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 .
Priority
This application filed 09/03/2024 Claims Priority from Provisional Application 63580122, filed 09/01/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/09/2024 complies with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the
examiner.
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.
Claim(s) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Parvin Mahdaviani et al., hereinafter Mahdaviani (Parvin Mahdaviani et al., Materials Science and Engineering C 80 (2017) 301–312) in view of Gary Braun et al., hereinafter Braun (Gary Braun et al., WO2018/085050A1) further in view of Ravi Shanker P. Singh et al., hereinafter Singh (Ravi Shanker P. Singh et al., Clinical Pharmacology in Drug Development 2022,11(7)).
Regarding claim 1, Mahdaviani teaches peptide functionalized PEG-PCL nano micelles for targeted drug delivery (lines 4-7, Abstract) (i.e. first and second amphiphilic block). Specifically, Mahdaviani teaches that polymeric micelles show advantages over traditional drug delivery systems, such as easy intravenous administration by an increase in hydrophobic drug solubility (page 302, lines 19-21). Additionally, as a targeting strategy, a fruitful approach is to utilize tumor specific peptides (page 302, 3rd paragraph). Mahdaviani teaches, a TMT (tumor metastasis targeting) homing peptide conjugated to the surface of the NPs (i.e. PEG-PCL) for promoting efficient and active targeting of the anticancer drug cabazitaxel (see page 302, Introduction last paragraph). Mahdaviani teaches preparation of micelle encapsulated cabazitaxel (i.e. encapsulated in the core) and conjugation of TMP peptide onto PEG-PCL micelles through the -COOH group of the prepared PEG-PCL (see section 2.6) (i.e. targeting moiety covalently coupled to the terminus of the hydrophilic PEG block; i.e. second amphiphilic block).
Mahdaviani does not teach IRAK4 targeting moiety and IRAK4 inhibitor.
Braun teaches tissue targeting peptide, comprising sequence VHPKQHRGGSKGC (SEQ ID NO:11) (i.e. 100 % identity to SEQ ID NO: 1 in instant) (see page 4, line 21) for targeting to inflammation sites (i.e. inflamed tissue) (line 9, page 17).
Singh teaches Zimlovisertib, first-in-class highly selective IRAK 4 inhibitor in the treatment of different inflammatory conditions (see Introduction, 1st three lines).
Obviousness can be established by combining or modifying the teachings of the prior art to
produce the claimed invention where there is some teaching, suggestion, or motivation to do so. In re
Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the
motivation-suggestion-teaching test as a guard against using hindsight in an obviousness analysis).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide-functionalized PEG-PCL nano micelle of Mahdaviani with a targeting peptide as suggested in Braun and an IRAK4 drug suggested in Singh, for delivery of an IRAK4 inhibitor. One motivated to do so would have a reasonable expectation of success, as homing peptide conjugated to NPs (i.e. PEG-PCL) promotes efficient and active targeting of drug (see Mahdaviani: page 302, Introduction last paragraph). Thus, one would have recognized that applying the teaching of Mahdaviani to the method of Braun and Singh, would have yielded predictable results and generated a nanoparticle comprising IRAK4 inhibitor, for targeting to inflamed tissue (See MPEP § 2143 l(A)(D)).
Regarding claim 2, the obviousness rationale has been set forth above. Additionally, Mahdaviani discloses the FTIR spectra in Fig 1 pointing to a peak at 2913 cm−1 attributed to Moc protecting groups of TMT (i.e. second amphiphilic block PEG-PCL) peptide (i.e. about 9:1 weight:weight). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.").
Regarding claim 3, the obviousness rationale has been set forth above. In addition, Singh teaches Zimlovisertib (see Introduction).
Regarding claim 4, Braun teaches inflammation site (e.g., V-CAM-binding peptide VHPKQHRGGSKGC (SEQ ID NO: 11) (see page 17, line 9), which is 100 % identical to instant SEQ ID NO: 1.
Regarding claim 5, the rejection is noted above.
Regarding claim 6, Mahdaviani teaches diluent culture medium (i.e. carrier) (see page 304, section 2.12, line 5).
