DETAILED ACTION
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 .
Response to Amendment
Those objections and rejections not repeated in this Office Action have been withdrawn.
Claims 24, 30-38, 40, 42, 43 and 46-48 are currently pending.
Claims 40, 42 and 43 are withdrawn from consideration as being directed to a nonelected invention.
Claims 24, 30-38 and 46-48 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24, 30-38 and 46-47 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 24 recite, “particles with a homogeneous size, wherein the particles have a diameter between 1 and 30 microns.” Claim 47 recites, “the particles have a diameter of 3 to 20 microns.”
These limitations are broader than what would have been reasonably supported by Applicant’s originally filed disclosure. Only examples 4 and 5 as presented on page 12, lines 32-34 and page 13, lines 26-28 appear to disclose a single particle size of 5 microns. The specification however does not provide clear support for the particles are of a homogeneous size and where the homogenous size is in the range of 1 to 30 and 3-20 microns. For example, support for the broader range of 1-30 microns would appear on page 6, lines 9-10 and 21-23, however this disclosure refers to an average diameter of 1-50 microns. Example 3.1 discloses a range of 3-30 microns. When discussing homogeneity, the specification on page 12, lines 17-24 discloses that “a more homogeneous” profile of the eyes was correlated to “better homogeneity” of the particle size added (1 micron). It is not clear that this disclosure specifically refers to particles of only one size because lines 21-22 appear to disclose that a higher number of eyes and a more homogeneous profile size of the eyes was the result of “better” homogeneity and not specifically using “only” one particle size. Page 12, lines 32-34 and page 13, lines 26-28 support particles with a homogeneous size of 5 micron, respectively. Therefore, while Applicant’s disclosure provides support for a homogeneous size of 5 microns, Applicant’s disclosure is not seen to reasonably support that the particulars can have a homogeneous size across the entire range of 1 to 30 microns.
Claims 30-38 and 47 are rejected based on their dependence to a rejected claim.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 24, 30-38 and 46-47 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 24 recites, “particles with a homogeneous size, wherein the particles have a diameter between 1 and 30 microns.” This limitation is not clear as to what “a homogeneous size” is referring to: a specific diameter of the particle, a volume, or some other dimension. In view of this, the claim is also not clear as to whether particles with a homogeneous size can still have different diameters.
Claims 30-38, 46-48 are rejected based on their dependence to a rejected claim.
Claim Rejections - 35 USC § 103
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 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 24, 30-35, 37, 38 and 46-78 are rejected under 35 U.S.C. 103 as being unpatentable over Berning (“Finest Kind Cheese & Yoghurt Making Manual”) in view of Hoffmann (WO 9306736) and in further view of Bullens (WO 9501729), Kerjean (FR 2682010) and in further view of Michalski (Functionality of smaller vs control native milk fat globules in Emmental cheese manufactured with adapted technologies.” Already of record). Messaoud et al. (“Alginate/sodium caseinate aqueous-core capsules: A pH-responsive matrix”) has been relied on as evidence.
Regarding claim 24, Berning teaches a process for making a Swiss- or Continental type cheese comprising: obtaining a milk composition and (b) adding to the milk composition one or both of lactic acid bacteria and proprionic bacteria (see Berning page 16, lactobacillus, streptococcus for Emmental cheese; see page 33, “Bacterium Propioni – Emmenthaler” and (c) a coagulant (see Berning page 24, “rennet is the ingredient added to milk in order to coagulate the milk”). It is noted that Applicant’s specification on page 1, lines 23-37 defines what is a “Swiss cheese type” and a “Continental cheese type.”
Claim 24 differs from Berning in specifically reciting adding to the milk composition simultaneously or in any order, particles with a homogeneous size, wherein the particles have a diameter between 1 and 30 microns and wherein the particles contain a compound selected from the list consisting of micellar casein, casein glycomacropeptide, polymerized casein glycomacropeptide, sodium caseinate and polycaseinate.
