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 .
Priority
Applicants’ claim for the benefit of a prior-filed application parent provisional application 63490186 filed on 03/14/2023 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted before the mailing date of the non-final first action on the merits. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
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.
Claim 1-12, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Moskowitz et al (WO 2021/158646 A1) in view of Fitzpatrick et al ( Blood, 2013) , Merideth et al ( Platelets, 2020), Rivera-Concepcion et al ( European Journal of Hematology, 2019), Cid et al ( British Journal of Hematology, 2017), Narvois et al ( American Journal of Hematology, 2005), and Bohm et al (US 2014/0294794 A1).
Regarding claims 1-3, and 5-10, Moskowitz teaches a platelet derived hemostatic compositions comprising of platelet derivatives, also referred to it as thrombosomes or freeze-dried platelets.[0028] and [0037]. Moskowitz et al also teach administering a therapeutically effective amount of thrombosomes intravenously to a subject to treat or prevent bleeding and promote hemostasis. [ 0012]. According to Moskowitz et al, the platelet-derived composition retains substantial hemostatic activity while exhibiting a markedly reduced propensity to aggregate compared with fresh platelets, with thrombosomes demonstrating approximately 1.7% aggregation compared with approximately 48.4% aggregation for platelet-rich plasma (i.e. intact platelet) in the presence of an agonist (i.e. ristocetin) and absence of divalent cation. [00138]. Moskowitz et al further teach that thrombosomes have the ability to generate thrombin and strengthen a blood clot, however Moskowitz et al do not expressly teach the particular thrombin generation assay recited in the claim 1, e.g. in the presence of tissue factor and phospholipid. [0095]. It is noted; however, that the composition disclosed by Moskowitz is the same platelet-derived hemostatic composition described in the instant specification e.g. the same Cellphire THROMBOSOMES platelet derivative technology described in instant specification; therefore, the physical characteristic recited in the instant claim, including the preserved thrombin-generating activity, are inherent properties of Moskowitz’s composition. Further, Fitzpatrick et al supplement Moskowitz et al by teaching intravenous administration of the same platelet-derivative composition (i.e. thrombosomes) taught by instant application i.e. same Cellphire THROMBOSOMES. ( See page 104S ). Fizpatrick et al further characterize the thrombosomes and demonstrate that, despite exhibiting markedly reduced platelet aggregation compared to fresh platelet, they retain the ability to generate thrombin in the presence of tissue factor and phospholipid. ( See section “Functional Characterization” on page 102S). Fitzpatrick et al, therefore, evidences that the thrombosomes of Moskowitz possess the same functional characteristics relied upon by Applicant.
It should be noted that Moskowitz and Fitzpatrick et al are using the same platelet-derivative product prepared using the same methodology as instant specification i.e. same Cellphire THROMBOSOMES. Because the prior art and instant specification employ the same platelet-derived composition, the resulting physical and functional characteristics of the thrombosomes, including their reduced platelets aggregation and retained thrombin-generating activity, would necessarily be possessed by the prior art compositions. Accordingly, to the extent the claims recite physical characteristic that they arise from the composition itself rather than from the manufacturing process, such characteristic are considered inherent properties of the prior art composition. See MPEP 2112.
Accordingly, Moskowitz et al teach administering a platelet-derived composition to a subject in need to promote hemostasis but do not expressly disclose administration to a subject having Hermansky-Pudlak syndrome (HPS).
Merideth et al teach that HPS is characterized by a platelet delta storage pool deficiency resulting in an increased tendency to bleed. ( See 2nd paragraph on page 2). Merideth et al further teach that platelet transfusion maybe used therapeutically for excessive bleeding in HPS patients and expressly state that platelets are effective in preventing or treating bleeding in individuals with HPS, although transfusion should be used judiciously to minimize alloimmunization in patients who may later require lung transplantation. ( See last paragraph on page 2). Moreover, Rivera-Concepcion et al teach that patients with HPS exhibit a platelet storage pool deficiency resulting in prolonged bleeding due to defective platelet function. Rivera-Concepcion et al also explain that platelet transfusion or replacement therapy constitute an accepted treatment for clinically significant bleeding in HPS patients. ( see the 3rd and the 5th paragraph on page 2).
Accordingly, one with ordinary skill in the art at the time the invention was filed would have been motivated to administer the thrombosomes of Moskowitz to a subject suffering from bleeding associated with HPS because the references collectively recognize that the underlying defect in HPS is platelet dysfunction, that platelet replacement therapy is an established and effective treatment for controlling HPS-associated bleeding. Since Moskowitz et al teach a stabilized thrombosomes that retain thrombin generating and hemostatic activity while avoiding many limitations of conventional platelet transfusion, thus one with ordinary skill in the art would have had a reasonable expectation that the known platelet derivative composition would serve as an effective substitute for the conventional platelet transfusion in HPS patients.
