\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
Continued Examination under 37 CFR 1.114
2. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/2025 has been entered.
Status of the application
3. Claims 1, 4, 7-9, 15-17, 21 are pending in this office action.
Claims 1 is further amended.
Claim 21 is new.
Claims 1, 4, 7-9, 15-17, 21 have been rejected.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
5. Claim 21 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. It is to be noted that amended independent claim 1 recites the claim limitation of “wherein the manganese in the fermented food product is reduced to a concentration below 0.006 ppm-0.0006”. New claim 21 depends on amended independent claim 1 which recites the identical claim limitation with identical range value of “wherein the manganese in the fermented food product is reduced to a concentration below 0.006 ppm-0.0006”. Therefore, claim 21 is improper dependent form for failing to further limit the subject matter of the independent claim 1 upon which it depends. This renders 112 fourth paragraph rejection of claim 21. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
6. 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.
7. 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:
a. Determining the scope and contents of the prior art.
b. Ascertaining the differences between the prior art and the claims at issue.
c. Resolving the level of ordinary skill in the pertinent art.
d. Considering objective evidence present in the application indicating obviousness or non-obviousness.
8. Claims 1, 4, 7-9, 15-17, 21 are rejected under 35 U.S.C. 103(a) as being unpatentable over Siedler et al. (WO 2019/202003 A2) in view of Nielsen et al. (WO 2019/081577).
9. Regarding claims 1, 15 and 21, Sielder et al. discloses that growth of unwanted microorganism e.g. fungi or mold can be controlled by reducing manganese concentration in a food product which can be achieved by adding manganese scavenger with the food product (At least in Abstract, page 1 line 28-page 2 line 5, page 2 line 15-page 3 line 24 , claims , fig 14, Tables page 8 , line 4-line 25, page 10 , line 30-page 11 , line 25 , page 12 , line4-page 13. Line 10). Sielder et al. also discloses manganese scavenger includes strains of bacteria family Lactobacillaceae spp. (at least in page 13, lines 4-10).
Sielder et al. discloses that the food product can be fermented food product e.g., yogurt or cheese (at least in pg.2 lines 30-34 and claims 5,6 7 of Sielder et al). Sielder et al. also discloses that the application of manganese scavenger can include in a food product including milk (i.e., dairy) (pg.2 lines 30-34 and claims 5,6 7 of Sielder et al. and pg. 8 lines 4-10) which reads on “dairy product” of amended claim 1.
Sielder et al. also discloses a method which comprises selecting a bacteria strain selected from bacteria family including Lactobacillus spp. (at least in page 13 lines 4-10) having manganese uptake with the help of manganese transport system as a manganese scavenging agent (at least on page 11, lines 23-26) and this manganese transporter system is belonging to and selected from manganese transporter family which includes and is designated as TC # 2.A.55 (page 12 lines 6-10). Sielder et al. also discloses that one or more bacterial strain comprises a manganese transporter TC # 2.A.55 or functional variants thereof (page 12 lines 27-29). Therefore, it reads on “manganese scavenger” is Lactobacillus spp. of claim 1.
However, Siedler et al. is specifically silent about Lactobacillus spp. includes Lactobacillus rhamnosus strain DSM 32092 as claimed in claim 1.
Regarding the claim limitation of manganese scavenger “Lactobacillus rhamnosus DSM 32092” as claimed in amended claim 1, Siedler et al. is silent about Lactobacillus ramnosus strain 32092 and /or Lactobacillus ramnosus strain 32666.
Nielsen et al. discloses that the dairy product made by using Lactobacillus ramnosus provides an improved organoleptic quality with an enhanced creamy flavor imparted to the final dairy product (page 2 lines 20-26). Nielsen et al. also discloses that Lactobacillus ramnosus strain which was used to make dairy product was deposited with the German Collection of Microorganisms and cell culture (DSMZ) under accession number DSM 32666 (page 3 lines 4-10, page 9 line 22) and under accession number 32092 (page 12 lines 15-20).
One of ordinary skill in the art before the effective filling date of the claimed invention would have been motivated to modify Siedler et al. to include the teaching of Nielsen et al. to include Lactobacillus ramnosus as preferred choice because it provides an improved organoleptic quality with an enhanced creamy flavor imparted (page 2 lines 20-26) in the final product.
