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 .
Claims 1-10 are under examination.
Response to Applicants Remarks/Amendments
The claim objection is being withdrawn because applicants have changed the term media (plural) to medium in the claims. Because claim 5 has been amended, the 112(b) rejection for claim 5 is withdrawn.
In the response dated November 07, 2025, applicant discusses that even though claims 12-17 (Group III in the past restriction) have been withdrawn, applicant “specifically reserves the right of rejoinder of non-elected Group III species in the event that a generic or linking claim is deemed allowable.” Claim 1 which is the independent claim in Group I currently being examined is significantly different than claim 12 of Group III. For example, claim 1 requires that a paste be formed from the dry ingredients, that there be a milling operation, and that a medium powder be produced which are not requirements recited in independent claim 12 of Group III. Group I (currently examined) recites a cell culture medium powder formulation method, while Group III is a method of reconstituting/rehydrating a powder in order to make a liquid medium. Currently, there are significant differences between Group I and Group III. Therefore, the examiner will not rejoin the groups/species at this time.
The examiner will address applicants’ arguments specific for Yang directly below the 102 rejection that cites Yang. Applicants’ 103 arguments will be addressed at the end of the 103 rejections.
Claim Rejections - 35 USC § 102
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.
Claims 1,5-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang (CN 111870732)
Yang discloses a method of making a dry cell culture medium powder comprising the steps of: providing dry ingredients of a desired cell culture medium (Page 2, Step 1-2—both dry carboxymethyl potato starch and a porcine-derived small intestinal submucosal layer/extracellular matrix layer are provided); mixing the dry ingredients with an aqueous solution to form a paste (Page 2, Step 3---the dry ingredients are mixed with solution to form a gel/paste); drying the paste to form a dehydrated medium product (Page 2, Step 4); and
milling the dehydrated medium product to achieve the dry cell culture medium powder of a desired particle size (Page 2, Step 5) as in instant Claim 1. Yang discloses mixing the dry ingredients and aqueous solution until the paste is homogeneous (Page 2, Step 3---The ingredients are mixed together for several hours) as in instant Claim 5. Yang discloses wherein the aqueous solution comprises at least one base (sodium hydroxide), used to pre-adjust a pH of the dry cell culture medium powder (Page 3, Step 3) as in instant Claims 6-8.
The reference anticipates the claimed invention.
Response to Applicants Arguments/Amendments
Applicants argue the following:
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Applicants are arguing that Yang does not teach a culture medium. Applicants’ specification in paragraph 77 states that the term “cell culture media” and “media” are used interchangeably and refer to a substance used during the culturing of cells to provide an environment and/or nutrients required by the cells. The cell culture medium may be a complete formulation, i.e. a cell culture medium that requires no supplementation to culture cells, may be an incomplete formulation, i.e. a cell culture medium that requires supplementation or may be a medium that may supplement an incomplete formulation or in the case of a complete formulation, may improve culture or culture results.”
The definition in the specification is so broad that it essentially encompasses any type of medium that can support cells. Yang’s carboxymethyl potato starch and extracellular matrix (both dry ingredients) can be combined together in order to produce an environment that is able to support cells/tissue and promote the regeneration of the cells/tissue (Summary Section of Yang). Yang’s composition composed of carboxymethyl potato starch and extracellular matrix (the dry ingredients) provide an environment which are needed by cells/tissue in order to promote growth and regeneration. There is no limitation that prevents the cell culture medium from having an in-vivo application. There is no additional claim language that further defines what the actual environment is that the cells/tissue are exposed to. Applicants mention an artificial environment with specific culture components described in the specification; however, the instant claim limitations do not mention an artificial environment with specific culture components. The instant claims do not include limitations that distinguish the invention structurally and/or functionally from the supportive medium taught in Yang.
Applicants further argue in italics, that “Yang’s hemostatic particles only contain carboxymethyl starch and extracellular matrix, which lack fundamental ingredients required for artificial cell growth/maintenance such as nutrients like glucose, amino acids, growth factors, buffering agents, and osmotic balancing agents……For at least these reasons, Yang’s hemostatic particles are entirely different from independent claim 1’s cultivating cell culture medium.”
This argument is not commensurate in scope with the instant set of claims because the instant claims are not requiring nutrients such as glucose, amino acids, growth factors, buffering agents, and osmotic balancing agents be present. The claims do not specify a specific amount of cell growth and/or cell expansion that must occur.
Applicants further argues the following:
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The examiner is not persuaded by this argument because independent claim 1 recites the following, “providing dry ingredients of a desired cultivating cell culture medium; mixing together the dry ingredients with an aqueous solution to form a paste….”
The second page of the translated Yang document states the following:
“Step 1: gelatinization of carboxymethyl starch solution: taking carboxymethyl starch (a dry ingredient) adding deionized water (an aqueous solution), and heating the water bath to form carboxymethyl starch paste (a paste) (this indicates mixing)….”
“Step 2: preparation of an extracellular matrix solution; after the animal-derived tissue is subjected to decellularization treatment, freeze-drying an extracellular matrix (these treatments would produce a dry ingredient), and after low temperature pulverization, deionized water (an aqueous solution) is added, and stirred and mixed to obtain an extracellular matrix solution.”
