DETAILED ACTION
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 Status
Claim 8 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention (product), there being no allowable generic or linking claim.
It is noted that should the claims 1 and 3-7 under examination be found in condition for allowance that claim 8 is ineligible for rejoinder in view of the election to the method.
Claims 1 and 3-7 are under current examination directed to the method of treating chronic kidney disease induced by renal fibrosis.
Applicants' arguments, declaration and amendment, filed on 12/29/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. 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 maintained/slightly modified in view of amendments
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.
Claim(s) 1 and 4-5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lilin Li et al. (Effect of graphene-based nanomaterials treatment in kidney disease published 5/23/2019- see IDS filed 7/22/2022).
Lilin et al. teach that administration of graphene quantum dots (composition) by injection though a tail vein in mice models which have chronic kidney disease CKD, see objectives and results and conclusions. Treatment of CKD is a disease that is induced by renal fibrosis as evidenced by claim 3. The injections attenuated thus treated renal fibrosis in kidney disease models by reducing tubulointerstitial injury in CKD, see results. The injection of the graphene quantum dots reduced TFG-β and Smad2/3 expression while increasing Smad7, see results and conclusion.
Response to 102(a)(1) rejection
Applicants argue that a Declaration by Byung Hee Hong establishes that the disclosure of Li and the present invention were made by the inventor or joint inventor of the present Application.
Applicants have submitted herewith a Declaration of inventor Byung Hee Hong pursuant to 37 C.F.R. § 1.130(a). The Declaration establishes that the disclosure of Li and the disclosure of the present application were both made by the inventor or joint inventor of the present application, i.e., Lilin Li, Joo Hee Kim, Jung Pyo Lee, Seung Hee Yang, and Byung Hee Hong, and authors Dong Hoon Kim and Jong Bo Park, listed in Li, acted at the instruction of Byung Hee Hong and did not contribute to the subject matter presently claimed. Applicant respectfully submits that the disclosure of Li, which was published less than 1 year before the effective filing date of the present application, was made by the inventors or joint inventors of the present application, and thus Li is not available as prior art under 35 U.S.C. § 102(a)(1).
Examiner respectfully submits that while it is acknowledged that the authors of the Li reference to Donghoon Kim worked under the direction of Byung Hee Hong, the Li reference lists the additional inventors of: Joo Hong Joun, Jung Nam An, Jeong Hwan Lee and Young Wook Choi.
From MPEP 717.01(a)(1):
In evaluating whether a declaration under 37 CFR 1.130(a) is effective, Office personnel will consider the following criteria:
(A) Whether the disclosure, which was applied in the rejection and is addressed in the affidavit or declaration, is subject to the exceptions of 35 U.S.C. 102(b)(1)(A) or 102(b)(2)(A). The provision of 37 CFR 1.130(a) is not available:
(1) If the disclosure was made (e.g., patented, described in a printed publication, or in public use, on sale, or otherwise available to the public) more than one year before the effective filing date of the claimed invention. See MPEP § 2152.01 to determine the effective filing date. For example, if a public disclosure by the inventor or which originated with the inventor is not within the grace period of 35 U.S.C. 102(b)(1), it would qualify as prior art under 35 U.S.C. 102(a)(1) and could not be excepted under 35 U.S.C. 102(b)(1).
(2) When the disclosure that is applied in a rejection is
(a) a U.S. patent or U.S. patent application publication that
(b) claims an invention that is the same or substantially the same as the applicant’s or patent owner’s claimed invention, and
(c) the affidavit or declaration contends that an inventor named in the U.S. patent or U.S. patent application publication derived the claimed invention from the inventor or a joint inventor named in the application or patent.
See MPEP § 717.01, subsection II., for more information on when declarations or affidavits pursuant to 37 CFR 1.130(a) are not available.
(B) Whether the affidavit or declaration shows sufficient facts, in weight and character, to establish that
(1) the disclosure was made by the inventor or a joint inventor, or
(2) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor.
Some factors to consider are the following:
(1) Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).
(2) A mere statement from the inventor or a joint inventor, without any accompanying reasonable explanation, may not be sufficient where there is evidence to the contrary, such as a contrary statement from another named author that was filed in another application on behalf of another party. See Ex parte Kroger, 219 USPQ 370 (Bd. App. 1982) (affirming rejection notwithstanding declarations by the alleged actual inventors as to their inventorship in view of a non-applicant author submitting a letter declaring the non-applicant author’s inventorship).
