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 .
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 6-7, 10-11, 21-22 and 24-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dimitrijevic et al (WO 2012/028928 A2) in view of Li et al (Inhibition of Clostridium perfringens Spore Germination and Outgrowth by Lemon Juice and Vinegar Product in Reduced NaCl Roast Beef) and Ballard et al (US 20190261662 A1).
Klont et al (Influence of Ultimate pH on Meat Quality and Consumer Purchasing Decisions) is relied upon as evidence of the meat pH as discussed below.
Independent claim 1 recites the following limitations:
A process for reducing or inhibiting the growth of clostridium in a food product selected from an emulsified sausage product having about 1 % or more fat by weight of the food product and/or has a pH of about 4 or more, wherein the process comprises adding:
vinegar comprising acetic acid, and
rosemary extract comprising a mixture of carnosic acid and carnosol, and
ascorbic acid to the food product,
wherein the ratio between acetic acid, ascorbic acid, and the mixture of carnosic acid and carnosol is from 94:3:3 to 20:40:40, and wherein the product is heated.
In regard to claim 1, Dimitrijevic et al discloses:
A method of protecting the colour of meat and meat products comprising the step of contacting the meat or the meat product with a composition comprising an acerola extract is provided. The composition may further comprise an extract of a plant of the Labiatae family, which may be rosemary, or beetroot extract or a combination thereof (Abstract).
[0003] Meat and meat products are subjected to colour change, microbiological decay and fat oxidation, which result in a changed taste, smell and colour. They also lose their nutritional value. In order to prevent or reduce the decay process, various synthetic additives are used as antioxidative and/or microbiological agents. These synthetic additives are ascorbic acid and salts thereof, isoascorbic acid and salts thereof, sodium acetate and others.
[0006] In an embodiment of the invention, there is provided a method of protecting the colour of meat and meat products comprising the step of contacting the meat or the meat product with a composition comprising an acerola extract.
[0007] In some embodiments of the invention, the composition includes ascorbic acid in an amount of between 0.01-30 wt% optionally between 15-25 wt%.
[0008] In some embodiments of the invention, the composition further comprises an extract of a plant of the Labiatae family, which may be rosemary.
[0009] In some embodiments of the invention, the amount of rosmarinic acid in the composition is between 0.01 wt% to 50 wt% optionally between 0.5 wt% to 5 wt%.
[00010] In some embodiments of the invention, the amount of carnosic acid in the composition is between 0.01 wt% to 50 wt% optionally between 0.5 wt% to 5 wt%.
[00014] According to some embodiments of the invention, there is provided a method of preventing oxidation and/or microbial spoilage of meat and meat products comprising the step of contacting the meat or the meat product with a composition comprising acerola extract and rosemary extract or beetroot extract or a combination of rosemary extract or beetroot extract.
[00017] In some embodiments of the invention, the composition of the invention comprises 0.1-30 % of ascorbic acid and 0-50 wt% of carnosic acid and/or 0-50 wl% of rosmarinic acid and/or 0-5 wt% of betanin and/or 0-20 wt% of anthocyanins.
Therefore, Dimitrijevic et al discloses meat and meat products undergo microbiological decay and fat oxidation, which has a negative effect on taste, smell and color ([0003]). Dimitrijevic et al discloses that there is a need in compositions containing natural ingredients capable of maintaining desired color of meat and also having antioxidative and/or antimicrobiological properties ([0005]).
In regard to claim 1 and 29, Dimitrijevic et al discloses the composition containing 0.1-30 % of ascorbic acid and 0-50 wt% of carnosic acid and/or 0-50 wl% of rosmarinic acid is applied to meat products ([00014], [00017).
Dimitrijevic et al discloses addition of citric to the composition as discussed above ([00047]). Dimitrijevic et al discloses addition of ascorbic acid to the food product ([0006] , [00017] , [00018] , [00020] , [00024] , [00025] , [00039] , [00041], [00042], Examples, etc).
