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
Claims 12-16 are new. Claims 1-16 are pending. Claims 6-11 are withdrawn. Claims 1-5 and 12-16 are under examination.
Priority
This application is a national stage entry of PCT/IB2022/059983 filed on 10/18/2022, which claims priority from CH070433/2021 filed on 10/22/2021 and IT102021000027167 filed on 10/22/2021.
Information Disclosure Statement
The information disclosure statement filed on 04/16/2024 has been considered by the examiner.
Election/Restriction
Applicant's election with traverse of Group I (claims 1-5 and 12-16) in the reply filed on 2/27/2026 is acknowledged. The traversal is on the ground(s) that the methods cannot be practiced with a materially different product. This is not found persuasive because the prior art teaches isolated milk vesicles and compositions thereof. The purified/isolated milk extracellular vesicles were the unifying feature between the method of making, method of using and composition claims of applicant. Applicant argues that Bolen did not teach the thermal treatment step of claim 1. This step is specific to the method of preparing the vesicles rather than a compositional or structural feature thereof that relates to the vesicles or methods of using that involve the vesicles. Applicant argues that it’s process provides high volume/high purity exosomes required for groups II and III. It remains that the prior art of Bolen teaches making purified isolated milk extracellular vesicles that can serve as drug delivery vehicles (the product that is the unifying feature of groups I-III). Additionally, in regards to claims to products and methods of using products that depend on the method of making steps, these amount to product-by-process steps for groups II and III. A materially similar product may be made by different process in the art (see MPEP 2113 regarding product-by-process). Since the prior art of Bolen teaches purified milk extracellular vesicles (purity that would be acceptable for drug delivery as Bolen teaches drug delivery), it breaks unity as it shows this feature does not make a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 6-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/27/2026.
Claim Objections
Claim 1, part c is objected to for having an unnecessary comma after “a liquid” and before “containing” in the limitation. Applicant may delete this comma.
Claim 1 is objected to for missing an “and” between the end of step g) and the beginning of step h).
Claim 1 is objected to for “EVs” without spelling it out for the first time in the claims as “extracellular vesicles”.
Claims 2, 14 and 15 are objected to for the recitation of “said milk coagulation step or enzyme mix of step (c)” as this appears redundant. Step c in claim 1 is a milk coagulation (coagulation) step and also involves an enzyme mix for the coagulation. Applicant may simply say “wherein said enzyme mix of step c) contains….” for claims 2 and 15 and “wherein said enzyme mix of step c) is obtained…” for claim 14.
Claim 5 is objected to for missing a comma “,” between the recitations of “cryoprotectants” and “and lyophilized” in the claim.
Claim 16 is objected to for (c/), which is more appropriately (c’), as step (c’) is where the thermal treatment takes place in claim 1.
Appropriate correction is required.
Claim Rejections - 35 USC § 112 (b)
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 1-5 and 12-16 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.
Claim 1 is indefinite for use of “optionally” for steps b) and f) as it is indefinite whether everything including the other steps (c-e and g) appearing after these recitations of “optionally” would be optional or if only step b) would be optional and only step f) would be optional with all the other steps needing to be present. For the purpose of compact prosecution, the examiner will consider these steps b) and f) as being optional, but steps c)-e) and g), which do not use “optionally”, needing to be present as the claim also indicates being to “isolation of purified milk EVs”. Applicant may consider removing these optional steps from claim 1 and making them dependent claims that also provide where the step would be within the method. As step h) appears last, it may use “optionally” since it would only make that last step of claim 1 optional without potentially affecting anything else.
Claims 2-5 and 12-16 are rejected as being dependent on an indefinite claim.
Claim 1 is indefinite for the phrase of “traditionally known filtration or decantation processes” as it is unclear which filtration or decantation processes would be considered traditionally known. “Traditionally known” in the claim does not provide for any particular processes for one to understand the metes and bounds of the claim. For the purpose of compact prosecution, if the prior art teaches a filtration or decantation process, then it will read on the limitation. Applicant may remove “traditionally known” from the claim and if there are specific processes that applicant would like to provide in the claim, applicant may amend the claim to import them as supported by the originally filed specification.
