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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 25 June 2026 has been entered.
Status of the Claims
Applicant’s submission filed 09 June 2026 has been entered. Claims 46-48, 68, 81, 122, 133-140, and 142-152 are pending. Claims 46-47, 133, 139-140, and 144-146 have been amended, while claim 141 has been cancelled without prejudice or disclaimer. Therefore, prosecution on the merits continues for claims 46-48, 133-140, and 142-152 as being drawn to the elected invention, with claims 68, 81, and 122 withdrawn for reading on the non-elected inventions. All arguments have been fully considered with the status of each prior ground of rejection set forth below.
Status of Prior Rejections/Response to Arguments
RE: Objection to claims 133, 140-142, and 144-146
The cancellation of claim 141 renders the objection of that claim moot. For the remaining claims, Applicant’s amendments to each of instant claims 131, 140, 142, and 144-146 obviate the
objections of record.
Therefore, the objections are withdrawn.
RE: Rejection of claims 46-48, 133-137, 139-142, 144, 147-150, and 152 under 35 USC 102(a)(1) over Borghese et al as evidenced by Barkey
The cancellation of claim 141 renders the rejection moot for that claim. For the remaining claims, Applicant’s arguments in Pages 6-9 of the Remarks filed 09 June 2026 with respect to the agitation and concentration of FGF-basic not being inherent features have been fully considered and are persuasive.
Therefore, the rejection is withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the claims as currently written:
Applicant has traversed the rejection, asserting in Pages 8-9 of the Remarks filed 09 June 2026 that Borghese et al disclose the use of heparin within the activation step, provided by the reference to Durante et al (of record on IDS filed 09 June 2026). In response, the Examiner respectfully submits that Durante et al only disclose the use of heparin following the activation and incubation steps – or the culture of calcium chloride with the platelet concentrate for 5, 10, 20, or 30 minutes – for the storage of the resulting supernatant aliquots. See, for example, Pages 130-131 of Durante et al. Then, Borghese et al disclose that the supernatant aliquots are stored without the addition of heparin. See, for example, Page 198 of Borghese et al. Therefore, the ordinary artisan would understand that the supernatant aliquots of Borghese et al resulting from the activation of a platelet concentrate with calcium chloride do not comprise any added heparin.
RE: Rejection of claims 46-48, 133-142, 144, 147-150, and 152 under 35 USC 103 over Borghese et al as evidenced by Barkey in view of Weissman et al
The cancellation of claim 141 renders the rejection moot for that claim. For the remaining claims, Applicant’s arguments in Pages 6-9 of the Remarks filed 09 June 2026 with respect to the agitation and concentration of FGF-basic not being inherent features have been fully considered and are persuasive.
Therefore, the rejection is withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the claims as currently written:
Applicant has traversed the rejection, asserting in Pages 10-11 of the Remarks filed 09 June 2026 that the ordinary artisan would not have had a reasonable expectation of success in importing the agitation rate of Weissman et al into the distinct protocol of Borghese et al. In response, the Examiner respectfully submits that it is not required that the expectation of success be a certainty; only one that is reasonable to a person of ordinary skill. In re Longi, 759 F.2d 887, 897 (Fed. Cir. 1985) (“Only a reasonable expectation of success, not absolute predictability, is necessary for a conclusion of obviousness”). In the instant case, the ordinary artisan would have recognized that the calcium chloride-platelet concentrate mixture from platelet rich plasma can be agitated as taught by Barkey (see 35 USC 103 rejection below). With that, the ordinary artisan would have reasonably understood from the disclosure of Weissman et al that platelet rich plasma contacted with 40 mM calcium chloride can be agitated at 50 rpm to form aggregates. See, for example, Paragraphs [0009], [0071], [0172], [0349] of Weissman et al. Therefore, a person of ordinary skill in the art would have reasonably expected the agitation rate of 50 rpm to allow for the formation of a clot from the platelet concentrate contacted with 40 mM calcium chloride given the combined disclosures of Borghese et al, Barkey, and Weissman et al.
