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 .
Election/Restrictions
In response to the restriction requirement dated March 2, 2026, Applicant elects, without
traverse: SEQ ID NO: 11 (MRGSHHHHHHGSIEGRVKELLFLKKTAEQMLEELKETNKALHDVRHLLENQSKL); as it pertains to claims 1-13 and 21-26 and chemotherapeutic agents as it pertains to claims 5-8 and 10-13, 21-26. Applicant's election in the reply filed on June 1, 2026, is acknowledged.
Claims 1-13 and 21-26, are hereby examined on the merits.
Priority
This application filed 09/01/2023 Claims Priority from Provisional Application 63515836 , filed 07/26/2023. 18460519 Claims Priority from Provisional Application 63374365 , filed 09/01/2022.
Information Disclosure Statement
There is no information disclosure statement (IDS) on record.
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.
Claim 1-26 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 having or comprising sequence of SEQ ID NO: 1. The claim also recites ‘wherein the protein…does not comprise’ and lists SEQ ID NO: 23 ‘excluding’ or SEQ ID NO: 23. It is unclear what the Applicant is trying to exclude, because ‘SEQ ID NO: 23’, in the last two lines of claim 1, comprises the sequence the Applicant excludes. Therefore, this limitation is ambiguous, and unclear as to what sequence is contained in SEQ ID NO: 1. Owing to the ambiguity, for prior art purpose, Examiner interprets SEQ ID NO: 1 as the sequence provided by the alternatives recited in the claim, without any excluding sequences. The recited transitional phrase “having or comprising’ is interpreted as the sequence with N/C terminal additions.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation ‘having or comprising’ in line 1, and the claim also recites ‘does not comprise’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 2, recites ‘optionally, at least one’. Here, the term is indefinite in the context of 75-99 % identity, as recited in the last three lines of the claim. In this instance it is unclear if ‘optionally’ replacing at least one leucine (i.e. one or more) should still meet the identity range of 75-99 % as recited, or in a sequence with replaced leucine, the substitutions are not counted towards calculating % identity. Therefore, the term ‘optionally, at least one’ can generate a list of potential alternatives that can vary and ambiguity arises.
Claim 3 recites the limitation "protein or peptide according to claim 1" in line 1. There is insufficient antecedent basis for this limitation in the claim because SEQ ID NO: 26 comprises a sequence, which claim 1 recites as ‘does not comprise’ (see last four lines of claim 1).
Claim 4 recites the limitation ‘optionally, at least one’. Here, the term is indefinite in the context of 75-99 % identity, as recited in the last three lines of the claim. In this instance it is unclear if ‘optionally’ replacing at least one leucine (i.e. one or more) should still meet the identity range of 75-99 % as recited, or in a sequence with replaced leucine, the substitutions are not counted towards calculating % identity. Therefore, the term ‘optionally, at least one’ can generate a list of potential alternatives that can vary and ambiguity arises.
Claim 13 recites having or comprising sequence of SEQ ID NO: 1. The claim also recites ‘wherein the protein…does not comprise’ and lists SEQ ID NO: 23 ‘excluding’ or SEQ ID NO: 23. It is unclear what the Applicant is trying to exclude, because ‘SEQ ID NO: 23’, in the last five lines of claim 13, comprises the sequence the Applicant excludes. Therefore, this limitation is ambiguous, and unclear as to what sequence is contained in SEQ ID NO: 1. Owing to the ambiguity, for prior art purpose, Examiner interprets SEQ ID NO: 1 as the sequence provided by the alternatives recited in the claim, without any excluding sequences. The recited transitional phrase “having or comprising’ is interpreted as the sequence with N/C terminal additions.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 13 recites the broad recitation ‘having or comprising’ in line 1, and the claim also recites ‘does not comprise’ which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 26, ‘optionally, at least one’. Here, the term is indefinite in the context of 75-99 % identity, as recited in the last three lines of the claim. In this instance it is unclear if ‘optionally’ replacing at least one leucine (i.e. one or more) should still meet the identity range of 75-99 % as recited, or in a sequence with replaced leucine, the substitutions are not counted towards calculating % identity. Therefore, the term ‘optionally, at least one’ can generate a list of potential alternatives that can vary and ambiguity arises.
