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 9/2/2025 wherein claims 1, 2, and 4 were amended.
Note(s): Claims 1-13 are pending.
Priority & Priority Document
This application is a CON of PCT/KR2023/019271 filed 11/27/2023 which claims benefit to Korea, Republic document KR10-2022-0160450 filed 11/25/2022.
Acknowledgment is made of Applicant’s claim for foreign priority under 35 USC 119 (a) – (d). The certified copy was filed in with the pending application on 6/23/2025.
While a certified copy of the prior document was submitted, an English language translation is not of record. Should Applicant desire to obtain the benefit of foreign priority under 35 USC 119 (a) – (d) prior to declaration of an interference, a certified English language translation or translations of the foreign application(s) should be submitted. 37 CFR 41.154(b) and 41.202(e). Failure to prove the certified translation(s) may result in no benefit being accorded for the non-English document(s).
Note(s): The earliest effective filing date is 11/27/2023 because there is no English translation of the priority document of record to establish that the pending invention is supported therein.
Claim Interpretation
Independent claim 1 is directed to a nanoplatform obtained by click chemistry reaction between albumin conjugated with a cyclooctyne functional group and a transmitter conjugated with an azide (N3) wherein the transmitter comprises a glucosyl group.
Applicant’s Election
Applicant elected the species wherein an albumin is conjugated to azide in combination with a transmitter comprising a glucosyl group without traverse.
Applicant’s elected species was searched and prior art was found which could be used to reject the claims as set forth in detail below (see ‘103 Rejection’ below).
Information Disclosure Statement
The information disclosure statement filed 5/15/2025 was considered.
Specification
The disclosure is objected to because of the following informalities: the structures appearing on page 10 are difficult to read. Some of the bonds, atoms, and substituents are not readable. Please submit readable copies of the structures.
Appropriate correction is required.
Prevention Claims
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 9-13 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. The instant application does not sufficiently describe the invention as it relates to the preventing of an inflammatory disease as set forth in claim 9 from which claims 10-13 depend. In particular, review of the disclosure does not provide support (evidence) that inflammatory diseases such as sepsis, septic shock, inflammatory bowel disease, peritonitis, inflammatory kidney disease, acute bronchitis, chronic bronchitis, osteoarthritis, enteropathic spondylitis, chronic obstructive pulmonary disease, rheumatoid arthritis, acute lung injury, and bronchopulmonary dysplasia are prevented (neither the condition nor symptoms appear) when administered the nanoplatform of the pending invention. 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 1-13 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 1-13: The claims are directed to a product (nanoplatform comprising albumin conjugated to a glucosyl group with azide). However, the each of the pending claims not only include the intend use of the product, but include active steps as well. According to MPEP 2173.05(p), a single claim directed to both a product and method steps for using such product is indefinite. In particular, the claim is indefinite because while the claim initially sets forth a product and the components thereof, the claim limitations are not limited to the product, but rather to actions involving the product which creates confusion as to when direct infringement occurs.
Specifically, it is unclear whether infringement occurs when one has a nanoplatform comprising albumin conjugated to a glucosyl group with azide or when (1) a click chemistry reaction occurs (see claim 1); (2) the cyclooctyne functional group is introduced into the albumin (see claim 2); (3) when the nanoplatform selectively targets a macrophage (see claim 8); (4) when the nanoplatform prevent or treats an inflammatory disease or targets M1 macrophage (see claim 9); (5) when the nanoplatform targets damaged tissue (see claim 10); (6) when the nanoplatform restores mitochondrial function within the damaged tissue and suppresses cell death (see claim 11); and (7) when the inflammatory tissue of specific diseases are targeted (see claims 12 and 13). Hence, the claims, which all depend upon claim 1 as well, are vague and indefinite.
Claim 1, line 4: Did Applicant intend to delete ‘functional group’ as the term ‘cyclooctyne’ was delete in line 3.
Claim 7, line 4: The claim contains the trademark/trade name “Flamma”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a chemical and, accordingly, the identification/description is indefinite.
112 Fourth Paragraph Rejections
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 8, 10, 11-13 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claims are not further limiting because independent claim 1 is directed to a product (nanoplatform) which the claims do not incorporate additional product components therein, but comprise active steps that are generally reserved for method claims. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-4 and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Colloids and Surfaces B: Biointerfaces, May 2023, Vol. 226, No. 113335, pages 1-10).
Independent claim 1 is directed to a nanoplatform obtained by click chemistry reaction between albumin conjugated with a cyclooctyne functional group and a transmitter conjugated with an azide (N3) wherein the transmitter comprises a glucosyl group.
Claim 2 is directed to the nanoplatform for targeting the inflammatory M1 macrophage of claim 1 wherein the azide or cyclooctyne functional group introduced into the albumin ranges from 1 to 14.
Claim 3 is directed to the nanoplatform for targeting the inflammatory M1 macrophage of claim 1 wherein the nanoplatform comprises 4 to 8 glucosyl groups.