It is to be noted that as the disclose strain the amended claim limitation of “ wherein the mutant strain does not secrete anti-listerial bacteriocins”
It is to be noted that even if the combined teachings of the prior arts of record are silent specifically that Lactobacillus ramnosus is anti-listerial, however, it is to be noted that the disclosed Lactobacillus ramnosus strain DSM 320922 is identical to the claimed Lactobacillus ramnosus strain DSM 320922, and, therefore, it would have identical claimed property of “wherein the mutant strain does not secrete anti-listerial bacteriocins”, yet inhibiting or delaying growth of listeria in a dairy product by reducing the amount of manganese in the dairy product as claimed in claim 1.
10. Regarding claims 1, 15, and 21, it is to be noted that the claim limitations of “wherein the manganese in the fermented food product is reduced to a concentration below 0.006 ppm-0.0006” as claimed in amended independent claim 1 and new claim 21 and also “below 0.004 ppm-0.0006 ppm” as claimed in claim 15, Sielder et al. discloses that the reduction of manganese concentration can be in an amount of below 0.006 ppm or below 0.004 ppm also (pg. 8, line 22) and the fermented food product is e.g., yogurt or cheese (at least in pg.2 lines 30-34 and claims 5,6 7 of Sielder et al). Therefore, it also meets claim limitation of “wherein the manganese in the fermented food product is reduced to a concentration below 0.006 ppm, thereby inhibiting or delaying growth of listeria in the fermented food product” as claimed in amended claim 1. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). It is also to be noted that the lower value of 0.0006 ppm is very negligible. This can also be interpreted that the residual value of 0.0006 ppm is considered as very minor/(practically) nil. Therefore, in this instance, the disclosed teaching of 0.006 ppm or below 0.004 ppm (in Siedler et al. pg. 8, line 22) meets the claimed range value of independent claim 1.
It is also to be noted that and also taught by Sielder et al. that (page 8 lines 4-5) the reduction of manganese to a desired concentration in the final food product is within the skill of one of ordinary skill in the art and is optimizable.
Absent showing of unexpected results, the specific amount of “reduction of manganese to a desired concentration in the final food product” is not considered to confer patentability to the claims. As the specific amount of reduction of manganese in the final product is variable, that can be modified, among others, by selecting the nature of manganese scavenging agent from lactobacillus strains, by adjusting the duration of contact of the probiotic microorganism with the dairy product, 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 residual manganese in the final food product in Sielder et al., to amounts, including that presently claimed, in order to obtain the desired effect e.g. desired amount of reduced manganese containing final product (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).
11. Regarding claim 4, it is also understood and is evidenced by applicants’ specification that the food product having pH higher than 4.3 and water activity higher than 0.92 is the favorable environment for the L. monocytogens to grow ([0003], [0004] in PGPUB).
In this instance, it is to be noted that the disclosed components including the disclosed identical Lactobacillus strain 32092 having manganese scavenger system , which is identical to claimed Lactobacillus strain 32092 will have identical claimed “anti-listerial property, therefore, will be able to delay growth of listeria even in the favorable environment containing food composition having pH higher than 4.3 and water activity higher than 0.92 which is the favorable environment for the L. monocytogens to grow.
12. Regarding claims 7, 16, as discussed above for claim 1, Sielder et al. discloses that bacteria strain having a manganese transporter selected from manganese transporter TC # 2.A.55 (page 12 lines 6-10). Sielder et al. also discloses that one or more bacterial strain comprises a manganese transporter TC # 2.A.55 or functional variants thereof (page 12 lines 27-29) and the bacterial strain includes strains of bacteria family Lactobacillaceae spp. (at least in page 13, lines 4-10). Therefore, it reads on claims 7 and 16.
13. Regarding claims 8, 17, as discussed above, Sielder et al. discloses that bacteria strain includes Lactobacillus spp. having a manganese transporter selected from manganese transporter TC # 2.A.55 (at least on page 12 lines 6-10, 27-29). Sielder et al. also discloses that one or more manganese scavengers strains of bacteria family Lactobacillus functional variants of SEQ ID #1 Lactobacillus having at least 90% sequence identity can be at least SEQ ID #4 (99.8% identity) in Table 1 (page 13 lines 6-10, 20-32 and page 14 , Table 1) and can be bacteria family Lactobacillus functional variants of SEQ ID #2 Lactobacillus having at least 55% sequence identity can be at least SEQ ID #12 in Table 2 (99.3% identity) page 13 lines 6-10, 20-32 and page 16 , lines 15-16 and Table 2). It is evidenced by applicants’ specification that the disclosed SEQ ID #1 (page 13, variant from SEQ ID #1 which is SEQ ID #4, WP_013245308.1) is identical to the applicants SEQ ID #1 (in PGPUB [0089], identical variant WP_013245308.1). It is also evidenced by applicants’ specification that the disclosed SEQ ID #2 (page 16) is identical to the applicants SEQ ID #2 (in PGPUB [0092], [0094], identical variant WP_012491767.1).
