DETAILED ACTION
This Office action details a first action on the merits for the above referenced application No. Claims 1-3, 5-11, and 13-22 are pending in this application.
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 .
Priority
This application is a 35 USC 371 National Stage filing of international application No. PCT/US2022/046338 filed on 11 Oct. 2022, and claims benefit under 35 USC 119(e) to US provisional application No. 63/254,523 filed on 11 Oct. 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 30 Oct. 2024 has been considered by the examiner.
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 6 is 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. In this case, claim 6 is dependent on cancelled claim 4.
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, 3, 5-7, 9, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1),(2) as being anticipated by Schulze et al. (US 2002/0034537 A1; published 21 Mar. 2002; see IDS filed on 30 Oct. 2024).
Regarding claims 1, 3, 5-7, 9, and 17-20, Schulze et al. disclose a composition comprising dextrin stabilized iron oxide particles. The classical route of co-precipitation of magnetite in the presence of a coating material such as dextran was applied. Particles with a Zaverage of 80 to 120 nm where utilized. Typically, a one mL solution contains approximately 0.2 mmol dextran and 31 mg which is 0.55 mmol Fe. Schulze et al. teach positively and negatively charged particles. An alternative synthesis used purchased dextran in three different size classes (10,000, 70,000, and 500,000 Daltons; high molecular weight) (examples 1-2).
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.
Claim(s) 1-3, 5-11, and 13-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Schulze et al. (US 2002/0034537 A1; published 21 Mar. 2002; see IDS filed on 30 Oct. 2024), in view of Canham et al. (WO 2007/034196 A2; published 29 Mar. 2007; see attached 892) and Brannigan et al. (Macromol. Biosci.; published 2019; see IDS filed on 30 Oct. 2024).
Schulze et al. teach cationic diagnostic, imaging and therapeutic agents associated with activated vascular stents (see title). Schulze et al. teach uptake of charged dextran coated iron oxide particles by human endothelial cell cultures. The measured iron concentration clearly shows that HUVEC uptake of positively charged dextran coated iron oxide particles is remarkably higher than uptake of neutral or negatively charged particles (example 3; [0083]-[0084]). Selective accumulation is achieved, and the amount of non-specific binding and side effects is minimized ([0089]). Schulze et al. teach selective targeting of angiogenic vascular endothelial cells in vivo ([0094]-[0095]). Schulze et al. teach chitosan ([0035], claim 18).
Schulze et al. do not teach dextran coated iron oxide nanoparticle comprises 0.533±0.05 mg iron per mg of DFeNP or the claimed method of synthesizing wherein the at least one polysaccharide-based biomaterial is medium molecular weight chitosan or high molecular weight chitosan. Schulze et al. do not further teach the claimed method of endoscopic tattooing comprising injecting to tissue a composition comprising biomaterial based composite ink comprising dextran or chitosan coated iron oxide nanoparticles optionally medium or high molecular weight chitosan or cysteine modified chitosan or catechol modified chitosan.
Canham et al. teach imaging agents (see title). Canham et al. teach that imaging agents are used to improve the visibility of internal body structures in an image generated using a range of imaging techniques including MRI (pg. 1). Canham et al. teach SPIO having a crystal iron oxide core and dextran (pg. 5). Canham et al. teach tissue markers. The methods of the invention include so called tattoos for use in positioning patients including repeat positioning in radiotherapy. The tattoo may be loaded with antibiotics to minimize risk of infection. (pgs 53-54). The tissue marker may be used for monitoring a site (pg. 58). Example 10 illustrates the use of porous silicon to mark the skin and which can be visualized in the form of a tattoo. The tattooing procedure was performed using a non-electrical, hand-held tattooing punch with needles of steel that insert the ink into the skin dermis. A tattoo was then placed into the skin of the tissue sample using the pSi/NACMC suspension as the tattoo ink/pigment. In vitro tissue trial show that porous silicon in particulate suspension can be used to mark the skin in the form of a tattoo. It has been shown that pSi as a skin marking agent provides substantially equivalent visibility (example 10).
Brannigan et al. teach the progress and current trends in the synthesis of novel polymers with enhanced mucoadhesive properties (see title). Chitosan has been formulated into nanoparticles and chitosan has been modified with a plethora mucoadhesive properties (pg. 2). Brannigan et al. teach catechol modified chitosan (fig. 8; pg. 5). Catechols adhere to a wide range of organic and inorganic surfaces (pg. 4). Brannigan et al. teach thiolated chitosan modified by conjugation with cysteine (Cys-CHI) (pg. 8; table 2).
It would have been obvious to a person of ordinary skill in the art before the effective filing date to modify Schulze et al. (composition comprising an iron oxide contrast agent, and at least one polysaccharide based biomaterial that is a derivative of chitosan such as medium/high molecular weight dextran and modified dextrin and their methods of synthesis) so that the at least one polysaccharide based biomaterial is chitosan including medium/high molecular weight chitosan, cysteine-modified chitosan, and catechol modified chitosan as taught by Schulze et al. and Brannigan et al. because the chitosans would have been expected to advantageously provide an equivalent charge modified polysaccharide based biomaterial suitable for coating iron oxide nanoparticles advantageously offering a wide range of adhesive properties. It would have been obvious to a person of ordinary skill in the art before the effective filing date to further modify Schulze et al. by arriving at a method of endoscopic tattooing comprising injecting to tissue a composition biomaterial based composite ink comprising the dextran or obvious chitosan coated iron oxide nanoparticles wherein the nanoparticle is encapsulated with the polysaccharide based biomaterial as taught by Schulze et al. and Canham et al. because it would have been expected to advantageously enable marking tissue with greater adhesion and less leakage than conventional tissue marking inks. The amount of iron per mg of DFeNP is variable that a person of ordinary skill in the art would have attempted to optimize at the time of invention. MPEP 2144.05.II. A person of ordinary skill in the art would have arrived at 0.533±0.05 mg of iron per mg of DFeNP in order to arrive at an optimal contrast enhancement.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN R DONOHUE whose telephone number is (571)270-7441. The examiner can normally be reached on Monday - Friday, 8:00 - 5:00 EST.
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/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618
/SEAN R. DONOHUE/
Examiner, Art Unit 1618
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