DETAILED ACTION
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 Application
Receipt of the Response and Amendment after Non-Final Office Action filed 10/21/2025 is acknowledged.
Applicant has overcome the following rejections by cancellation of the claims: (1) the 35 U.S.C. §112(b) rejection of claim 19 has been withdrawn; and (2) the 35 U.S.C. §103 rejection of claim 19 over Sviridenko and UniProt has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 16-18, 20-30
Withdrawn claims: 22-25, 27-30
Previously cancelled claims: None
Newly cancelled claims: 1-15, 19
Amended claims: 16, 20
New claims: 21-30
Claims currently under consideration: 16-18, 20-21, 26
Currently rejected claims: 16-18, 20-21, 26
Allowed claims: None
Election/Restrictions
Newly submitted claims 22-25 and 27-30 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: the new claims are directed to a method of manufacturing fermented milk and claims directed to such a method were part of non-elected Group III.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 22-25 and 27-30 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 16-18, 20-21, and 26 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 (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites that the composition comprises “a protein phosphatase activity and a phosphorylated protein […] wherein the protein has protein phosphatase activity”. However, it is unclear as to whether the protein that has protein phosphatase activity refers to the “protein phosphatase” or the “phosphorylated protein”. Therefore, the claim is indefinite. For the purpose of this examination, the protein that has protein phosphatase activity is interpreted as being the “protein phosphatase”.
Claims 17-18, 20-21, and 26 are rejected by reason of dependency from claim 1.
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 16-18, 20-21, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Sviridenko (RU 2,092,066 C1; English translation relied on for citations; previously cited) in view of UniProt II (UniProtKB, [online], Accession No. A0A1T3CP59, 2018, https://rest.uniprot.org/unisave/A0A1T3CP59?format=txt&versions=8) as evidenced by search results filed 06/06/2025.
Regarding claim 16, Sviridenko discloses a composition (corresponding to milk) comprising a protein having phosphatase activity (corresponding to phosphatase) and a phosphorylated protein (corresponding to casein) (page 2, paragraph beginning “In the technology” – paragraph beginning “Based on the obtained experimental data”). Sviridenko discloses that the phosphatase has activity at pH 5.5-6.5 (page 2, paragraph beginning “Based on the obtained experimental data”). Sviridenko also teaches that 0.40 kg of phosphatase having an activity of 60 U/mL may be added to 100 kg of milk (page 6, paragraph beginning “Example 1”). Since 1 mL of milk is considered to weigh about 1 g, Sviridenko teaches that the composition may contain about 0.24 U/mL of the protein phosphatase, which falls within the claimed concentration.
Sviridenko does not disclose that the protein having phosphatase activities one of proteins (i)-(ii).
However, UniProt II discloses a phosphatase (corresponding to phosphoesterase) having acid phosphatase-like activity (description beside line labeled “DE”; description beside 5th line labeled “DR”). The phosphatase has 89.4% similarity to SEQ ID NO: 2 as evidenced by the search results (result 5). Although this amount of similarity does not fall within the claimed similarity range, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). See MPEP 2144.05.I.
It would have been obvious for a person of ordinary skill in the art to have modified the composition of Sviridenko by using the protein taught by UniProt II. Since Sviridenko discloses that the phosphatase has activity at pH 5.5-6.5 (page 2, paragraph beginning “Based on the obtained experimental data”) and only exemplifies one phosphatase in Example 1 (page 6), a skilled practitioner would have been motivated to an additional reference such as UniProt II for other suitable phosphatases having activity at an acidic pH. Furthermore, “[t]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol. "Reading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." 325 U.S. at 335, 65 USPQ at 301.).” MPEP 2144.07. Therefore, the claimed protein (ii) is rendered obvious.
Regarding claims 17 and 18, Sviridenko teaches the invention as described above in claim 16, including the phosphorylated protein is a phosphorylated milk protein and phosphorylated casein (page 2, paragraph beginning “Based on the obtained experimental data”).
Regarding claim 20, modified Sviridenko teaches the invention as described above in claim 16, including the protein having phosphatase activity (UniProt II, description beside line labeled “DE”; description beside 5th line labeled “DR”) has 89.6% similarity to SEQ ID NO: 2 as evidenced by the search results (result 5). Therefore, modified Sviridenko discloses that the protein having phosphatase activity does not comprise the amino acid sequence of SEQ ID NO: 2.
