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 .
Response to Amendment
The Amendment filed 01/27/2026 has been entered. Applicant’s amendments are in response to in the Non-Final Office Action mailed 10/27/2025. Applicant’s claims have been amended in the following manner: independent claim 1 has been modified by inclusion of limitations from now-cancelled claims 2 and 3, respectively. Thus, claim 1 now represents a narrower interpretation of the now-cancelled claims 2 and 3. The ground of rejection remains the same as before, with minor editing related to the amendments. The following objections/rejections are withdrawn: 112b (regarding “about”; however, Applicant did not respond to the 112b rejection, regarding broad and narrow ranges in claim 7 of the previous Office Action, which is therefore, maintained) rejection.
The Examiner further acknowledges the following:
Claims 1 and 4-20 are pending.
Claims 9-20 are withdrawn from consideration as directed to non-elected inventions.
Claims 1 and 4-8 are presented for examination and rejected as set forth below.
Claim Objection
Claim 1 recites “including a natural or synthetic polymers” where the term “polymers” should not be plural. Appropriate correction is required.
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.
Claim 7 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.
Claim 7 still recites broad and narrow ranges. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. For examination purposes, the broadest ranges are used. Applicant can select a single range to represent the claim scope (either a broad or narrow one).
Claim Rejections - 35 USC § 103
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 1, 4-5, and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US20230106258A1; published 04/06/2023), and in further view of Zarrintaj (Bioeng Transl Med., 2022), and Li (Food Hydrocolloids, 2019).
Applicant’s claims (especially independent claim 1) are directed to a composition, comprising: a plurality of exosomes; and a polymer-polymer complex including a natural or synthetic sulfated polymers crosslinked comprising carrageenan with a crosslinking agent cationic polyamine comprising E-poly-L-lysine. Furthermore, the term “including” or “includes” used throughout the claim set (claims 1 and 5-6) is interpreted to have the same meaning as “comprising” or “comprises.” Such that: The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended.").
Furthermore, the term “crosslinked” describing the “polymer-polymer complex” of instant claim 1 is further considered, such that claim 1 is written in a way that describes a general crosslinking of the “natural or synthetic sulfated polymer crosslinked” with no specific instruction of the nature of the crosslinking. To understand how this broad interpretation compares to Applicant’s embodiment, the Specification was referred to. According to Applicant’s specification, cross-linking occurs during an electrostatic interaction between cationic polylysine and anionic sulfates of carrageenan [0061-0062]. Thus, the mixing of the two individual ingredients is expected to form a cross-linked network, where Applicant demonstrates cross-linking conditions in a more general sense [0054] and also, to result from mixing of 3 wt% carrageenan, 0.21 wt/% polylysine, and 0.09 wt% NaOH in 96.7 wt% water at high temperature [0064].
Cho teaches a method of preparing an ultra-high concentration medical exosome solution composition (abstract). Cho’s exosome technology also has application to cosmetics [0054].
Regarding claim 1: Cho teaches “modifying” exosomes with “functional materials” to make “functional exosomes” (Cho – claim 1). “Functional materials” can include the biocompatible polymers such as polylysine (reads on cationic polyamine) and carrageenan (reads on natural or synthetic sulfated polymer) [0043-0044]. In the present disclosure, the term “modification” means loading or crosslinking functional materials (e.g.: biochemical substances) on the surface of the double lipid membrane of exosomes or inside of exosomes [0042]. Thus, the instant complex resulting from crosslinking a sulfated polymer like carrageenan combined with a cationic polyamine like poly-L-lysine (i.e., from instant claim 1) is obvious.
Regarding claim 5: Cho teaches stem cell exosomes [0048].
Regarding claim 7: Cho teaches exosome amounts in 20 billion exosome particles/1 mL or 1 trillion/50 mL (thus, reading on the broader range recited in instant claim 7) [0054], where the dose varies (and could be potentially optimized) with the type of application [0054].
