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 7/17/2026 wherein claims 1, 5-8, and 13 were amended and claims 9-12 were canceled.
Note(s): Claims 1-8 and 13 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/17/2026 has been entered.
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.
Once again, 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.
Election by Original Presentation
Newly amended claim 13 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the claims previously presented and examined were directed to a product (nanoplatform) comprising albumin conjugated to a transmitter. Newly amended claim 10 is no longer directed to a product but has been amended to a method of preventing or treating a kidney disease as set forth therein. Thus, the scope of this invention is different from that presented earlier for examination.
Since Applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 13 is WITHDRAWN from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Withdrawn Claims
Claim 13 is withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Response to Applicant’s Amendment and/or Arguments
The Applicant's arguments and/or amendment filed 7/17/2026 to the rejection of claims 1-10, 12, and 13 made by the Examiner under 35 USC 103 and/or 112 have been fully considered and deemed persuasive-in-part for the reasons set forth below.
Prevention Claims
While the rejection is WITHDRAWN over claims 9, 10, and 12 due to the amending of those claims, claim 13 is still directed to the prevention of kidney disease. In addition, it is noted that since claim 13 is currently withdrawn due to election by original presentation, at which point the claim is examined in the future, the rejection may be reinstated.
112 Second Paragraph Rejections
Note(#1): It should be noted that due to the amending of claim 13 to subject matter that was not previously examined, the claim is withdrawn by election by original presentation. Furthermore, at which point the claim is examined, the rejection may be reinstated.
Note(#2): The rejection was modified to address the pending claims.
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 1-8 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 1-8: The claims are directed at a product (nanoplatform) and active steps involving the product 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 the nanoplatform or when (1) the transmitter is conjugated with an azide functional group to result in the formation of a triaza-5-membered ring (see independent claim 1); (2) when the nanoplatform is configured to target inflammatory M1 macrophage (see independent claim 1); and/or (3) when the nanoplatform is configured to selectively target a macrophage with overexpressed GLUT (glucose transporter) (see claim 8).
Hence, since claims 2-8 depend upon independent claim 1, those claims are vague and indefinite as well.
APPLICANT’S ASSERTIONS
In summary, it is asserted that the phrases of interest are being replaced with other phrases that Applicant believes do not recite intended use or active steps. Thus, it is Applicant’s position that the amendments to the claims overcome the rejections.
EXAMINER’S RESPONSE
Applicant is respectfully requested to once again thoroughly review the claims. Several of the amended claims replace what was indicated as active steps with other active steps that are generally associated with method/process claims, not product claims. Thus, the rejections are still deemed proper. Applicant is respectfully requested to review the following sections of the MPEP for assistance with the claim language: (1) MPEP 2173.05(p) which address some situations wherein claims contain both process and product limitations and (2) MPEP 608.01(m) and 37 CFR 1.75, both of which are directed to the form of claims.
Possible options for claim 1 which avoids active steps and intended use of the product incorporated into the claim: “A nanoplatform comprising albumin linked to a triaza-5-membered ring to a transmitter wherein the transmitter comprises a glucosyl group” OR “A nanoplatform comprising albumin linked to a cyclooctyne group conjugated to a transmitter linked to an azide (N3) group wherein the transmitter comprises a glucosyl group”.
Note(s): One interpretation of pending claim 1 from the product perspective: “A nanoplatform comprising albumin linked to a cyclooctyne group conjugated to a transmitter linked to an azide (N3) group wherein the transmitter comprises a glucosyl group”.
Another interpretation of pending claim 1 is “A nanoplatform comprising albumin linked to a triaza-5-membered ring to a transmitter wherein the transmitter comprises a glucosyl group”.
112 Fourth Paragraph Rejections
The 112 fourth paragraph rejections are WITHDRAWN.
103 Rejection
Note(s): The rejection was modified to address the pending claims.
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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sang et al (KR 20160110119, English Translation).
Amended independent claim 1 is directed to a nanoplatform comprising albumin conjugated with a transmitter wherein the albumin is conjugated with a cyclooctyne functional group and the transmitter is conjugated with an azide functional group; and wherein the transmitter comprises a glucosyl group. While the claim was amended to include active steps such as the nanoplatform being configured to target inflammatory M1 macrophage and that the cyclooctyne and azide react to form a triaza-5-membered ring, those are active steps that are being incorporated into a product claim.
