DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 12/30/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1, 3-7 and 39-40 are rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (USP 6,046,046 A), in view of Sullivan et al (US 2015/0342177A1).
Hassanein taught a therapy system (Fig. 4, perfusion system 10) comprising: an oxygen source configured to provide oxygen (col. 14, lines 60-62); a hemoglobin source (i.e., blood reservoir 30, col. 7, lines 33-36) configured to provide topical hemoglobin (col. 30, lines 52-55: the blood is depleted of leukocyte; i.e., it is a source of topical hemoglobin for the organ; e.g. reads on natural hemoglobin); and means (i.e., oxygenators 38 or 208; reads on in-line mixer) for mixing the oxygen and the topical hemoglobin to form a mixture (col. 7, lines 54-59) and to provide the mixture to a dressing via the outlet (col. 9, lines 19-21). Hassanein was drawn to maintaining a harvested organ [abstract], where it is recognized in the art as desirable to achieve prolonged ex vivo preservation of organs [col 3, lines 5-7].
Hassanein was silent a pad and a drape, as recited in claim 1.
Sullivan taught techniques relating to the ex vivo care of organs at physiologic or near-physiologic conditions [title and abstract]. Sullivan’s system circulated an oxygenated, nutrient enriched perfusion fluid to the organ at or near physiological temperature, pressure, and flow rate. In some embodiments, the system employed a blood product-based perfusion fluid to more accurately mimic normal physiologic conditions [0005]. In some embodiments, an organ chamber assembly included a pad, sized and shaped for inter-fitting within a bottom of the housing (e.g., reads on configured to couple to the mixer), wherein a wrap was attached to the pad on one side, and the remaining portion of the wrap was draped over the organ (e.g., reads on configured to couple to a tissue site). The pad cushioned the organ from mechanical vibrations and shocks; additionally, the wrap served several functions, including to secure the organ, helping to maintain sterility, and preserving the moisture in the organ, by acting as a vapor barrier [0012-0013, 0271].
Since Hassanein was drawn to maintaining a harvested organ, where it is recognized in the art as desirable to achieve prolonged ex vivo preservation of organs, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Hassanein, a pad and a drape, as taught by Sullivan. The ordinarily skilled artisan would have been so motivated, because pads and drapes, when included within systems that circulate oxygenated, nutrient enriched perfusion fluid to organs, help to provide care for said organs, by cushioning the organs from mechanical vibrations and shocks; securing the organs, helping to maintain sterility, and by preserving the moisture in the organs, by acting as a vapor barrier, as taught by Sullivan et al at ¶s [0012-0013, 0271].
Hassanein, in view of Sullivan, reads on claims 1, 3, 7 and 39-40.
Regarding claim 6, Hassanein was not specific that the oxygen was medically pure humidified oxygen, as instantly recited. However, it would be prima facie obvious to one of ordinary skill in the art to use medically pure humidified oxygen, as instantly recited. Since Hassanein taught compositions, methods, systems/devices and media for maintaining a harvested organ in a functioning and viable state prior to implantation [abstract], the ordinarily skilled artisan would be motivated to use an oxygen source that met medical standards.
Claim(s) 2 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (USP 6,046,046 A), in view of Sullivan et al (US 2015/0342177A1) and further in view of Plomer et al (USP 5,840,851A).
The 35 U.S.C. 103 rejection over Hassanein and Sullivan was previously discussed.
Additionally, Hassanein taught a water heater 40 that provided warmed water through a water circuit 42 which maintained the fluid within perfusion circuit 14 at about 37° C. (normothermia). The warmed perfusion fluid then maintained donor organ 12 at a normothermic temperature. Alternatively, water heater 40 can also remove heat from the water circulating through water circuit 42 for cooling the preservation fluid within perfusion circuit 14 (e.g., reads on a hydrolysis device) [col 7, line 65 to col 8, line 5].
Hassanein did not teach an aerosol hemoglobin, as recited in claim 2.
Plomer taught purified hemoglobin [abstract and title] delivered by aerosol administration, as a conventional means [col 16, line 60].
It would have been prima facie obvious to one of ordinary skill in the art to include an aerosol hemoglobin within Hassanein, as taught by Plomer. The ordinarily skilled artisan would have been motivated to included administration of the hemoglobin by conventional means, as taught by Plomer et al [col 16, line 60].