Regarding claim 7, ‘for delivery…subject’ is interpreted by the examiner as intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children's Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP § 2111. 02 (II)). Examiner interprets the method, comprising administering to a subject in need thereof. Accordingly, Mahdaviani teaches in vitro method of treating human cells with peptide functionalized nanomicelles (see Figs 6-11 (MCF-7 and MDA-MB-231 cells). Additionally, Singh teaches Phase I single-dose study of Zimlovisertib in human subjects (see Methods, page 816) (i.e. administration).
Claim(s) 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Parvin Mahdaviani et al., hereinafter Mahdaviani (Parvin Mahdaviani et al., Materials Science and Engineering C 80 (2017) 301–312) in view of Gary Braun et al., hereinafter Braun (Gary Braun et al., WO2018/085050A1) further in view of Yongbin Chi et al., hereinafter Chi (Yongbin Chi et al., Journal of Drug Targeting, 24:3, 224-232) further in view of Ravi Shanker P. Singh et al., hereinafter Singh (Ravi Shanker P. Singh et al., Clinical Pharmacology in Drug Development 2022,11(7)).
The teachings of Mahdaviani, Braun and Singh, have been set forth above.
Additionally, regarding claim 8, Chi teaches glioma homing peptide-modified PEG-PCL nanoparticles for enhanced anti-glioma therapy (see Title). Specifically, Chi teaches intravenous administration (i.e. systemic) of nanoformulation in glioma-bearing mice (see page 231, section: in vivo anti-glioma efficacy).
Regarding claim 9, Singh teaches human subjects (see Methods, page 816).
Regarding claim 10, ‘for treating…subject’ is interpreted by the examiner as intended use. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children's Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (see MPEP § 2111. 02 (II)). Regarding the claim limitation ‘administering’, Singh teaches Phase I single-dose study of Zimlovisertib in human subjects (see Methods, page 816) (i.e. administration).
Regarding claim 11, Chi teaches intravenous administration (i.e. systemic) of nanoformulation in glioma-bearing mice (see page 231, section: in vivo anti-glioma efficacy).
Regarding claim 12, Singh teaches human subjects as noted above.
Claim(s) 1-15 are rejected under 35 U.S.C. 103 as being unpatentable over Parvin Mahdaviani et al., hereinafter Mahdaviani (Parvin Mahdaviani et al., Materials Science and Engineering C 80 (2017) 301–312) in view of Gary Braun et al., hereinafter Braun (Gary Braun et al., WO2018/085050A1) further in view of Bo Yan et al., hereinafter Yan (Bo Yan et al., Bosn J Basic Med Sci. 2022;22(6):872-881) further in view of Ravi Shanker P. Singh et al., hereinafter Singh (Ravi Shanker P. Singh et al., Clinical Pharmacology in Drug Development 2022,11(7)) further in view of Yongbin Chi et al., hereinafter Chi (Yongbin Chi et al., Journal of Drug Targeting, 24:3, 224-232).
The teachings of Mahdaviani, Braun, Chi and Singh, have been set forth above.
Regarding claim 13, Yan teaches IRAK1/4 inhibitors in an experimental colitis model (See last line of Introduction). Yan discloses that IRAK1/4 inhibitor treatment alleviates symptoms of colitis, intestinal inflammation, mucosal damage and barrier function (see Results).
Consequently, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the peptide functionalized PEG-PCL nano micelle of Mahdaviani with a targeting peptide as suggested in Braun and an IRAK4 drug suggested in Singh, for treatment of colitis as suggested in Yan. One motivated to do so would have a reasonable expectation of success, as Yan specifically discloses alleviation of colitis symptoms and suggests that the experimental studies should translate into clinical applications for patients with ulcerative colitis (see last line of Discussion). Thus, one would have recognized that applying the teachings of Mahdaviani to Braun and Singh, to the method of Yan, would have yielded predictable results to generate a nanoparticle for treating colitis (See MPEP § 2143 l(A)(D)).
Regarding claim 14, Chi teaches intravenous administration (i.e. systemic) (see page 231, section: in vivo anti-glioma efficacy).
Regarding claim 15, Singh teaches human subjects (see Methods, page 816).
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARCHANA VARADARAJ whose telephone number is (571)272-2366. The examiner can normally be reached Monday-Friday 10:00am-5:00pm.
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/ARCHANA VARADARAJ/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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