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 .
Claim status
In the reply on 23 December 2025, Applicant has withdrawn 7-14. Therefore, claims 1-14 are herein pending.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-6 drawn to a hypothermic oxygenated perfusion solution for repairing kidney injury in the reply filed on 23 December 2025 is acknowledged.
Claims 7-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-6 are under current examination.
Priority
This application was filed 06/27/2023, which claims benefit to the foreign priority to 202211515265.6 filed on 11/30/2022. Filing of a certified untranslated copy of the CN Application No. 202211515265.6, filed 11/30/2022 is acknowledged.
MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a) -(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 06/27/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/13/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Claim Rejections - 35 USC § 112(b)
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.
Claim 6 contains the trademark/trade name “KidneyPerfusion-Solution-1 (KPS-1)”. Applicant also use Histidine-Tryptophan-Ketoglutarate (HTK) solution, and University of Wisconsin (UW). HTK and UW are known with different trademark name such as Custodiol® and SPS-1®. 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 KPS-1®, HTK and UW are used as the organ preservation solution, however these trademark represents the source of product rather than the identify the product composition or details. Accordingly, the trademark description is indefinite.
The rejection may be obviated by amending the claim 6 to recite the generic organ preservation solution name which identifies the solution composition itself.
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 1, 2, 5 and 6 rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bhattacharjee et al., (Transplantation 2018;102: 1066–1074; cited in PTO892; hereinafter “Bhattacharjee”).
Claim Interpretation: Claim 1, drawn to a product, recites a preamble reciting intended use (“repairing kidney injury”). The body of the claim sets forth the limitations of the claimed product, and therefore, the preamble is not considered a further limitation to the claim. See MPEP 2111.02(II).
With respect to claims 1, 2, 5 and 6, Bhattacharjee teaches hypothermic storage device comprising a hypothermic oxygenated perfusion solution for a novel clinically relevant ex vivo organ preservation strategy, wherein the hypothermic oxygenated perfusion solution is an organ preservation solution (i.e., University of Wisconsin solution (UW) carrying 200μM carbon monoxide-releasing molecules (i.e., CO releasing molecules (CORM)-401) (abstract, p. 1067 right col. 3 and 5th ¶; p. 1069 “RESULTS” ¶)
Accordingly, Bhattacharjee anticipates the instant claims 1, 2, 5 and 6.
Claim Rejections - 35 USC § 112(a)
(Written description)
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 3, 4, and 5 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 contains subject matter that 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 pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
REQUIREMENTS TO ESTABLISH ACTUAL REDUCTION TO PRACTICE
"In an interference proceeding, a party seeking to establish an actual reduction to practice must satisfy a two-prong test: (1) the party constructed an embodiment or performed a process that met every element of the interference count, and (2) the embodiment or process operated for its intended purpose." Eaton v. Evans, 204 F.3d 1094, 1097, 53 USPQ2d 1696, 1698 (Fed. Cir. 2000).
The same evidence sufficient for a constructive reduction to practice may be insufficient to establish an actual reduction to practice, which requires a showing of the invention in a physical or tangible form that shows every element of the count. Wetmore v. Quick, 536 F.2d 937, 942, 190 USPQ 223, 227 (CCPA 1976). For an actual reduction to practice, the invention must have been sufficiently tested to demonstrate that it will work for its intended purpose, but it need not be in a commercially satisfactory stage of development. See, e.g., Scott v. Finney, 34 F.3d 1058, 1062, 32 USPQ2d 1115, 1118-19 (Fed. Cir. 1994) (citing numerous cases wherein the character of the testing necessary to support an actual reduction to practice varied with the complexity of the invention and the problem it solved). If a device is so simple, and its purpose and efficacy so obvious, construction alone is sufficient to demonstrate workability. King Instrument Corp. v. Otari Corp., 767 F.2d 853, 860, 226 USPQ 402, 407 (Fed. Cir. 1985).
