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 .
Detailed Action: Election/Restrictions
Applicant's election “Applicant hereby elects the subject matter of Group I (currently claims 1-10 and 16-19), drawn to a method for producing a yogurt comprising galacto-oligosaccharides. In response to the Election of Sequences Requirement, Applicant elects SEQ ID NOs 7-11. Pending claims 1-10, 16, 17, 18 (in part) and 19 read on, recite, or embrace the elected subject matter. These elections are made with traverse to the extent they are based on a finding that WO2015/086746A1 and WO2020/117548A1 destroy unity of invention for the claimed subject matter as a whole” in the reply filed on 02/03/2026 is acknowledged. Examiner continues to maintain that the cited references WO2015/086746A1 and WO2020/117548A1 do indeed render the instant invention as whole obvious. Examiner would like to point out that applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, and because applicants’ 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 § 818.03(a)).The restriction requirement is still deemed proper and is therefore made FINAL.
Claims 1-19 are pending in this application; and Group I claims 1-10 and 16-19, and elected sequences SEQ ID NOs: 7-11 reading on the elected invention is now under consideration for examination; non-elected claims 11-15 and non-elected sequences SEQ ID NOs:1-6 and 12-15 (in claim 18) are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Priority
Acknowledgment is made of applicants’ claim for foreign priority under 35 U.S.C. 119(a)-(d). This application is a 371 of PCT/EP2022/056189 filed on 03/10/2022 and claims the priority date of EPO application 21162010.9 filed on 03/11/2021.
Information disclosure statement
The information disclosure statement (IDS) submitted on 09/18/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS statement is considered and initialed by the examiner.
Claim Objections
Claim 18 is objected to, as said claim recites non-elected subject-matter/SEQ ID NOs.
Claim Rejections: 35 USC § 102 (AIA )
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.
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 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.
Claims 1, 4-10 and 17-19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Larsen et al., (WO 2015/086746 A1, in IDS) when given the broadest reasonable interpretation.
Larsen et al., (WO 2015/086746 A1, in IDS) disclose a process for stable generation of galacto-oligosaccharides (GOS) in different dairy products including yogurt by the use of transglycosylating beta-galactosidase (see Abstract; page 11, lines 19-24; page 53, lines 17-25 page 54, line 10; pages 68-75, Example 4a; Tables 3a, 4a, 5a, 6a, 7a; and entire document), said reference polypeptides obtained from Bifidobacterium sp., and having 97.1%-98.5% sequence identities to SEQ ID NOs: 8, 9, 10 of the instant application (page 3, line 4 to page 5, line 5; and also see provided sequence alignments); said reference discloses a milk based substrate comprising at least 1% w/v-15%w/v (page 22, lines 8-13; page 37, lines 3-8; page 56, lines 12-30), equivalent to 0.96% w/w- 14.47% w/w of lactose concentration and see page 64, line 31 to page 65, line 1 of Larsen et al., (WO 2015/086746 A1, in IDS) provides the formula for converting w/v concentration of lactose to w/w of lactose concentration; said reference discloses in Table 1a (pages 63-64) and Example 1a, page 64 and provides guidance regarding determination of specific activities of different beta-galactosidases and guidance for their usage depending on experimental need (page 37, lines 9-30); said reference discloses heat treatment at 800C and time of exposure (page 20, lines 3-8); enzymatic reaction was carried out between 10C-700C for a period of 30 minutes to 24 hours and preferably at 45 minutes (page 21, lines 7-13); said reference also discloses the pressure during heat treatment is done without backpressure at 950C and at atmospheric pressure (page 20, lines 21-23); said dairy product is stable for at least 14 days to 24 weeks (page 27, lines 14-18).
Therefore, the reference of Larsen et al., (WO 2015/086746 A1, in IDS) is deemed to anticipate claims 1, 4-10 and 17-19 as written and when given the broadest reasonable interpretation.
Since the Office does not have the facilities for examining and comparing applicants’ method with the method of the prior art, the burden is on the applicant to show a novel or unobvious difference between the claimed method and the method of the prior art (i.e., that the method of the prior art does not possess the same material structural and functional characteristics of the method of the instant invention). See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald et al., 205 USPQ 594.
Claim Rejections: 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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(a) 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.
Claims 1-10 and 16-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Larsen et al., (WO 2015/086746 A1, in IDS) as applied to claims 1, 4-10 and 17-19 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Tossavaine et al., (US 10,085,462 B2), Hendriksen et al., (US 10,058,107 B2) and Nguyen et al., (Food Bioprocess Technol., 2014, Vol. 7: 2538-2548).
