DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/17/2025 has been considered by the examiner.
Status of the Claims
The response filed 10/30/2025 is acknowledged.
Claims 1-19 are pending.
Claims 1, 6, 9, and 11 are independent.
Applicant’s election without traverse of Group I, claims 1-5 in the reply filed on 10/30/2025 is acknowledged.
Claims 6-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/30/2025.
Claims 1-5 are treated on the merits in this action.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. Rejections not reiterated herein have been withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
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 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 pre-AIA the applicant regards as the invention.
Claim 1 includes the limitation – two or more populations of nanoparticles – which is unclear. This limitation suggests the populations are different but the claim does not explain what difference is required to meet the required particle population limitation. This difference may be interpreted in a number of different ways, e.g., selection of polypeptide, size, polymer composition, etc., but the skilled artisan is left to guess. In this instance there is more than one reasonable way to interpret which species of nanoparticle populations are required to satisfy the requirement of two or more populations of nanoparticles. The further limitation that each population of nanoparticles independently comprises selected polypeptides does not reveal the required difference in the populations of nanoparticles since each population may independently contain the same peptide.
This rejection may be overcome by incorporating the limitations of claim 4 and claim 5 as alternative options into claim 1.
Clarification is required.
Claim Rejections - 35 USC § 102
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 1-3 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Lee, US 20230321190.
Lee teaches nanoparticles (Lee, e.g., 0169, claims 14-16) comprising one or more proteins, e.g., IL-4 and/or IL-10 (Lee, e.g., claim 42). Lee teaches the nanoparticles in a polyethylene glycol carrier (Lee, e.g., 0170) which means the nanoparticles have a polyethylene glycol coating. Lee teaches the composition comprising two or more populations of particles, e.g., liposomes and nanoparticles, liposomes and secretomes, or liposomes and exosomes and microvesicles. See Lee, e.g., claims 1 and 11-16 and 18.
Lee anticipates the subject matter of instant claims 1-3.
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Anderson, US 20200113943.
Anderson teaches vesicles for treatment of inflammation and neurological damage (Anderson, e.g., Title, Abstract, claims). Anderson teaches wherein the vesicles are exosomes Anderson, e.g., 0005, 0006, claim 1), which are nanoparticles having a size ranging from 30-200 nm (Anderson, e.g., 0019). See also sizes disclosed in 0153 and 0172. The population of exosomes may be heterogenous, i.e., differ in some material aspect, e.g., differing amount of protein or different size (Anderson, e.g., 0094). Cytokines encapsulated in the exosomes (Anderson, e.g., 0023) include IGF1, TGFβ, IL-4 and IL-10 (Anderson, e.g., 0012, 0021, 0023, 0024, 0029). Only one or all of these meet the polypeptide limitations of claims 1-3. Nanoparticles may be formulated in a carrier, e.g., a polymeric carrier selected from a group including polyethylene glycol (Anderson, e.g., 0174-0175). Formulating the exosome nanoparticles in a polyethylene glycol carrier meets the limitation of polymer/polyethylene glycol coated nanoparticles.
Anderson anticipates the subject matter of instant claims 1-3.
Claim Rejections - 35 USC § 103
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 of this title, 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.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson, US 20200113943 and Tawarayama, Sci Rep, 8, 2018 (cited on IDS dated 01/17/2025).
The teachings of Anderson enumerated above apply here. Anderson teaches vesicles for treatment of inflammation and neurological damage (Anderson, e.g., Title, Abstract, claims). Anderson teaches compositions comprising a heterogeneous population of vesicles (Anderson, e.g., 0094) which are nanoparticles, e.g., exosomes having a size ranging from about 30 nm – 200 nm (Anderson, e.g., 0119). Anderson teaches agents (proteins) encapsulated in the exosome (Anderson, e.g., 0023). Anderson teaches agents including IGF1, TGFβ, IL-4 and IL-10 (Anderson, e.g., 0012, 0021, 0023, 0024, 0029). Anderson teaches the nanoparticles in a polyethylene glycol carrier, i.e., having polyethylene glycol coating (Anderson, e.g., 0174-0175). Formulating the exosome nanoparticles in a polyethylene glycol carrier meets the limitation of polymer/polyethylene glycol coated nanoparticles.
Compositions are neuroprotective, including, e.g., reduction of apoptosis of neural cells (Anderson, e.g., 0111). Anderson teaches compositions effective for treating ischemic events (Anderson, e.g., 0236), e.g., stroke (Anderson, e.g., 0248).
Anderson does not expressly teach the composition further comprising nanoparticles containing a draxin polypeptide.
