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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. However, no English translation has been provided.
Information Disclosure Statement
The information disclosure statements (IDS) are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-12 in the reply filed on 3/23/2026 is acknowledged.
Claims 13-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 3/23/2026.
Claims 1-12 are currently under examination.
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.
Claims 3, 5, 6, 9 and 11 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.
Claims 3 and 9 recite the limitation "the medium composition for extracting exosomes” in line 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 5 and 11, the term "e.g" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The metes and bounds of claim 6 are rendered uncertain by the phrase “the cosmetic composition is formulated into” in line 2 because it is not clear if Applicant is claiming that composition is in these forms or if there is an additional step to provide a different product. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
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 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural composition of matter without significantly more.
Claims 1-5 and 7-11 recite a cosmetic/pharmaceutical composition, comprising exosomes derived from urine-derived stem cells as an active ingredient for skin regeneration, skin whitening, antioxidation, or wound healing. Claim 6 recites the cosmetic composition of claim 1 formulated into skin lotions, skin softeners, toners, astringents, lotions, milk lotions, moisturizing lotions, nutritional lotions, essences, nutritional essences, packs, cleansing foams, cleansing waters, cleansing lotions, body lotions, body cleansers, soaps, and powders. Claim 12 recites the pharmaceutical composition, comprising exosomes derived from urine-derived stem cells is a topical skin formulation selected from gels, ointments, skin suspensions, transdermal patches, mask packs, medicated bandages, lotions, or a combination thereof.
These instantly claimed limitations are drawn to a product of nature, namely naturally occurring exosomes derived from urine-derived stem cells. Extraction of urine-derived stem cells only concentrates and portions the naturally occurring exosomes. Thus, a claim to exosomes from urine-derived stem cells would tie up and monopolize exosomes that are found in the urine-derived stem cells. Please note that in Myriad, excising DNA to isolate the DNA from its natural source did not constitute a product which was “markedly different” from the naturally occurring DNA even though the excised ends of the DNA were different in structure when compared to native DNA. Therefore, the answer to Step 2A, Prong One, is Yes.
Thus, the analysis must move to Step 2A, Prong Two, which asks if the claim recites additional elements that integrate the judicial exception into a practical application. As discussed in MPEP § 2106.04(d)(2) this evaluation is performed by identifying whether there are additional elements recited in the claim beyond the judicial exception and evaluating these additional elements to determine whether the claim as a whole integrates the exception into a practical application. In this case, the claims are directed to composition in the form of skin lotions, skin softeners, toners, astringents, lotions, milk lotions, moisturizing lotions, nutritional lotions, essences, nutritional essences, packs, cleansing foams, cleansing waters, cleansing lotions, body lotions, body cleansers, soaps, powders, transdermal patches, mask packs, medicated bandages and lotions. Thus, the answer to Step 2A, Prong Two, is No.
The analysis must then move to Step 2B which asks if claims recite additional elements that amount to significantly more than the judicial exception. MPEP § 2106.05 states that this evaluation is performed by “Evaluating additional elements to determine whether they amount to an inventive concept requires considering them both individually and in combination to ensure that they amount to significantly more than the judicial exception itself.” In this case, the exosomes are part of a composition and are in specific forms. There is no recited additional ingredient and the forms themselves do not provide anything markedly different, since exosomes can naturally occur in aqueous formulations and in water. Thus, the answer to Step 2B is No. Therefore, the claims are not directed to patent eligible subject matter.
Please note that some of the forms have not been included in the 101 rejection (e.g. emulsion), since they provide forms that would provide slow release/provide markedly different characteristics.
Claim Rejections - 35 USC § 102
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.
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) 1-4 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Yuan et al. ("Exosomes secreted by human urine-derived stem cells accelerate skin wound healing by promoting angiogenesis in rat," Cell Biology International, Vol. 41, No. 8, (2016). “Other Documents” number 2 on Applicant’s IDS dated 8/17/2023).
