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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 7/8/24. Claims 1, 3, 9, 11, 15-17, 19, 22-24, 28, 36-38, 40-43, and 45 are pending and considered on the merits.
Claim Objections
Claim 40 is objected to for the molecular formula of sodium bicarbonate. NaHCO3 should either be deleted or amended to NaHCO3 where the “3” is subscripted.
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.
Claims 1, 3, 9, 11, 15-17, 19, 22-24, 28, 36-38, 40-43, and 45 are 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.
The term “platelet derivatives” so broad it is indefinite. This term can refer to any component that compose platelets include proteins, lipids, and polysaccharides. The Specification refers to platelet derivatives includes “thrombosomes” [0069] or lyopreserved platelets [0079] but does not refer to small subunits that comprise the platelet (proteins, lipids, sugars). This muddles the metes and bounds of the term.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 3, 9, 11, 15-17, 19, 22-24, 28, 36-38, 40-43, and 45 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for platelet derivatives including lyophilized platelets, thrombosomes and otherwise intact whole platelets, does not reasonably provide enablement for components of platelets including any isolated proteins, lipids, or polysaccharides. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims. While the claims are enabled for whole platelet compositions including “thrombosomes” [0069] or lyopreserved platelets [0079] they are not enable for small subunits that comprise the platelet (proteins, lipids, sugars). The Applicant provides no examples, references, or description that one of ordinary skill in the art would expect a platelet component to successfully treat coagulopathy or restore normal hemostasis in a subject.
Claim Rejections - 35 USC § 103
Claim(s) 1, 3, 38, 40-43 and 45 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (US 2011/0027861).
Ho et al. teach a method of treating diseases including anemia, blood loss, and hemophilia by administering a biologic [0059]. One of ordinary skill will recognize that treating any of these disease will result in a return to homeostasis. Also one of ordinary skill would recognize hemophilia is a cause for coagulopathy, therefore treating this disease is also treating coagulopathy. They teach this biologic are platelets in platelet rich plasma lyophilized in a concentrated dehydration buffer (cDHB) [0076-0077]. The cDHB is a saline solution (0.9% NaCl) comprising the following ingredients [0065]:
100 mM HEPEs (a buffer);
200 μM adenosine;
100 mM glucose;
10 mM K2PO4;
10 % Dextran-70; and
12% trehalose (a cryoprotectant).
Ho et al. also teaches the cDHB can include polysucrose as an alternative to dextran [0034] and fluidizers including the solvents DMSO and/or glycerin [0037].
While Ho et al. does not expressly teach all the claim limitations in a single embodiment, it would be obvious for one of ordinary skill in the art to perform the claimed method after reviewing the entire disclosure. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (US 2011/0027861) as applied to claims 1, 3, 38, 40-43 and 45 above, and further in view of De Koning et al. (J. Thrombosis and Haemostasis, 2016).
Ho et al. teach using lyophilized platelets in a buffer, with salts, and cryoprotectant. to treat coagulopathy, in particular hemophilia, to return the subject to homeostasis. They do not teach the INR of the subject. This would be obvious in view of De Koning et al. who teach subjects with hemophilia A have an INR of 1.5-2.0 (De Koning, pg. 868, Summary).
Therefore it would be obvious for the hemophilic subjects of Ho et al. to have an INR of 2 or less since De Koning et al. teach that is the range for persons with hemophilia A.
Claim(s) 9, 11, and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ho et al. (US 2011/0027861) and De Koning et al. as applied to claims 1, 3, 22-24, 38, 40-43 and 45 above, and further in view of Schutgens (J. Thrombosis and Haemostasis, 2016).
Ho et al. and De Koning et al. teach a method of treating coagulopathy with a composition comprising lyophilized platelets in a buffer comprising salts and trehalose to treat hemophilia and other blood diseases. De Koning et al. teach that hemophilic populations with non-valvular atrial fibrillation (AF) are treated with direct oral anticoagulants (DOACs) (De Koning, pg. 869, col 1, 1st full paragraph). However De Koning et al does not teach which DOACs. This would be obvious in view of Schutgens et al. who teach anticoagulant therapy for atrial fibrillation in hemophilia patients with an INR ≥ 2 (Schutgens, Figs 1, left branch) with a DOAC including dabigatran (Schutgens, 2472, col 2, 1st full paragraph).