It is also noted that Moskowitz et al do not expressly teach a continuous form of administration as recited in step (i) of claim 1 or the repeated form of administration at a frequency of about 1 hour or more as recited in claim 5.
Cid et al further supplement Moskowitz et al by teaching that the continuous platelet infusion is a recognized alternative platelet transfusion strategy for patients with platelets refractoriness, particularly in the setting of ongoing bleeding or when HLA/HPA- compatible platelets are unavailable.( See 2nd paragraph on left column on page 386 (i.e. 1st page)). Cid et al state that published guidance had previously suggested employing platelet “drips” based on just two original reports of an approach that comprised a massive prophylactic platelet transfusion or slow infusion of platelets in two and three patients, respectively. ( See 1st paragraph on the left column on page 386 (i.e. 1st page)). Building on these reports, Cid et al describe a continuous platelet transfusion for approximately 24 hours in patients with refractory bleeding to maintain hemostatic platelet activity, wherein the platelet concentrates were divided into separate units and infused continuously over successive intervals to comply with blood product expiration requirements. Cid et al report that bleeding stopped during the 24-hour continuous infusion, no transfusion reactions were observed, and conclude that 24-hour continuous infusion of platelets is a feasible, safe, and efficacious strategy for treating and preventing bleeding in patients requiring platelet transfusion. ( See the right column on page 386). Thus, it would have been prima facie obvious to one with ordinary skill in the art to administer the composition of Moskowitz by continuous intravenous infusion as taught by Cid because Cid et al demonstrate that continuous infusion of platelets is a feasible, safe, and efficacious strategy for treating and preventing bleeding in patients requiring platelet transfusion. As such, one with ordinary skill in the art would have reasonably expected that the platelet-derivative composition of Moskowitz which retains the hemostatic properties of platelets could likewise be administered by a continuous infusion regimen to provide sustained hemostatic activity.
Narvious et al further corroborate that platelet concentrates may be administered by slow intravenous infusion as an alternative method of platelet transfusion. Specifically, Narvios et al disclose administering either random-donor platelets (RDP) or single-donor platelets (SDP) by slow infusion over approximately six hours using an infusion pump, with the platelet count being assessed following the infusion. Narvios et al further report that the slow infusions were well tolerated by patients without reported adverse effects and expressly state that administration of platelets concentrates by slow infusion is a feasible method in patients requiring platelet transfusion. ( See “ Slow Infusion of Platelets: A Possible Alternative in the Management of Refractory Thrombocytopenic Patients “ on page 80). Accordingly, Narvios et al reinforce Cid et al’s teachings that prolonged or continuous infusion represented a recognized mode of administering platelet-based therapies.
Bohm et al, on the other hand, supplement Moskowitz et al by teaching that a population of platelet or subpopulations of platelets maybe administered in a therapeutically effective amount to treat a bleeding disorder, and that the appropriate dosing regimen is selected based upon clinical condition, method of administration, and other clinical considerations.[0050]. According to Bohm et al, “Appropriate dosing regimens can also be determined by one of skill in the art without undue experimentation, in order to determine, for example, whether to administer the agent in one single dose or in multiple doses, and in the case of multiple doses, to determine an effective interval between doses”.[0272]. Accordingly, it would have been prima facie obvious to one with ordinary skill in the art to employ repeated administration of the platelet derived composition of Moskowitz because Bohm et al expressly teach that platelet-based therapies maybe administered either as a single or in multiple doses and that selection of the appropriate dosing interval is a matter of routine optimization based on the patients therapeutic needs. Accordingly, optimizing the frequency and interval as well as the number of the doses to maintain hemostatic activity would have been well within the ordinary skill in the art.
Taken together, it would have been prima facie obvious to one with ordinary skill in the art at the time the invention was filed to use Moskowitz’s thrombosomes and administer them intravenously to treat bleeding associated with HPS as suggested by Meredith and Rivera-Concepcion, and deliver them continuously or by multiple dosing as taught by Cid, Narvois, and Bohm and with a reasonable expectation of successfully reducing bleeding in HPS patients.
