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 .
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.
Claims 1,6,8,10,12,14,16,18,20,22,24,27,29,32 and 33 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.
Regarding claims 1,8,10,14,16,18,20,22,24,29 and 33, the phrases "preferably" and “such as” renders the claims indefinite because it is unclear whether the limitation(s) following the phrases are part of the claimed invention. See MPEP § 2173.05(d). Claims 6,12,27 and 32 incorporate the indefiniteness by dependency. For the purposes of examination the recitations after preferably were not considered limiting.
Claim 27 recites the limitation "linker" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 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) 1,6,8,10,12,14,16,18,20,22,24,29,32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira "Development of New Nanocarriers for Controlled Release of Olanzapine and Camptothecin", 41f. Tese Universidade Federal do Rio Grande do Norte, Natal, 2018, https://repositorio.ufm_br/handle/ 123456789/26504, 142 pages, cited IDS, in view of Rivero-Buceta et al. ACS Omega, Vol. 4 pages 1281-1291, 15.01.2019, cited IDS, in view of Bradbury et al. (WO 2014/145606), cited IDS.
Oliveira teaches nanoparticles of a covalent organic network to which the therapeutic agent camptothecin is covalently attached via amine groups by succinic acid linker, the nanoparticles had a diameter or 31.4 + 10.4 nm, lower than the claimed lower size limit. See entire disclosure, especially abstract, pages 4-6 and 11.
Oliveira does not teach the claimed imaging agent or anti-FOLH1 monoclonal antibody bound to the nanoparticle.
Rivero-Buceta teaches porous silica nanoparticles that present organic ligands including anti-FOLH1 monoclonal antibody and docetaxel, bound by amine groups to the nanoparticle. See entire disclosure, especially pages 1282-1283, fig 2 and S3. The anti-FOLH1 antibody targeted the nanoparticle to prostrate cancer cells. Rivero-Buceta also teaches covalent bonding of Rhodamine B to the nanoparticle via terminal amino groups.
Bradbury teaches silica nanoparticles with theranostic ability, functionalized with docetaxel, fluorescent agent, radioisotopes, methoxy terminated PEG and antibody targeting PSMA. See entire disclosure, especially abstract, page 4,31-32 and claims, especially 1-3,5,10-16. Methoxy-PEG was said to further enhance particle clearance while maintaining a small hydrodynamic size. See example 2
Since Oliveira already teaches how to attach therapeutics to the covalent organic network nanoparticles by amide and succinic acid linker one of ordinary skill would have a high expectation of success in extending the types of agents bound to the nanoparticles such as anti-FOLH1 monoclonal antibody, docetaxel, imaging agent and PEG taught in the secondary references of Rivero-Buceta and Bradbury. Reason to make such a modification would be to target the nanoparticles to prostrate cancer cells using anti-FOLH1 monoclonal antibody while tracing the delivery of anticancer agent doxorubicin using imaging agents. Reason to use PEG would be to enhance particle clearance while maintaining a small hydrodynamic size. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Regarding claim 18, this claim further limits an optional component of base claim 1, and therefore is not limiting.
Claim(s) 1,6,8,10,12,14,16,18,20,22,24,29,32 and 33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Oliveira, cited above, in view of Rivero-Buceta, cited above in view of Bradbury, cited above in view of Giblin et al. “In Vitro and in Vivo Comparison of Human Escherichia coli Heat-Stable Peptide Analogues Incorporating the 111In-DOTA Group and Distinct Linker Moieties”, Bioconjugate Chemistry 2004 15 (4), 872-880.
Oliveira is disclosed above. The reference while teaching amino linkages is silent with respect to the linkage of claim 27, 11-aminoundecanoic acid.
Giblin is used only for its disclosure that 11-aminoundecanoic acid was a known linkage useful in conjugates. See entire disclosure, especially abstract, page 875 lft col. Inclusion of the 11-undecanoic acid spacer greatly increased the hydrophobicity of the conjugate.
Since Oliveria already teaches use of linkers in its conjugate one of ordinary skill in the art would have a high expectation of success in extending the types of linkers used in the nanoparticle conjugate including 11-undecanoic acid. Reason to make such a modification would be to increase hydrophobicity of the attached drug. Thus, the claimed invention would have been prima facie obvious since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAMES W ROGERS whose telephone number is (571)272-7838. The examiner can normally be reached 9:30-6:00 PM.
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.
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.
/JAMES W ROGERS/Primary Examiner, Art Unit 1618