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 .
Status of Claims
Claims 1-15 are pending and under examination
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.
Claims 1-11 and 15 is/are rejected under 35 U.S.C. 103 as being obvious over Jorgensen (WO 0190317) in view of Sibakov (WO 2008037839).
Jorgensen teaches a method for producing a dairy product comprising galacto-oligosaccharides. The method of Jorgensen et al comprises incubating lactose with beta-galactosidase. [Lines 16-19, page 11] In the instant case, lactose is a milk-base substrate. And Jorgensen’s method is to make galacto-oligosaccharide. The beta-galactosidase of Jorgensen is derived from Bifidobacterium bifidum. [Abstract]The method of Jorgensen is performed at temperature range of 5-75 degrees C and time period of 1-50 hours. [lines 21-26, page 11] In the instant case, while Jorgensen does not explicitly state that the incubation process includes a heating step, the temperature range, along with the time period provided establishes that the method works for a range of temperature and time period.
It is noted that the temperature and time range of Jorgensen overlaps with the claimed range. MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Moreover, Sibakov establishes that in the preparation of conventional milk-based products, it is usual that conventional heat treatment methods are used. Sibakov also notes of the various heat treatments and time cycles including pasteurization (for example 72 C, 15s), ESL (for example 130 C, 1-2s), UHT (for example 138 C, 2-4s) or high temperature pasteurization (95 C, 5 min). [Lines 5-12, Page 8]
Given the teachings of Sibakov, it would have been obvious to one of ordinary skill in the art before the effective filing date to heat the incubated beta-galactosidase with lactose for the range of temperature and time disclosed by Sibakov. With respect to the overlapping temperature and time range, MPEP §2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
It is further noted that Jorgensen does not expressly teach that the temperature and time ranges are directed toward zeroing the residual activity of the beta- galactosidase. However, Sibakov teaches that it is desirable that the reaction between milk having lactose with beta- galactosidase be performed under a condition as to provide a high yield of galactooligosaccharides. [Lines 31-32, page 7] Given this teaching, it would have been obvious to one of ordinary skill in the art to have varied the amount of beta- galactosidase to ensure that a complete reaction is performed and no beta- galactosidase is wasted.
Regarding claim 11, Jorgensen teaches of beta- galactosidase that has been C-terminally truncated. [Abstract]
Regarding claim 15, neither Jorgensen nor Sibakov teaches storing the dairy product at below 10 degrees C. In the instant case, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have stored the dairy of product of Jorgensen and Sibakov below 10 degrees C. One of ordinary skill in the art would have been motivated to do so to prolong the shelf life of the dairy product. One of ordinary skill in the art would have had a reasonable expectation of success for doing so because cold storage prolongs shelf life of dairy products.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jorgensen, in view of Sibakov and further view of Larsen (WO 2013182686).
Regarding claims 12-13, it is not readily apparent if the beta- galactosidase of Jorgensen is at least 50% to claimed SEQ ID NO. 2. However, Larsen teaches a beta- galactosidase having 100% sequence identity to claimed SEQ ID NO. 2. See attached sequence alignment. See further lines 25-31, page 23 of the instant specification. At the cited passage, the specification acknowledges that the beta-galactosidase of Larsen has the sequence shown as SEQ ID NO. 2. In the instant case, it would have been obvious for one of ordinary skill in the art before the effective filing date of the invention to have used the beta-galactosidase of Larsen instead of the beta-galactosidase of Jorgensen. One of ordinary skill in the art before the effective filing date of the invention would have been motivated to do so to make a dairy product. One of ordinary skill in the art before the effective filing date of the invention would have had a reasonable expectation of success for doing so because substitution of one known equivalent for another is routinely practiced in the art.
Regarding claim 14, as noted above, lines 25-31, page 23 of the instant specification. At the cited passage, the specification acknowledges that the beta-galactosidase of Larsen has the sequence shown as SEQ ID NO. 2. At the same passage, Applicant acknowledges that the sequence of Larsen has a ratio of transgalactosylation activity of at least 150%.
Response to Arguments
Applicant argues that Jorgensen does not teach nor suggest “the specific heat treatment of the milk-based substrate comprising beta-galactosidase and GOS at a temperature of 72-78 degrees C for at least 12 minutes so that the residual activity of the beta-galactosidase is at most 0.1% as recited in claim 1.
Applicant’s correct to note that Jorgensen does not teach nor suggest “the specific heat treatment of the milk-based substrate comprising beta-galactosidase and GOS at a temperature of 72-78 degrees C for at least 12 minutes so that the residual activity of the beta-galactosidase is at most 0.1% as recited in claim 1. Had Jorgensen teaches such, Jorgensen would have been noted to have anticipated said claim language. In the instant case, Jorgensen teaches a temperature range of 5-75 degrees C. This temperature range overlaps with the claimed range of 72-78 degrees C. Jorgensen also teaches a time period of 1-50 hours. This time period overlaps with the claimed time period of “at least 12 minutes”. In the instant case, a prima face case of obviousness exists when the ranges overlap. Regarding the residual activity of the beta-galactosidase is at most 0.1%, Applicant is correct to note that Jorgensen does not teach such. However, as noted in the rejection, Sibakov teaches that it is desirable the reaction between milk having lactose with beta-galatosidase be performed under a condition as to provide a high yield of galactooligosaccharides. Given this, as established in the rejection, it would have been obvious to one of ordinary skill in the art to have varied the amount of beta- galactosidase to ensure that a complete reaction is performed and no beta- galactosidase is wasted.