Claims 2-5 and 12-16 are rejected as being dependent on an indefinite claim.
Claim 1 is indefinite for the phrase of “a pre-defined temperature and time” as “pre-defined” does not provide for a particular temperature and time for one to read the claim. “Pre-defined” in the claim does not provide for any particular time and temperature to read on the limitation. For the purpose of compact prosecution, if the prior art teaches a time and temperature, then it will read on the limitation. Applicant may remove “pre-defined” and if applicant intends particular time and temperature ranges, then applicant may import them into the claim as supported by applicant’s originally filed specification.
Claims 2-5 and 12-16 are rejected as being dependent on an indefinite claim.
Claims 1 and 4 are indefinite for “at least one ultrafiltration and concentration steps” as it is unclear if applicant means the limitation to choose “at least one of an ultrafiltration step and/or one of a concentration step” or if they mean to choose “at least one ultrafiltration step and at least one concentration step”. For the purpose of compact prosecution, the examiner will consider the claim as it reads ““at least one of an ultrafiltration step and/or one of a concentration step”. If applicant intends for both, the applicant may consider deleting “at least one” from this limitation so it reads “subjecting said clear solution to ultrafiltration and concentration steps…”.
Claims 2-3, 5 and 12-16 are rejected as being dependent on an indefinite claim.
Claim 1 is indefinite for “defined pore-sizes and ionic strength” as this does not provide how the sizes or ionic strength are defined in order to read on the claim. “Defined” does not provide for particular size or ionic strength values. Therefore, it is unclear how to read the metes and bounds of this limitation of “defined” as used in the claim. For the purpose of compact prosecution, if the prior art teaches filters/membranes with pores and a material with ionic strength, it will read on the claim. Applicant may consider removing “defined” from this limitation and if they would like to offer values for such items, the could consider limitations to such values as supported by applicant’s originally filed specification.
Claims 2-5 and 12-16 are rejected as being dependent on an indefinite claim.
Claim 1 is indefinite for “adjusted water or buffer” as it is unclear how the water or buffer are adjusted in order to read this limitation. As adjustments could include numerous factors such as pH, additional components, temperature, osmolarity, viscosity, and others, it is unclear how one would read “adjusted” to define water or buffer in the claim. If the prior art teaches use of water, aqueous composition, or buffer or other items that may be construed as an adjusted water or buffer, it will read on the claim limitation. Applicant may consider removing “adjusted” from this limitation.
Claims 2-5 and 12-16 are rejected as being dependent on an indefinite claim.
Claim 1 is indefinite for “filtration/clarification” as it is indefinite whether this should be read as “filtration and clarification”, “filtration or clarification” or “filtration and/or clarification”. For the purpose of compact prosecution, the examiner will consider the limitation as “filtration and/or clarification”.
Claims 2-5 and 12-16 are rejected as being dependent on an indefinite claim.
Claims 1 and 13 are indefinite for “standard sterile filters” as it is unclear what would represent the standard (e.g. material of the filter, structure of the material, manner in which they are sterilized and to what degree, etc.). Applicant may delete standard and recite “using sterile filters”.
Claims 2-5, 12, and 14-16 are rejected as being dependent on an indefinite claim.
Claim 3 is indefinite for the recitation of “at least tens of minutes” as it is unclear what tens of minutes applicant is referring to for this range as tens may be 10, 20, 30, 40, 100 or etc. Tens also appears to suggest multiple tens, so 20, for example, might be considered to be the lowest part of the range. Thus, it is unclear how to read the metes and bounds of this range as to what the lowest value would be. Applicant might consider amending the limitation to say “at least ten minutes” where ten would be the minimum.