Considering this, it would be obvious to treat atrial fibrillation in hemophilia patients by administering dabigatran either before or after the composition of claim 1 since this provides an effectively therapy for this combined condition.
Claim(s) 1, 3, 15-17, 28, 36-38, and 40-42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crowe et al. (US 2002/0076445) in view of RØJKJǼR et al. (WO 03/039582).
Crowe et al. teach a method of making platelets loaded with therapeutic substances for drug delivery (Crowe [0064]). These drug-loaded platelets are for blood-borne drug delivery including removal of thrombi (Crowe [0065]). These platelets are loaded with trehalose and lyophilized (Crowe [0065]). This lyophilization is performed with the platelets contacted with a drying buffer or freeze drying buffer (Crowe [0105]). This freeze-drying buffer comprises (Crowe [0157]):
130 mM NaCl;
10 mM HEPES (a buffer);
5mM KCl; and
150 mM trehalose (a cyroperservative);
Crowe et al. teach that after lyophilization, the platelets can be rehydrated for intravenous injection using a suitable carrier (Crowe [0095]) which reads on the composition being freeze-dried then rehydrated prior to administration.
While Crowe et al. teach these loaded platelets can deliver drugs, they do not expressly teach loading the platelets with an anti-fibrinolytic including ε-aminocaproic acid (EACA) to treat hemophilia. However this would be obvious in view of RØJKJǼR et al. who teach administering various agents including recombinant FVIIa or ε-aminocaproic acid to treat bleeding episodes in hemophilia A and B patients (RØJKJǼR, pg. 2, 5-25). RØJKJǼR et al. also teach that platelets are also administered for moderate bleeding episodes (RØJKJǼR, pg. 2, 25-35). RØJKJǼR et al. is clear that to minimize bleeding in hemophilia subjects is to form “stable and solid hemostatic plugs, not easily dissolved by fibrinolytic enzymes” (RØJKJǼR, sentenced bridging pgs. 2-3).
One of ordinary skill would recognize that loading EACA as the drug into the platelets of Crowe et al. would be an obvious improvement for the following reasons:
Crowe et al. desires to deliver drugs to thrombi (hemostatic plugs or clots) at the site of vascular injuries (e.g. bleeding); and
EACA is an inhibitor to fibrinolytic enzymes including plasmin (RØJKJǼR, pg. 2, lines 10-15) and therefore will ensure the formation of stabile thrombi to curb bleeding.
One of ordinary skill would recognize that combining these teachings to produce platelets loaded with EACA will be an obvious improvement to treat bleeding in hemophilia A and B patients since the loaded platelets will deliver the plasmin inhibitor directly to the blood clot where it will help stabilize it and end the bleeding. One of ordinary skill would recognize hemophilia is a cause for coagulopathy, therefore treating this disease is also treating coagulopathy. Also one of ordinary skill will recognize that treating hemophilia will result in a return to homeostasis.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 19, 28, 36-38, 40-43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-22 of U.S. Patent No. 11701388. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a method of treating coagulopathy in a subject by administering a platelet derivative with a salt, organic solvent, buffer and cryoprotectant including the polysaccharide trehalose or polysucrose. They both teach the same buffers including HEPES as well as phosphate salts. Since treating coagulopathy will also treat hemostasis, then the method of US ‘388 continues to overlap with the current claims. The difference between US’388 and the current claims is the coagulopathy is caused by the administration of an antiplatelet agent. However the current claims are written broadly that read on any source of coagulopathy.
Claims 1, 3, 19, 28, 36-38, 40-43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 12419914. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a method of treating bleeding (e.g. coagulopathy) in a subject by administering a platelet derivative with a salt, organic solvent, buffer and cryoprotectant including the polysaccharide trehalose or polysucrose. They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the method of US ‘914 continues to overlap with the current claims. The difference between US’914 and the current claims is the coagulopathy/bleeding is caused by the administration of an antiplatelet agent. However the current claims are written broadly that read on any source of coagulopathy.
