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Claims 1, 3, 5-18, 20 and 21 are pending in this application, Claims 1, 3 and 5-11 are acknowledged as withdrawn, Claims 12-18, 20 and 21 were examined on their merits.
The objection to the Specification because the Abstract of the disclosure 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to assist readers in deciding whether there is a need for consulting the full patent text for details has been withdrawn due to the Applicant’s amendments to the Specification filed 07/30/2026.
The objection to the Specification because of the improper use of Trademarks has been withdrawn due to the Applicant’s amendments to the Specification filed 07/30/2026.
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 20 is newly 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, as necessitated by Applicant’s amendment to the claims filed 07/30/2026. In light of the arguments filed herewith, it appears Applicant intended to amend Claim 20 to “106-108” instead of “106-108”, and the claim has been interpreted thusly. Claim 20 now recites; “wherein the photosynthetic cells are present in the composition at a density of between 106-108 cells/ml” and “and wherein the photosynthetic cells are present in the composition at a density of no more than 108 cells/ml”. The claimed range was interpreted in the prior Non-Final Action as, “wherein the photosynthetic cells are present in the composition at a density of between 106-108 cells/ml”, which would be about 1.06x102 to 1.08x102 cells/ml. However, Applicant’s instant arguments at Pg. 7, Lines 28-31 and Pg. 8, Lines 1-5, suggest that the claimed cell density should be 106-108 cells/ml. This discrepancy between the intended exponential values vs. the claimed non-exponential result in a difference in terms of how the claims are ultimately interpreted
Therefore, it is unclear if the cell density as claimed is a range of 106-108 and no more than 108 cells/ml or a cell density in the range of 106-108 and no more than 108 cells/ml. For purposes of examination, the examiner has interpreted the claim as requiring a cell density in the range of 106-108 and no more than 108 cells/ml.
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), of record.
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 calcium chloride, potassium chloride and magnesium chloride, and thus being a saline solution), 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.
With regard to Claim 20, the Cohen reference teaches that the concentration of the photosynthetic cells in the ex vivo suspension may be up to about 107 cells/ml (contained within the claimed range of 106-108 cells/ml and not more than 108 cells/ml) (Pg. 4, Paragraph [0034]).
Claim(s) 12-18, 20 and 21 are newly 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), both of record, as necessitated by Applicant’s amendment to Claim 21 in the amendments filed 07/30/2026.
The teachings of Cohen et al. were discussed above.
Cohen et al. did not specifically teach a method wherein the photosynthetic cells comprise C. reinhardtii, and wherein the cells remain viable for at least 24 hours in the biocompatible solution and are perfused through the organ for preservation of the organ, as required by Claim 21.
As discussed above, Cohen et al. teaches perfusing an organ with a (e.g. any) preservation solution in which an effective dose of (e.g. any) photosynthetic organisms has been suspended (Pg. 6, Paragraph [0050]), wherein the preservation solution can be any preservation solution known in the art for organ maintenance (e.g. biocompatible) (Pg. 5, Paragraph [0041]).
The Examiner further notes that Cohen et al. further teaches the preservation solution perfused organ is transplanted (Pg. 6, Paragraph [0050]). This is indicative that the organ is perfused with the preservation solution in which an effective dose of photosynthetic organisms has been suspended.
The Examiner further notes that Cohen et al. teaches the photosynthetic microorganisms can be present for a period of time, in order to effect the desired correction of metabolic imbalance, wherein the period of time may be up to about 2 days or more (Pg. 6, Paragraph [0051]). This is indicative of the photosynthetic cells being viable (e.g., metabolically active) for the claimed time period of at least 24 hours.
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). Thus, given the teachings of Cohen and Wang above, the ordinary artisan would reasonably expect that any photosynthetic organism (including the C. reinhardtii taught by Wang) would remain viable for at least 24 hours in the generic organ preservation solution of Cohen, absent any evidence to the contrary.
This appears to be an intrinsic property or characteristic of the claimed “biocompatible solution” which is met by the biocompatible organ preservation/perfusion solution of the prior art and would therefore be expected to have the same properties and characteristics, absent any evidence to the contrary.
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.
Response to Arguments
Applicant’s arguments, see Remarks, filed 07/30/2026, with respect to the above withdrawn objections have been fully considered and are persuasive.
Applicant's remaining arguments filed 07/30/2026 have been fully considered but they are not persuasive.
The Applicant argues that the previously restricted Groups have Unity of Invention under 37 CFR 1.475 as the groups are directed to a product and process of use of the product and thus have Unity of Invention (Remarks, Pg. 5, Lines 27-30 and Pg. 6, Lines 1-8).
