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 .
Application Status
In response to Non-Final Office Action mailed on 03/04/2026, applicants' response, arguments and amendments filed on dated 06/04/2026 is acknowledged; in said response applicants’ have amended claims 1, 8, 15 and 18, canceled claims 3 and 6 and added a new claim 20. Applicants’ in their response have presented the following arguments regarding non-elected sequences “Upon entry of these amendments, claims 1, 2, 4, 5, and 7-20 will be pending in this application, with claims 11-15 and 20 being withdrawn from consideration pursuant to the restriction and election of species requirements, but retained for possible rejoining. Applicant respectfully requests reconsideration of these claims.”
Examiner maintains the position that sequence election is not a species election, as characterized by the applicants’ in their response dated 06/04/2026 and the search will not be extended to additional non-elected sequences for the following reasons: regarding elected Group 1, claims 1, 4-5, 7-10 and 16-19 in part, examiner would like to reiterate that the sequences in claim 18 and newly added claim 20 are considered to be unrelated, since each encoded polypeptide sequence claimed is structurally and functionally independent and distinct for the following reasons and each of these sequences has a unique polypeptide sequence identifier (SEQ ID NOs). As such the genus of polypeptide(s) sequences in each of claims 18 and 20 are not considered to constitute a proper genus, and is therefore subject to restriction. Furthermore, in this case, a search of more than one of the polypeptide sequence(s) claimed in claims 18 and 20 presents an undue burden on the Patent and Trademark Office due to the complex nature of the search in terms of computer time needed to perform the search and the subsequent analysis of the search results by the examiner. In view of the foregoing, 5 (five) polypeptide sequences encompassed in the elected Group 1 (SEQ ID NOs: 7-11) are considered to be a reasonable number of sequences for examination. Searching structurally distinct molecules like polypeptide(s) having 90% sequence identity to the all the recited sequences in claims 18 and newly added claim 20 are not coextensive and the sequence search systems of the USPTO are at or near capacity, and search of multiple sequences in a significant number of patent applications is not practical, representing a real burden on the Office. Thus, a comphrensive search of each of the polypeptide(s) and their method of use would be a burden on the Office. The searches for any one invention are not required for and are not coextensive with the searches for any other invention, thereby creating an undue burden of search and examination. The results from a search of each of these inventions have different considerations with respect to the prior art. Burden Iies not only in the search of sequence databases, U.S. patents, but also in the search for Iiterature and foreign patents and in examination of the claim Ianguage and specification for compliance with the statutes concerning new matter, distinctness, written description and enablement. Thus, a comphrensive search of all inventions in Groups’ 1 and 2 and all the sequences would be a serious burden and contrary to applicants’ arguments, the requirement is still deemed proper and is therefore made FINAL.
Thus, amended claims 1-2, 4-5 and 7-20 are pending in this application; elected Group 1 claims 1-2, 4-5, 7-10 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 newly added claim 20 and non-elected sequences SEQ ID NOs:1-6 and 12-15 (in claim 20) 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.
Withdrawn-Claim Rejections: 35 USC § 102 (AIA )
Previous rejection of claims 1, 4-10 and 17-19 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), is being withdrawn due to claim amendments.
Withdrawn-Claim Rejections: 35 USC § 103
Previous rejection of claims 1-10 and 16-19 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), is being withdrawn due to claim amendments.
New-Claim Rejections: 35 USC § 103
Necessitated by claim amendments
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 1-2, 4-5, 7-10 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) and further in view of Deya et al., (EP 0 458 358 A1), 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).
Regarding claim 1, 4-5, 7-10 and 16-19 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); at a pH range of 3.5-6 (page 30, lines 21-24); said reference also discloses fermentation temperature of 430C (page 70, lines 13-14; page 71, lines 25-27; Table 7a, page 73); said reference also discloses fermentation range of at least 0.01 second to at most 1300 seconds (page 20, lines 1-5); 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). Certain relevant sections from Larsen et al., (WO 2015/086746 A1, in IDS) is reproduced below:
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Page 70, lines 13-14, pH 4.6, fermentation temperature 430C
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The disclosure of Larsen et al., (WO 2015/086746 A1, in IDS) as applied to claims 1, 4-5, 7-10 and 16-19 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).
Regarding claim 1, analogous art Deya et al., (EP 0 458 358 A1) also provide teaching, suggestion and motivation for the use b-galactosidase enzyme at a temperature of 20-500C during enzymatic reaction/fermentation with the enzyme and in preparing skim milk powder comprising galacto-oligosaccharides; wherein following the enzymatic reaction, heating the reaction mixture to 70-850C for 30 seconds to terminate reaction and suggest optimizing the reaction time by measuring the amount of galacto-oligosaccharides formed by the enzymatic reaction (see Abstract; and page 3, lines 5-20, reproduced below). EP 0 458 358 A1; Abstract, page 1
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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); Tossavaine et al., (US 10,085,462 B2) provides clear suggestion and motivation for the use of low lactose and lactose free milk product including yogurt (see col. 3, lines 8-12; reproduced below)
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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) also provides 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 1-3 and 16 of the instant invention, such as that of references of Deya et al., (EP 0 458 358 A1), 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 Deya et al., (EP 0 458 358 A1), 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 1-2, 4-5, 7-10 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) and further in view of Deya et al., (EP 0 458 358 A1), 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).