In regard to the meat product Dimitrijevic et al discloses sausages and frankfurters prepared from meat emulsions ([00085]).
In regard to the fat content recitation in claims 1, 6 and 27, Dimitrijevic et al discloses meat product having more than 1% fat content:
[00085] The following ingredients were used to prepare meat emulsions, which in turn were used to prepare sausages and frankfurters: 45% pork meat (30 % shoulder, 15 % meat with cca 15 % fat), 25 % fat, 25 % ice/water, 2 % nitrite or vacuum salt and 0.3 % phosphates.
In regard to the recitation of controlling microbial growth, Dimitrijevic et al discloses:
[00044] According to some embodiments of the invention, the composition is characterized by antioxidation properties.
[00045] According to some embodiments of the invention, the composition is characterized by antimicrobial properties.
In regard to claim 1, Dimitrijevic et al teaches heating the food product ([0086], [0087]).
Claim 1 further recites the optional limitation of the meat product having pH of 4 or more. According to the Klont et al (Influence of Ultimate pH on Meat Quality and Consumer Purchasing Decisions), the pH of meat can range from 5.2 to 7, with the highest quality products tending to fall in the pH range of 5.7 to 6.0. Therefore, the pH of the meat products as disclosed by Dimitrijevic et al meets the limitations of claim 1. It is further noted that the pH limitation is optional.
In summary, Dimitrijevic et al discloses a process for controlling microbial growth in a food product selected from emulsified sausage having about 1% or more fat by weight of the food product and/or has a pH of about 4 or more, wherein the process comprises the addition of a composition that comprises 0.1-30 % of ascorbic acid and 0-50 wt% of carnosic acid and/or 0-50 wl% of rosmarinic acid.
Dimitrijevic et al does not disclose addition of vinegar in combination with a rosemary extract comprising a mixture of carnosic acid and carnosol and ascorbic acid. Dimitrijevic et al discloses addition of citric acid to the composition containing rosemary extract and ascorbic acid ([00047]).
Li et al discloses evaluating inhibition of Clostridium perfringens spore germination and outgrowth in reduced sodium roast beef by a blend of buffered lemon juice concentrate and vinegar (MoStatin LV1) during abusive exponential cooling (Abstract). Li et al discloses:
Cooked, ready-to-eat meat products should be cooled rapidly to reduce the risk of Clostridium perfringens spore germination and outgrowth. Meat processors are reducing the sodium chloride content of the processed meats as a consequence of the dietary recommendations. Sodium chloride reduces the risk of C. perfringens spore germination and outgrowth in meat products. Antimicrobials that contribute minimally to the sodium content of the product should be incorporated into processed meats to assure food safety. Buffered lemon juice and vinegar can be incorporated into meat product formulations to reduce the risk of C. perfringens spore germination and outgrowth during abusive cooling (page M598).
Lemon juice and vinegar, the natural source of citric acid and acetic acid, respectively, are likely to have inhibitory effect on the growth of C. perfringens according to previous studies on organic acid salts (Juneja and Thippareddi 2003; Velugoti and others 2007).However, their juices cannot be used in meat and poultry products because of the accompanying undesirable organoleptic property changes and protein denaturation resulting in reduced binding of meat matrix. Nevertheless, buffered counterparts of organic acids or their salts can be used with minimal impact on meat quality (page M599).
... blend of lemon juice concentrate and vinegar (MoStatin LV1; Iso age Technologies, Athens, Ga., U.S.A.) at concentrations of 0%, 2.0%, and2.5% were dissolved in water and added to the raw beef (page M599).
Sodium chloride is widely used in processed meat as flavor enhancer and as an antimicrobial agent. In this study, 2% NaCl effectively prevented the germination and outgrowth of C. perfringens spores in ground, roast beef within 9 h of (abusive) cooling. Reducing sodium concentration in the roast beef resulted in greater increases (P ≤ 0.05) in C. perfringens population. The blend of buffered lemon juice concentrate and vinegar was effective in controlling germination and outgrowth of C. perfringens spores in ground roast beef during abusive cooling times regardless of NaCl content (page M602).
