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 .
Examiner Note: A review of applicant’s specification does not provide any structure to the koji or sake derived vesicles. Just that they are inherently formed and derived when rice, barley, soybean, or yeast are contacted with the Koji or Sake. It seems like the contact with Sake or Koji would inherently produce the inhibiting composition.
Claim Rejections - 35 USC § 112 (Indefiniteness)
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 and 7-12 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.
Regarding claim 1, the claims require inhibiting the binding of the spike protein to ACEII or CD147 of the vesicles.
It is unclear if the ACE II enzyme or CD147 are part of the vesicles or whether they are what the vesicles are acting on.
Looking at applicants claim 4 it seems that the vesicles are inhibiting the ACE II receptor or CD147. Applicant should amend claim 1 to be structurally set similar to claim 4.
Claims 7 and 11 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.
Regarding claims 7 and 11, it is unclear as to how something could be isolated from something that does not contain it. If you have a composition that is considered non-exosome materials, how would you get exosomes. Also, what would non-exosome materials mean if they do have exosomes. A review of the specification shows no explanation that would help interpret this claim.
Claim Rejections - 35 USC § 112 (Written Description – New Matter)
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 7 and 11 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. A review of the specification does not find much if any support for isolation of exosomes, specifically from non-exosome materials. Thus, the introduction of isolation from non-exosome material in the claims amendments on 10/24/24 introduce new matter to the specification.
Claim Rejections - 35 USC § 112 (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 1-3 and 7-12 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 1-3 and 7-12 mechanically is simple in that exosomes (Koji/Sake derived) are used to treat coronavirus infection.
A review of applicant’s specification provides the following:
There was no actual “in vivo” testing of their invention where they validated that corona virus invention is inhibited or treated in humans or any living organism.
The only examples utilize an “in vitro” or controlled environment using a COVID-19 Spike ACE2 Binding Assay kit manufactured by RAYBIO to test binding inhibition.
The control was not even another plant derived exosome but the exosome of an ACE2 protein expressing PNT2 cell. So, it is unclear if Koji or sake loading adds any value from normal plant derived exosomes.
A review of the literature shows that years after the filing date of the instant application, the use of Exosomes to treat SARS-Cov-2 Infection (coronavirus) is not settled. Specifically, Li et al. (Exosomes and SARS-COV-2 Infection) teaches that “exosomes are a double-edged sword in viral infection. Future studies should aim to elucidate these dual roles and examine how exosome-mediated interactions can be harnessed to devise novel therapeutic strategies against COVID-19.” (See conclusion section on page 6).
This reference seems to highlight the issues of in vivo actual use verses in vitro testing.
Additionally, Turner et al. teaches that as of 2023 there were no approved exosome treatments used to treat coronavirus (Covid-19). (See Page 1 left column 1st full paragraph).
Due to post filing literature questioning exosomes effectiveness to treat coronavirus and the lack of actual human trials by the application, the disclosure does not support the fact that applicant had in possession an exosome that could inhibit actual coronavirus infection in a medicinal or pharmaceutical way.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
With respect to claims 4-6 the claimed invention is directed to a product of nature without significantly more. The claim recites an inhibitor (rice koji) that is just a vesicle (exosome) produced from a rice plant that has been loaded with Aspergillus Orzae. This judicial exception is not integrated into a practical application because rice koji can occur in nature because “Aspergillus Oryzae grows on the heads of rice plants in East Asia. This is their optimal breeding ground. It can be found natural in the rice fields of Japan, China, and Korea,a nd harvested by hand by workers tromping through the soggy fields.” (See Miyamoto). The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the applicant has not provided any specific structure or method for forming making koji rice different than what would occur in nature.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muranaka (WO 2020/158930 A1), US2022/0133826 A1 is the English language equivalent of WO 2020/158930 A1).
Regarding claims 1-8, Muranaka teaches a koji rice or miso exosome used in medicinal/pharmaceutical applications with additives (carriers). (See paragraph 0002, 0008, 0032, 0041).
While Muranaka does not explicitly treat coronavirus it must flow from the use of the koji/miso derived exosome so the office assumes that this activity is inherent in Muranaka’s composition.
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 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Muranaka (WO 2020/158930 A1), US2022/0133826 A1 is the English language equivalent of WO 2020/158930 A1) in further view of Zhang (US 20230201244 A1).
Regarding claims 9-12, Muranaka teaches a koji rice or miso exosome used in medicinal/pharmaceutical applications with additives (carriers). (See paragraph 0002, 0008, 0032, 0041).
While Muranaka does not explicitly treat coronavirus it must flow from the use of the koji/miso derived exosome so the office assumes that this activity is inherent in Muranaka’s composition.
With respect to claims 9-12, Muranaka does not teach wherein the Koji/Miso exosomes are applied to treat Coronavirus.
However, Zhang teaches that plant exosomes could treat Coviod-19. (See paragraphs 0044 and 0204).
It would have been obvious to select available plant exosomes like Muranaka’s exosomes to treat covid as suggested by Zhang.
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 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18690212(reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both applications central inventive component is koji derived exosomes and structurally they are the same thing and would be used with acceptable pharmaceutical carriers to allow for medicinal use which is notoriously well known in the art.
Claims 9-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18690212(reference application) in further view of Zhang (US 20230201244 A1) as described above in the 103. Although the claims at issue are not identical, they are not patentably distinct from each other because both applications central inventive component is koji derived exosomes and structurally they are the same thing and would be used with acceptable pharmaceutical carriers to allow for medicinal use which is notoriously well known in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMJAD A ABRAHAM whose telephone number is (571)270-7058. The examiner can normally be reached Mon-Friday 830 AM to 500 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amjad A Abraham can be reached at 571-270-7058. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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AMJAD A. ABRAHAM
SPE AU 1663
Art Unit 1663
/Amjad Abraham/SPE, Art Unit 1663