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 21-23 have been added.
Claims 1-5, 7-11, 13 and 15-23 are pending.
Claims 6, 12, and 14 are cancelled.
Claims 3-4 are withdrawn.
Claim 1 has been amended.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn.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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/04/2025 has been entered.
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 1, 2, 5, 7-11, 13, and 15-21 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.
Claim 1 recites “the cilia-targeting nanoparticles consist of a core nanoparticle, a polyethylene glycol (PEG) coating on the core nanoparticle, and a cilia-targeting antibody”. This is considered closed language. However, claim 1 goes on to further recite “further comprising a fatty acid coating between the core nanoparticle and the PEG coating, and a pharmaceutical agent”. The claim is indefinite since the use of “consist” prevents other components from being added to the composition. This is followed by the open language of “comprising” in regard to a fatty acid coating between the core nanoparticle and the PEG coating, and a pharmaceutical agent.
For the sake of compact prosecution, the claim is interpreted as cilia targeting nanoparticles comprising a core nanoparticle, a polyethylene glycol (PEG) coating on the core nanoparticle, and a cilia-targeting antibody further comprising a fatty acid coating between the core nanoparticle and the PEG coating, and a pharmaceutical agent.
The dependent claims fall therewith.
Claim 23 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.
Claim 23 recites “ A nanoparticle delivery formulation for ciliopathy treatment: a plurality of cilia-targeting nanoparticles consisting of a core nanoparticle, a polyethylene glycol (PEG) coating on the core nanoparticle, and a cilia-targeting antibody and further comprising: a fatty acid coating between the core particle and the PEG coating, and a dopamine receptor agonist”. It is unclear if open or closed language should be used to interpret the claim.
For the sake of compact prosecution, the claim is interpreted as, a nanoparticle delivery formulation for ciliopathy treatment comprising: a plurality of cilia-targeting nanoparticles consisting of a core nanoparticle, a polyethylene glycol (PEG) coating on the core nanoparticle, and a cilia-targeting antibody and further comprising: a fatty acid coating between the core particle and the PEG coating, and a dopamine receptor agonist.
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, 5, 7-11, 13, and 15-23 are rejected under 35 U.S.C. 103 as being unpatentable over YALLAPU (PEG-Functionalized Magnetic Nanoparticles for Drug Delivery and Magnetic Resonance Imaging Applications. Pharm Res. 2010.) in view of WEIMBS (Emerging targeted strategies for the treatment of autosomal dominant polycystic kidney disease. CKJ Review. 2018.) and KATHEM (Ciliotherapy: A Novel Intervention in Polycystic Kidney Disease. Pharmacy Faculty Articles and Research. 2014.).
YALLAPU teaches iron oxide core nanoparticles coated with oleic acid and then further coated with polyethylene glycol (PEG) that can be used as a drug delivery system (abstract), which reads on a core nanoparticle with a fatty acid coating between the core nanoparticle and the PEG coating. The nanoparticle can conjugate to an antibody (abstract). The oleic acid layer entraps the drug and allows for sustained dug release over time, potentially lowering the dosing frequency (Page 11, paragraph 3). The PEG layer prevents the rapid clearance of the nanoparticles, improving circulation time in the body, and further provides functional groups for the conjugation of a targeting ligand, such as an antibody (Page 2 , paragraph 3). The encapsulation of the drug within the nanoparticle prevents systemic drug toxicity (page 11, paragraph 3).
YALLAPU does not teach specifically using a cilia-targeting antibody.
WEIMBS teaches that using antibodies to systemically deliver drugs to a specific area can lead to less side effects during treatment for polycystic kidney disease (PKD) (abstract). Drugs, such as etanercept, can be used to treat dysfunctional primary cilia (Page i28, paragraph 8), but can be too toxic for use for long-term therapy if the entire body is subjected to the drug, therefor targeted delivery, using antibodies, to the polycystic kidneys is necessary to prevent unwanted side effects (Page 132, paragraph 1).
KATHEM teaches that polycystic kidney disease (PKD) is caused by the abnormal structure of primary cilia and causes hypertension (abstract). A targeted therapy focused on the primary cilia is needed (abstract). Fenoldopam is a drug that is a targeted dopamine agonist to regulate cilia length and used to treat PKD (abstract). KATHEM teaches that Fenoldopam activates dopamine receptor 5 (Page 67, paragraph 5).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using a cilia-targeting antibody. The person of ordinary skill in the art would have been motivated to make those modifications, because it would allow for effective targeted treatment of PKD, which is caused by dysfunctional primary cilia, and is a disease in which targeted drug delivery using antibodies is necessary to prevent toxic side effects for the subjects and reasonably would have expected success because the nanoparticle system of YALLAPU is designed for targeted drug delivery using an antibody.
Regarding claim 2, 5 and 8, YALLAPU teaches that the nanoparticle is iron oxide (abstract), which reads on a magnetic nanoparticle.
Regarding claim 7 and 21, YALLAPU teaches that oleic acid is used (abstract).
Regarding claim 9, YALLAPU teaches a PEG coated nanoparticle (abstract), which is PEGylation and would read on “Activated PEG”.
