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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/5/2026 has been entered.
Claims 17-20 have been canceled, and claims 1-16 have been considered on the merits. All arguments have been considered.
Claim Rejections - 35 USC § 112
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.
Claim 3 is 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. This is a new matter rejection.
Claim 3 discloses that the subject afflicted with a chronic kidney disease has anemia. The newly added limitation is not supported by the specification of the originally filed application. The specification discloses in two places: “In some embodiments, the kidney disease is acute renal failure, chronic kidney disease, end-stage renal disease, or anemia.” (p. 1, lines 24-25); and ““Kidney disease” refers to any type of disease or disorder that may compromise one or more kidney functions, including, but not limited to, acute renal failure (e.g., caused by poison, trauma, shock, infection, blockage such as kidney stones, heart failure, etc.), chronic kidney disease (CKD) (e.g., gradual loss of kidney function due to aging, genetics, blockage such as kidney stones, diabetes, infection, dental disease, immunological disease, high blood pressure, thyroid disorder, cancer, congenital kidney malformation, congenital polycystic kidney disease, etc.), end-stage renal disease, anemia, etc.” (p.2, line 31 thru p.3, line 3). There is no other disclosure with regard to “anemia” in the instant specification.
As evidenced above, the instant specification discloses that anemia as a separate species for the “kidney disease” along with chronic kidney disease. There is no support for the subject afflicted with chronic kidney disease having anemia as claimed. Thus, the instant amendment introduces new matter to the instant application.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06 - § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
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.
Claim(s) 1-2, 4-7 and 9-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penn (US2010/0166717; of record) in view of Preston et al. (1997, Journal of Hypertension; of record), Chen et al. (2014, PLOS One; IDS ref. #13 filed on 12/14/2021) and Zhu et al. (2013, Stem Cells; of record).
Penn teaches a method of treating an ischemic disorder including ischemic kidney disease (paras. 34-35) in a mammalian subject (para. 37) by administering a viral vector encoding the SDF-1 protein (para. 73, 76-77) at an amount sufficient for the SDF-1 protein to be expressed to a degree which allows for highly effective therapy to the kidney of the subject (para. 95, 139).
Regarding the limitation directed to the direct injection of the nucleic acid vector encoding SDF-1 into a kidney, Penn teaches the injection of the vector directly to or into the apoptotic cell or the periphery of the ischemic tissue (para. 95) or direct injection of the vector into the ischemic tissue (para. 98). As Penn teaches that the method is intended to treat cell apoptosis associated with the ischemic disorders and/or tissue injury, and the ischemic disorder includes ischemic kidney disease (para. 6), thus, it would have been obvious to a person skilled in the art to directly inject the vector of Penn into the kidney of the subject having ischemic kidney disease with a reasonable expectation of success.
Regarding claim 1 directed to the chronic kidney disease, Penn does not particularly teach the limitation. However, ischemic renal disease taught by Penn would encompass chronic renal failure, i.e. chronic kidney disease because Preston et al. teach that chronic renal failure resulting from atherosclerotic renal artery disease is called ischemic renal disease (IRD) (Introduction, p.1365). The term “chronic renal failure” is considered the same as “chronic kidney disease” (see para. 2 of the instant specification).
It would have been obvious to a person skilled in the art to use the method of Penn for a subject having chronic kidney disease caused by ischemic injury as Preston et al. teach that ischemic renal disease can cause chronic renal failure with a reasonable expectation of success.
Furthermore, Chen et al. teach that augmentation of SDF-1/CXCR4 signaling pathway, the CKD can be attenuated as SDF-1 signaling preserves microvascular integrity and renal function (Abstract). A person skilled in the art would recognize that the augmentation of SDF-1 signaling can be carried out by expressing SDF-1, and the method of Penn would be able to augment SDF-1. As SDF-1 is capable of preserving microvascular integrity and renal function in CKD according to Chen et al., one skilled in the art would expect that the method of Penn would be beneficial to treat CKD.
Regarding claims 4-7, Penn teaches that the mammalian subject includes human beings, cats, dogs, horses (para. 37).
Regarding claims 9-10, Penn teaches the pharmaceutical composition in a unit dosage injectable form is sterile and comprise a carrier (para. 57).
Regarding claim 11, Penn teaches the injection within the kidney. Regarding the plurality of sites, as the direct injection to or into the apoptotic cell of the ischemic tissue, i.e. kidney, it would have been obvious to one skilled in the art to carry out the injection to multiple sites if necessary based on the location of apoptotic cells or the size of ischemic injury of the kidney.
Regarding claim 12 directed to the kidney disease comprises cellular disruption and/or fibrosis of the kidney, it is submitted that the apoptotic cells of the ischemic kidney is considered to meet the cellular disruption. Furthermore, it is known in the art that ischemic kidney disease results in fibrosis (Zhu et al. 2013, Stem Cells; Introduction; Fig.1). Thus, the scope of ischemic kidney disease of Penn would encompass the IKD comprising fibrosis, and it would have been obvious to a person skilled in the art to treat the IKD comprising fibrosis with the method of Penn with a reasonable expectation of success.