Applicants’ have traversed the above 35 U.S.C. 103(a) rejection following claim amendments and said arguments are relevant to the new rejection (see pages 6-9 of Applicants’ REMARKS dated 06/04/2026).
Applicants’ argue (A): “…The Office Action cited Larsen as allegedly disclosing a process for stable generation of galacto-oligosaccharides in dairy products including yogurt by the use of transglycosylating beta- galactosidase, including "heat treatment at 80°C and time of exposure." Office Action, page 4 (emphasis in original). However, Larsen does not teach or suggest a method as claimed, comprising inactivating a beta-galactosidase enzyme by subjecting a fermented milk-based substrate comprising galacto-oligosaccharides having a pH below 5 to heat treatment at a temperature from 70°C to 80°C for 5 to 60 seconds.
… Thus, Larsen does not suggest or provide a reasonable expectation of success for the claimed methods. To the contrary, the ability to obtain a stable yogurt product by the claimed methods, wherein the galacto-oligosaccharides comprised in the yogurt are stable for at least 5 days when the yogurt is stored at a temperature of 15-37°C and a pressure of 1 atm, is surprising and unexpected in view of Larsen, which indicates that exponentially longer inactivation times would be required at the recited temperatures.”
Reply (A): Applicants’ arguments have been fully considered but are not deemed persuasive for the following reasons. Contrary to applicants’ arguments and assertions, examiner has provided new reference Deya et al., (EP 0 458 358 A1) and provides teaching, suggestion and motivation for the use b-galactosidase enzyme at a temperature of 20-500C during enzymatic reaction/fermentation with the enzyme and in preparing skim milk powder comprising galacto-oligosaccharides; wherein following the enzymatic reaction, heating the reaction mixture to 70-850C for 30 seconds to terminate reaction and suggest optimizing the reaction time by measuring the amount of galacto-oligosaccharides formed by the enzymatic reaction (see Abstract; and page 3, lines 5-20, for details see the rejection above).
Contrary to applicants’ arguments and assertions, examiner continues to maintain the position that Tossavaine et al., (US 10,085,462 B2) provides clear suggestion and motivation for the use of low lactose and lactose free milk product including yogurt as 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.
Applicants’ further argue (B): “…The Office Action also cited Nguyen as allegedly relevant to a stable yogurt product, but Nguyen also does not support the obviousness rejection or provide an expectation of success for a method as claimed. For example, there is no indication in Nguyen that its buffalo yogurt was made by a process comprising treating a milk-based substrate comprising at least 1% w/w lactose with a beta-galactosidase enzyme to generate galacto-oligosaccharides. Accordingly, Nguyten is largely irrelevant to the subject matter of the pending claims.”
Reply (B): Applicants’ arguments have been fully considered but are not deemed persuasive for the reasons stated in the Office-action dated 03/04/2026, and additionally for the following reasons. Larsen et al., (WO 2015/086746 A1, in IDS) discloses Page 70, lines 13-14, pH 4.6, fermentation temperature 430C
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Examiner continues to maintain that Nguyen et al., (Food Bioprocess Technol., 2014, Vol. 7: 2538-2548) is relevant and pertinent as said reference provides motivation and scientific rationale i.e., provides 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.
Applicants’ further argue (C): “…In summary, it is only the present application that teaches and shows that the recited methods, comprising (a) treating a milk-based substrate comprising at least 1% w/w lactose with a beta-galactosidase enzyme to generate galacto-oligosaccharides; (b) before or after said treating, fermenting the milk-based substrate until a pH below 5 is reached; and (c) inactivating the beta- galactosidase enzyme by subjecting the fermented milk-based substrate comprising galacto- oligosaccharides having a pH below 5 to heat treatment at a temperature from 70°C to 80°C for 5 to 60 seconds, is effective for producing yogurt comprising galacto-oligosaccharides. such that the galacto-oligosaccharides. comprised in the yogurt are stable for at least 5 days when the yogurt is stored at a temperature of 15-37°C and a pressure of 1 atm. See, e.g., Specification, page 4, lines 28-32; page 5, lines 1-6. For example, as reported in Example 3, yogurt prepared by a method as claimed exhibited stability such that the total level of GOS remained stable for at least 21 days of storage. See Specification, pages 18-19. The efficacy of the claimed methods in this regard could not have been predicted or expected from the cited combination of references.”
Reply (C): Some of the Applicants' arguments are based on superior/unexpected results in by the Applicants’ method and the use of claimed b-galactosidase enzymes (see response page 9, ¶ 2, dated 06/04/2026) and contrary to applicants’ arguments and assertions, rejected claims are directed to genera of structures having 90% sequence identities to SEQ ID NOs: 7-11 and the instant specification only discloses the use of structural and functional elements/enzymes as disclosed in the prior art, examiner has provided references that disclose the following: (j) 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; and (ii) (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).
