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, 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7-11, 13-15, 19, 41, 45, 54 and 119 are pending in this application, Claims 19, 41, 45, 54 and 119 are acknowledged as withdrawn, Claims 1, 2, 4, 5, 7-11 and 13-15 were examined on their merits.
The rejection of Claims 1, 4, 5, 7-11 and 13 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2019/0082678 A1) and Mangino (US 2017/0151198 A1), has been withdrawn in view of the new rejections set forth below.
The rejection of Claims 1, 4, 5, 7-11 and 15 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of record, has been withdrawn in view of the new rejections set forth below.
The rejection of Claims 1, 2, 4, 5, 7-11 and 15 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5,540,911), all of record, has been withdrawn in view of the new rejections set forth below.
The rejection of Claims 1, 4, 5, 7-11, 14 and 15 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9,049,856 B2), all of record, has been withdrawn in view of the new rejections set forth below.
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(s) 1, 4, 5 and 7-11 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Agulnick et al. (US 2016/0250262 A1), as evidenced by Ingber et al. (US 2016/0143949 A1), both of record.
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]).
With regard to the limitation of Claim 1, “wherein the composition reduces
oxidative damage to a cell, tissue, or organ relative to a preservation solution lacking the superoxide dismutase, catalase, DL-alpha tocopherol acetate, DL alpha-tocopherol, and glutathione”, the Examiner notes that the claimed composition is anticipated by the composition of the prior art and must therefore have the same properties and characteristics, when in use. See the MPEP at 2112.01, II.
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), all of record.
The teachings of Agulnick et al. were discussed above.
Agulnick et al. did not teach a B27 organ or tissue composition further comprising at least 10 of: sodium chloride, potassium chloride, magnesium chloride, calcium chloride, phosphate buffer, magnesium sulfate, sodium bicarbonate, glucose, histidine, tryptophan, glutamic acid, a-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 at least 10 of the organ preservation solution components of Thatte and Mangino because Thatte teaches a composition for organ or tissue preservation comprising a physiological salt solution comprising one or more salts and Mangino teaches that known organ preservation solutions can be modified (that is, subject to addition, removal or substitution of components).
While the references listed above do not specifically teach the limitation of the composition comprising at least 10 of the claimed additional components, one of ordinary skill in the art would recognize that the number of additional components in an organ preservation composition is a result-effective optimizable variable. Thatte teaches a composition for organ or tissue preservation comprising a physiological salt solution comprising one or more salts and Mangino teaches that known organ preservation solutions can be modified (that is, subject to addition, removal or substitution of components). This is motivation for someone of ordinary skill in the art to practice or test the addition of other organ preservation composition components widely to find those that are functional or optimal which then would be inclusive or cover that components as instantly claimed. Absent any teaching of criticality by the Applicant concerning the number of additional components in the organ preservation composition, it would be prima facie obvious that one of ordinary skill in the art would recognize these limitations are an optimizable variable which can be met as a matter of routine optimization (see MPEP § 2144.05 (II)(B). 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), as applied to Claims 1, 4, 5 and 7-11 above, 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 and 7-11 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), as applied to Claims 1, 4, 5 and 7-11 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.
Agulnick et al. did not 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. 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 Agulnick et al. does not 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 and 14 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), as applied to Claims 1, 4, 5 and 7-11 above, and further in view of Chang et al. (US 9,049,856 B2), all of record.
The teachings of Agulnick et al. were discussed above.
Agulnick et al. did not 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. 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. and Chang et al. separately teach organ preservation compositions/solutions.
Response to Arguments
Applicant’s arguments, see Remarks, filed 08/28/2026, with respect to the rejection(s) of claim(s) 1, 2, 4, 5, 7-11 and 13-15 under 35 U.S.C. § 103 have been fully considered and are persuasive. Therefore, the rejections has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Agulnick et al. (US 2016/0250262 A1), as evidenced by Ingber et al. (US 2016/0143949 A1), as set forth above.
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.
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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 09/08/2026
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