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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/04/2026 has been entered.
Claims 1, 2, 4, 5, 7-11, 13-15, 19, 41, 45, 54 and 119 are pending in this application, Claims 19, 41, 45, 54 and 119 are acknowledged as withdrawn, Claims 1, 2, 4, 5, 7-11 and 13-15 were examined on their merits.
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.
Claims 1, 4, 5, 7-11 and 13 are rejected under 35 U.S.C. § 103 as
being unpatentable over Agulnick et al. (US 2016/0250262 A1), as evidenced by Ingber
et al. (US 2016/0143949 A1), both of record, and further in view of Thatte (US 2019/0082678 A1) and Mangino (US 2017/0151198 A1).
Agulnick et al. teaches organ/tissue preservation solutions/compositions
including B27 Supplement (Pgs. 38-39, Paragraph [0253]), reading on Claim 1.
With regard to Claims 1, 4, 5, 7, 8, 9, 10 and 11, Ingber et al. evidences that B27 Supplement consists of: biotin, L-carnitine HCL, corticosterone, ethanolamine HCL, D- galactose, reduced glutathione, linoleic acid, linolenic acid, progesterone, DL-α- tocopherol, DL-α-tocopherol acetate, Vitamin A acetate, bovine serum albumin fatty acid free fraction V (BSA), catalase, human recombinant insulin, human transferrin, superoxide dismutase, putrescine 2HCL, sodium selenite, and triiodo-I-thyronine (T3) (Pg. 30, Paragraph [0381]).
The teachings of Agulnick et al. were discussed above.
Agulnick et al. did not teach a B27 organ or tissue composition further comprising
sodium chloride, potassium chloride, magnesium chloride, calcium chloride, phosphate buffer, magnesium sulfate, sodium bicarbonate, glucose, histidine, tryptophan, glutamic acid, α-ketoglutarate, lactobionic acid, mannitol, hydroxyethyl starch, raffinose, adenosine, and allopurinol, as required by Claim 13.
Thatte teaches a composition for organ or tissue preservation comprising: a physiological salt solution comprising one or more salts selected from; potassium phosphate, potassium chloride, sodium chloride, sodium bicarbonate, calcium chloride, magnesium chloride and magnesium sulfate (Pg. 32, Claims 1 and 7);
a sugar which may be glucose (Pg. 33, Claims 19-20);
and that known organ preservation compositions can comprise mannitol, lactobionic acid, histidine, glutamic acid, raffinose, adenosine, allopurinol and hydroxyethyl starch (Pgs. 16-17, Table 1-1).
Mangino teaches that known (organ) preservation solutions can be modified, including Bretschneider histidine tryptophan ketoglutarate solution, which includes histidine (200 mM), mannitol (30 mM), tryptophan and alpha-ketoglutaric acid and low concentrations of sodium, potassium, and magnesium (Pg. 9, Paragraph [0094]).
It would have been obvious to obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the known B27 organ preservation composition/solution of Agulnick et al. with the organ preservation solution components of Thatte and Mangino because Mangino teaches that known organ preservation solutions can be modified (that is, subject to addition, removal or substitution of components). Those of ordinary skill in the art would have been motivated to make this modification in order to provide an organ preservation solution with different components and therefore different functional properties. There would have been a reasonable expectation of success because all the references are drawn to the same field of endeavor, that is, organ preservation compositions.
Claims 1, 4, 5, 7-11 and 15 are rejected under 35 U.S.C. § 103 as
being unpatentable over Agulnick et al. (US 2016/0250262 A1), as evidenced by Ingber
et al. (US 2016/0143949 A1), and further in view of Arduini et al. (US 7,422,844 B2), all
of record.
The teachings of Agulnick et al. were discussed above.
Agulnick et al. did not teach a B27 organ or tissue preservation composition further comprising sodium, potassium, glucose, mannitol and phosphate bicarbonate (EuroCollins solution), as required by Claim 15, (g).
Arduini et al. teaches a modified EuroCollins organ preservation solution comprising sodium, potassium chloride, glucose, phosphate and bicarbonate (Column 2, Table 1 and Column 4, Table 3), and which can additionally comprise one or more antioxidants such as: glutathione, catalase, superoxide dismutase, mannitol and Vitamin E (Column 4, Table 3 and Lines 44-52).
It would have been obvious to obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to combine the B27 organ preservation composition/solution of Agulnick et al. with the organ preservation solution of Arduini et al. because it is prima facie obvious to combine two compositions separately taught in the prior art for the same purpose into a third composition for the same purpose. See the MPEP at 2144.06, I. Those of ordinary skill in the art would have been motivated to make this modification in order to provide a combined organ preservation solution. There would have been a reasonable expectation of success because Agulnick et al. and Arduini et al. separately teach two organ preservation solutions.
Claims 1, 2, 4, 5, 7-11 and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over Agulnick et al. (US 2016/0250262 A1), as evidenced by Ingber et al. (US 2016/0143949 A1), and further in view of Arduini et al. (US 7,422,844 B2), as applied to Claims 1, 4, 5, 7-11 and 15 above, and further in view of Hartmann et al. (US 5,540,911), all of record.
The teachings of Agulnick et al. and Arduini et al. were discussed above.
Neither Agulnick et al. or Arduini et al. teach an organ or tissue preservation composition wherein the superoxide dismutase is manganese-dependent SOD, as required by Claim 2.
Hartmann et al. teaches a method of prolonging organ survival by adding manganese superoxide dismutase to the perfusion medium of an isolated organ (Column 22, Claim 3).
