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 .
Election/Restrictions
Applicant’s election of Group II, claims 26-39, in the reply filed on 06/04/2026 is acknowledged. Claims 1-25 (Group I) and 40-51 (Group III) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. This election was made without traverse in the reply filed on 06/04/2026
Priority
Receipt is acknowledged of certified copies (PRO 63/245,632 – filed 09/17/2021) required by 37 CFR 1.78.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 03/11/2024 and 10/07/2025 have been certified and made of record.
Specification
The use of the term HEMOPURE® (Page 22), which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 26-39 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim 26. See MPEP § 608.01(n). However, for compact prosecution, claim 26 will be examined on the merits without the dependency present, specifically by examining the isolated perfusate mixture limited to claim 1.
Claim Rejections - 35 USC § 112
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 26-39 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. Specifically, claim 26 is indefinite because it includes a limitation drawn from a withdrawn claim. For examination purposes, the claim will be examined as an isolated perfusate mixture limited to claim 1.
Claim 26 recites the limitation "the hypothermic preservation". There is insufficient antecedent basis for this limitation in the claim. Claims 27-39 depend on claim 26 fail to cure the deficiencies of the claim, and therefore, are included in the rejection.
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 26-39 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Daniele et al. (WO 2019157277 A1) (referenced in 892).
Regarding claim 26, Daniele et al. teaches a system for normothermic preservation of an intact mammalian brain (abstract), the system comprising: a perfusion device comprising the perfusion loop; and a controller programmed to regulate at least a perfusate temperature within the perfusion loop to maintain normothermic conditions (p. 3). Furthermore, the system disclosed by Daniele et al. would be structurally capable of performing perfusion of an isolated perfusion mixture into the mammal. Thus, the claim is anticipated.
Regarding the limitation of the system being used in “hypothermic” preservation, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate form the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II).
Therefore, the perfusion device taught by Daniele et al. would be fully capable of achieving every intended use because Daniele et al.’s system teaches the features of a perfusion loop; and a controller programmed to regulate at least a perfusate temperature within the perfusion loop for the preservation of mammalian brains (p. 3), and the system would be structurally capable of being used in “hypothermic” preservation. Structurally, the controller would be capable of being programmed to regulate the perfusate temperature at hypothermic conditions, and thus, the perfusion device taught by Daniele et al. would be fully capable of achieving every intended use
Regarding claim 27, Daniele et al. teaches the system of claim 26. Daniele et al. further teaches that the perfusion loop further comprises at least one pulse generator programed to generate a pressure pulse within the perfusate within the perfusion loop (p. 3). Thus, the claim is anticipated.
Regarding claim 28, Daniele et al. teaches the system of claim 26, and teaches “In some embodiments the perfusion loop includes a venous loop, a filtration loop and an arterial loop, wherein: the venous loop comprises at least one perfusion pump; the filtration loop comprises at least one perfusion pump, and at least one hemodiafiltration unit adapted and configured to remove metabolic toxins from and add nutrients to the perfusate; the arterial loop comprises at least one gas exchange source and at least one gas mixer adapted and configured to supply oxygen and carbon dioxide to the perfusate; wherein the brain enclosure unit, venous loop, filtration loop and arterial loop are in fluidic communication such that the perfusate can be carried from the brain enclosure unit, through the venous loop, through the filtration loop, through the arterial loop and back to the brain enclosure unit.” (p. 3-4), which anticipates the claim limitation of claim 28.
Regarding claim 29, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “one or more components selected from the group consisting of the venous loop, the filtration loop and the arterial loop further comprise a reservoir containing excess perfusate” (p. 4) which anticipates the claim limitation.
Regarding claim 30, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, one or more components selected from the group consisting of the brain enclosure unit, the venous loop, the filtration loop and the arterial loop further comprise one or more elements selected from the group consisting of: one or more valves adapted and configured to regulate the flow of the perfusate” (p. 4) , which anticipates the claim limitation.
Regarding claim 31, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, the one or more sensors measure the concentration of at least one dissolved metabolite selected from the group consisting of nitric oxide, lactate, bicarbonate, oxygen, carbon dioxide, total hemoglobin, methemoglobin, oxyhemoglobin, carboxyhemoglobin, sodium, potassium, chloride, calcium, glucose, urea, ammonia, and creatinine.” (p. 4), which anticipates the claim limitation.
Regarding claim 32, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, the brain perfusion apparatus comprises one or more sensors for measuring one or more properties of the perfusate selected from the group consisting of pressure and flow rate.” (p. 4), which anticipates the claim limitation.