Li et al discloses that the blend of buffered lemon juice concentrate and vinegar was effective in controlling germination and outgrowth of C. perfringens spores in ground roast beef
Both references are directed to the compositions containing citric acid intended for meat treatment in order to maintain microbial stability. Dimitrijevic et al discloses the composition comprising rosemary extract and ascorbic acid in combination with citric acid is applied to meat to maintain microbial stability of the meat product. Dimitrijevic et al discloses that such composition may further contain acids. Li et al discloses that the blend of buffered lemon juice concentrate and vinegar was effective in controlling germination and outgrowth of C. perfringens spores in ground roast beef. One of ordinary skill in the art would have been motivated to combine prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to include buffered vinegar in the composition containing rosemary and ascorbic acid. The result of such combination is predictable. All the elements of the combination lead to the same predictable result of microbial stability.
Ballard et al is further relied upon as a teaching of addition of vinegar in combination with ascorbic acid from Acerola juice and rosemary extract to the meat product to obtain an “all-natural hot dog” ([0006], [0016], [0019], [0020], [0022], [0025], [0029], [0030], claims 1, 3, 11, 13, 19 and 20).
In regard to claims 1, 26 and 29, Li et al discloses that blend of lemon juice concentrate and vinegar (MoStatin LV1; Iso age Technologies, Athens, Ga., U.S.A.) at concentrations of 0%, 2.0%, and2.5% were dissolved in water and added to the raw beef (page M599).
Dimitrijevic et al discloses the following composition:
[00017] In some embodiments of the invention, the composition of the invention comprises 0.1-30 % of ascorbic acid and 0-50 wt% of carnosic acid and/or 0-50 wl% of rosmarinic acid and/or 0-5 wt% of betanin and/or 0-20 wt% of anthocyanins.
One of ordinary skill in the art would have been motivated to vary the amount of vinegar based on the desired Clostridium perfringens inhibiting effect and microbial stability of the meat product.
Further in regard to the concentration recitations, it is noted that:
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) (MPEP 2144.05, II A).
In regard to claim 6, Dimitrijevic et al teaches:
[00085] The following ingredients were used to prepare meat emulsions, which in turn were used to prepare sausages and frankfurters: 45% pork meat (30 % shoulder, 15 % meat with cca 15 % fat), 25 % fat, 25 % ice/water, 2 % nitrite or vacuum salt and 0.3 % phosphates.
In regard to claim 7, Li et al teaches buffered vinegar:
Nevertheless, buffered counterparts of organic acids or their salts can be used with minimal impact on meat quality (page M599).
In regard to claim 10, Dimitrijevic et al discloses:
[00086] The sausages emulsions were prepared by mixing the ingredients in a food processor machine and placing the prepared emulsions in polyamide casings (diameter 60 mm). Once the casings were filled they were cooked in water at 80°C for 45 minutes (till core temperature 72-74°C) and cooled in ice water for 30 minutes.
[00087] The same emulsions were used for preparing the frankfurters; however, the emulsions were placed in natural lamb casings (diameter 22-24 mm). Once the casings were filled, they were cooked in water at 80°C for 20 minutes (till core temperature 72-74°C) and cooled in ice water 15 minutes.
Further in regard to the concentration and pH recitations, it is noted that:
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) (MPEP 2144.05, II A).
In regard to claim 11, Dimitrijevic et al is silent as to the L*, a* or b* values. Further in this regard, it is noted that although the reference does not specifically disclose every possible quantification or characteristic of its product, these characteristics would have been expected to be as claimed absent any clear and convincing evidence and/or arguments to the contrary. The references discloses the same starting materials and methods as instantly (both broadly and more specifically) claimed, and thus one of ordinary skill in the art would recognize that the reduced growth of listeria, clostridium or salmonella, and L*, a* or b* values among many other characteristics of the product obtained by referenced method, would have been an inherent result of the process disclosed therein. The Patent Office does not possess the facilities to make and test the referenced method and product obtain by such method, and as reasonable reading of the teachings of the references has been applied to establish the case of obviousness, the burden thus shifts to applicant to demonstrate otherwise.