Yuan teaches that exosomes isolated from urine-derived stem cells have the effect of accelerating skin wound healing (see abstract). Yuan teaches that the stem cells are from humans and are administered to rats that have had wounds created by incision (which reads on both allogenic and xenogenic- claims 4 and 10, incisions of claims 5 and 11). Yuan further teaches that the exosomes are combined with PBS and injected to treat wounds (See e.g. page 6, “Rat skin wound model and treatment”) (which reads on a cosmetic and pharmaceutical formulation with exosomes as the active). Yuan further teaches Dulbecco's Modified Eagle Medium (DMEM) is contained as a medium for culturing the stem cells, and triiodothyronine (T3) is contained as an additive component (see abstract), and the feature of D2 of cultivating urine-derived stem cells in a medium comprising Dulbecco's Modified Eagle Medium (DMEM) and Ham's F12 in a ratio of 3:1, fetal bovine serum (FBS), and triiodo-L-thyronine as an additive component (see page 548).
Yuan does not expressly teach exosomes isolated from urine-derived stem cells cultured in the medium composition claimed. However, it should be noted that claims 2, 3, 8 and 9 constitute Product-by-Process type claims. In Product-by-Process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art. See In re Thorpe, 227 USPQ 964 (CAFC 1985); In re Marosi, 218 USPQ 289, 292-293 (CAFC 1983) and In re Brown, 173 USPQ 685 (CCPA 1972). Consequently, even if a particular process used to prepare a product is novel and unobvious over the prior art, the product per se, even when limited to the particular process, is unpatentable over the same product taught in by the prior art. See In re King, 107 F.2d 618, 620, 43 USPQ 400, 402 (CCPA 1939); In re Merz, 97 F.2d 599, 601, 38 USPQ 143-145 (CCPA 1938); In re Bergy, 563 F.2d 1031, 1035, 195 USPQ 344, 348 (CCPA 1977) vacated 438 US 902 (1978); and United States v. Ciba-Geigy Corp., 508 F. Supp. 1157, 1171, 211 USPQ 529, 543 (DNJ 1979). Finally, since the Patent Office does not have the facilities for examining and comparing Applicant's composition with the compositions of the prior art reference, the burden is upon Applicant to show a distinction between the material, structural and functional characteristics of the claimed composition and the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Therefore, the reference anticipates the instantly claimed invention.
Claim(s) 1-4 and 7-11 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Chen et al. ("Exosomes secreted by human urine-derived stem cells accelerate skin wound healing by promoting angiogenesis in rat," Cell Biology International, Vol. 41, No. 8, (2016). “Other Documents” number 2 on Applicant’s IDS dated 8/17/2023).
Chen teaches that in vivo, USC-Exos (exosomes) promotes angiogenesis and wound healing in STZ-induced diabetic mice (See e.g. p. 1607 “Introduction”) and can be topically applied (See e.g. p 1618, column 1)(thus, urine exosomes are effective for both wound healing and skin repair/treatment). Chen further teaches that the stem cells are from humans (See e.g. “Isolation, culture and identification of human USCs” on page 1608) and are administered to rats that have had wounds created by incision (which reads on both allogenic and xenogenic- claims 4 and 10, incisions of claims 5 and 11). Chen further teaches that the exosomes are combined with PBS and injected to treat wounds (See e.g. page 1612, “Mouse skin wound model and treatments”) (which reads on a cosmetic and pharmaceutical formulation with exosomes as the active).