Claims 5-12 and 21-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite owing to their dependency on a rejected base claim.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 10-12 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(1) as being anticipated by Piul Rabbani et al., hereinafter Rabbani (Piul Rabbani et al., US2022/0096709 A1; EFD: Sep 30, 2020).
Regarding claim 1, Rabbani teaches SEQ ID NO: 2, which meets the limitations of the claim. As noted above in the rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, owing to the ambiguity in the claim limitation, Examiner interprets SEQ ID NO: 1 in the instant application as the sequence provided by the alternatives recited in the claim, without any excluding sequences. The recited transitional phrase “having or comprising’ is interpreted as the sequence with N/C terminal additions.
Regarding claim 2, Rabbani teaches SEQ ID NO: 2 [0036]. SEQ ID NO:2 as noted below (Db) is 82.1 % identical to SEQ ID NO: 10 (Qy) in the instant claim.
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Regarding claim 3, Rabbani teaches SEQ ID NO: 1 [0036].
Regarding claim 4, Rabbani teaches SEQ ID NO: 1 [0036], which is 78.9 % identical to SEQ ID NO: 11; 81.7 % identical to SEQ ID NO: 12; 88.3 % identical to SEQ ID NO: 18 (i.e. 75-99 % identity).
Regarding claim 5, Rabbani teaches nanofibers comprising protein Q ([0006], line 3). Embodiments of the specification disclose ‘protofibers’ as comprising a plurality of proteins and/or peptides ([0017], line 5).
Regarding claim 10, Rabbani teaches a mean fiber diameter of 171.1 ±7.8 nm (see Fig 4C) i.e. 20 nm to 2 µm.
Regarding claim 11, Rabbani teaches nanofibers comprising protein Q ([0006], line 3). Embodiments of the specification disclose ‘protofibers’ as comprising a plurality of proteins and/or peptides ([0017], line 5).
Regarding claim 12, Rabbani teaches hydrogel composition ([0007] line 5).
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) 1-12, 21-26 are rejected under 35 U.S.C. 103 as being unpatentable over Piul Rabbani et al., hereinafter Rabbani (Piul Rabbani et al., US2022/0096709 A1; EFD: Sep 30, 2020) in view of Ke Tang et al., hereinafter Tang (Delivery of chemotherapeutic drugs in tumour cell-derived microparticles Nat Commun 3, 1282 (2012).
The applied reference has a common Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The teachings of Rabbani, have been set forth above. Additionally,regarding claim 6, Rabbani teaches therapeutic agents (i.e. compound) ([0063], line 6). Embodiments of the specification disclose compounds to include therapeutic agents ([0133], line 3).
Regarding claim 7, Rabbani teaches hydrophobic agents ([0026], line 13).
Regarding claim 8, Rabbani teaches antibiotics [0059], lipids (i.e. fatty acids) ([0065] line 4]), RNA (i.e. nucleic acids), proteins (i.e. amino acids), exosomes (i.e. extracellular materials) ([0026], line 16).
Rabbani does not teach chemotherapeutic agents.
Tang teaches that the selective delivery of chemotherapeutic drugs to tumor cells is a major challenge in cancer chemotherapy and packaging clinically approved drugs into nanoscale vesicular vehicles (i.e. exosomes) can effectively deliver chemotherapeutic drugs to tumor sites, leading to improved pharmacokinetic efficiency and therapeutic efficacy (see Introduction).
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 teachings of Rabbani of Exo-Q using the method in Tang. One motivated to do so, would have a reasonable expectation of success, as both references teach exosome compositions and clinical utility. Thus, one would have recognized that applying the teaching of Rabbani and Tang would have yielded predictable results and improved the clinical utility of the composition. See MPEP §2143.
Regarding claim 9, Rabbani teaches exosomes [0065].
Regarding claim 21, the teachings of Rabbani have been set forth above.
Rabbani does not teach cancer.