Nonetheless, Hoffman (WO 9306736) teaches adding milk protein particles for controlling eye formation (see page 1, lines 37 to page 2, line 11) and where the particles can be milk protein particles (see page 2, line 15 and page 3, line 16-17). Hoffman also teaches that the particles can be natural milk protein particles prepared by conventional methods (see page 2, lines 9-11).
Since Berning teaches cheese which has eye formation, such as Emmental and Swiss, to thus modify Berning and to include natural milk component protein particles as taught by Hoffman would have been obvious to one having ordinary skill in the art for the purpose of controlling and “improving” eye formation and distribution.
Regarding the limitation of, “particles with a homogeneous size, wherein the particles have a diameter between 1 and 30 microns” and wherein the particles contain a compound selected from the list consisting of micellar casein, casein glycomacropeptide, polymerized casein glycomacropeptide, sodium caseinate and polycaseinate, the above combination is not specific in this regard.
It is noted however, that Hoffman teaches that the particle size is not restricted to the disclosed ranges (see page 5, lines 1-2) and therefore teaches and suggests experimenting with the particle size.
Bullens (WO 9501729) teaches making cheese (see page 3, lines 1-25) where the process can include adding particles having a particle size of 5-15 microns (see page 4, line 5) and which particles can comprise sodium caseinate (see page 4, lines 10-11) which can also be construed as polycaseinate since sodium caseinate is a natural polymer, as evidenced by Messaoud on page 2, left column 3rd paragraph) and therefore suggests some plurality of particles containing sodium caseinate as a milk protein and having a particle diameter of 5 microns. Since Bullens is not discussing an average particle size or a particle size distribution, it would have been obvious to one having ordinary skill in the art that Bullens is also encompassing providing particles with a homogeneous size and which particles have a diameter between 1 and 30 microns, such as 5 microns. Bullens teaches that such particles can be added during the making of cheese, for the purpose of lowering the fat of the cheese while providing similar flavor, mouthfeel and consistency to full fat cheese (see page 2, lines 1-6). Bullens is suggesting more than one particle with a size of 5 microns, and therefore teaches “particles with a homogeneous size, wherein the particles have a diameter between 1 and 30 microns.”
Kerjean (FR 2682010) teaches that it has been conventional to use casein particles (see paragraph 7, lines 57-58 of the machine translation) in amounts such as 13mg per liter of milk (i.e. 0.013g/L of milk)(see paragraph 7, lines 54-56) for providing even distribution of eyes in the cheese (see the abstract paragraph 7, lines 44-50, “distributed openings”). 0.013g per liter of milk equates to 1.3g per 100L of milk thus falling within the range as recited in claim 46.
In view of these teachings, the prior art is providing a reason to add to a milk composition, particles that are homogeneous in size and have a diameter between 1 and 30 microns and can comprise sodium caseinate, for the purpose of lowering the fat of the cheese while providing similar flavor, mouthfeel and consistency and where particles comprising milk protein such as casein have also been recognized in the art to be useful for providing a requisite degree of eye formation.
To therefore modify Brennan and to include particles containing sodium caseinate and which particles have a homogeneous size and the particles have a diameter within the range of 1-30 microns, such as 5 microns, to Brennan’s milk composition together with adding lactic acid bacteria and propionic bacteria and a coagulant, would have been obvious to one having ordinary skill in the art for lowering the fat of the cheese while also providing a requisite degree of eye formation.
Since the prior art teaches using particles with a diameter of 5 microns and which particles can comprise sodium caseinate and which particles can also be used for eye formation and distribution, it would have been reasonable to expect that the prior art would also have improved eye formation and distribution compared a process that comprises obtaining a milk composition, adding the one or both of lactic acid and propionic bacteria and the coagulant but does not add the particles.
Further regarding the particles with a homogeneous size, it is also noted that Michalski teaches a method of making Emmenthal cheese (see the abstract) where particles having a size such as about 4.5microns or about 3.3 microns were added to the milk composition (see table 1) and where the larger 4.5 micron particles provided larger eyes compared to the smaller 3.3 micron particles (see page 195, Figure 1C). As shown in figure 1C, it would have been obvious to one having ordinary skill in the art that a homogeneous particle size would have helped to provide more uniformity in the eye formations. Therefore, it would have been obvious to one having ordinary skill in the art to at least experiment with particles having a homogeneous size for the purpose of providing uniformity in the eyes formed in the cheese.