Hence, claims and the specification are not limited to the specific structures/b-galactosidase enzymes that are novel and non-obvious; examiner has provided references that teach the structural and functional elements of the instant invention and therefore applicants’ argument is not found particularly persuasive because the evidence necessary to overcome a prima facie case of obviousness must not only be clear and convincing, but must also be commensurate in scope with the claimed subject matter. Further, it is well recognized that “unexpected” effects are highly unpredictable and are very dependent on the specific conditions including specific structure of the claimed enzyme/b-galactosidase enzymes. Thus any combination for which synergism or “unexpected” effect is not clearly established would be properly rejected because non-obviousness would not have been established. The scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim.
Therefore, examiner has provided ample evidence regarding structural and functional elements of the claimed enzymes/b-galactosidase enzymes having the associated function (for details see 35 U.S.C. 103 rejection above) and continues to take the position that each and every element of the instant invention is taught in the combination of cited references and that the combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the composition/enzyme/b-galactosidase enzymes claimed herein and the method of use of claimed composition/enzyme/b-galactosidase enzymes and the claimed benefits are very much expected and predictable.
Furthermore, "it is prima facie obvious to combine two compositions or two 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.
Examiner has provided arguments above and it is obvious to follow the teaching, suggestion or motivation in the prior art. To reject a claim based on this rationale, Office personnel must resolve the Graham factual inquiries. Then, Office personnel must articulate the following:
(1) a finding that there was some teaching, suggestion, or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings;
(2) a finding that there was reasonable expectation of success; and
(3) whatever additional findings based on the Graham factual inquiries may be necessary, in view of the facts of the case under consideration, to explain a conclusion of obviousness. MPEP 2143(I)(G).
All of the above elements are directly discussed in the body of the rejection. Regarding element (2), the reasonable expectation of success as examiner has provided references that teach the structural and functional elements/b-galactosidase enzymes of the instant invention.
The Supreme Court has acknowledged: When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation...103 likely bars its patentability...if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person's skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions ...... the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
Examiner continues to hold the position that the cited references render claims 1-2, 4-5, 7-10 and 16-19 prima facie obvious to one of ordinary skill in the art when one applies the Teaching, Suggestion and Motivation (TSM) test under the rationale for arriving at a conclusion of obviousness as suggested by the KSR ruling. The rationale applied for this rejection is as follows:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try”–choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
The combined teachings in the cited prior art provides a reasonable expectation of success and predictability for the claimed invention. In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
Therefore, in the light of the above teachings in the prior art, examiner holds the position that applicant’s arguments are directed against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Obviousness does not require an absolute certainty of success but merely a reasonable expectation thereof, so long as the motivation or suggestion to combine the teaching of the cited references is known or disclosed in the prior art and is obvious to one skilled in the art and this is sufficient to establish a prima facie case of obviousness;
Moreover, the objectives of the cited references need not be the same as the instant invention to be used in an Obviousness rejection. So long as the motivation or suggestion to combine the teaching of the cited references is known or disclosed in the prior art and is obvious to one skilled in the art. This is sufficient to establish a prima facie case of obviousness; and
Summary of Pending Issues
Claims 1-2, 4-5, 7-10 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) and further in view of Deya et al., (EP 0 458 358 A1), 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).
Claims 11-15 and newly added claim 20 and non-elected sequences SEQ ID NOs:1-6 and 12-15 (in claim 20) 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.
Conclusion
None of the claims are allowable. Claims 1-2, 4-5, 7-10 and 16-19 are rejected for the reasons identified in the Rejections and Summary sections of this Office Action. Applicants must respond to the rejections in each of the sections in this Office Action to be fully responsive for prosecution.
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 extension fee 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.
Regarding filing an After Final amendment, Applicants are directed to MPEP 714.13, which states:
II. ENTRY NOT A MATTER OF RIGHT
It should be kept in mind that applicant cannot, as a matter of right, amend any finally rejected claims, add new claims after a final rejection (see 37 CFR 1.116) or reinstate previously canceled claims. Except where an amendment merely cancels claims, adopts examiner suggestions, removes issues for appeal, or in some other way requires ONLY A CURSORY REVIEW by the examiner (e.g., typographical errors), compliance with the requirement of a showing under 37 CFR 1.116(b)(3) is expected in all amendments after final rejection. An affidavit or other evidence filed after a final rejection, but before or on the same date of filing an appeal, may be entered upon a showing of good and sufficient reasons why the affidavit or other evidence is necessary and was not earlier presented in compliance with 37 CFR 1.116(e). See 37 CFR 41.33 and MPEP § 1206 for information on affidavit or other evidence filed after appeal. (Examiner's emphasis) If more than a cursory review is required, Applicants are referred to CFR §1.114.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GANAPATHIRAMA RAGHU whose telephone number is (571)272-4533. The examiner can normally be reached on M-F 8:30am-5pm EST.
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, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GANAPATHIRAMA RAGHU/ Primary Examiner, Art Unit 1652
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