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 .
Drawings and Specification
Applicant’s amended drawings, filed 12/23/2025, are legible and entered. The objection to the drawings of 09/23/2025 are withdrawn. Applicant’s amended specification filed 12/23/2025 is entered and fixes the issues. The objection to the specification of 09/23/2025 is withdrawn.
Response to Amendment
The amendment filed on 12/23/2025 has been entered. Claims 1-14 and 17-18 are pending in the application. Claims 1-8 are withdrawn and claims 15-16 are cancelled.
Applicant’s amendments to the claims have not introduced new matter and are supported in the specification in at least [0006] of the instant specification.
Applicant’s amendments to the claims have overcome the Claim Objections made on 09/23/2025. However, the amendments have not overcome the 35 USC 112(b) rejections and those are maintained and presented again below for new claims 17-18.
Response to Arguments
Applicant's arguments filed 12/23/2025 have been fully considered but they are not persuasive.
Applicant argues on Pg. 7 that Gao fails to disclose a hybrid nanoparticle comprising a poly (lactic-co-glycolic acid) nanomatrix comprising poly(lactide-co-glycolide) (PLGA), poly (lactide-co-glycolide)-b-poly(ethylene glycol)-maleimide (PLGA-PEG-Mal) or a combination thereof and at least one cerium oxide nanoparticle.
However, Gao teaches a nano-CeO2 (cerium oxide) particle loaded co-polymer matrix, where the cerium oxide nanoparticles are encapsulated on poly-(lactide-co-glycolide)-polyethylene glycol (PEG-PLGA) copolymer matrix (Abstract). Gao teaches the PLGA component of the copolymer matrix is comprised of poly (lactic-co-glycolic acid) (PLGA) (Pg. 185, 2.1). Gao clearly teaches a hybrid nanoparticle matrix comprising PLGA and cerium oxide nano particles, meeting the limitations of claim 9.
Applicant argues on Pg. 7 regarding the 35 USC 103 rejections that for the reasons discussed above for Gao, the dependent claims are also not obvious.
However, Gao anticipates the hybrid nanoparticle of claim 9 and accordingly the subsequent rejections under 35 USC 103 are maintained below.
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.
Claims 17-18 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.
Regarding claim 17, the metes and bounds of the claim are indefinite because claim 17 is directed to the use of the hybrid nanoparticle of claim 9 “in an effective amount for treatment of a central neuronal system disease”. The person of ordinary skill in the art before the effective filing date of the claimed invention would not be apprised of when infringement of claim 17 would begin because Applicant has not provided a definition of what an ‘effective’ amount would be and the specification does not permit the ordinarily skilled artisan to determine the ‘effective amount’ when the claim is read in light of the supporting disclosure (see MPEP 2173.05(c)(III) which describes that the phrase “effective amount” may or may not be indefinite and that “an effective amount” may be definite “when read in light of the supporting disclosure”).
Turning to Applicant’s specification, Examiner has located [0050] which discusses the terms “effective” and “sufficient” but does not provide a particular definition of these terms.
Additionally, Examiner has considered [0053] which discusses “treating” and “treatment” but notes that a particular definition of these terms is not provided such that an ordinarily skilled artisan could reasonably resolve the ambiguity in claim 17 as to what an ‘effective amount’ of the hybrid nanoparticle of claim 9 would be for the treatment of any type of CNS disease.
Regarding claim 18, Claim 18 depends from claim 17 and is thus also rendered indefinite. Additionally, claim 1 is rejected because the scope of the claim is indefinite. Specifically, “neonatal hypoxic-ischemic, stroke,…” is unclear. While neonatal hypoxic-ischemic encephalopathy as well as stroke are recognized, it is unclear if ‘encephalopathy’ is missing or if the comma between ‘ischemic’ and ‘stroke’ is a typo. Furthermore, stroke is also recognized as a neonatal brain injury and so the metes and bounds of the claim are unclear. Examiner also notes the presence of other claim elements such as ‘brain injury’ and ‘post-traumatic stress disorder’. These phrases are credible/legitimate medical phenomenon but are nebulous descriptions in an ever-advancing medical field/profession. For example, a concussion is a recognized brain injury but it is unclear if it would be considered as a central nervous system disease.
We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
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.
Claims 9, 11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gao et al. (J. Photochem. Photobio. B, Bio. 2018, 187, 184-189).
Regarding claim 9, Gao teaches a nano-CeO2 (cerium oxide) particle loaded co-polymer matrix, where the cerium oxide nanoparticles are encapsulated on poly-(lactide-co-glycolide)-polyethylene glycol (PEG-PLGA) copolymer matrix (Abstract). Gao teaches the PLGA component of the copolymer matrix is comprised of poly (lactic-co-glycolic acid) (PLGA) (Pg. 185, 2.1). Gao teaches the CeO2 nanoparticle loaded PEG-PLGA material is a nanocomposite, where the particles are nanometric in size, as clearly depicted in Fig. 2A and 2B (Pg. 186, left and right col.; Fig. 2A and 2B). A nanometric in size nanocomposite meets the limitation “nanomatrix”.
Regarding claim 11, Gao teaches the CeO2 nanoparticles dispersed in the polymer are between 5 to 10 nm (Pg. 186, Right Col.; Fig. 2B).
Regarding claim 13, Gao teaches the cerium oxide nanoparticle act as antioxidants (Pg. 188, left col. “The biological results of CeO2 nanoparticles with polymer groups are acted as antioxidants…”).