Claim 16 is rejected as being dependent on an indefinite claim.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 1-4, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bolen WO2020010161A1 (1-9-2020), Nordin et al (Nanomedicine: Nanotechnology, Biology and Medicine, May 2015, volume 11, pages 879-883) and Wijenayake et al (bioRxiv, August 14, 2020, doi: https://doi.org/10.1101/2020.08.14.251629) as evidenced by Hasegawa et al (FEMS Microbiology Letters, 2003, volume 223, pages 41-46).
As the process uses “comprises” as the transition phrase, it is open to other steps and elements of the prior in addition to what is in the claims.
Each step beginning with “optionally” will be read as being optional.
Bolen teaches milk vesicles such as exosomes and other vesicles (pages 11-27). Bolen teaches purification of exosomes/vesicles (examples 1 and 5 in Bolen), and thus, recognizes this goal of its methods. The basic process of Bolen is “In some embodiments, the method for preparing a composition comprising milk vesicles may comprise: (i) providing a first milk sample; (ii) removing casein and/or lactoglobulin from the first milk sample to produce a second milk sample; and (iii) isolating milk vesicles from the second milk sample to produce a composition comprising the milk vesicles” (page 7). Bolen teaches that milk can be processed with a combination of one or more of homogenization, pasteurization, sterilization and/or irradiation (page 16). Bolen teaches casein removal with enzymes capable of coagulating or digesting casein, for example, using rennet (a mixture of enzymes capable of curdling milk) (page 93). Bolen teaches rennet includes the enzyme, chymosin and optionally other enzymes like pepsin (page 93). Example 4 of Bolen teaches preparation of milk vesicles involving casein removal via coagulation with vegetable rennet (page 104). Bolen offers reasoning to remove/eliminate caseins with sizes of 25-30 kDa and/or lactoglobulins of sizes 10-20kDa (page 93). Bolen teaches enrichment of the milk vesicles by tangential flow filtration (page 94). Bolen teaches modifications to milk vesicles may be subject to extrusion (once or multiple times) through a filter with suitable size (e.g. 50 nM, 75 nM or 100 nM) to change size distribution (page 27). The layer in the filter with pores is the membrane (as evidenced by Hasegawa that shows such filters have porous membranes, abstract and introduction of Hasegawa). Bolen teaches “In some embodiments, a filter such as a 0.2 micron filter is used to remove larger debris from solution. In some embodiments, the method for separation of milk vesicle (for example, in the 80-120 nanometer range) includes separation based on specific milk vesicle properties such as size, charge, density, morphology, protein content, lipid content, or epitopes recognized by antibodies on an immobilized surface (immuno-isolation)” (pages 90 and 91). On page 91, Bolen allows for ultracentrifugation as a further technique of separation and allows for size exclusion based on different filters such as 0.45 micron or 0.22 micron filters. Bolen teaches buffer substances such as potassium sorbate to make pharmaceutical compositions (bottom of page 73). Bolen teaches methods for homogenization, pasteurization, sterilization and irradiation of milk are known in the art (page 16, lines 22-32). Bolen allows for different pasteurization processes and indicates that pasteurization is heating up milk and then quickly cooling it to eliminate certain bacteria (page 16, lines 9-15). Bolen teaches milk vesicles being stable at 60-80 C for 30 minutes (page 23, lines 28-30). Thus, Bolen provides for providing milk (a sample of milk) in step a, optional filtration process of step b due to its teachings of filtration as a separation technique and reasons for filtering, subjecting the milk to an enzyme mix for coagulation of milk protein(s) to obtain liquid with coagulated protein(s) of step c, separating coagulated proteins with at least one filter (where filters have porous layers) in step d since it is recognized as a suitable separation technique, separations based on other factors such as size, charge (relates to ionic states) and density that would partially provide step e, adding agents like potassium sorbate (step f) (buffering substance in Bolen, page 73) to form a pharmaceutical composition and teachings of pH adjusted compositions that promotes adjusting pH (bottom of page 75) (also step f), subjecting the composition to a second filtration/clarification step by teachings of possible multiple filtrations/separations in Bolen (step g) and using sterile filtration with filters of pore sizes less than one micron (optional step h). As Bolen teaches filtrations, enzyme treatment to remove casein, and separations of the milk in a process to obtain the exosomes/vesicles, there is an expectation of the liquid becoming clearer/more transparent with each separation.