Tang teaches administering exosomes comprising chemotherapeutic agent in a subject with cancer. In Fig 4e, Tang specifically teaches in vivo, doxorubicin-packaging MPs are i.p. injected into mice that previously received an injection of H22 cells. About 11.8% of the tumour cells are found red fluorescent and most of these red cells could be stained with Annexin V, the marker of cellular apoptosis (see section ‘Tumour cells take up chemotherapeutic drug-packaging MPs’). In Fig 4g, Tang teaches that drugs within MPs are delivered more efficiently to tumour cells than those not packaged into MPs, MPs from 100-μg doxorubicin-treated 1 × 107 tumour cells in 4-ml culture media are prepared, and then 10% of the prepared MPs and the corresponding 10 μg doxorubicin added to 1 × 107 tumour cells in 4-ml fresh media, respectively. After 4 h, cells were collected for flow cytometric analysis. In the MP group, tumour cells effectively took up MPs and showed strikingly high fluorescence. In contrast, in the 10-μg doxorubicin group, although tumour cells showed positive fluorescence the relative intensity was much weaker (see section ‘Efficiency of MP-mediated drug delivery’).
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 teachings of Rabbani of Exo-Q using the method in Tang. One motivated to do so, would have a reasonable expectation of success, as both references teach exosome compositions and clinical utility. Thus, one would have recognized that applying the teaching of Rabbani and Tang would have yielded predictable results and improved the drug delivery of the chemotherapeutic agent. See MPEP §2143.
Regarding claim 22, the obviousness rationale has been set forth above.
Tang teaches that the malignant tumour model in Tang, i.e. ovarian cancer, is chosen in order to emphasize the efficiency of MP-based therapeutics. On the other hand, the difference between normal (5–8 nm) and tumour capillary permeability (100–780 nm) implies that MPs might be used to deliver drugs to solid tumours (i.e. any sold tumor, encompassing TNBC, brain and head and neck) by blood flow. (see Discussion, 3rd paragraph).
Regarding claim 23, the in vivo model is noted in the rejection for claim 21.
Regarding claim 24, Tang teaches injection of MTX-packaging MPs to mice peritoneal H22 tumour for 5 days (i.e. directly to tumor) (see Fig 4f).
Regarding claim 25, the rejection is as applied in claim 21.
Regarding claim 26, Rabbani teaches SEQ ID NO: 10 in the instant claim (as noted in the rejection under claim 2); SEQ ID NO: 11, 12 and 18 in the instant claim (as noted in the rejection under claim 4). The obviousness rationale for the method of treatment comprising peptide and chemotherapeutic agent has been set forth in the rejection under claim 21.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Piul Rabbani et al., hereinafter Rabbani (Piul Rabbani et al., US2022/0096709 A1; EFD: Sep 30, 2020) in view of Daaboul, G. et al., hereinafter Daaboul (Daaboul, G. et al., Digital Detection of Exosomes by Interferometric Imaging. Sci Rep 6, 37246 (2016)).
The applied reference has a common Inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
The teachings of Rabbani have been set forth above. Additionally, regarding claim 13, Rabbani teaches administration of Exo-Q to mice ([0090], line 18) (i.e. compound bound to one or more peptide fibers). Rabbani teaches that exosomes preferably express tetraspanins ([0042] line 26).
Rabbani does not teach ‘wherein the location of the compound…fibers’.
Daaboul teaches detection of exosomes by interferometric imaging. As a demonstration of clinical utility, Daaboul teaches that in very small volume of hCSF, using antibodies directed against tetraspanins, interferometric imaging method could capture exosomes (see Abstract).
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 teachings of Rabbani for detection of Exo-Q using the method in Dabboul. One motivated to do so, would have a reasonable expectation of success, as both references teach exosome compositions expressing tetraspanins and Dabboul teaches detection as a demonstration of clinical utility. Thus, one would have recognized that applying the teaching of Rabbani and Dabboul would have yielded predictable results and improved the clinical utility of the composition. See MPEP §2143.
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 1-13 and 21-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5, 8, 9, 12, 15, 18-20 of copending Application No. 17/490,156 in view of Daaboul, G. et al., hereinafter Daaboul (Daaboul, G. et al., Digital Detection of Exosomes by Interferometric Imaging. Sci Rep 6, 37246 (2016)) further in view of Ke Tang et al., hereinafter Tang (Delivery of chemotherapeutic drugs in tumour cell-derived microparticles Nat Commun 3, 1282 (2012).
Regarding claim 1, reference application ‘156 teaches SEQ ID NO: 2, which meets the limitations of the claim (see claim 1, 9).
