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 .
Acknowledgments and Claim Status
The Examiner acknowledges receipt of the amendment filed 5/30/2023 wherein claims 3, 4, 7-10, 13, 15, 19, 20, 22-24, 30, 32-35, 37, 39, 41, and 42 were canceled and the specification and claims 5, 6, 11, 12, 14, 16, 18, 21, 25, 27, 28, 31, 36, 38, and 40 were amended.
Note(s): Claims 1, 2, 5, 6, 11, 12, 14, 16-18, 21, 25-29, 31, 36, 38, and 40 are pending.
Priority
This application is a 371 of PCT/US21/61862 filed 12/3/2021 and claims benefit to PRO 63/121,688 filed 12/4/2020.
Note(s): The earliest effective filing date is 12/4/2020 for all species except
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(see claim 2). The species
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is not present in the provisional application.
Claim Interpretation
Independent claim 1 is directed to a room temperature phosphorescence nanoparticle comprising: (1) a solid core comprising a metal-free organic phosphor embedded in a polymer wherein the polymer is hydrophobic, glassy, and oxygen-permeable and the metal-free organic phosphor is present in an amount of about 0.1 wt% to about 20 wt% based on the total weight of the polymer and (2) a shell surrounding the core wherein the shell comprises a lipid.
Applicant’s Election
Applicant's election without traverse of Group I (pending claims 1, 2, 5, 6, 11, 12, and 14) filed 5/30/2023 is acknowledged. The restriction requirement is still deemed proper and is therefore made FINAL.
In addition, the Examiner acknowledges receipt of the Applicant’s elected species filed 3/27/2026 wherein: the metal free organic phosphor substance is Br6A; the first solvent is THF; the second solvent is a combination of ethanol and water; the polymer is poly(4-bromostyrene); the lipid is 1,2-dimyristoyl-sn-glycero-3-phosphate; and the fluorescent dye is IR-780. Claims 1, 2, 5, 6, 11, 12, and 14 read on the elected species.
Initially, Applicant’s elected species was searched and prior art was not found to reject the species. Thus, the search was expanded to other species encompassed by Group I. During the expanding of the search, prior art was found which could be used to reject the claims (see below). Hence, the search was not further extended.
Withdrawn Claims
Claims 16-18, 21, 25-29, 31, 36, 38, and 40 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
The information disclosure statement filed 1/29/2024 was considered.
Specification
The disclosure is objected to because of the following informalities: the structures on pages 10 (paragraph [0044]) and 12 (paragraph [0054]) are difficult to read. Applicant is respectfully requested to submit readable structures.
Appropriate correction is required.
Written Description Rejection
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1, 2, 5, 6, 11, 12, and 14 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Applicant is reminded that an inventor is entitled to a patent to protect his work only if he/she produces or has possession of something truly new and novel. The invention being claimed must be sufficiently concrete so that it can be described for the world to appreciate the specific nature of the work that sets it apart from what was before. The inventor must be able to describe the item to be patented with such clarity that the reader is assured that the inventor actually has possession and knowledge of the unique composition that makes it worthy of patent protection.
(1) The pending application does not sufficiently describe the invention as it relates to metal free organic phosphor agents other than
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, and
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. (2) In addition, the pending application does not sufficiently describe the invention as it relates to hydrophobic, glassy, and oxygen-permeable polymers other than polystyrene. Thus, what the reader gathers from the instant application is a desire/plan/first step for obtaining a desired result. While the reader can certainly appreciate the desire for achieving a certain end result, establishing goals does not necessarily mean that an invention has been adequately described.
While compliance with the written description requirements must be determined on a case-by-case basis, the real issue here is simply whether an adequate description is necessary to practice an invention described only in terms of its function and/or based on a disclosure wherein a description of the components necessary in order for the invention to function are lacking. In order to satisfy the written description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. In other words, the specification should describe an invention and does so in sufficient detail that one skilled in the art can clearly conclude that the inventor created what is the claimed. Thus, the written description requirement is lacking in the instant invention since the various terms as set forth above are not described in a manner to clearly allow persons of ordinary skill in the art to recognize that Applicant invented what is being claimed.
112 Second Paragraph Rejections
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, 6, 11, 12, and 14 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.
Claims 1, 2, 5, 6, 11, 12, and 14: Independent claim 1 is ambiguous for the following reasons: (1) it is unclear what polymer(s) Applicant is referencing that are hydrophobic, glassy, and oxygen-permeable that at room temperature are phosphorescence nanoparticles compatible. (2) Also, independent claim 1 is ambiguous because it is unclear what metal free organic phosphor substances Applicant is referencing that are compatible with the pending invention. Since claims 2, 5, 6, 11, 12, and 14 depend upon independent claim 1 for clarity, they are vague and indefinite as well.
Claim 2: The claim is ambiguous because of the phrase ‘can be’ in lines 4 and 6. Specifically, according to MPEP 803.02, a Markush group requires a closed listing. The use of ‘can be’ instead of ‘is’ or ‘selected from’, for example, allows for unnamed components (integers) to be present in the listing.
