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 .
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.
Withdrawn Rejections
The examiner previously rejected the instant claims as anticipated by Zhong et al. (CN 112076159 A). This rejection has been withdrawn in view of applicant having provided an English language copy of the foreign priority document. As such, the effective filing date of the instant application is understood to be 14 September 2020. This is earlier than the publication date of Zhong, which is 15 December 2020. As such, Zhong is no longer considered to be prior art, and the previously applied anticipation rejection over Zhong has been withdrawn.
Claim Rejections - 35 USC § 112(b) – Indefiniteness
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 1 and 9 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 1 recites the following, which is reproduced below.
PNG
media_image1.png
50
620
media_image1.png
Greyscale
PNG
media_image2.png
104
624
media_image2.png
Greyscale
That the claim recites text in parentheses is understood to render the claim indefinite. For example, it is unclear if the limitation regarding the 3000-8000 Da molecular weight applies to all hydrophilic chain segments or only those delineated with the subscript “m.” It is unclear whether the 2.5-6 times that of the hydrophilic chain segments applies to all hydrophobic segments, or only those delineated with the subscripts “x” and “y.” Furthermore, that the claim appears to define polylactic acid chain segments as the polymer blocks delineated with the subscript “n” would appear to go against the specification on page 3, lines 1-3, which indicates that the “n” chain is polyaspartic acid (abbreviated as “PAsp.”). Also, it is unclear if n is between 5 and 20, or if n is 17-50% of the molecular weight of the hydrophilic chain segments. As such, it is unclear how the claim requirements in parentheses further limit claim 1.
For the purposes of examination under prior art, the examiner will examine the claims with the understanding that
The block “m”, which is actually a polyethylene glycol block, has a molecular weight between 3000-8000 Da. This is about 68 to 182 repeat ethylene glycol units, given a 44 Dalton molecular weight for each repeat unit.
The blocks “x”+“y” have a combined molecular weight of about 7500 Daltons to about 48,000 Daltons. The minimum value of about 7500 Daltons is calculated as 2.5 multiplied by 3000 Daltons. The maximum value of 48,000 Daltons is calculated as 6 multiplied by 8000 Daltons.
The molecular weight of the block delineated as “n”, which the examiner understands to be polyaspartic acid, is understood to be in the range of about 510 Daltons to about 4000 Daltons. The minimum value is calculated as 3000 multiplied by 0.17. The maximum value is calculated as 8000 multiplied by 0.5. Polyaspartic acid is understood to have a molecular weight of about 99 Daltons per repeat unit. As such, the value of 510 Daltons is about 5 repeat units, and the value of 4000 Daltons is about 40 repeat units. The examiner notes that the upper end of this range conflicts with requirements elsewhere in the claim that n be between 5 and 20 repeat units; however, for the purposes of examination under prior art, the examiner has assumed that the broader range of n being between 5 and 40 limits the claim.
Response to Arguments Regarding Indefiniteness Issues
The applied indefiniteness rejection is understood by the examiner to be a new ground of rejection necessitated by applicant’s claim amendments. The examiner has not substantively addressed the arguments presented by applicant regarding the indefiniteness issues in applicant’s response on 3 November 2025. This is because applicant’s arguments appear to relate to indefiniteness rejections that have been withdrawn. In contrast, the applied rejection is a new ground of rejection necessitated by applicant’s amendment; as such, the arguments presented do not appear to be applicable and have not been addressed substantively by the examiner.
Claim Interpretation
The examiner understands claim 1 to require that the presence of a peptide is optional. The examiner has annotated claim 1 in the following manner to best explain this position.
PNG
media_image3.png
272
695
media_image3.png
Greyscale
As such, the peptide is understood to be optional.
For the purposes of examination under prior art, a composition lacking a peptide is understood to be within the scope of claim 9, as is a composition comprising one of the recited peptides. However, a composition comprising a peptide different from one of the recited peptides of claim 9 is not understood to be in the scope of claim 9.
Claim Rejections - 35 USC § 103 – Obviousness
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.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meng et al. (CN 110229323 A1) in view of Sikic et al. (US 2007/0009535 A1).
Meng was originally published in Chinese. The examiner has provided an English-language translation. All page and paragraph citations are to the English language translation unless indicated otherwise. The material cited in the English translation is assumed by the examiner to be present in the original Chinese document.
Meng et al. (hereafter referred to as Meng) is drawn to a polymer vesicle with an asymmetric membrane structure intended for treatment of liver cancer, as of Meng, page 1 of translation, title and abstract. The polymer of Meng may be of the following structure, as of Meng, page 1/19 of original document, paragraph 0004, relevant diagram reproduced below.
PNG
media_image4.png
278
458
media_image4.png
Greyscale
As such, the amphiphilic block copolymer of Meng appears to be essentially the same as the amphiphilic block copolymer of the instantly claimed invention.
Meng differs from the claimed invention because Meng does not teach the required anti-cancer agent.
Sikic et al. (hereafter referred to as Sikic) is drawn to treatment of cancer patients, as of Sikic, title and abstract. Sikic teaches administration of various agents to treat cancers, as of Sikic, paragraph 0150,
PNG
media_image5.png
316
408
media_image5.png
Greyscale
As such, Sikic teaches mitoxantrone and daunorubicin to treat liver cancer.
