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 .
Receipt is acknowledged of Applicant’s Request for Continued Examination and Amendment filed on 01/07/2026; and IDS filed on 06/30/2026, 03/26/2026, and 01/22/2023.
Claims 1, 11 have been amended.
Claims 2-3, 6-7 have been canceled.
Claims 1, 4-5, 8-22, 45-46 are pending in the instant application.
Claims 4-5, 18-22, 46 are withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/07/2026 has been entered.
Claim Rejections - 35 USC § 112, 1st paragraph
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 recite the newly amended limitation of “123Iodine, 124Iodine”; however, the specification as-filed does not provide a written description or set forth the metes and bounds of this phrase. The instant claims now recite limitations which were not clearly disclosed in the specification as-filed and now change the scope of the instant disclosure as-filed. Such limitations recited in the present claims, introduce new concepts and thus violate the written description requirement of the first paragraph of 35 U.S.C. §112.
Applicant is required to cancel the new matter in the response to this Office action. Alternatively, Applicant is invited to identify sufficient written support in the original specification for the "limitations" indicated above.
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.
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, 8-11, 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIU et al (Brachytherapy Using Injectable Seeds That Are Self-Assembled from Genetically Encoded Polypeptides In Situ. Cancer Res (2012) 72 (22): 5956–5965) in view of MOKHTARI et al (Combination therapy in combating cancer. Oncotarget, 2017, Vol. 8, (No. 23), pp: 38022-38043), and MACKAY et al (Self-assembling chimeric polypeptide–doxorubicin conjugate nanoparticles that abolish tumours after a single injection. Nat. Mater. 2009 Dec; 8(12): 993-9).
LIU teaches a self-assembling (see title) composition comprised of: elastin-like polypeptide radiolabeled with 131I (see abstract; and pg. 5956, under Introduction), which reads on one radionuclide coupled to a first elastin-polypeptide. Additional disclosures include: injectable depot of covalently conjugated radionuclide (see pg. 5956, 2nd col); elastin-like polypeptides (ELP) transition temperature is tunable by adjusting the amino acid and molecular weight (see pg. 5956, 2nd col); ELP can be used with radioactivity or other drugs (see pg. 5956, 2nd col); ELP used are VPGVP with 60, 120, 240 pentapeptides and tyrosine residues of 1, 4, or 7 (see pg. 5957, under ELP design and synthesis), which reads on claim 3 and would have the same inherent physical/chemical properties as claimed by Applicant, such as the transition temperature; micelles with sizes of 36.9 nm (see pg. 5959, 1st col), which reads on nanoparticles (see Applicant’s specification at [0077] defining “nanoparticles” to include micelles); 131I (see abstract), which would have the same irradiation properties as claimed by Applicant; the composition is used as brachytherapy for treating tumor (see abstract).
LIU does not teach adding a nanoparticle chemotherapeutic.
MOKHTARI teaches the prior art had known of combination therapy, a treatment modality that combines two or more therapeutic agents, is a cornerstone of cancer therapy. The amalgamation of anticancer drugs enhances efficacy compared to the mono-therapy approach because it targets key pathways in a characteristically synergistic or an additive manner (see abstract).
MACKAY teaches nanoparticles (see title) of self-assembling polypeptide-doxorubicin conjugate nanoparticle, wherein doxorubicin is a chemotherapeutic drug and the self-assembling polypeptide is an elastin-like polypeptide (see pg. 993, 1st col), with an amino sequence of SKGPG(XGVPG)160-WPG(GGC)7 (see pg. 994, Fig. 1a)
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Additional disclosures include: micelle (see pg. 994, Fig. 1b and pg. 996, 2nd col); spontaneous formation of nanoparticles (see abstract); elastin-like polypeptide undergo inverse phase-transition in aqueous solutions at a characteristic transition temperature (Tt), above which they desolvate and phase separate from bulk water (see pg. 993); treats tumor (see abstract).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a nanoparticle chemotherapeutic drug as taught by MACKAY. The person of ordinary skill in the art would have been motivated to make those modifications, because adding another type of drug for treating cancer would have an additive effect in treating the cancer, and reasonably would have expected success because both references dealt in the same field of endeavor, such as using ELP with a cancer treating agent for treating cancer.
Claim(s) 1, 8-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIU et al (Brachytherapy Using Injectable Seeds That Are Self-Assembled from Genetically Encoded Polypeptides In Situ. Cancer Res (2012) 72 (22): 5956–5965) in view of MOKHTARI et al (Combination therapy in combating cancer. Oncotarget, 2017, Vol. 8, (No. 23), pp: 38022-38043), MACKAY et al (Self-assembling chimeric polypeptide–doxorubicin conjugate nanoparticles that abolish tumours after a single injection. Nat. Mater. 2009 Dec; 8(12): 993-9) and CHILKOTI et al (US 2011/0110866).