Claim 2 is directed to the nanoplatform of claim 1 wherein the azide or cyclooctyne functional group conjugated to the albumin ranges from 1 to 14.
Claim 3 is directed to the nanoplatform of claim 1 wherein the nanoplatform comprises 4 to 8 glucosyl groups.
Claim 4 is directed to the nanoplatform of claim 1, wherein the azide or cyclooctyne functional group is conjugated to the 6th carbon of the glucosyl group.
Claim 5 is directed to the nanoplatform of claim 1 wherein the transmitter further comprises a radioactive isotope as set forth in claim 5.
Claim 6 is directed to a nanoplatform of claim 5 wherein the radioactive isotope is conjugated to a chelating agent and the chelating agent is one set forth in claim 6.
Claim 7 is the nanoplatform 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), and ICG (indocyanine green).
Claim 8 is directed to the nanoplatform of claim 1, wherein the nanoplatform selectively targets a macrophage with overexpressed GLUT (Glucose Transporter).
Sang et al is directed to albumin-based disease targeting diagnostic or therapeutic nanoplatforms. The albumin nanoplatform comprising albumin bound to an azide or cyclooctyne group. The albumin-based platform is found to be effective because of its size which prevents binding and reabsorption in the kidney. The drug delivery and radiopharmaceutical do not result in nephrotoxicity. The albumin-based disease targeting nanoplatform facilitates effective drug delivery to target tissues and organs by minimizing deformation and bin present in the intravascular compartment for an extended period (see entire document, especially abstract).
The nanoplatform may be generated using click chemistry reaction. Possible radioisotope that may be attached to a chelating agent include 14Cl, 32P, 35S, 36Cl, 45Ca, 51Cr, 57Co, 58Co, 68Ga, 111In, 99mTc, 125I, 186Re as well as other radioisotopes disclosed on page 2, lines 10-12. Possible chelating agents that may be conjugated to the radioisotope include NOTA, DOTA, DFO, STPA, N2S2, p-SCN-Bn-NOTA, NODAGA, p-SCN-Bn-DOTA, TETA, p-SCN-Bn-DFO, and HYNIC (page 2, lines 13-15).
Sang et al disclose that one may have a cyclooctyne group present. The cyclooctyne group may be any one of those disclosed on bridging pages 2-3 and 6-7. The albumin monomers to which an azide is bound or albumin monomers to which a cyclooctyne group is bound using a click chemistry reaction (page 3, lines 4-11; page 4, paragraph [0001]; page 5, fifth and sixth paragraphs; page 10, first complete paragraph). Cyclodextrin is bonded to an albumin monomer (page 3, lines 15-18) which results in the incorporation of glucosyl groups as evidenced by Esteso et al (International Journal of Molecular Sciences, 2024, Vol. 25, No. 4547, pages 1-5). Esteso et al is made of record because the document discloses that it is well known in the art that cyclodextrins are cyclic oligosaccharides that contain at least sic d-(+)-glucopyranose unites linked by alpha-1,4- glucosidic bonds. The three natural cyclodextrins, alpha-, beta-, and gamma- cyclodextrin) have 6, 7, and 8 glucose units, respectively (see entire document, especially, page 1, first paragraph).
One may have 1-20 azide or cyclooctyne groups present (page 13, lines 9-18 and 3-33). In addition, the albumin nanoplatform may be delivered (transmitted) to the target using a radioisotope, a fluorescent substance, a target molecule, an active substance, or a combination thereof. A variety of radioisotopes, chelating agents, and fluorescent substance (e.g., TAMRA, indocyanine green, Cy3, Cy5, and Cy7 may be used (page 14, ninth – twelfth paragraphs). Furthermore, Sang et al disclose that the compositions may be used to diagnose or evaluate diseases including cancer (page 15, fourth and fifth complete paragraphs).
The invention of Sang et al differs from that of the pending invention in that one discloses that the pending invention nanoplatform comprises both albumin conjugated with a cyclooctyne functional group and the transmitter (comprising glucosyl) conjugated with a functional group. However, it would have been obvious to the skilled artisan to have both an albumin nanoplatform comprising an azide and a cyclooctyne group. Specifically, Sang et al allows for both azide and a cyclooctyne group to be present. Furthermore, according to MPEP 2144.06, it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose in order to form a third composition comprising all the components and used for the same purpose. Thus, the idea of combining the compositions flows logically from having been individually taught in the prior art.