Bolen does not teach a heating step after the enzyme coagulation step and temperatures of this step in dependent claims. Bolen does not teach ultrafiltration, but allows for filtration and various separation techniques in its processes.
Nordin teaches ultrafiltration with a subsequent size exclusion chromatography involved in a process for high yield isolation extracellular vesicles (abstract). Figure 1 of Nordin notes that ultrafiltration allows for efficient isolation of intact EVs (figure 1 legend). Figure 1A provides a flow chart that provides for a comparison of ultrafiltration with ultracentrifugation in the process. Nordin teaches that the ultrafiltration process can be extended to complex biological fluids (page 883).
Wijenayake teaches that milk is a highly complex, heterogeneous biological fluid (abstract). Wijenayake teaches “In this study, we tested: 1) three pre-processing methods to remove cream, fat, and casein proteins from bovine milk to determine whether pre-processing of whole milk, prior to long-term storage, improves MDE (milk-derived exosomes) isolations, 2) two commonly-used exosome isolation methods, and 3) four extraction protocols for obtaining high quality MDE RNA from bovine and human milk” (abstract). Wijenayake teaches ultracentrifugation in method 2 (page 8). Wijenayake teaches hold pasteurization involving 62.5 °C temperature treatment for 30 min also does not appear to adversely affect the integrity and biological function of MDEs, and pasteurized MDEs were shown to be as functionally beneficial as raw milk MDEs in therapeutics (pages 19 and 20). Thus, heating to pasteurize milk can still be done without affecting the exosomes. Thus, as pasteurizing (sterilizing milk by heating to kill harmful microbes) is a recognized process of the prior art in milk preparations to isolate exosomes and may be done at temperatures at or near those of applicant’s claims for 30 minutes, one of ordinary skill in the art would incorporate it into the claimed process to further sterilize the vesicles/exosomes.
One of ordinary skill in the prior art before the time of filing would have adjusted methods of Bolen to incorporate ultrafiltration of Nordin as it as seen as helping to produce high quality exosomes from complex liquids while also allowing for temperature treatments such as pasteurization at around 62.5 C for 30 minutes while keeping exosomes stable. Pasteurization is a sterilization technique for milk products that involves heating then cooling to eliminate unwanted bacteria/microbes (see teachings of Bolen above). Note that pasteurization is recognized in Bolen, but the further teachings of Wijenayake provide for lower temperature heating for longer times that keep stability of the exosomes. Thus, the steps and materials (milk, filtrations, enzyme treatment with chymosin/pepsin, ultrafiltration, heating, size exclusions, formulating with buffering agents, adjusting pH values and sterilizing) are recognized in the cited prior art in regards to isolating and purifying exosomes from complex liquids like milk. One of ordinary skill in the prior art would note by teachings of the references that these processes are routinely adjustable to optimize for better purifying milk exosomes. In regards to claim 15, Bolen sees chymosin as being the main component of rennet with optional enzymes like pepsin. As Bolen sees these enzymes as important to the coagulation of milk proteins in the process, one of ordinary skill in the art would adjust and optimize the amounts of such known enzymes of the prior art (chymosin, pepsin) to achieve an enzyme mix for coagulation of milk proteins with a reasonable expectation of success in obtaining the coagulation function. One of ordinary skill in the art by the teachings of Bolen and Nordin that teach filtrations/size exclusions would have adjusted pore size of filters or size exclusions and how many filtrations/size exclusions were performed based on the materials to be excluded from or maintained with the exosome preparations with a reasonable expectation of obtaining purified milk exosomes of appropriate sizes for therapeutic purposes.
