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 .
Applicant should note that the instant application has been reassigned to a new examiner and now resides in Art Unit 1617.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/24/2026 has been entered.
Status of the Claims
Claims 14, 21, 23, 24, 26, 28, 30, 31, 33, 35, 37, and 38 are pending and under current examination.
All rejections not reiterated have been withdrawn.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 14, 21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gardeazabal et al. (Human Gene Therapy; abstracts from 27th Annual Congress In collaboration with SETGyc Barcelona, Spain, A178, P543: 10/22-25/2019; cited in the IDS filed 05/19/2023) in view of Kshirsagar et al. (Journal of Clinical and Diagnostic Research Vol 9(4):PC01-PC-04; April 2015) and Samuel et al. (Scientific Reports 7:5933; publication year 2017).
Gardeazabal discloses a method in which exosomes that have been isolated from human breast milk are applied to wounds and healing is accelerated in a mouse model (title; abstract).
Gardeazabal does not disclose that the exosomes are derived from colostrum.
Kshirsagar teaches that colostrum contains many factors that are responsible for healthy cell growth and repair of tissues like skin, muscle, cartilage, and bone (page 1, left col). In an experiment comparing a conventional dressing to a dressing containing colostrum, fewer number of dressings, short healing time, rapid healing, and decreased pain was seen in the colostrum group compared to conventional dressings (abstract).
Samuel teaches that colostrum contains exosomes that have many biologically active substances and their analysis revealed that exosomes from colostrum are significantly enriched with proteins that can potentially regulate the immune response and growth relative to milk produced later (abstract).
It would have been prima facie obvious to use colostrum as the source of exosomes in Gardeazabal’s method of treating wounds with exosomes. The artisan of ordinary skill would have been motivated to do so in order to explore related sources of healing exosomes and had reasonable expectation of success because powder derived from colostrum had already been shown to be effective in improving wound healing and because colostrum exosomes contain many bioactive substances.
Regarding claims 14, 21, 23, and 24, the steps of isolating the exosomes from colostrum are considered product by process language as the claims are directed to a method of use rather than a method of manufacture. The cited prior art teaches application of isolated exosomes, and no evidence has been made of record that Gardeazabal’s exosomes do not contain the fraction of exosomes isolated by the method steps recited in the instant product by process language. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), see MPEP 2113. Moreover, as pointed out above, it would have been prima facie obvious to optimize the conditions under which the most potent components of colostrum are contained using routine methods such as centrifugation and filtration.
Claims 21, 23, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Gardeazabal et al. (Human Gene Therapy; abstracts from 27th Annual Congress In collaboration with SETGyc Barcelona, Spain, A178, P543: 10/22-25/2019) in view of Kshirsagar et al. (Journal of Clinical and Diagnostic Research Vol 9(4):PC01-PC-04; April 2015) and Samuel et al. (Scientific Reports 7:5933; publication year 2017) as applied to claims 14, 21, 23, and 24 above and further in view of Izumi et al., (EP 3192518 A1, July 19, 2017; Morinaga Milk Industry, cited by applicant on IDS), Bolen et al. (US 2018/0193270 A1, July 12, 2018; of record) and Thery et al. (Journal of Extracellular Vesicles, 2018; cited in the IDS filed 06/24/2026).
Instant claims 3-7 have been rejected as being obvious over Gardeazabal and Kshirsagar as set forth supra. However, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, the product by process language of instant claims 21, 23, and 24 is also obvious as follows:
However, Izumi discloses a method for isolating exosomes from milk, comprising: a centrifugation step of centrifuging raw milk so as to remove fat and cells at 4 degrees Celsius; a step of removing centrifuged fat and cells; a step of adjusting the pH to 4.6 by adding 10% acetic acid and precipitating casein; a step of centrifuging the milk in which casein is precipitated at 4,500 × g and 4°C for 30 minutes, and collecting a supernatant; and a step of filtering the collected supernatant by using a 0.22 µm filter ([0046]), reading on claims 3-4 and 6-7.
