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 .
Claim status
In this prosecution, examiner is pursuing the amended claims dated 06 February 2026, Applicant has cancelled claims 16-17. Therefore, claims 1-15 and 18-22 are herein pending.
Election/Restrictions
Applicant’s election with traverse of Group 1, claims 1-15 drawn to a method for preparing a culture medium-derived component or a crystallized culture medium exhibiting a high level of biological stability or activity in the reply filed on 06 February 2026 is acknowledged.
Applicant argues that the special technical feature linking the inventions of Groups I-III clearly does constitute a special technical feature, which provides a contribution over the cited art. This is not found persuasive because the examiner was able to provide art which satisfied the limitations of method of group I, thereby demonstrating that the special technical feature lacks novelty. Accordingly, a lack of unity still exists between the restricted groups
Claims 18-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 1-15 are under current examination.
Priority
This application was filed 07/07/2023 and is a 371 application of PCT/KR2022 /000401, filed 01/10/2022 which claims foreign priority to KR 10-2021-0002725, filed 01/08/2021. Examiner acknowledged the certified untranslated copy of the KR 10-2021-0002725 filed 07/07/2023.
MPEP 2304.01(c) states: Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action, 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Thus, the earliest possible priority for the instant application is 01/10/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/07/2023, 08/07/2024, 11/13/2024 and 01/30/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner and the signed and initialed PTO Forms 1449 are mailed with this action.
Abstract Objection
The abstract of the disclosure filed 07/07/2023 is objected to because the abstract is 175 words in length. Therefore, submitted abstract is considered non-compliant.
Applicant is reminded of the proper language and format for an abstract of the disclosure. MPEP §608.01(b) states that the abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
Therefore, appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
(Written description)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12, 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor, at the time the application was filed, had possession of the claimed invention.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
Claim 1 encompasses a genus of any culture medium to obtain the mixture contains DMSO and acetone. However, the specification doesn't have adequate support in the disclosure for any culture medium. The SPEC states that the culture medium-derived component or crystallized culture medium obtained by applying the culture supernatant obtained by culturing chondrocytes to the Precipitation with Compressed Fluid Anti-solvent (PCA) drying process. This supernatant can exhibit a chondrocyte recovery effect and an osteoarthritis treatment effect ([0055] of US20240066069A1).
The chondrocytes were cultured until the saturation of the chondrocytes reached 100%, and then, the medium was removed, and the chondrocytes were washed twice with phosphate buffer. Subsequently, the culture medium for chondrocytes, from which FBS was removed, was added to the chondrocytes again and incubated for 7 days, and a culture supernatant was obtained therefrom [0084]. Furthermore, Example 1-3 disclose the preparation of culture medium-derived component of chondrocytes using PCA drying [0085]. More specifically, the culture medium is obtained by culturing chondrocytes in a medium and collecting the medium [0083]. Therefore, SPEC discloses the DMSO and acetone is mixed into a culture supernatant was obtained therefrom. However, specification does not disclose the co-solvent containing DMSO and acetone into any culture medium to obtain a mixture. Therefore, the specification fails to identify the any culture medium.
The prior of Hiroi et al. (US20190327959A1; published on Oct. 31, 2019; cited in PTO892; hereinafter “Hiroi”) provides a cryopreservation vessel which has a coating that is capable of inhibiting the adhesion of cells or proteins and is resistant not only to aqueous solvents but also to organic solvents (for example, cryoprotectants, in particular, dimethyl sulfoxide) (abstract of Hiroi). Furthermore, Hiroi teaches that the cell culture medium was prepared by adding 10 (v/v) % DMSO and 10% Fetal Bovine Serum (CORNING) to Dulbecco's Modified Eagle Medium (DMEM) (Waka Pure Chemical Industries, Ltd.) ([0249] of Hiroi) and allowed the cells to be stored at -80°C. without causing a significant change in cell count before and after the storage (Fig. 7) [0250]. Therefore, it is obvious that the cells to be stored at -80°C using specific culture medium (i.e., DMEM) and the prior art does not support to identify the generic culture medium for the cell or protein cryopreservation.
Therefore, one of skill in the art would neither expect nor predict the appropriate method of precipitating the culture medium-derived components in a pressure vessel using the instantly claimed genus of any culture medium or any culture medium to obtain the mixture contains DMSO and acetone.
Therefore, it concludes that the claimed genus of any culture medium to obtain the mixture contains DMSO and acetone for preparing a culture medium-derived component or a crystallized culture medium doesn't have an adequate written description. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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, 7-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (KR20200106779, published on 09/15/2020; attached STIC MT copy; cited in IDS filed 07/07/2023; hereinafter “Lee’779”), in view of Lee et al., (US20220177828A1, Priority Data of Foreign Application KR1020190025421: Mar. 5, 2019; cited in PTO892; hereinafter “Lee’828”).
