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 .
Status of the Claims
Applicant’s submission filed on October 29, 2025 has been entered and considered. Rejections and/or objections not reiterated from the previous office action mailed July 29, 2025 are hereby withdrawn. The following rejections and/or objections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application. The text of those sections of Title 35 U.S.C. not included in this action can be found in a prior office action.
Claims 1-10 have been canceled.
Claim 11 has been amended to recite additional limitations of administration of milk exosomes to a subject in need thereof.
Claim 14 has been amended to recite additional limitations of treating obesity or a metabolic disease via inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes.
Claims 11-17 are pending and examined on the merits.
Priority
Applicant claims foreign priority to Korean patent application KR10-2020-0110132 filed on August 31, 2020. Receipt is acknowledged of certified copies of papers received in the original language required by 37 CFR 1.55. Claims 1-17 are entitled to the benefit of Korean patent application KR10-2020-0110132 and are given a priority date of August 31, 2020.
Information Disclosure Statement
The information disclosure statements (IDS) filed on August 22, 2022; July 13, 2023; and June 26, 2024 are acknowledged and have been considered by the examiner.
Objection to Drawings
Figure 4 of the Specification does not conform to standards as “readable and reproducible for publication purposes” as set forth in MPEP § 507 (see also 37 CFR 1.84(b)). Specifically, it is not possible to determine intracellular uptake of milk exosomes as indicated in the instant specification.
Figure 5B of the Specification does not conform to standards as set forth in MPEP § 507 (see also 37 CFR 1.84(p)(5)) because they do not include the following reference sign mentioned in the description: the Pgs. 14 and 22 of the specification indicate that Figure 5B depicts beige adipocyte specific genes in hADSC cells. Figure 5B is labeled as 3T3-L1 cells and appears to show electron chain proteins.
Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Withdrawn Claim Rejections - 35 USC § 112
In view of the cancellation of claim 10 in the response filed October 29, 2025, the prior rejection of claim 10 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is rendered moot.
Withdrawn Claim Rejections - 35 USC § 101
In view of the cancelation of claims 1-10 in the response filed October 29, 2025, the rejections of claims 1-10 under 35 U.S.C. 101 as being drawn to a product of nature without significantly more are rendered moot.
Withdrawn Claim Rejections - 35 USC § 102
The prior rejection of claims 1-17 under 35 U.S.C. 102(a)(1) as being anticipated by Izumi et al. (EP 3192518A1, found in IDS dated 07/13/2023, hereafter “Izumi”) as evidenced by Li et al. (2016. Comparative analysis of the miRNome of bovine milk fat, whey and cells. PloS one, 11(4), e0154129, found in IDS dated 06/26/2024, hereafter “Li”), Lai et al. (2017. Inflammation-related microRNA expression level in the bovine milk is affected by mastitis. PloS one, 12(5), e0177182, hereafter “Lai”) and ThermoFisher (TaqMan MicroRNA Assay, “hsa-miR-122”, Assay ID 002245) is withdrawn is light of Applicant’s cancelation of claims 1-10 and amendments to claim 11 to recite additional limitations of administration of milk exosomes to a subject in need thereof and claim 14 to recite additional limitations of treating obesity or a metabolic disease via inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes.
Claim Rejections - 35 USC § 102
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Izumi et al. (EP 3192518A1, found in IDS dated 07/13/2023, hereafter “Izumi”), as evidenced by Li et al. (2016. Comparative analysis of the miRNome of bovine milk fat, whey and cells. PloS one, 11(4), e0154129, found in IDS dated 06/26/2024, hereafter “Li”), Lai et al. (2017. Inflammation-related microRNA expression level in the bovine milk is affected by mastitis. PloS one, 12(5), e0177182, hereafter “Lai”) and ThermoFisher (TaqMan MicroRNA Assay, “hsa-miR-122”, Assay ID 002245).
This is a new rejection necessitated by Applicant’s amendment in the response filed October 29, 2025. This rejection provides additional interpretation of claims and shares substantial similarity to the rejection as set forth in the previous office action dated July 29, 2025. Any aspect of Applicant’s traversal that pertains to the rejection as newly set forth will be provided following the new statement of rejection.
