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
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
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.
Claim 1-12 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.
Regarding Claim 1, the term “titration” renders the claim indefinite because it is not clear as to how the step of titrating leads to checking the percentage of the fat content of the semi-skimmed milk. That is, the term “titrating” is commonly associating with determining acidity. The specification does not provide any disclosure as to how the step of titration leads to determining the fat content of the semi-skimmed milk. Also, the claim is not clear as to what is being titrated with the skimmed milk during the titration step.
Also, the term “said raw milk” recited in line 4 lacks sufficient antecedent basis.
Also, the step “adding rennet and whey starter” recited in line 6 is unclear as to what the rennet and whey starter is being added to (i.e. cream or at least semi-skimmed milk).
Also, the step “cooking in vats to obtain a cheese mass” recited in line 7 is unclear as to what is being cooked.
Also, the term “the desired cheese wheels” recited in lines 8-9 lacks proper antecedent basis.
Also, the term “said stored raw milk” recited in line 13 lacks proper antecedent basis.
Also, limitation “where said centrifugation step produces cream and skimmed milk” renders the claim indefinite because it is not clear if “cream and skimmed milk” is the same or different element as the previously recited “cream and at least semi-skimmed milk” recited in line 4.
Also, the term “it” recited in line 8 and 18 is unclear as to what is being referred to as “it”.
Also, the term “said re-added cream delivered from the separated step” recited in line 24 lacks sufficient antecedent basis. The term should recite “said addition of cream recovered from the separating step”.
Claims 2-12 are rejected based on their dependency on a rejected claim.
Regarding Claim 3, the term “pre-heating step” is indefinite because it is not clear which pre-heating step is being referred to from Claim 1.
Regarding Claim 7, the term “said step of adding rennet to said at least semi-skimmed milk” lacks proper antecedent basis.
Regarding Claims 5, 6, 10, 11, 12, the term “it” recited in line 3 of claim 5, line 2 of claim 6, and line 1 of claims 10-12 is unclear as to what is being referred to as “it”.
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Krabsen et al. (US 5,683,733) in view of Bylund (Dairy Processing Handbook, 1995) and Hynes et al. (Proteolysis on Reggianito Argentino Cheeses Manufactured with Natural Whey Cultures and Selected Strains of Lactobacillus helveticus, Journal of Dairy Science, 2003).
Regarding Claim 1, Krabsen discloses an industrial production process of a cheese made from milk (cheese formation properties of milk, see abstract) comprising the steps of:
- collecting milk from milkings and storing it in a single tank (raw milk M, Col. 3, ln 3-5); that is, the fact that raw milk is obtain would inherently include that it was collected from at least one milking;
- separating said raw milk to obtain cream and at least semi-skimmed milk (centrifugation unit 4, Col. 3, ln. 5-8);
- checking the percentage of the fat fraction present in said at least semi-skimmed milk (Col. 4, ln. 35-54); that is, the fact that Krabsen indicates the desired fractions obtained from the cream and skim milk portion would suggest one of ordinary skill in the art to check the percentages of the fat fraction present in the skimmed milk;
characterized in that:
- said separating step comprises a step of pre-heating said stored raw milk (heated to 45° to 65°C, Col. 3, ln. 28-32) and a centrifugation step (centrifuge 104, Col. 3, ln. 32-39), where said centrifugation step produces cream and skimmed milk with a fat content substantially equal to 0% (0.03 to 0.1%, Col. 4, ln. 45-50);
- between the step of separating said raw milk to obtain cream and at least semi-skimmed milk and the step of checking the percentage of the fat fraction present in said at least semi-skimmed milk, it comprises a step of eliminating spores and bacteria from said skimmed milk by means of bactofugation (Col. 4, ln. 4-8 and ln. 22-29). In this case, the bactofugation is occurring simultaneously with the centrifugation, and thus construed to be between the steps of separating said raw milk and checking the percentage of the fat fraction. Krabsen also discloses a standardizing step where cream recovered from the separating step is re-added to the skimmed milk with spores remove to obtain a “standardized content of fat” (Col. 3, Ln. 52-56) and wherein said re-added cream undergoes a pasteurizing step (Col. 3, ln. 47-52).
While Krabsen is directed to treating milk in preparation for cheesemaking, Krabsen does not specifically recite the steps of:
- adding rennet and whey starter;
- cooking in vats to obtain a cheese mass;
- treating the cheese mass thus produced and moulding it to obtain the desired cheese wheels;
- salting said cheese wheels;
- maturing said cheese wheels,
characterized in that:
- said step of checking the percentage of the fat fraction present in said at least semi-skimmed milk comprises titration of the skimmed milk with spores removed, delivered from the bactofugation process, and addition of cream recovered from the separating step to bring the skimmed milk with spores removed to a fat content of 2.8-3% to obtain titrated milk with spores removed, wherein said re-added cream delivered from the separating step, before being added, undergoes a pasteurizing step and a pre-heating step to 65°C and then immediately cooled to 35°C.
