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 .
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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-3, 6, 8, and 11-14 in the reply filed on 19 December 2025 is acknowledged.
Claims 4-5, 7, and 9-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 19 December 2025.
Claim Rejections - 35 USC § 112(b) – 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, 6, 8, and 11-14 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 1 recites a plant-derived exosome, as of the first line of the claim. This would appear to be drawn to a composition. However, on the fourth line of claim 1, that the plant-derived exosomes are given to a particular human derived adipose cell or other cell type. This appears to be a method step.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph. See MPEP 2173.05(p)(II). In this case, it appears as if claims 1-3 and 8-9 are claiming both a product and a process in the same claim, thereby rendering these claims to be indefinite.
Claims 2 and 8 further limit claims 1 and 6 in that claims 2 and 8 further recite how the compositions of claims 1 and 6 are given. Similarly, claims 3 and 9 further limit claims 1 and 6 by reciting how the compositions of claims 3 and 9 are used. These claims appear to be indefinite for similar reasons.
For the purposes of examination under prior art as well as 35 U.S.C. 101, the examiner will examine claim 1 as recite that the plant-derived exosomes are drawn to a composition and are intended to be given to the human-derived adipose cells or other cell type. The examiner will examine claims 2 and 8 as reciting that the plant-derived exosomes are intended to be given to the human-derived adipose cells. The examiner will examine claims 3 and 9 as reciting that the plant-derived exosomes are capable of being used to accelerate a recovery after osteoarthritis or another recited disease.
Claim Interpretation
The skilled artisan would have understood that an exosome refers to a vesicle delineated by material (i.e. membrane lipids and membrane proteins) used to form a cell membrane, but lacking the interior found in cells and lacking organelles and a cell nucleus. Consequently, the term “derived”, as in the recited “plant-derived exosome” is understood to require that the membrane of the exosome be made from membrane lipids and membrane proteins found in and/or obtained from plant cell membranes.
Claim Rejections - 35 USC § 101 – Subject Matter Eligibility
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.
Claims 1-3, 6, 8, and 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural product (e.g. as of MPEP 2106.01(b)(II)) without significantly more. The examiner presents the following argument in support of this position:
Subject matter eligibility is determined in the following manner, as of MPEP 2106(III), wherein the relevant flowchart is reproduced below.
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Step 2A is further divided into two prongs, as per MPEP 2106.04(II)(A), relevant figure reproduced below.
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Regarding Step 1 of the eligibility analysis, the instant claims under examination are drawn to a composition of matter.
Regarding Step 2A, Prong 1 of the eligibility analysis, the examiner understands the instant claims to be drawn to a product of nature, which is a judicial exception. The instant claims recite plant-derived exosomes. The skilled artisan would have understood exosomes to have naturally been present inside a living plant. This determination is made in view of Kalluri et al. (Science, Vol. 367 (640), 2020, pages 1 followed by 1-15). Kalluri et al. (hereafter referred to as Kalluri) teaches that all cells produce extracellular vesicles and that these include exosomes, as of Kalluri, left-most column. As such, the skilled artisan would have expected that exosomes would have been present in natural plants due to plant cells releasing exosomes.
Regarding Step 2A, Prong 2 of the eligibility analysis, this judicial exception is not integrated into a practical application because, while the claims recite that the composition is capable of being used for a particular treatment, the required method of eliciting said treatment is not recited by the claim; this is because the examined claims are composition claims rather than method claims. In support of this position, the examiner cites MPEP 2106.01(d)(2), which teaches the following as of the fourth paragraph of the section.
Examiners should keep in mind that in order to qualify as a "treatment" or "prophylaxis" limitation for purposes of this consideration, the claim limitation in question must affirmatively recite an action that effects a particular treatment or prophylaxis for a disease or medical condition. An example of such a limitation is a step of "administering amazonic acid to a patient" or a step of "administering a course of plasmapheresis to a patient." If the limitation does not actually provide a treatment or prophylaxis, e.g., it is merely an intended use of the claimed invention or a field of use limitation, then it cannot integrate a judicial exception under the "treatment or prophylaxis" consideration.
