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 1-15,19,23,35-36 are under examination.
Claim Objections
Claim 10 is objected to because of the following informalities: “VX-166, VX-740” should be drafted –VX-166, VX-740--.Instant claim 10 has too many spaces. Appropriate correction is required.
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 10 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 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 inventors, at the time the application was filed, had possession of the claimed invention. Claim 10 recites “wherein the caspase inhibitor is emericasan (IDN-6556),vx-765 (belnacasan), Q-VD-OPh, VX-166,VX-740, GS-9540,Ac-DEVD-CHO, Ac-FLTD-CMK, Z-DEVD-FMK, INF 4E, Z-VAD-FMK, or derivatives thereof.” Applicants have not satisfied the written description requirement for the term “derivatives thereof.”
“[T]he purpose of the written description requirement is to ‘ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353-54 (Fed. Cir. 2010) (en banc) (quoting Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920 (Fed. Cir. 2004)). 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 2163.04.
A described in MPEP § 2163, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice...reduction to drawings...or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus’...See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."
The genus of claim 10 encompasses all the caspase inhibitors listed in claim 10 and all possible derivatives of each of the listed caspase inhibitors. In analyzing whether the written description is met for the genus, the specification is first assessed to determine whether a representative number of species of the genus have been described so that one is able to comprehend the structure of the genus. The specification must make it clear what the variations of the derivatives are. The specification refers vaguely to derivatives of each of the species listed in claim 10 without discussing what structure and/or function must be present in each of the derivatives of the listed caspase inhibitors.
Conclusion: The specification does not provide species examples of each of the derivatives of the caspase inhibitors listed in claim 10. One cannot determine what structures and/or functions must be present in each of the caspase inhibitor derivatives.
The claimed invention as a whole is not adequately described if the claims require essential or critical elements which are not adequately described in the specification, and are not conventional in the art as of Applicants’ effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the claimed invention in a detailed drawing, or by describing the invention with sufficient, relevant, identifying characteristics (as it relates to the claimed invention as a whole), such that one of skill in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641, 1646 (1998). In the instant case, the breath of the genus lacks a written description. To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof. In this case, there is not even identification of any particular portion of each caspase inhibitor that must be conserved. As stated above, it is not even clear what region of each caspase inhibitor is required and which is not required. The specification does not provide a complete structure of the variants and fails to provide a representative number of species for the encompassed genus. Accordingly, in the absence of sufficient recitation of distinguishing identifying characteristics, the specification does not provide adequate written description of the recited genus.
The skilled artisan cannot envision the detailed chemical structure of all the fragments, derivatives, or variants, that are encompassed by the claims, and therefore, conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method. Adequate written description requires more than a mere statement that is part of the invention, and a reference to a potential method of isolating it. See Fiers v. Reveal, 25 USPQ2d 1601, 1606 (Fed Cir. 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016 (Fed. Cir. 1991).
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481, 1483. In Fiddes, claims directed to mammalian FGFs were found to be unpatentable due to lack of written description for that broad class. The specification only provided the bovine sequence.
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 6-7,9,11-12 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 6-7 are problematic because claim 6 recites that it depends from “claim 0.” Because an existing claim from which claim 6 depends is not clearly identified, the metes and bounds of claim 6 cannot be properly ascertained. Furthermore, dependent claim 7 fails to correct this dependency issue. Claims 9 and 11-12 have the same dependency issue because they also recite that they depend from “claim 0.” Because an actual independent claim from which these claims depend from is not listed, the metes and bounds of claims 9,11-12 cannot be properly ascertained.
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.
Claims 1-5,8-14,35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sandlin (US 20170223949).
Sandlin discloses a method for preserving a biological tissue sample (blood sample), the method comprising providing the biological tissue sample (blood sample) with a solution containing an apoptosis inhibitor (caspase inhibitor) for a first period of time, thereby providing a treated biological tissue sample (Abstract and paragraphs 10,13,15 of Sandlin) as in instant Claims 1,8,9,14,35. Sandlin discloses storing the biological tissue sample in solution (Abstract, Paragraphs 10,13,15 of Sandlin) as in instant Claim 2. Sandlin teaches that the blood (biological tissue sample) is stored at 2-25°C (Paragraph 21 of Sandlin) as in instant Claims 3-5. Sandlin discloses use of Q-VD-OPh and/or Z-VAD-FMK (Paragraph 15 of Sandlin) as in instant Claim 10. Q-VD-OPh inhibits caspases 1,3,7-10, and 12, and Z-VAD-FMK is an irreversible pan-caspase inhibitor as in instant Claims 9 and 11. The biological sample is maintained for at least 24, 36,48,72, and 96 hours (Paragraph 21) as in instant Claim 12. Sandlin discloses mannitol which is an antioxidant (Paragraphs 11 and 13) as in instant claim 13.
