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 .
Claims 1 has been amended.
Claims 1-4 and 8-16 are pending.
Claims 5-7 and 17-20 are cancelled.
Claims 10 and 11 are withdrawn.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
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.
Claims 1, 2, 4, 8, 9 and 12-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by LU (US 9,289,504 B2).
Regarding claim 1, LU teaches a protein nanocapsule that comprises a protein core (abstract). The core’s surface was then labeled with a 1.4 nm gold nanoparticle (column 23, paragraph 4), which reads on the protein functions as a core and the metal nanoparticle is bound to a surface of a protein core.
Note, the prior art’s composition would have the same chemical/physical properties of “the complex has a half-life in blood from 1 to 3 hours and the metal nanoparticle part has a size that allows renal excretion, the complex is excreted by kidneys after being administered in vivo and used for X-ray contrast imaging” as claimed by Applicant, because the prior art has the same ingredients as claimed by Applicant, unless proven otherwise. Furthermore, LU Teaches the composition has a long half-life (column29, paragraph 5) and the size claimed by Applicant 1.4 nm gold nanoparticle (column 23, paragraph 4).
Claim 1 is a product claim with intended use “used for X-ray contrast imaging”. As the prior art teaches the product, it would be capable of the use.
Regarding claim 2, Mono-sulfo-N-hydroxy-succinimido nanogold particles are used for binding to the protein (column 23, paragraph 3), which is a gold nanoparticle with a linker, which reads on the nanoparticle and protein are linked via a linker.
Regarding claims 4 and 12-16, LU teaches that bovine serum albumin (column 6, paragraph 3 and example 1), which is a functional protein (Applicant’s specification, page 9, paragraph 0028), can be used to make the nanoparticles
Regarding claim 8 and 9, the prior art has the same composition as claimed by the Applicant and therefore would be capable of performing the intended use of “a vascular contrast agent” and “an x-ray contrast agent”.
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.
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.
Claims 1, 2, 4, 8, 9 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over LU (US 9,289,504 B2) in view of COLE (Gold nanoparticles as contrast agents in x-ray imaging and computed tomography. Nanomedicine. 2015.).
LU teaches Applicant’s invention as discussed above. LU further teaches using the composition for imaging (column 28, paragraph 8).
As discussed above, LU’s composition would be capable of being used for X-ray contrast imaging inherently. Although, LU does not explicitly state it can be used for X-ray imaging.
COLE teaches that gold nanoparticles can be used as a contrast agent due to exhibiting a high x-ray attenuation, nontoxicity and facile synthesis and surface functionalization for colloidal stability and targeted delivery (abstract). Gold nanoparticles also exhibit a long vascular reten-tion time which potentially increases the available imaging window, this means it remains in the blood stream for a prolonged period of time for imaging (page 322, paragraph 5-6), which relates to the half-life of the composition.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using the composition as an X-ray contrast agent/the composition inherently being able to be used as a x-ray contrast agent. The person of ordinary skill in the art would have been motivated to make those modifications, because gold nanoparticle exhibit a high x-ray attenuation, nontoxicity and remain in the bloodstream for a long time and reasonably would have expected success because the references are in the same field of endeavor, such as compositions comprising gold nanoparticles that are used for imaging.
Claims 1-4, 8, 9 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over LU (US 9,289,504 B2) and COLE (Gold nanoparticles as contrast agents in x-ray imaging and computed tomography. Nanomedicine. 2015.) in view of XIAO (Influence of ligands property and particle size of gold nanoparticles on the protein adsorption and corresponding targeting ability. International Journal of Pharmaceutics. 2018.).
LU and COLE teaches Applicant’s invention as discussed above, including using a linker to connect the gold nanoparticle and bovine serum albumin.
Regarding claim 3, LU and COLE do not specifically teach using a linker with a thiol group and a carboxylic group.
