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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 20, 2026, has been entered.
Election/Restrictions
Applicant’s election with traverse of Species A (Claims 1-3, 5-17, and 20) in the reply filed on December 31, 2024, is acknowledged. Applicant further elected heart valves as the tissue.
Claims 13 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim.
DETAILED ACTION
The claims filed on March 20, 2026, have been acknowledged. Claim 4 was cancelled. Claims 1-2 and 20 were amended. In light of the Applicant’s elected species, claims 13 and 18-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1-3, 5-12, 14-17, and 20 are pending and examined on the merits.
Rejections and/or objections not reiterated from the previous office action mailed October 7, 2025, are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Priority
The applicant claims domestic priority from U.S. provisional application No. 63/094,591, filed on October 21, 2020. Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Claims 1-3, 5-12, 14-17, and 20 receive domestic benefit from U.S. provisional application No. 63/094,591, filed on October 21, 2020.
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 17 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. This is a new rejection that is substantially similar to a previous rejection of record. Applicant’s traversal is addressed below.
Claim 17 recites that “wherein the third tissue has reduced immunogenicity in humans as compared to a corresponding wild type tissue or genetically modified tissue obtained from the same donor, the corresponding wild type tissue or genetically modified tissue obtained from the same donor having a reduced immunogenicity achieved by via crosslinking with glutaraldehyde”.
It is clear that claim 17 requires that the third tissue has reduced immunogenicity in humans as compared to a corresponding wild type tissue or genetically modified tissue obtained from the same donor. However, the rest of the claim is unclear.
First, it is unclear whether the corresponding wild type tissue or genetically modified tissue is supposed to have reduced immunogenicity, as well, as could be understood by the “corresponding wild type tissue or genetically modified tissue obtained from the same donor having a reduced immunogenicity” language or if the having a reduced immunogenicity is meant to refer back to the third tissue.
Second, it is unclear whether the glutaraldehyde crosslinking is associated with the corresponding tissue with increased immunogenicity compared to the third tissue or if glutaraldehyde crosslinking is occurring in the third tissue causing the third tissue to have reduced immunogenicity (a reduced immunogenicity achieved by via crosslinking with glutaraldehyde suggests that the crosslinking caused the reduced immunogenicity).
Response to Arguments
Applicant's arguments filed March 20, 2026, are acknowledged.
Applicant argues that that the recitation is clear and that the claim means that the third tissue has lower immunogenicity than either the wild type tissue or the genetically modified tissue obtained from the same donor having a reduced immunogenicity which was achieved by via crosslinking with glutaraldehyde. In other words, the third tissue has even lower immunogenicity than a genetically modified tissue whose immunogenicity has been reduced via glutaraldehyde crosslinking or a wild type tissue (page 9, paragraph 5-page 10, paragraph 1).
Applicant's arguments have been fully considered but they are not persuasive.
As stated in the rejection above, the claim language is considered unclear for multiple reasons. Although Applicant identifies their interpretation of the claim language, this is not the only way to read the claims, leading to a lack of clarity. Applicant is recommended to modify the claim language to more closely resemble the language used in Applicant’s arguments or in claim 16 which uses similar language and is not considered to lack clarity.
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 (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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 3, 5-7, 10-12, 15-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 8440390 (‘390), Vasquez-Rivera et al. (Analyst 143: 420-428. 2018), Sierad et al. (Tissue Engineering: Part C 21: 1284-1296. 2015), Huber et al. (Biopreservation and Biobanking 10: 1-6. 2012), and Theodoridis et al. (Acta Biomaterialia 43: 71–77. 2016), as evidenced by Seifert et al. (Journal of Surgical Research 193: 933-941. 2015) and Bloch et al. (Tissue Engineering Part A 17: 2399-2405. 2011). This is a new rejection made in response to Applicant’s amendments to the claims that is substantially similar to a previous rejection of record. Applicant’s traversal has been considered but is moot in response to the new rejection of record.