Chen does not expressly teach exosomes isolated from urine-derived stem cells cultured in the medium composition claimed. However, it should be noted that claims 2, 3, 8 and 9 constitute Product-by-Process type claims. In Product-by-Process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art. See In re Thorpe, 227 USPQ 964 (CAFC 1985); In re Marosi, 218 USPQ 289, 292-293 (CAFC 1983) and In re Brown, 173 USPQ 685 (CCPA 1972). Consequently, even if a particular process used to prepare a product is novel and unobvious over the prior art, the product per se, even when limited to the particular process, is unpatentable over the same product taught in by the prior art. See In re King, 107 F.2d 618, 620, 43 USPQ 400, 402 (CCPA 1939); In re Merz, 97 F.2d 599, 601, 38 USPQ 143-145 (CCPA 1938); In re Bergy, 563 F.2d 1031, 1035, 195 USPQ 344, 348 (CCPA 1977) vacated 438 US 902 (1978); and United States v. Ciba-Geigy Corp., 508 F. Supp. 1157, 1171, 211 USPQ 529, 543 (DNJ 1979). Finally, since the Patent Office does not have the facilities for examining and comparing Applicant's composition with the compositions of the prior art reference, the burden is upon Applicant to show a distinction between the material, structural and functional characteristics of the claimed composition and the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Therefore, the reference anticipates the instantly claimed invention.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 5 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yuan et al. ("Exosomes secreted by human urine-derived stem cells accelerate skin wound healing by promoting angiogenesis in rat," Cell Biology International, Vol. 41, No. 8, (2016). “Other Documents” number 2 on Applicant’s IDS dated 8/17/2023) as applied to claims 1-4 and 6-11 above, and further in view of Chen et al. (U, Theranostics. 2018 Feb 7;8(6):1607–1623), and Reed et al. (N, WO 2020018926 A1).
The teachings of Yuan are set forth above and applied as before. Yuan does not expressly teach topical administration or that the exosomes are used for skin treatment.
Chen teaches that in vivo, USC-Exos (exosomes) promotes angiogenesis and wound healing in STZ-induced diabetic mice (See e.g. p. 1607 “Introduction”) and can be topically applied (See e.g. p 1618, column 1)(thus, urine exosomes are effective for both wound healing and skin repair/treatment).
Yuan does not teach the exact formulations claimed.
Reed teaches skin care compositions comprising exosomes for skin treatment, wherein the exosomes can be from urine (See e.g. paragraph 0042). Reed further teaches that a cosmetic can be in the form of moisturizing creams, skin benefit creams and lotions, softeners, day lotions, gels, ointments, cleansers or toners (See e.g. para 0114).
It would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to modify the composition taught by Yuan by using the composition for both wound healing and skin treatment as taught by Chen and to prepare a cosmetic or pharmaceutical formulation in the form of a cream, lotion, gel, and/or ointment as taught by Reed for skin treatment. A person of ordinary skill in the art would have understood before the effective filing date to modify the composition taught by Yuan and Chen to be in a suitable skin treatment formulation in form of a cream, lotion, gel, and/or ointment based upon the beneficial teachings of Reed with expectation of success. Therefore, the skilled artisan would have been motivated before the effective filing date of the claimed invention to modify the composition taught by Yuan and Chen to be in a suitable skin treatment formulation in form of a cream, lotion, gel, and/or ointment based upon the beneficial teachings of Reed.
From the teachings of the above references, it is apparent that one of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Reed et al. (WO 2020018926 A1).
Reed teaches skin care compositions comprising exosomes for skin treatment, wherein the exosomes can be from urine (See e.g. paragraph 0042). Reed further teaches that the cosmetic can be moisturizing creams, skin benefit creams and lotions, softeners, day lotions, gels, ointments, cleansers or toners (See e.g. para 0114).