14. Regarding claim 9, Sielder et al. discloses that bacteria strain can be free of superoxide dismutase, preferably manganese superoxide dismutase (page 23 lines 11-14).
Response to arguments
15. Applicant’s arguments and amendments have been considered. However, they are not persuasive. The reasons are discussed below. It is to be noted that examiner has not considered the prior used secondary prior art by NPL Zaika et al. in this office action. Therefore, the arguments made for NPL Zaika et al. is considered as moot. Examiner has not considered the prior used evidentiary reference by Ross et al. also.
16. Applicants argued that
(a) “As described in the previous response, Siedler and the present specification are each directed toward distinct problems to be solved, where Siedler provides a method of inhibiting fungal growth, while the present specification teaches a method of inhibiting or delaying the growth of listeria in a fermented food product. The teachings of the present specification underscore the non- obviousness of the presently claimed method over Siedler. As stated on page 4, lines 4-7 of the present specification, the concentration of manganese required for inhibition is lower than that
required by yeast and mold.
(b) The disclosures of Siedler would not obviously lead a person of skill in the art to the presently claimed method; rather, a person of skill in the art may apply the teachings of Siedler and find that Listeria growth is not inhibited at low levels of manganese. It is only in the present specification where levels of manganese below 0.006 ppm, including 0.0006 and 0.00006 ppm, are tested and it is determined that Listeria growth can successfully be limited with reduced free manganese.”
In response to (a) and (b), it is to be noted that the combined teaching of Siedler et al. in view of Nielsen et al. disclose identical Lactobacillus rhamnosus strain DSM 32092 having identical manganese transporter TC# 2.A. 55 which serves as manganese scavenger system, and is identical to the claimed Lactobacillus rhamnosus strain DSM 32092 manganese transporter TC# 2.A. 55, therefore, having identical property of reduction of manganese to a concentration below 0.006 ppm to 0.0006 ppm by using manganese scavenging property and thereby delaying growth of Listeria in the fermented dairy product , even if this strain does not secrete anti-listeria bacteriocins.
However, it is also to be noted that Siedler et al. broadly discloses “controlling growth of unwanted microorganisms” and, the disclosure discussed, more specifically, “a method of inhibiting or delaying growth of yeast and mold” by reducing the manganese concentration in the product (At least in Abstract). The disclosure of Siedler et al., as a whole, can be interpreted as the microorganisms which depend on ‘manganese’ concentration for their growth are inhibited by the disclosed Lactobacillus spp. having manganese transporter TC# 2.A.55 as manganese scavenger system to reduce manganese in the final product.
16. Applicants argued that “Further, although Nielsen discloses the presently claimed strain DSM 32092 in methods for producing a dairy product, Nielsen is silent regarding the ability of the strain to be either anti-listerial or manganese scavenging. It is only in the disclosures of the present specification that strain DSM 32092 is described and demonstrated to be suitable for a process of inhibiting or delaying growth of listeria in a fermented food product”.
In response, it is to be noted that Nielsen is used to modify Siedler’s broadly disclosed Lactobacillus spp (Genus) with manganese scavenging system with the Lactobacillus species strain DSM 32092 in methods for producing a dairy product in order to provide an improved organoleptic quality with an enhanced creamy flavor imparted (page 2 lines 20-26) in the final dairy product. However, even if Nielsen is silent regarding the ability of the strain to be either anti-listerial or manganese scavenging, as alleged by the applicants, it is considered as inherent property of this particular Lactobacillus DSM 32092 strain. Therefore, the rejection with the combined teachings of the prior arts of record is proper.
However, note that while Nielsen et al. does not disclose all the features of the present claimed invention, Nielsen et al. is used as teaching reference, and therefore, it is not necessary for this secondary reference to contain all the features of the presently claimed invention, In re Nievelt, 482 F.2d 965, 179 USPQ 224, 226 (CCPA 1973), In re Keller 624 F.2d 413, 208 USPQ 871, 881 (CCPA 1981). Rather this reference teaches a certain concept, namely , Lactobacillus species strain DSM 32092 provides an improved organoleptic quality with an enhanced creamy flavor imparted (Nielsen et al., page 2 lines 20-26) and in combination with the primary reference, discloses the presently claimed invention.
Conclusion
17. 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