Bolen teaches methods of producing exosomes (Abstract) from milk ([0009]) by a first step of centrifugation ([0970] – [0972]), then a first filtration step to further remove fat and cells therefrom ([0973 – 0979]), then a dilution step of adding distilled water to the filtered milk as needed (approximately 10 mL) in order to satisfy manufacturer instructions for properly filled/balanced tubes ([0980]), reading on claim 3.
Thery teaches that for the separation of extracellular vesicles (i.e. exosomes), there is no single optimal separation method, so choose based on the downstream applications and scientific question (Table 1, page 13). Thery et al. teaches the k factor can be determined from the rotor type, tube/adapter, and centrifuge speed and must sometimes be adjusted (Table 1, subparagraph a). Thery et al. teaches for filtration techniques; one must take care to remove cells and other large membranous structures prior to ultrafiltration and that the pore size of the matrix should be taken into account (Table 1 subparagraph b). Thery et al., teaches that time and temperature are also factors that may require adjustment during the exosome separation process (Table 1, Examples for classical technique). A person of ordinary skill in the art, with a reasonable expectation of success, would have been able to adjust the k factor and time of the first centrifugation step to encompass 4,000 to 6,000 x g for 20 to 40 minutes as recited in claim 4, the desired mesh size of the strainer to 20 to 60 µm or 30 to 50 µm as recited in claims 3 and 5, an equal amount of distilled water added to the filtered milk or goat milk as recited in claim 3, and the temperature to room temperature as recited in claim 7 in the instant application with repeated experimentation and a reasonable expectation of success based on the teachings of Thery.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the exosome preparation processes of Izumi and Bolen to prepare the exosomes taught by Gardeazabal/Kshirsagar/Samuel motivated by the desire to optimize the separation process according to the downstream application of the exosomes (Thery, Table 1) and to adjust the volume of liquid in the tubes in order to satisfy manufacturer instructions for properly filled/balanced tubes (Bolen, ([0980]).
Claims 14, 21, 23, 24, 26, 28, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al. (TW201620498; publication date: 06/16/2016; citing the English machine translation) in view of Weon et al., (KR 2019/0045829 A, May 03, 2019; of record) and Samuel et al. (Scientific Reports 7:5933; publication year 2017).
Liang discloses that colostrum is a milk that is produced within three days after calving and has higher nutrient content, lower fat, and a large number of immune and growth factors (page 1). Liang teaches a method of applying an effective does of the colostrum to skin for scavenging free radicals and that the colostrum can be further utilized in manufacturing cosmetic compositions or pharmaceutical compositions for antioxidation or anti-aging (i.e. reducing wrinkles; abstract). Liang discloses further that the colostrum can be fractionated by centrifugation at low temperature and the speed of centrifugation affects the substances present in each layer (page 2, example 1). Further molecular sieves are used to separate the components of the colostrum. The colostrum itself is the active in Liang’s invention, i.e. it does not serve as a carrier for a drug.
Liang teaches fractionating colostrum by centrifugation and filtration, as noted above, but does not expressly disclose application of isolated exosomes per se.
Weon teaches a therapeutic method for enhancing transdermal penetration of exosomes ([0016]). The method comprises the steps of topically applying a composition containing exosomes as an active ingredient to the skin of a mammal ([0018]). The term "exosomes" refers to vesicles measuring tens to hundreds of nanometers (preferably approximately 30 to 200 nm) in size and contain proteins, nucleic acids (mRNA, miRNA, etc.) ([0019]) and means all vesicles having a nano-sized vesicle structure secreted from various cells of animals released into the extracellular space ([0021]). Various exosomes can be used as long as they are applicable to the skin and do not cause adverse effects on the human body ([0022]). The method is also used for treating skin disease ([0038]). Skin disease treatment means removing, alleviating or improving pigmented skin lesions, and alleviating, improving or restoring to normal of autoimmune progesterone dermatitis and neurogenic scratch wounds ([0025]). The method is also used for improving the condition of the skin, which can include skin regeneration, wrinkle removal or improvement, whitening ([0037]; emphasis added). In Example 6, exosomes were applied to pig skin at a proper concentration of 1 × 10 5 to 1 × 10 9 particles / mL, demonstrating that the method helps transdermal permeation of exosomes to pig skin ([0075]).
