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 .
Election/Restrictions
Applicant’s election of Group III (claim 10) and SEQ ID NO: 1 in the reply filed on 16 Sep 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
The amended claim set filed 2023 Mar 14 is acknowledged. Claims 1-16 are currently pending. Of those, claims 1-7, 10-11, 14, and 16 are currently amended, and no claims are new. Claims 1-9 and 11-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 16 Sep 2025. No claims are cancelled. Claim 10 will be examined on the merits herein.
For clarity of the record, references to the specification use paragraph numbers from the Pre-Grant Publication US-20240294864-A1 (PTO-892).
Priority
Acknowledgment is made of applicant's claim for priority under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) based upon an application filed in EP20306016.5 on 11 Sep 2020. The claim for priority cannot be based on said application because the subsequent nonprovisional or international application designating the United States (PCT/EP2021/075121, filed 13 Sep 2021) was filed more than twelve months thereafter and no petition under 37 CFR 1.55 or request under PCT Rule 26bis.3 to restore the right of priority has been granted.
Applicant may wish to file a petition under 37 CFR 1.55(c) to restore the right of priority if the subsequent application was filed within two months from the expiration of the twelve-month period and the delay was unintentional. A petition to restore the right of priority must include: (1) the priority claim under 35 U.S.C. 119(a)-(d) or (f), 365(a) or (b), or 386(a) in an application data sheet, identifying the foreign application to which priority is claimed, by specifying the application number, country (or intellectual property authority), day, month, and year of its filing (unless previously submitted); (2) the petition fee set forth in 37 CFR 1.17(m)(3); and (3) a statement that the delay in filing the subsequent application within the twelve-month period was unintentional. The petition to restore the right of priority must be filed in the subsequent application, or in the earliest nonprovisional application claiming benefit under 35 U.S.C. 120, 121, 365(c), or 386(c) to the subsequent application, if such subsequent application is not a nonprovisional application. The Director may require additional information where there is a question whether the delay was unintentional. The petition should be addressed to: Mail Stop Petition, Commissioner for Patents, P.O. Box 1450, Alexandria, Virginia 22313-1450.
Therefore, effective filing date for claim 10 used to search the art is 13 Sep 2021.
Information Disclosure Statement
The information disclosure statements (IDS), both submitted on 25 Aug 2023, were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner. Signed copies of these statements are attached with this action.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Objections
Claim 10 is objected to as being dependent on a withdrawn base claim (claim 7). The claim should be amended so claim 10 is complete. Appropriate correction is required.
Also, abbreviations such as “siRNA”, “miRNA”, and “EV” should be defined at their first use.
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.
Claim 10 is 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.
MPEP 2173.05(q) states: “Attempts to claim a process without setting forth any steps involved in the process generally raises an issue of indefiniteness under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. For example, a claim which read: "[a] process for using monoclonal antibodies of claim 4 to isolate and purify human fibroblast interferon" was held to be indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. Ex parte Erlich, 3 USPQ2d 1011 (Bd. Pat. App. & Inter. 1986).”
Claim 10 reads “A method for treating a parasitic infection and/or infectious disease in plants, said method comprising the use of the Chlorella-derived EV as defined in claim 7”. This claim, like the claim in Erlich, does not recite any steps, and only claims using the Chlorella-derived EVs.
Claim Rejections - 35 USC § 112(a)
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.
Claim 10 is 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 treating a parasitic infection and/or infectious disease in plants with method steps involving Chlorella-derived extracellular vesicle (EV) containing a population of functional small interfering RNAs (siRNAs) targeting genes essential for said parasite and/or pathogen’s growth or virulence, does not reasonably provide enablement for treating a parasitic infection and/or infectious disease in plants using any Chlorella-derived extracellular vesicle (EV) containing a population of functional small interfering RNAs (siRNAs) targeting any generic target gene, which may or may not have any relationship to the infection to be treated. 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.
The factors to be considered in determining whether a disclosure would require undue experimentation include: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) and MPEP 2164.01. Although all factors were considered, the Wands factors that were most relevant for this decision are discussed in detail below.
The breadth of the claims: Claim 10 reads “A method for treating a parasitic infection and/or infectious disease in plants, said method comprising the use of the Chlorella-derived EV as defined in claim 7”. The Chlorella-derived EVs are a product defined by their process of making (see withdrawn claim 7).
MPEP 2113.I states: “"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). … The structure implied by the process steps should be considered when assessing the patentability of product-by-process claims over the prior art…” The process in claim 7 results in EVs with the following properties: being derived from Chlorella would impart structural features to the proteins and lipids making up the EVs and would be distinct from other species EVs (note the specification teaches different proteins present in different species in Table 1 [0288]). Also, claim 7 requires the EV contain “a population of functional small iRNAs targeting one or several region(s) in said at least one target gene(s).” There is no evidence of record that the other steps of claim 7 impart structure to the product used in claim 10, especially in view of Examples 11-12 which teach that EVs produced by different culture conditions have the same size distribution [0398] and antibacterial efficacy [0400].
Importantly, claim 10 states the EVs can contain any “functional small iRNAs targeting one or several region(s) in said at least one target gene(s)”, and the claim requires that these EVs be useful “for treating a parasitic infection and/or infectious disease in plants” with a reasonable expectation of success.
