Prosecution Insights
Last updated: April 18, 2026
Application No. 18/276,886

NUTRIENT MEDIA FOR CELL CULTURE CONTAINING PLANT PROTEIN HYDROLYSATES

Non-Final OA §102§103§112
Filed
Aug 11, 2023
Examiner
BABIC, CHRISTOPHER M
Art Unit
1633
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Bühler AG
OA Round
1 (Non-Final)
61%
Grant Probability
Moderate
1-2
OA Rounds
3y 6m
To Grant
84%
With Interview

Examiner Intelligence

Grants 61% of resolved cases
61%
Career Allow Rate
229 granted / 377 resolved
+0.7% vs TC avg
Strong +24% interview lift
Without
With
+23.7%
Interview Lift
resolved cases with interview
Typical timeline
3y 6m
Avg Prosecution
66 currently pending
Career history
443
Total Applications
across all art units

Statute-Specific Performance

§101
3.1%
-36.9% vs TC avg
§103
37.0%
-3.0% vs TC avg
§102
21.4%
-18.6% vs TC avg
§112
27.4%
-12.6% vs TC avg
Black line = Tech Center average estimate • Based on career data from 377 resolved cases

Office Action

§102 §103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Priority The instant application is a national stage entry of PCT application PCT/EP2022/053163, filed 0 8 /1 1 /20 23 under 35 USC 371. Acknowledgment is made of applicant's claim for foreign priority based on an application EP21156945.4 filed in Europe on 0 2 /1 2 /20 21 . Election/Restrictions Applicant’s election of Group II, claims 22-28, directed to a plant-based protein hydrolysate , in the reply filed on 02/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, c lai ms 2 2-28 have been considered on the merits . Claims 16-21 and 29-30 are withdrawn from consideration pursuant 37 CFR 1.142(b). Claim Objections Claim s 22 and 25 are objected to because of the following informalities: Claim 22 has parentheses in the claim. Parentheses should be used for reference characters . Generally, the presence or absence of such reference characters does not affect the scope of a claim. See MPEP 608.01 (m). In the instant case, the use of parentheses makes it ambiguous whether the limitation in the parentheses is part of the claim . claim 25 recites “pre-mix” , while other claims ( claim s 23 and 26) recite “premix”, it is recommended to replace the word “pre-mix” with “premix” in claim 25 to enhance the consistency and clarity of claim language . Appropriate correction is required. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 2 3 -28 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. The term “preferably” in claims 23 and 27 is a relative term which renders the claims indefinite. The word "preferably" renders the claim indefinite because it is unclear whether the limitations following the word are part of the claimed invention. See MPEP § 2173.05(d). For examination purposes, examiner has interpreted the limitation as not required for the claimed invention. Claims 24-26 and 28 depend from, at least, claim 23 , and thus inherit the deficiency and are rejected on the same basis. Claim Interpretation Claim 22 is a product-by-process claim , which is directed to a plant-based protein hydrolysate . MPEP 2113.I states: "[E] ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. 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) . Similarly, claim 23 recites “ a first plant-based protein hydrolysate obtainable by the method of claim 16 ”, claim 27 recites “ a second plant-based protein hydrolysate prepared from primary food stream material by acid hydrolysis, wherein said primary food stream material has a protein content of at least 30% (w/w dry matter) protein and a fiber content of 5% (w/w dry matter) or less, wherein preferably the primary food stream material has been prepared from soy bean, fava bean, wheat, rice, pea, potato, or cotton seed ”, both are product-by-process claim s, therefore the patentability is based on the product itself . See MPEP 2113.I. Furthermore, c laim 23 recites a preamble “ suitable for use as medium component supporting the growth of e ukaryotic cells ” is considered as an intended use. The preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation to be given patentable weight and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). See MPEP 2111.02. Claim Rejections - 35 USC § 102 In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis ( i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale , or otherwise available to the public before the effective filing date of the claimed invention. (a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. Claims 22-2 6 are rejected under 35 U.S.C. 102(a) (1) and (a)(2) as being anticipated by Knudsen et al. ( WO 2006/084826 A1 , published in 2006 ) . Knudsen et al. teach improved methods for producing interesting polypeptides in eukaryote cells in a serum-free culture liquid (p1, L4-5). Regarding claim 22, Knudsen et al. teach Example 1, experiment was performed to produce Factor VII in a small pilot-scale culture (p29, L23-24). CHO K 1 c ells were thawed and cultured, t he medium used for propagation had a concentration of soy protein hydrolysate of around 5.0 g/L (p30, L2-3) . The