The reference anticipates the claim invention.
Claims 1-12,14,23, and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoglen et al. “A Caspase Inhibitor, IDN-6556, Ameliorates Early Hepatic Injury in an Ex Vivo Rat Model of Warm and Cold Ischemia” Liver Transplantation 13:361-366, 2007. Hoglen is already of record and was disclosed by applicants in an IDS form.
Hoglen discloses a method for preserving a biological tissue sample with a perfusate and a storage solution comprising an apoptosis inhibitor (IDN-6556) for a first time period, thereby providing a treated biological tissue sample (Page 362, Ex Vivo Cold Ischemia and Warm Reperfusion Model of Hoglen) as in instant Claim 1. Hoglen discloses wherein said providing comprises perfusing the biological tissue sample with perfusate or storing the biological tissue sample in the solution (Page 362, Ex Vivo Cold Ischemia and Warm Reperfusion Model of Hoglen) as in instant Claim 2. Page 362, Syngeneic Liver Transplant Model Section states that the preservation temperature is 4°C which is considered hypothermic cooling as in instant Claims 3-5. Hoglen discloses wherein said providing comprises storing the biological tissue sample in a storage solution comprising a first apoptosis inhibitor; and perfusing the biological tissue sample with the perfusate comprising a second apoptosis inhibitor, wherein the first and second apoptosis inhibitor are same or different (Page 362, Ex Vivo Cold Ischemia and Warm Reperfusion Model) as in instant Claim 6. Hoglen discloses wherein said storing comprises hypothermic conditions (Page 362, Ex Vivo Cold Ischemia and Warm Reperfusion Model) as in instant Claim 7. Hoglen discloses the use of apoptotic inhibitor IDN-6556/emricasan/a pan-caspase inhibitor/ a caspase 8 and 9 inhibitor (Abstract of Hoglen) as in instant Claims 8-11. Hoglen discloses where the concentration is maintained during the first time period (Figure 1A-C) as in instant Claim 12. Hoglen discloses that the providing comprises delivering to an in vitro system the biological tissue sample (Page 362 of Hoglen) as in instant Claim 14. Hoglen discloses a biological sample with a solution at a hypothermic temperature; cooling the biological tissue sample to a hypothermic temperature, warming the biological sample to a recovery temperature; and perfusing the biological tissue sample with a recovery solution (Page 361, Ex Vivo Cold Ischemia and Warm Reperfusion Model, of Hoglen) as in instant Claim 23. Hoglen samples are rat livers (Page 361 of Hoglen) as in instant Claim 35. Hoglen teaches wherein the viability was checked using ALT (Page 362, Ex Vivo Cold Ischemia and Warm Reperfusion Model) as in instant Claim 36.
The reference anticipates the claim limitations.
Claims 1-14,23, and 35-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hoglen et al. “A Caspase Inhibitor, IDN-6556, Ameliorates Early Hepatic Injury in an Ex Vivo Rat Model of Warm and Cold Ischemia” Liver Transplantation 13:361-366, 2007 in light of Southard et al. “Organ Preservation” Annu. Rev. Med 1995. 46: 235-47. Southard is used to teach inherent components of the University of Wisconsin Solution.
Hoglen applies as above to teach claims 1-12,14,23, and 35-36. Hoglen mentions that the solution includes the University of Wisconsin (UW) solution. This is a well-known preservation solution frequently used in cryopreservation and freezing applications. Hoglen fails to teach specific components of the University of Wisconsin solution. However, Southard teaches that the University of Wisconsin preservation solution contains glutathione which serves as an antioxidant (Abstract) as in instant Claim 13. Southard is used to teach an inherent component of the University of Wisconsin (UW) solution.