Regarding claim 3, XIAO teaches a gold nanoparticle that is conjugated to a protein (abstract). The protein and nanoparticle are connected via carboxymethyl-polyethylene glycol-thiol (SH-PEG-COOH), which has a thiol group and a carboxyl group (page 106, paragraph 4). The additional of the linker reduces plasma protein adsorption (abstract), which can increase in vivo half-life in the body (107, paragraph 9), which is important because it is how long a composition remains active in the body.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate an SH-PEG-COOH linker. The person of ordinary skill in the art would have been motivated to make those modifications, because it is an alternate way to attach the protein to the gold nanoparticle and can increase the in vivo half-life of the composition which will increase efficacy because the composition is remaining in the blood stream longer and active longer, and reasonably would have expected success because the references are in the same field of endeavor, such as gold nanoparticles conjugated to a protein.
Response to Arguments
Applicant argues, Paragraph [0018] of the as-filed specification states that "with the average particle size of less than 1 nm, the absorption amount of X-rays would be small, and this would make it difficult to obtain a high-contrast image. In addition, with the average particle size of less than 1 nm, the metal nanoparticle would have a smaller specific surf ace area, and this would make it difficult to form a complex with the protein." Paragraph [0021] of the specification states that "nanoparticles and proteins with a size less than 6 nm are known to be able to pass through the glomerular filtration membrane, but particles with a size of 6 nm or greater are known not to be able to pass through this filtration membrane." Paragraph [0026] of the specification further states that "the protein is used to delay the renal excretion time of the metal nanoparticle by forming the complex together with the metal nanoparticle with a size that would otherwise allow rapid renal excretion."
The Examiner does not find the argument persuasive because as discussed above, LU teaches a protein nanocapsule that comprises a protein core (abstract). The core’s surface was then labeled with a 1.4 nm gold nanoparticle (column 23, paragraph 4), which reads on the protein functions as a core and the metal nanoparticle is bound to a surface of a protein core.
Note, the prior art’s composition would have the same chemical/physical properties of “the complex has a half-life in blood from 1 to 3 hours and the metal nanoparticle part has a size that allows renal excretion, the complex is excreted by kidneys after being administered in vivo and used for X-ray contrast imaging” as claimed by Applicant, because the prior art has the same ingredients as claimed by Applicant, unless proven otherwise. Furthermore, LU Teaches the composition has a long half-life (column29, paragraph 5) and the size claimed by Applicant 1.4 nm gold nanoparticle (column 23, paragraph 4).
Claim 1 is a product claim with intended use “used for X-ray contrast imaging”. As the prior art teaches the product, it would be capable of the use.
Additionally, as taught by COLE, gold nanoparticles are often used as x-ray imaging agents and contribute to a compositions half-life.
Applicant argues, the Au nanoparticles described in Lu are used merely as labels for imaging the nanocapsules by TEM, and are not used as an imaging agent, which is one type of surface modifier. Furthermore, TEM imaging is performed using an electron beam, not "X-ray contrast imaging". Applicant respectfully submits that this distinction has been made even clearer by the present amendment.
The Examiner does not find the argument persuasive because as discussed above, the composition of LU can be inherently used for x-ray contrast imaging and COLE further teaches that gold nanoparticles are often used for x-ray contrast imaging.
Applicant argues, In Lu, the imaging agent is attached to the polymer shell on the surface of the nanocapsule, rather than to the protein. Lu does not disclose or suggest combining a protein with metal nanoparticles having "a size that allows renal excretion" (1 nm to 5.5 nm) so as to adjust the blood hallife to 1 to 3 hours and thereby permit renal excretion "after being administered in vivo and used for X-ray contrast imaging".
The Examiner does not find the argument persuasive because as discussed above, LU teaches a protein nanocapsule that comprises a protein core (abstract). The core’s surface was then labeled with a 1.4 nm gold nanoparticle (column 23, paragraph 4), which reads on the protein functions as a core and the metal nanoparticle is bound to a surface of a protein core. Instant claim 1 does not require the protein to be directly bound to the nanoparticle. Additionally, LU teaches a 1.4 nm gold nanoparticle which falls into Applicant’s claimed range.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/S.L.M./ Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618