Applicant argues that Jorgensen is completely silent as to the conditions needed to achieve enzyme inactivation and GOS stability.
Applicant’s argument has been considered; however, it is not found persuasive. As noted throughout the previous and instant office action, Sibakov teaches that it is desirable the reaction between milk having lactose with beta-galactosidase be performed under a condition as to provide a high yield of galactooligosaccharides. Given this, as established in the rejection, it would have been obvious to one of ordinary skill in the art to have varied the amount of beta- galactosidase to ensure that a complete reaction is performed and no beta- galactosidase is wasted. Had Jorgensen expressly disclosed the conditions needed to achieve enzyme inactivation and GOS stability, then, Sibakov would not be introduced.
Applicant argues that Jorgensen “does not teach or suggest, or render obvious that the heat treatment step is performed would be sufficient for enzyme inactivation. On the contrary, this reference teaches a time of at least 1 hour, potentially up to 50 hours”.
Applicant’s argument has been considered; however, it is not found persuasive. Had Jorgensen teaches the heat treatment step is performed would be sufficient for enzyme inactivation, then, Sibakov would not be needed. With respect to Applicant’s argument, “[O]n the contrary, this reference teaches a time of at least 1 hour, potentially up to 50 hours”, it should be note that the time period is within the claimed range. Applicant is advised that if Applicant alleges that the noted time period would not be sufficient for enzyme inactivation, then, it appears that Applicant is suggesting that the full scope of the claimed invention is not enabling.
Applicant also argues that the heat treatment of Sibakov does not achieve enzyme inactivation while avoiding off-flavors produced by high temperature. To advance this position, applicant notes that Sibakov teaches ESL (130 C for 1-2s), UHT (138C for 2-4s) and high temperature pasteurization (95C for 5 mins).
Applicant’s argument has been considered; however, it is not found persuasive. Applicant’s argument does not commensurate with the claims. There is absolutely noting in the claim relating avoiding off flavors. Moreover, it should be noted that the high temperature pasteurization (95C for 5 mins” of Sibakov overlaps with the claimed time range. Additionally, it is noted that Applicant has not given the teachings of Sibakov for its full effect. In the portion of the argument, applicant omitted to recognize that Sibakov teaches pasteurization at 72 C for 15 seconds. The pasteurization temperature and time of Sibakov is within the claimed range.
Applicant argues that a person skilled int eh art would not reasonably expect that the enzyme would be inactivated using a normal pasteurization at 75 C for only 15s.
Applicant’s argument has been considered; however, it is not found persuasive. Applicant is reminded that Jorgensen teaches a temperature and time range that overlaps with the claimed range. The same can be said for Sibakov.
Applicant argues that Larsen teaches enzyme inactivation at 95c for 10 mins causes off-flavor production and is thus unsuitable for the present invention
Applicant’s argument has been considered; however, it is not found persuasive. Applicant’s argument does not commensurate in scope with the claims. The claims require a temperature range of 72-78 and a time range of “at least 12 minutes”. In the instant case, Jorgensen teaches a temperature and time range that overlaps with the claimed ranges. Hence, in the absence of evidence showing unexpected result, a prima facie case of obviousness is established.
Applicant argue that the data presented in the specification shows very low residual beta-galactosidase activity. More specifically Applicant pints to Table 1, which shows that “inactivation at 75C results in very low residual beta-galactosidase activity when using an inactivation time of at least 12 minutes, but not at 5 or 8 minutes.
Applicant’s argument has been noted, however, it is not found persuasive. As noted earlier, Jorgensen teaches a temperature and time range that overlaps with the claimed ranges. Hence, in the absence of evidence showing unexpected result, a prima facie case of obviousness is established.
Applicant also notes that inactivation at 70, 80, 90 C for 5, 8, 12 or 15 mutes does not achieve very low residual activity. And, it appears that Applicant is using this data to assert unexpected results.
Applicant’s argument has been considered; however, it’s not found persuasive. As noted above, Jorgensen teaches a temperature and time range that overlaps with the claimed ranges. Hence, in the absence of evidence showing unexpected result, a prima facie case of obviousness is established. With respect to Applicant’s assertion of unexpected results, the argument is not persuasive. The data provided by Applicant demonstrate that temperature and time is a result effective variable; and adjustment of result effective variable is routinely practiced in the art.
Applicant further argues that lower inactivation temperature is generally preferred to avoid off flavors of the final dairy product.
Applicant’s argument has been considered; however, it is not found persuasive. The argument does not commensurate in scope with the claim. Furthermore, Applicant’s discovery of a previously unappreciated property does not make the claimed invention any more patentable.
Additionally, it is noted that Applicant has argued against the references individually. Applicant is reminded that one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references." In re Keller and In re Merck & Co
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, as demonstrated above, the claimed invention is obvious over the cited combination of references.s
Conclusion
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Emily Le whose telephone number is (571)272-0903. The examiner can normally be reached Generally available M-F 7:00 A.M.-3:00 P.M.
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.
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.
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793
Prosecution Insights