Claim(s) 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (USP 6,046,046 A), in view of Sullivan et al (US 2015/0342177A1) and further in view of Barnikol et al (USP 5,985,332).
The 35 U.S.C. 103 rejection over Hassanein and Sullivan was previously discussed.
Additionally, Hassanein was drawn to compositions, methods, systems/devices and media for maintaining a harvested organ in a functioning and viable state prior to implantation. The organ perfusion apparatus included a preservation chamber for storing the organ during the preservation period. A perfusion circuit was provided for providing an oxygenated fluid to the organ, and for carrying depleted fluid away from the organ [abstract].
Hassanein did not teach carbonylated hemoglobin, as recited in claim 4.
Barnikol taught artificial oxygen carriers composed of native or modified hemoglobins which were reliably and lastingly protected against loss of function until they were used, which prior to use required no further treatment, and whose reactivation was controllable after use began. Artificial oxygen carriers on the basis of hemoglobins are required for many purposes, but during their preparation and storage they can lose their functionality partially or completely. To prevent this, it is necessary that artificial hemoglobin oxygen carriers remain usable and capable of storage for as long as possible. [col 1, lines 9-20]. And as such, Barnikol was drawn to converting hemoglobin entirely to carbonylhemoglobin (e.g., carboxyhemoglobin) and storing it in this form, and also using it even thus, as an artificial oxygen carrier, without further treatment [col 3, lines 20-30].
Carboxyhemoglobin is known to be extremely stable against spontaneous oxidation, even during storage at room temperature, so that, as an achievable advantage, the preparations according to Barnikol can be stored over a long time without untoward consequences for their function as artificial oxygen carriers [col 3, line 65 to col 4, line 3]. Another important advantage of the use of hemoglobins, protected according to Barnikol, against loss of functionality, as artificial oxygen carriers, is to be seen in the possibility--adapted to the requirements of the individual patient or of the special application--of gradually releasing their operation. After therapeutic administration in an organism, no transitory relative oversupply of oxygen occurs in less blood-perfused organs; the tissue, functionally adapted to hypoxia, is thus preserved against oxidative shock by toxic oxygen damage (so-called "reperfusion damage") [col 4, lines 12-21].
Since Hassanein taught organ perfusion for storing and preserving organs by providing oxygenated fluid to the organ, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Hassanein, carbonylated hemoglobin, as taught by Barnikol. The ordinarily skilled artisan would have been so motivated, because carboxyhemoglobin is known to be extremely stable against spontaneous oxidation, even during storage at room temperature, so that, as an achievable advantage, carboxyhemoglobin can be stored over a long time without untoward consequences for their function as artificial oxygen carriers [Barnikol: col 3, line 65 to col 4, line 3]. Another important advantage of the use of carboxyhemoglobin, against loss of functionality, as artificial oxygen carriers, is to be seen in the possibility--adapted to the requirements of the individual patient or of the special application--of gradually releasing their operation. After therapeutic administration in an organism, no transitory relative oversupply of oxygen occurs in less blood-perfused organs; the tissue, functionally adapted to hypoxia, is thus preserved against oxidative shock by toxic oxygen damage (so-called "reperfusion damage") [Barnikol: col 4, lines 12-21].
Claim(s) 5 is rejected under 35 U.S.C. 103 as being unpatentable over Hassanein et al (USP 6,046,046 A), in view of Sullivan et al (US 2015/0342177A1) and further in view of Cooper et al (US 2020/0131247A1).
The 35 U.S.C. 103 rejection over Hassanein and Sullivan was previously described.
Hassanein was silent as to fetal or adult hemoglobin, as recited in claim 5.
Cooper taught human or adult fetal hemoglobin [0026] as a blood substitute, having an enhanced oxygen-carrying capability, and with reduced cytotoxicity [0016-0021], for use in organ perfusion [0324-0325].
Since Hassanein taught organ perfusion for storing and preserving organs by providing oxygenated fluid to the organ, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Hassanein, fetal or adult hemoglobin, as taught by Cooper. The ordinarily skilled artisan would have been motivated to include, for use in organ perfusion, a protein having an enhanced oxygen-carrying capability, with reduced cytotoxicity, as taught by Cooper et al [0016-0021, 0324-0325].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612
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