As discussed above, LIU in view of MOKHTARI and MACKAY teaches Applicant’s invention.
LIU, MOKHTARI and MACKAY do not teach using a specific chemotherapeutic drug, such as vinblastine or paclitaxel.
CHILKOTI teaches the prior art had known of chemotherapeutics, such as doxorubicin, paclitaxel and vinblastine (see [0129), wherein vinblastine is a cytoskeletal disruptor drug, using ELP as a drug carrier (see [0126]), which would inherently form nanoparticles of micelles (see [0121]) due to their amphiphilic nature (see [0121]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a chemotherapeutic, such as doxorubicin, paclitaxel, and vinblastine into MACKAY’s nanoparticle composition. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because doxorubicin and paclitaxel are functional equivalents of chemotherapeutic drugs.
Claim(s) 1, 8-13, 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIU et al (Brachytherapy Using Injectable Seeds That Are Self-Assembled from Genetically Encoded Polypeptides In Situ. Cancer Res (2012) 72 (22): 5956–5965) in view of MOKHTARI et al (Combination therapy in combating cancer. Oncotarget, 2017, Vol. 8, (No. 23), pp: 38022-38043), and THODETI et al (US 2013/0150432).
LIU teaches a self-assembling (see title) composition comprised of: elastin-like polypeptide radiolabeled with 131I (see abstract; and pg. 5956, under Introduction), which reads on one radionuclide coupled to a first elastin-polypeptide. Additional disclosures include: injectable depot of covalently conjugated radionuclide (see pg. 5956, 2nd col); elastin-like polypeptides (ELP) transition temperature is tunable by adjusting the amino acid and molecular weight (see pg. 5956, 2nd col); ELP can be used with radioactivity or other drugs (see pg. 5956, 2nd col); ELP used are VPGVP with 60, 120, 240 pentapeptides and tyrosine residues of 1, 4, or 7 (see pg. 5957, under ELP design and synthesis), which reads on claim 3 and would have the same inherent physical/chemical properties as claimed by Applicant, such as the transition temperature; micelles with sizes of 36.9 nm (see pg. 5959, 1st col), which reads on nanoparticles (see Applicant’s specification at [0077] defining “nanoparticles” to include micelles); 131I (see abstract), which would have the same irradiation properties as claimed by Applicant; the composition is used as brachytherapy for treating tumor (see abstract).
LIU does teach adding a nanoparticle comprising a chemotherapeutic, such as paclitaxel bound to human serum albumin.
MOKHTARI teaches the prior art had known of combination therapy, a treatment modality that combines two or more therapeutic agents, is a cornerstone of cancer therapy. The amalgamation of anticancer drugs enhances efficacy compared to the mono-therapy approach because it targets key pathways in a characteristically synergistic or an additive manner (see abstract).
THODETI teaches the prior art had known of albumin paclitaxel nanoparticle commercially available as Abraxane (see [0115]), which is paclitaxel bound to human serum albumin, used for treating breast cancer (see [0115]). Additional disclosure include: human serum albumin (see [0148]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a nanoparticle chemotherapeutic drug such as paclitaxel bound to human serum albumin commercially available as Abraxane. The person of ordinary skill in the art would have been motivated to make those modifications, because adding another type of drug for treating cancer would have an additive effect in treating the cancer, and reasonably would have expected success because both references dealt in the same field of endeavor, such cancer treatment
Response to Arguments
Applicant argues that the present application discloses that compositions as claimed significantly outperform standard of care external beam radiotherapy (EBRT) cancer treatment. The present application discloses an additive relationship, at best, between chimeric polypeptide micelles conjugated to paclitaxel (CP-PTX) and 5x5 Gy fractionated EBRT, as shown by the observed tumor sizes being within the bounds of the Bliss prediction's 95% Cl (FIG. 18D). In contrast, compositions including a collection of self-assembling conjugates, including an iodine-based radionuclide coupled to an elastin-like polypeptide (ELP), and a nanoparticle including a chemotherapeutic demonstrate a synergistic response in depressing tumor volume (FIGs. 18A-C). Thus, the present application demonstrates a unique synergy by combining an iodine radiolabeled ELP with a nanoparticle chemotherapy that is not found when using standard of care EBRT.
The Examiner finds this argument unpersuasive, because in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In this instance, Applicant’s independent claim 1 does not recite chimeric polypeptide micelles conjugated to paclitaxel, which appears to be recited separately in claims 13 and claim 15.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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