(C) Whether the formal requirements of a declaration or affidavit are met. See MPEP § 717.01(c)
(D) Whether the affidavit or declaration is timely presented. See MPEP § 717.01(f) .
In the instant case, the Declaration does not provide a reasonable explanation of the presence of the additional authors of: Joo Hong Joun, Jung Nam An, Jeong Hwan Lee and Young Wook Choi in the Li reference. It is not clear what the nature of the collaboration was for the additional authors of the Li reference and thus it cannot be determined if these additional inventors contribute to the stated subject matter in the absence of a reasonable explanation for their presence. Accordingly, the Li rejection is maintained.
37 CFR 1.130(a) Declaration
The examiner acknowledges receipt of the Declaration under 37 CFR 1.130(a) by Byung Hee Hong filed on 12/29/2025.
The Declaration is insufficient to overcome the Lilin Li rejection of record because while it is acknowledged that the authors of the Li reference to Donghoon Kim and Jong Bo Park worked under the direction of Declarant Byung Hee Hong, the reference lists the additional inventors of: Joo Hong Joun, Jung Nam An, Jeong Hwan Lee and Young Wook Choi.
MPEP 717.01(a)(1):
In evaluating whether a declaration under 37 CFR 1.130(a) is effective, Office personnel will consider the following criteria:
(A) Whether the disclosure, which was applied in the rejection and is addressed in the affidavit or declaration, is subject to the exceptions of 35 U.S.C. 102(b)(1)(A) or 102(b)(2)(A). The provision of 37 CFR 1.130(a) is not available:
(1) If the disclosure was made (e.g., patented, described in a printed publication, or in public use, on sale, or otherwise available to the public) more than one year before the effective filing date of the claimed invention. See MPEP § 2152.01 to determine the effective filing date. For example, if a public disclosure by the inventor or which originated with the inventor is not within the grace period of 35 U.S.C. 102(b)(1), it would qualify as prior art under 35 U.S.C. 102(a)(1) and could not be excepted under 35 U.S.C. 102(b)(1).
(2) When the disclosure that is applied in a rejection is
(a) a U.S. patent or U.S. patent application publication that
(b) claims an invention that is the same or substantially the same as the applicant’s or patent owner’s claimed invention, and
(c) the affidavit or declaration contends that an inventor named in the U.S. patent or U.S. patent application publication derived the claimed invention from the inventor or a joint inventor named in the application or patent.
See MPEP § 717.01, subsection II., for more information on when declarations or affidavits pursuant to 37 CFR 1.130(a) are not available.
(B) Whether the affidavit or declaration shows sufficient facts, in weight and character, to establish that
(1) the disclosure was made by the inventor or a joint inventor, or
(2) the subject matter disclosed was obtained directly or indirectly from the inventor or a joint inventor.
Some factors to consider are the following:
(1) Where the authorship of the prior art disclosure includes the inventor or a joint inventor named in the application, an "unequivocal" statement from the inventor or a joint inventor that he/she (or some specific combination of named joint inventors) invented the subject matter of the disclosure, accompanied by a reasonable explanation of the presence of additional authors, may be acceptable in the absence of evidence to the contrary. See In re DeBaun, 687 F.2d 459, 463, 214 USPQ 933, 936 (CCPA 1982).
(2) A mere statement from the inventor or a joint inventor, without any accompanying reasonable explanation, may not be sufficient where there is evidence to the contrary, such as a contrary statement from another named author that was filed in another application on behalf of another party. See Ex parte Kroger, 219 USPQ 370 (Bd. App. 1982) (affirming rejection notwithstanding declarations by the alleged actual inventors as to their inventorship in view of a non-applicant author submitting a letter declaring the non-applicant author’s inventorship).
(C) Whether the formal requirements of a declaration or affidavit are met. See MPEP § 717.01(c)
(D) Whether the affidavit or declaration is timely presented. See MPEP § 717.01(f) .
In the instant case, the Declaration does not provide a reasonable explanation of the presence of the additional authors of: Joo Hong Joun, Jung Nam An, Jeong Hwan Lee and Young Wook Choi in the Li reference. . It is not clear what the nature of the collaboration was for thee additional authors of the Li reference and thus it cannot be determined if these additional inventors contribute to the stated subject matter in the absence of a reasonable explanation for their presence.