RE: Rejection of claims 46-48, 133-137, and 139-152 under 35 USC 103 over Borghese et al as evidenced by Barkey in view of Woods et al
The cancellation of claim 141 renders the rejection moot for that claim. For the remaining claims, Applicant’s arguments in Pages 6-9 of the Remarks filed 09 June 2026 with respect to the agitation and concentration of FGF-basic not being inherent features have been fully considered and are persuasive.
Therefore, the rejection is withdrawn.
However, Applicant’s remarks are addressed in so far as they are applicable to the claims as currently written:
Applicant has traversed the rejection, asserting in Pages 12-14 of the Remarks filed 09 June 2026 that Woods et al disclose a human platelet lysate composition, which is not synonymous with a releasate. In response, the Examiner respectfully submits that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Woods et al is a secondary reference relied upon to teach that 1) platelets can be frozen prior to processing the bioactive fraction of the platelets, 2) the platelet concentrate can be filtered, and 3) the volume of a composition comprising a platelet concentrate. Therefore, the ordinary artisan would recognize that these teachings can be applied to the platelet releasate composition of the instant claims, even if the disclosure of Wood et al comprises lysing steps.
New Grounds of Rejection
Claim 139 is objected to because of the following informalities:
Regarding claim 139: Applicant has amended the claim language to consistently recite “releasate composition”, yet still refers to the “the releasate” within instant claim 139. Applicant must amend the recitation of “releasate” in claim 139 to “releasate composition” in order to match the term utilized throughout the claim language.
Appropriate correction is required.
Claim Interpretation
Claims 46-48, 133-140, and 142-152 are drawn to products, described using product-by-process language. The limitations of the process of production are considered only in so far as the process of production imparts distinct structural or chemical characteristics or properties to the claimed product. Therefore, if the product, as claimed, is the same or obvious over a product of the prior art (i.e. is not structurally or chemically distinct), the claim is considered unpatentable over the prior art, even though the prior art product is made by a different process. See MPEP § 2113.
For claim 46 and dependents thereof: Claim 46 is directed to a releasate composition comprising FGF-basic at about 75-750 pg/mL and CaCl2, wherein the releasate composition is produced by a method comprising the steps of:
adding CaCl2 to a solution consisting essentially of mammalian platelet concentrate to a final concentration of between 25 mM and 100 mM, thereby generating a mixture; and,
agitating the mixture for less than 6 hours thereby forming a clot and the releasate composition, and
wherein the method does not comprise a cellular lysis step.
In instant claim 46, the manner in which the releasate composition is produced is determined to be a product-by-process limitation. However, the process of production as claimed imparts distinct structural and chemical characteristics to the final releasate composition. Therefore, the prior art is required to teach the addition of calcium chloride to a solution consisting essentially of a mammalian platelet concentrate.
It is of note that claims 147-150 further limit the method by which the releasate composition is produced and, barring any evidence to the contrary, do not further impart distinct structural or chemical characteristics or properties to the claimed releasate composition itself. On the contrary, claims 134-138, 144-146, and 152 further limit the method by which the releasate composition is produced and do further impart distinct structural or chemical characteristics or properties to the claimed releasate composition itself, namely the concentration of CaCl2 (claims 134-135), agitation duration and rate (claims 136-138), separation (claim 144) and filtering (claims 145-146) of the releasate, as well as the concentration of the mammalian platelets (claim 152).
For claim 47 and dependents thereof: Claim 47 is directed to a cell culture medium comprising a releasate composition comprising FGF-basic at about 75-750 pg/mL and CaCl2, wherein the releasate composition is produced by a method comprising the steps of:
adding CaCl2 to a solution consisting essentially of mammalian platelet concentrate to a final concentration of between 25 mM and 100 mM, thereby generating a mixture; and,
agitating the mixture for less than 6 hours thereby forming a clot and the releasate composition, and
wherein the method does not comprise a cellular lysis step.