Claim 5 in addition to Claims 1-4, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bolen WO2020010161A1 (1-9-2020), Nordin et al (Nanomedicine: Nanotechnology, Biology and Medicine, May 2015, volume 11, pages 879-883), Wijenayake et al (bioRxiv, August 14, 2020, doi: https://doi.org/10.1101/2020.08.14.251629) and Kusuma et al (Frontiers in Pharmacology, Oct 2018, volume 9, pages 1-17) as evidenced by Hasegawa et al (FEMS Microbiology Letters, 2003, volume 223, pages 41-46).
Bolen, Nordin and Wijenayake teach the claims as discussed above. Bolen teaches milk vesicles as drug delivery vehicles for therapeutics (abstract of Bolen).
Bolen, Nordin and Wijenayake do not teach further spray drying and/or freezing and then lyophilized as in claim 5.
Kusuma teaches conventional methods for extracellular vesicle preservation for therapeutics including cryopreservation, lyophilization, freeze drying and spray drying (page 5). Kusuma teaches cryopreservation with cryoprotectants (page 5). Kusuma notes that each of these processes helps stabilize the EV’s to be used for therapeutic purposes.
One of ordinary skill in the prior art before the time of filing would conventionally spray dry or freeze isolated exosomes taught by Bolen, Nordin and Wijenayake used for therapeutic purposes and further lyophilize the prepared exosomes for stable storage. Therefore, there was a reasonable expectation of success in preparing exosomes/extracellular vesicles by these conventional methods to ensure their storage stability until therapeutic use.
Claims 1-5, and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bolen WO2020010161A1 (1-9-2020) and Patel US 10729156 B2 as evidenced by Hasegawa et al (FEMS Microbiology Letters, 2003, volume 223, pages 41-46).
As the process uses “comprises” as the transition phrase, it is open to other steps and elements of the prior in addition to what is in the claims.
Each step beginning with “optionally” will be read as being optional.
Bolen teaches milk vesicles such as exosomes and other vesicles (pages 11-27). Bolen teaches purification of exosomes/vesicles (examples 1 and 5 in Bolen), and thus, recognizes this goal of its methods. The basic process of Bolen is “In some embodiments, the method for preparing a composition comprising milk vesicles may comprise: (i) providing a first milk sample; (ii) removing casein and/or lactoglobulin from the first milk sample to produce a second milk sample; and (iii) isolating milk vesicles from the second milk sample to produce a composition comprising the milk vesicles” (page 7). Bolen teaches that milk can be processed with a combination of one or more of homogenization, pasteurization, sterilization and/or irradiation (page 16). Bolen teaches casein removal with enzymes capable of coagulating or digesting casein, for example, using rennet (a mixture of enzymes capable of curdling milk) (page 93). Bolen teaches rennet includes the enzyme, chymosin and optionally other enzymes like pepsin (page 93). Example 4 of Bolen teaches preparation of milk vesicles involving casein removal via coagulation with vegetable rennet (page 104). Bolen offers reasoning to remove/eliminate caseins with sizes of 25-30 kDa and/or lactoglobulins of sizes 10-20kDa (page 93). Bolen teaches enrichment of the milk vesicles by tangential flow filtration (page 94). Bolen teaches modifications to milk vesicles may be subject to extrusion (once or multiple times) through a filter with suitable size (e.g. 50 nM, 75 nM or 100 nM) to change size distribution (page 27). The layer in the filter with pores is the membrane (as evidenced by Hasegawa that shows such filters have porous membranes, abstract and introduction of Hasegawa). Bolen teaches “In some embodiments, a filter such as a 0.2 micron filter is used to remove larger debris from solution. In some embodiments, the method for separation of milk vesicle (for example, in the 80-120 nanometer range) includes separation based on specific milk vesicle properties such as size, charge, density, morphology, protein content, lipid content, or epitopes recognized by antibodies on an immobilized surface (immune-isolation)” (pages 90 and 91). On page 91, Bolen allows for ultracentrifugation as a further technique of separation and allows for size