Reed does not expressly teach exosomes isolated from urine-derived stem cells cultured in the medium composition claimed. However, it should be noted that claims 2, 3, 8 and 9 constitute Product-by-Process type claims. In Product-by-Process type claims, the process of producing the product is given no patentable weight since it does not impart novelty to a product when the product is taught by the prior art. See In re Thorpe, 227 USPQ 964 (CAFC 1985); In re Marosi, 218 USPQ 289, 292-293 (CAFC 1983) and In re Brown, 173 USPQ 685 (CCPA 1972). Consequently, even if a particular process used to prepare a product is novel and unobvious over the prior art, the product per se, even when limited to the particular process, is unpatentable over the same product taught in by the prior art. See In re King, 107 F.2d 618, 620, 43 USPQ 400, 402 (CCPA 1939); In re Merz, 97 F.2d 599, 601, 38 USPQ 143-145 (CCPA 1938); In re Bergy, 563 F.2d 1031, 1035, 195 USPQ 344, 348 (CCPA 1977) vacated 438 US 902 (1978); and United States v. Ciba-Geigy Corp., 508 F. Supp. 1157, 1171, 211 USPQ 529, 543 (DNJ 1979). Finally, since the Patent Office does not have the facilities for examining and comparing Applicant's composition with the compositions of the prior art reference, the burden is upon Applicant to show a distinction between the material, structural and functional characteristics of the claimed composition and the composition of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977).
Reed does not expressly teach using urine derived stem cells, but teaches them as an alternative.
Therefore, it would have been obvious before the effective filing date of the claimed invention to one of ordinary skill in the art to prepare a cosmetic and/or pharmaceutical formulation in the form of a cream, lotion, gel, and/or ointment using urine derived stem cells by substituting and trying urine derived stem cells, since Reed teaches that stem cells for skin care can be obtained from urine. A person of ordinary skill in the art would have understood before the effective filing date to use urine-derived stem cells in the instantly claimed form of a cream, lotion, gel, and/or ointment based upon the beneficial teachings of Reed with expectation of success. Therefore, the skilled artisan would have been motivated before the effective filing date of the claimed invention to modify the composition taught by Reed to incorporate urine-derived stem cells in form of a cream, lotion, gel, and/or ointment.
From the teachings of the reference, it is apparent that one of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-20 of copending Application No. 18/696,513 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant application is drawn to a cosmetic composition, comprising exosomes derived from urine-derived stem cells as an active ingredient for skin regeneration, skin whitening, antioxidation, or wound healing and pharmaceutical composition, comprising exosomes derived from urine-derived stem cells as an active ingredient for skin regeneration, skin whitening, antioxidation, or wound healing. The instant claims of the ‘513 application are drawn to urine-derived stem cells, cultured in the culture medium of claim 1. Claim 1 of ‘513 recites a culture medium for isolating and culturing urine-derived stem cells, wherein the culture medium comprises: a basic medium containing Dulbecco's Modified Eagle Medium (DMEM) and Ham's F-12, 5% or less fetal bovine serum, and parathyroid hormone (PTH), and further comprises at least one additive selected from the group consisting of fibroblast growth factor 23 (FGF23), triiodothyronine (T3), calcifediol, bovine serum albumin, and a lipid mixture (chemically defined lipids). Claims 2 and 8 of the instant application are drawn to the stem cells being cultured in a medium composition comprising: a basic medium containing Dulbecco's Modified Eagle Medium (DMEM) and Ham's F12 at a 3:1 ratio; 2.5% or less of fetal bovine serum; and an additive, wherein the additive is at least one selected from a group consisting of bovine serum albumin, a lipid mixture (chemically defined lipids), FGF23 (fibroblast growth factor 23), T3 (triiodothyronine), and calcifediol. The stem cells in the ‘513 Application and those in the instant application appear to be the same but with different intended uses and slightly different culturing solutions. The intended use and product by process does not patentably distinguish that exosomes or cell therapy product, which could be a pharmaceutical formulation. The instant claims are drawn to compositions comprising these exosomes, which could be construed to be the medium in which the stem cells are grown. Further, there are no additional ingredients recited in the instant claims, thus the cells themselves can make up a composition on their own.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amy L. Clark whose telephone number is (571)272-1310. The examiner can normally be reached M-F 8:00am-5:00pm.
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/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628
Prosecution Insights