The reference anticipates the claim limitations
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.
Claims 1-15,19,23,35-36 are rejected under 35 U.S.C. 103 as being unpatentable over Hoglen et al. “A Caspase Inhibitor, IDN-6556, Ameliorates Early Hepatic Injury in an Ex Vivo Rat Model of Warm and Cold Ischemia” Liver Transplantation 13:361-366, 2007 in light of Southard et al. “Organ Preservation” Annu. Rev. Med 1995. 46: 235-47 and in view of Yarmush (US 20140030231). Southard is used to teach inherent components of the University of Wisconsin Solution
Hoglen and Southard apply as above to teach claims 1-14,23, and 35-36. Hoglen teaches using a apoptosis inhibitor in a solution and/or perfusate (Abstract of Hoglen) Hoglen discloses perfusing a sample. However, Hoglen does not mention that the perfusion operation is carried out by a machine. However, Yarmush teaches that the perfusion operation can be carried out using a machine (Figure 54 and Paragraph 119 of Yarmush). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used the perfusate machine taught by Yarmush. An artisan would have been motivated to have used Yarmush’s machine perfusion device because it allows for the evaluation of the function of the graft prior to transplantation while perfusion is occurring (Paragraph 227 of Yarmush). For example, a machine capable of carrying out perfusion can be designed to evaluate tissues samples/graft by measuring the ALT levels (Paragraph 227 of Yarmush), allowing for assessing of tissue before transplant. Because Yarmush’s perfusion machines are able to successfully evaluate signs of viability in tissue samples used for therapeutic purposes, there would have been a high expectation for success using Yarmush’s machine perfusion system with the process of Hoglen.
Dependent Claims taught by Yarmush—Yarmush teaches that the organ preservation can be carried out in sub-zero non-freezing conditions (Paragraphs 38-39) as in instant Claims 3-5,7. Yarmush teaches that the concentration of the preservation agent is maintained during the first time period (Paragraphs 61-63) as in instant Claim 12. Yarmush teaches wherein the perfusate can contain antioxidants (Paragraph 256 of Yarmush) as in instant Claim 13. Yarmush teaches delivering to an in-vitro system further comprising the biological tissue sample (Figure 54 and Paragraphs 119, 227, Paragraphs 344-349) as in instant Claim 14. Yarmush teaches said providing comprises injecting the biological tissue sample (Figure 54 and Paragraph 119 illustrate that perfusate can be injected into the biological sample) as in instant Claim 15. Yarmush teaches flushing the biological tissue sample with a solution; and perfusing the biological sample with a perfusate by machine perfusion (Paragraphs 344-349) as in instant Claim 19.
Hoglen teaches perfusing tissue using an apoptotic inhibitor. Hoglen does not teach that such a perfusion operation can be carried out by an automated machine. However, an artisan of ordinary skill in the art would have been motivated to have used Yarmush’s machine to carry out such an operation to control the perfusion process and to successfully monitor the tissue sample. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
All of the clamed elements were known in the prior art, and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be highly educated individuals possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable in molecular biology and tissue preservation. Therefore, the level of ordinary skill in this art is high.
Double Patenting
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 1-5,8-11,13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2,4-5,9-12 of U.S. Patent No. 10,750,739. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of Patent 10,750,739 recites placing a tissue sample (whole blood) in a storage solution comprising an apoptosis inhibitor/caspase inhibitor which recites the limitations of instant claims 1-2, and 8,14. Claim 2 of Patent 10,750,739 corresponds to instant claims 9-11. Claims 5,9-12 of Patent 10,750,739 corresponds to instant claims 3-5. Claims 1 and 4 of Patent 10,750,739 corresponds to instant claim 13.
