--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 .
Applicant’s response dated January 19, 2026 is acknowledged.
Priority
This application is a CIP of PCT/CN2022/115489 filed on 08/29/2022, which claims foreign priority in Chinese application CN202111003702.1 filed on 08/30/2021.
Claim Status
Claims 1-20 are pending and examined.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1-10), drawn to a liposome in the reply filed on January 19, 2026, is acknowledged.
Claims 1-10 were searched and they are not anticipated nor obvious over the prior art of record as described in below.
Pursuant to the procedures set forth in MPEP § 821.04(a), the restriction requirement among Groups I-IV, as set forth in the Office action mailed on November 20, 2025, hereby is withdrawn and method claims 11-20 are rejoined and fully examined for patentability under 37 CFR 1.104. In view of the withdrawal of the restriction requirement, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant pplication. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
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 6 and 10-20 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.
Claim 6 requires the tumor cell membrane protein (CMP) to be one or more selected from the group consisting of RG2, C6, U251, U87, and BT-325. The claim is indefinite because RG2, C6, U251, U87, and BT-325 are tumor cells and not tumor cell membrane proteins. For the purpose of searching and applying prior art, the claim is interpreted to require a tumor CMP obtained from a tumor cell selected from the group consisting of RG2, C6, U251, U87, and BT-325.
Claim 10 recites the limitation "the MCT" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the TPGS" in lines 3-4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the soybean phospholipid" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the DSPE-PEG2000-Tf" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the glycerol" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the osmotic pressure regulator" in line 6. There is insufficient antecedent basis for this limitation in the claim.
The term “high-speed” in claim 11 is a relative term which renders the claim indefinite. The term “high-speed” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 11 is a method of making the composition of claim 1, where the method steps account for every component of the composition required by claim 1 except for absolute ethanol. Claim 11 is indefinite because it does not recite absolute ethanol in the method of making the composition of claim 1.
Claim 13 recites the limitation "the osmotic pressure regulator" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the glycerol" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the glucose" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the sucrose" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the trehalose" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the maltose" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the mannitol" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 is indefinite because it recites a method of use of the composition of claim 1 in a treatment of glioma without setting forth any steps involved in the process.
Claim 17 is indefinite because it recites a method of use of the composition of claim 1 in preparation of a drug for treating glioma, without setting forth any steps involved in the process.
Claims 12, 14, 15, and 18-20 are indefinite because the claims depend from an indefinite claim.
Allowed Claims
Claims 1-5 and 7-9 are allowed.
The closes prior art of record is Xie (CN 109260156 A Published January 25, 2019 – English language machine translation appended thereto) and Ishida (Pharmaceutical Research, Vol. 18, No. 7, 2001, pages 1042-1048).
Xie teaches cabazitaxel-elemene composite liposome and its preparation method and application. The cabazitaxel-elemene composite liposome is prepared by the following method: the cabazitaxel is dissolved in absolute ethyl alcohol, followed by adding polyethylene glycol derivative, cholesterol, phospholipids, and elemene, and raising the temperature to 70~90 degrees centigrade to obtain the organic phase; glycerol and water are mixed at 50~70 degrees centigrade to obtain the water phase, and then the organic phase and the water phase are combined under shearing at high speed and then homogenized at high pressure; thereby obtaining the composite liposome, wherein mass ratio of cabazitaxel to elemene is 1: 10 ~ 150 (Abstract). Examples 2-10 (pages 7-9) teach specific examples of composite liposomes. The composite liposome had curative effect increased up to 7~14 times for the taxol-resistant colon cancer (top of page 10).
Xie does not teach DSPE-PEG-Tf.
The teachings of Ishida are related to transferrin (TF)-pendant-type polyethyleneglycol (PEG)-liposomes (TF-PEG-liposomes), in which TF was covalently linked to the distal terminal of PEG chains on the external surface of PEG-liposomes as a carrier for in vivo cytoplasmic targeting to tumor cells. Small unilamellar TF-PEG-liposomes (100–140 nm in diameter)
were prepared from DSPC, CH, DSPE-PEG, and DSPEPEG-COOH (2:1:0.11:0.021, molar ratio), and were conjugated to TF via the carboxyl residue of DSPE-PEG-COOH. The intracellular targeting ability of TF-PEG-liposomes to tumor cells was examined in vitro and in Colon 26 tumor-bearing mice. TF-PEG-liposomes, bearing approximately 25 TF molecules
per liposome, readily bound to mouse Colon 26 cells in vitro and were internalized by receptor-mediated endocytosis. TF-PEG-liposomes showed a prolonged residence time in the circulation and low RES uptake in Colon 26 tumor-bearing mice, resulting in enhanced extravasation of the liposomes into the solid tumor tissue. Electron microscopic studies in Colon 26 tumor-bearing mice revealed that the extravasated TF-PEG-liposomes were internalized into tumor cells by receptor-mediated endocytosis. TF-PEG-liposomes had the capabilities of specific receptor
binding and receptor-mediated endocytosis to target cells after extravasation into solid tumors in vivo. Such liposomes should be useful for in vivo cytoplasmic targeting of chemotherapeutic agents or plasmid DNAs to target cells (page 1042, left column).
It would have been obvious to combine the teachings of Xie and Ishida because both references are concerned with liposomes intended for treating colon cancer. It would have been obvious to modify Xie’s liposomes by adding DSPE-PEG-Tf, with a reasonable expectation of success because it was known from Ishida that liposomes made from DSPC, CH, DSPE-PEG, and DSPE-PEG-Tf bind to cancer cells and are readily internalized into tumor cells by receptor-mediated endocytosis. Thus, modifying Xie in view of Ishida would have improved Xie’s liposomes.
Neither Xie nor Ishida teach forming the liposomes with tumor cell membrane proteins.
The claimed invention would not have been obvious over the prior art of record because a person skilled in the art would not have been motivated to further modify Xie’s liposome by forming the liposome with a tumor cell membrane protein. Additionally, it would not have been obvious to form the Xie’s liposome having each of the components in a range of concentrations that renders the claimed ranges obvious because no prior art was found that teaches a suitable concentration of tumor cell membrane protein in a composition intended for cancer treatment, or specifically in a liposome.
Conclusion
Claims 1-5 and 7-9 are allowed. Claims 6 and 10-20 are rejected.
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/ALMA PIPIC/Primary Examiner, Art Unit 1617