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 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 10 is rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (J. Photochem. Photobio. B, Bio. 2018, 187, 184-189), as evidenced by Kuo et al. (J. Mater. Res. Tech. 2019, 8, 1, 887-895).
Regarding claim 10, Gao anticipates the hybrid nanoparticle of claim 9 and Gao further teaches the blocks of PEG-PLGA groups have been self-assembled into the copolymer matrix with their hydrophobic cores incorporated with CeO2 nanoparticles (Pg. 185, right col.). Gao further teaches the polymer contains hydrophobic groups that form an apolar cavity that provides the ability to form binding sites with drug molecules and active nanoparticles (Pg. 185, left col.). Incorporation of the CeO2 nanoparticles with the hydrophobic cores of the copolymer matrix sufficiently describes a hydrophobic interaction, as evidenced by Kuo, who describes hydrophobic interactions as interactions between metal oxide nanoparticles and the surface of PLGA nanoparticles (Pg. 888, right col.).
Claims 12 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (J. Photochem. Photobio. B, Bio. 2018, 187, 184-189).
Regarding claim 12, Gao anticipates the hybrid nanoparticles of claim 9 and Gao further teaches the TEM and SEM images that depict the CeO2 nanoparticles loaded into PEG-PLGA matrix display a size of approximately 50 nm, with a size bar of 200 nm encompassing entire composite particles (Fig. 2). Gao teaching the particle sizes of the CeO2 in the PEG-PLGA matrix being less than at least 200 nm requires the PLGA particles to be within that range as well, meeting the limitation required by the claim. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. MPEP 2144.05 (I). In the instant case, the range taught by Gao (nanocomposite particles less than about 200 nm) overlaps with the claimed range (50-300 nanometers). Therefore, the range in Gao renders obvious the claimed range.
Regarding claims 17, Gao anticipates the hybrid nanoparticles of claim 9.
Gao further teaches the cerium oxide particles can be used to defend and have a biological result against cerebral ischemic brain stroke and/or brain injury related to Cerebral ischemic stroke (Pg. 188, left col.; Abstract). Gao teaching that the Ce nanoparticles have a ‘biological result’ of reducing ischemic brain injury meets the BRI of at least the recited options of stroke and/or brain injury.
Further, claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). From MPEP 2112.
Therefore, absent evidence of criticality and given that Gao meets the structural requirements of the claimed hybrid nanoparticle as well as being directed to reducing ischemic brain injury, Gao meets the requirements of the present claims.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (J. Photochem. Photobio. B, Bio. 2018, 187, 184-189) in view of Danhier et al. (J. Cont. Rel. 2012, 161, 505-522).
Regarding claim 14, Gao anticipates the hybrid nanoparticle of claim 9 and the claim further requires “a targeting ligand bonded to the hybrid nanoparticle,” to which Gao does not explicitly state.
Danhier teaches the functionality of PLGA nanoparticles where targeting ligands are grafted onto the nanoparticle surface via PEG chains (Pg. 506, right col.). Advantageously, incorporating targeting ligands into PLGA nanoparticles comprising PEG chains increases selective cellular binding and internalization through receptor-mediated endocytosis, while allowing the affinity of binding receptors to be matched with ligands (Pg. 506, right col.; Fig. 3).
Note, Gao teaches the cerium oxide nanoparticles are encapsulated on poly-(lactide-co-glycolide)-polyethylene glycol (PEG-PLGA) copolymer matrix, lending feasibility to the combination with Danhier of PEG chains incorporated with PLGA.
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to include a targeting ligand in the product of Gao in order to increase selective cellular binding and internalization through receptor-mediated endocytosis as taught by Danhier.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gao et al. (J. Photochem. Photobio. B, Bio. 2018, 187, 184-189) in view of Singh et al. (Nanoscale, 2012, 4, 2597).
Regarding claim 18, Gao anticipates the hybrid nanoparticle of claim 9 and makes obvious the hybrid nanoparticle of claim 17. The claim further requires “the central neuronal system disease comprises Alzheimer's disease, Multiple sclerosis, Brain tumor, glioblastoma, neuroblastoma, Parkinson's disease, Epilepsy, neonatal hypoxic-ischemic, stroke, Amyotrophic lateral sclerosis, Huntington's disease, Spinal cord injury, brain injury, post-traumatic stress disorder, and/or frontotemporal dementia,” to which Gao does not describe a central neuronal disease other than brain injury and stroke being treated that falls within the required groups.
Singh teaches the facile synthesis of PLGA encapsulated cerium oxide nanoparticles that are used to treat diseases including Parkinson’s and Alzheimer’s disease (Pg. 2597, left col.). Advantageously, PLGA encapsulated cerium oxide nanoparticle composites display antioxidant ability in addition to controlled release of nanoparticle and complete biodegradability (Pg. 2597, right col.).
Thus, prior to the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to administer the PLGA encapsulated cerium oxide nanoparticle material when using the product of Gao in order to treat diseases including Parkinson’s and Alzheimer’s, as taught by Singh.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jordan Wayne Taylor whose telephone number is (571)272-9895. The examiner can normally be reached Monday - Friday, 7:30 AM - 5 PM EST; Second Fridays Off.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sally A. Merkling can be reached on (571)272-6297. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.W.T./Examiner, Art Unit 1738
/SALLY A MERKLING/SPE, Art Unit 1738