The amount of direction provided by the inventor and the existence of working examples: The specification teaches that the effect of small RNAs is to silence corresponding genes [0003, 0005]. The specification teaches that this effect is sequence specific, and the specification teaches that a recombinant bacteria can be produced that expresses a small RNA-resilient version of the hrpL gene that contains as many silent mutations as possible in the small RNA targeted region, in order to alter the binding of anti-hrpL small RNAs to hrpL mRNAs, whilst producing wild type HrpL proteins [0293]. In the working examples, the data of Examples 5-6 and 8 show that the Chlorella-derived EVs are consistent with the previous teachings about the properties of small RNAs. The specification states “The results reported in EXAMPLES 5 and 6 provide thus a proof-of-concept demonstrating that Chlorella can be engineered to produce effective antibacterial small RNAs acting in a sequence-specific manner.” [0293]
The state of the prior art: The specification cites to the prior art in many locations in order to support their statements. A search of the art has not identified references teaching that small RNA interference works differently than described by the specification.
The level of predictability in the art: In view of the art and the experimental data, there is a high level of predictability that Chlorella-derived EVs will exhibit anti-pathogen activities in a sequence specific manner.
The quantity of experimentation needed to make or use the invention: The standard of an enabling disclosure is not the ability to make and test if the invention works but one of the ability to make and use with a reasonable expectation of success and without undue experimentation. A patent is granted for a completed invention, not the general suggestion of an idea (MPEP 2164.03 and Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1325-26 (Fed. Cir. 2004).
The instant specification is not enabling across the scope claimed because the specification teaches that Chlorella-derived EVs exhibit anti-pathogen activities in a sequence specific manner, but the claims require that the function of “treating a parasitic infection and/or infectious disease in plants” be performed with a broader range of siRNAs that could target any generic gene(s). For example, there is no amount of experimentation that would permit an anti-mammalian actin siRNA to treat bacterial disease in plants, because bacteria are not mammals and do not comprise mammalian actin genes. No amount of experimentation will make the siRNAs within the Chlorella-derived EVs behave in a non-sequence specific manner, based on the teachings of the art and the specification.
The amount of experimentation required for enabling guidance, commensurate in scope with what is claimed, goes beyond what is considered ‘routine' within the art, and constitutes undue further experimentation in order to use the method with a reasonable expectation of successfully treating a parasitic infection and/or infectious disease in plants using Chlorella-derived EVs comprising any siRNAs targeting any generic target gene(s). Therefore, claim 10 is rejected under 35 U.S.C. §112(a) or 35 U.S.C. §112, first paragraph, for failing to meet the enablement requirement.
When considering potential responses and/or amendments, applicant is reminded of this unusual definition from the specification: “As used therein, the term “virulence gene” refers to any bacterial gene that has been shown to play a critical role for at least one of the following activity: pathogenicity, disease development, colonization of a specific host tissues (e.g., vascular tissues) or host cell environment (e.g., the apoplast), suppression of plant defense responses, modulation of plant hormone signaling and/or biosynthesis to facilitate multiplication and/or disease development, interference with conserved host regulatory processes to facilitate multiplication and/or disease development, etc.” [0159]. The specification’s definition differs from the typical definition of being used for both bacterial and also non-bacterial pathogens.
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.
Claim 10 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of copending Application No. 18/044,868 in view of Wang et al. (2017; PTO-892). This is a provisional nonstatutory double patenting rejection.
‘868 claim 10 reads “A method for treating a parasitic infection and/or infectious disease, comprising administering in a subject in need thereof the Chlorella-derived EVs as defined in claim 7.”, and ‘868 claim 7 confirms that “said EV contain[s] a population of functional small iRNAs targeting one or several region(s) in said at least one target gene(s).” This is identical to the instant claim 10 except that instant claim 10 requires that the method is performed in plants. Wang et al. teaches that it is possible to suppress fungal diseases by directly applying pathogen–targeting RNAs on crops and post-harvest products (Abstract), and teaches that antimicrobial RNAs have been used in plants to protect against plants against nematodes, insects, fungi, and oomycetes (summarized at pg. 136 col. 2 par. 4). Therefore, one of ordinary skill in the art would consider it obvious to apply the siRNA-containing Chlorella-derived EV therapy to treat parasitic infection and/or infectious disease in plants specifically, instead of the generic subject in the claims of ‘868, because Wang teaches that siRNA therapies are well known to be useful to achieve the disclosed beneficial function in plants. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination.”
Additional Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Navarro et al. (WO 2020035620 A1, published 20 Feb 2020; PTO-892) teaches the use of plant EVs comprising siRNA to reduce bacterial growth, survival and / or pathogenicity (Abstract). The reference does not mention algae or Chlorella specifically.
Lin et al. (2013; PTO-892) teaches Chlorella transformed with short interference RNA antisense-psbO (siRNA-psbO) fragments, and teaches that the resulting RNA structure was functional when expressed and can be used to knock down the corresponding gene by as much as 10-fold (Abstract). The reference does not mention extracellular vesicles, whether the Chlorella produced EVs, or whether the siRNA fragments were present in the EVs.
Kuruvinashetti et al. (July 29-31 2020; PTO-892) teaches that EVs from “green algae” have therapeutic applications including being loaded with a therapeutic agent (Abstract), and specifically teaches that “Exosome’s RNA can be used as the RNA based therapeutics for drug delivery, and target them into a specific cellular compartment” (pg. 357 col. 1 par. 9). The reference does not mention Chlorella specifically.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMELIA NICOLE DICKENS whose telephone number is (571)272-0381. The examiner can normally be reached M-R 8:30-4:30, and every other F 8:30-4:30 (EDT/EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Gary Nickol can be reached at (571)272-0835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/AMELIA NICOLE DICKENS/Examiner, Art Unit 1645
/GARY B NICKOL/Supervisory Patent Examiner, Art Unit 1645