Samuel teaches that colostrum contains exosomes that have many biologically active substances and their analysis revealed that exosomes from colostrum are significantly enriched with proteins that can potentially regulate the immune response and growth relative to milk produced later (abstract).
It would have been prima facie obvious to specifically use the colostrum (i.e. early stage milk) exosome fraction in a method of reducing wrinkles or whitening skin. The artisan of ordinary skill would have been motivated to do so because Weon teaches exosomes penetrate into the skin, where the would execute their biological activity. The skilled artisan would have had reasonable expectation of success because Liang/Weon together indicate that exosomes were effective for this purpose and because colostrum exosomes contain many bioactive substances.
Regarding claims 28, 30, 31, 35, 37, and 38 the steps of isolating the exosomes from colostrum are considered product by process language as the claims are directed to a method of use rather than a method of manufacture. The cited prior art teaches application of isolated exosomes, and no evidence has been made of record that the exosomes of Liang/Weon do not contain the fraction of exosomes isolated by the method steps recited in the instant product by process language. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process, In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), see MPEP 2113. Moreover, as pointed out above, it would have been prima facie obvious to optimize the conditions under which the most potent components of colostrum are contained using routine methods such as centrifugation and filtration.
Claims 21, 23, 24, 28, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al. (TW201620498; publication date: 06/16/2016; citing the English machine translation) in view of Weon et al., (KR 2019/0045829 A, May 03, 2019; of record) and Samuel et al. (Scientific Reports 7:5933; publication year 2017) as applied to claims 14, 21, 23, 24, 26, 28, 30, and 31 above and further in view of Izumi et al., (EP 3192518 A1, July 19, 2017; Morinaga Milk Industry, cited by applicant on IDS), Bolen et al. (US 2018/0193270 A1, July 12, 2018) and Thery et al. (Journal of Extracellular Vesicles, 2018; cited on IDS).
Instant claims 21, 23, 24, 28, 30, and 31 have been rejected as being obvious over Liang and Won as set forth supra. However, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, the product by process language of instant claims 21, 23, 24, 28, 30, and 31 is also obvious as follows:
However, Izumi discloses a method for isolating exosomes from milk, comprising: a centrifugation step of centrifuging raw milk so as to remove fat and cells at 4 degrees Celsius; a step of removing centrifuged fat and cells; a step of adjusting the pH to 4.6 by adding 10% acetic acid and precipitating casein; a step of centrifuging the milk in which casein is precipitated at 4,500 × g and 4°C for 30 minutes, and collecting a supernatant; and a step of filtering the collected supernatant by using a 0.22 µm filter ([0046]), reading on claims 3-4 and 6-7.
Bolen teaches methods of producing exosomes (Abstract) from milk ([0009]) by a first step of centrifugation ([0970] – [0972]), then a first filtration step to further remove fat and cells therefrom ([0973 – 0979]), then a dilution step of adding distilled water to the filtered milk as needed (approximately 10 mL) in order to satisfy manufacturer instructions for properly filled/balanced tubes ([0980]), reading on claim 3.
Thery teaches that for the separation of extracellular vesicles (i.e. exosomes), there is no single optimal separation method, so choose based on the downstream applications and scientific question (Table 1, page 13). Thery et al. teaches the k factor can be determined from the rotor type, tube/adapter, and centrifuge speed and must sometimes be adjusted (Table 1, subparagraph a). Thery et al. teaches for filtration techniques; one must take care to remove cells and other large membranous structures prior to ultrafiltration and that the pore size of the matrix should be taken into account (Table 1 subparagraph b). Thery et al., teaches that time and temperature are also factors that may require adjustment during the exosome separation process (Table 1, Examples for classical technique). A person of ordinary skill in the art, with a reasonable expectation of success, would have been able to adjust the k factor and time of the first centrifugation step to encompass 4,000 to 6,000 x g for 20 to 40 minutes as recited in claim 4, the desired mesh size of the strainer to 20 to 60 µm or 30 to 50 µm as recited in claims 3 and 5, an equal amount of distilled water added to the filtered milk or goat milk as recited in claim 3, and the temperature to room temperature as recited in claim 7 in the instant application with repeated experimentation and a reasonable expectation of success based on the teachings of Thery.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the exosome preparation processes of Izumi and Bolen to prepare the exosomes taught by Liang/Weon/Samuel motivated by the desire to optimize the separation process according to the downstream application of the exosomes (Thery, Table 1) and to adjust the volume of liquid in the tubes in order to satisfy manufacturer instructions for properly filled/balanced tubes (Bolen, ([0980]).
