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 .
Status of the Claims
Claims 2-6 and 13-27 are currently pending.
Claims 2-6, 13-19, 21-22, 24, and 26-27 are amended.
Claims 1, 7-12, and 28-50 are cancelled.
Claims 2-6 and 13-27 have been considered on the merits.
Claim Objections
Claim 2 is objected to because of the following informalities: an “and” needs to be inserted between “a base,” and “a loading agent”. In line 5. Appropriate correction is required.
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 2-3, 6, 13-21, and 24-27 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 18, 53, 56, and 73 of U.S. Patent No. US11965178B2 (‘178). Although the claims at issue are not identical, they are not patentably distinct from each other because the invention of the independent claim 2 is wholistically encompassed by the method of claim 1 of ‘178.
The instant claim 2 requires the two steps of (a) providing platelets, and (b) treating the platelets with a drug and with a loading buffer comprising a salt, a base, and a loading agent to form the drug-loaded platelets. Claim 1 of ‘178 recites the steps of (a) providing platelets and (b) treating the platelets with a small molecule cancer chemotherapy drug in the presence of a loading buffer comprising a salt, a base, and a loading agent. Therefore, the method of the instant claim 2 is encompassed fully by claim 1 of ‘178. Additionally, instant claim 13 limits wherein the loading agent is a mono- or disaccharide and instant claim 14 limits wherein the loading agent is chosen from a group containing trehalose; which are both fully encompassed by the loading agent being limited to trehalose in claim 1 of ‘178. Instant claim 16 limits wherein the platelets are loaded with the drug in a period of time of 5 min to 48 hours which is encompassed by claim 73 of ‘178. Instant claim 17 limits wherein the concentration of the drug in the platelets is 1nM to 100mM, which is fully encompassed by claim 1 of ‘178. Instant claim 18 limits wherein the organic solvent is chosen from the listed organic solvents, which is fully encompassed by claim 18 of ‘178. Instant claim 19 contains the limitation of further cold storing, cryopreserving, freeze-drying, thawing, rehydrating, or combinations and instant claim 20 limits to specifically freeze-drying and instant claim 21 limits wherein the platelets are rehydrated; which is fully encompassed by claims 1, 53, and 56. Instant claim 27 limits wherein the method does not comprise an organic solvent which is fully encompassed by claim 1 of ‘178.
Claim Rejections - 35 USC § 112(a)
Written Description
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 2-6 and 13-27 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 4, and 5 recite the limitation of treating platelets with a drug. The claims do not limit the drug to any specific drug genus or species at any point. The specification describes a drug as “the term "drug" refers to any agent suitable for the treatment of cancer other than a messenger RNA” ([0182]). The specification describes the use of Doxorubixin, Olaparib, and Paclitaxel as the drug in the method of loading the platelets with a drug in the Examples.
Although the specification describes various methods of loading drugs into platelets, including passive diffusion, endocytosis, electroporation, and liposome-mediated delivery, and provides examples across select drug types, the claims remain broadly directed to any drug. While the disclosure may enable the skilled artisan to perform these method with reasonable predictability, it does not demonstrate possession of the entire genus of any drug, or any drug suitable for the treatment of cancer. Therefore, the entire genus of any drug which is suitable for the treatment of any cancer cannot be readily envisioned. The disclosure is limited to Doxorubixin, Olaparib, and Paclitaxel and lacks a sufficient description of structural features or other characteristics that would allow a person of ordinary skill in the art to visualize or recognize the claimed genus of drugs beyond those examples.
Therefore, the concept of any drug and/or the concept of any suitable drug for the treatment of any cancer, lacks written description other than the drugs taught in the examples: Doxorubixin, Olaparib, and Paclitaxel.
Claim Rejections - 35 USC § 112(b)
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 20-21 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.
Claim 20 recites the limitation "the drying step" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 21 recites the limitation "the drying step" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 2-6 and 13-27 are rejected under 35 U.S.C. 103 as being unpatentable over Xu et al (Scientific Reports, “Doxorubicin-loaded platelets as a smart drug delivery system: An improved therapy for lymphoma”, 2017) in view of Ho et al (US20070243178A1).