Regarding claim 33, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, one or more components selected from the group consisting of the brain enclosure unit, the venous loop, the filtration loop and the arterial loop comprise one or more heat exchange units comprising: one or more heat exchangers; one or more temperature regulation units; one or more temperature regulating pumps; a thermoregulation fluid; and one or more pipes configured and adapted to transport the thermoregulation fluid, wherein the one or more pipes are in fluidic communication with the one or more heat exchangers, the one or more temperature regulation units and the one or more temperature regulating pumps” (p. 4), which anticipates the claim limitation.
Regarding claim 34, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, the one or more components selected from the group consisting of the brain enclosure unit, the venous loop, the filtration loop and the arterial loop comprise one or more sensors adapted and configured to measure the temperature within the perfusion device” (p. 4), which anticipates the claim limitation.
Regarding claim 35, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “the one or more sensors adapted and configured to measure the temperature within the perfusion device, the one or more temperature regulation units and the one or more temperature regulating pumps are in electronic communication with a computer programmed to regulate the temperature of the thermoregulation fluid and the specified flow rate of the one or more temperature regulating pumps to maintain a specified temperature within the perfusion device.” (p. 4-5), which anticipates the claim limitation.
Regarding claim 36, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, the hemodiafiltration unit is adapted and configured to supply one or more nutrients to the perfusate, selected from the group consisting of Glycine, L-Alanyl-Glutamine L-Arginine hydrochloride, L-Cystine, L-Histidine hydrochloride-H2O, L-Isoleucine, L-Leucine, L-Lysine hydrochloride, L-Methionine, L-Phenylalanine, L-Serine, L-Threonine, L-Tryptophan, L-Tyrosine, L-Valine, Vitamins, Choline chloride, D-Calcium pantothenate, Folic Acid, Niacinamide, Pyridoxine hydrochloride, Riboflavin, Thiamine hydrochloride, i-Inositol, Inorganic Salts, Calcium Chloride (CaCl.sub.2-2H.sub.2O), Ferric Nitrate (Fe(NO.sub.3).sub.3 9H.sub.2O), Magnesium Sulfate (MgSO.sub.4-7H.sub.2O), Potassium Chloride (KCl), Sodium Bicarbonate (NaHCO.sub.3), Sodium Chloride (NaCl), Sodium Phosphate monobasic (NaH.sub.2PO.sub.4-2H.sub.2O), Other Components, D-Glucose (Dextrose), Phenol Red, Sodium Pyruvate, free fatty acids, cholesterol and nucleic acid constitutes.” (p. 5), which anticipates the claim limitation.
Regarding claim 37, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, the system as described herein perfuses the brain with the perfusate at a cardiac pulsatile pressure of about 20 mmHg to about 140 mmHg.” (p. 5), which anticipates the claim limitation.
Regarding claim 38, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, the system as described herein perfuses the brain with the perfusate through the pulse generator at a rate of about 40 to about 180 beats per minute.” (p. 5), which anticipates the claim limitation.
Regarding claim 39, Daniele et al. teaches the system of claim 28. Daniele et al. further teaches “In some embodiments, the system as described herein further includes a computer in electronic communication with one or more elements of the system.” (p. 5). Structurally, the controller and computer both use electronic communication with the elements in the system, and therefore, the claim is anticipated.
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 26-39 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11998001 B2 (herein referred to as ‘001) (claims 1, 2, 6-14, 16, 18, 19). Although the claims at issue are not identical, they are not patentably distinct in that each is drawn to a perfusion system for the preservation of an organ in a mammal (instant claim 26; ‘001 claim 1) comprising: a perfusion device (instant claim 26; ‘001 claim 1), perfusion loop (instant claim 26, ‘001 claim 1), and controller (instant claim 26; ‘001 claim 1). Furthermore, the systems feature a pulse generator (instant claim 27, ‘001 claim 2), venous loop, arterial loop, filtration loop, and hemodiafiltration unit (instant claims 28+; ‘001 claims 3+). Furthermore, the difference in perfusate compositions between ‘001 and the instant application, although not identical, are not patentably distinct from each other because the structures of each perfusion system (normothermic or hypothermic) would be capable of using the perfusate compositions within the claimed components of ‘001 and the instant application (perfusion loop, controller).
Conclusion
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/JULIUS FRANCIS YOH/Examiner, Art Unit 1799 /William H. Beisner/Primary Examiner, Art Unit 1799
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