In this case, the claims are understood to recite that the claimed composition is capable of treating certain conditions. However, for the purposes of examination under 35 U.S.C. 101, the actual steps of treatment of said conditions are not recited by the elected claims; see the above rejection under 35 U.S.C. 112(b). As such, the recited treatments are understood to be intended uses, and do not integrate the judicial exception.
Regarding Step 2B of the eligibility analysis, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not recite additional elements in addition to the exosome.
Claims 13-14 Not Rejected Under 35 U.S.C. 101: This rejection does not apply to claims 13-14. This is because claims 13-14 recite dissolving the plant-derived exosome in 0.9% isotonic serum. As best understood by the examiner, the term “serum” would appear to refer to a liquid. This would appear to be markedly different from the plant-derived exosomes as they exist in nature. This is because the plant-derived exosomes in nature would have been present in the extracellular space between plant cells, which is either a solid environment or a highly viscous environment. In contrast, an 0.9% isotonic serum would appear to have a viscosity similar to that of water, which would appear to be a very different environment from that in which the exosomes existed in their natural environment. This would appear to enable administration by injection, which would not have been possible for a living plant. As such, the environment in which the exosomes are present in claim 13 appears to be markedly different from the environment in which the exosomes were present in nature; as such, claim 13 and claims dependent thereon have not been rejected as patent-ineligible.
Claim Rejections - 35 USC § 102(a)(1) – Anticipation
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 person shall be entitled to a patent unless –
(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) 1-3, 6, 8, and 11-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sahin et al. (WO 2019/027387 A2).
Sahin et al. (hereafter referred to as Sahin) is drawn to a product containing plant-derived exosomes, as of Sahin, title. The plant-derived exosomes may be obtained from wheatgrass, garlic, and ginger, as of Sahin, abstract; Sahin also teaches wheatgrass exosomes, as of Sahin, page 8, relevant text reproduced below.
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This wheatgrass appears to be the same as the material from which the composition of the instant application is obtained; as per the instant specification on page 7, relevant text reproduced below.
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As such, the exosomes of Sahin appear to be essentially the same as those of the instant application, and thereby read on the claimed exosomes.
As to claim 1, the claim recites administering the exosome to particular stem cells or immature cells to produce bone and cartilage cells via differentiation. Sahin does not teach that the wheatgrass exosomes are capable of accomplishing this. Nevertheless, because the exosomes of Sahin appear to be essentially the same as those of the instant invention, the skilled artisan would have expected the exosomes of Sahin to have inherently been capable of this. Something which is old (e.g. the wheatgrass exosomes of Sahin) does not become patentable upon the discovery of a new property (that said exosomes would have been capable of inducing cell differentiation), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Also see MPEP 2112.01(I & II) and MPEP 2114(II), whereupon the rationale regarding “apparatus” claims in MPEP 2114(II) also applies to composition claims such as the pending instant claims.
Additionally as to claim 1, once a reference teaching a product appearing to be substantially identical [to the claimed product] is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden shifts to the applicant. See MPEP 2112(V). In this case, the product of Sahin is drawn to wheatgrass exosomes; in fact, these appear to have been prepared in the same manner as the claimed invention. This determination is made by comparing Sahin, page 8, lines 5-20 with the instant specification on page 7, lines 18-30. As the product of Sahin appears to be wheatgrass exosomes prepared in the same manner as recited by the instant application, there would have been a reasonable expectation that the functions recited by the instant claims would have been inherent in the composition of Sahin.
As to claim 2, the examiner’s position regarding inherency as it relates to claim 1 is also applicable to claim 2.
As to claim 3, the examiner’s position regarding inherency as it relates to claim 1 is also applicable to claim 3.
As to claim 6, Sahin teaches exosomes in the serum form on page 8 line 17.
As to claim 8, the examiner’s position regarding inherency as it relates to claims 1-2 is also applicable to claim 8.