Accordingly, the Declaration is considered unpersuasive.
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, 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.
Claim(s) 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kyung-Sun et al. (WO2019103541), Lilin Li et al. (Effect of graphene-based nanomaterials treatment in kidney disease- see IDS filed 7/22/2022) and Sureshubabu et al. (TGF-β signaling in the kidney: profibrotic and protective effects).
Kyung-Sun teaches using compositions which comprise graphene quantum dots to treat anti-inflammatory disease, see pages 1-3 and claim 1. The treatment of such inflammatory diseases can be carried out by decreasing inflammatory cytokine IL-23 or decreasing TFG-β, see pages 4 and 8. Administration can be intravenous and injectable, see pages 8-9 and 11. The graphene quantum dots are administered at a size from 1-5 nm rendering obvious the claimed size range of 1-5 nm or 0.5-2.5 nm, see pages 7-8 and claims 1-5. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Kyung-Sun does not expressly teach that the anti-inflammatory disease is a chronic kidney disease or end stage kidney disease (ESKD). As evidenced by instant claims 1 and 3, the EKSD is a disease that is induced by renal fibrosis.
However, Lilin et al. teach that graphene quantum dots reduce TGF- β1 and treat kidney diseases. Graphene quantum dots showed treatment attenuated fibrosis in CDK kidney disease models, see objectives conclusions and results. Administration reduced TGF- β1, p-Smad2/3, fibronectin and collagen I, see results and conclusion. Smad7 expression level increased, see results.
Thus, Lilin indicates that diseases that can also be treated with graphene based quantum dots to decrease TGF- β include chronic kidney disease with graphene oxide quantum dots protecting against kidney fibrosis.
Sureshubabu et al. teaches that renal fibrosis is the common pathway in kidney injury leading to end-stage kidney disease, see concluding remarks and profibrotic effects of TGF- β1.
It would have been prima facie obvious to utilize the graphene quantum dots of Kyung-Sun in the method of treating chronic kidney disease including end stage kidney disease.
An ordinary skilled artisan would have been motivated to utilize Kyung-Sun’s graphene quantum dots to treat kidney disease because Lilin teaches that graphene quantum dots are also useful in treating kidney diseases by reduction of TGF-β1 and Smad2/3 while increasing Smad7. Sureshubabu further teaches that renal fibrosis leads to end stage kidney disease. Therefore, the treatment to attenuate renal fibrosis would help treat end stage kidney disease and thus would treat a chronic kidney disease induced by fibrosis such as end stage kidney disease.
There would have been a reasonable expectation of success because graphene quantum dots are disclosed in Kyung-Sun as decreasing TGF- β and per the teachings of Lilin, TGF-β1 is significantly reduced by graphene quantum dots and protects against kidney fibrosis.
Claim(s) 1 and 4-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kyung-Sun et al. (WO2019103541), Sureshubabu et al. (TGF-β signaling in the kidney: profibrotic and protective effects) and Du et al. (Combination of Ginsenoside Rg1 and Astragaloside IV reduces oxidative stress and inhibits TGF-β1/Smads signaling cascade on renal fibrosis in rats with diabetic nephropathy).
Kyung-Sun teaches using compositions which comprise graphene quantum dots to treat anti-inflammatory disease, see pages 1-3 and claim 1. The treatment of such inflammatory diseases can be carried out by decreasing inflammatory cytokine IL-23 or TFG-β, see pages 4 and 8. Administration can be intravenous and injectable, see pages 8-9 and 11. The graphene quantum dots are administered at a size from 1-5 nm rendering obvious the claimed size range of 1-5nm or 0.5-2.5nm, see pages 7-8 and claims 1-5.
Kyung-Sun does not expressly teach that the anti-inflammatory disease is a chronic kidney disease or end stage kidney disease (ESKD). As evidenced by instant claims 1 and 3, the EKSD and diabetic nephropathy is a disease that is induced by renal fibrosis.
Sureshubabu et al. teaches that renal fibrosis is the common pathway in kidney injury leading to end-stage kidney disease, see concluding remarks and profibrotic effects of TGF- β1.