“Step 3: blending and crosslinking: mixing the extracellular matrix solution with the carboxymethyl starch paste….to eventually obtain a uniform gel solution”
Steps 1 and 2 show that dry ingredients are mixed with an aqueous solution (deionized water). Furthermore, the carboxymethyl starch (initially a dry ingredient) is mixed with an extracellular matrix (initially a dry ingredient) and deionized water in step 3. Instant claim 1 does not clearly establish that the dry ingredients are first mixed together by themselves before the addition of an aqueous solution. Such a limitation could be used to distinguish the invention from the prior art.
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, 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 1-3 and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN 111870732) in view of Von Hagen (US 20180223250)
Yang applies as above to teach claims 1,5-8. Yang discloses drying/lyophilizing the paste using a freeze drying technique without vacuuming. Von Hagen teaches that lyophilization can be accomplished using a vacuum (Paragraphs 9, 200-201). It would have been obvious to an artisan of ordinary skill at the time of effective filing to have used vacuuming in the process taught by Yang. An artisan would have been motivated to have used a vacuum to carry out lyophilization because Von Hagen states that a vacuum can be used in the final drying process of lyophilization to remove unwanted water/moisture (Paragraphs 200-201 of Von Hagen). It would be expected that the vacuum drying would be employed to remove as much moisture as possible. There would have been a high expectation for success because Von Hagen teaches that vacuuming can be used to lyophilize/dry a product (Paragraphs 200-201) as in instant Claims 2-3.
Dependent Claims taught by Von Hagen
Von Hagen teaches mixing the ingredients until the paste is homogenous (Paragraphs 151-152) as in instant Claim 5.
Yang teaches a production of a culture medium. Yang carries out dehydration thorough freeze-drying lyophilization. Yang does not mention vacuuming. Von Hagen uses vacuuming in a process that involves freeze drying lyophilization. An artisan would have been motivated to have included the vacuuming taught by Von Hagen in the process taught by Yang since vacuuming removes unwanted moisture/water from the composition. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
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 combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be high educated individuals, possessing advanced degrees, including M.D.s and Ph.Ds. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and medium formulation. Therefore, the level of ordinary skill in this art is high.
Claims 1, 4-8 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN 111870732) in view of Fike (US 20060275886)
Yang applies as above to teach claims 1,5-8. Yang dries its paste using a freeze-drying process. Yang does not dry its product using heating. However, Fike teaches that heating is another means of carrying out drying to create a powder (Paragraphs 103 and 121). An artisan would have been motivated to have used the drying technique taught by Fike because it results in a dried powder like the freeze-dried lyophilization process taught by Yang. Because heating can be used like freeze drying (taught in Yang) to dry a product, remove water, and create a powder, there would have been a high expectation for success using heating in place of freeze-drying (Paragraphs 103 and 121 of Fike) as in instant Claim 4.
Yang teaches a method of making a dried cell culture medium powder. Yang does not teach that heating is employed. However, an artisan would have been motivated to have used heating in place of freeze drying since heating like freeze drying can successfully dehydrate and dry a composition forming a powder (Paragraphs 103 and 121 of Fike). Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
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 combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be high educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and medium formulation. Therefore, the level of ordinary skill in this art is high.
Claims 1,5-10 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN 111870732) in view of Shea (US 20150209293)
Yang applies above to teach claims 1,5-8. Although Yang teaches that the pH of its product can be adjusted using sodium hydroxide and HCl (Page 3), Yang does not teach coating its dry lyophilized product with sodium bicarbonate. However, Shea teaches that a therapeutic material can be combined with sodium bicarbonate. It would have been obvious to an artisan of ordinary skill at the time of effective filing to have combined the dehydrated product of Yang with sodium bicarbonate as taught by Shea. An artisan would have been motivated to have added sodium bicarbonate to Yang’s dehydrated product because Shea teaches that it can be used to successfully control the pH of the composition (Paragraphs 21 and 73 of Shea). Because sodium bicarbonate can control pH there would have been a high expectation for success as in instant Claims 9 and 10.
Yang teaches production of a culture medium. Yang adjusts the pH of its product by adding hydrochloric acid and/or sodium bicarbonate. Yang does not mention using sodium bicarbonate as a buffer to successfully control the pH of the dehydrated product. An artisan would have been motivated to have added a buffer such as sodium bicarbonate to Yang’s dried medium product because sodium bicarbonate can be used to better control the pH of the product as taught by Shea. Given the teachings of the cited references and the level of skill of an ordinary skilled artisan at the time of applicants’ invention, it must be considered absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
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 combinations would have yielded predictable results to one of ordinary skill in the art at the time of the invention (See KSA International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007). People of ordinary skill in the art will be high educated individuals, possessing advanced degrees, including M.D.s and Ph.D.s. They will be medical doctors, scientists, or engineers. Thus, these people most likely will be knowledgeable and well-read in the relevant literature and have the practical experience in molecular biology, cell culture, and medium formulation. Therefore, the level of ordinary skill in this art is high.
Response to Applicants Arguments
The main argument against Von Hagen, Fike, and Shea is that these references fail to remedy the deficiencies of Yang. Because Yang is not deficient, Von Hagen, Fike and Shea are not defective. The 892 form in the past office action had the correct Publication number for the Von Hagen reference. There was a small typo in the rejection in the last office action so the examiner corrected it. The Publication number for Von Hagen in the rejection was missing a zero in the rejection so examiner has since added it.
Conclusion
All claims stand rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN K VAN BUREN whose telephone number is (571)270-1025. The examiner can normally be reached M-F:9:30am-5:40pm; 9:00-10:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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LAUREN K. VAN BUREN
Examiner
Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638