Regarding claims 4 ,11-12, and 16, Moskowitz et al further teach administering the platelet derivative composition in a therapeutically effective amount, including concentration ranging from about 1*102 to about 1*1013 particles/kg, as well as at broader therapeutic ranges, which encompass the claimed range. ( See claims 6-8 and [0017]). Moskowitz et al further teach that thrombosomes can be administered parenterally or intravenously. ( See [00120-00121]. As per administering at a frequency of every 1 hour or more, as discussed above Moskowitz et al in view of Bohm et al render obvious administering platelets composition as single or multiple doses and that the appropriate dosing as well as the interval maybe routinely determined by one with ordinary skill in the art without undue experimentation. Therefore, selecting an administration interval of 1 hour or more frequently would have been an obvious matter of routine optimization based upon the patients clinical needs. As per the recited increase in one of the platelet biomarker including CD62P, PAC-1 or CD63, this is an inherent property that necessarily flows from the combined teachings of the prior arts. Specifically, administration of a functional platelets derivative to treat bleeding necessarily results in platelet mediated hemostasis, which inherently involves activation of endogenous platelets . Activated endogenous platelets inherently exhibit increased activation in one of the recited biomarkers. In other words, the increased level in one of the platelet biomarkers is considered an inherent property that would results from practicing the combined teachings of the prior arts.
Regarding claim 15, Moskowitz et al also teach that the thrombosomes composition can be formulated and administered by topical administration at the site of bleeding. ( See [00119]).
Claims 13-15, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Moskowitz et al in view of Fitzpatrick et al, Merideth et, Rivera-Concepcion et al ( European Journal of Hematology, 2019), Cid et al, Narvois et al and Bohm et al as applied to claim 1-12, and 16 above, and further in view of Montgomery et al ( US 2020/0346167 A1, which was subsequently issued as U.S. Patent No.11,529,587) as evidenced by Montgomery et al ( WO 2023/081804 A1).
Regarding claims 17 and 19, following the discussion above, the combined teachings of the cited prior art render obvious a method of treating a subject having HPS by administering a platelet composition ( i.e. platelet derivative/thrombosomes) to reduce or stop bleeding. Moskowitz et al further teach that the administered platelet derivative retain the hemostatic properties including the ability to promote clot formation and hemostasis. [0095] and [00150]. Moskowitz et al further teach platelet derivative composition having controlled particle size distributions, including particles within the claimed size ranges and compositions in which the majority of the particles are between about 0.3 um and 5 um. ( See [0046-0047]). Moskowitz et al, however, do not expressly disclose that less than 5% of the platelet derivatives in the composition are microparticle having a diameter or less than 0.5 um.
Montgomery et al supplement Moskowitz et al by disclosing platelet derivative (i.e. thrombsomes) prepared using the same Cellphire THROMBOSOMES platelet derivative technology described in instant specification. Montgomery et al teach thrombosomes having a particle size of at least 0.5 um, and teach that in some embodiments, 95-99% of the thrombosomes have a particle size of at about 0.5 um to about 5 um. [0147-0148]. Montgomery et al further teach characterizing the same thrombosomes composition, including platelet derivatives having at least 65% CD41 positivity, at least 65% CD42 positivity, and CD62 positivity in excess of the claimed threshold. ( See [0435-0436] and [0451]). Montgomery et al further teach methods of treating clotted-related diseases by administering a therapeutically effective amount of the disclosed platelet derivative to a subject in need. [0491-0494].Montgomery et al identifies exemplary clotting related disorder including Von Willebrand Disease, a hemophilia, thrombasthenia, thrombocytopenia, thrombocytopenic purpura, trauma, or a combination thereof. [0494].Thus, Montgomery, not only teach the structural characteristics of the platelet derivative but also its therapeutic administration for disorders involving impaired hemostasis.
It should also be noted that instant specification expressly identifies the claimed platelet derivative as THROMBSOMES platelet derivative and incorporate by reference Example 1 of Patent No.11,529,587, the issued counterpart of Montgomery et al (US 2020/0346167 A1). See pargraph [00082] of instant specification. This confirms that the platelet derivative relied upon in instant specification is the platelet derivative composition previously disclosed and characterized in Montgomery et al (US 2020/0346167 A1). Accordingly, Montgomery et al is relied upon to establish the known structural characteristics of the platelet derivative composition employed in the combined therapeutic method.
Taken together, Montgomery et al teach the same composition of instant application and expressly state that the composition for clotting related diseases while further characterizing its structural properties, including particle size. Moskowitz et al, likewise, use the same class of thrombosomes and demonstrate in view of prior art the preservation of platelet hemostatic function.[0037]. Accordingly, an ordinary skill in the art would have understood that Moskowitz and Montgomery describe the same composition of instant application. Because the prior arts teach substantially the same platelet derivative composition produced by substantially the same manufacturing procedure, the claimed limitation that less than 5% of the platelet derivatives are microparticle having less than 0.5 um is an inherent property of the prior art composition that necessarily flows from practicing the disclosed process. The claimed particle size distribution therefore, does not patentably distinguish over the prior art.