In summary, Cho teaches a composition comprising exosomes and crosslinked biocompatible polymers such as carrageenan and polylysine as a way of “modifying” the exosomes. However, Cho does not teach specifically Epsilon-poly-L-lysine (instant claim 1), the molar ratio of the sulfated polymer to polyamine (instant claim 4).
Zarrintaj teaches the different types of polylysine (pg 7, figure 1). Based on the inherent feature of using only lysine in a polylysine, there is a finite number of polylysines that make up the group of polylysines including the Epsilon variant, as taught by Zarrintaj (pg 7, figure 1), which would be obvious to try based on the general teaching of genus polylysine by Cho [0042-0044].
Li teaches that carrageenan and E-polylysine (note that this polymer has a number of representative nomenclatures such as PLL or epsilon-polylysine or Epsilon-poly-L-lysine), made from L-lysine (pg 212, paragraph 3) synergistically combine to provide favorable interaction mechanisms on gel properties (abstract), including in applications to cosmetics and drugs (pg 212, paragraph 1). For example, the storage modulus, gel-sol transition temperature, thermal stability, and decrease in water mobility increases with polylysine addition (abstract), making the ratio of carrageenan and Epsilon-poly-L-lysine as result-effective variable, that a PHOSITA would optimize to improve final properties of the product for application. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation). Furthermore, Li teaches Epsilon-poly-L-lysine concentrations of 0.05 to 0.3 w/v% compared to 1 w/v% carrageenan (note this ratio overlaps with the instant range in claim 4). Thus, Li teaches the benefits of combining carrageenan and Epsilon-poly-L-lysine in specific amounts for the improvement of gel properties. Furthermore, the carrageenan and polylysine mixtures (i.e., KCP notation) are made analogously (by heating and mixing, pg 213, ‘2.2. gel preparation’) to Applicant’s Specification [0054-0064], where the cross-linking interaction of the polylysine cationic amine and carrageenan anionic sulfate would be expected. Additionally, KCP is described as a crosslinked network (pg 215, paragraph 1), with improved network formation and gel strength compared to carrageenan (KC) only gels (pg 214, paragraph 1).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Cho with the Epsilon variant of polylysine (i.e., Epsilon-poly-L-lysine) because it is a common polylysine employed in gel formation for topical use, as taught by Zarrintaj and Li, wherein the primary reference Cho teaches polylysine generally [0042-0044]for therapeutic delivery in terms of delivering proteins and genetic materials to cells around lesion tissues [0005].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Cho with the Epsilon-poly-L-lysine to carrageenan ratios taught by Li because Li teaches the ratio of Epsilon-poly-L-lysine to carrageenan modifies and synergistically improves the rheological properties of final compositions for cosmetic use, where Cho discusses formulation types of exosomes for cosmetic and medical use [0054]. Furthermore, the cross-linked KCP (i.e., carrageenan and polylysine compositions) of Li (pg 215, paragraph 1), provide improved network formation and gel strength compared to carrageenan (KC) only gels (pg 214, paragraph 1).
Claims 1, 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (US US20230106258A1), Zarrintaj (Bioeng Transl Med., 2022), and Li (Food Hydrocolloids, 2019), as applied to claims 1, 4-5, and 7, and in further view of Ou (CN113616586A; machine translation provided), and Mukherjee (Acta Pharmacologica Sinica, 2022).
As discussed above, Prior Art teaches a composition comprising exosomes and crosslinked biocompatible polymers such as carrageenan and Epsilon-poly-L-lysine, as a way of “modifying” the exosomes. However, the Prior Art does not teach plant exosomes (instant claim 6), and the positioning of the exosome inside/outside a liposome (instant claim 8).
Ou teaches 1-5 wt% plant exosome for incorporation into a skin care product composition for a soothing and relieving effect (abstract). Ou teaches plant exosomes are enriched with active lipids, proteins, RNA, and other components that can have beneficial effects on skin [n0003-n0004].