Regarding claim 1 and 20, ‘390 teaches that a method of ice-free cryopreservation of sheep and porcine (received from slaughterhouses, i.e. wild type) heart valve tissue wherein a tissue Is immersed in a solution having a cryoprotectant concentration of at least about 75%, by weight relative to the weight of the solution wherein this kills all of the living cells of the tissue as a result of the increase in cryoprotectant concentration. ‘390 teaches that the single step concentration increase can occur for a time sufficient for the cryoprotectant to permeate the tissue such as at least 60 minutes (claims 1 and 3-4, Example 1, and column 9, line 60-column 10, line 36). ‘390 teaches that after the infiltration step, the heart valves are then placed individually in sterile polyester bags containing 70-80 ml of the cryopreservation solution. Each bag was evacuated of air, heat-sealed and cooled. The bags were then stored at -80° C. Valves were stored at -80°C. until implantation. An 83 wt % cryopreservation formulation (CS 83 wt %; made up of three components: 4.65 mol/L DMSO, 4.65 mol/L formamide and 3.31 mol/L 1,2-propanediol in Euro-Collins solution) was employed, and no ice was observed at the -80°C (Examples 1 and 2). Cryopreserved sheep valves were stored for a year before thawing for transplantation. Transplanted valves were examined for histology 7 months after initial transplantation. As such, if any immune reaction occurred, it was non-life threatening (Example 1). ‘390 teaches that their method could be used with allogeneic and xenogeneic tissues (column 23, lines 4-16).
Vasquez-Rivera teaches that the diffusion rates of each of the components of VS83, DMSO, formamide, and propanediol (propylene glycol) in heart valves. It takes more than an hour for formamide to reach 80% diffusion and more than an hour for propanediol to reach 50% diffusion. As such, it would have been obvious to perform the cell killing step for over an hour to ensure full diffusion of the VS83 solution into the heart valve tissue for improved cell killing.
‘390 does not teach a step of removing the residual cell material in a bioreactor.
Sierad teaches that xenogeneic transplantation of porcine aortic roots failed due to strong immune reactions caused by incomplete decellularization (page 1285, column 2, paragraph 1). Sierad teaches a method of decellularizing aortic roots ( a heart valve) through perfusion in a bioreactor. Aortic roots were assembled into the PDCell System. All steps were performed with a cyclic transmural pressure gradient of about 52±2 mmHg and mechanical stretching for 3 min on and 30 s off. Sequential steps consisted of hypotonic shock (ddH2O, 24 h, 22°C), loosening of the extracellular matrix and initialization of cell removal (0.1M NaOH, 2 h, 22°C), detergent decellularization (1% sodium dodecyl sulfate, 1% Triton X-100, 1% sodium deoxycholate, and 0.2% EDTA in 50mM TRIS, pH 7.5, for 8 and 16 days with fresh solution change every 4 days, 22°C), enzymatic removal of nucleic acids (720 mU/mL deoxyribonuclease and 720 mU/mL ribonuclease in 5mM magnesium chloride in 1xDPBS, 4 days with fresh solution every 2 days at 37°C), and sterilization (0.1% peracetic acid in PBS, pH 7.5, 1 h, 22C). Each step was followed by rinsing with water, ethanol, or 1xDPBS as appropriate. Immediately following, the distal root outflow constrictors were removed with sterile tools and the mounted valve roots were transferred to sterile individual 300-mL wide mouth glass containers with silicone membrane sealing lids on an orbital shaker for final sterilization (0.1% peracetic acid in PBS, pH 7.5, 1 h, 22°C) (page 1286, column 2, paragraph 1). Sierad teaches that 16 days of perfusion resulted in full decellularization and an additional step of nuclease treatment led to complete DNA removal (page 1290, column 2, paragraph 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the cell killing and cryopreservation step of ‘390 with the decellularization steps of Sierad to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to combine with a reasonable expectation of success because ‘390 and Sierad are focused on improving the efficacy of transplanted heart valves. ‘390 teaches that if the tissue is frozen, ice crystals may form within the tissue that may mechanically disrupt its
structure and thus damage its ability to function correctly when it is transplanted into a recipient column 1, lines 26-29) and Sierad teaches that full decellularization is critical to preventing an immune response to xenogeneic heart valves during human transplantation. As such, it would have been obvious to combine the ice-free cryopreservation with cell killing and decellularization to further improve the efficacy of transplanting heart valves. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
‘390 teaches an ice-Free Cryopreservation (IFC) and Storage method. IFC was achieved by gradually infiltrating the heart valve tissues in six 15-minute-steps at 4°C. with increasing concentrations of a pre-cooled cryopreservation solution (CS) to achieve a final concentration of 12.6 mol/L (CS 83 wt %; made up of three components: 4.65 mol/L DMSO, 4.65 mol/L formamide and 3.31 mol/L 1,2-propanediol in Euro-Collins solution). After the infiltration step the heart valves were placed individually in sterile polyester bags containing 70-80 ml of the cryopreservation solution.