Regarding claim 10 and 11, YALLAPU teaches using PEG, the PEG is specifically SUNBRIGHT OE-040 CS (Page 3, paragraph 1), which has is a PEG with a molecular weight of 4,000 daltons according to Applicant’s specification (page 18, paragraph 0069).
Regarding claim 13, KATHEM teaches using fenoldopam, which is a drug that is a targeted dopamine agonist to regulate cilia length and used to treat PKD (abstract). KATHEM teaches that Fenoldopam is directed towards dopamine receptor 5 (Page 67, paragraph 5).
Regarding claim 15, KATHEM teaches administering fenoldopam (Page 64, paragraph 4).
Regarding claim 16 and 17, the references are towards treating the ciliopathy polycystic kidney disease (PKD) (WEIMBS abstract and KATHEM abstract).
Regarding claim 18, the references are towards treating PKD and KATHEM teaches that PKD causes hypertension (abstract) and therefore hypertension can be treated using the method.
Regarding claim 19, KATHEM teaches using the pharmaceutical agent Fenoldopam which is a drug that is a targeted dopamine agonist and is towards dopamine receptor 5 (Abstract and Page 67, paragraph 5).
Regarding claim 20, YALLAPU teaches that the magnetic nanoparticles can be used with a magnetic field to cause hyperthermia to destroy cancer cells (abstract). YALLAPU further teaches using a magnetic force, in the form of magnetic resonance imaging, which allows for an image-guided therapy because the nanoparticles can be imaged using MRI and simultaneously deliver drugs to the targeted tissue (Page 12, paragraph 2).
Regarding claim 22, as discussed above, YALLAPU teaches iron oxide core nanoparticles coated with oleic acid and then further coated with polyethylene glycol (PEG) that can be used as a drug delivery system (abstract), which reads on a plurality of cilia-targeting nanoparticles consisting of a core nanoparticle, a polyethylene glycol (PEG) coating on the core nanoparticle, and a fatty acid coating between the core particle and the PEG coating,
YALLAPU does not teach specifically using a cilia-targeting antibody.
WEIMBS teaches that using antibodies to systemically deliver drugs to a specific area can lead to less side effects during treatment for polycystic kidney disease (PKD) (abstract). Drugs, such as etanercept, can be used to treat dysfunctional primary cilia (Page i28, paragraph 8), but can be too toxic for use for long-term therapy if the entire body is subjected to the drug, therefor targeted delivery, using antibodies, to the polycystic kidneys is necessary to prevent unwanted side effects (Page 132, paragraph 1).
KATHEM teaches that polycystic kidney disease (PKD) is caused by the abnormal structure of primary cilia and causes hypertension (abstract). A targeted therapy focused on the primary cilia is needed (abstract). Fenoldopam is a drug that is a targeted dopamine agonist to regulate cilia length and used to treat PKD (abstract). KATHEM teaches that Fenoldopam activates dopamine receptor 5 (Page 67, paragraph 5).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using a cilia-targeting antibody. The person of ordinary skill in the art would have been motivated to make those modifications, because it would allow for effective targeted treatment of PKD, which is caused by dysfunctional primary cilia, and is a disease in which targeted drug delivery using antibodies is necessary to prevent toxic side effects for the subjects and reasonably would have expected success because the nanoparticle system of YALLAPU is designed for targeted drug delivery using an antibody.
Regarding claim 23, as discussed above, YALLAPU teaches iron oxide core nanoparticles coated with oleic acid and then further coated with polyethylene glycol (PEG) that can be used as a drug delivery system (abstract), which reads on A nanoparticle delivery formulation for ciliopathy treatment: a plurality of cilia-targeting nanoparticles consisting of a core nanoparticle, a polyethylene glycol (PEG) coating on the core nanoparticle and a fatty acid coating between the core particle and the PEG coating,
YALLAPU does not teach specifically using a cilia-targeting antibody.
WEIMBS teaches that using antibodies to systemically deliver drugs to a specific area can lead to less side effects during treatment for polycystic kidney disease (PKD) (abstract). Drugs, such as etanercept, can be used to treat dysfunctional primary cilia (Page i28, paragraph 8), but can be too toxic for use for long-term therapy if the entire body is subjected to the drug, therefor targeted delivery, using antibodies, to the polycystic kidneys is necessary to prevent unwanted side effects (Page 132, paragraph 1).
KATHEM teaches that polycystic kidney disease (PKD) is caused by the abnormal structure of primary cilia and causes hypertension (abstract). A targeted therapy focused on the primary cilia is needed (abstract). Fenoldopam is a drug that is a targeted dopamine agonist to regulate cilia length and used to treat PKD (abstract). KATHEM teaches that Fenoldopam activates dopamine receptor 5 (Page 67, paragraph 5), which reads on a dopamine receptor agonist.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using a cilia-targeting antibody. The person of ordinary skill in the art would have been motivated to make those modifications, because it would allow for effective targeted treatment of PKD, which is caused by dysfunctional primary cilia, and is a disease in which targeted drug delivery using antibodies is necessary to prevent toxic side effects for the subjects and reasonably would have expected success because the nanoparticle system of YALLAPU is designed for targeted drug delivery using an antibody.
Conclusion
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/S.L.M./Examiner, Art Unit 1618 /JAKE M VU/Primary Examiner, Art Unit 1618