Mukherjee teaches exosome-liposome hybrids (figure 6) and liposomes with layered orientations (figure 3). Mukherjee teaches liposomes as vehicles for drugs, and exosomes also carry active ingredients (abstract). Furthermore, exosome-liposome hybrids are known to deliver active ingredients as next-generation drug delivery vehicles (pg 2770, last paragraph) by for example tuning efficacy, pH-triggered drug release, improved pharmacokinetics, lower immunogenicity, better stability, and targeting (pg 2772, first paragraph). The layering of an exosome inside or outside of a liposome is obvious based on the visual image of an OLV and MVV that shows liposome-like structures can be layered, which could obviously provide an additional degree of functionalization (figure 3).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Cho with the amounts and use of plant exosomes as taught by Ou because Ou teaches plant exosomes in the 1-5 wt% range are useful in soothing the skin because they have active compounds with beneficial effects on skin [abstract, n0003-n0004]. Furthermore, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (see 2144.05(I)). See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). Ou teaches typical amounts wherein an exosome demonstrates activity in a topical formulation for skin benefits, where Cho teaches a technology to obtain ultra concentration of exosomes for use in cosmetics [0054].
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the compositions of Cho by developing multilayered exosome-liposome hybrids because exosome-liposome hybrids are known to deliver active ingredients as next-generation drug delivery vehicles (pg 2770, last paragraph) by for example tuning efficacy, pH-triggered drug release, improved pharmacokinetics, lower immunogenicity, better stability, and targeting (pg 2772, first paragraph) and the multilayered nature would provide an additional degree of functionalization capability.
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 and 4-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable the copending Applications listed below, and in further view of Cho (US20230106258A1), Zarrintaj (Bioeng Transl Med., 2022), Li (Food Hydrocolloids, 2019), Ou (CN113616586A; machine translation provided), and Mukherjee (Acta Pharmacologica Sinica, 2022):
claims 1-6 and 8-20 of copending Application No. 17/713,679 (reference application)
claims 1-6 of copending Application No. 17/952,593 (reference application)
claims 1-7 of copending Application No. 18/438,944 (reference application)
claims 1-20 of copending Application No. 19/196,805 (reference application)
claims 1-20 of copending Application No. 19/284,978 (reference application)
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach a composition ‘comprising’ a plurality of exosomes in the presence of epsilon poly-L-lysine. The copending applications differ only significantly by not including a synthetic sulfated polymer such as carrageenan to crosslink with the cationic polyamine such as epsilon poly-L-lysine and the inclusion of plant exosomes, and the layering of exosomes with liposomes.
This is remedied by the secondary references above (also taught in the 103 rejection), where the advantages of combining the secondary elements are presented in the 103 rejection above (e.g., the carrageenan and polylysine and crosslinking to modify the exosome provides modified exosomes that can be mass-produced for use in medicine or cosmetics at ultra-high concentrations, as taught by Cho [0042-0044, 0050-0052]). The motivations for incorporating the other references are detailed in the 103 rejection above.
This is a provisional nonstatutory double patenting rejection.
Claims 1 and 4-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over the Patents listed below, and in further view of Cho (US20230106258A1), Zarrintaj (Bioeng Transl Med., 2022), Li (Food Hydrocolloids, 2019), Ou (CN113616586A; machine translation provided), and Mukherjee (Acta Pharmacologica Sinica, 2022):
claims 1-6 of Patent 11931458
claims 1-9 of Patent 12390560
claims 1-20 of Patent 12409136
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim sets teach a composition comprising a plurality of exosomes in the presence of epsilon poly-L-lysine. The Patents differ only significantly by not including a synthetic sulfated polymer such as carrageenan to crosslink with the cationic polyamine such as epsilon poly-L-lysine and the inclusion of plant exosomes, and the layering of exosomes with liposomes.
This is remedied by the secondary references above (also taught in the 103 rejection), where the advantages of combining the secondary elements are presented in the 103 rejection above (e.g., the carrageenan and polylysine and crosslinking to modify the exosome provides modified exosomes that can be mass-produced for use in medicine or cosmetics at ultra-high concentrations, as taught by Cho [0042-0044, 0050-0052]). The motivations for incorporating the other references are detailed in the 103 rejection above.
