, 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
Status of the application
Claims 2-12, 14-18 are pending I this office action.
Claims 1, 13 have been cancelled.
Claims 2-12, 14-18 have been rejected.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claim 12 is rejected under 35 U.S.C. 101.
In reference to claim12:
(a) Step 1: Claim 12 is product claim. It is to be noted that applicants have not provided any additional features for the deposited strains DSM 34278 and DSM 34279 as claimed in claim 12 which amount to significantly more than the nature-based product. and, therefore, it is not known where the history of the detailed information of further modification of the deposited strains DSM 34278 and DSM 34279 are.
(b) Step 2A Prong 1: The independent claim 12 recites “Pichia kluyveri deposited as DSM 34278, DSM 34279’.
The additional elements in claim 12 claim the deposition of the strains which are considered as conventional features in product 12. As such, there are no additional features which amount to significantly more than the nature-based product.
There are no additional limitations of claim 12 which adds or integrates the nature-based product into a practical application nor amount to significantly more than the nature-based product.
Therefore, claim 12 is directed at an original nature- based product and not patent eligible.
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.
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 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.
7. Claim(s) 2-7, 9, 10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Saerens et al. US 2017/0183612.
8. Regarding claims 2, Sarens et al. discloses a method of brewing beer (at least in Abstract) by using mixed fermentations of Pichia spp. and S. cerevisiae and both can be added at the same time (at least in 0016]) and the fermentation method preferably produce low alcohol, reduced-alcohol or non- alcohol beer, all of which have alcohol content of between 1.2% to 4.2% alcohol by volume (ABV) (Abstract [0100], [0066]-[0068]).
It is to be noted that claim 2 claims “Pichia kluyveri is not PK-KR1 and PK-KR2. However, Sarens et al. broadly discloses “the Pichia strain” is Pichia kluyveri ([0097]). Sarens et al. discloses preferably PK-KR1 and PK-KR2 ([0098]). Therefore, it can be interpreted as Sarens et al. discloses the inhibitory effect is exhibited by any type of Pichia kluyveri strain including claimed Pichia kluyveri as claimed in claim 2. Therefore, it meets claimed Pichia kluyveri of claim 2. It is to be noted that it is inevitable that due to competition for nutrients, S. cerevisiae growth will be inhibited which will restrict alcohol production by S. cerevisiae and will produce low alcohol, reduced-alcohol or non- alcohol beer, all of which have alcohol content of between 1.2% to 4.2% alcohol by volume (ABV) (Abstract [0100], [0066]-[0068]).
It is also to be noted that when two microorganisms are present in the medium, the disclosed microorganisms are identical to the claimed microorganism and, therefore, the property of the disclosed microorganism will be identical to the claimed microorganism including the claimed property of inhibiting growth of S. cerevisiae by Pichia Kluyveri strain.
Regarding the claim limitations of “ adding an effective amount of Pichia kluyveri “ and percent inhibition by at least 40% when inoculated simultaneously”, and also regarding the the claim limitation “ is inhibited by at least 50%” as claimed in claim 10, it is to be noted that it is within the skill of one of ordinary skill in the art to optimize the starter culture amount and fermentation conditions (e.g. duration of fermentation etc.) by which the desired degree of inhibition of growth of S. cerevisiae in order to have reduced amount of alcohol production can be achieved.
Absent showing of unexpected results, the specific amount of percent inhibition is not considered to confer patentability to the claims. As the percent inhibition is variable that can be modified, among others, by adjusting the amount which depends on starting amount and ratio of the culture(s), their growth curves etc., the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of growth inhibition of S cerevisiae by Pichia Kluyveri strain in Sarens et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired inhibition of growth of S. cerevisiae in order to have reduced amount of alcohol production (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
9. Regarding claims 3, 4, 7, 9, they depend on claim 2. Therefore, the rejection made for claim 2 is applicable for claims 3,7 and 9 also. In addition, Sarens et al. discloses that the fermentation preferably produces low alcohol, reduced-alcohol or non- alcohol beer, all of which have alcohol content of between 1.2% to 4.2% alcohol by volume (ABV) (Abstract [0100], [0066]- [0068]). Therefore, it also meets claims 3, 4, 7 and 15.
10. Regarding claim 6, it is to be noted that claim 6 depends on claim 2, which is method claim. As discussed above, Sarens et al. broadly discloses “the Pichia strain” is Pichia kluyveri ([0097]). Sarens et al. discloses preferably PK-KR1 and PK-KR2 ([0098]). Therefore, the method step is applicable to any Pichia kluyveri strain (at least in [0097]) including claimed strain of DSM 34278 and DSM 34279 as claimed in claim 6 also.