In regard to claim 21, Dimitrijevic et al discloses:
[00011] In some embodiments of the invention, the composition further comprises beetroot extract or anthocyanins derived from a natural source. The amount of betanin or the anthocyanins in the composition is, in some embodiments, between 0.05-10 wt%.
[00012] In some embodiments of the invention, the composition further comprises beetroot extract or anthocyanins derived from a natural source. In some embodiments of the invention, the amount of the betanin or the anthocyanins in the composition is between 0.05-10 wt%.
[00017] In some embodiments of the invention, the composition of the invention comprises 0.1-30 % of ascorbic acid and 0-50 wt% of carnosic acid and/or 0-50 wl% of rosmarinic acid and/or 0-5 wt% of betanin and/or 0-20 wt% of anthocyanins.
[00018] In some embodiments of the invention, there is provided a composition comprising 17-30 wP/o of ascorbic acid and 0-2 wl% of carnosic acid and/or 0-2 wt% of rosmarinic acid and/or 0-0.20 wt% of betanin and/or anthocyanins.
[00019] In some embodiments of the invention, there is provided a composition comprising a rosemary extract, acerola extract and beetroot extract, wherein the beetroot extract is stabilised by an addition of EDTA and/or paprika oleoresin and/or acerola extract. The final concentration of active components in the composition is optionally 0.5-2.00wt. % of rosmarinic acid and/or 10-20 wt. % of ascorbic acid and/or 0.1-1.0 wt. % of EDTA and/or 0.2-3.00 wt. % of paprika oleoresin and/or 0.01- 0.6 wt. % of betanin.
[00020] In some embodiments of the invention, the final concentration of active components in the composition is 1.00 wt. % of rosmarinic acid and/or 15.50 wt. % of ascorbic acid and/or 0.36 wt. % of EDTA and/or 0.86 wt. % of paprika oleoresin and/or 0.11wt. % of betanin.
[00021] According to some embodiments of the invention, the total concentration of the ascorbic acid and/or carnosic acid and/or rosmarinic acid and/or betanin and/or anthocyanins in the meat or meat product after the administration of the composition is at least 1 ppm.
In regard to claim 22, Dimitrijevic et al discloses betanin from beetroot extract
[00034] In some embodiments of the invention, the composition including the beetroot extract comprises betanin.
Beetroot is Beta vulgaris plant. Hence, Dimitrijevic et al meets the limitation of claim 22.
In regard to claim 24, Dimitrijevic et al discloses that the main antioxidative active ingredient in the acerola extract is ascorbic acid. ( [0002] ). Dimitrijevic et al discloses using acerola extract as a source of ascorbic acid ([0006], [00014] , [00015] , [00018], Examples).
In regard to claim 25, Dimitrijevic et al discloses addition of natural ingredients that do not require addition of nitrite.
In regard to claim 28, it is noted that although the reference does not specifically disclose every possible quantification or characteristic of its product, these characteristics would have been expected to be as claimed absent any clear and convincing evidence and/or arguments to the contrary. The references discloses the same starting materials and methods as instantly (both broadly and more specifically) claimed, and thus one of ordinary skill in the art would recognize that the lack of Clostridium botulinum among many other characteristics of the product obtained by referenced method, would have been an inherent result of the process disclosed therein. The Patent Office does not possess the facilities to make and test the referenced method and product obtain by such method, and as reasonable reading of the teachings of the references has been applied to establish the case of obviousness, the burden thus shifts to applicant to demonstrate otherwise.