Sikic does not teach the required polymer structure.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the active agents of Sikic with the composition of Meng. Meng is drawn to a composition intended to treat liver cancer, as of Meng, title and abstract. Sikic teaches that daunorubicin and mitoxantrone are useful for treating liver cancer. As such, the skilled artisan would have been motivated to have combined the daunorubicin and mitoxantrone of Sikic with the composition of Meng for predictable treatment of liver cancer with a reasonable expectation of success. Combining prior art elements (e.g. the daunorubicin and mitoxantrone of Sikic with the composition of Meng) according to known methods to yield predictable results (treatment of liver cancer) is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
As to claim 1, the claim requires a particular small molecule which may be vincristine sulfate, daunorubicin, or mitoxantrone. Sikic teaches daunorubicin and mitoxantrone, and also teaches vincristine (but does not specify the sulfate counter-ion).
As to claim 1, Meng teaches a hydrophilic molecular weight of 3000-10,000 Da, as of page 16 of translation, claim 7 of Meng. This overlaps with the claimed range of 3000-8000 Da.
As to claim 1, the examiner has interpreted the claim as requiring a hydrophobic block with a molecular weight of between about 7500 and 48,000 Daltons. See the section above under 35 U.S.C. 112(b). Meng teaches the following on page 7 of translation, top two lines, reproduced below.
PNG
media_image6.png
40
706
media_image6.png
Greyscale
This appears to be a teaching of DTC+TMC, which appear to be the hydrophobic blocks, of 17 kDa in total. The value of 17 kDa is calculated by adding 2k+15k, wherein the examiner understands the abbreviation “k” in this context to refer to kilodaltons, wherein 1 kilodalton is 1000 Daltons or 1000 grams per mole. This would appear to be within the scope of what claim 1 requires regarding the molecular weight of the hydrophobic block. See the above rejection under 35 U.S.C. 112(b) for more explanation of this issue.
As to claim 1, the claim is understood by the examiner to require that n is 5-40; see the above rejection under 35 U.S.C. 112(b). Meng appears to provide motivation for the skilled artisan to have optimized the polyaspartic chain length, as of at least Meng, page 8 of translation, description of Table 6 and page 9 of translation at bottom, description of Table 8. It would have been prima facie obvious for one of ordinary skill in the art to have optimized a result-effective variable. See MPEP 2144.05(II)(B).
As to claim 9, the examiner understands the above rejection to be applicable to claim 9 because claim 9 is not understood by the examiner to require a particular peptide. See the section above entitled “Claim Interpretation.” The examiner has presented an additional ground of rejection below under the assumption that the peptide of claim 9 is required rather than optional.
Claim(s) 1 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meng et al. (CN 110229323 A1) in view of Sikic et al. (US 2007/0009535 A1), the combination further in view of Finlayson et al. (US 2019/0381127 A1)
Meng teaches a particular polymer. Sikic teaches an anti-cancer agent. See the rejection above over Meng in view of Sikic by themselves.
For the purposes of this rejection, the examiner understands that neither Meng nor Sikic teach the required peptide.
Finlayson et al. (hereafter referred to as Finlayson) is drawn to a cancer treatment, as of Finlayson, title and abstract. Finlayson teaches the peptide KPSSPPEE for treating cancer, as of paragraph 0052; this appears to be the same as the peptide labeled as “Seq. ID #1.”
Finlayson does not teach the required polymer structure.
It would have been prima facie obvious for one of ordinary skill in the art to have combined the peptide of Finlayson with the composition of Meng. Meng is drawn to a composition intended to treat liver cancer, as of Meng, title and abstract. Finlayson teaches that the peptide with the sequence KPSSPPEE is useful for treating cancer. As such, the skilled artisan would have been motivated to have combined the peptide of Finlayson with the composition of Meng for predictable treatment of cancer with a reasonable expectation of success. Combining prior art elements (e.g. the peptide of Finlayson with the composition of Meng) according to known methods to yield predictable results (treatment of cancer) is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
Response to Arguments Regarding Obviousness Rejections
In applicant’s response on 3 November 2025 (hereafter referred to as applicant’s response), applicant makes the following arguments on page 8.
PNG
media_image7.png
240
646
media_image7.png
Greyscale
The examiner disagrees. Meng teaches and/or renders the above-indicated elements prima facie obvious for the reasons set forth above.
Applicant then argues that the combination of Meng in view of Sikic fails to teach the required peptides of Seq. ID 1, 2, or 3, as of page 9 of applicant’s response. This is not persuasive, as this element has been taught by Finlayson.
Non-Statutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1 and 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 18/012,410 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons:
The instant claims are drawn to a peptide targeted polymer vesicle made from a polymer with a specific structure recited by instant claim 1.
The copending claims are drawn to a drug-loaded polymer vesicle. This vesicle has the specific structure recited by copending claim 1, which appears to be the same as that recited by instant claim 1.
The instant and copending claims differ because the instant claims optionally recite a peptide, which is not recited by the copending claims. Nevertheless, the peptide in the instant claims appears to be optional. As such, the subject matter of the copending claims appears to be within the scope of that of the instant claims. Therefore, the subject matter of the copending claims appears to effectively anticipate that of the instant claims, resulting in a prima facie case of provisional anticipatory-type non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments Regarding Double Patenting Rejections
Applicant takes the position that applicant will address the double patenting rejection upon indication of allowability, if necessary, as of applicant’s response on page 9. In response, the examiner takes the position that the claims are not in condition for allowance other than the double patenting rejection. As applicant has not provided arguments specific to the double patenting rejection, this rejection has been maintained by the examiner.
Conclusion
No claim is allowed.
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 ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Frederick F Krass can be reached at (571)272-0580. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612
Prosecution Insights