Claims 33, 35, 37, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al. (TW201620498; publication date: 06/16/2016; citing the English machine translation) in view of Weon et al., (KR 2019/0045829 A, May 03, 2019; of record) and Samuel et al. (Scientific Reports 7:5933; publication year 2017) as applied to claims 14, 21, 23, 24, 26, 28, 30, and 31 above, and further in view of Lee et al. (KR20050078393; publication date: 08/05/2005; citing the English machine translation).
The relevant disclosures of Liang, Weon, and Samuel are set forth above. None teach a method of whitening skin in a subject in need thereof.
Lee teaches colostrum as a main ingredient of a skin whitening cream.
It would have been prima facie obvious to use the colostrum exosomes of Liang/Weon/Samuel to whiten skin in a subject in need thereof. The artisan of ordinary skill would have recognized colostrum derived exosomes as suitable for this purpose. See MPEP 2144.07.
Claims 35, 37, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al. (TW201620498; publication date: 06/16/2016; citing the English machine translation) in view of Weon et al., (KR 2019/0045829 A, May 03, 2019; of record) and Samuel et al. (Scientific Reports 7:5933; publication year 2017), and Lee et al. (KR20050078393; publication date: 08/05/2005; citing the English machine translation) as applied to claims 14, 21, 23, 24, 26, 28, 30, 31, 33, 35, 37, and 38 above, and further in view of Izumi et al., (EP 3192518 A1, July 19, 2017; Morinaga Milk Industry, cited by applicant on IDS), Bolen et al. (US 2018/0193270 A1, July 12, 2018) and Thery et al. (Journal of Extracellular Vesicles, 2018; cited in IDS).
Instant claims 35, 37, and 38 have been rejected as being obvious over Liang, Weon, Samuel, and Lee as set forth supra. However, purely arguendo, for the purposes of complete prosecution, and for the purposes of this ground of rejection only, the product by process language of instant claims 35, 37, and 38 is also obvious as follows:
Izumi discloses a method for isolating exosomes from milk, comprising: a centrifugation step of centrifuging raw milk so as to remove fat and cells at 4 degrees Celsius; a step of removing centrifuged fat and cells; a step of adjusting the pH to 4.6 by adding 10% acetic acid and precipitating casein; a step of centrifuging the milk in which casein is precipitated at 4,500 × g and 4°C for 30 minutes, and collecting a supernatant; and a step of filtering the collected supernatant by using a 0.22 µm filter ([0046]), reading on claims 3-4 and 6-7.
Bolen teaches methods of producing exosomes (Abstract) from milk ([0009]) by a first step of centrifugation ([0970] – [0972]), then a first filtration step to further remove fat and cells therefrom ([0973 – 0979]), then a dilution step of adding distilled water to the filtered milk as needed (approximately 10 mL) in order to satisfy manufacturer instructions for properly filled/balanced tubes ([0980]), reading on claim 3.