Regarding claims 21 and 26, modified Sviridenko teaches the invention as described above in claim 16 and 20, including the composition is a raw material milk composition (page 2, paragraph beginning “In the technology”; page 6, paragraph beginning “Example 1”).
Response to Arguments
Priority: A certified copy of the JP20202-071708 application has been filed.
Claim Rejections – 35 U.S.C. §112(b) of claims 16-20: Applicant canceled claim 19; therefore, its rejection is withdrawn. Claims 16-18 and 20 remain rejected for the reason provided above.
Claims Rejections – 35 U.S.C. §103 of claims 16-20 over Sviridenko and UniProt: Applicant’s amendments and arguments have been fully considered and are not considered to overcome the rejections of claims 16-18, 20-21, and 26.
Applicant canceled claim 19. Applicant amended claim 16 to recite that the protein phosphatase comprises one of (i) a protein comprising an amino acid sequence of SEQ ID NO: 2; and (ii) a protein comprising an amino acid sequence having at least 90% sequence identity with the amino acid sequence of SEQ ID NO: 2. Applicant also amended claim 16 to recite that the composition comprises 0.1-25 U/mL of the protein phosphatase. Applicant then argued that neither Sviridenko nor UniProt disclose a protein phosphatase having the amino acid sequence as now recited by amended claim 16. Applicant also argued that neither reference discloses the amount of protein phosphatase in the composition as now required by amended claim 16 (Applicant’s Remarks, page 6, 1st paragraph under “35 U.S.C. § 103” – page 7, 3rd paragraph).
However, in the new grounds of rejection necessitated by the amendment of the claim, claim 16 is rejected over Sviridenko and cxv II. As described above in the rejection of amended claim 16, Sviridenko teaches that 0.40 kg of phosphatase having an activity of 60 U/mL may be added to 100 kg of milk (page 6, paragraph beginning “Example 1”). Since 1 mL of milk is considered to weigh about 1 g, Sviridenko teaches that the composition may contain about 0.24 U/mL of the protein phosphatase, which falls within the claimed concentration.
Also as described above in the rejection of amended claim 16, Sviridenko discloses that the phosphatase has activity at pH 5.5-6.5 (page 2, paragraph beginning “Based on the obtained experimental data”) and only exemplifies one phosphatase in Example 1 (page 6). Therefore, a skilled practitioner would have been motivated to an additional reference such as UniProt II for other suitable phosphatases having activity at an acidic pH. UniProt II discloses a phosphatase having acid phosphatase-like activity (description beside line labeled “DE”; description beside 5th line labeled “DR”). The phosphatase has 89.4% similarity to SEQ ID NO: 2 as evidenced by the search results (result 5). Although this amount of similarity does not fall within the claimed similarity range, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close, particularly wherein the Applicant has not demonstrated a marked difference between a protein phosphatase having 89.4% similarity to similarity to SEQ ID NO: 2 and a protein phosphatase having the claimed 90% similarity to similarity to SEQ ID NO: 2 . MPEP 2144.05.I.
Applicant then argued that a skilled practitioner would understand that Sviridenko teaches using phosphatases as well as protosubtilin and renninomesenterin to hydrolyze casein into low-molecular-weight degradation products to be consumed by lactic acid bacteria starters. Applicant argued that this objective differs from the objective of the claimed invention wherein protein phosphatase is used to dephosphorylate casein to increase hydrophobicity, thus affecting the physical property of milk and fermented milk. Applicant argued that the neither Sviridenko nor UniProt disclose these technical effects of the claimed composition (Applicant’s Remarks, page 7, 4th paragraph – page 8, 2nd paragraph).
However, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the combined features of (1) the phosphorylated protein being casein and (2) the composition being milk or fermented milk) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In addition to the combination of asserted features not being recited by present claims, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). The combination of Sviridenko and UniProt discloses the features of the present claims and thus render the present claims obvious, even if Sviridenko does not disclose that the dephosphorylated casein in the composition has increased hydrophobicity compared to phosphorylated casein.
Since the prior art is shown to render claims 16-18, 20-21, and 26 obvious and Applicant’s arguments are shown to be unpersuasive, the rejections of the claims stand as written herein. The rejection of claim 19 is withdrawn due to its cancelation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791