In instant claim 47, the manner in which the releasate composition is produced is determined to be a product-by-process limitation. However, the process of production as claimed imparts distinct structural and chemical characteristics to the final releasate composition. Therefore, the prior art is required to teach the addition of calcium chloride to a solution consisting essentially of a mammalian platelet concentrate.
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 46-48, 134-137, 139-140, 144, 147-150, and 152 are rejected under 35 U.S.C. 103 as being unpatentable over Borghese et al (Vox Sanguinis, 2016, of record on IDS filed 08 October 2021) in view of Barkey (Barkey Plasmatherm Instruction Manual, 2007, of record) and Chu et al (US 2006/0136050 A1).
Borghese et al and Chu et al are each considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2). Barkey is considered prior art under 35 USC 102(a)(1).
Regarding claims 46 and 134-137: Borghese et al disclose the formation of a releasate composition, wherein calcium chloride at a final concentration of 40 mM is added to a solution consisting of platelet-rich plasma – or a platelet concentrate – which is then incubated for approximately 60 minutes within a Plasmatherm device to allow for the formation of a clot (Page 198, PRP-R/SRGF production).
Borghese et al do not disclose that the calcium chloride-platelet concentrate mixture is agitated during incubation, nor that the resulting releasate composition comprises FGF-basic at a concentration of about 75-750 pg/mL, as required by instant claim 46.
However, in regards to the agitation, Barkey discloses that the Plasmatherm device comprises a paddle to agitate mixtures during incubation, wherein the starting material is plasma (Pages 3-4, 7, 51-52, 78 and Figure 1).
With that, in regards to the FGF-basic concentration, Chu et al disclose that platelet-rich plasma releases FGF-basic at a concentration of 48.4 ± 25.0 pg/mL, and that activating the platelet-rich plasma with at least calcium chloride causes the platelets to release additional stores of growth factors (Paragraphs [0053], [0065]-[0067]; Table 2). It is of note that the upper bound of 48.4 ± 25.0 pg/mL FGF-basic is 73.4 pg/mL FGF-basic, which is about 75 pg/mL FGF-basic.
Therefore, it would have been prima facie obvious to have modified the method of Borghese et al such that the calcium chloride-platelet concentrate mixture is agitated at a rate of 50 rpm during incubation and comprises a final concentration of about 75 pg/mL FGF-basic, as respectively taught by Barkey and Chu et al. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to agitate the calcium chloride-platelet concentrate mixture, as the starting material is plasma, and would have had a reasonable expectation of success given that the disclosure of Borghese et al utilizes the Plasmatherm device for the generation of a releasate composition and clot from a platelet-rich plasma starting material. See MPEP § 2143(I)(G). With that, one of ordinary skill in the art before the effective filing date of the invention also would have been motivated to ensure the final releasate composition has a concentration of FGF-basic of about 75 pg/mL, as the released factors from the activated platelet-rich plasma have significant effects on cell growth and migration (Chu et al: Paragraphs [0069]-[0070]), and would have had a reasonable expectation of success given that the disclosure of Borghese et al and Chu et al are concerned with the activation of platelet-rich plasma via calcium chloride. See MPEP § 2143(I)(G).
Consequently, Borghese et al as modified by Barkey and Chu et al disclose the formation of a releasate composition comprising about 75 pg/mL FGF-basic and calcium chloride, wherein calcium chloride at a final concentration of 40 mM (claims 134-135) is added to a solution consisting of a mammalian platelet concentrate, which is then incubated for approximately 60 minutes (claims 136-137) within a Plasmatherm device to allow for the formation of a clot and the releasate composition. As there is no cellular lysis step and the Plasmatherm device agitates the calcium chloride-platelet concentrate mixture, this therefore renders obvious the releasate composition of instant claim 46.
Regarding claim 47: Following the discussion of claim 46, Borghese et al further disclose that the releasate composition is comprised within a cell culture medium for the culture of MSCs (Pages 198-201). This therefore reads on the cell culture medium of the instant claim.