In regard to the claims containing intended use of the nanoplatform targeting inflammatory M1 macrophage and overexpressed GLUT (see claims 1 and 8), Applicant is respectfully reminded that a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In particular, it is noted that the composition/product of the prior art is the same/similar as that being claimed by Applicant. Also, the prior art discloses that the composition, like Applicant invention, may be used to diagnose or evaluate cancer (page 15, fourth and fifth complete paragraphs); thus, the composition (product) would be capable of having the same use as Applicant's invention because a composition/product and its properties are inseparable. Hence, Applicant's composition (product), like the cited prior art, would be 'capable of' performing the same function.
In addition, according to MPEP 2112.01.II, products of identical chemical composition cannot have mutually exclusive properties. Thus, a chemical composition and its properties are inseparable. As a result, if both Applicant and the prior art disclose overlapping products, if Applicant is able to target inflammatory M1 macrophage and overexpressed GLUT, then so would the product of the prior art since the products overlap.
For the reasons set forth supra, the pending invention is rendered obvious by the cited prior art and the limitations of claims 1-8 are met.
APPLICANT’S ASSERTIONS
In summary, it is asserted that that the cited prior art does not teach or suggest the amended transmitter comprising a glucosyl group and the English translation incorrectly renders ‘cyclooctyne’ as ‘cyclodextrin’. It is asserted that that the term ‘cyclodextrin’ in the translation of Sang et al (KR20160110119) is erroneous and as a result, the document does not provide or suggest the presence of a glucosyl group.
EXAMINER’S RESPONSE
For clarity of the record, the English translation of Sang et al (KR20160110119) does specifically disclose the presence of cyclodextrin. While it is asserted that the term is not in the original Korean document, no evidence of record has been made to support that position. Thus, Applicant is respectfully requested to provide a translation of the Korean document to indicate the contrary; otherwise, the machine translation that discloses the presence of cyclodextrin which comprises and renders obvious the glucosyl groups in the pending invention is still deemed to be an accurate translation of KR20160110119. Hence, the disclosure of Sang et al is still deemed proper and renders obvious the pending invention.
NEW GROUNDS OF REJECTION
112 Second Paragraph Rejection
Claims 1-8 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 1-8: Independent claim 1 is ambiguous because it is unclear how one should actually interpret the claim. In particular, (Interpretation #1) independent claim 1 may be interpreted as a nanoplatform comprising (a) albumin linked to a cyclooctyne group and (b) a transmitter linked with an azide (N3) group wherein the transmitter comprises a glucosyl group.
(Interpretation #2) A nanoplatform comprising albumin linked to a triaza-5-membered ring to a transmitter wherein the transmitter comprises a glucosyl group.
Applicant is respectfully requested to thoroughly review independent claim 1 for clarity of the claimed invention.
Since claims 1-8 depend upon independent claim 1 for clarity, those claims are also vague and indefinite.
Claim 8: The limitation incorporated into claim 8 is that the nanoplatform ‘is configured to selectively target a macrophage with overexpressed GLUT (glucose transporter)’. This limitation is directed to an active step generally reserved for process claims. The limitation does not further incorporate a product component (e.g., wherein the transmitter further comprises a radioisotope) into the claim. Thus, the product components of the nanoplatform itself are not further limited.
Double Patenting Rejection
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5-7, and 9-12 of copending Application No. 19/307,491 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a nanoplatform comprising (a) albumin linked to a cyclooctyne group and conjugated to (b) a transmitter comprising a glucosyl and an azide functional group. Thus, the skilled artisan would recognize that both groups disclose overlapping components and that the nanoplatform may further comprise a radioisotope, chelating agent, or fluorescent material. Hence, the inventions disclose overlapping subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Evidentiary Reference
Esteso et al (International Journal of Molecular Sciences, 2024, Vol. 25, No. 4547, pages 1-5) was previously made of record because the document discloses that it is well known in the art that cyclodextrins are cyclic oligosaccharides that contain at least sic d-(+)-glucopyranose unites linked by alpha-1,4- glucosidic bonds. The three natural cyclodextrins, alpha-, beta-, and gamma- cyclodextrin) have 6, 7, and 8 glucose units, respectively.
Conclusion
Claims 1-8 are rejected and claim 13 is 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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/D. L. Jones/
Primary Patent Examiner
Art Unit 1618
August 18, 2026
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