103 Rejection
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, 6, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al (Angew. Chem., Int. Ed, 2017, Vol. 56, pages 16207-16211) in view of Rossi et al (J. Phys. Chem., 2014, Vol. 4, No. 5, pages 241-246) in further view of Bochicchio et al (Scientific Reports, 2017, Vol. 7, No. 6357, pages 1-9) and Negoda et al (Biochimica et Biophysica Acta, 2013, Vol. 1828, pages 2215-2222).
Independent claim 1 is directed to a room temperature phosphorescence nanoparticle comprising: (1) a solid core comprising a metal-free organic phosphor embedded in a polymer wherein the polymer is hydrophobic, glassy, and oxygen-permeable and the metal-free organic phosphor is present in an amount of about 0.1 wt% to about 20 wt% based on the total weight of the polymer and (2) a shell surrounding the core wherein the shell comprises a lipid.
Claim 2 is directed to is directed to various metal free organic phosphors as set forth therein.
Claim 5 is directed to the nanoparticle of claim 1 wherein the polymer comprises a polystyrene homopolymer, a halogenated polystyrene, a polystyrene copolymer, or a combination thereof.
Claim 6 is directed to the nanoparticle of claim 5, wherein the polystyrene copolymer is polystyrene-b-poly(4-vinylpyridine) or wherein the halogenated polystyrene is poly (4-bromostyrene).
Claim 12 is directed to the nanoparticle of claim 1 further comprising a fluorescent dye embedded in the polymer.
Claim 14 is directed to the nanoparticle of claim 1 wherein the metal-free organic phosphor is present in an amount of about 1 wt% to about 10 wt%, based on the total weight of the polymer.
Yu et al is directed to room temperature phosphorescence based core-shell polymer nanoparticles that contain metal free organic phosphors. The nanoparticles have a polystyrene core (see entire document, especially, abstract; page 16208, left column, first complete paragraph). In Figure 1 (page 16208), the phosphors,
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(C1) and
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(Br6A), are disclosed (see also, page 16208, right column first and second paragraph rejections). In Figure 2 (page 16208), the synthetic routes of C1 crosslinked nanoparticles (see excerpt below). C1 was compared Br6A
Yu et al , Figure 2, page 16208
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While Yu et al disclose a room temperature phosphorescence based polystyrene nanoparticle containing metal free organic phosphors, the document fails to specifically incorporate a lipid therein (in the shell).
Rossi et al is made of record because it sets forth that polystyrene (PS) nanoparticles comprising a lipid are well known in the art. Specifically, polymer-lipid interactions were evaluated. The lipids evaluated include 1-palmitoyl-2-oleoyl-phosphatidylcholine (POPC), phosphatidylcholine (PC), dilinoleyl-PC (DLiPC), dipalmitoyl-PC (DPPC), and cholesterol (CHOL). The nanoparticles are solid (see entire document, especially, abstract; page 242, left and right columns, bridging paragraph; page 242, Figure 2; pages 242-243, bridging paragraph; page 244, Figure 3 and Table 2).
On page 243, Table 1 is disclosed. The table contains data directed to compositions comprising various amounts of polystyrene and POPC. As a result, it would have been obvious to one of ordinary skill at the time the invention was made to incorporate a lipid into the nanoparticle and optimize the polymer in regards to other components in the composition. In particular, Rossi et al disclose Table 1 wherein the PS percentages are alter. This is consistent with MPEP 2144.05 which sets forth that when 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. Thus, the combination of Yu et al and Rossi et al render obvious a room temperature phosphorescence nanoparticle comprising a solid core comprising a metal free organic phosphor substance, a polymer, and shell surrounding the core that comprises a liquid wherein the components therein are maximize according to weight amounts.
Both Bochicchio et al and Negoda et al are made of record as evidentiary references to illustrate that the combination of polystyrene and lipid nanoparticles are well known in the art. For example, Bochicchio et al which is directed to polystyrene nanoparticles were placed in contact with POPC, DPPC, DLiPC, and CHOL (see entire document, especially, abstract; page 2, second and third complete paragraphs). Negoda et al, which is directed to polystyrene nanoparticles in combination with a lipid is known in the art (see entire document, especially, abstract). Hence, based on the prior art and the fact that it is known that polystyrene nanoparticles and lipids are known to be together in composition, it would have be obvious to a skilled artisan prior to the effective dated of Yu et al to incorporate a lipid into the nanoparticle. As indicated by Negoda et al (page 2216, left column second complete paragraph), the presence of a lipid (e.g., phospholipid) can impart changes in charge distributions to influence pore ion selectivity and alter penetration/release of material in the nanoparticle. Similarly, Rossi et al’s teachings are consistent with those of Negoda et al (see page 242, left and right columns, bridging paragraph; pages 242-243, bridging paragraph; page 243, Table 1; page 243; right column, first complete paragraph; page 244; Figure 3 and Table 2).
For the reasons of record, the pending claims are rendered obvious over the cited prior art.
Comments/Notes
The full scope of Group I was not searched. The claim was only searched to the extent that it reads on the elected species and the cited prior art above.
Conclusion
Claims 1, 2, 5, 6, 11, 12, and 14 are rejected and claims 16-18, 21, 25-29, 31, 36, 38, and 40 are withdrawn.
Future Correspondences
Any inquiry concerning this communication or earlier communications from the examiner should be directed to D L Jones whose telephone number is (571)272-0617. The examiner can normally be reached M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael G. 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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
June 8, 2026
Prosecution Insights