Regarding claim 48: Following the discussion of claim 47, Borghese et al further disclose that the releasate composition does not comprise any added heparin (Page 198, PRP-R/SRGF production). This therefore reads on the cell culture medium of the instant claim.
Regarding claims 139-140: Following the discussion of claim 46, Borghese et al further disclose that the releasate composition comprises the growth factors (claim 139) of PDGF-AA, PDGF-AB, PDGF-BB, EGF, and VEGF (claim 140) (Page 198, ELISA assay of growth factors; Pages 200-201). This therefore reads on the releasate composition of the instant claims.
Regarding claim 144: Following the discussion of claim 46, Borghese et al further disclose that the clot is separated from the releasate composition (Page 198, PRP-R/SRGF production). This therefore reads on the releasate composition of the instant claim.
Regarding claims 147-150: The instant claims are product-by-process limitations further describing the method steps by which the releasate composition is produced. See Claim Interpretation -above, the content of which is incorporated herein in its entirety.
Accordingly, the recited method step parameters do not change the resulting releasate composition of parent claim 46, per se. Therefore, claims 147-150 are rejected for the same reason as instant claim 46.
Regarding claim 152: Following the discussion of claim 46, Borghese et al further disclose that the platelet concentrate is platelet-rich plasma, wherein the platelet-rich concentrate is formed by removing an amount of plasma (Page 198, PRP-R/SRGF production). This therefore reads on the releasate composition of the instant claim.
Claims 46-48, 133-140, 142, 144, 147-150, and 152 are rejected under 35 U.S.C. 103 as being unpatentable over Borghese et al (Vox Sanguinis, 2016, of record on IDS filed 08 October 2021) in view of Barkey (Barkey Plasmatherm Instruction Manual, 2007, of record) and Chu et al (US 2006/0136050 A1), and further in view of Weissman et al (US 2012/0156306 A1, of record).
The discussion of Borghese et al as modified by Barkey and Chu et al regarding claim 46 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Borghese et al as modified by Barkey and Chu et al render obvious claims 46-48, 134-137, 139-140, 144, 147-150, and 152. Weissman et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 133: As aforementioned in the discussion of claim 46 above, Borghese et al as modified by Barkey and Chu et al disclose the formation of a releasate composition comprising about 75 pg/mL FGF-basic, wherein calcium chloride at a final concentration of 40 mM is added to a solution consisting of a mammalian platelet concentrate, which is then agitated for approximately 60 minutes to allow for the formation of a clot and the releasate composition.
Chu et al further disclose that fibrinogen within the platelet-rich plasma is activated upon contact with calcium chloride (Paragraph [0067]).
The combination of Borghese et al, Barkey, and Chu et al fail to teach that the releasate composition comprises fibrinogen at a level of less than 0.05 mg/dL, as required by instant claim 133.
Weissman et al, however, disclose a viral-safe platelet extract that is subject to calcium chloride treatment at a final concentration of 40 mM and agitated (Abstract; Paragraphs [0009], [0071]-[0073], [0171]-[0172], [0270]). Weissman et al further disclose that fibrinogen within a starting sample of plasma is activated upon contact with calcium chloride such that the fibrinogen immediately transforms to insoluble fibrin to form a clot (Paragraph [0349]). Weissman et al further disclose that the clotted plasma is devoid of fibrinogen (Paragraph [0258], Table 2).
Therefore, it would have been prima facie obvious to have modified the releasate composition of Borghese et al in view of Barkey and Chu et al such that the releasate composition does not comprise fibrinogen, as detailed in Weissman et al. One of ordinary skill in the art would have been motivated to ensure the releasate composition is devoid of fibrinogen, as that indicates that a clot has been fully formed, and would have had a reasonable expectation of success since both Borghese et al and Weissman et al are concerned with the generation of a platelet liquid fraction from a starting plasma sample. See MPEP § 2143(I)(G).
