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
Applicant’s election without traverse of Group I in the reply filed on 4/24/26 is acknowledged.
Claim Status
Claims 1-16 are pending. Claims 3-10 and 14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/24/26.
Claims 1-2, 11-13, and 15-16 are currently under consideration for patentability under 37 CFR 1.104.
Information Disclosure Statement
The information disclosure statements filed on 6/22/23, 4/29/24, 7/24/25, 10/22/25 have been considered. Signed copies are enclosed.
Notably, the disclosure statement filed lists a Search Report. The listing of the references cited in a Search Report itself is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, "the list ... must be submitted on a separate paper." Therefore, the references cited in the Search Report have not been considered. Applicant is advised that the date of submission of any item of information or any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the IDS, including all "statement" requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
Note: If copies of the individual references cited on the Search Report are also cited separately on the IDS (and these references have not been lined-through) they have been considered.
Claim Rejections - 35 USC § 112(b)
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 15 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.
The term “low” in claim 15 is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 1-2, 11-13, and 16 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(1)as being anticipated by Bogdanov (US 2014/0065425 A1; filed 3/14/13; published 3/6/14).
Instant claim 1 is directed to a method of stabilizing a nanoparticle comprising a capture agent on the surface, the method comprising conjugating a positively-charged polymer to the nanoparticle, wherein the positively-charged polymer is a homopolymer of a positively charged amino acid or a heteropolymer of two or more positively charged amino acids. Instant claim 2 is directed to the method of claim 1, wherein the nanoparticle is stabilized in a solution. Instant claim 11 is directed to the method of claim 1, wherein the nanoparticle is a metal nanoparticle. Instant claim 12 is directed to the method of claim 1, wherein the positively-charged polymer is polylysine. Instant claim 13 is directed to the method claim 1, wherein the capture agent is an antibody. Instant claim 15 is directed to the method or claim 2, wherein the solution has a low ionic strength and/or a pH of 3.5-7. Instant claim 16 is directed to the method of claim 11, wherein the metal nanoparticle is a gold particle.
Regarding the limitations of instant claim 1 and 11-13, Bogdanov teaches a nanoparticle preparation comprising the generation of a mixture comprising a plurality of metal containing compounds and a copolymer of a polyethylene glycol and an amine-containing polyamino acid polylysine where a metal core and polymer shell nanoparticle is formed (see e.g. Bogdanov abstract, claim 1 and 31). The instant specification defines polylysine as a positively charged polymer (see e.g. instant specification paragraph [0037]). The nanoparticles can be attached to an imaging agent or therapeutic agent, such as an antibody (see e.g. Bogdanov paragraph [0045]).
Regarding the limitations of instant claims 2, Bogdanov teaches preparation of the nanoparticles in a solution (see e.g. claim 4).
Regarding the limitation of instant claim 16, Bogdanov teaches that the nanoparticle core can be gold (see e.g. claim 29 and paragraph [0008]).
Claim(s) 1-2, 11-13, and 16 is/are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(1)as being anticipated by Peyman (US 2020/0246179 A1; filed 4/8/20; published 8/6/20).
Instant claim 1 is directed to a method of stabilizing a nanoparticle comprising a capture agent on the surface, the method comprising conjugating a positively-charged polymer to the nanoparticle, wherein the positively-charged polymer is a homopolymer of a positively charged amino acid or a heteropolymer of two or more positively charged amino acids. Instant claim 2 is directed to the method of claim 1, wherein the nanoparticle is stabilized in a solution. Instant claim 11 is directed to the method of claim 1, wherein the nanoparticle is a metal nanoparticle. Instant claim 12 is directed to the method of claim 1, wherein the positively-charged polymer is polylysine. Instant claim 13 is directed to the method claim 1, wherein the capture agent is an antibody. Instant claim 15 is directed to the method or claim 2, wherein the solution has a low ionic strength and/or a pH of 3.5-7. Instant claim 16 is directed to the method of claim 11, wherein the metal nanoparticle is a gold particle.