The disclosures of Larsen et al., (WO 2015/086746 A1, in IDS) as applied to claims 1, 4-10 and 17-19 is described above. However, Larsen et al., are silent regarding wherein said method further comprising a further step of storing the yogurt comprising galacto-oligosaccharides at a temperature of 15-37°C, and stable for at least 5 days when the yogurt is stored at a temperature of 15-37°C (as in claims 2-3); and wherein the fermenting is carried out at 43°C (as in claim 16).
Regarding claims 2-3, the following references, provide teaching, suggestion and motivation for storing the yogurt comprising galacto-oligosaccharides at a temperature of 15-37°C, and stable for at least 5 days when the yogurt is stored at a temperature of 15-37°C:
(i) Tossavaine et al., (US 10,085,462 B2), discloses low lactose and lactose free milk product including yogurt prepared by fermenting with enzyme lactase/beta-galactosidase wherein, the organoleptic properties of a milk product prepared according to the invention unexpectedly keep at room temperature even during a long storage; the nutritional value of a well-preserving milk product prepared with the process of the invention does not weaken even during storage and the process is easy to perform in production conditions without significant extra costs (see col. 3, lines 17-31; col. 4, lines 41-58; col. 7, lines 31-38; Examples 1-7; and entire document); and
(ii) Hendriksen et al., (US 10,058,107 B2) also disclose methods for producing dairy product/yogurt utilizing enzymes having lactase/beta-galactosidase activity, said reference polypeptides having 99.9%-100% sequence identities to the polypeptides SEQ ID NOs: 7-11 of the instant invention (see provided sequence alignments) and having enzyme activity at temperatures 370C-520C and at pH range of 5-6.5 and allowing milk treatment at 520C and a process for producing yogurt (col. 2, lines 59-67 to col. 3, lines 30; dairy product/Fermented dairy product, col. 5, lines 6-67 to col. 6, lines 29; col. 15, lines 2-25; and entire document).
Regarding claim 16, wherein the fermenting is carried out at 43°C, the following reference Nguyen et al., (Food Bioprocess Technol., 2014, Vol. 7: 2538-2548) provide teaching, suggestion and motivation for fermenting temperature of 430C and said process results in production of yogurt with desirable microstructure, physicochemical and rheological properties and storage (see Abstract; Materials & Methods, col. 2, page 2539; Fig. 1, page 251; Fig. 2, page 2542; Fig. 3, page 2544; and entire document).
As such, disclosure of strategy, methods and advantages for “wherein said method further comprising a further step of storing the yogurt comprising galacto- oligosaccharides at a temperature of 15-37°C, and stable for at least 5 days when the yogurt is stored at a temperature of 15-37°C; and wherein the fermenting is carried out at 43°C”; as in claims 2-3 and 16 of the instant invention, such as that of references of Tossavaine et al., Hendriksen et al., and Nguyen et al., teaching the advantages of said modifications, clearly suggests to a skilled artisan to modify the teachings of Larsen et al., and incorporate the structural and functional elements of Tossavaine et al., Hendriksen et al., and Nguyen et al., in the claimed method for the production of low lactose or lactose free yogurt with desired physicochemical and rheological properties as claimed in the instant invention. One of ordinary skill in the art would have a reasonable expectation of success, since the use of beta-galactosidase for the production of low lactose or lactose free yogurt with desired physicochemical and rheological properties are well known in the art.
Regarding specific choice of pH, temperature are also provided/suggested in the combination of references, and examiner also takes the position the following position; optimization of known variables, and the examiner finds support in: MPEP 2144.05 [R-5]: A. Optimization Within Prior Art Conditions or Through Routine Experimentation Generally, differences in pH, temperature and optimizing pH, temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation". As to optimization results, a patent will not be granted based upon the optimization of result effective variables when the optimization is obtained through routine experimentation unless there is a showing of unexpected results which properly rebuts the prima facie case of obviousness. See In re Boesch, 617 F.2d 272,276,205 USPQ 215,219 (CCPA 1980). See also In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (Fed. Cir. 1990), and In re Aller, 220 F2d 454,456,105 USPQ 233,235 (CCPA 1955). Furthermore, "it is prima facie obvious to combine two or more methods each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition or third method to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980)”. Therefore, the above invention would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Therefore, claims 1-10 and 16-19 are rejected under 35 U.S.C. 103(a) as being unpatentable over Larsen et al., (WO 2015/086746 A1, in IDS) as applied to claims 1, 4-10 and 17-19 (see 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) rejection above) and further in view of Tossavaine et al., (US 10,085,462 B2), Hendriksen et al., (US 10,058,107 B2) and Nguyen et al., (Food Bioprocess Technol., 2014, Vol. 7: 2538-2548).
Allowable Subject Matter/Conclusion
None of the claims are allowable.
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/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652