exclusion based on different filters such as 0.45 micron or 0.22 micron filters. Bolen teaches buffer substances such as potassium sorbate to make pharmaceutical compositions (bottom of page 73). Bolen teaches methods for homogenization, pasteurization, sterilization and irradiation of milk are known in the art (page 16, lines 22-32). Bolen allows for different pasteurization processes and indicates that pasteurization is heating up milk and then quickly cooling it to eliminate certain bacteria (page 16, lines 9-15). Bolen teaches milk vesicles being stable at 60-80 C for 30 minutes (page 23, lines 28-30). Thus, Bolen provides for providing milk (a sample of milk) in step a, optional filtration process of step b due to its teachings of filtration as a separation technique and reasons for filtering, subjecting the milk to an enzyme mix for coagulation of milk protein(s) to obtain liquid with coagulated protein(s) of step c, separating coagulated proteins with at least one filter (where filters have porous layers) in step d since it is recognized as a suitable separation technique, separations based on other factors such as size, charge (relates to ionic states) and density that would partially provide step e, adding agents like potassium sorbate (step f) (buffering substance in Bolen, page 73) to form a pharmaceutical composition and teachings of pH adjusted compositions that promotes adjusting pH (bottom of page 75) (also step f), subjecting the composition to a second filtration/clarification step by teachings of possible multiple filtrations/separations in Bolen (step g) and using sterile filtration with filters of pore sizes less than one micron (optional step h). As Bolen teaches filtrations, enzyme treatment to remove casein, and separations of the milk in a process to obtain the exosomes/vesicles, there is an expectation of the liquid becoming clearer/more transparent with each separation.
Bolen does not teach a heating step after the enzyme coagulation step and temperatures of this step in dependent claims. Bolen does not teach ultrafiltration, but allows for filtration and various separation techniques in its processes.
Patel teaches methods of purifying exosomes from whey (separated from a milk product) (abstract). Patel teaches ultrafiltration for its process (abstract). Patel teaches optionally drying to form a powder after isolating the exosomes (abstract). Drying to form a powder is lyophilization. Patel teaches enzymatic coagulation may be used and rennet may be used for the enzymes (column 5, lines 22-30). Patel teaches temperatures after the first ultrafiltration or second ultrafiltration may be raised to about 55 degrees C (column 6, lines 55-60 or column 7, lines 40-42). Patel teaches membranes configured to retain molecules greater than about 10 kda or greater than 100 kda (column 2). Patel provides the drying involves spray drying (column 2, lines 25-30). Patel teaches a freeze-dried powder (column 9, lines 8-12).
One of ordinary skill in the art before the time of filing would have included an ultrafiltration step as well as heated to temperatures including 55 degrees C between steps in an exosome isolation procedure by the combined teachings of the prior art. As both Bolen and Patel are to the making of exosomes from milk, one of ordinary skill in the art would utilize the steps of filtration and ultrafiltration, enzyme coagulation, heating and spray drying/freeze drying to make purified milk exosome products as these are seen as steps used in methods of isolating exosomes from milk products. There would be a reasonable expectation of success in achieving better purified exosomes by combining isolation/purification steps of the prior art known for such a purpose. One of ordinary skill in the art by the teachings of Bolen and Patel that teach filtrations/ultrafiltrations would have adjusted pore size of filters or size exclusions and how many filtrations were performed based on the materials to be excluded from or maintained with the exosome preparations with a reasonable expectation of obtaining purified milk exosomes of appropriate sizes for therapeutic purposes.
Conclusions
No claim is allowed.
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/MARK V STEVENS/Primary Examiner, Art Unit 1613