DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 165-184 and 192-194 in the reply filed on 22 December 2025 is acknowledged. The traversal is on the ground(s) that there is no undue search burden, and that the product cannot be made by any other way (See Interview Summary 12/26/25). The Examiner has considered Applicant’s arguments and they are persuasive. As such, the restriction requirement between Groups I and II (See 10/24/2025) is withdrawn.
Status of Application
The instant application is being examined under expedited examination under the Track One program.
Claims 165-177, 179-194 and 196 and are pending and subject to examination on the merits.
Priority
The instant application is a CON of PCT/IB2024/059990 filed 11 October 2024 which claims benefit US Provisional 63698265 filed 24 September 2024; and has various continuity and support back to CIP application PCT/IB2024/053805 filed 18 January 2024.
Information Disclosure Statement
The twenty-two different information disclosure statements (IDS) submitted on 05 November 2025, 12 September 2025 and 13 January 2025 have been considered by the examiner. See initialed and signed PTO/SB/08’s.
Claim Objections
Claims 172-173 are objected to because of the following informalities: periods in claims are not permitted except at the end of the claim and when used for abbreviations (See MPEP 608.01(m)). Thus, it is suggested to replace, for example, “a.” with “(a)” or “a)”, etc.
Claims 185 is objected to because of the following informalities: in the first line of part (a), it appears that a comma is missing between “free amino acids” and “peptides”.
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.
Claim 168 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 168 recites “wherein the initial thermal pretreatment of the source of protein…..”, in reference to claim 167 and 165. However, neither claims 167 or 165 recite any kind of thermal pretreatment.
Claims 165-177, 179-191 and 196 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims recite mixing a protein source with a protease to produce hydrolysate, and then producing a modified protein hydrolysate by mixing the protein hydrolysate with an enzyme with phytase activity in order to cleave inositol hexaphosphate thereby producing phosphate ions. However, in order for this to occur, the starting protein source must necessarily be a protein source comprising inositol hexaphosphate and phosphate ions in the first place because not all protein sources comprise inositol hexaphosphate (also known as IP6, phytic acid or phytate).
Claims 185-190 and 196 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims are dependent upon claim 182; which is a method of making a culture medium comprising four steps in the following order: (a) mixing a source of protein with an enzyme having phytase activity to cleave inositol hexaphosphate; (b) further mixing the source of the protein treated with the phytase with a proteolytic enzyme to generate a modified protein hydrolysate; (c) removing residues from the modified protein hydrolysate by filtration or centrifugation and (d) addition at least one nutritional additive. Claim 185 is drawn to a culture medium made by the method of claim 182, and then also made by the method as stipulated in the claim by steps (a)(i)-(a)(iii) and step (b), e.g. four steps in total. However, there is an inconsistency because the steps in steps (a)(i) and (a)(ii) and reversed compared to the same steps in claim 182. That is in claim 182 the protein source is first contacted with an enzyme having phytase activity and then a proteolytic enzyme; however, in claim 185, while saying the culture medium is made by the method of claim 185, it further states it is made by a slightly different method wherein the protein source is first contacted with a proteolytic enzyme and then an enzyme with phytase activity. Thus, it is unclear exactly which steps are used to make the culture medium of claims 185-190 and 196 are actually made.
Claims 185-190 and 196 are further rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claims are deemed indefinite for incomplete method steps because in part (a)(i), there is no substrate or substance for the proteolytic enzyme to act upon in order to generate a protein hydrolysate.
Claim 194 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
The claim recites that the free phosphate ions in the culture medium at in a range from 50% to 100%. However, it is unclear how the free phosphate percentage range is calculated/measured. For instance, is the 50% to 100% of free phosphate ions measured by comparison with the amount/percentage of the cumulative amount of IP5, IP4, IP3, IP2, etc. remaining in the composition. Or is merely calculated as a comparison of how much phytin is reduced. It will be interpreted that at least a portion of the composition comprises some free phosphate ions.
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.
Claim(s) 192-194 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barakova et al. (Processes and Food Production Equipment, 2023 – cited herein).
Barakova et al. teach a method of decreasing the content phytic acid (also known as IP6, phytate or inositol hexaphosphate) by contacting a composition comprising water and full-fat soybean flour and adding various concentrations of phytase (Phytaflow, Novozymes – See Abstract and p. 5) thereto to reduce said phytic acid/inositol hexaphosphate, thereby inherently generating both free phosphate and varying levels of IP5, IP4, IP3, IP2, etc. – See English Abstract. The process is performed at 50Co for 120 minutes. The concentration of Phytaflow/phytase enzyme is added at a concentration of 20, 40, 60 and 80 U/g of soybean flour. Given the ambiguity of claim 194 (see 112(b) rejection above), it is asserted that at least some free phosphate is obtained.
While Barakova et al. do not stipulate that the composition is for culturing non-human metazoan cells, it is asserted the resultant composition would be able to function in this capacity at some level. Furthermore, given the claims require no non-human metazoan cells (just the intended use that that is what the composition is for), then the Barakova et al. is taken as anticipatory over the instant claims.
