DETAILED ACTION
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 and 38-56 are pending.
The instant application claims priority as a 371 filing of PCT/US2023/018648 filed 4/14/2023 which claims priority to provisional application 63/331,777 filed 4/15/2022.
Information Disclosure Statement
An IDS filed 10/10/2024 has been identified and the documents considered. The signed and initialed PTO Form 1449 has been mailed with this action.
Claim Objections
Claims are objected to because of the following informalities: independent limitations each require their own articles. In claims 1, 43 and 54, the term “sterile water” requires the article “a”. In claim 41, “L-ascorbic acid” should be preceded by the article “the” . In claim 54, lone 1, “organ” requires the article “a” and in line 4, “the”.
Appropriate correction is required.
Claim Construction
Claim 43 indicates that there are some optional components. The claim construction indicates that these are only sugar and nitric oxide substrate. Hence, the components following including a buffering agent and physically acceptable salt are not optional.
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.
Claim 49 is 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.
Claim 49 recites the limitation "the nitric oxide substance" in claim 43. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 38, 39, 41, 43-47, 49 and 52-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thatte et al (US 20040102415).
Thatte et al teach compositions for preservation of tissues and organs (see abstract). The composition can be a powder (see e.g. ¶0021). The main composition is set forth below meets claims 1, 43-47.
0020] The present invention contemplates the present invention may be an aqueous solution or the present invention may be composed of powders and concentrated solutions that could be mixed with sterile water, as needed. The present invention also contemplates that the invention may be composed of a quantity of HBSS along with a supplement package that may be mixed with the HBSS.
[0021] The present invention contemplates an aqueous solution for organ and tissue preservation, comprising: a) calcium ions; b) D-glucose (from about 50 mM to about 120 mM); c) potassium ions (from about 100 mM to about 250 mM; derived from compounds selected from the group consisting of potassium chloride, and potassium phosphate); d) magnesium ions (from about 2 mM to about 20 mM; derived from compounds selected from the group consisting of magnesium sulfate, and magnesium chloride); e) sodium ions; f) ascorbic acid in a concentration of about 25-1000 mM; g) glutathione in a concentration of about 50-2000 mM; h) L-arginine in a concentration of about 250-2000 mM; i) an anticoagulant (selected from heparin and hirudin) at a concentration sufficient to substantially inhibit blood coagulation (for heparin this would be from about 50 units/l to about 250 units/l); and j) a buffer (the buffer is selected from the group consisting of sodium phosphate and sodium bicarbonate) in an amount sufficient to maintain the pH of said aqueous organ preservation solution at about 6.8 to 8.0.
A later passage limits the pH to 7.0 (see ¶0018).
As set forth above and claimed in claim 38, the sugar can be glucose and in claim 39 and 52, the salt sodium bicarbonate and as well anhydrous calcium chlorides (see ¶0016).
As required in claim 41 and 53, the ranges overlap. The concentration of D-glucose from about 50 mM to about 120 mM overlaps instant claim concentrations at 50 mm, ascorbic acid in a concentration of about 25-1000 mM overlaps instant claim concentrations at 500-1000 mM; glutathione in a concentration of about 50-2000 mM instant claim concentrations at 50-2000 mM; L-arginine in a concentration of about 250-2000 mM overlaps the entire range of instant claim concentrations.
The solution is for injection for organ preservation with sterile water (see ¶0052) as recited in claims 54-56 (it is noted that claim 56 is an alternative should saline be selected).
Claims 1, 38, 39, 41, 43-47, 49 and 52-56 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thatte et al (WO 2016201126).
Thatte et al teach compositions for preservation of tissues and organs (see abstract). The composition can be a powder (see e.g. ¶0065). The composition comprises glucose, glutathione, ascorbic acid, salt and arginine (see ¶0009) as recited in claims 1, 38, 43-47 and 49). It is noted that L-arginine is optional (see Table 1 and ¶0082).
Salts in alternative forms are provided for wherein potassium and magnesium OR calcium salts as well as sodium bicarbonate are included (¶0016). This allows claims 39, 40, 42, 50-52).
The concentration of D-glucose from about 5 mM to about 10 mM overlaps instant claim concentrations at 5-10 mM, ascorbic acid in a concentration of about 1 mM overlaps instant claim concentrations at 1mM; glutathione in a concentration of about 0.5 to 3 mM overlapping instant claim concentrations at .5-2 mM; L-arginine in a concentration of about . 5mM-7 mM overlaps the instant claim concentrations of .5-2 mM as recited in claims 41 and 53.
The solution is for injection (see ¶0006) with sterile water (see e.g. ¶0115) as recited in claims 54-56 (it is noted that claim 56 is an alternative should saline be selected).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 44-46, 48, 50 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Sterne et al (U.S. patent 5,552,267) in view of Hudson (BioProcess International, 2013, pages 1-10).
Sterne teaches a composition for preservation of organs. The solution comprises n-acetylcysteine (reducing agent), Vitamin C (antioxidant), magnesium, glucose, and a pH of about 7.0 (see e.g. abstract and col 3, lines 23-25).
Sterne does not teach that the composition can be a powder. However, formulation of such compositions as a powder was well known in the art with well-known benefits as shown by Hudson.
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to prepare the solution of Sterne et al in powdered form as taught by Hudson et al. Such a modification would have resulted in a method encompassed by claim 35. As noted above: 1) 1) Sterne teaches a composition to be used by laboratories and more for preserving organs and tissues and 2) Hudson teaches that shipping and preparation consistency is enhanced providing such solutions in powdered form. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded method would allow improved treatment.
The solution does not use calcium salts or sodium chloride (see e.g. col 3, lines 4-5). The above described preservation solution of Sterne does not include a nitric oxide substrate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1634
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