Consequently, Borghese et al as modified by Barkey, Chu et al, and Weissman et al render obvious a releasate composition, wherein the releasate composition does not comprise fibrinogen. This therefore renders obvious the releasate composition of the instant claim.
Regarding claim 138: As aforementioned in the discussion of claim 46 above, Borghese et al as modified by Barkey and Chu et al disclose the formation of a releasate composition comprising about 75 pg/mL FGF-basic, wherein calcium chloride at a final concentration of 40 mM is added to a solution consisting of a mammalian platelet concentrate, which is then agitated for approximately 60 minutes to allow for the formation of a clot and the releasate composition.
The combination of Borghese et al, Barkey, and Chu et al fail to teach that the calcium chloride-platelet concentrate mixture is agitated at 50-500 rpm, as required by instant claim 138.
Weissman et al, however, disclose a viral-safe platelet extract that is subject to calcium chloride treatment at a final concentration of 40 mM and agitated at 50 rpm (Abstract; Paragraphs [0009], [0071]-[0073], [0171]-[0172], [0270]).
Therefore, it would have been prima facie obvious to have modified the releasate composition of Borghese et al in view of Barkey and Chu et al such that the calcium chloride-platelet concentrate mixture is agitated at 50 rpm, as detailed in Weissman et al. One of ordinary skill in the art would have been motivated to agitate the mixture at a rate known to be effective for platelet concentrates supplemented with 40 mM calcium chloride, and would have had a reasonable expectation of success since both Borghese et al (as taught by Barkey) and Weissman et al are concerned with the generation of a platelet liquid fraction, wherein human platelet samples are subject to a calcium chloride treatment and agitation. See MPEP § 2143(I)(G).
Consequently, Borghese et al as modified by Barkey, Chu et al, and Weissman et al render obvious a releasate composition, wherein the releasate composition is agitated at 50 rpm. This therefore renders obvious the releasate composition of the instant claim. See MPEP § 2131.03.
Claims 46-48, 134-137, 139-140, 142, 144, 147-150, and 152 are rejected under 35 U.S.C. 103 as being unpatentable over Borghese et al (Vox Sanguinis, 2016, of record on IDS filed 08 October 2021) in view of Barkey (Barkey Plasmatherm Instruction Manual, 2007, of record) and Chu et al (US 2006/0136050 A1), and further in view of Amable (Stem Cell Research & Therapy, 2013, of record).
The discussion of Borghese et al as modified by Barkey and Chu et al regarding claim 46 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Borghese et al as modified by Barkey and Chu et al render obvious claims 46-48, 134-137, 139-140, 144, 147-150, and 152. Amable et al is considered prior art under 35 USC 102(a)(1).
Regarding claim 142: As aforementioned in the discussion of claim 46 above, Borghese et al as modified by Barkey and Chu et al disclose the formation of a releasate composition comprising about 75 pg/mL FGF-basic, wherein calcium chloride at a final concentration of 40 mM is added to a solution consisting of a mammalian platelet concentrate, which is then agitated for approximately 60 minutes to allow for the formation of a clot and the releasate composition.
The combination of Borghese et al, Barkey, and Chu et al fail to teach that the releasate composition comprises one or more of IL-2, IL-7, IL-15, or IL-17, as required by instant claim 142.
Amable et al, however, disclose platelet-rich plasma preparations, and the cytokine and growth factor expression profile therefrom (Abstract).
As such, Amable et al disclose a platelet-rich plasma preparation that has been centrifuged twice and activated with calcium chloride (Page 3, Blood collection and…). Amable et al further disclose that this activated platelet-rich plasma preparation expresses IL-17, as it is a platelet-secreted factor (Pages 9-10, Proinflammatory cytokines; Figure 6; Table 5).