Claim 4 is directed to the nanoplatform for targeting the inflammatory M1 macrophage of claim 1, wherein the azide or cyclooctyne functional group is conjugated to the 6th carbon of the glucosyl group.
Claim 7 is the nanoplatform for targeting the inflammatory M1 macrophage of claim 1, wherein the transmitter further comprises a fluorescent material, and the fluorescent material is one or more selected from the group consisting of FNR (Ferrodoxin NADP(+) reductase), cyanine-based fluorescent material, TAMRA (tetramethylrhodamine-5-maleimide), Flamma® fluorescent material and ICG (indocyanine green).
Claim 8 is directed to the nanoplatform for targeting the inflammatory M1 macrophage of claim 1, wherein the nanoplatform selectively targets a macrophage with overexpressed GLUT (Glucose Transporter).
Claim 9 is directed to a pharmaceutical composition for preventing or treating an inflammatory disease, comprising the nanoplatform for targeting the inflammatory M1 macrophage of claim 1 as an active ingredient.
Claim 10 is directed to the pharmaceutical composition of claim 9, wherein the nanoplatform for targeting the inflammatory M1 macrophage selectively targets a damaged tissue.
Claim 11 is directed to the pharmaceutical composition of claim 9, wherein the nanoplatform for targeting the inflammatory M1 macrophage restores mitochondrial function within the damaged tissue and suppresses cell death.
Claim 12 is directed to the pharmaceutical composition of claim 9, wherein the inflammatory disease is one or more selected from the group consisting of sepsis, septic shock, inflammatory bowel disease (IBD), peritonitis, inflammatory kidney disease, acute bronchitis, chronic bronchitis, osteoarthritis, enteropathic spondylitis, chronic obstructive pulmonary disease (COPD), rheumatoid arthritis, acute lung injury and bronchopulmonary dysplasia.
Claim 13 is directed to a pharmaceutical composition for preventing or treating a kidney disease, comprising the nanoplatform for targeting the inflammatory macrophage of claim 1 as an active ingredient wherein the kidney disease is one or more selected from the group consisting of nephritis, pyelonephritis, nephrotic syndrome, kidney cancer, acute pyelonephritis, chronic pyelonephritis, renal tuberculosis, urinary tract infection, urolithiasis, ureteral calculus, acute renal failure, chronic renal failure, diabetic nephropathy, renal fibrosis, chronic glomerulonephritis, rapidly progressive glomerulonephritis, nephrotic syndrome, focal segmental glomerulosclerosis, membranous nephropathy and membranoproliferative glomerulonephritis.
Lee discloses click chemistry based novel albumin nanoparticles for anti-cancer treatment via hydrogen peroxide generation. Nanoparticles using dibenzyl cyclooctyne (DBCO)-modified albumin, azide-modified albumin, and azide-modified glucose oxidase (see entire document, especially, abstract). Click chemistry was performed using DBCO and azide is mainly used to functionalize the surface of nanoparticles. The nanoparticles of Lee, GOD-bovine serum albumin (BSA) nanoparticles, were prepared vial a DBCO-azide (page 2, left column, second complete paragraph; page 2, Scheme 1; page 3, left column ‘DBCO-azide reaction of GOD-BSA nanoparticles’). The nanoparticles may further comprise Cy5 (pages 3-4, bridging paragraph). Thus, based on the disclosure of Lee and a result of using a glycosyl material (glucose oxidase), the limitations of claims 1-4 and 7-13 are met.
Note(s): As stated in detail supra (see ‘112 Second Paragraph’ section), since the claims are not further limiting of the product (nanoplatform), then they are encompassed within the cited prior art.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over Lee (Colloids and Surfaces B: Biointerfaces, May 2023, Vol. 226, No. 113335, pages 1-10) in view of Lee (Seoul Nat. University R&D, KR 10-2366189, English translation).
Lee (see detailed discussion supra) fails to disclose a radioactive isotope and chelator attached to the nanoplatform.
Lee (KR 10-2366189) is directed to nanoplatforms for targeting macrophage and compositions which prevent or treat metastatic cancer. The nanoplatform is obtained by click chemistry of albumin to which and azide (N3) or a cyclooctyne function group is bound (see entire document, especially, abstract).
It is disclosed in the claims (see page 2 of the translation) that one may have various chelators (e.g., NOTA, DFO, DTPA, DOTA, TETA, HYNIC) present which may be complexed to a radioisotope (e.g., 3H, 11C, 18F, 32P, 35S, 45Ca, 64Cu, 67Ga, 68Ga, 90Y, 99mTc, 111In, 131I, 125I, 186Re, 188Re, 225Ac, and 212Pb).
Since both Lee documents are directed to nanoplatforms that have a click chemistry between albumin to which an azide or cyclooctyne functional group is bound, the references may be considered to be within the same field of endeavor. Thus, the reference teachings are combinable. Hence, the combined cited prior art renders obvious the limitations of claims 1-13.
Conclusion
Claims 1-13 are rejected.
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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
September 25, 2025