11. Regarding claim 12, claim 12 is an independent claim. Sarens et al. broadly discloses “the Pichia strain” is Pichia kluyveri ([0097]). Sarens et al. discloses preferably PK-KR1 and PK-KR2 ([0098]).
It is to be noted that applicants’ specification recited that these strains were deposited on May 31, 2022, by the applicants (Table 4, applicant’s specification). However, claim 12 is an independent claim. It has 101 rejections as discussed above. It is also to be noted that, Sarens et al. broadly discloses “the Pichia strain” is Pichia kluyveri ([0097]). Pichia kluyveri strain (at least in [0097]) includes claimed strain of DSM 34278 and DSM 34279 as deposited as DSM 34278, DSM 34279.
12. Claims 8, 11, 14- 17 are rejected under 35 U.S.C. 103 as being unpatentable over Sarens et al. US 2017/0183612 as applied to claim 2 and further in view of Saerens et al. WO 2013/064678 A1 (Hereinafter Saerens ‘678).
13. Regarding claims 8, 11, 14, 16, it is to be noted that Sarens et al. discloses that hops contribute flavor in beer ([0013]). Sarens et al. also discloses the flavor profile of beer can be tuned by using different combinations of Pichia spp. strains and hops (Abstract) and there is an interaction of the hops with the Pichia spp. yeast strain to enhance the flavor of beer ([0001]). Therefore, selection of hops contributes an improved flavor in beer ([0013], [0016]) with an increased amounts of production of aromas present in beer ([0115]).
However, Sarens et al. is silent about the concentration of Pichia spp. as claimed in claims 8, 18 and the amount of Pichia spp. required for the 40% inhibition of growth of S cerevisiae as claimed in claim 11.
Regarding claims 11, 16, regarding the claimed concentration of Pichia spp., and in presence of S cerevisiae, Saerens et al. ‘678 discloses that yeast stains including Pichia kluyveri PK-KR1 can be inoculated at 10^4 to 10^10 cfu/g (at least page 9), and it can be 5 million CFU/g in presence of S cerevisiae for fermentation (Under Example 1, first paragraph under Fermentation set up) which is effective to make taste, aroma in the fermented product at this concentration (at least under Result, at least in paragraphs 5- 7).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Saerens et al. with the teaching of Saerens ‘678 to consider the disclosed concentration of Pichia kluyveri to perform fermentation in order to have taste, aroma and an enhanced flavor profile in the fermented product at this concentration (at least under Result , paragraph 9).
According to MPEP 2143.01, “Obviousness can 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. In re Kahn, 441 F.3d 977, 986, 78 USPQ2d 1329, 1335 (Fed. Cir. 2006) (discussing rationale underlying the motivation-suggestion-teaching test as a guard against using hindsight in an obvious analysis). Axonics, Inc. v. Medtronic, Inc., 73 F.4th 950, 957-58, 2023 USPQ2d 795 (Fed. Cir. 2023) (the court found an erroneous framing of the motivation inquiry led to an incorrect conclusion of nonobviousness)”.
This teaching of Saerens ‘678 is considered as guidelines for one of ordinary skill in the art to optimize the amount at this range CFU/g (CFU/ml for liquid) which overlaps the claimed range amount of claims 11, 16 in order to evaluate the desired enhanced flavor and also the degree of inhibition of S. cerevisiae in order to have reduced alcohol containing beer. Therefore, this is optimizable.
Absent showing unexpected results, the specific amount of concentration of Pichia kluyveri to achieve enhanced flavor and desired degree of inhibition of S. cerevisiae to make reduced alcohol containing beer, is not considered to confer patentability to the claims. As the percent inhibition is variable that can be modified, among others, by adjusting the amount which depends on starting amount and ratio of the culture(s), their growth curves etc., the precise amount would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed amount cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the amount of growth inhibition of S cerevisiae by Pichia Kluyveri from the disclosed concentration of Pichia kluyveri strain (5 million CFU/g ) for fermentation in Sarens et al.in view of Saeren ‘678 ( e.g. Saeren ‘678 (Under Example 1), to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired enhanced flavor profile (e.g. in Saeren et al. [0115]) and desired inhibition of growth of S. cerevisiae in order to have reduced amount of alcohol production (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
14. Regarding claim 14, claim 14 depends on method claim 11. The Examiner notes that claim 14 is product-by-process claim.