Thery teaches that for the separation of extracellular vesicles (i.e. exosomes), there is no single optimal separation method, so choose based on the downstream applications and scientific question (Table 1, page 13). Thery et al. teaches the k factor can be determined from the rotor type, tube/adapter, and centrifuge speed and must sometimes be adjusted (Table 1, subparagraph a). Thery et al. teaches for filtration techniques; one must take care to remove cells and other large membranous structures prior to ultrafiltration and that the pore size of the matrix should be taken into account (Table 1 subparagraph b). Thery et al., teaches that time and temperature are also factors that may require adjustment during the exosome separation process (Table 1, Examples for classical technique). A person of ordinary skill in the art, with a reasonable expectation of success, would have been able to adjust the k factor and time of the first centrifugation step to encompass 4,000 to 6,000 x g for 20 to 40 minutes as recited in claim 4, the desired mesh size of the strainer to 20 to 60 µm or 30 to 50 µm as recited in claims 3 and 5, an equal amount of distilled water added to the filtered milk or goat milk as recited in claim 3, and the temperature to room temperature as recited in claim 7 in the instant application with repeated experimentation and a reasonable expectation of success based on the teachings of Thery.
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined the exosome preparation processes of Izumi and Bolen to prepare the exosomes taught by Liang/Weon/Samuel motivated by the desire to optimize the separation process according to the downstream application of the exosomes (Thery, Table 1) and to adjust the volume of liquid in the tubes in order to satisfy manufacturer instructions for properly filled/balanced tubes (Bolen, ([0980]).
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive.
On page 7, Applicant argues that exosomes obtained from different sources comprise significantly different types and concentrations of internal components (e.g. depending on the cell or tissue of origin) and therefore exhibit different functions. Applicant argues that nothing in Gupta or Lee indicates that exosomes isolated from colostrum had a recognized suitability for use in a method as claimed. On pages 8-9, Applicant argues that one of ordinary skill would not have expected exosomes from a particular source to exhibit broad therapeutic effects and cites Hamzah, Ren, and Sancho Alberto to support the position that it was known in the art that exosomes obtained from different sources have different types and concentrations of internal components therefore exhibit different functions.
The new grounds of rejection have addressed Applicant’s position that one having ordinary skill would not have expected exosomes isolated from colostrum to have factors that would accelerate healing, treat wrinkles, or lighten skin. Together, the prior art teaches that one having ordinary skill would have expected exosomes from colostrum to accelerate healing, treat wrinkles, and lighten skin. Moreover, Conclusive proof of efficacy is not required to show a reasonable expectation of success, and obviousness does not require absolute predictability, but at least some degree of predictability is required. See MPEP 2143.02(I) and (II). In the instant case, the teachings that colostrum contains exosomes, that exosomes are enriched in proteins that can potentially regulate the immune response and growth (Samuel), and the teaching that colostrum fractions that have been separated by centrifugation and filtration (Liang), and the teachings that colostrum can effect skin whitening (Lee) have the claimed effects provides sufficient expectation of success to the artisan of ordinary skill.
Applicant’s arguments referring to Schuh on page 8 are moot as Schuh is no longer cited in the current rejection.
In page 10, Applicant argues that the rejection is based entirely on improper hindsight.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
On page 10, Applicant cites experimental example 8 and Fig 8 as showing that HCat keratinocytes or HDFs are treated with commercial milk exosomes or exosomes from colostrum, proliferation capacity and cell migration in the colostrum-derived exosome treated cells is greater than that of the commercial milk exosome treated cells. Applicant points to figure 16 as showing improved tissue regeneration in an animal model in groups treated with colostrum exosomes over milk exosomes. On page 11, Applicant points to experimental examples 8 and 9 of the specification as showing enhanced expression of elastin and Type I collagen as well as suppression of MMP-2, providing superior anti-wrinkle and tissue repair phenotype compared to commercial exosomes isolated from milk. Finally, Applicant cites figure 19 as showing that exosomes isolated from colostrum significantly reduced melanin content relative to control.
Please refer to MPEP 716.02(b) which details the burden on Applicant to establish that results in a side-by-side comparison to the closest prior art are unexpected and significant. Specifically, Applicant must establish that differences in results are in fact unexpected and unobvious and are of both practical and statistical significance. Additionally, evidence of unexpected properties must be commensurate in scope with the claims.
