DETAILED ACTION
Claims 19-46 are currently pending. Claims 19-22, 25-27 and 36 are currently under examination.
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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 05/20/2026 is acknowledged. The traversal is on the ground(s) that the claims are linked by a single inventive concept and share a common technical features to use specifically recited telodendrimers in combination with non-antibacterial tetracyclines, including CMT-3< for anti-inflammatory application. The cited reference does not disclose or suggest the elected PEG5kCa4Ve4 in combination with CMT-e as recited in the pending claims. This is not found persuasive because the special technical features is a nanocarrier composition comprising one or more telodendrimer suitable for binding one or more tetracyclines and one or more tetracyclines have substantially no antibacterial activity. The special technical feature does not require the tetracycline be present (suitable for binding) and does not require the specific PEG5kCa4Ve4.
The requirement is still deemed proper and is therefore made FINAL.
Claims 28-35, 37-46 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/20/2026.
Applicant's election with traverse of PEG5kCa4Ve4 and CMT-3 in the reply filed on 05/20/2026 is acknowledged. The traversal is on the ground(s) that the claims are linked by a single inventive concept and share a common technical features to use specifically recited telodendrimers in combination with non-antibacterial tetracyclines, including CMT-3< for anti-inflammatory application. The cited reference does not disclose or suggest the elected PEG5kCa4Ve4 in combination with CMT-e as recited in the pending claims. This is not found persuasive because the special technical features is a nanocarrier composition comprising one or more telodendrimer suitable for binding one or more tetracyclines and one or more tetracyclines have substantially no antibacterial activity. The special technical feature does not require the tetracycline be present (suitable for binding) and does not require the specific PEG5kCa4Ve4.
The requirement is still deemed proper and is therefore made FINAL.
Claims 23-24 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 05/20/2026.
Priority
The instant application is a national stage entry of PCT/US2023/010041, filed 01/03/2023, which claims priority to provisional applications 63/296,389, filed 01/04/2022 and 63/296,420, filed 01/04/2022.
Information Disclosure Statement
No Information Disclosure Statement has been filed in the instant application. Applicants are reminded of their duty to disclose all information known to them to be material to patentability as defined in 37 C.F.R. 1.56.
Claim Objections
Claims 21, 25 and 36 is objected to because of the following informalities: Claims 21, 25 and 36 contain the limitations PEG5kCA4Ve4, PEG 5kCa4Ura4 and PEGnkCVa4-L-VE4, wherein abbreviations of PEG, CA, Ve, Ura and nk are used without being previously defined. It is also noted that “Ve” and “VE” are used, wherein if referring to vitamin E [0088] in both instances it would be appropriate to use a single abbreviation and not mix capital and lowercase letter. Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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 20, 25 and 27 is 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 20 recites the limitation "the tetracycline". There is insufficient antecedent basis for this limitation in the claim. Claim 19, from which it depends, recites one or more tetracyclines, wherein “the tetracycline” does not properly refer back to “one or more”.
Regarding claim 25, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claim 25 contains “(such as wherein n=…), wherein both the term such as and the use of parenthesis leads to unclear metes and bounds in the claim as to whether the limitation following such as and included in parenthesis is required or not.
Claim 27 recites wherein CMT-3 is physically bound to the one or more telodendrimer. It is unclear if the CMT-3 is in addition to the “one or more tetracycline” recited in claim 19 or is an additional component, as it does refer back to the one or more tetracycline in instant claim 19. Thus the claim has unclear metes and bounds as to if two components are required (one or more tetracycline and CMT-3) or if the CMT-3 is the one or more tetracycline thus requiring just one component.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 19-22, 25-26 and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huang (Huang, Wenzhe, et al., Mol. Pharmaceutics, 2015, 12, 1216-1229).
Regarding claim 19-22, 25-26 and 36, the limitation of a nanocarrier composition comprising one or more telodendrimers suitable for binding to tone or more tetracyclines; and one or more tetracyclines have substantially no antibacterial activity is met by Huang teaching telodendrimers for delivery of gambogic acid in colon cancer treatment (title) composed of linear PEG blocking dendritic oligomer of cholic acid (CA) and vitamin E (VE) have been designed with architecture optimized for efficient delivery of GA and other natural anticancer compounds. The two telodendrimers were segregated CA and VE domains self-assembled into stable cylindrical and/or special nanoparticles after being loaded with GA (abstract). The structure of PEG5kCA4VE4 (VET2) is taught (Scheme 1, the elected telodendrimer).
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Regarding the limitation of “suitable for binding…” and the specifically elected CMT-3, is intended use, wherein the elected telodendrimer is taught and therefore capable of binding the specific tetracycline. Suitable to bind does not require the specific CMT-3 be present.