Therefore, it would have been prima facie obvious to have modified the releasate composition of Borghese et al in view of Barkey and Chu et al such that the releasate composition comprises IL-17, as detailed in Amable et al. One of ordinary skill in the art would have been motivated to have this platelet-secreted cytokine comprised within the releasate composition, as it indicates that the platelets have been activated (Amable et al: Abstract – Results, Line 8). Furthermore, the ordinary artisan would have had a reasonable expectation of success since the disclosures of both Borghese et al and Amable et al are concerned with the generation and analysis of a platelet-rich plasma releasate, wherein human platelet samples are subject to a calcium chloride treatment. See MPEP § 2143(I)(G).
Consequently, Borghese et al as modified by Barkey, Chu et al, and Amable et al render obvious a releasate composition, wherein the releasate composition comprises IL-17. This therefore renders obvious the releasate composition of the instant claim.
Claims 46-48, 134-137, 139-140, and 143-152 are rejected under 35 U.S.C. 103 as being unpatentable over Borghese et al (Vox Sanguinis, 2016, of record on IDS filed 08 October 2021) in view of Barkey (Barkey Plasmatherm Instruction Manual, 2007, of record) and Chu et al (US 2006/0136050 A1), and further in view of Woods et al (US 2015/0064133 A1, of record).
The discussion of Borghese et al as modified by Barkey and Chu et al regarding claim 46 can be observed above and is relied upon herein, the content of which is incorporated in its entirety. Borghese et al as modified by Barkey and Chu et al render obvious claims 46-48, 134-137, 139-140, 144, 147-150, and 152. Woods et al is considered prior art under 35 USC 102(a)(1) and 35 USC 102(a)(2).
Regarding claim 143: As aforementioned in the discussion of claim 46 above, Borghese et al as modified by Barkey and Chu et al disclose the formation of a releasate composition comprising about 75 pg/mL FGF-basic, wherein calcium chloride at a final concentration of 40 mM is added to a solution consisting of a mammalian platelet concentrate, which is then agitated for approximately 60 minutes to allow for the formation of a clot and the releasate composition.
The combination of Borghese et al, Barkey, and Chu et al fail to teach that the mammalian platelet concentrate is from previously frozen or cold-stored platelets, as required by instant claim 143.
Woods et al, however, disclose a composition comprising a bioactive fraction derived from a platelet concentrate, methods of making the bioactive fraction, and culture medium supplemented with the bioactive fraction (Abstract).
As such, Woods et al disclose a composition comprising a bioactive fraction of a human blood-derived platelet concentrate, wherein a calcium chloride clotting agent is added to a human platelet lysate composition and agitated to allow for the separation of the generated clot from the releasate (Paragraphs [0022], [0061]-[0062], [0086], [0155]-[0159]).
Woods et al further disclose that the human platelets were previously frozen prior to use to preparate the bioactive fraction – or releasate (Paragraphs [0039]-[0040], [0155], [0160], [0164]).
Therefore, it would have been prima facie obvious to have substituted the starting sample of human platelets from Borghese et al with samples that had been frozen prior to concentrating, as doing so would be a simple substitution of one platelet sample preparation for another. See MPEP § 2143(I)(B). One of ordinary skill in the art before the effective filing date of the invention would have recognized that the platelet samples are functionally comparable, and thus would have been able to substitute the samples with predictable results. This predictability is further supported since both Borghese et al (as taught by Barkey) and Woods et al have subjected the human platelet concentrate samples to a calcium chloride treatment and agitation.
Consequently, Borghese et al as modified by Barkey, Chu et al, and Woods et al render obvious a releasate composition, wherein the starting sample of mammalian platelets has been previously frozen prior to be concentrated. This therefore renders obvious the releasate composition of the instant claim.
Regarding claims 145-146: As aforementioned in the discussion of claim 46 above, Borghese et al as modified by Barkey and Chu et al disclose the formation of a releasate composition comprising about 75 pg/mL FGF-basic, wherein calcium chloride at a final concentration of 40 mM is added to a solution consisting of a mammalian platelet concentrate, which is then agitated for approximately 60 minutes to allow for the formation of a clot and the releasate composition.
