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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119
(a)-(d). Acknowledgment is made of Applicants’ claim for benefit to foreign application GB2217332.2 filed 11/18/2023.
This application claims the benefit of priority to Patent Application PCT/GB2023/053027. Acknowledgement is made of Applicants’ claim for benefit to prior filed to Patent Application Number PCT/GB2023/053027, filed on 11/17/2023.
Information Disclosure Statement
The IDS filed 08/28/2025 has been considered by the Examiner.
Status of Claims
Claims 65-94 are under examination.
Claim 1-64 are cancelled.
Claim Rejections - 35 USC § 103
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.
Claims 65-94 are rejected under 35 U.S.C. 103 as being unpatentable over Griffith et al. (WO-2022003357-A1) in view of Holzmeister et al. (WO-2022175546-A1).
Regarding claim 65, Griffith et al. teach delivery of an AAV viral vector to a human kidney (page 5, lines 9-14). Griffith et al. further teach administration into the renal artery (page 5, lines 9-14). The method of Griffith et al. does not comprise a step of clamping the renal artery of the kidney, the renal vein of the kidney, or the aorta or a step of inserting a catheter into the renal vein of the kidney.
Griffith et al. do not teach inserting a catheter into the renal artery of the kidney and injecting or infusing the viral vector into the renal artery via the catheter.
Holzmeister et al. teach a method for treating a renal condition by perfusion of a composition comprising an AAV vector to one or both of a patient's kidneys (cover page & page 35, abstract, paragraph 0197). Holzmeister et al. teach a perfusion catheter is positioned in the renal artery of the kidney (cover page, abstract). Holzmeister et al. teach the method minimizes systemic adverse effects, significantly reducing required vector doses, overcoming immunologic limitations, and with the potential to repeat treatment (page 42, paragraph 0221). Holzmeister et al. provide motivation by teaching that their method for perfusing a drug in one or both kidneys is minimally invasive (page 11, paragraph 0103).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have combined the teachings of Griffith et al. for a viral vector comprising a nucleotide sequence encoding a complement protein, wherein the nucleotide sequence is operably linked to a podocyte-specific promoter and/or the viral vector is capable of specifically transducing podocytes with the teachings of Holzmeister et al. for a perfusion catheter positioned in the renal artery of the kidney for AAV delivery. Holzmeister et al. provide motivation by teaching that their method for perfusing a drug in one or both kidneys is minimally invasive. Holzmeister et al. further provide motivation reduce risks and/or adverse immune response to the administration of a drug suitable for treatment of a renal condition. One of skill in the art would have had a reasonable expectation of success at combining Griffith et al. and Holzmeister et al. because they both teach methods of treating kidney disease utilizing AAV vectors.
Regarding claim 66, Griffith et al. and Holzmeister et al. make obvious the method of delivering a viral vector to a subjects kidney. Holzmeister et al. teach the method includes inflating a ballon to occlude the renal artery, and wherein the inflating occurs after the inserting of the catheter into the renal artery of the kidney, but before the injecting or infusing the viral vector into the renal artery via the catheter (page 16, paragraph 0120).
Regarding claim 67, Griffith et al. do not teach occluding the renal vein of the kidney.
Regarding claim 68, Holzmeister et al. teach the catheter is introduced percutaneously via internal jugular and femoral access (page 12, paragraph 0107).
Regarding claim 69, Griffith does not teach forming a closed circuit through the kidney.
Regarding claim 70, Holzmeister et al. teach the catheter is an occlusion ballon catheter (page 44, claim 2).
Regarding claims 71 and 72, Holzmeister et al. teach the renal artery is occluded from about 5 minutes to about 5 hours, from about 15 minutes to about 4 hours, from about 30 minutes to about 3 hours, or from about 1 hour to about 2 hours (page 28, paragraph 0164).
Regarding claim 73, Holzmeister et al. teach one or more of the perfusion catheter and the recovery catheter are introduced percutaneously (page 3, paragraph 0021).
Regarding claim 74, Holzmeister et al. teach the catheter is introduced percutaneously via internal jugular and femoral access (page 12, paragraph 0107). Holzmeister et al. teach each catheter may be compatible with a stearable introducer sheath (page 15, paragraph 0114).
Regarding claims 75 and 76, Holzmeister et al. teach perfusion is maintained over a duration of about 15 minutes, 30 minutes, 45 minutes, 1 hour, 2 hours, 3 hours, 4 hours, or within any range between (page 3, paragraph 0024).
Regarding claims 77 and 78, Holzmeister et al. teach a nephron-specific promoter may be specific to a particular subunit of the nephron, like the glomerulus, to provide higher or exclusive expression in that particular subunit (page 37, paragraph 0204). Griffith further teach AAV vectors were used to transduce human podocytes and glomerular endothelial cells (page 68, lines 31-32).
Regarding claim 79, Holzmeister et al. teach the promoter provides for an expression of the target protein in the kidney of the patient that has been treated with the gene therapy vector.
Regarding claim 80, Holzmeister et al. teach the subject is an adult (page 12, paragraph 0107).