Response to Arguments
Applicants arguments, see pg 5-11, filed 01/27/2026, with respect to the 103 rejection of claims 1-8 have been fully considered but they are not persuasive. The 103 rejection has been modified with respect to amendments made to the claim set. The ground of the rejection remains the same as before, relying on the same references, with minor editing in line with the amendments made.
On page 5, Applicant argues that the term “about” is defined by a range of experimental error, and further defined within the context of the Specification [0011]. This is persuasive, and the 112b rejection is removed, without requiring amending to the term “about”.
Note that the 112b rejection based on broad and narrow limitations was not addressed in the remarks.
On page 5-10, Applicant presents a piecewise method of argumentation against each reference individually. The Examiner will treat the collective arguments of pg 5-10, as a whole, in the interest of conciseness, and references the 103 rejection the rationale behind the pieces of Art that combine to demonstrate obviousness.
The general recognized theme of the arguments is that the references are treated piecewise, which is per se unpersuasive. It is the combined teachings that define the art. However, the Examiner will respond to arguments of substance when presented.
Note that each reference need not teach all elements: All elements of each prior art reference need not read on the claimed invention, rather, the proper test for obviousness is what the combined teachings would have suggested to a person of ordinary skill in the art. In re Kotzab, 217 F.3d 1365, 1370 (Fed. Cir. 2000). Furthermore, in consideration of whether the references serve as analogous art: Applicant is reminded that the scope of analogous art is to be considered broadly. Wyers v. Master Lock Co., No. 2009-1412, 2010 WL 2901839 (Fed. Cir. July 22, 2010). Art is analogous if it is (1) from the same field of endeavor, regardless of the problem addressed, or (2) reasonably pertinent to the particular problem with which the inventor is involved. In re Clay, 966 F.2d 656, 658–59 (Fed. Cir. 1992). Herein, all Prior Art references are reasonably pertinent to the instant invention (see 103 rejection above) with rationale to combine. Particular attention is paid to arguments against the closest prior art Cho (see below).
With regard to the recitation of case law provided by Applicant on pg 8-9 (section containing underlined material) for combining references, the Examiner has provided suitable rationale in the 103 rejection above to combine references (that was reorganized based on the amending of limitations by Applicant but carries the same basic ground of rejection as the previous action). When Applicant recites case law, and then makes a conclusory statement that a combination of references is not obvious, that does not constitute a specific argument that can be rebutted.
The only specific argument of substance that can be consistently identified is that the instant invention has an effect of “preserving exosomes by deterring disadvantageous occurrences such as, for example, aggregating or clumping and making the exosome composition more stable” (see pg 6, 7 (3 times), 8 (2 times), 9, and 10). In response to this, in an obviousness analysis, it is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention); Cross Med. Prods., Inc. v. Medtronic Sofamor Danek, Inc., 424 F.3d 1293, 1323, 76 USPQ2d 1662, 1685 (Fed. Cir. 2005) (“One of ordinary skill in the art need not see the identical problem addressed in a prior art reference to be motivated to apply its teachings.”); In re Lintner, 458 F.2d 1013, 173 USPQ 560 (CCPA 1972) (discussed below); In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990), cert. denied, 500 U.S. 904 (1991). Thus, proper rationale can be found in the 103 rejection above to combine references for an obviousness rejection.