Claims 1, 3, 19, 28, 36-38, 40-43, and 45 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-30 of U.S. Patent No. 12208122. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a method of treating bleeding (e.g. coagulopathy) in a subject by administering a platelet derivative with a salt, organic solvent, buffer and cryoprotectant including the polysaccharide trehalose or polysucrose. They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the method of US ‘122 continues to overlap with the current claims. The difference between US’122 and the current claims is the coagulopathy/bleeding is caused by the administration of an antiplatelet agent. However the current claims are written broadly that read on any source of coagulopathy.
Claim 1, 3, 9, 11, 19, 28, 36-38, and 40-43 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 19053371. Although the claims at issue are not identical, they are not patentably distinct from each other because both claims are to treating bleeding (e.g. coagulopathy) to restore homeostasis in a subject by administering a platelet derivative with a salt, organic solvent, buffer and cryoprotectant including the polysaccharide trehalose or polysucrose either before or after anticoagulant treatment . They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the method of US ‘371 continues to overlap with the current claims. The difference between US’371 and the current claims is the coagulopathy/bleeding is caused by the administration of an antiplatelet agent. However the current claims are written broadly that read on any source of coagulopathy.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 19, 28, 36-38, and 40-43, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-30 of U.S. Patent No. 12295972. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a method of treating bleeding (e.g. coagulopathy) in a subject by administering a platelet derivative with a salt, organic solvent, buffer and cryoprotectant including the polysaccharide trehalose or polysucrose. They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the method of US ‘972 continues to overlap with the current claims. The difference between US’972 and the current claims is the coagulopathy/bleeding is caused by the administration of an antiplatelet agent. However the current claims are written broadly that read on any source of coagulopathy.
Claims 1, 3, 28, 36-38, and 40-43, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-21 of U.S. Patent No. 12370219. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a composition for treating coagulopathy in a subject by administering a platelet derivative with a salt, organic solvent, buffer and cryoprotectant including the polysaccharide trehalose or polysucrose. They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the composition of US ‘219 continues to overlap with the current claims.
Claims 1, 3, 15, 16, 17, 28, 36-38, and 40-43, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 11903971. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a composition for treating coagulopathy caused by von Willebrand disease in a subject by administering a platelet derivative with a salt, organic solvent, buffer, a cryoprotectant including the polysaccharide trehalose or polysucrose, and a antifibrinolytic agents (see current claim 16). They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the composition of US ‘971 continues to overlap with the current claims.
Claims 1, 3, 9, 11, 15, 16, 17, 19, 22-24, 28, 36-38, 40-43 and 45, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 12290532. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a composition for treating coagulopathy caused by von Willebrand disease in a subject by administering a platelet derivative with a salt, organic solvent, buffer, a cryoprotectant including the polysaccharide trehalose or polysucrose, and a antifibrinolytic agents (see current claim 16). They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the composition of US ‘532 continues to overlap with the current claims.
Claims 1, 3, 9, 11, 15, 16, 17, 19, 22-24, 28, 36-38, 40-43 and 45, are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-20 of U.S. Patent No. 11903971. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a composition for treating coagulopathy caused by von Willebrand disease in a subject by administering a platelet derivative with a salt, organic solvent, buffer, a cryoprotectant including the polysaccharide trehalose or polysucrose, and a antifibrinolytic agents (see current claim 16). They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the composition of US ‘971 continues to overlap with the current claims.
Claims 1, 3, 9, 11, 15, 16, 17, 19, 22-24, 28, 36-38, 40-43 and 45 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19234179. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a composition for treating coagulopathy in a subject by administering a platelet derivative with a salt, organic solvent, buffer, and a cryoprotectant including the polysaccharide trehalose or polysucrose. They both teach the same buffers including HEPES as well as phosphate salts. Since treating bleeding will also treat coagulopathy and hemostasis, then the composition of App. ‘179 continues to overlap with the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 3, 9, 11, 15, 16, 17, 19, 22-24, 28, 36-38, and 40-43 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-48 of copending Application No. 18052709. Although the claims at issue are not identical, they are not patentably distinct from each other because both teach a composition for treating coagulopathy to restore homeostasis in a subject by administering a platelet derivative with a salt, organic solvent, buffer, and a cryoprotectant including the polysaccharide trehalose or polysucrose (see App ‘709, claim 33). Since treating bleeding will also treat coagulopathy and hemostasis, then the composition of App. ‘709 continues to overlap with the current claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699