As to the pasteurizing step and pre-heating step to 65°C for the re-added cream, Krabsen discloses a step of sterilizing cream at a temperature of 70°C and immediately cooled to 45°C (Col. 3, ln. 47-52). While the heating conditions of the sterilized cream of Krabsen do not overlap with the claimed range, the temperatures are merely close such that one of ordinary skill in the art would have expected them to have similar properties (see MPEP 2144.05.I). Generally, differences in concentration or 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Bylund is relied on to teach known processes of cheese making comprising the steps of:
- adding rennet and starter (Starter, page 296);
- cooking in vats to obtain a cheese mass (Heating/cooking/scalding, page 302);
- treating the cheese mass thus produced and moulding it to obtain the desired cheese wheels (Pressing, page 307);
- salting said cheese wheels (brine salting, page 310); and
- maturing said cheese wheels (Ripening and storage of cheese, page 314); and
- addition of cream recovered from the separating step to bring the skimmed milk with spores removed to a fat content of 3% to obtain milk with spores removed (see standardisation, page 204).
Since Krabsen is directed to preparing raw milk for cheese making, it would have been obvious to one of ordinary skill in the art to further process the milk into cheese using the process taught by Bylund.
While Bylund provides a starter (Starter addition, page 300), the combination is silent to specifically using whey starters. Hynes is relied on to teach a step of reusing whey, from a previous process of cheese making, as a natural whey starter (“In this way, the supply of whey starter cultures is readily available from the whey of the previous cheesemaking day” page 3832, left column, line 6-9) which contributes certain flavor and aroma to the final product (page 3832, left column, second paragraph). Therefore, it would have been obvious to use whey starter as a starter for cheesemaking based on the desired flavor and aroma contributed by the natural whey starter.
As to wherein the step of checking the percentage of the fat fraction present in said at least semi-skimmed milk comprises titration of the skimmed milk with spores removed, delivered from the bactofugation process, the combination does not teach a step of “titration”; however, since the claimed step is simply to check the percentage of the fat fraction and does not physically or chemically modify the skimmed milk with spores removed, the specific method of checking the percentage of the fat fraction is not patentable over the prior art since the prior art is also concerned with monitoring the fat content of the milk to achieve a standardized milk. That is, it would have been obvious to one of ordinary skill in the art to use any known method of checking the fat content of milk to determine the adjustments needed to standardize the milk.
Regarding Claims 2 and 3, Krabsen is silent to wherein said bactofugation comprises two stages in succession, at a temperature of 35°C, to eliminate at least 98% of spores and bacteria from said skimmed milk and obtain milk with spores removed (Claim 2), and wherein the pre-heating step brings the temperature of the raw milk to 35°C (Claim 3). Bylund is relied on to teach known processes of bactofugation comprising two phase bactofuge (see page 293) which reduces spores by 98% (see 1. Two-phase Bactofuge with continuous discharge of bactofugate, page 293-294). While Bylund does not disclose the operating temperature of 35°C, Krabsen discloses operating the separating step at a temperature of 45°C which is construed to be close to the claimed 35°C. Generally, differences in concentration or 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In this case, since both Krabsen and Bylund achieves a process of separating raw milk and reducing the bacterial spores from the separated milk, the claimed pre-heat temperature is not seen to provide a patentable distinction over the prior art, absent a showing of criticality over the claimed temperature.
Regarding Claim 4, both Krabsen and Bylund discloses a step of subjecting milk to bactofugation to reduce bacterial spores. The combination does not specifically subject the cream phase of the separated raw milk to bactofugation; however, since both Krabsen and Bylund recognizes the advantages of bactogfugation (see 1. Two-phase Bactofuge with continuous discharge of bactofugate, page 293-294) and Krabsen already discloses a step of sterilizing cream (Col. 3, ln. 47-52), it would have been obvious to one of ordinary skill in the art to duplicate the steps of bactofugation on the cream phase for the purpose of reducing the bacterial spores of the cream.
Regarding Claim 5, Krabsen further teaches a step of cooling to 2°C to 10°C after the standardizing step (see Col. 3, ln. 60-63). While the combination does not specifically recite the cooling step prior to the step of checking, since the step of “checking” does not physically or chemically change the milk, it is noted that the selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results. In re Burhans, 154 F.2d 690, 69 USPQ 330 (CCPA 1946).
Regarding Claim 6, the combination does not specifically recite preheating the titrated milk with spores removed to a temperature of 37°C; however, Bylund discloses an optimal temperature for starter culture in cheesemaking in a range of 20 and 40°C (Additives in cheesemilk, page 296). Therefore, it would have been obvious to one of ordinary skill in the art to pre-heat the milk to temperatures between 20-40°C prior to adding rennet and starter to provide an optimal environment for the starter culture.
Regarding Claim 7, Bylund further teaches wherein said step of adding rennet to said at least semi-skimmed milk comprises the step of providing a plant-derived microbial rennet (Substitutes for animal rennet, page 299).
Regarding Claim 8, Bylund further teaches wherein said step of salting is carried out in saturated brine solutions for 7 days (page 317, second to last paragraph).
Regarding Claim 9, the combination discloses a matured hard cheese obtainable with the process according to claim 1 (Emmenthal, page 317 of Bylund).
Regarding Claim 10, the combination is silent to requiring preservatives; therefore, the combination is construed to suggests cheese that is free of preservative.
Regarding Claim 11, Bylund further teaches comprising plant-derived microbial rennet (Substitutes for animal rennet, page 299).
Regarding Claim 12, Bylund further teaches comprising 1.2% salt (Emmenthal, table 14.3, page 313).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANH H NGUYEN whose telephone number is (571)270-0346. The examiner can normally be reached 10am-6pm.
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, Erik Kashnikow can be reached at 571-270-3475. 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.
/T.H.N/Examiner, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
Prosecution Insights