Claims 1-5,7-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 4 of U.S. Patent No. 11,612,163. Although the claims at issue are not identical, they are not patentably distinct from each other because Patent 11,612,163 claim 1 discloses a method for preserving a biological tissue sample comprising providing the biological tissue sample (sample of whole blood) with a solution comprising an apoptosis inhibitor for a first time period, therapy providing a treated biological tissue sample wherein the biological sample is stored as in instant claims 1-2. Claim 1 of Patent 11,612,163 recites that the tissue sample is placed in a storage solution at 2-25°C which corresponds to instant clams 3-5. Claim 4 of Patent 11,612,163 recites Q-VD-OPh and/or Z-VAD-FMK (Paragraph 15 of Sandlin) as in instant Claim 10. Q-VD-OPh inhibits caspases as in instant Claims 1,3,7-10, and 12, and Z-VAD-FMK is an irreversible pan-caspase inhibitor as in instant Claims 8-11. Claim 1 of Patent 11,612,163 recites that the first time period is 24 hours which corresponds to instant claim 12. Claim 1 of Patent 11,612,163 recties that mannitol (an antioxidant) can be used as in instant Claim 13. Claim 1 of Patent 11,612,163 mentions an in vitro system that comprises the biological tissue sample as in instant Claim 14.
Claims 1-6,13,36 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-9 of U.S. Patent No 12/058,996. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent 12,058,996 discloses an apoptosis inhibitor, a solution, and a biological tissue sample. Claim 8 of Patent 12,058,996 discloses preserving a biological tissue sample in a storage solution that contains Trolox (an apoptosis inhibitor) which corresponds to instant claim 1. The storage solution mentioned in claim 8 of Patent 12,058,996 is further perfused through the biological tissue sample. Therefore, instant claim 2 also corresponds to claim 8 of Application 12/058,996. The method of preservation of claim 8 corresponds to partial freezing which corresponds to instant claims 3-5 which mention subzero/partial freezing. Claim 8 of Patent 12,058,996 corresponds to instant claim 6. Claim 9 of Patent 12,058,996 corresponds to instant claim 13 since trehalose is an antioxidant. Claim 8 of Patent 12/058,996 corresponds to instant claim 36 because a cell is a tissue sample.
Claims 1-5,13,35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 8 of U.S. Patent No. 12,239,126. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 8 of Patent 12,239,126 recites preserving a biological tissue sample by contacting the tissue sample with a perfusate that contains hypothermosol (a apoptosis inhibitor) which corresponds to instant claim 1. Instant claim 2 also corresponds to claim 8 of Patent 12,239,126. Claim 8 of Patent 12,239,126 encompasses a supercooling process which corresponds to instant claims 3-5. Claim 8 of Patent 12,239,126 also corresponds to instant claim 13 because claim 8 of Patent 12,239,126 recites that trehalose is included; trehalose is an antioxidant. Claim 8 of Patent 12,239,126 involves preserving an organ which corresponds to instant claim 35.
Claims 1-5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4 of U.S. Patent No.12,167,729. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Patent 12,167,729 recite the limitations present in instant claims 1-2. Claim 4 of Patent 12,167,729 recites a perfusion solution containing insulin (an apoptosis inhibitor) that is used to preserve a biological sample. Claim 4 teaches the limitations of instant claims 1 and 2. Claim 4 of Patent 12,167,729 recites that perfusion occurs under normothermic temperatures and the perfusion solution is used for supercooling. Therefore, claim 4 of Patent 12,167,729 also corresponds to instant claims 3-5.
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of U.S. Patent No. 12/329,150. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 12 of Patent 12/329,150 is a species of claims 1-2. Claims 12 discloses at least one apoptotic inhibitor (insulin) in a perfusion solution used to reduce ischemic damage in an organ.
Claims 1-5 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4,39-41,50-52,61-62,64-66,68-69,72-74,79-80,82-84,89,93-95 of copending Application No. 19,380,667 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1,39,50-51,61,65,69,74,82 of Application 19,380,667 recite placing cells (a biological tissue sample) in storage solution that contains F68 which is a type of apoptotic inhibitor as in instant Claims 1-2. Claim 2 of Application 19/380,667 further recites storing the biological sample in a solution at a temperature between about -196 and about 30°C or between about -5 and about 15°C which corresponds to instant claims 3-5. Claims 3,40,51,62,66,72,79,83,93-95 recite F68 (a apoptotic inhibitor) and claims 4,41,52,64,68,73,80,84,93-95 recite Trolox (another apoptotic inhibitor) used in a storage solution which contains a biological tissue sample which corresponds to instant claims 1-2. Claim 89 recites that the preservation solution is stored at a temperature between about 2°C and about 8°C for up to 72 hours which corresponds to instant claims 3-5. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
All claims stand rejected.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638