Tawarayama teaches draxin was known and effective to inhibit apoptosis and sparing neuroblasts (Tawarayama, e.g., Title, Abstract and pg. 8 including Fig. 5). Draxin is suggested as useful for neuronal survival supporting neurogenesis in disorders involving ischemia (Tawarayama, e.g., pg. 1, ¶ 1).
It would have been obvious before the effective filing date of the presently claimed invention to modify compositions understood from Anderson by including a population of nanoparticles, e.g., exosomes, which contain draxin to improve the composition in the same way suggested by Tawarayama with a reasonable expectation of success. Since Anderson desired formulating compositions including exosomes which contain proteins expressed when stem cells are exposed to ischemic events, the skilled artisan would have been motivated to include draxin for the neuroblast sparing and neurogenesis benefits reported by Tawarayama. The skilled artisan would have had a reasonable expectation of success because Anderson teaches exosomes may be loaded with any desired agent, and both references teach proteins useful in neurological disease states including ischemic contexts.
Accordingly, the subject matter of claims 1-5 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Claims 1-5 are rejected under 35 U.S.C. 103 as being unpatentable over Lavik, US 20140242180 in view of Anderson, US 20200113943 and Tawarayama, Sci Rep, 8, 2018 (cited on IDS dated 01/17/2025).
Lavik teaches compositions comprising a plurality of nanoparticles, wherein the nanoparticles contain therapeutic compounds, e.g., wherein at least two nanoparticles of the plurality is associate with one or more different therapeutic compounds (Lavik, e.g., 0049). Therapeutic agents may include IL-4, IL-10, IGF1, (Lavik, e.g., 0053). Lavik teaches the nanoparticle comprising a polymeric core and a polyethylene glycol coating attached to the core (Lavki, e.g., 0036-0039, examples 2, 6, 11, 12, and example 13). Lavik teaches compositions effective for treating trauma resulting in ischemia and anoxia (Lavik, e.g., 0072).
Lavik does not expressly exemplify a composition comprising two or more populations of nanoparticles containing IL-10, IGF1, TGFβ and draxin or IL-4, IL-10, IGF1, TGFβ and draxin.
However, the teachings of Anderson and Tawarayama enumerated above cures this defect.
Anderson teaches vesicles for treatment of inflammation and neurological damage (Anderson, e.g., Title, Abstract, claims), including ischemia related diseases, e.g., stroke (Anderson, e.g., 0085, Example 5, and 0248). Anderson teaches compositions comprising a heterogeneous population of vesicles (Anderson, e.g., 0094) which are nanoparticles, e.g., exosomes having a size ranging from about 30 nm – 200 nm (Anderson, e.g., 0119). Anderson teaches agents (proteins) encapsulated in the exosome (Anderson, e.g., 0023). Anderson teaches agents including IGF1, TGFβ, IL-4 and IL-10 (Anderson, e.g., 0012, 0021, 0023, 0024, 0029).
Compositions are neuroprotective, including, e.g., reduction of apoptosis of neural cells (Anderson, e.g., 0111). Anderson teaches compositions effective for treating ischemic events (Anderson, e.g., 0236), e.g., stroke (Anderson, e.g., 0248).
Anderson does not expressly teach a draxin polypeptide.
Tawarayama teaches draxin was known and effective to inhibit apoptosis and spare neuroblasts (Tawarayama, e.g., Title, Abstract and pg. 8 including Fig. 5). Draxin is suggested as useful for neuronal survival supporting neurogenesis in disorders involving ischemia (Tawarayama, e.g., pg. 1, ¶ 1).
It would have been obvious before the effective filing date of the presently claimed invention to formulate compositions comprising two or more populations of nanoparticles, e.g., nanoparticles containing different therapeutic agents as understood from Lavik by incorporating actives in each nanoparticle, e.g., IGF1, TGFβ, IL-10, draxin and IL-4 suggested as useful for treating ischemic events by Anderson and Tawarayama with a reasonable expectation of success. Since Lavik teaches compositions useful for treating event causing ischemia and anoxia, the skilled artisan would have been motivated to incorporate known proteins suggested by the art as effective for treating ischemic events such as IGF1, TGFβ, IL-10, draxin and IL-4 to improve the composition’s effectiveness in ameliorating ischemia and hypoxia associated with anoxia in the same way reported by Anderson and Tawarayama. The skilled artisan would have had a reasonable expectation of success because Lavik clearly suggests the nanoparticles may contain protein actives, e.g., interleukins and growth factors.
Accordingly, the subject matter of claims 1-5 would have been prima facie obvious before the effective filing date of the presently claimed invention, absent evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM A CRAIGO whose telephone number is (571)270-1347. The examiner can normally be reached on Monday - Friday, 9am - 6pm, PDT.
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/WILLIAM CRAIGO/Examiner, Art Unit 1615