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, 3, 5-18, 20 and 21 are pending in this application.
Election/Restrictions
Applicant's election with traverse of Group II (Claims 12-18, 20 and 21) in the reply filed on 02/02/2026 is acknowledged. The traversal is on the ground(s) that the amended claims make a contribution over the cited prior art. This is not found persuasive because of the reasoning below in the rejection based on Cohen et al. (US 2016/0310547 A1). Claims 1, 3 and 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 02/02/2026.
Claims 12-18, 20 and 21 were examined on their merits.
The requirement is still deemed proper and is therefore made FINAL.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it is too short to describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The use of the term GRAPHPAD PRISM™, 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 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.
Claim(s) 12-18 and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Cohen et al. (US 2016/0310547 A1).
Cohen et al. teaches perfusing an organ with a preservation solution in which an effective dose of photosynthetic organisms has been suspended (Pg. 6, Paragraph [0050]);
wherein the photosynthetic microorganism is a Synechococcus species, e.g. S. elongatus (Pg. 3, Paragraph [0026]);
wherein the preservation solution can be any preservation solution known in the art for organ maintenance (e.g. biocompatible) (Pg. 5, Paragraph [0041]);
wherein the preservation solution may be Ross-Marshall citrate or Celsior solutions containing the cell impermeant agent mannitol (Pg. 5, Paragraph [0042]), and reading on Claim 12.
While the Cohen et al. reference does not teach a single anticipatory embodiment of the claimed invention, the ordinary artisan would have found obvious the combination of the separately taught elements into a single method because the reference separately teaches the claimed elements and the only difference between the claimed invention and the prior art is the lack of actual combination of the elements. See the MPEP at 2143, I, A., referencing KSR. Those of ordinary skill in the art would have been motivated to make this modification in order to perfuse an organ with a known biocompatible preservation solution in which an effective dose of photosynthetic organisms has been suspended, thus maintaining viability of the organ. There would have been a reasonable expectation of success in making this modification because the reference already separately teaches all of the claimed elements.
With regard to Claims 13 and 14, Cohen et al. teaches the methods of the invention are provided for reducing the adverse effects of ischemia on a human individual wherein an effective dose of photosynthetic microorganism is brought into fluid communication with a tissue or organ that is ischemic or at risk of ischemia (Pg. 5, Paragraph [0047]).
With regard to Claim 15, Cohen et al. teaches the preservation solution perfused organ is transplanted (Pg. 6, Paragraph [0050]).
With regard to Claim 16, Cohen et al. teaches the organ is contacted with a dose of photosynthetic microorganism in the presence of a light source (Pg. 2, Paragraph [0013]).
With regard to Claim 17, Cohen et al. teaches the tissue contacted with the effective dose of photosynthetic microorganism may be present in vivo or ex vivo, e.g. as an isolated organ for transplantation (Pg. 2, Paragraph [0012]).
With regard to Claim 18, it would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Cohen et al. which teaches the contacting/perfusion of a tissue or organ with a preservation solution comprising photosynthetic cells in vivo or ex vivo, to perform the contacting/perfusing in situ as there are only a finite number of ways in which a tissue/organ can be predictably contacted/perfused with a solution, either in vivo, ex vivo or in situ. See MPEP at 2143, I., E., referencing KSR. Those of ordinary skill in the art would have been motivated to make this modification in order to contacting/perfusion of a tissue or organ with a preservation solution neither in vivo or ex vivo. as desired. There would have been a reasonable expectation of success in making this modification because the Cohen reference already teaches two of the three known routes of contacting/perfusion of a tissue or organ with a preservation solution.
While the Cohen reference does not specifically teach the limitation of Claim 20, that the concentration of the photosynthetic cells in the composition is between 106-108 cells/ml, one of ordinary skill in the art would recognize that the concentration of cells in a composition is a result-effective, optimizable variable. Cohen et al. teaches the concentration of the photosynthetic cells in an ex vivo suspension may be up to 102 cells/ml (containing the claimed range of 106-108 or 1.06x102-1.08x102 cells/ml). This is a starting point for the experimentation to determine the optimal concentration of cells in the composition. This is motivation for someone of ordinary skill in the art to practice or test the organ preservation composition cell concentration parameter values widely to find those that are functional or optimal to sufficiently preserve a perfused organ which then would be inclusive or cover the instantly claimed values. Absent any teaching of criticality by the Applicant concerning the cell concentration, 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 before the effective filing date of the claimed invention would have been motivated to make this modification in order to obtain a preserved organ. There would have been a reasonable expectation of success in making these modifications because the Cohen references teaches the same composition components for the same purpose comprising the same cells in a similar concentration.
Claim(s) 12-18, 19 and 20 are rejected under 35 U.S.C. § 103 as being unpatentable over Cohen et al. (US 2016/0310547 A1), as applied to Claims 12-18 and 20 above, and further in view of Wang et al. (2019).
The teachings of Cohen et al. were discussed above.
Cohen et al. did not teach a method wherein the photosynthetic cells comprise C. reinhardtii, as required by Claim 21.
Wang et al. teaches, “Engineered O2-producing biomaterials represent an
emerging field with enormous potential to address tissue ischemia and hypoxia without revascularization. The clinical applications span nearly the entire domain of medicine and include the areas of tissue engineering and regeneration, organ preservation, wound healing, diabetic microvascular disease, and cardiovascular, cerebrovascular, and peripheral vascular disease”;
the reference further teaches that photosynthetic microorganism have been used to treat hypoxia in vivo, noting that Synechococcus elongatus was used to treat cardiac ischemia and C. reinhardtii was used to treat the molecular response of mouse fibroblasts to hypoxia (Pg. 843, Column 1, Lines 1-8 and Column 2, Lines 1-3, 21-22 and 39-42).
It would have been obvious to those of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Cohen et al. of contacting/perfusion of a tissue or organ with a preservation solution comprising Synechococcus elongatus photosynthetic cells to use C. reinhardtii cells as taught by Wang et al. because both species are known to be useful in methods of preventing ischemia/hypoxia damage in eukaryotic cells. Those of ordinary skill would have been motivated to make this modification based on artisan preference and the availability of the photosynthetic microorganisms. There would have been a reasonable expectation of success in making this modification because both species are art-recognized as suitable for the same purpose, that is, the treatment/prevention of cell damage in eukaryotic cells due to hypoxia/ischemia.
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 02/25/2026
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