With regards to claim 2, Xu teaches a method of preparing drug-loaded platelets through the steps of providing platelets (pg. 11, para 5); and treating the platelets with a drug and loading buffer, PBS, which contains a salt and a base (pg. 11, para 6). Xu teaches that the platelets are treated with PBS prior to treating the platelets with a drug; additionally, the platelets are treated with PBS and the drug; finally that the platelets with the drug are treated in PBS, therefore Xu teaches that the platelets are both treated with the drug in either sequential order and/or concurrently as required by claims 3-5, and 6 (pg. 11, para 5-6). Xu teaches that the platelets are isolated prior to the treating step as required by claim 15 (pg. 11, para 5). The platelets are loaded with the drug for 1 hour which falls within the claimed range of between 5 min and 48 hours as required by claim 16 (pg. 11, para 6). The concentration of the drug tested ranged from 0.025 to 0.4 mM which falls withing the claimed range of 1 nM to 100 mM as required by claim 17 (Fig.2 D; see concentration range). Xu teaches that the drug is modified with an imaging agent prior to treating the platelets with the drug and that the platelets are treated and loaded with the drug-imaging agent conjugate as required by claims 24-26 (pg. 2, para 3; and Fig. 2A(b)). Additionally, Xu teaches that the method does not comprise treating with an organic solvent as the materials and methods section of Xu makes no mention of treatment with an organic solvent as required by claim 27 (pg. 11, para 5-6; methods section in entirety). Finally, Xu teaches drug-loaded platelets as required by claim 22 (pg. 11, para 5-6).
Xu does not teach that the loading buffer contains a loading agent as required by claims 2 and 4-5. Xu does not teach that the loading agent is a mono- or disaccharide as required by claim 13. Xu does not teach that the loading agent is selected from sucrose, maltose, trehalose, glucose, mannose, or xylose as required by claim 14. Xu does not teach the inclusion of one or more organic solvents listed in claim 18 as required by claim 18. Xu does not teach the cold storing, cryopreserving, freeze-drying, thawing, rehydrating, and combinations thereof as required by claim 19. Xu does not teach that the “drying” comprises freeze-drying as required by claim 20. Xu does not teach rehydrating as required by claim 21. Xu does not teach dried and rehydrated drug loaded platelets as required by claim 23.
However, Ho discloses a method of producing freeze-dried and/or rehydrated platelets for therapeutic purposes. Ho discloses that the platelets of the invention can be incubated with drugs prior to use in treatment of individuals ([0114]). Ho discloses the loading of trehalose into platelets prior to freeze-drying to provide freeze-dried trehalose stabilized platelets as required by claims 2, 3-4, 13-14, and 19-20 ([0043]/[0047]). Ho also discloses that the saccharide stabilizer can also be maltose, sucrose, glucose, mannose, or xylose as required by claims 13 and 14 ([0147]). Ho discloses that the platelets are able to be cold stored or cryopreserved ([0038]), freeze-drying ([0046]/[0170]), thawing ([0151]), and rehydrated ([0046]/[0170]/[0154]) as required by claims 19, 21, and 23. Finally, Ho teaches that the composition that it suitable for loading trehalose into platelets can additionally comprise ethanol as required by claim 18 and as optionally required by claims 4-5 ([0132]).
One of ordinary skill in the art would find it obvious at the effective filling date of the instant invention to combine the drug loaded platelets taught by Xu with the platelet loading agent and platelet freeze-drying process taught by Ho to arrive at the instant invention. One of ordinary skill in the art would be motivated to make this combination because Ho teaches both the development of freeze-dried platelets for therapeutic purposes and Ho discloses that the platelets of the invention can be incubated with drugs prior to use in treatment of individuals ([0114]). One of ordinary skill in the art would have a reasonable expectation of success when combining Xu with Ho because Ho teaches that the method provides “freeze-dried platelets that, upon reconstitution, function well in the process of blood clotting, and thus can be used successfully in therapeutic applications” ([0046]).
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the effective time of filing of the invention, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/KARA D JOHNSON/Primary Examiner, Art Unit 1632