Therefore, it is to be noted that, in this case, the courts have held that when the prior art factor appears to differ from the claimed factor only in the method of obtaining the factor, the burden of persuasion was on applicants to show that the claimed product exhibited unexpected properties compared with that of the prior art. The courts further noted that “no objective evidence has been provided establishing that no method was known to those skilled in this field whereby the claimed material might have been synthesized.” 10 USPQ2d in 1926.
The courts also held that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340, 1370 n 14, 92 USPQ2d 1289, 1312, n 14 (Fed. Cir. 2009). See MPEP §2113.
Lastly the courts have held that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). The examiner further notes that “The Patent Office bears a lesser burden of proof in making out a case of prima facie obviousness for product-by-process claims because of their peculiar nature” than when a product is claimed in the conventional fashion. In re Fessmann, 489 F.2d 742, 744, 180 USPQ 324, 326 (CCPA 1974). Once the examiner provides a rationale tending to show that the claimed product appears to be the same or like that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an unobvious difference between the claimed product and the prior art product. In re Marosi, 710 F.2d 798, 802, 218 USPQ 289, 292 (Fed. Cir. 1983). See MPEP §2113.
15. Regarding claim 15, claim 15 depends on claim 11. Therefore, the rejection made for claim 11 is applicable for claim 15 also. In addition, Sarens et al. discloses that the fermentation preferably produces low alcohol, reduced-alcohol or non- alcohol beer, all of which have alcohol content of between 1.2% to 4.2% alcohol by volume (ABV) (Abstract [0100], [0066]- [0068]). Therefore, it also meets claim 15.
16. Regarding claim 17, Searens et al. discloses the product is low alcohol, reduced alcohol or non- alcohol beer, all of which have alcohol content of between 1.2% to 4.2% alcohol by volume (ABV) (Abstract [0100], [0066]- [0068]). Therefore, the disclosed low alcohol beer can be in liquid form also and it meets claim 17.
17. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Sarens et al. US 2017/0183612 in view of Saerens et al. WO 2013/064678 A1 (Hereinafter Saerens ‘678) as applied to claim 14 and further in view of Branduardi et al. US 2006/0234360 A1.
18. Regarding claim 18, Sarens et al. discloses that hops contribute flavor in beer ([0013], [0016]). Sarens et al. also discloses hops are added to the wort to balance the sweetness of the malt with bitterness and impart onto the beer desirable flavors and aromas and includes Halleratau Aroma (at least in [0077]) and the flavor profile of the beer by adding different varieties of hops ([0085]). Sarens et al. also discloses that fruity flavor can be achieved with the addition of Amarillo hop ([0131]). Therefore, it meets “one or more flavorants” as claimed in claim 18.
It is to be noted that Sarens et al. discloses that hops contribute flavor in beer ([0013]). Sarens et al. also discloses the flavor profile of beer can be tuned by using different combinations of Pichia spp., strains and hops (Abstract) and there is an interaction of the hops with the Pichia spp. yeast strain to enhance the flavor of beer ([0001]). Therefore, selection of more than one hops to contribute an additional flavor in beer can read on “further comprising flavorants” ([0013], [0016]) with an increased amounts of production of aromas present in beer ([0115]) can read on “further comprising flavorings” which meets claim 18.
However, additionally, more specifically, Sarens et al. in view of Saerens ‘678 are silent about further comprising an antioxidant as claimed in claim 18.
Branduardi et al. discloses that L-ascorbic acid is approved for use as a dietary supplement and chemical preservative by the U.S. Food and Drug Administration and is on the FDA's list of substances generally recognized as safe. L-ascorbic acid may be used as an antioxidant in foods including beer, which serves as stabilizer in beer also ([0008]).
One of the ordinary skills in the art before the effective filling date of the claimed invention would have been motivated to modify Sarens et al. in view of Saerens ‘678 to include the teaching of Branduardi et al. to include further L-ascorbic acid in food e.g. in Beer to provide an antioxidant which serves as stabilizer in beer ([0008]).
Conclusion
19. Any inquiry concerning the communication or earlier communications from the examiner should be directed to Bhaskar Mukhopadhyay whose telephone number is (571)-270-1139.
If attempts to reach the examiner by telephone are unsuccessful, examiner’s supervisor Erik Kashnikow, can be reached on 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BHASKAR MUKHOPADHYAY/
Examiner, Art Unit 1792
Prosecution Insights