Regarding claim 2, reference application ‘156 teaches SEQ ID NO: 2, which meets the limitations of the claim (see claim 1, 9).
Regarding claim 3, reference application ‘156 teaches SEQ ID NO: 1, which meets the limitations of the claim (see claim 1, 8).
Regarding claim 4, reference application ‘156 teaches SEQ ID NO: 1, which is 78.9 % identical to SEQ ID NO: 11; 81.7 % identical to SEQ ID NO: 12; 88.3 % identical to SEQ ID NO: 18 (i.e. 75-99 % identity) (see claim 1, 8).
Regarding claim 5, reference application ‘156 teaches nanofibers (see claims 1, 12, 15).
Regarding claim 6, reference application ‘156 teaches compound (see claim 2).
Regarding claim 7, reference application ‘156 teaches hydrophobic agents (see claim 12, i.e. triterpenoid).
Regarding claim 8, reference application ‘156 teaches exosomes (see claim 2).
Regarding claim 9, reference application ‘156 teaches exosomes (see claim 2).
Regarding claim 10, reference application ‘156 teaches a composition that is substantially identical to the peptide as instantly claimed. Therefore, the claimed properties or functions are presumed to be inherent Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). (See MPEP § 2112.01 (I)).
Regarding claim 11, reference application ‘156 teaches nanofibers (see claims 1, 12, 15)
Regarding claim 12, reference application ‘156 teaches hydrogel composition (see claims 1, 5, 14).
Regarding claim 13, reference application ‘156 teaches administration (see claim 18).
Reference application does not teach ‘wherein the location of the compound…fibers’.
Daaboul teaches detection of exosomes by interferometric imaging as noted above in the obviousness rationale. 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 teachings of the reference application ‘156 for detection of Exo-Q using the method in Dabboul. One motivated to do so, would have a reasonable expectation of success, as both references teach exosome compositions expressing tetraspanins and Dabboul teaches detection as a demonstration of clinical utility. Thus, one would have recognized that applying the teaching of reference application ‘156 and Dabboul would have yielded predictable results and improved the clinical utility of the composition. See MPEP §2143.
Regarding claim 21, reference application ‘156 teaches administration of the composition (see claims 18, 19, 20).
Reference application ‘156 does not teach cancer.
Tang teaches administering exosomes comprising chemotherapeutic agent in a subject with cancer. In Fig 4e, Tang specifically teaches in vivo, doxorubicin-packaging MPs are i.p. injected into mice that previously received an injection of H22 cells. 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 teachings of the reference application ‘156 of Exo-Q using the method in Tang. One motivated to do so, would have a reasonable expectation of success, as both references teach exosome compositions and clinical utility. Thus, one would have recognized that applying the teaching of Rabbani and Tang would have yielded predictable results and improved the drug delivery of the chemotherapeutic agent. See MPEP §2143.
Regarding claim 22, the obviousness rationale has been set forth above (see claims 18, 19, 20). Reference application does not teach TNBC, brain cancer and head and neck cancer.
Tang teaches that the malignant tumour model in Tang, i.e. ovarian cancer, is chosen in order to emphasize the efficiency of MP-based therapeutics. On the other hand, the difference between normal (5–8 nm) and tumour capillary permeability (100–780 nm) implies that MPs might be used to deliver drugs to solid tumours (i.e. any sold tumor, encompassing TNBC, brain and head and neck) by blood flow. (see Discussion, 3rd paragraph).
Regarding claim 23, the in vivo model is noted in the rejection for claim 21. (see claims 18-20).
Regarding claim 24, reference application teaches administration (see claims 18-20) but does not teach direct administration to the tumor site. Tang teaches injection of MTX-packaging MPs to mice peritoneal H22 tumour for 5 days (i.e. directly to tumor) (see Fig 4f). (see claims 18-20).
Regarding claim 25, the rejection is as applied in claim 21. (see claims 18-20).
Regarding claim 26, reference application ‘156 teaches SEQ ID NO: 10 in the instant claim (as noted in the rejection under claim 2); SEQ ID NO: 11, 12 and 18 in the instant claim (as noted in the rejection under claim 4). The obviousness rationale for the method of treatment comprising peptide and chemotherapeutic agent has been set forth in the rejection under claim 21. (see claims 18-20).
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
Prosecution Insights