The combined teachings of ‘390, Vasquez-Rivera, and Sierad do not teach that the ice-free cryopreservation step comprises infiltrating the third tissue with a second cryoprotectant solution for at least an hour.
However, Huber teaches a single step ice-free cryopreservation incubation period prior to cooling wherein the valves were placed in sterile polyethylene bags containing VS83 and incubated for at least 1 h at room temperature prior to cooling (page 2, column 2, paragraph 2). Huber teaches that the multistep addition of the cryoprotectant can be replaced with a single step with similar results or better results (Figure 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cryopreservation method of ‘390, Vasquez-Rivera, and Sierad by incorporating a single step infiltration step before placing the tissue in a sealed bag for cooling to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because after decelluarizing the tissue, an infiltration step with the cryoprotectant solution will need to occur prior to cooling, as shown by Huber. Huber teaches that the multistep addition of the cryoprotectant can be replaced with a single step with similar results. As such, it would have been obvious to use a single step infiltration before placing the heart valves in bags with fresh VS83 solution for cooling as this results in a simpler process. Furthermore, as stated supra, Vasquez-Rivera teaches that the diffusion rates of each of the components of VS83, DMSO, formamide, and propanediol (propylene glycol) in heart valves. It takes more than an hour for formamide to reach 80% diffusion and more than an hour for propanediol to reach 50% diffusion. Therefore, it would have been obvious to perform the infiltration step for over an hour to ensure full diffusion of the VS83 solution into the heart valve tissue before cooling. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
The teachings of ‘390, Vasquez-Rivera, Sierad, and Huber are as discussed above.
The combined teachings of ‘390, Vasquez-Rivera, Sierad, and Huber are silent as to whether the tissues did not undergo glutaraldehyde crosslinking and chemical fixation.
However, Theodoridis teaches that non-fixed, decellularized allogeneic heart valve scaffolds seem to be the best choice for heart valve replacement as the growth potential and natural haemodynamics of decellularized heart valves render these valves superior to glutaraldehyde fixed bioprostheses (abstract and page 76, column 1, paragraph 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use non-fixed decellularized porcine heart valves with the method of the combined teachings of ‘390, Vasquez-Rivera, Sierad, and Huber. One of ordinary skill in the art would have a reason to use non-fixed decellularized porcine heart valves as part of this method with a reasonable expectation of success because Theodoridis teaches that non-fixed, decellularized allogeneic heart valve scaffolds seem to be the best choice for heart valve replacement as the growth potential and natural haemodynamics of decellularized heart valves render these valves superior to glutaraldehyde fixed bioprostheses. As such, there would be no reason to fix the tissues as decellularized tissues are already considered superior. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Regarding claims 3 and 12, as stated supra, ‘390 teaches they cryopreserved heart valves.
Regarding claim 5, as stated supra, ‘390 teaches that the cell killing step can last for at least 60 minutes. ‘390 teaches that cell killing can occur in temperatures between 0°C and 37°C (room temperature is around 20-22°C) (column 9, line 60-column 10, line 36). Although ‘390 does not state that they used sterile polyester bags during the cell killing step, they do teach that the heart valves were placed individually in sterile polyester bags containing 70-80 ml of the cryopreservation solution for cooling (column 17, lines 33-35). As such, it would have been obvious that these bags could also be used during the cell killing step. Regarding the shaker, ‘390 is silent as to the use of a shaker, but it would have been obvious to use a shaker to evenly distribute the components of the VS83 solution and ensure efficient cell killing.