Regarding claim 30, Bullens also teaches the particles can be in powdered form (see page 3, lines 30-34, “dry state”).
Regarding claims 31-34, Berning teaches the milk composition having 3.3-5% fat and 3-4% protein (see page 6 and the fat and protein content of milk from Jersey and Friesien breeds). Therefore, Berning teaches a milk composition with a fat and protein content within the claimed ranges.
Regarding claim 35, Berning teaches using streptococcus thermophilus bacteria as well as lactobacillus lactis bacteria (see page 16, example 2). Berning also suggests using propionic acid bacteria (see page 33, “Bacterium Propioni”).
Regarding claim 37, Berning teaches using rennet as the coagulant (see page 24) which can be of microbial origin (see page 24 “microbial rennet”) or bovine origin (see page 24, Animal Rennet. Rennet extracted from the stomachs of calves”).
Regarding claim 38, Berning teaches that milk can be obtained from cow breeds at different stages of lactation (see page 5, the table), which suggests a more “mature milk” and would have been performed prior to “adding.” Berning also teaches on page 13, to pasteurize milk or add potassium nitrate to milk, which can thus suggest maturing the milk by a physical or a chemical means. It is noted that the claims and specification do not limit what can be construed as “maturing,” and therefore reads on any form of maturing.
Regarding claim 46, since the combination already suggests particles that comprise milk proteins such as sodium caseinate, to modify the combination and to use 1.3g of the particles per 100L of milk as taught by Kerjean, would have been obvious to one having ordinary skill in the art for also providing even distribution of the eyes in the cheese.
Regarding claims 47 and 48, the combination as applied to claim 24 teaches the particles have a diameter of 5 microns.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over the combination, as applied to claim 24 above, which relies on Berning (“Finest Kind Cheese & Yoghurt Making Manual”) as the primary reference and in further view of Rodriguez (“The Role of Copper in Manufacture of Finnish Emmental Cheese”)
Regarding claim 36, Berning, suggests Propionibacterium but does not specifically recite Propionibacterium freudenreichii subsp freudenreichii.
However, it would have been obvious to one having ordinary skill in the art to have used known Propionibacterium. In this regard, Rodriguez teaches the bacteria comprise Propionibacterium freudenreichii ssp. freudenreichii (see figure 1 on page 4833).
Therefore, to modify Berning and use another known propionic bacteria such as Propionibacterium freudenreichii subsp freudenreichii would have been obvious to one having ordinary skill in the art as a matter of engineering and/or design based on conventional propionic bacteria used for producing cheese having eye formation.
Response to Arguments
In view of Applicant’s arguments on page 6 directed to micellar casein the previous remarks directed to micellar casein not improving the distribution of the eye formation has been withdrawn.
Further on pages 6-7 of the response, Applicant urges that the importance of the particle size homogeneity to produce good eye formation is only taught in the present specification and is not taught, implied or made obvious based on the teachings of Berning, Hoffman, Bullens, Kerjean or Rodriguez.
These arguments have been considered but are not sufficient for the reasons presented in the rejection, as discussed above. That is, the claim only requires an undefined number of particles with a homogeneous size while also appearing to recite that the particles can have a diameter between 1-30 microns. In this regard, it would have been obvious to one having ordinary skill in the art that the prior art disclosure of particles comprising casein with a particle size of 5-15 microns would also have resulted in some plurality of particles having a homogeneous size and a particle size within the range of 1-30 microns, 3-20 microns and specifically 5 microns. It is further noted that while the specification provides data with respect to a particle size of 5 microns (examples 4 and 5), the specification does not provide sufficient specificity as to what occurs at the broader range of 1-30 microns. It is also noted that examples 4 and 5, which appear to show improved eye formation and distribution are specifically directed to using CGMP particles (see page 14, line 15 to page 15, line 17).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/VIREN A THAKUR/Primary Examiner, Art Unit 1792