Claim Rejections - 35 USC § 103
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) 19-22, 25-27 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0328742 in view of Huang and US 5,773,430.
The ‘742 publication teaches nanocarriers comprising linear dendritic telodendrimers having desirable loading properties and stabilized structure and can be used efficient in vivo delivery (abstract). The structure of PEG5kCA4Rf4 is taught (Figure 1 & 13).
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Doxorubucin (DOX) is one of the most popular anthracycline chemo drugs used for treatment of many cancers [0004]. The nanocarriers taught have desirable loading properties and have stabilized structure for efficient in vivo drug delivery. The nanoparticles have sizes of 20-40 nm [0007]. The telodendrimers have two functional segments hydrophilic PEG and hydrophobic cholic acid [0008]. The nanocarriers comprising a self-assembled plurality of the telodendrimer that form a nanocarrier having hydrophobic core and hydrophilic exterior. The nanocarriers have a hydrophobic pocket formed in the interior of the nanocarrier [0010]. The administration of one or more drugs is taught [0012]. A telodendrimer moiety is taught to be cholic acid, riboflavin (Fr) and vitamin E [0059]. The treatment is taught to include inflammation (statement 11). It is noted that encapsulate in the telodendrimer reads on “binding” absent a clear definition.
The ‘742 publication does not specifically teach binding one or more tetracyclines; and one or more tetracyclines have substantially no antibacterial activity (claim 19) wherein the tetracycline is CMT-3 (claim 20) wherein CMT-3 is physically bound to one or more telodendrimers (claim 27).
The ‘742 publication does not specifically teach the telodendrimer structure of claim 24.
Huang teaching telodendrimers for delivery of gambogic acid in colon cancer treatment (title) composed of linear PEG blocking dendritic oligomer of cholic acid (CA) and vitamin E (VE) have been designed with architecture optimized for efficient delivery of GA and other natural anticancer compounds. The two telodendrimers were segregated CA and VE domains self-assembled into stable cylindrical and/or special nanoparticles after being loaded with GA (abstract). The structure of PEG5kCA4VE4 (VET2) is taught (Scheme 1, the elected telodendrimer).
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The ‘430 patent teaches method of inhibiting activity of serine proteinase comprising administering hydrophobic tetracycline to reduce tissue destruction during inflammation (abstract). Tetracyclines such as doxyclycine Is taught to be used for infection but can lead to undesirable side effects such as reduction of healthy flora (column 3, lines 5-15). Chemically modified tetracyclines (CMT’s) include CMT-3 (column 3, lines 35-45) which is taught to inhibit inflammatory destruction (column 5, lines 5-10, column 6, lines 10-25, column 7, lines 20-30). The tetracycline is taught to be hydrophobic (title).
It would have been prima obvious to one of ordinary skill in the art before the filing date of the claimed invention to use CMT-3 in the nanocarriers taught by the ‘742 publication because the ‘742 publication teaches the nanocarriers to be used to treat inflammation and the ‘430 publication teaches CMT-3 to be used to treat inflammation. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘742 publication teaches the inclusion of hydrophobic in the nanocarrier to encapsulate active agents and the ‘430 patent teaches the CMT-3 to be a hydrophobic active agent. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success and motivation to use CMT-3 in the nanocarriers taught by the ‘742 publication because the ‘742 publication teaches drug delivery of cycline drugs for treatment of inflammation and the ‘430 patent teaches tetracycline active agent to be delivered to treat inflammation wherein the benefits include treating inflammation while avoiding the undesirable side effects such as reduction of healthy flora.
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use a combination of cholic acid and vitamin E groups on the telodendrimer as taught by Huang for the telodendrimer taught by the ‘742 publication because Haung teaches linear PEG blocking dendritic oligomer of cholic acid (CA) and vitamin E (VE) have been designed with architecture optimized for efficient delivery. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use CA and VE on the telodendrimer in order to optimize drug delivery. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as Huang and the ‘742 publication are both directed to telodendrimers used as nanocarriers wherein the telodendrimer contains PEG with Cholic acid moieties and wherein Vitamin E is taught to be moiety that my be used, thus making it obvious to use the specific structure taught by Haung for the telodendrimer taught by the ‘742 publication.
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 19 and 25-26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,369,614. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘614 patent teaches a telodendrimer comprising PEG groups and CA groups wherein the telodendrimer is taught to be a nanocarrier for an active agent such as anthracycline, rendering obvious the nanocarrier composition comprising a telodendrimer comprising PEG and CA groups which is suitable to for binding one or more tetracyclines, as the telodendrimer of the ‘614 patent contains the same PEG and CA groups and is taught as an active agent carrier and thus capable of binding one or more tetracyclines absent factual evidence to the contrary.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/ Examiner, Art Unit 1613
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