soy protein hydrolysate is a plant-based protein hydrolysate. Regarding claim 23, Knudsen et al. teach CHO K 1 c ells were thawed and cultured, t he medium used for propagation had a concentration of soy protein hydrolysate of around 5.0 g/L . The medium used are free of serum and other animal derived components (see p30, L 2 -5). Knudsen et al. also teach i n one embodiment, the medium is composed as shown in Table 3a or Table 3b ( see p22-28), and t he medium is preferably a medium lacking animal-derived components (p28, L2). Since these chemicals in Table 3a or 3b are in culture medium for feeding the cells, the chemicals are considered as food grade premix of one or more minerals (e.g., Mg 2+ in m agnesium chloride anhydrous , Ca 2+ in c alcium chloride anhydrous ), one or more vitamins (e.g., Vitamin B12 , folic acid ), one or more of amino acids (e.g., L-glutamic acid , L-serine ) and one or more salts ( e.g., NaCl, KCl ), combining with the plant protein hydrolysate in the culture medium , the teaching anticipates the composition of instant claim, which comprising a first plant-based protein hydrolysate , and a food grade premix comprising one or more minerals, one or more vitamins, one or more amino acids, and one or more salts; wherein said composition is devoid of animal proteins , as recited in instant claim. Regarding claim 24, as discussed above, Knudsen et al. teach Example 1, experiment was performed to produce Factor VII in a small pilot-scale culture (20 L) (p29, L23-24). CHO K 1 c ells were thawed and cultured, t he medium used for propagation had a concentration of soy protein hydrolysate of around 5.0 g/L (p30, L2-3) . The soy protein hydrolysate is a plant-based protein hydrolysate, and the concentration of the plant-based protein hydrolysate is 0.5% (w/w), which is in the range of 0.1%-50% (w/w) , therefore Knudsen et al. anticipate instant claim. Regarding claim 25, following the discussion above , Knudsen et al. teach in one embodiment, the medium is composed as shown in Table 3a or Table 3b (see p22-28), wherein the medium comprising one or more minerals (e.g., Mg 2+ in m agnesium chloride anhydrous , Ca 2+ in c alcium chloride anhydrous ), one or more vitamins (e.g., Vitamin B12 , folic acid ), one or more of amino acids (e.g., L-glutamic acid , L-serine ) and one or more salts ( e.g., NaCl , KCl ). Regarding claim 26, following the discussion above, Knudsen et al. teach the medium is composed as shown in Table 3a or Table 3b (see p22-28) , which comprising multiple minerals, vitamins, amino acids, and salt s. For instance, the range of sodium chloride is 0-70,000 mg/L (7% w/w), the range of p otassium chloride is 0-3118 mg/L (0.3 % w/w), the range of the vitamins including L-alanine , L-arginine and others (see e.g., the various amino acids on p23) is around 36,000 mg/L ( 3.6 % w/w) , in addition of other salts, minerals and vitamins, the food premix in the composition would be at least more than 10%, which is in the range of 10% to 99.9%. 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. Claim s 22-28 are rejected under 35 U.S.C. 103 as being unpatentable over Knudsen et al. ( WO 2006/084826 A1, published in 2006 ) in view of Lee et al. ( J. Korean Soc. Appl. Biol. Chem. 52, 607–612 , 2009 ). Knudsen et al. teach improved methods for producing interesting polypeptides in eukaryote cells in a serum-free culture liquid (p1, L4-5). Regarding claim 22, Knudsen et al. teach Example 1, experiment was performed to produce Factor VII in a small pilot-scale culture (p29, L23-24). CHO K 1 c ells were thawed and cultured, t he medium used for propagation had a concentration of soy protein hydrolysate of around 5.0 g/L (p30, L2-3) . The soy protein hydrolysate is a plant-based protein hydrolysate. Regarding claim 23, Knudsen et al. teach CHO K 1 c ells were thawed and cultured, t he medium used for propagation had a concentration of soy protein hydrolysate of around 5.0 g/L . The medium used are free of serum and other animal derived components (see p30, L2-5). Knudsen et al. also teach i n one embodiment, the medium is composed as shown in Table 3a or Table 3b (see p22-28), and t he medium is preferably a medium lacking animal-derived components (p28, L2). Since these chemicals in Table 3a or 3b are in culture medium for feeding the cells, the chemicals are considered as food grade premix of one or more minerals (e.g., Mg 2+ in m agnesium chloride anhydrous , Ca 2+ in c alcium chloride anhydrous ), one or more vitamins (e.g., Vitamin B12 , folic acid), one or more of amino acids (e.g., L-glutamic acid , L-serine ) and one or more salts ( e.g., NaCl, KCl ), combining with the plant protein hydrolysate in the culture medium, the teaching reads on the composition of instant claim, which comprising a first plant-based protein hydrolysate , and a food grade premix comprising one or more minerals, one or more vitamins, one or more amino acids, and one or more salts; wherein said composition is devoid of animal proteins , as recited in instant claim. Regarding