With regard to the results of decreased cellular disruption and/or decreased fibrosis of the kidney, as Penn teaches the identical method as the claimed invention, the results are expected the same.
Regarding claims 13-16, Penn teaches that SDF-1 can have an amino acid sequence that is substantially similar to a native mammalian SDF-1 or the mammalian SDF-1 includes human, mouse or rat (para. 40). Penn also teach that SDF-1 can comprise two isoform, SDF-1a and SDF-1b (para. 40). It is noted that Penn does not teach cat SDF-1 (claim 15). However, it would have been at once envisaged that SDF-1 would be cat SDF-1 as the subject being treated is a cat (para. 37).
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penn in view of Preston et al. and Chen et al.as applied to claims 1-2, 4-7 and 9-16 above, and further in view of Nakhoul et al. (2016, Cleveland Clinic Journal of Medicine)
Regarding claim 3 directed to the subject afflicted with CKD having anemia, Penn in view of Preston et al. and Chen et al. do not teach the limitation.
However, it is known in the art that anemia is a frequent complication of CKD and it is mainly caused by a decrease in erythropoietin production in the kidneys according to Nakhoul et al. (Abstract; p.613, 2nd col.)
Thus, one skilled in the art would recognize that the subject having chronic kidney disease would encompass those with anemia as anemia is common complication for CKD patients according to Nakhoul et al. Thus, it would have been obvious to a person skilled in the art that the method of treating ischemic kidney disease taught by Penn in view of Preston et al. and Chen et al. would be applicable to those having CKD with anemia with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Penn in view of Preston et al. and Chen et al.as applied to claims 1-2, 4-7 and 9-16 above, and further in view of Joyce et al. (2017, Pediatr. Nephrol.; of record)
Regarding claim 8 directed to the kidney disease being chronic interstitial nephritis (CIN), Penn in view of Preston et al. and Chen et al. do not particularly teach the limitation.
Joyce et al. teach that tubulointerstitial nephritis (TIN; i.e. interstitial nephritis) is a frequent cause of acute kidney injury (AKI) that can lead to chronic kidney disease (Abstract). Thus, it is reasonable to consider the “chronic” TIN as one of CKD.
It would have been obvious to a person skilled in the art to treat chronic interstitial nephritis in a subject by injecting the nucleic acid encoding SDF-1 taught by Penn in view of Preston et al. and Chen et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because chronic interstitial nephritis is considered as one of chronic kidney disease based on the teaching of Joyce et al.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Response to Arguments
Applicant's arguments filed 2/5/2026 have been fully considered but they are not persuasive. It is noted that the claim rejections presented above have been modified to clarify the rejection. Claim 3 is rejected separately along with a newly cited reference in order to address the new limitation.
Regarding the 103 rejections, applicant asserted that Penn teaches away from the method of claim because Penn teaches direct injection of transfected target cells into ischemic tissue to minimizes the potential for an inflammatory response which can occur with direct injection of a vector into the ischemic tissue. First, Penn clearly stated that where the target cell comprises an apoptotic cell, a cell of the ischemic tissue, or about the periphery of the ischemic tissue, the vector can be delivered by direct injection (para. 95). The paragraph [0098] of Penn cited by applicant is directed to the embodiment using a transfected target cell in culture being transplanted to the ischemic tissue. It is acknowledged that this embodiment is for the possible inflammatory response in the ischemic tissue from the direct injection of the vector into the ischemic tissue. However, the Examiner does not consider this teaching as teaching away from the claimed method. Rather, the use of target cells transfected with SDF-1 nucleic acid ex vivo is an alternative to the direct injection of vector to the ischemic tissue.
Applicant argued that Penn as a whole is directed to ischemic cardiopathy, and it merely lists “ischemic kidney disease” among many other diverse disorders and surgeries, and there is no teaching or suggestion in Penn of how to apply their disclosure with regard to cardiac tissue to improve a kidney function in a subject afflicted with a chronic kidney disease as claimed. The Examiner respectfully disagrees with this argument. It is acknowledged that Penn did not exemplify ischemic kidney disease. However, the teaching of Penn is directed to a method of treating any ischemic disease including ischemic kidney disease. There is no requirement that Penn has to provide detailed examples or data for the obviousness rejection. Rather reasonable expectation of success is required for obviousness rejections. As the Penn’s method is not limited to ischemic cardiopathy, and the ischemic disease taught by Penn includes ischemic kidney disease, there is a reasonable expectation of success to use the method of Penn in treating ischemic kidney disease by expressing SDF-1 in the ischemic tissue.
Conclusion
No claims are allowed.
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/TAEYOON KIM/Primary Examiner, Art Unit 1631
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