Du et al. teach that diabetic nephropathy (DN) is one of the most common complications of diabetes which leads to end stage kidney disease, see introduction. Overactivation of TGF-β1/Smads is linked to renal fibrosis, see discussion. Smad7 can downregulate TGF-β1/Smads signal transduction thus providing a vital target in treating diabetic nephropathy, see discussion
It would have been prima facie obvious to utilize the graphene quantum dots of Kyung-Sun in the method of treating chronic kidney disease including end stage kidney disease by inhibition of TGF-β /Smads and enhanced signaling of Smad 7.
An ordinary skilled artisan would have been motivated to utilize Kyung-Sun’s graphene quantum dots to treat kidney disease because Kyung-Sun utilizes graphene quantum dots to reduce TFG-β and reduce inflammation and Du suggest that reducing TGF- β signaling/Smads through expression of Smad7 which downregulates TGF- β signaling/Smads is vital targets for treating diabetic nephropathy since overactivation of TGF- β signaling/Smads causes renal fibrosis. Treatment of this disease would treat ESKD because if diabetic nephropathy is left untreated this leads to end stage kidney disease as suggested by Du. Thus the treatment of diabetic nephropathy which prevents EKDD treats a chronic kidney disease induced by renal fibrosis.
There would have been a reasonable expectation of success because graphene quantum dots are disclosed in Kyung-Sun as decreasing TGF- β and per the teachings of Du, TGF-β1/Smad can be downregulated by Smad 7 which helps treat kidney disease such as diabetic nephropathy, see introduction and discussion of Du et al.
Response to remarks regarding the 103 over Kyung-Sun et al., Lilin Li et al. and Sureshubabu et al.
Applicants argue that as noted above in view of the Declaration, Lilin Li is not available as prior art.
However, as noted above, the Lilin Li reference lists additional authors with no accompanying reasonable explanation of their presence. In the instant case, the Declaration does not provide a reasonable explanation of the presence of the additional authors of: Joo Hong Joun, Jung Nam An, Jeong Hwan Lee and Young Wook Choi in the Li reference. It is not clear what the nature of the collaboration was for thee additional authors of the Li reference and thus it cannot be determined if these additional inventors contribute to the stated subject matter in the absence of a reasonable explanation for their presence.
Applicants further argue that Kyung-Sun relates to methods of treating and preventing inflammatory bowel disease whereas the instating claims prevent and treat chronic kidney disease. There is no suggestion in Kyung-Sun there would be any effect on renal fibrosis. The present disclosure demonstrates through experiments that graphene quantum dots exhibit various direct therapeutic effects against renal fibrosis in renal fibrosis induced mice and cells.
Examiner respectfully submits that while Kyung-Sun teaches treatment of inflammatory diseases including that of the colon by decreasing TGF-beta expression, Lilin et al. teach that graphene quantum dots also reduce TGF- β1 and treat kidney diseases. Graphene quantum dots showed treatment attenuated fibrosis in CDK kidney disease models, see objectives conclusions and results. Administration reduced TGF- β1, p-Smad2/3, fibronectin and collagen I, see results and conclusion. Smad7 expression level increased, see results. Thus, Lilin indicates that diseases that can also be treated with graphene based quantum dots to decrease TGF- β include chronic kidney disease with graphene oxide quantum dots protecting against kidney fibrosis.
Sureshubabu et al. teaches that renal fibrosis is the common pathway in kidney injury leading to end-stage kidney disease, see concluding remarks and profibrotic effects of TGF- β1.
It would have been prima facie obvious to utilize the graphene quantum dots of Kyung-Sun in the method of treating chronic kidney disease including end stage kidney disease because Lilin teaches that graphene quantum dots are also useful in treating kidney diseases by reduction of TGF-β1 and Smad2/3 while increasing Smad7. Sureshubabu further teaches that renal fibrosis leads to end stage kidney disease. Therefore, the treatment to attenuate renal fibrosis would help treat end stage kidney disease.
There would have been a reasonable expectation of success because graphene quantum dots are disclosed in Kyung-Sun as decreasing TGF- β and per the teachings of Lilin, TGF-β1 is significantly reduced by graphene quantum dots and protects against kidney fibrosis. The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Response to remarks regarding 103 over Kyung-Sun et al. Sureshubabu et al. and Du et al.
