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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/21/24;3/10/23 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Allowable Subject Matter
Claim 31 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 32-33 are further objected to based on dependence on claim 31.
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)(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.
Claims 1-4, 13-16, 18-19, 30, 36, 41-42 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Foy et al. (US 2020/0054866) (“Foy”). Foy discloses:
A method for blood vessel embolization in a blood vessel, comprising the steps of: supplying at least one gelling component in liquid form to the lumen of a blood vessel by means of a microcatheter having a first lumen, a second lumen, and a mixing chamber, and wherein the at least one gelling component is biocompatible and biodegradable; and wherein the at least one gelling component forms in situ a deformable solid matrix in the lumen of the blood vessel. Figs.6A-E,7A-C
the first lumen is at least partially disposed inside the second lumen. [0113] see claim 16
the mixing chamber is formed by a section of the second lumen that extends beyond an end of the first lumen. See Figs.6A-E,7A-C
a first gelling component of the at least one gelling component is supplied through the first lumen and a second gelling component of the at least one gelling component is supplied through the second lumen. [0104]
the first lumen is completely surrounded by the second lumen. [0113] see claim 16
the second gelling component is supplied to the blood vessel before the first gelling component. Figs.6A-E
during a release of the first gelling component there is also a release of the second gelling component. Figs.6A-E
the second gelling component consists of at least 50% water or blood. [0062,0108] see abstract (dilution)
Foy further comprising the step of supplying one or more liposomes, virosomes, micro/nano spheres, peptides, proteins, nanorobotics systems, tumor cell bicarbonate neutralizing agents, or therapeutic agents to the blood vessel through the microcatheter. [0073-0074]
the one or more liposomes, virosomes, micro/nano spheres, Peptides, proteins, nanorobotics systems, tumor cell bicarbonate neutralizing agents, or therapeutic agents are supplied together with a gelling component of the at least one gelling component. [0073-0074]
Foy further comprising the step of supplying bicarbonate to the blood vessel together with a gelling component of the at least one gelling component. [0381]
the mixing chamber is a microfluidic mixing chamber. (vessel)
the virosomes are specifically added to the PEG stream. See Figs.6A-E,7A-C
the at least one gelling component is biocompatible, biodegradable, and contains a radiopaque element. [0093-0094,0083-0084,0098]
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.
Claims 5-12, 17, 34-35, 37-40, 43 are rejected under 35 U.S.C. 103 as being unpatentable over Foy.
Foy discloses the invention as substantially claimed, see above, and including at least one gelling component bonded to a contrast material ([0062-0063,0103] see claim 28) but further, the selection of compositions and form is an element of obvious design choice. Compositions amongst those found in claims 5-12, 34-35,37-40, 43. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified Foy with any of the compositions as in claims 5-12, 34-35,37-40, 43, the form as in claim 17, as a matter of obvious design choice well known to those skill in the art of hemostatic treatment.
Claims 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Foy in view of Lerouge et al. (US 2017/0360912) (“Lerouge”).
Foy discloses the invention as substantially claimed, see above, but does not directly disclose wherein the therapeutic agents are selected from the group consisting of anti-neoplastic agents falling into the broad classes of cytotoxic chemotherapy, small molecule targeted agents, biologics, anti-viral agents, or nucleotide based therapeutics. Lerouge, in the analogous art, teaches methods for embolizing a blood vessel [0065] comprising Ipilimumab [0096]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the components used for the same end result of embolization within a vessel as a design consideration.
Claims 24-29 are rejected under 35 U.S.C. 103 as being unpatentable over Foy in view of Vogel et al. (US 2008/0220077) (“Vogel”).
Foy discloses the invention as substantially claimed, see above, but does not directly disclose wherein the one or more therapeutic agent is bound to a magnetic nano-based material scaffold. Vogel, in the analogous art, teaches embolization compositions (abstract) comprising superparamagnetic nano-based material [0258,0261] for delivery with a therapeutic agent [0032]. Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to utilize the method of Foy with the compositions as taught by Vogel as a matter of obvious design choice.
Vogel further teaches the magnetic nano-based material scaffold is supraparamagnetic iron oxide that also functions as an MRI contrast agent [0258,0261], platinum or a coating to achieve this iron based contrast agent is also a design choice of Vogel [0291,0258]
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 9:00am-5:30pm est.
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, Kevin Sirmons can be reached at 571-272-4965. 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.
/DEANNA K HALL/Primary Examiner, Art Unit 3783