Claim(s) 192-194 is rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Veit et al. (WO 2001062947 – cited herein).
Veit et al. teach a method of decreasing the phytic acid content (e.g. (myo-inositol hexakisphosphate or from any salt thereof (phytates)) by adding a phytase (EC 3.1.3.8, 3-phytase; EC 3.1.3.26, 6-phytase (now known as 4-phytase) or 5-phytase), obtained from bacteria, yeast, fungi, or plant, or may be commercially purchased, and adding any of these to a pre-composition comprising a substrate comprising phytin obtained from things such as tubers, roots, whole grains, corn, wheat, etc. (See p. 6, lines 30-37) intended for fermentation (e.g. prep of a culture medium) – See p. 7, line 30 to p. 9, line 25, Example 1 and Figures 1-3. In Figure 3, it is demonstrated that 100% of available phytin is removed/reduced, meaning, inherently there has been a significant liberation of free phosphate and production of IP5, IP4, IP3, etc. Given the ambiguity of claim 194 and the calculation of free phosphate, it is asserted that at least some free phosphate is comprised in the composition.
While Veit et al. do not stipulate that the composition is for culturing non-human metazoan cells, it is asserted the resultant composition would be able to function in this capacity at some level. Furthermore, given the claims require no non-human metazoan cells (just the intended use that that is what the composition is for), then the Veit et al. is taken as anticipatory over the instant claims.
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.
Claim 165-166, 174, 176, 182, 185-186 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-5, 8, 24-30 of copending Application No. 19029060 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they overlap to such an extent to be obvious variations of one another.
The instant claims in their broadest are drawn to a method for producing a culture medium for the cultivation of non-human metazoan cells, comprising: mixing a source of protein with at least one proteolytic enzyme to cleave peptide bonds to provide a protein hydrolysate; mixing the protein hydrolysate with at least one enzyme having phytase activity to cleave inositol hexaphosphate, a derivative thereof, or a combination thereof, to provide a modified protein hydrolysate, wherein the modified protein hydrolysate contains phosphate ions, and wherein the majority of phosphate ions are originated from the cleavage of the inositol hexaphosphate, a derivative thereof, or a combination thereof; removing solid residues from the modified protein hydrolysate by at least one purification process selected from filtration and centrifugation to provide purified protein hydrolysate; and adding at least one nutritional additive to the purified protein hydrolysate to produce the culture medium for the cultivation of non-human metazoan cells. Nutritional additives are selected from saccharides, mineral compounds, vitamins, amino acids, peptides, organic amines, signaling compounds, oligonucleotides, fatty acids, phospholipids, and organic micronutrients (Dependent claim 174). Dependent claim 176 stipulates the culture medium further comprises a shear protectant agent.
The claims to the ‘060 application in their broadest are drawn to A method for preparing a culture medium for the cultivation of cells comprising: providing a protein hydrolysate as a source of amino acids, wherein the protein hydrolysate is prepared by enzymatic hydrolysis of a protein substrate, adding the protein hydrolysate to the culture medium in a total amount, expressed as dry protein weight, in a range of 8g/L to 50 g/L; and wherein a total input of amino acids from the protein hydrolysate, including amino acids in the form of peptides, bioavailable derivatives, or a combination thereof, is at least 75% by weight of a total input of all amino acids in the culture medium; wherein the cells are non-human metazoan cells. Dependent claim 25 recites at least two types of enzymes are utilized for enzymatic hydrolysis including endo- and exo-proteases; or at least one serine protease, cysteine protease, metalloprotease, glutamic protease, or aspartic protease. Dependent 28 recites the culture medium is filtered. And dependent claim 30 recites that the protein substrate is further enzymatically treated by a phytase enzyme. Independent claim 1 is drawn to a culture medium for culturing non-human metazoan cells comprising a protein hydrolysate prepared by enzymatic hydrolysis or a protein substrate, wherein the protein substrate is from a plant or is bakers yeast (dependent claim 3), and wherein the culture medium further comprises one or more selected from vitamins, sugars, minerals, organic amines, micronutrients, iron supplemental compound (e.g. nutritional additives) or shear protectants (Dependent claim 4).
Thus, when the claims of the ‘060 application are combined, it is obvious that the method steps include the same steps as currently claimed (e.g. hydrolysis of a protein substrate with at least a protease and a phytase; and also a filtration step). The fact that the claims of the ‘060 application are silent with respect to inositol hexaphosphates does not diminish the fact that the steps employed and claimed in the ‘060 application necessarily will result in the same removal of inositol hexaphosphates given the protein substrates are plant containing, as is clear dependent claim 3. Regarding the added at least one nutritional supplement as in the instant claims, it would be obvious given the claims culture medium as in claims 1 and 4, that a nutritional additive may be added to culture medium methods.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUZANNE M NOAKES whose telephone number is (571)272-2924. The examiner can normally be reached M-F (7-4).
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/SUZANNE M NOAKES/Primary Examiner, Art Unit 1656 03 February 2026