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 .
Receipt is acknowledged of Applicant’s Restriction Requirement Response filed on 01/05/2026; and IDS filed on 03/22/2024.
Claim 15 has been amended.
Claims 8, 13 and 16 are drawn to non-elected species
Claims 1, 3-9, 11-13, 15-16, 19-20, 24-25, 27-29 are pending in the instant application.
Claims 8, 13, 15-16, 19-20, 24-25, 27-29 are withdrawn from further consideration.
Election/Restrictions
Applicant’s election of Group I (claims 1, 3-9, 11-13) and species of “PEG derivative”; “checkpoint inhibitor” (claim 11) and “second chemotherapeutic agent, such as paclitaxel” (claim 13); and “PET imaging” (claim 28) in the reply filed on 01/05/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicant was supposed to elect claim 11 or claim 13, in which claim 9 is the generic claim; however, Applicant elected both claims 11 and 13. For examination purposes, the Examiner will elect the first specie (claim 11).
Note, claims 8, 13 and 16 are drawn to non-elected species.
Claim Rejections - 35 USC § 112, 2nd paragraph
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, 3-7, 9, 12 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.
The term “ultrasmall” in claim 4 is a relative term which renders the claim indefinite. The term “ultrasmall” 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. In this instance, at what size is it NOT ultrasmall?
The term "PEG derivative" in claim 7, renders the scope of said claim unclear since, on reading the document, a person skilled in the art would not know which structures are supposed to be encompassed by this term. The term "derivative" encompasses compounds obtained by chemical reaction from another compound, including compounds of which the structure is far removed from the starting element, functional derivatives (such as compounds in which the heteroatoms are replaced by other atoms), compounds comprising numerous different types of side groups, etc.
For examination purposes, any PEG will read on PEG derivative.
Claims 1, 3-7, 9, 12 contain the term "CCR2", “ECL1i”, “PEG”, “CTLA” and/or “PD-1”, which is not defined by the claims. Claims must stand alone to define the invention, and should not rely on the description or the drawings to give them meaning (see Ex Parte Fressola, 27 USPQ 2d 1608). Thus, the first claim using these abbreviations, at the very least, should define “CCR2", “ECL1i”, “PEG”, “CTLA” and/or “PD-1”, by its formal chemical name; once the abbreviation is defined, the abbreviation may be subsequently recited.
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.
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, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIU et al (US 2017/0348442) in view of DAVIS et al (US 2014/0249202).
Regarding claims 1, 5, and 7, LIU teaches a composition comprised of: CCR2 binding peptide (see claim 1), wherein the CCR2 binding peptide has TFLK sequence (see [0012]) and has no more than 200 amino acids, such as 7 amino acids (see SEQ ID NO: 2 at pg. 44; and [0093]); conjugated to a nanoparticle (see claim 1 and claim 8); a linker (see claim 1), such as TA-PEG-maleimide (see claim 10 at (vi)), which reads on PEG derivative, wherein the linker can be covalently attached to the nanoparticle (see [0017]; [0113]). Additional disclosures include: imaging agents (see abstract), such as a radiolabel (see claim 1), wherein the composition can be used to treat cancer (see [0027]) and using a delivery system similar to that used for delivering chemotherapy to specific tumors (see [0187]).
LIU does not teach adding a chemotherapeutic agent.
DAVIS teaches the prior art had known of using chemotherapeutic agent covalently conjugated to a nanoparticle (see [0182]) to treat cancer (see [0050]). Chemotherapeutic agents include taxane (see [0205]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate chemotherapeutic agent conjugated to the nanoparticle. The person of ordinary skill in the art would have been motivated to make those modifications, because it would have an additive effect in treating the cancer, and reasonably would have expected success because both references dealt in the same field of endeavor, such as nanoparticles and cancer.
Regarding claim 3, LIN teaches the composition has a size of 5.0 nm (see [0247]).
Regarding claim 4, LIN teaches the nanoparticle can be nanocluster (see [0016]) and copper (see [0016]), thus, it would have been obvious to use nanoclusters of copper.
Claim(s) 1, 3-7, 9, 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIU et al (US 2017/0348442) in view of DAVIS et al (US 2014/0249202) and NOVOBRANTSEVA et al (US 2021/0317461).
As discussed above, the references teach Applicant’s invention.
Regarding claim 6, the references teach the CCR2 binding peptide is ECL1i (see LIN at [0012), but does NOT teach that the chemotherapeutic agent is gemcitabine.
NOVOBRANTSEVA teaches the prior art had known of chemotherapeutic agents, such as taxane and gemcitabine. Additional disclosures include: targeting CCR2 (see title), such as CCR2 peptide that consists of TFLK sequence (see [0208]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate gemcitabine as the chemotherapeutic agents. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because taxane and gemcitabine are functional equivalents of chemotherapeutic agents.
Regarding claims 9, and 11-12, the references do NOT teach using immunotherapeutic agent, such as immune checkpoint inhibitor, such as anti-PD-1.
NOVOBRANTSEVA teaches the prior art had known of combination therapy for additive or synergistic effect (see [0037]), wherein combination with an addition agent such as an immune checkpoint therapy (see [0037]), such as PD-1 (see [0473] and [0476]). Immune checkpoints and their sequences are well-known in the art. Immune checkpoints generally relate to pairs of inhibitory receptors and the natural binding partners (see [0476]). Addition disclosures include: treatment of the associated cancer with a cancer therapy (e.g., anti-immune checkpoint, chemotherapeutic, and/or radiation therapy) (see [0064]).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate immunotherapeutic agent, such as immune checkpoint inhibitor, such as anti-PD-1. The person of ordinary skill in the art would have been motivated to make those modifications it would provide additive or synergistic effect and reasonably would have expected success because the prior art had now of using combination therapies for cancer treatment.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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