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 .
Applicant’s response to restriction requirement filed on January 22, 2026 have been received and entered. Claims 1-6, 8, 10, 12, 14, 17-18, 20, 24, 26 and 27 are pending in the instant application.
Election/Restrictions
Applicant’s election of claims 1-6, 8, 10, 12, 14, 17-18, 24, 26 and 27 (group I) in the reply filed on January 27, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on January 27, 2026.
Priority
This application is a 371 of PCT/EP2021/086156 filed on 12/16/2021, which claims priority from foreign applications SW2130002-5 filed on 01/04/2021 and UK 2111815.3 filed on 08/18/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/03/2023 and 10/10/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claims 1-6, 8, 10, 12, 14, 17-18, 24, 26 and 27 are under consideration.
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.
Claims 1-2 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Steen (WO97/22244, dated 6/27/1997).
Claims are directed to a method for the preservation of lipid layers above 0C, wherein the lipid layers are present in cells, comprising administering Dextran 1 to a solution or suspension of the cells.
With respect to claims 1-2, Steen teaches a method of preserving lipid bilayer present in a cell, said method comprising immersing the muscle cells in the preservation medium (see fig. 2, page 6, line 9), wherein the preservation solution comprises low-molecular dextran having an average molecular weight of about 1000 Daltons (e.g. dextran 1) (see page 9, lines 27-28) and stored at a temperature of 0.5-8°C for at most 36 h for long-term preservation (see page 14, lines 3-5). Accordingly, Steen anticipates claims 1-2.
Claims 1-4 and 6 are rejected under 35 U.S.C. 102(a) (1) as being anticipated by Steen (US 8980541, dated 03/17/2015).
Claims are directed to a method for the preservation of lipid layers above 0C, wherein the lipid layers are present in cells, comprising administering Dextran 1 to a solution or suspension of the cells.
With respect to claims 1-4, Steen teaches a method of preserving cells and tissue including red blood cells in a preservation solution containing dextran-1 (1000 Dalton) in a concentration 10-140 g/L (see col. 2, lines 27-29, col. 5, lines 32-36). Steen further teaches a method of evaluating said preservation solution according the invention mixed with the serum solution containing red blood cells, followed by evaluation of the cells, organ or tissue in the same solution until transplantation at around 370C (see col. 10, lines 14-20).
Regarding claim 6, Steen teaches the preservation solution containing dextran-1 is in amount 10-14g/L that is 1g/100ml to 1.4g/100ml (see col. 5, lines 35-36).
Accordingly, Steer anticipates claims 1-4 and 6.
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 1-5, 6, 8, 10, 12, 24 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Steer (WO97/22244, dated 6/27/1997), Steer (US8980541, dated 03/17/2015) and Beutler et al (Blood. Vol. 54. No. 1 (July), 1979, 280-284).
With respect to claims 1 and 2, Steen teaches a method of preserving lipid bilayer present in a cell, said method comprising immersing the muscle cells in the preservation medium (see fig. 2, page 6, line 9), wherein the preservation solution comprises low-molecular dextran having an average molecular weight of about 1000 Daltons (e.g. dextran 1) (see page 9, lines 27-28) and stored at a temperature of 0.5-8°C for at most 36 h for long-term preservation (see page 14, lines 3-5). Regarding claim 6, Steen teaches preservation solution comprises 5-15% by weight low-molecular dextran having an average molecular weight of about 1 00 Daltons, about 0.1-2.6% glucose, buffer, about 4-25 mM potassium, about 1-30 16 mM magnesium, about 50-150 mM sodium and about 50-150 mM chloride, based on the final preservation solution (see page 9, lines 27-32) (limitation of claim 8).
Steen (‘244) differs from claimed invention by not disclosing tissue being (i) blood containing RBC or thrombocytes and (ii) preservation solution comprises glucose, sodium chloride and dextran 1 further comprises adenine (limitation of claims 5, 10, 24).
Steen (‘541) cure the deficiency by disclosing a method of preserving cells and tissue including red blood cells in a preservation solution containing dextran-1 (1000dalton) in a concentration 10-140 g/L (see col. 2, lines 27-29, col. 5, lines 32-36). Steen further teaches a method of evaluating preservation solution according the invention mixed with the serum solution containing red blood cells, followed by evaluation of the cells, organ or tissue in the same solution until transplantation at around 370C (see col. 10, lines 14-20). Regarding claim 5, Steen teaches the preservation solution containing dextran-1 is in amount 10-14g/L that is 1g/100ml to 1.4 g/100ml (see col. 5, lines 35-36). While Steen (‘541) teaches citrate/ phosphate/ dextrose as part of solution but differs from claimed invention by not disclosing preservation solution comprises: glucose; sodium chloride; adenine
However, before the effective filing date of instant application, it was routine to collect blood into a collection bag containing CPDA solation comprising citric acid, of sodium citrate., glucose., NaH2PO4.H20 and adenine as blood-preservative (see page Beutler page 281, para. 2) (limitation of claims 5, 10, 12, 24). It is further disclosed that CPDA-1 have been shown to be suitable for the storage of whole blood and red cells for 35 days (limitation of claim 26). One of the advantages of this new preservation solution is that the longer shelf life of stored blood should decrease outdating in many blood banks and should provide the flexibility needed to ensure availability of blood during a period of decreased blood collection (See page 283, para. 4).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of prior art to modify the method of Steer to use erythrocyte as disclosed in Steen (‘541) in a collection bag in presence of CPDA preservation solation as suggested in Beutler, in the method of preserving erythrocyte above 00C, as instantly claimed, with a reasonable expectation of success, before the effective filing date of instant application. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so in order to formulate new preservation solution with longer shelf life of stored blood thereby ensuring availability of blood during a period of decreased blood collection (see above) . One of skill in the art would have been expected to have a reasonable expectation of success in incorporating CPDA- I in blood preservation solution containing dextran-1 (1000dalton) disclosed in Steen because prior art recognized said preservation solation has long shelf life of about 35 days. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Steer (WO97/22244, dated 6/27/1997), Steer (US 8980541, dated 03/17/2015) and Scott et al (Transfusion, 1980, 20, 5, 489-497).