claim 24, Knudsen et al. teach Example 1, experiment was performed to produce Factor VII in a small pilot-scale culture (20 L) (p29, L23-24). CHO K 1 c ells were thawed and cultured, t he medium used for propagation had a concentration of soy protein hydrolysate of around 5.0 g/L (p30, L2-3) . The soy protein hydrolysate is a plant-based protein hydrolysate, and the concentration of the plant-based protein hydrolysate is 0.5% (w/w), which is in the range of 0.1%-50% (w/w) . Regarding claim 25, Knudsen et al. teach in one embodiment, the medium is composed as shown in Table 3a or Table 3b (see p22-28), wherein the medium comprising one or more minerals (e.g., Mg 2+ in m agnesium chloride anhydrous , Ca 2+ in c alcium chloride anhydrous), one or more vitamins (e.g., Vitamin B12 , folic acid ), one or more of amino acids (e.g., L-glutamic acid , L-serine ) and one or more salts ( e.g., NaCl, KCl ). Regarding claim 26, Knudsen et al. teach the medium is composed as shown in Table 3a or Table 3b (see p22-28) , which comprising multiple minerals, vitamins, amino acids, and salt s. For instance, the range of sodium chloride is 0-70,000 mg/L (7% w/w), the range of p otassium chloride is 0-3118 mg/L (0.3 % w/w), the range of the vitamins including L-alanine , L-arginine and others (see e.g., the various amino acids on p23) is around 36,000 mg/L ( 3.6 % w/w) , in addition of other salts, minerals and vitamins, the food premix in the composition would be at least more than 10%, which is in the range of 10% to 99.9%. Regarding claims 27 and 28, Knudsen et al. do not teach the composition further comprising: (iii) a second plant-based protein hydrolysate , and the s econd plant-based protein hydrolysate is present in a concentration in the range from 0.1% to 50% (w/w) . However, such was disclosed by Lee et al. at the time of instant invention. Lee et al. teach select ing a few growth promoting protein hydrolysates (Broadbean, Soy F, and Soy P) and ma king mixture compositions with those hydrolysates, which considerably improved the growth and viability of Chinese hamster ovary (CHO) cells (Abstract) . Regarding claim 27, Lee et al. conduct study of plant protein hydrolysate mixtures to explore the effects of various mixtures of unfractionated and fractionated plant protein hydrolysates on the growth and function of CHO cells (p608, left column). Table 1 demonstrates the composition of various mixtures of selected protein hydrolysates (p608, right column). This teaching reads on the composition comprising a second plant-based protein hydrolysate . Regarding claim 28, Lee et al. teach figure 2 shows the effect of the composition of each mixture of plant protein hydrolysates on a suspension culture of CHO cells. Each mixture contained a hydrolysate that was added at a concentration of 3 g/L to the initial cell culture. Herein for example in the mixture of SFc : SPc : BBc =1:1:1, the second plant-based protein hydrolysate is 1g/L (0.1% w/w), which is in the range of 0.1%-50%. 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 modify Knudsen et al. ’s medium having a composition comprising soy protein hydrolysate , and use a second plant-based protein hydrolysate in the composition. The only difference between instant claim and Knudsen et al. ’s medium having a composition comprising soy protein hydrolysate is instant claim has a second plant-based protein hydrolysate in the composition. Given that Lee et al. teach CHO cell growth and viability may be improved in media containing a mixture of unfractionated or fractionated plant protein hydrolysates compared with media containing a single hydrolysate (Abstract), o ne of ordinary skill in the art would have substitute d Knudsen et al .’s medium comprising soy protein hydrolysate for the cell culture, and use at least two plant-based protein hydrolysate s for the cell culture depends on their research interest or preference . This simple substitution of one known element ( use at least two plant-based protein hydrolysates in the culture medium ) for another known element ( use one plant-based protein hydrolysate in the culture medium ) is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, B.). Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT QINHUA GU whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (703)756-1176 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT M-F: 9:00 - 5:00 . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Christopher Babic can be reached at FILLIN "SPE Phone?" \* MERGEFORMAT (571)272-8507 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Q.G./ Examiner, Art Unit 1633 /FEREYDOUN G SAJJADI/ Supervisory Patent Examiner, Art Unit 1699
Read full office action

Prosecution Timeline

Aug 11, 2023
Application Filed
Mar 31, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
61%
Grant Probability
84%
With Interview (+23.7%)
3y 6m
Median Time to Grant
Low
PTA Risk
Based on 377 resolved cases by this examiner. Grant probability derived from career allow rate.

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