Regarding claims 1, 7-12, and 14-15, Lee’779 discloses a crystallization method of the culture medium solution using a precipitation with a compressed anti-solvent (PCA) process [0012], comprising the steps of: supplying a culture solution to a container and supplying, to the container, DMSO that is a third solvent; and adding a compressed anti-solvent (i.e., Carbon dioxide ([0015], [0025] of Lee’779) to the container, wherein the temperature and pressure of the container are obtained by being adjusted to 0-40 °C and 35-500 bar, respectively (see the abstract, paragraphs [0001] and [0012]-[0020], and claims 1-10 of Lee’779; STIC MT attached copy). Furthermore, Lee’779 discloses the crystallization method may be used to dry a stem cell culture solution including a protein (e.g., target protein evaluated by VEGF) that is sensitive to temperature and maintains a microstructure through crystallization ([0007] of Lee’779). Therefore, the multi-component mixture, and the cell culture solution are precipitated (crystalized) with co-solvent (claim 4, [0031], [0022] of Lee’779).
Although, Lee’779 does not disclose the co-solvent contain acetone, however, such was known in the prior art.
Regarding claims 1 and 4, Lee’828 discloses a method for crystallization and supercritical drying of culture solution to obtain target material by drying a culture solution containing a first solvent and the target material dissolved in the first solvent comprises crystallizing the target material by replacing the first solvent with a second solvent (i.e., acetone) in the culture solution, and changing a phase of the second solvent to a supercritical phase (abstract, [0029] of Lee’828). The method of Lee’828 farther comprise vaporizing the second solvent in the supercritical phase and carried out at a temperature of 0-40° C. and a pressure of 35-500 bar ([0031]-[0032] of Lee’828). Furthermore, Lee’828 teaches that in the liquid phase step, a mixture of CO2 and EtOH substitutes water to crystallize the material dissolved in the culture solution ([0047] of Lee’828).
MPEP 2143 (A) states that combining prior art elements according to known methods to yield predictable results. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395. Accordingly, it would have been obvious to practice the crystallization method of the culture medium solution of Lee’779 and include acetone and alcohol in the culture medium as taught by Lee’828 with a reasonable expectation of success. The POSITA would have been motivated at the time of filing to do so as taught by Lee’828 because crystallization and supercritical drying of the culture solution of Lee’828 can dry the culture solution while preventing the structural stability and activity of the target material ( dried material) dissolved in the culture solution from being denatured ([0085] of Lee’828).The POSITA would have had a reasonable expectation of success in combining the teachings of Lee’779 and Lee’828 because each of these teachings both successfully generated the crystallization and supercritical drying of the culture solution. Therefore, the products and method as taught by Lee’779 et al. in view of Lee’828 et al. would have been prima facie obvious over the products and method of the instant application. In regard to the reasonable expectation of success in doing so, include the Acetone and ethanol of Lee’828 had a reasonable expectation of success since the steps thereof required no more than pipetting the appropriate DMSO and acetone in a ratio and Ethanol v/v concentration and freeze-drying technology.
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Subject Matter Free of Art
Current application claimed a method for preparing a culture medium-derived component or a crystallized culture medium exhibiting a high level of biological stability or activity, comprising: (a) adding a co-solvent containing DMSO and acetone to a culture medium to obtain a mixture; (b) adding a compressed anti-solvent (CO2) to the mixture obtained above. Dependent claims 2-3, 5-6 requires the DMSO and acetone ratio in the solvent and the co-solvent and the culture medium ratio. Furthermore, claim 13, limits the claim scope of the culture medium that obtained by culturing chondrocytes in a medium and collecting the medium.
The prior teachings of Lee’779 and Lee’828 successfully generated the crystallization and supercritical drying of the culture solution. Therefore, the method as taught by Lee’779 et al. in view of Lee’828 et al. would have been prima facie obvious over the method of the instant application. However, Lee’779 or Lee’828 does not teach or fairly suggest to prepare the DMSO and acetone ratio in the solvent and the co-solvent and the culture medium ratio as claimed in claims 2-3 and 5-6. More specifically prior art does not teach claim scope of the culture medium that obtained by culturing chondrocytes in a medium and collecting the medium.
However, claims 2-3, 5-6 and 13 are objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claims are allowed.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MASUDUR RAHMAN whose telephone number is (571)272-0196. The examiner can normally be reached M-F 8-5 (EST).
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/MASUDUR RAHMAN/ Patent Examiner, Art Unit 1633
/JEREMY C FLINDERS/ Primary Examiner, Art Unit 1684