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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 02/19/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
Election/Restrictions
Newly submitted claim 22 directed to an invention that lacks unity with the invention originally claimed for the following reasons: the technical feature of plant exosome is known in the art as taught by Sahin et al. (WO2021045712) and can not be used as special technical feature to link inventions together.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 22 is withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claims 1,3, 5-9, 12, 14, 16-22 are pending, Claims 1,3, 5-9, 12, 14, 16-21 are under examination.
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.
Claims 1,3, 5-9, 12, 14, 16-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. The claim(s) recite(s) a product comprises a plant exosome in 0.9% isotonic serum (0.9% of sodium chloride), which is not markedly different from its naturally occurring counterpart. This judicial exception is not integrated into a practical application because there is no indication that isolation has caused the plant exosome and 0.9% of sodium chloride aqueous solution to have any characteristics that are different from the naturally occurring plant exosome in plant. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the clim does not recite any additional elements.
Response to Argument:
Applicants argue by declaration that their results are unexpected from those in the literature without providing the details of the literature and teaching.
In response to this argument: this is not persuasive. As discussed in the following response to declaration, since applicants failed to provide details of literature and relevant teaching, there is insufficient information for the examiner to evaluate whether there is markedly difference between pineapple exosome in natural and pineapple exosome in 0.9% isotonic serum. Thus, applicant’s arguments are not sufficient to overcome the 101 rejection.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 5-9, 16-21 are rejected under 35 U.S.C. 103 as being unpatentable over Sahin et al. (WO2021045712) in view of Sahin et al. (Sahin2 thereafter, US20200230196).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Sahin et al. teaches Pineapple Exosome (page 3, line 20-25; page 4, line 1-25; page 5, line 1-10; page 10, claims 1-3) as a product having the effect of enhancing viability and, by stimulating the hair follicles, enhancing hair growth in skin cells. Pineapple, garlic and pomegranate are preferred as the plants from which the exosomes are isolated. The plant exosomes can be isolated by many methods such as isolation by two phase separation, graduated centrifuge, ultrafiltration, chromatographic methods, polymer based isolation and isolation by microbeads. The two phase liquid system is utilized for isolation of exosomes from plant lysate, which system comprises the steps of removing the large size particles and impurities resulting from plant disintegration by centrifugation performed between 2,000 g and 10,000 g for 5-20 minutes filtering to remove the particles sized 220 nanometers and above, and separating the obtained homogeneous exosome-protein mixture. Exosomes are cleared of nonexosomal proteins, cellular fats and other impurities by utilizing the chemical tendency of the PEG phase to the proteins and of the DEX (dextran) phase to the phospholipid structured membranes in the two-phase liquid system (page 3, line 20-25; page 4, line 1-25; page 5, line 1-10; page 10, claims 1-3). A personal care product in the form of cream comprising Pineapple Exosome is disclosed (page 5, line 20). The concentration of Pineapple Exosome is 25ug/ml, 50yg/ml, 75ug/ml and 100ug/ml (Fig. 2).
Sahin2 teaches A product containing plant derived exosome that may be used in cancer treatment and wound healing (abstract). The product is in a form of serum, syrup, tablet, drug, gel or cream (claims 1 and 7). The collected wheatgrass was first ground in 1% PBS (phosphate buffered saline) and then filtered. The obtained filtrate wheatgrass was centrifuged at 1000×g for 10 minutes, 3200×g for 20 minutes, 15000×g for 60 minutes, and then the cell culture was isolated by using exosome isolation kit. The isolated exosomes were dissolved in 0.9% isotonic serum ([90061]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Sahin et al. is that Sahin et al. do not expressly teach 0.9% isotonic serum. This deficiency in Sahin et al. is cured by the teachings of Sahin2.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sahin et al., as suggested by Sahin2, and produce the instant invention.
One of ordinary skill in the art would have been motivated to replace 0.9% isotonic serum for cream because this is simple substitution of one known formulation for plant exosome for another to obtain predictable results. MPEP 2143, it is prima facie obviousness for simple substitution of one known element for another to obtain predictable results. Under guidance from Sahin2 teaching serum (0.0% isotonic) is alternative to cream for plant exosome, it is obvious for one of ordinary skill in the art to replace 0.9% isotonic serum for cream and produce instant claimed invention with reasonable expectation of success.