With regard to claims 11 and 14, Izumi discloses a method for therapeutic or prophylactic treatment of inflammation or a disease accompanied by inflammation comprising administering milk-derived exosomes to an animal or human (Para. [0037], lines 14-19) and comprises an embodiment wherein the disease to be treated is a metabolic syndrome such as obesity (Para. [0036], lines 4-6). Izumi discloses that the milk exosomes can be obtained from cow’s milk (Para. [0022]) and prepared by centrifugation, filtration, (Para. [0025]) and via use of kits for isolating exosomes (Para. [0027]). Thus, it does not appear that the milk exosomes as instantly claimed are structurally different that the milk-derived exosomes as disclosed by Izumi absent evidence to the contrary.
MPEP 2112.02(II) states:
During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963)
The recitation in the preamble of claim 11 of the intended use of the method “for inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes” and recitation in the preamble of claim 14 of “for treating obesity or a metabolic disease via inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes” does not appear to make a manipulative difference between the method as instantly claimed and the method as disclosed by Izumi and is therefore not considered to be limiting, absent evidence to the contrary. The method of Izumi appears to disclose the same composition, method of administration (Para. [0038]), and subject “in need thereof” (i.e., a person being treated for obesity) as the instantly claimed method.
In the event that the intended use of the method imparts a manipulative difference between the method as instantly claims and the method as disclosed by Izumi, an alternative interpretation is set forth.
MPEP 2112.01(I) states:
“Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977).”
MPEP 2112.01(II) states:
“’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.”
MPEP 2112(I) states:
"[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).
MPEP 2112.02(II) further states:
…when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated.
Therefore, inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes by administration of milk exosomes as instantly claimed appears to be a previously unappreciated property of the milk exosomes as disclosed by Izumi and is therefore considered to be an inherent property of Izumi’s milk exosomes.
With regard to claims 12-13 and 15-16, as detailed above, Izumi discloses milk-derived exosomes and further discloses that the milk-derived exosomes comprise miRNA (Paras [0009], Para. [0023]). However, Izumi is silent to milk exosomes comprising one or more miRNAs selected from the group consisting of miR-11987, miR-122, and miR-11980; and wherein miR-11987 comprises a base sequence of SEQ ID NO: 49, miR-122 comprises a base sequence of SEQ ID NO: 50, and miR-11980 comprises a base sequence of SEQ ID NO: 51 as instantly claimed. However, presence of miR-11987 comprising a base sequence of SEQ ID NO: 49, miR-122 comprising a base sequence of SEQ ID NO: 50, and miR-11980 comprising a base sequence of SEQ ID NO: 51 appears to be an inherent property of milk exosomes as evidenced by Li, Lai, and ThermoFisher. Li provides evidence that miR-11987 comprising SEQ ID NO: 49 and miR-11980 comprising SEQ ID NO: 51 are naturally present in exosomes isolated from cow’s milk (Table 4). Lai and ThermoFisher (TaqMan Assay ID 002245) provide evidence that miR-122 comprising SEQ ID NO: 50 is naturally present in milk whey, which is considered to reasonably read on exosomes from cow’s milk.
As explained above, the milk-derived exosomes of Izumi appear to be identical to the instantly claimed milk exosomes and products of identical composition cannot have mutually exclusive properties (See MPEP 2112.01(I) and MPEP 2112.01(II). Thus, the composition comprising milk exosomes as taught by Izumi would inherently comprise miR-11987 comprising a base sequence of SEQ ID NO: 49, miR-122 comprising a base sequence of SEQ ID NO: 50, and miR-11980 comprising a base sequence of SEQ ID NO: 51 as these miRNAs appear to be naturally present in milk exosomes, absent evidence to the contrary.
With regard to claim 17, which depends from claim 14, Izumi teaches a method of treatment comprising administering a composition comprising milk exosomes to an animal or human (Para. [0037], lines 13-17) which can be used to treat “metabolic syndromes” (Para. [0036], line 50) and diseases “accompanied by inflammation” (Para. [0036], lines 48-49). Thus the method of treatment of the Markush group of metabolic diseases as recited in claim 17 is considered to be an inherent property of the composition comprising milk-derived exosomes as taught by Izumi. Additionally, one having ordinary skill in the art would recognize that inflammation plays a significant role in diabetes.
Response to Applicant’s Traversal
Applicant’s traversal dated October 29, 2025 has been entered and fully considered but is not found persuasive.