This is not found to be persuasive for the following reasons, 37 CFR 1.475(b) restricts the combinations of different categories of invention which may be presented in an internation or national stage application to have Unity of Invention a priori. However, 37 CFR 1.475(a) states that where a group of inventions are claimed in an application Unity of Invention shall be fulfilled only when there is a technical relationship amount those inventions involving the same or corresponding special technical features. As discussed in the prior action, the Examiner has established that Unity of Invention is not present a postiori and the restriction requirement is maintained.
The Applicant argues that the fact that Cohen separately discloses perfusion, a photosynthetic microorganism and a preservation solution does not establish that combining them as claimed would have been predictable.
Applicant notes that is was allegedly surprising that microalgae would survive in Ringer’s lactate and mannitol solution because the elevated osmolality was known to impair growth and photosynthesis in the microalgae. Applicant concludes the Examiner has used improper hindsight (Remarks, Pg. 7, Lines 7-27).
In response to Applicant's argument that the Examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). In this instance, Cohen et al. teaches perfusing an organ with a preservation solution in which an effective dose of photosynthetic organisms has been suspended wherein the preservation solution can be any preservation solution known in the art for organ maintenance (e.g. biocompatible) and wherein the preservation solution may be Ross-Marshall citrate or Celsior solutions (containing calcium chloride, potassium chloride and magnesium chloride, and thus being saline solutions) containing the cell impermeant agent mannitol. Cohen et al. further teaches the photosynthetic microorganisms can be present for a period of time, in order to effect the desired correction of metabolic imbalance, wherein the period of time may be up to about 2 days or more (Pg. 6, Paragraph [0051]).
This is indicative of the photosynthetic cells being viable (e.g., metabolically active) for the claimed time period of at least 24 hours. Thus, it would not be unexpected that the photosynthetic microalgae would survive in the preservation solutions of Cohen et al. above. While the Cohen et al. reference does not teach a single 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. There would have been a reasonable expectation of success in making this modification because the reference already separately teaches all of the claimed elements. The MPEP states that conclusive proof of efficacy is not required to show a reasonable expectation of success nor is an absolute predictability of success required. See the MPEP at 2143.02, I.
The Applicant argues that the Examiner’s contention that Cohen teaches the claimed cell density of 106-108 (or 102) cells/ml is incorrect as a 102 cell density is below the claimed 106-108 cells/ml range. Applicant argues that the routine optimization rationale is overcome as there is criticality regarding cell toxicity at densities over 108 cells/ml (Remarks, Pg. 7, Lines 28-31 and Pg. 8, Lines 1-5 and 15-26).
This is not found to be persuasive for the following reasons, as discussed in the new rejection under 35 U.S.C. § 112(b), it is unclear if the claimed cell density is a range of 106-108 and no more than 108 cells/ml or a cell density in the range of 106-108 and no more than 108 cells/ml. For purposes of examination, the Examiner has interpreted the claim as requiring a cell density in the range of 106-108 and no more than 108 cells/ml. The Cohen reference teaches that the concentration of the photosynthetic cells in the ex vivo suspension may be up to about 107 cells/ml (contained within the claimed range of 106-108 cells/ml and not more than 108 cells/ml) (Pg. 4, Paragraph [0034]), thus meeting the claimed limitation. The Examiner notes that the new grounds for rejection based upon Applicant’s amendment to the claims do not rely on optimization and thus a showing of criticality is not persuasive.
The Applicant argues that the Examiner’s motivation rationale that substitution of the C. reinhardtii of Wang for the S. elongatus of Cohen based on artisan preference and availability of the photosynthetic microorganisms is insufficient as Wang only used the C. reinhardtii microalgae to treat hypoxia in vitro and only associates S. elongatus with in vivo ischemia treatment. Applicant asserts that Wang does not provide a reasonable expectation that the C. reinhardtii microalgae would remain viable for at least 24 hours in a perfusion solution and perfuse an organ as claimed (Remarks, Pg. 8, Lines 27-31 and Pg. 9, Lines 1-8).
In response to Applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Cohen teaches that any photosynthetic organism, including the microalgae S. elongatus can be combined with any organ preservation solution, including a saline organ preservation solution and used to perfuse an organ wherein the microalgae remain active/viable for at least 2 days (e.g. the photosynthetic cells remain viable for at least 24 hours). Wang teaches that both S. elongatus and C. reinhardtii are known photosynthetic microorganisms used to treat hypoxia/ischemia, therefore the ordinary artisan could reasonably expect that one could be substituted for the other and that the substituted cells would also remain viable for at least 24 hours with a reasonable expectation of success, absent any evidence to the contrary. Those of ordinary skill would have been motivated to make this modification based on artisan preference and the availability of the photosynthetic microorganisms, which is sufficient motivation to make the substitution.
Conclusion
No claims are allowed.
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.
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
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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