As to claim 11, the examiner’s position regarding inherency as it relates to claim 6 is also applicable to claim 11.
As to claim 12, the examiner’s position regarding inherency as it relates to claim 6 is also applicable to claim 12.
As to claims 13, Sahin teaches the following method for isolating exosomes, as of Sahin, page 8, relevant text reproduced below.
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This appears to be the same process as required by the instantly claimed invention. As such, the skilled artisan would have expected the exosomes of Sahin to have been the same as the claimed exosomes.
As to claim 14, Sahin teaches growing the wheatgrass seeds for 1.5 weeks, as of Sahin, page 8, lines 10-11, relevant text reproduced below.
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As such, the wheatgrass seeds of Sahin were grown for the length of time required by the instant claims. As such, the skilled artisan would have expected the exosomes of Sahin to have been the same as the claimed exosomes.
Note Regarding Reference Date: The instant application ultimately claims foreign priority to a Turkish application filed on 4 January 2021. As such, the earliest effective filing date of the instant application appears to be 4 January 2021. Sahin was published on 7 February 2019. This is over a year earlier than the effective filing date of the instant application. As such, Sahin is prior art under AIA 35 U.S.C. 102(a)(1) due to having been published earlier than the effective filing date of the instant application. As Sahin was published over a year prior to the effective filing date of the instant application, the exceptions under AIA 35 U.S.C. 102(b)(1)(A) or 102(b)(1)(B) would not appear to be applicable.
Claim Rejections - 35 USC § 103 – Obviousness
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.
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.
Claim(s) 1-3, 6, 8, and 11-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sahin et al. (WO 2019/027387 A2).
Sahin et al. (hereafter referred to as Sahin) is drawn to a product containing plant-derived exosomes, as of Sahin, title. The plant-derived exosomes may be obtained from wheatgrass, garlic, and ginger, as of Sahin, abstract; Sahin also teaches wheatgrass exosomes, as of Sahin, page 8, relevant text reproduced below.
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This wheatgrass appears to be the same as the material from which the composition of the instant application is obtained; as per the instant specification on page 7, relevant text reproduced below.
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As such, the exosomes of Sahin appear to be essentially the same as those of the instant application.
As to claim 1, the claim recites administering the exosome to particular stem cells or immature cells to produce bone and cartilage cells via differentiation. Sahin does not teach that the wheatgrass exosomes are capable of accomplishing this. Nevertheless, because the exosomes of Sahin appear to be essentially the same as those of the instant invention, the skilled artisan would have expected the exosomes of Sahin to have inherently been capable of this. Something which is old (e.g. the wheatgrass exosomes of Sahin) does not become patentable upon the discovery of a new property (that said exosomes would have been capable of inducing cell differentiation), and this feature need not have been recognized at the time of filing. See MPEP 2112(I & II). Also see MPEP 2112.01(I & II) and MPEP 2114(II), whereupon the rationale regarding “apparatus” claims in MPEP 2114(II) also applies to composition claims such as the pending instant claims.
Additionally, once a reference teaching a product appearing to be substantially identical [to the claimed product] is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden shifts to the applicant. See MPEP 2112(V). In this case, the product of Sahin is drawn to wheatgrass exosomes; in fact, these appear to have been prepared in the same manner as the claimed invention. This determination is made by comparing Sahin, page 8, lines 5-20 with the instant specification on page 7, lines 18-30. As the product of Sahin appears to be wheatgrass exosomes prepared in the same manner as recited by the instant application, there would have been a reasonable expectation that the functions recited by the instant claims would have been inherent in the composition of Sahin.