The teaching of Steer (244), Steer (‘541) have been described above and relied in same manner here. The combination of references differs from claimed invention by not disclosing cells are thrombocytes (limitation of claim 27).
Scott cures the deficiency by disclosing storing platelets isolated from the blood for 72 hours (3 days) in CPDA-1 preservation solution (see page 489, col. 2, para. 2 and 3) at room temperature (see page 490, col. 1, para. 1).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of prior art to modify the method of Steer and Steen (‘541) to use thrombocytes in a collection bag in presence of CPDA preservation solation as suggested in in Scott, in the method of preserving thrombocyte above 00C , as instantly claimed, with a reasonable expectation of success, before the effective filing date of instant application. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so in order to formulate new preservation solution with longer shelf life of stored thrombocyte (see above) . One of skill in the art would have been expected to have a reasonable expectation of success in preserving thrombocyte in solution CPDA-1 and dextran-1 because prior art recognized that the solution maintains viability and function comparable to that of CPD. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Steer (WO97/22244, dated 6/27/1997), Steer (US 8980541, dated 03/17/2015) and Beutler et al (Blood. Vol. 54. No. 1 (July), 1979, 280-284) as applied above for claim 1 and further in view of Chen (Transfusion Alternatives in Transfusion Medicine, 2008, 22-25).
The teaching of Steer (244), Steer (‘541) and Beutler have been described above and relied in same manner here. The combination of references differs from claimed invention by not disclosing dextran is used to supplement whole blood during hemodialysis (limitation of claim 14).
However, before effective filing date of instant application, Chen teaches use of low-molecular-weight iron dextran preparations to patients receiving erythropoietin therapy (see page 23, col. 1). It is further disclosed that presence of low-molecular-weight iron dextran removal through the hemodialysis process is minimal during hemodialysis (see page 25, col. 2, last para.).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of prior art to modify the method of prior art by substituting dextran-1 with low molecular weight dextran-iron as suggested in Chen in the blood collection bag during hemodialysis as suggested in Chen, as instantly claimed, with a reasonable expectation of success, before the effective filing date of instant application. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would be motivated to do so in order to formulate solution that is difficult to be removed during hemodialysis (see above) . One of skill in the art would have been expected to have a reasonable expectation of success in incorporating dextran-1 with iron during hemodialysis because prior art successfully reported using low molecular weight dextran-iron in subject undergoing hemodialysis. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Claims 1, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Steer (US 8980541, dated 03/17/2015), Kim-Shapiro (Transfusion. 2011 Apr;51(4):844–851) as evidenced by Huang et al (BioMed Research International, 2019, 1-10).
Steen (‘541) teaches a method of preserving cells and tissue including red blood cells in a preservation solution containing dextran-1 (1000dalton) in a concentration 10-140 g/L (see col. 2, lines 27-29, col. 5, lines 32-36). Steen further teaches a method of evaluating preservation solution according the invention mixed with the serum solution containing red blood cells, followed by evaluation of the cells, organ or tissue in the same solution until transplantation at around 370C (see col. 10, lines 14-20) (limitation of claim 18). Steen teaches the preservation solution containing dextran-1 is in amount 10-14g/L that is 1g/100ml to 1.4 g/100ml (see col. 5, lines 35-36). While Steer teaches a method of preserving cells and tissue including red blood cells in a preservation solution containing dextran-1 (1000dalton) but differs from claimed invention by not disclosing vesicles suspended in Dextran-1.
However, before the effective filing date of instant application, it was generally known that stored red cells become less deformable and more fragile as they age. This fragility leads to release of cell-free hemoglobin and formation of microparticles, sub-micron hemoglobin-containing vesicles (see abstract Kim-Shapiro). In view of foregoing, it is apparent that Steen teaches method of preserving cells and tissue including red blood cells in a preservation solution containing dextran-1 that would inherently contain vesicles as evident from the teaching of Kim-Shapiro. This is further supported by Huang who reported exosomes are present in stored RBC units that possess multiple miRNA (abstract).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art to combine the teachings of prior art to modify the method of Steen (‘541) to use exosome present in the stored blood as suggested in Kim-Shapiro and Huang, in the method of preserving RBC that inherently contain exosome (micro vesicles), as instantly claimed, with a reasonable expectation of success, before the effective filing date of instant application. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of skill in the art would have been expected to have a reasonable expectation of success in preserving RBC derived vesicles (exosome) in solution containing dextran-1 because prior art recognized that the solution maintains viability and function of stored RBC and exosome. It should be noted that the KSR case forecloses the argument that a specific teaching, suggestion, or motivation is required to support a finding of obviousness See the recent Board decision Ex parte Smith, --USPQ2d--, slip op. at 20, (Bd. Pat. App. & Interf. June 25, 2007) (citing KSR, 82 USPQ2d at 1396) (available at http: www. uspto.gov/web/offices/dcom/bpai/prec/fd071925.pdf).
Conclusion
No claims allowed.
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/ANOOP K SINGH/ Primary Examiner, Art Unit 1632
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