The combination of Borghese et al, Barkey, and Chu et al fail to teach that the releasate composition is further filtered through a 0.1-200 micron filter, as required by instant claims 145-146.
Woods et al, however, disclose a composition comprising a bioactive fraction derived from a platelet concentrate, methods of making the bioactive fraction, and culture medium supplemented with the bioactive fraction (Abstract).
As such, Woods et al disclose a composition comprising a bioactive fraction of a human blood-derived platelet concentrate, wherein a calcium chloride clotting agent is added to a human platelet lysate composition and agitated to allow for the separation of the generated clot from the releasate. Woods et al further disclose that the releasate is subjected to depth sterile filtration, wherein the sterile filter is a 0.2 μm sterile filter (Paragraphs [0022], [0061]-[0062], [0086]-[0087], [0155]-[0159]).
Therefore, it would have been prima facie obvious to have modified the releasate composition of Borghese et al in view of Barkey and Chu et al such that the releasate composition is further subjected to filtration through a 0.2 μm sterile filter, as disclosed in Woods et al. One of ordinary skill in the art before the effective filing date of the instant invention would have been motivated to remove suspended solids from the composition, such as any remaining platelet debris, cellular debris, and clot solids (Woods et al: Paragraph [0087]), and would have had a reasonable expectation of success since both Borghese et al (as taught by Barkey) and Woods et al are concerned with the generation of a platelet liquid fraction, wherein human platelet samples are subject to a calcium chloride treatment and agitation. See MPEP § 2143(I)(G).
Consequently, Borghese et al as modified by Barkey, Chu et al, and Woods et al render obvious a releasate composition, wherein the releasate composition is further subjected to filtration (claim 145) through a 0.2 μm sterile filter (claim 146). This therefore renders obvious the releasate composition of the instant claims.
Regarding claim 151: As aforementioned in the discussion of claim 46 above, Borghese et al as modified by Barkey and Chu et al disclose the formation of a releasate composition comprising about 75 pg/mL FGF-basic, wherein calcium chloride at a final concentration of 40 mM is added to a solution consisting of a mammalian platelet concentrate, which is then agitated for approximately 60 minutes to allow for the formation of a clot and the releasate composition.
The combination of Borghese et al, Barkey, and Chu et al fail to teach that the releasate composition is at least 50 liters, as required by instant claim 151.
Woods et al, however, disclose a composition comprising a bioactive fraction derived from a platelet concentrate, methods of making the bioactive fraction, and culture medium supplemented with the bioactive fraction (Abstract).
As such, Woods et al disclose a composition comprising a bioactive fraction of a human blood-derived platelet concentrate, wherein a calcium chloride clotting agent is added to a human platelet lysate composition and agitated to allow for the separation of the generated clot from the releasate. (Paragraphs [0022], [0061]-[0062], [0086], [0155]-[0159]). Woods et al further disclose that the separated liquid of the bioactive fraction – or releasate – fills a 100 liter bag (Paragraph [0156]).
Therefore, it would have been prima facie obvious to have modified the releasate composition of Borghese et al in view of Barkey and Chu et al such that the releasate composition fills a 100 liter bag, as disclosed in Woods et al. One of ordinary skill in the art before the effective filing date of the instant invention would have been motivated to pool the treated and agitated releasates to allow for a more efficient composition processing (Woods et al: Paragraphs [0039], [0155]-[0156]), and would have had a reasonable expectation of success since both Borghese et al (as taught by Barkey) and Woods et al are concerned with the generation of a platelet liquid fraction, wherein human platelet samples are subject to a calcium chloride treatment and agitation. See MPEP § 2143(I)(G).
Consequently, Borghese et al as modified by Barkey, Chu et al, and Woods et al render obvious a releasate composition that fills a 100 liter bag. As 100 liters is greater than 50 liters, this therefore renders obvious the releasate composition of the instant claims, wherein the volume of the releasate composition is at least 50 liters. See MPEP § 2131.03.
Conclusion
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/ALYSSA G WESTON/Examiner, Art Unit 1633
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