Regarding claim 81, Holzmeister et al. teach treatment of renal diseases, and localized delivery of therapeutic agents to a patient's kidney (page 1, paragraph 0002).
Regarding claim 82, Holzmeister et al. teach the subject may have various glomerular diseases, for example lgA nephropathy which is a form of glomerulonephritis or an inflammation of the glomeruli of the kidney (page 62, lines 4-15).
Regarding claim 83, Holzmeister et al. teach the vector, cell or pharmaceutical composition may be administered at varying doses. Holzmeister et al. teach the physician will determine the actual dosage which will be most suitable for any individual subject and it will vary with the age, weight and response of the particular subject. Holzmeister et al. further teach AAV vectors are generally delivered at doses of 1010 to 1014 vg/kg, or 1011 to 1013 vg/kg may be administered (page 60, lines 16-20).
Regarding claim 84, Griffith et al. teach AAV were used to transduce human podocytes and glomerular endothelial cells (page 68, lines 31-32).
Regarding claims 85-87, Griffith et al. teach a vector that is capable of specifically transducing glomerular podocytes (page 13, lines 14-16).
Regarding claim 88, Griffith et al. teach a viral vector which is selected from an adeno-associated virus (AAV) vector, an adenoviral vector, a herpes simplex viral vector, a retroviral vector, or a lentiviral vector. (page 86, claim 4).
Regarding claims 89 and 90, Griffith et al. teach the protein may be selected from the list consisting of CFH, FHL-1, C1INH, C4BP, MASP2, C3, C5aR1, C5, C5a, CD55, CD35, CD46, CD59, vitronectin, and clusterin, or fragments or derivatives thereof (pages 3-4, lines 35-36 and line 1), which are all polypeptide involved in podocyte-associated genetic glomerular disease (as listed on page 5 of the specification).
Regarding claims 91-92, Griffith et al. teach herein the nucleotide sequence is operably linked to a podocyte-specific promoter (page 86, claim 3).
Regarding claim 93, Griffith et al. teach pharmaceutical composition is administered by injection into the renal artery (page 91, claim 40).
Regarding claim 94, Holzmeister et al. teach delivery may be administered directly and only to the kidney or kidneys (page 28, paragraph 0165).
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
Applicant’s argument: Applicant argues that Griffith does not supply specific examples of human administration or renal artery administration. In Examples 4 and 10, administration to mouse models of disease via tail injection was described.
Examiner’s response: As stated in the above rejection Griffith teaches administration to a human subject (page 5, lines 9-10). Griffith further teaches administration by injection into the renal artery (page 5, lines 12-14).
Applicant’s arguments: Applicant argues Holzmeister includes using arterial and venous catheters and steps of placing the venous catheter in position in the kidney vein and inflating the balloon. The treatment is performed, and the balloons are deflated in step.
Examiner’s response: An embodiment describes one way the invention could be utilized but is not all encompassing of the invention. Holzmeister teaches in some embodiments, the system includes a venous recovery catheter that may be inserted, for example, via the vena femoralis and sealed within the renal vein with a flow rate appropriate for recovery of the venous flow. Holzmeister teaches in some embodiments, the system includes an extracorporeal membrane oxygenator system that fluidly connects the venous blood flow from the kidney to the arterial blood flow of the kidney, and is capable of oxygenizing the venous blood (page 13, paragraph 0108). However there are no catheters taught in Griffith so utilization of a collection catheter is not required for delivery of a viral vector to a patient’s kidney, it is only required for full isolation of the treatment. Therefore, as described in the rejections above, Griffith and Holzmeister make obvious the invention of the present application.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Rejection updated to note it is provisional:
Claims 65-79, 81-88, and 93 are provisionally rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-6, 10-12, 14-15, 20-22, 28-32, and 35 of copending Application No. 19130404. This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
Applicant’s Arguments: Applicant notes that no rejection was explicitly articulated, and that a pending application cannot form the basis for a non-statutory double patenting rejection. The referenced section in the MPEP specifies, "The claims of each application may ... be rejected on the grounds of provisional double patenting based on the claims of the other application.... The provisional double patenting rejection should continue to be made by the examiner in each application as long as there are patentably indistinct claims in more than one application unless that provisional double patenting rejection is the only rejection remaining in one of the applications." (MPEP § 822, emphasis added.) The cited co-pending application is still in the USPTO's "DOCKET CENTRAL" and apparently not yet assigned to an examiner. Upon allowance of claims in this application, Applicant intends to pursue non-identical claims in the cited application and/or file a terminal disclaimer at such time that alleged patentably indistinct claims that might be examined in that application are otherwise deemed allowable.
Examiner’s Response: The rejection now states it is a provisional statutory double patenting rejection. A double patenting rejection is when two or more applications filed by the same applicant or assignee contain patentably indistinct claims. Applicant can file a terminal disclaimer and amend claims to pursue non-identical claims in the cited application. Provisional double patenting rejection stands and there are still other rejections over the claims.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/C.L.M./Examiner, Art Unit 1638
/Anna Skibinsky/
Primary Examiner, AU 1635
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