Regarding claim 1, prior art teaches pineapple exosome in 0.9% isotonic serum, and “treatment of fat cell” is intended use, not limiting.
Regarding claim 5, this is regarded as intended use, not limiting.
Regarding claims 6-7, 9, and 20, these are regarded as inherency of prior art product. Since prior art discloses the same product, this same product must have the same properties. MPEP 2112. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
Regarding claims 8, 16-18, Sahin et al. teaches exosome concentration 25ug/ml, 50yg/ml, 75ug/ml and 100ug/ml, encompassing 30, 50, 75 and 100 ug/ml.
Regarding claim 19, one of ordinary skill in the art would have been motivated to optimize the concentration of exosome to have 200ug/ml through routing experimentation. MPEP 2144.05. Especially in the absence of showing criticality of claimed range.
Regarding claim 21, Sahin2 teaches isolation steps of centrifuging at 1000×g for 10 minutes, 3200×g for 20 minutes, 15000×g for 60 minutes. Furthermore, this is considered product by process. Please note that in product-by-process claims, “once a product appearing to be substantially identical is found and a 35 U.S.C. 102/103 rejection [is] made, the burden shifts to the applicant to show an unobvious difference.” MPEP 2113. This rejection under 35 U.S.C. 102/103 is proper because the “patentability of a product does not depend on its method of production.” In re Thorpe, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Please note that the Patent and Trademark Office is not equipped to conduct experimentation in order to determine whether Applicants’ hydrated (vitrified matrix) collagen gel differs and, if so, to what extent, from that of the discussed reference. Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the Applicants.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 3, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Sahin et al. (WO2021045712) in view of Sahin et al. (Sahin2 thereafter, US20200230196), as applied for the above 103 rejection for claims 1, 5-9, 16-21, further in view of Jeong et al. (KR102391636. Machine translation)
Determination of the scope and content of the prior art
(MPEP 2141.01)
Sahin et al. and Sahin et al. teaching have already been discussed in the above 103 rejection and are incorporated herein by reference.
Jeong et al. teaches weak wheat exosome exhibit skin and hair condition improvement effects (page 3). Weak wheat exosome promotes hair growth (page 14, example 12) and prevent hair loss (page 15, example 14).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Sahin et al. is that Sahin et al. do not expressly teach wheat exosoem. This deficiency in Sahin et al. is cured by the teachings of Jeong et al.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Sahin et al., as suggested by Jeong et al., and produce the instant invention.
One of ordinary skill in the art would have been motivated to include wheat exosome with pineapple exosome because both plant exosome promote hair growth as suggested by Sahin et al. and Jeong et al. MPEP 2144.06, "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). Therefore, it is obvious for one of ordinary skill in the art to include wheat exosome with pineapple exosome and produce instant claimed invention with reasonable expectation of success.
Regarding claims 12 and 14, these are regarded as inherency of prior art product. Since prior art discloses the same product, this same product must have the same properties. MPEP 2112. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Declaration
The Declaration of Canpolat under 37 CFR 1.132 filed 02/19/2026 is insufficient to overcome the rejection of claims 1, 5-9, 16-21 based upon Sahin et al. (WO2021045712) in view of Sahin et al. (Sahin2 thereafter, US20200230196) as set forth in the Office action because:
Applicants argue that their results are unexpected from those in the literature without providing the details of the literature and teaching.
In response to this argument: this is not persuasive. Firstly, since applicants failed to provide details of literature and relevant teaching, there is insufficient information for the examiner to evaluate whether indeed it is unexpected. Secondly, applicants failed to compare with closest prior art Sahin et al. teaching pineapple exosome. It is still the examen’s position that applicant’s claimed functional properties are new use of previous known old product. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Response to Argument:
Applicants argued that unexpected results as well as inherency.
In response to this argument: this is not persuasive. As discussed in the above response to declaration, Firstly, since applicants failed to provide details of literature and relevant teaching, there is insufficient information for the examiner to evaluate whether indeed it is unexpected. Secondly, applicants failed to compare with closest prior art Sahin et al. teaching pineapple exosome. It is still the examen’s position that applicant’s claimed functional properties are new use of previous known old product. "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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, Brian-Yong Kwon can be reached at (571)272-0581. 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.
/JIANFENG SONG/Primary Examiner, Art Unit 1613
Prosecution Insights