For additional cases pertaining to the requirements necessary to establish actual reduction to practice see DSL Dynamic Sciences, Ltd. v. Union Switch & Signal, Inc., 928 F.2d 1122, 1126, 18 USPQ2d 1152, 1155 (Fed. Cir. 1991) ("events occurring after an alleged actual reduction to practice can call into question whether reduction to practice has in fact occurred"); Fitzgerald v. Arbib, 268 F.2d 763, 765-66, 122 USPQ 530, 531-32 (CCPA 1959) ("the reduction to practice of a three-dimensional design invention requires the production of an article embodying that design" in "other than a mere drawing"); Birmingham v. Randall, 171 F.2d 957, 80 USPQ 371, 372 (CCPA 1948) (To establish an actual reduction to practice of an invention directed to a method of making a product, it is not enough to show that the method was performed. "[S]uch an invention is not reduced to practice until it is established that the product made by the process is satisfactory, and [ ] this may require successful testing of the product."). See MPEP 2138.05.
Claims 3, 4 and 5 are broadly drawn a final concentration of the carbon monoxide-releasing molecules 2, 3 and 401 respectively. However, the disclosure as originally filed does not provide adequate written description support for the full breadth of the invention as presently claimed.
The specification discloses the kidney was placed into a kidney machine perfusion system for perfusion, carbon monoxide-releasing molecules-401 with a concentration of 200μM [0044], 400μM [0047], 600μM [0049] and 800μM [0053] respectively were added into an organ preservation solution, a KPS-1 solution. Therefore, SPEC has specific adequate support for specific concentration (200-800μM) of the specific carbon monoxide-releasing molecules-401 is 20-800μM in the hypothermic oxygenated perfusion solution. Therefore, the hypothermic oxygenated perfusion solution is only capable of inducing expression of specific molecules possessing regenerative activity. However, the specification does not show any embodiments that meet all the limitations of the claim reduced to practice. Therefore, an actual reduction to practice of an invention directed to a product of hypothermic oxygenated perfusion solution with the final concentration of the carbon monoxide-releasing as disclosed in claims 2-4 is not established at the time of filling. The successful testing of the product of the current invention is not shows reduced to practice, therefore, it is not established that the product made by the process is satisfactory. See MPEP 2163(I)-(II) and 2163.02.
Therefore, the specification fails to adequately describe the full scope of claims 3-5. The specification supports only a narrow scope of the inventive concept as described in above, but does not provide support for the full scope of the product hypothermic oxygenated perfusion solution, wherein the final concentration of the carbon monoxide-releasing molecules 2, 3 and 401 respectively is 20-800μM.
In the prior art Bhattacharjee et al. (Transplantation 2018;102: 1066–1074; cited in PTO892; hereinafter “Bhattacharjee”) teaches hypothermic storage device comprising a hypothermic oxygenated perfusion solution for a novel clinically relevant ex vivo organ preservation strategy, wherein the hypothermic oxygenated perfusion solution is an organ preservation solution (i.e., University of Wisconsin solution (UW) carrying 200 μM carbon monoxide-releasing molecules (i.e., CO releasing molecules (CORM)-401) (abstract, p. 1067 right col. 3 and 5th ¶; p. 1069 “RESULTS” ¶ of Bhattacharjee). Furthermore, Bhattacharjee showing successful testing of the product shows reduced to practice, wherein kidneys were treated with either 200μM CORM-401 or inactive CORM-401, respectively and establish that CORM-401 provides renal protection after cold storage of kidneys and provides a novel clinically relevant ex vivo organ preservation strategy (abstract of Bhattacharjee). Therefore, reduction to practice of the product made by the process of Bhattacharjee is satisfactory.
Accordingly, an actual reduction to practice of instant invention directed to a a product is not established at the time of filling and POSITA cannot predictably identify a product that exercise in this invention of hypothermic oxygenated perfusion solution, wherein the final concentration of the carbon monoxide-releasing molecules 2, 3 and 401 respectively is 20-800μM.
The Examiner concludes that there is insufficient written description of the instantly claimed genus of product the hypothermic oxygenated perfusion solution, wherein the final concentration of the carbon monoxide-releasing molecules 2, 3 and 401 respectively is 20-800μM. Specifically, doesn't have an adequate written description on actual reduction to practice of instant invention directed to the product is not established at the time of filling. The successful testing of the product of the current invention is not shows reduced to practice, therefore, it is not established that the product made by the process is satisfactory. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed in claims 3-5.
Pertinent References
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure is the following:
Bhattacharjee et al. (Renal protection against ischemia reperfusion injury: hemoglobin-based oxygen carrier-201 versus blood as an oxygen carrier in ex vivo subnormothermic machine perfusion”, Transplantation, 104(3), pp.482-489, 2020; cited in PTO892; hereinafter “Bhattacharjee-2020”)
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684