Applicant asserts on Pg. 5 that the therapeutic method of treating obesity using milk-derived exosomes Izumi does not inherently include the differentiation of white adipocytes into beige or brown adipocytes as Izumi does not disclose or necessarily results in the specific adipocyte differentiation process recited in the present claims. Applicant has amended claim 11 to recite a method “for inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes” and has also amended claim 14 to recite that the method for treating obesity or a metabolic disease occurs “via inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes.” Applicant traverses that the feature of inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes is not disclosed or suggested by Izumi as Izumi’s teaching is drawn toward an anti-inflammatory agent comprising milk-derived exosomes which result in suppression of TNF-α. Applicant traverses that Izumi does not describe, imply, or investigate adipocyte differentiation, browning, or thermogenic gene expression and that Izumi’s mechanism is anti-inflammatory activity which operates through immune modulation, not metabolic activation. Applicant further traverses that the instantly claimed methods target differentiation of white adipocytes into beige or brown adipocytes which is a distinct pathway from TNF-α suppression which “cannot be presumed to occur because Izumi’s composition may alleviate inflammation in obese subjects”. Applicant asserts that Izumi’s composition does not necessarily or inevitably cause the specific adipocyte differentiation as instantly claimed and that the Office has provided no evidence demonstrating that the milk exosomes of Izumi inherently induce adipocyte differentiation, thus inherency cannot be established.
Applicant’s traversal has been fully considered but is not persuasive.
First, based on Applicant’s amendments to claims 11 and 14, the instantly claimed method comprises administration of milk exosomes to a subject in need thereof. The recitation in the preamble of the intended use of the method “for inducing differentiation of white adipocytes into beige adipocytes or brown adipocytes” in claim 11 and “for treating obesity or a metabolic disease via inducting differentiation of white adipocytes into beige adipocytes or brown adipocytes” does not appear to make a manipulative difference between the instant method and the method as disclosed by Izumi (see MPEP 2111.02(II)). Thus, it appears that the instant method steps and those of the prior art of Izumi are the same, absent evidence to the contrary.
Secondly, as detailed above and similarly recited in the office action dated July, 29, 2025, the milk exosomes as disclosed by Izumi appear to be structurally the same as the milk exosomes of the instant disclosure. Per, MPEP 2112.01(II) products of identical chemical composition cannot have mutually exclusive properties. Further, MPEP 2112(I) states that the discovery of a new property of a prior art composition does not render the old composition patentable and that claiming a new use, function, or unknown property, which is inherently present in the prior art does not make the claim patentable and MPEP 2112.02(II) states “when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)”. Based on Applicant’s traversal, it appears that the instant method claims are intended to be evaluated based on the ability of milk exosomes, a known composition, to induce adipocyte differentiation. As the milk-derived exosomes of Izumi appear to be the same as the milk exosomes as instantly claimed, it appears that Applicant’s claims are drawn to a new function or unknown property (adipocyte differentiation) of milk exosomes which was inherently present, absent evidence to the contrary. Additionally, although Izumi is silent to adipocyte differentiation, there is no requirement that this inherent feature be recognized at the time of Izumi’s invention in order for Izumi’s disclosure to be anticipatory (See MPEP 2112 (II) and 2160.079(a)).
Thirdly, Although Izumi’s disclosure is directed to the anti-inflammatory properties of milk-derived exosomes and investigates the ability of milk-derived exosomes to suppress TNF-α, Izumi does disclose use of milk-derived exosomes for treatment of diseases which are accompanied by inflammation, and provides an embodiment wherein the disease is a metabolic syndrome such as obesity (Para. [0036]). Thus, Izumi supports use of milk-derived exosomes in obesity treatment. Izumi discloses that milk-derived exosomes are able to suppress TNF-α (Figs. 1 & 2, Para. [0029]). It is noted that Applicant’s instant specification also details that the milk exosomes of Applicant’s instant invention suppress TNF-α (Fig. 12B), similar to Izumi. Thus, it appears that the milk-derived exosomes of Izumi and the instantly claimed milk exosome possess the same properties as it relates to suppression of TNF-α. Therefore, one having ordinary skill in the art could reasonably expect that the milk-derived exosomes of Izumi would also possess the ability to induce adipocyte differentiation, despite the fact that Izumi is silent as to that property.
Conclusion
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 ERIN V PAULUS whose telephone number is (571)272-6301. The examiner can normally be reached Mon-Fri 8 AM-5 PM.
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/ERIN V PAULUS/Examiner, Art Unit 1631
/ARTHUR S LEONARD/Examiner, Art Unit 1631