Furthermore, Applicant argues that Cho does not teach “crosslinking agents” such as E-poly-L-lysine (pg 6). However, Cho teaches “modifying” exosomes with “functional materials” to make “functional exosomes” (Cho – claim 1). “Functional materials” can include the biocompatible polymers such as polylysine (reads on cationic crosslinking agent, since Applicant defines polylysine as a cationic crosslinking agent – see Applicant’s Specification [0031], and a compound and its properties are inseparable) and carrageenan (reads on natural or synthetic sulfated polymer) [0043-0044]. In the disclosure, the term “modification” means loading or crosslinking functional materials (e.g., biochemical substances) on the surface of the double lipid membrane of exosomes or inside of exosomes [0042] such that the configuration of claim 1 (as interpreted at the beginning of the 103 rejeciton) is obvious. Furthermore, Li teaches the carrageenan and polylysine mixtures (i.e., KCP notation) are made analogously (by heating and mixing, pg 213, ‘2.2. gel preparation’) to Applicant’s Specification [0054-0064], where the cross-linking interaction of the polylysine cationic amine and carrageenan anionic sulfate would be expected. Additionally, Li teaches KCP as a crosslinked network (pg 215, paragraph 1), with improved network formation and gel strength compared to carrageenan (KC) only gels (pg 214, paragraph 1).
Thus, the instant composition resulting from crosslinking a sulfated polymer like carrageenan combined with a cationic polyamine like poly-L-lysine (i.e., from instant claim 1) in the presence of exosomes is obvious. Cho alone teaches a combination of polylysine and carrageenan to modify exosomes [0044], where polylysine by definition of its identity is a crosslinking cationic polyamine [0042-0044] (i.e., a chemical and its properties are inseparable), where cross-linking is proposed [0042]. Furthermore, the species E-poly-L-lysine could be at once envisaged, as the polylysine used by Cho [0044], because it is commonly used in the hydrogel art (see Li) and one of few polylysine variants known in the Art of the larger grouping of polylysine (see Zarrintaj).
In regard to the claim that the instant invention has an effect of “preserving exosomes by deterring disadvantageous occurrences such as, for example, aggregating or clumping and making the exosome composition more stable” (see pg 6, 7 (3 times), 8 (2 times), 9, and 10), when Cho teaches the instant combination of ingredients (i.e., exosomes, carrageenan, and polylysine in crosslinked formulations) as shown in instant claim 1, then the properties (i.e., stabilization of the exosome) that result from that combination of elements is expected.
In support of this conclusion, Cho teaches a method that looks to an improvement of stability and quality of the exosome solution [0060] by employing modifications [0042-0044]; and furthermore, Li teaches the synergistic interaction between carrageenan and E-polylysine (abstract) that improves the overall gel properties and stability of formulations with use in carrier systems of bioactive compounds (pg 217, ‘conclusions’), and for example, has demonstrated stabilizing effects for arachin protein (pg 212-213, ‘introduction’). Note that Cho defines an exosome as a vesicle with a membrane structure containing proteins, RNA, etc. for therapeutic effect [0003-0006]. Thus, the literature supports the stabilization of exosome formulations through the combination of carrageenan and E-polylysine.
However, Applicant may demonstrate non-obviousness by relying on objective data or evidence (Applicant may file an affidavit/declaration (see MPEP 716), or point to the Specification). It should be remembered that “a showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997) (conclusory statements regarding unusually low immune response or unexpected biological activity that were unsupported by comparative data held insufficient to overcome prima facie case of obviousness).” There is no evidence (supported by argument) that results of the invention are surprising/unexpected with respect to the Prior Art.
In response to claims of unexpected results, the Office would consider the arguments and unexpected result data presented, and search whether the unexpected result was in fact expected based on information known to PHOSITA in the literature, or whether the unexpected result is a property of the composition taught by the Art.
Furthermore, demonstration of criticality of range (i.e., where the purported effect only occurs within the ratio is discussed by claim 4, or within the exosome amount in claim 7) may provide further support for unexpected results. To establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). Any range demonstrated as critical should be commensurate in scope with the claim set.
On page 10-11, Applicant concludes (without addressing the double patenting rejections). The Examiner maintains the double patenting rejections on until prosecution is further advanced.
Correspondence
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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/R.P./Examiner, Art Unit 1614 2/19/2026
/SEAN M BASQUILL/Primary Examiner, Art Unit 1614