Regarding claims 18 and 20, following the discussion of claims 17 and 19 above, it is submitted that neither Montgomery et al (US 2020/0346167 A1) nor the cited prior arts disclose thrombosomes composition wherein the platelet derivatives exhibit an increased thrombin generation in an in vitro assay as compared to platelets, and wherein the presence of thrombospondin (TSP) on their surface is at a level that is greater than on the surface of resting platelets”. It is, however, noted that Moskowitz, Montgomery et al and Fitzpatrick et al disclose thrombosomes composition prepared by Cellphire. It is also noted that the thrombosomes composition cited by Moskowitz and Montgomery et al are the same composition disclosed by instant application. For example, as discussed above Montgomery et al (2020) discloses in Example.1 composition/Process which is later issued as U.S Patent No.11,529,587). Instant application expressly states that the FPH used in thrombin generation assay was prepared according to Example 1 of U.S. patent U.S Patent No.11,529,587 which issued from US 2020/0346167 A1 (Montgomery et al 2020). Therefore, the thrombin generation data in the instant application is testing the same composition that Montgomery previously disclosed. Because the later-filed application characterize the same previously disclosed composition, the later filed data is relied upon only as evidence that Montgomery composition inherently possessed the claimed thrombin generation property.
Furthermore, it is noted that Applicant post-filing by Montgomery et al (WO 2023/081804 A1) , disclose the same composition disclosed by Montgomery et al (2020) and Moskowitz et al.
For example, Montgomery et al (WO 2023/081804 A1) state in [000121] that “ As used herein, "thrombosomes" (sometimes also called Tsomes) or "thrombosomes platelet
derivatives" are platelet derivatives that have been treated with a preparation agent (e.g., any of the preparation agents described herein) and lyopreserved (such as freeze-dried). In some cases, thrombosomes platelet derivatives can be prepared from pooled platelets. Thrombosomes platelet derivatives can have a shelf life of 2-3 years in dry form at ambient temperature and can be rehydrated with sterile water within minutes for immediate infusion. One example of thrombosomes freeze-dried platelet derivatives are THROMBOSOMES® freeze-dried platelet derivatives (Cellphire Inc., Rockville,MD), which are in clinical trials. In non-limiting illustrative embodiments, thrombosome compositions, or illustrative freeze-dried platelet-derivative compositions herein, such as those prepared according to Example 1 herein, are compositions that include platelet derivatives, wherein at least 50% of the platelet derivatives are CD 41-positive platelet derivatives, wherein less than 15%, 10%, or in further, nonlimiting
illustrative embodiments less than 5% of the CD 41-positive platelet derivatives are
microparticles having a diameter of less than 0.5 μM, and wherein the platelet derivatives have a potency”.
It is further noted that Montgomery et al (2023) (WO 2023/081804 A1) measure the TSP-1 on the surface of the freeze-dried platelet derivatives and compares it with resting and activated fresh platelets [000616-000617 ] and Figures. 36. Paragraph [000621] states that the expression of TSP1 in resting platelet is 1,223 and on thrombosomes is 91,448. Thus, Montgomery et al (2023) (WO 2023/081804 A1) concludes that the fluorescence signal was significantly higher than the signal generated by the resting or fresh platelets, indicating that TSP1 on the surface of thrombosomes is greater than on the surface of resting platelets. This is a direct evidence supporting the limitation of increased TSP1relative to resting or fresh platelets. ( See example 19).
Montgomery et al (2023) (WO 2023/081804 A1) further measure vWF on the surface of thrombosomes and resting platelets and reports an MFI of 4771 for vWF on the surface of the resting platelets and an average value of 13,991 MFI on the surface of thrombosomes. Montgomery et al (2023) (WO 2023/081804 A1) conclude that vWF amount on the surface of thrombosomes is greater than that seen on resting platelets. ( See example.20, and [000622-000625]). This directly supports the alternative limitation of increased vWF relative to resting platelets.