Applicants argue that it is difficult to infer a preventative or therapeutic effect on chronic kidney disease induced by renal fibrosis based solely on suppression of increased TGF- β1 expression. Applicants argue that although Example 5 and Figure 14F show decrease in TGF- β1 in the colon, these examples do not show whether graphene quantum dots had any effect on an increase or decrease in TGF- β1.
Examiner respectfully submits that the method of claim 1 is not administering to a patient in need thereof meaning they must have CKD induced by renal fibrosis, but rather administering a pharmaceutical composition with graphene quantum dots as an active to a subject results in a treatment of CKD induced by renal fibrosis. Furthermore, Du establishes that overactivation of TGF- β1/Smads is linked to renal fibrosis. Kyung-Sun teaches that the graphene quantum dots treats anti-inflammatory diseases by a mechanism of decreasing TGF- β. Since graphene quantum dots are known to decrease TGF- β and overactivation of TGF- β1 leads to kidney fibrosis, one of ordinary skill in the art would have been motivated to decrease expression of TGF- β1 given Kyung-Sun teaches that the graphene quantum dots do in fact act to decrease TGF- β1.
Applicants argue that even if graphene quantum dots have an effect of suppression of increased TGF- β1, this merely demonstrates anti-inflammatory activity and that alone is not sufficient to provide a therapeutic effect for chronic kidney disease induced by renal fibrosis. Applicants argue that a person of ordinary skill in the art would not be able to clearly determine whether graphene quantum dots would exhibit a preventative or therapeutic effect on chronic kidney disease induced by renal fibrosis like the instant specification has demonstrated.
Examiner respectfully submits that it is established by Kyung-Sun that graphene quantum dots decrease TGF- β1 and per the teachings of Du, overactivation of TGF- β1 is linked to rental fibrosis therefor rendering it obvious to decrease expression of such to treat renal fibrosis. One of ordinary skill in the art would have linked the decrease of TGF- β1 expression to the graphene quantum dots as suggested by Kyung-Sun to diseases that result in overexpression of TGF- β1. Since graphene quantum dots can reduce its expression, then it would have been obvious to utilize the graphene quantum dots to reduce overexpression of TGF- β1 in diseases that have too much expression of such.
Applicants argue that Sureshubabu discloses that blockage of TGF- β1 suppresses anti-inflammatory effects thereby promoting renal fibrosis and that blocking the function is not sufficient to suppress fibrosis.
It appears that Applicants are arguing that a full blockage of TGF- β1 results in renal fibrosis, however the rejection is not completely blocking the expression of TGF- β1. Rather, the quantum dots of the obviousness is based on a reduction of overexpression of TGF- β1. It is further noted that this is the same mechanism of instant claim 4 in which TGF- β1 expression is reduced and not completely blocked.
Applicants argue that it would not be easy to predict effects unless it is experimentally confirmed that graphene quantum dots exhibit a direct inhibitory effect on chronic kidney disease induced by renal fibrosis. Kyung-Sun confirms a therapeutic effect only on IBS and mouse colitis model. Sureshubabu an Du do not disclose graphene quantum dots or any effects which would make it difficult to understand the effects without undue experimentation.
Examiner respectfully submits that since three is a link between treatment of CKD and inflammatory bowl disease in that there is the desire to reduce overexpression of TGF- β1, one of ordinary skill in the art would have been motivated per the teachings of the combined references to administer graphene quantum dots which are known per the teachings of Kyung-Sun to decrease overexpression of TGF- β1.While Sureshubabu and Du do not explicitly disclose graphene quantum dots, the references link overexpression of TGF- β1 to renal fibrosis thus suggesting that expression of TGF- β1 should be modulated. Since the graphene quantum dots of Kyung-Sun are taught to expressly decrease overexpression of TGF- β1, one of ordinary skill in the art would have been motivated to utilize these graphene quantum dots in pathways which desire to decrease the overexpression of TGF- β1.
Conclusion
Applicant’s arguments/remarks are considered unpersuasive. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Currently, no claims are allowed and all claims are rejected.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ALAWADI whose telephone number is (571)270-7678. The examiner can normally be reached Monday-Friday 10:00am-6:30pm EST.
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/SARAH ALAWADI/Primary Examiner, Art Unit 1619
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