It would have been obvious to obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the organ preservation composition of Agulnick et al. and Arduini et al. which comprises generic superoxide dismutase to use the manganese superoxide dismutase of Hartmann et al. because Hartmann et al. teaches a specific superoxide dismutase which is suitable for use in organ preservation solutions and neither Agulnick et al. or Arduini et al. limit the superoxide dismutase to any particular type. Those of ordinary skill in the art would have been motivated to make this modification in order to provide an organ preservation solution with a suitable superoxide dismutase.
Claims 1, 4, 5, 7-11, 14 and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over Agulnick et al. (US 2016/0250262 A1), as evidenced by Ingber et al. (US 2016/0143949 A1), and further in view of Arduini et al. (US 7,422,844 B2), as applied to Claims 1, 4, 5, 7-11 and 15 above, and further in view of Chang et al. (US 9,049,856 B2), all of record.
The teachings of Agulnick et al. and Arduini et al. were discussed above.
Neither Agulnick et al. or Arduini et al. teach an organ or tissue preservation composition wherein the organ or tissue preservation solution comprises pentafraction, lactone, potassium phosphate monobasic, magnesium sulfate heptahydrate, raffinose pentahydrate, adenosine, allopurinol, and potassium hydroxide, as required by Claim 14.
Chang et al. teaches a UW organ preservation solution comprising pentafraction, lactone, potassium phosphate monobasic, magnesium sulfate heptahydrate, raffinose pentahydrate, adenosine, allopurinol, and potassium hydroxide (Column 23, Table 2).
It would have been obvious to obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to combine the organ preservation composition of Agulnick et al. and Arduini et al. with the organ preservation solution of Chang et al. because it is prima facie obvious to combine two (or more) compositions separately taught in the prior art for the same purpose into a third composition for the same purpose. See the MPEP at 2144.06, I. Those of ordinary skill in the art would have been motivated to make this modification in order to provide a combined organ preservation solution. There would have been a reasonable expectation of success because Agulnick et al., Arduini et al. and Chang et al. separately teach organ preservation compositions/solutions.
Response to Arguments
Applicant's arguments filed 03/04/2026 have been fully considered but they are not persuasive.
The Applicant argues that Agulnick allegedly does not disclose a preservation solution but instead refers to B27 medium as being added to cell culture media. Applicant asserts that Paragraph [0252] of the reference describes three organ preservation solutions and the comparison to a control in which B27 was added. Applicant notes that the B27 control had lower cell viability and greater cytotoxicity than the three tested organ preservation solutions and therefore the ordinary artisan would have no motivation to add B27 media to any other organ preservation solution (Remarks, Pg. 6, Lines 19-26 and Pg. 7, Lines 1-15).
This is not found to be persuasive for the following reasons, clearly Agulnick discloses a B27 media comprising organ preservation solution control as a basis for comparison with three other organ preservation solutions. That the control is a non-preferred embodiment does not negate this fact. See the MPEP at 2123, I. and II. The Examiner maintains that those of ordinary skill in the art would have been motivated to modify Agulnick in view of the other cited prior art set forth in the above rejections in order to provide an organ preservation solution with different components and therefore different functional properties.
The Applicant argues that Ingber and Arduini do not remedy the alleged deficiencies of Agulnick, noting that Agulnick is drawn to a control cell culture medium, Ingber teaches a podocyte induction medium or mesoderm differentiation medium and Arduini teaches an organ or tissue preservation composition and it would not be obvious to combine them (Remarks, Pg. 7, Lines 16-26).
This is not found to be persuasive for the following reasons, as discussed above, Agulnick does teach that B27 is an organ preservation solution. Inger was cited as an evidentiary reference of the composition of B27 medium and Arduini was cited merely for its’ teachings of additional organ preservation solution components. The Examiner maintains that those of ordinary skill in the art would have been motivated to modify Agulnick in view of the other cited prior art set forth in the above rejections in order to provide an organ preservation solution with different components and therefore different functional properties.
The Applicant argues that the claimed composition has benefits including
preserving heart function and extended shelf life of organs relative to those treated with
standard preservation solutions (Remarks, Pg. 7, Lines 27-29 and Pg. 8, Lines 1-6).
This is not found to be persuasive for the following reasons, the Examiner notes
that the claimed invention is drawn to a composition and not to a method of use of the
composition.
In response to Applicant's argument that the references fail to show
certain features of the invention, it is noted that the features upon which Applicant relies
(i.e., preserving heart function and extended shelf life of organs relative to those treated
with standard preservation solutions) are not recited in the rejected claim(s). Although
the claims are interpreted in light of the specification, limitations from the specification
are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057
(Fed. Cir. 1993). Further, Applicant has provided no evidence on the record of any
comparison between the claimed composition and the closest cited prior art.
The Applicant argues that Hartmann does not remedy the alleged deficiencies of
Agulnick and there would not be any motivation to arrive at the claimed invention with a
reasonable expectation of success (Pg. 8, Lines 12-15).
This is not found to be persuasive for the following reasons, as set forth above,
Agulnick et al., as evidenced by Ingber et al. and further in view of Arduini et al. clearly obviates the claimed composition. Hartmann was cited only for its’ teaching of the use of a particular manganese superoxide dismutase in an organ preservation solution.
The Applicant argues that Chang does not remedy the alleged deficiencies of
Agulnick and the other cited references (Remarks, Pg. 8, Lines 22-24).
This is not found to be persuasive for the following reasons, as set forth above,
Agulnick et al., as evidenced by Ingber et al. and further in view of Arduini et al. clearly obviates the claimed composition. Chang was cited merely for its’ teaching of the composition of UW organ preservation solution.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to PAUL C MARTIN whose telephone number is (571)272-3348. The Examiner can normally be reached Monday-Friday 12pm-8pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, Applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Sharmila G Landau can be reached at (571) 272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL C MARTIN/Examiner, Art Unit 1653 05/20/2026
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