clearness or exactness in stating Applicant’s invention (Ex parte Cahill, 1893 C. D., 78; 63 O. G., 2125). Clarification is requested.
Until the applicant clarifies, the Examiner sees the said limitations as “sigma receptor targeting ligand H8” in claims 19 and 30 and as nanoformulation containing CSP-H8 in claim 22.
Appropriate correction is required.
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 19-23 and 30-34 are rejected under 35 U.S.C. 103 as being unpatentable over Kandu et al. (IN201841009113A, IDS of 10/02/2023) in view of Pal et al., “Structure-activity study to develop cationic lipid-conjugated Haloperiodol derivatives as a new class of anticancer therapeutics,” Journal of Medicinal Chemistry, 2011, 54, pp. 2378-2390 (IDS of 10/02/2023) and Papadopoulos et al., “Haloperidol induced cell cycle arrest and apoptosis in glioblastoma cells”, Biomedicines, 2020, pp. 1-12.
Applicant claims the below claims 19 and 30 filed on 02/10/2026:
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For examination purpose, note that the term “kit” of instant claim 30 does not carry any patentable weight, because it would have been obvious to provide the known pharmaceutical composition in kit form because packaging a known composition as a kit represents a routine packaging or presentation of the known product and does not change the composition itself, and therefore the kit recited in instant claim 30 is seen as the pharmaceutical composition of instant claim 19.
Determination of the scope and content of the prior art (MPEP 2141.01); Ascertainment of the difference between the prior art and the claims (MPEP 2141.02) and Finding of prima facie obviousness Rational and Motivation (MPEP 2142-2143)
Prior Art
Kandu teaches tumor mass targeting delivery system; in particular, Kandu discloses a conjugate comprising carbon nanospheres (CSP) and a folate receptor targeting ligand (F8), a complex or composition comprising the same (CSP-F8) (e.g., [0001] and [0011]); [0083] of Kandu discloses preparation of CSP-FA where 10 mg CSP and 1.5 mM (=1.5x10-3) solution of folic acid (FA)(Mw 42g/mol)(3mL=0.003L) are used and here, FA is used in 4.5x10-6 mol (=1.5x10-3 x0.003L), and 4.5x10-6 mol x42g Mw= 1.89x10-4g which corresponds to 0.189mg and thus, CSP (10mg) : FA (0.189mg) =1:0.019 which is within the claimed range of 1:0.08 to 1:0.2, MPEP 2144.05:“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).”; and this prior art further teaches administration of the composition containing CSP-F8-DOX to tumor site ([0028] and Fig. 7) (instant claims 19, 30 and 33-34, in part); the CSP is glucose ([0066])(instant claim 20); the conjugate further comprises DOX (doxorubicin) as an anticancer agent ([0014])(instant claims 22 and 31); and the CSP-F8-DOX conjugate is used for targeting tumor cells, tumor epithelial cells (TEC) and tumor-associated macrophages (TAM) in glioblastoma mass ([0018]) (instant claims 23 and 32-34: targeting TEC and TAM).
However, Kandu does not expressly teach sigma receptor targeting ligand H8 of instant claims 19, 21, 30 and 33-34. The deficiency is cured by Pai and Papadopoulos.
Pai discloses Haloperidol(HP), a neuroleptic drug, shows high affinity toward sigma receptors (SR), HP and reduced-HP at higher concentration were known to induce apoptosis in SR-overexpressing carcinomas and melanomas, and development of cationic lipid-conjugated haloperidol as a new class of anticancer therapeutics, and in comparison to HP, the C-8 carbon chain analogue (HP-C8) showed significantly high, SR-assisted antiproliferative activity against cancer cells via caspase-3-mediated apoptosis and down-regulation of pAkt, and moreover, melanoma tumor aggressiveness in HP-C8-treated mice was significantly lower than that in HP-treated mice, and HP derivatives as a promising class of anticancer therapeutic that concurrently affects cancer and tumor environment associated angiogenic vascular cells through induction of apoptosis and Akt protein down-regulation (abstract). That is, Pai teaches H8 is effective to treat carcinomas/tumors.
Papadopoulos discloses haloperidol has antitumoral effect in glioblastoma (GBM) U87, U251 and T98 cell lines, and here, haloperidol reduced viability of glioblastoma cell lines (abstract).
Kandu teaches conjugation of a ligand F8 to a CSP carrier to achieve selective tumor cell targeting. A person of ordinary skill in the art would recognize that CSP is a versatile carrier suitable for functionalization with a variety of bioactive ligands, and the conjugation chemistry is routine (see e.g., ligand F8 is conjugated on the surface of CSP ([0085]) and thus ligands can associate with the surface of CSPs that acts as a nanoparticle platform for ligand conjugation; and Pai and Papadopoulos disclose H8 as a sigma receptor ligand possessing anticancer activity against tumor cells. Therefore, it would have been obvious to a skilled artisan to substitute F8 in the CSP-F8 system with H8 to obtain a CSP-H8 conjugates with the reasonable expectation that H8 would retain its sigma receptor-mediated activity when conjugated to the CSP. Combining the teachings of Kandu and Pai and Papadopoulos would have provided motivation to attach H8 to the CSP carrier for tumor targeting. Such modification would have been made with a reasonable expectation of success in revealing predictable results of anticancer effect, since CSP conjugation are known and H8 is chemically compatible with the CSP functionalization techniques taught in Kandu. Accordingly, the claimed CSP-H8 conjugate would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the combined teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the combined references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYUNG S CHANG whose telephone number is (571)270-1392. The examiner can normally be reached M-F 8-5.
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/KYUNG S CHANG/Primary Examiner, Art Unit 1613