Taken together, Moskowitz and Montgomery teach the same composition of instant application using substantially the same manufacturing process, Applicants post-filing application WO 2023/081804 demonstrates that thrombosomes produced by the same process inherently exhibit elevated surface TSP-1 and vWF compared with resting platelets. It should be noted that the post-filing application is relied upon solely as evidentiary support confirming an inherent property of the previously known composition, rather than as a prior art supplying a missing claim limitation. Therefore, these functional limitation “ wherein the platelet derivatives exhibit an increased thrombin generation in an in vitro assay as compared to platelets, and wherein:(a) the presence of thrombospondin (TSP) on their surface is at a level that is greater than on the surface of resting platelets” are considered to be prima facie present per natural law of cell biology in the teachings of Montgomery and Moskowitz et al and they reasonably fulfill the functional limitation that is being claimed
As per the MPEP "Products of identical chemical composition cannot have mutual exclusive properties." A compound and its properties are inseparable (In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963)). Any properties exhibited by or benefits from are not given any patentable weight over the prior art provided the composition is inherent. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the disclosed properties are necessarily present. In re Spada, 911 F.2d 705,709, 15 USPQ 1655, 1658 (Fed. Cir. 1990). See MPEP §2112.01. The burden is shifted to the applicant to show that the prior art product does not inherently possess the same properties as the instantly claimed product.
Furthermore, there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. Schering Corp. v. Geneva Pharm. Inc., 339 F.3d 1373, 1377, 67 USPQ2d 1664, 1668 (Fed. Cir. 2003).
Regarding claims 13-14, following the discussion above, the combined teachings of the cited prior arts render obvious a method of treating a subject having HPS by administering a platelet derivative composition ( i.e. platelet derivative/thrombosomes) to reduce or stop bleeding. Moskowitz et al further teach administering thrombosomes composition to a subject by intravenous administration to reduce bleeding and promote hemostasis. Also, Moskowitz et al teach that the composition forms clots and functions as a hemostatic agent, including that therapeutically effective amounts of unloaded thrombosomes form clots and are capable of clot formation in vWF-deficient plasma. ( See Moskowitz paragraphs [0097-99]. As discussed above, Montgomery et al (2020) teach the preparation of thrombosomes composition corresponding to the composition administered by Moskowitz et al. Therefore, the combined teachings of Moskowitz and Montgomery et al would have suggested administering the thrombosomes composition intravenously to improve hemostasis in bleeding subject. It is submitted that Neither Moskowitz nor Montgomery 2020 disclose the functional limitation “wherein the administering leads to an improvement in clot formation in the subject as compared to the subject after being administered apheresis platelets, but before the administering of the platelet derivatives”.
However, it is noted that Applicant post-filing by Montgomery et al (2023) (WO 2023/081804 A1) , disclose the same composition disclosed by Montgomery et al (2020) and Moskowitz et al.
For example, Montgomery et al (WO 2023/081804 A1) state in [000121] that “ As used herein, "thrombosomes" (sometimes also called Tsomes) or "thrombosomes platelet
derivatives" are platelet derivatives that have been treated with a preparation agent (e.g., any of the preparation agents described herein) and lyopreserved (such as freeze-dried). In some cases, thrombosomes platelet derivatives can be prepared from pooled platelets. Thrombosomes platelet derivatives can have a shelf life of 2-3 years in dry form at ambient temperature and can be rehydrated with sterile water within minutes for immediate infusion. One example of thrombosomes freeze-dried platelet derivatives are THROMBOSOMES® freeze-dried platelet derivatives (Cellphire Inc., Rockville,MD), which are in clinical trials. In non-limiting illustrative embodiments, thrombosome compositions, or illustrative freeze-dried platelet-derivative compositions herein, such as those prepared according to Example 1 herein, are compositions that include platelet derivatives, wherein at least 50% of the platelet derivatives are CD 41-positive platelet derivatives, wherein less than 15%, 10%, or in further, nonlimiting
illustrative embodiments less than 5% of the CD 41-positive platelet derivatives are
microparticles having a diameter of less than 0.5 μM, and wherein the platelet derivatives have a potency”.
It is further noted that Applicant post-filing by Montgomery et al (WO 2023/081804 A1) which is cited solely as evidence of the inherent biological properties of thrombosomes composition disclosed in Montgomery et al 2020, demonstrates that the same example 1 composition possess increased surface fibrinogen relative to resting platelets and generate substantially greater thrombin than apheresis unit, properties that enhance the composition ability to form clots. As such, these data provide confirmatory evidence that administering the previously disclosed composition would inherently results in improved clot formation compared with administration of apheresis unit. ( See WO 2023/081804 A1 paragraph [000194]).
Conclusion
No claim is allowed.
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/FATIMAH KHALAF MATALKAH/Examiner, Art Unit 1638
/Tracy Vivlemore/ Supervisory Primary Examiner, Art Unit 1638
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