As to claim 1, purely en arguendo and in regard to this ground of rejection only, the examiner takes the position that Sahin teaches all of the claimed requirements but not in the same embodiment. As such, the examiner takes the position that, purely en arguendo and in regard to this ground of rejection only, while the prior art teaches all of the claimed components, the prior art is not anticipatory insofar as these components must be selected from various lists/locations in the prior art reference. It would have been prima facie obvious; however, to have selected the recited components from various lists/locations in the prior art reference and to have combined them together. This is because such a modification would have represented nothing more than the predictable use of prior art components according to their established functions. Combining separate prior art components (from a single prior art reference) according to known methods to yield predictable results is prima facie obvious. See MPEP 2143, Exemplary Rationale A.
Additionally in regard to claim 1, the examiner notes that MPEP 2112(III) states that there is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102. The examiner also notes that MPEP 2112(V), first paragraph in section, states that whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same.
As to claim 2, the examiner’s position regarding inherency as it relates to claim 1 is also applicable to claim 2.
As to claim 3, the examiner’s position regarding inherency as it relates to claim 1 is also applicable to claim 3.
As to claim 6, Sahin teaches exosomes in the serum form on page 8 line 17.
As to claim 8, the examiner’s position regarding inherency as it relates to claims 1-2 is also applicable to claim 8.
As to claim 11, the examiner’s position regarding inherency as it relates to claim 6 is also applicable to claim 11.
As to claim 12, the examiner’s position regarding inherency as it relates to claim 6 is also applicable to claim 12.
As to claims 13, Sahin teaches the following method for isolating exosomes, as of Sahin, page 8, relevant text reproduced below.
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This appears to be the same process as required by the instantly claimed invention.
As to claim 14, Sahin teaches growing the wheatgrass seeds for 1.5 weeks, as of Sahin, page 8, lines 10-11, relevant text reproduced below.
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As such, the wheatgrass seeds of Sahin were grown for the length of time required by the instant claims.
Relevant Prior Art – No Rejection
As relevant prior art over which the claims have not been rejected, the examiner cites Sahin et al. (WO 2020/050808 A1). Sahin et al. (hereafter referred to as Tasli after the second inventor) is drawn to plant exosomes for use in the treatment of autoimmune diseases, cell, tissue, and organ transplantation, and Graft vs. Host disease, as of Tasli, title and abstract.
In selecting the references to be used in rejecting the claims, the examiner should carefully compare the references with one another and with the applicant’s disclosure to avoid an unnecessary number of rejections over similar references. The examiner is not called upon to cite all references that may be available, but only the "best." (See 37 CFR 1.104(c).) Multiplying references, any one of which is as good as, but no better than, the others, adds to the burden and cost of prosecution and should therefore be avoided. See MPEP 904.03, third paragraph in section. It is the examiner’s position that Tasli is just as good as but no better than Sahin et al. (WO 2019/027387 A2). This is because Tasli, like Sahin teaches plant-derived exosomes that appear to have the same chemical structure as that of the instantly claimed exosomes but are intended for a different intended use as compared with the claimed plant-derived exosomes. As such, Tasli appears to be just as good as, but no better than Sahin; as such, the examiner has not rejected the claims over Tasli in view of the guidance provided by MPEP 904.03, third paragraph.
Non-Statutory 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, 6, 8, and 11-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 10,881,706. Although the claims at issue are not identical, they are not patentably distinct from each other because for at least the following reasons:
The instant claims are drawn to plant-derived exosomes usable for achieving differentiation of a particular cell type. The exosome may be obtained from wheatgrass, as of instant claim 14.
The conflicting claims are drawn to plant-derived exosomes used for wound healing or cancer treatment which may be obtained from wheatgrass; see conflicting claim 1.
The instant and conflicting claims differ because the instant claims recite that the exosomes are used for various properties which are not recited by the conflicting claims. Nevertheless, the skilled artisan would have expected that the exosomes of the conflicting claims would have been capable of achieving the cell differentiation recited by the instant claims because the exosomes of the conflicting claims are made from the same materials as those disclosed in the instant application. See the rationale discussed in the above-applied anticipation rejection relying upon MPEP 2112(I & II), MPEP 2112(V), MPEP 2112.01(I & II), and MPEP 2114(II), which is also understood to be applicable for this double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612