With regard to the benefits of exosomes derived from colostrum over those from milk, as noted in the rejections (1) Samuels teaches enrichment of many proteins involved in immune response and growth in colostrum exosomes relative to milk exosomes, (2) Liang teaches that colostrum fractions isolated by centrifugation and filtration show anti-oxidation and anti-aging (i.e. anti-wrinkle) effects, and (3) Lee teaches colostrum as a component of a skin whitening cream. Thus, it does not appear that one having ordinary skill in the art would have found it surprising that colostrum-derived exosomes are beneficial in wound healing, anti-aging/anti-wrinkle, and skin whitening settings. The evidence currently of record is equivocal as to the unexpected nature of the results. Also, the experiments comparing to breast milk, in the case of the anti-wrinkle effects, do not represent a side-by-side comparison to the closest prior art. With regard to Fig. 19 showing an improvement of col M-exo over control, a proper comparison would have been to e.g. Lee’s composition for skin whitening containing colostrum.
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 14, 21, 23, 24, 26, 28, 30, 31, 33, 34, 35, 37, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over
claims 1, 5, 6, and 9-20 of copending Application No. 18/133,886;
claims 1-9 of copending Application No. 18/133,901; and
claims 1 and 3-9 of copending Application No. 18/133,918
in view of Weon et al., (KR 2019/0045829 A, May 03, 2019) (hereinafter Weon).
The copending claims are directed to a methods of administering an effective amount of exosomes isolated from cow milk or goat milk, or colostrum wherein the exosomes are not drug carriers, but do not embrace a method of accelerating regeneration of wounded skin, reducing wrinkles, or whitening skin of a subject in need thereof.
However, Weon teaches a cosmetic method for regulating the condition of mammalian skin other than for therapeutic use or a method for treating skin disease by using the method for enhancing transdermal penetration of exosomes ([0015]). The method comprises the steps of topically applying a composition containing exosomes as an active ingredient to the skin of a mammal ([0018]). The term "exosomes" refers to vesicles measuring tens to hundreds of nanometers (preferably approximately 30 to 200 nm) in size and contain proteins, nucleic acids (mRNA, miRNA, etc.) ([0019]) and means all vesicles having a nano-sized vesicle structure secreted from various cells of animals released into the extracellular space and having a composition similar to exosomes (e.g., exosome-like vesicles) (0021]). Various exosomes can be used as long as they are applicable to the skin and do not cause adverse effects on the human body ([0022]). Skin disease treatment means removing, alleviating or improving pigmented skin lesions, and alleviating, improving or restoring to normal of autoimmune progesterone dermatitis and neurogenic scratch wounds ([0025]). Regulating the condition of the skin means improving the condition of the skin, which can include skin regeneration, wrinkle removal or improvement, whitening ([0037]). Accordingly, it would have been obvious to one of ordinary skill in the art to use the exosomes of the copending claims in a method of accelerating regeneration of wounded skin, reducing wrinkles, or whitening skin of a subject in need thereof since exosomes are used as an active ingredient that regenerate skin, including wounded skin, remove wrinkles, and whiten skin, as taught by Weon.
Response to Arguments
Applicant's arguments filed 06/24/2026 have been fully considered but they are not persuasive.
On page 11, Applicant argues that the OTDP rejections rely on Lee to allegedly bridge the gap between the pending claims and the cited claims but as shown in the traversal of the obviousness rejections, Lee does not suggest or provide a reasonable expectation of success for using exosomes isolated form colostrum in a method as claimed, thus the OTDP rejections should be withdrawn. On page 12, Applicant argues that the intended uses/outcomes of the methods embraced by the copending applications differ from those of the instant invention and therefore the inventions are patentably distinct.
This is not persuasive because the central discover of the instant invention appears to be that milk exosomes have various uses including in functional cosmetics, functional health food with various functions such as improving gut health and immunity, and drugs including a wound healing medication (see instant abstract); however, this property of exosomes appears to have been appreciated in the art as of the instant effective filing date, see Weon.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE PEEBLES whose telephone number is (571)272-6247. The examiner can normally be reached Monday through Friday: 9 am to 3 pm.
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/KATHERINE PEEBLES/Primary Examiner, Art Unit 1617
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