Regarding claim 6, as stated supra, Sierad teaches that their decellularization method occurs over 16 days and completely removes all cell remnants (Figures 2-4).
Regarding claim 7, as stated supra, Huber teaches a one step infiltration step wherein the valves were placed in sterile polyethylene bags containing VS83 and incubated for at least 1 h at room temperature prior to cooling. Regarding the shaker, Huber is silent as to the use of a shaker, but it would have been obvious to use a shaker to evenly distribute the components of the VS83 solution and ensure efficient diffusion of the solution into the tissue. As stated supra, ‘390 teaches that the after the infiltration step, the heart valves were placed individually in sterile polyester bags containing 70-80 ml of the cryopreservation solution and heat sealed before cooling (column 23, lines 22-42).
Regarding claim 10, Sierad teaches that following 16 day decellularization and additionally treating with nucleases, there was no DNA detected (Figure 4).
Regarding claim 11, as stated supra, ‘390 teaches that they used a cryoprotectant solution with 83 wt %; made up of three components: 4.65 mol/L DMSO, 4.65 mol/L formamide and 3.31 mol/L 1,2-propanediol in Euro-Collins solution.
Regarding claim 15, ‘390 teaches that storing the tissue at -80°C is above the glass transition phase of the 83% solution (column 17, lines 46-60).
Regarding claim 16, Seifert evidences that ice free cryopreserved porcine tissues are less immunoreactive than fresh (i.e. unmodified) porcine tissues when cultured with human PBMCs (Figures 3 and 5).
Regarding claim 17, Bloch evidences that conventional biological heart valves treated with glutaraldehyde (GA) reveal a limited lifespan due to calcification. This is assumed to be an immune response initiated process, which is not seen with decellularized valves. However, a considerable anti-a-Gal antibody response was observed in patients with GA-treated porcine valves, whereas decellularized valves revealed a minor decrease in the IgM response. IgG antibodies were considerably increased with GA-treated porcine ( p < 0.05) and bovine ( p < 0.01) xenografts, whereas there was lack of response with decellularized valves (abstract). As such, the decellularized tissues of the combined teachings of 390, Vasquez-Rivera, Sierad, Huber, and Theodoridis would also show a reduced immune response compared to GA-treated porcine valves.
Claims 1-2 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 8440390 (‘390), Vasquez-Rivera et al. (Analyst 143: 420-428. 2018), Sierad et al. (Tissue Engineering: Part C 21: 1284-1296. 2015), Huber et al. (Biopreservation and Biobanking 10: 1-6. 2012), and Theodoridis et al. (Acta Biomaterialia 43: 71–77. 2016) as applied to claim 1 above, and further in view of Zhang et al. (Acta Biomaterialia 72: 196–205. 2018). This rejection is repeated with regards to the previous rejection of the Final Office Action mailed on October 7, 2025. Applicant’s traversal has been addressed above.
The teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis are as discussed above.
The combined teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis do not teach wherein the porcine tissue is genetically modified.
However, Zhang teaches that bioprosthetic heart valves (BHVs) originating from pigs are extensively used for heart valve replacement in clinics. However, recipient immune responses associated with chronic calcification lead to structural valve deterioration (SVD) of BHVs. Two well-characterized epitopes on porcine BHVs have been implicated in SVD, including galactose-a1,3-galactose (aGal). It has been reported that BHV from aGalknockout pigs are associated with a significantly reduced immune response by human serum. Moreover, valves from aGal (GGTA1)/Neu5Gc (CMAH)-deficient pigs could further reduce human IgM/IgG binding when compared to BHV from aGal-knockout pigs. Recently, another swine xenoantigen, Sd(a), produced by b-1,4-N-acetyl-galactosaminyl transferase 2 (b4GalNT2), has been identified. Zhang made GGTA1, CMAH, and b4GalNT2 triple gene-knockout (TKO) pigs by CRISPR/Cas9 mediated gene targeting. Their results showed that the expression of aGal, Neu5G and Sd(a) on TKO pigs was negative and that human IgG/IgM binding to pericardium was minimal. Moreover, the analysis of collagen composition and physical characteristics of porcine pericardium from the TKO pigs indicated that elimination of the three xenoantigens had no significant impact on the physical proprieties of porcine pericardium. Their results demonstrated that TKO pigs would be an ideal source of BHVs (abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the wildtype porcine tissue of the combined teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis with the TKO porcine tissue of Zhang to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to substitute with a reasonable expectation of success because Zhang teaches that the TKO pigs have reduced immune response from humans without negatively impacting the physical properties of the porcine heart. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 8440390 (‘390), Vasquez-Rivera et al. (Analyst 143: 420-428. 2018), Sierad et al. (Tissue Engineering: Part C 21: 1284-1296. 2015), Huber et al. (Biopreservation and Biobanking 10: 1-6. 2012), and Theodoridis et al. (Acta Biomaterialia 43: 71–77. 2016) as applied to claim 1 above, and further in view of Assmann et al. (J Tissue Eng Regen Med: 11: 3530–3543. 2017). This rejection is repeated with regards to the previous rejection of the Final Office Action mailed on October 7, 2025. Applicant’s traversal has been addressed above.
The teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis are as discussed above.
The combined teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis do not teach wherein the decellularization occurs detergent-free.
However, Assmann teaches that they evaluated a detergent-free, non-proteolytic, actin-disassembling regimen (BIO) for decellularization of heart valve. Porcine aortic valve samples (n= 106) were decellularized using detergents (group DET) or the BIO regimen. BIO decellularization results in effective elimination of cellular proteins and significantly improves removal of DNA as compared with group DET, while the extracellular matrix (ECM) structure as well as mechanical properties are preserved. The present biological, detergent-free, non-proteolytic regimen balances effective decellularization and ECM preservation in cardiovascular grafts, and provides optimized bio-functionality.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the detergent based decellularization composition of the combined teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis with the detergent free decellularization composition of Assmann to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to substitute with a reasonable expectation of success because Assmann teaches that detergent free decellularization results in effective elimination of cellular proteins and significantly improves removal of DNA as compared with group detergent based decellularization, while the extracellular matrix (ECM) structure as well as mechanical properties are preserved. The present biological, detergent-free, non-proteolytic regimen balances effective decellularization and ECM preservation in cardiovascular grafts, and provides optimized bio-functionality. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Claims 1 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over United States Patent No. 8440390 (‘390), Vasquez-Rivera et al. (Analyst 143: 420-428. 2018), Sierad et al. (Tissue Engineering: Part C 21: 1284-1296. 2015), Huber et al. (Biopreservation and Biobanking 10: 1-6. 2012), and Theodoridis et al. (Acta Biomaterialia 43: 71–77. 2016) as applied to claim 1 above, and further in view of Brockbank (Ann Thorac Surg 91: 1829-1835. 2011). This rejection is repeated with regards to the previous rejection of the Final Office Action mailed on October 7, 2025. Applicant’s traversal has been addressed above.
The teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis are as discussed above. ‘390 teaches that for warming, each valve was placed in a 37° C. water bath until the solution moves freely. The valve was then transferred onto ice and the bag externally cleaned with 70% ethanol.
The combined teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis do not teach wherein the sealed container is stored at room temperature.
However, Brockbank teaches that they cryopreserved heart valves using VS83 cryoprotectant (same as ‘390) in polyethylene bags and cooled them to -80°C. For warming the tissue to -30°C, the tissues in the bags were warmed in a 30% DMSO in water bath at room temperature. As the Applicant does not provide a definition of storage nor a time frame for the storage, the warming period in the room temperature water bath is considered to fall within the limitations of storing the sealed container at room temperature.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the warming process of the tissue of the combined teachings of ‘390, Vasquez-Rivera, Sierad, Huber, and Theodoridis by using a room temperature water bath, as identified by Brockbank, to arrive at the instantly claimed invention. One of ordinary skill in the art would have a reason to modify with a reasonable expectation of success because Brockbank reduces to practice that room temperature water baths can also be used for warming. Furthermore, using a room temperature water bath means that the water does not need to be heated, reducing the cost of the warming process and allows for any container with water to be used rather than a special container with heated water. Because the prior art teaches all of the elements of the claimed invention, there is a reasonable expectation of success.
Conclusion
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/KEENAN A BATES/Examiner, Art Unit 1631
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