Regarding the limitations of instant claim 1 and 12-13, Peyman teaches antibody coated nanoparticles (see e.g. paragraph [0018] and claim 1). The antibody coated nanoparticles can be coated with a cationic polymer such as polylysine (see e.g. paragraph [0324]). The antibodies are conjugated to the nanoparticles (see e.g. paragraph [0257]). The structural limitations of the claim are anticipated by the reference, and therefore the nanoparticle would inherently be stabilized.
Regarding the limitations of instant claims 2, Peyman teaches that the antibody can be presented in a solution having a physiologic pH (see e.g. paragraph [0213]).
Regarding the limitations of instant claims 11 and 16, Peyman teaches that the nanoparticle can be made from gold (see e.g. paragraph [0247]).
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) 1-2, 11-13, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peyman (US 2020/0246179 A1; filed 4/8/20; published 8/6/20).
Instant claim 1 is directed to a method of stabilizing a nanoparticle comprising a capture agent on the surface, the method comprising conjugating a positively-charged polymer to the nanoparticle, wherein the positively-charged polymer is a homopolymer of a positively charged amino acid or a heteropolymer of two or more positively charged amino acids. Instant claim 2 is directed to the method of claim 1, wherein the nanoparticle is stabilized in a solution. Instant claim 11 is directed to the method of claim 1, wherein the nanoparticle is a metal nanoparticle. Instant claim 12 is directed to the method of claim 1, wherein the positively-charged polymer is polylysine. Instant claim 13 is directed to the method claim 1, wherein the capture agent is an antibody. Instant claim 15 is directed to the method or claim 2, wherein the solution has a low ionic strength and/or a pH of 3.5-7. Instant claim 16 is directed to the method of claim 11, wherein the metal nanoparticle is a gold particle.
Regarding the limitations of instant claim 1 and 12-13, Peyman teaches antibody coated nanoparticles (see e.g. paragraph [0018] and claim 1). The antibody coated nanoparticles can be coated with a cationic polymer such as polylysine (see e.g. paragraph [0324]). The antibodies are conjugated to the nanoparticles (see e.g. paragraph [0257]). The structural limitations of the claim are anticipated by the reference, and therefore the nanoparticle would inherently be stabilized.
Regarding the limitations of instant claims 2, Peyman teaches that the antibody can be presented in a solution having a physiologic pH (see e.g. paragraph [0213]).
Regarding the limitations of instant claims 11 and 16, Peyman teaches that the nanoparticle can be made from gold (see e.g. paragraph [0247]).
Peyman does not teach the exact pH and/or ionic strength of the instant claims.
Peyman does teach administration in a solution adjusted to physiologic pH of 7-7.5 (see e.g. paragraph [0213]).
It would have been prima facie obvious to one of ordinary skill in the art at the effective filing date of the invention to produce a solution with the pH of the instant claims. Peyman teaches a range that overlaps with the instant claimed range. According to MPEP 2144.05, In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In addition, MPEP 2144.05 states that “generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The determination of pH in the instant composition, that would allow the component to function as claimed, requires only routine experimentation for one of ordinary skill in the art. Therefore, given that combination of the claimed components has been previously described, without specific evidence that the indicated pH range is critical to the formulation, the identification of these properties will not render the subject matter patentable.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that if a technique has been used to improve one method, and a person of ordinary skill would recognize that it would be used in similar methods in the same way, using the technique is obvious unless its application is beyond that person’s skill. It would be obvious to apply a known technique to a known product to be used in a known method that is ready for improvement to yield predictable results. Thus, the combination of prior art references as combined provided a prima facie case of obviousness, absent convincing evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREA MCCOLLUM whose telephone number is (571)272-4002. The examiner can normally be reached 9:00 AM to 6:00 PM 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, VANESSA FORD can be reached at (571)272-0857. 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.
/ANDREA K MCCOLLUM/Examiner, Art Unit 1674
Prosecution Insights