Response to Arguments
Applicant's arguments filed March 27, 2026 have been fully considered but they are not persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Dimitrijevic et al is not relied upon as a teaching of vinegar. Li et al and Ballard et al are relied upon as a teaching of vinegar. As stated in the rejection above, Li et al discloses evaluating inhibition of Clostridium perfringens spore germination and outgrowth in reduced sodium roast beef by a blend of buffered lemon juice concentrate and vinegar (MoStatin LV1) during abusive exponential cooling (Abstract). Li et al discloses:
Cooked, ready-to-eat meat products should be cooled rapidly to reduce the risk of Clostridium perfringens spore germination and outgrowth. Meat processors are reducing the sodium chloride content of the processed meats as a consequence of the dietary recommendations. Sodium chloride reduces the risk of C. perfringens spore germination and outgrowth in meat products. Antimicrobials that contribute minimally to the sodium content of the product should be incorporated into processed meats to assure food safety. Buffered lemon juice and vinegar can be incorporated into meat product formulations to reduce the risk of C. perfringens spore germination and outgrowth during abusive cooling (page M598).
Lemon juice and vinegar, the natural source of citric acid and acetic acid, respectively, are likely to have inhibitory effect on the growth of C. perfringens according to previous studies on organic acid salts (Juneja and Thippareddi 2003; Velugoti and others 2007).However, their juices cannot be used in meat and poultry products because of the accompanying undesirable organoleptic property changes and protein denaturation resulting in reduced binding of meat matrix. Nevertheless, buffered counterparts of organic acids or their salts can be used with minimal impact on meat quality (page M599).
... blend of lemon juice concentrate and vinegar (MoStatin LV1; Iso age Technologies, Athens, Ga., U.S.A.) at concentrations of 0%, 2.0%, and2.5% were dissolved in water and added to the raw beef (page M599).
Sodium chloride is widely used in processed meat as flavor enhancer and as an antimicrobial agent. In this study, 2% NaCl effectively prevented the germination and outgrowth of C. perfringens spores in ground, roast beef within 9 h of (abusive) cooling. Reducing sodium concentration in the roast beef resulted in greater increases (P ≤ 0.05) in C. perfringens population. The blend of buffered lemon juice concentrate and vinegar was effective in controlling germination and outgrowth of C. perfringens spores in ground roast beef during abusive cooling times regardless of NaCl content (page M602).
Li et al discloses that the blend of buffered lemon juice concentrate and vinegar was effective in controlling germination and outgrowth of C. perfringens spores in ground roast beef. Ballard et al is further relied upon as a teaching of addition of vinegar in combination with ascorbic acid from Acerola juice and rosemary extract to the meat product to obtain an “all-natural hot dog” ([0006], [0016], [0019], [0020], [0022], [0025], [0029], [0030], claims 1, 3, 11, 13, 19 and 20).
In response to applicant's argument that Li et al is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, both references are directed to the compositions containing citric acid intended for meat treatment in order to maintain microbial stability. Dimitrijevic et al discloses the composition comprising rosemary extract and ascorbic acid in combination with citric acid is applied to meat to maintain microbial stability of the meat product. Dimitrijevic et al discloses that such composition may further contain acids. Li et al discloses that the blend of buffered lemon juice concentrate and vinegar was effective in controlling germination and outgrowth of C. perfringens spores in ground roast beef. One of ordinary skill in the art would have been motivated to combine prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to include buffered vinegar in the composition containing rosemary and ascorbic acid. The result of such combination is predictable. All the elements of the combination lead to the same predictable result of microbial stability.
In response to Applicant’s arguments regarding the ranges of ratios of composition ingredients, Li et al discloses that blend of lemon juice concentrate and vinegar (MoStatin LV1; Iso age Technologies, Athens, Ga., U.S.A.) at concentrations of 0%, 2.0%, and2.5% were dissolved in water and added to the raw beef (page M599).
Dimitrijevic et al discloses the following composition:
[00017] In some embodiments of the invention, the composition of the invention comprises 0.1-30 % of ascorbic acid and 0-50 wt% of carnosic acid and/or 0-50 wl% of rosmarinic acid and/or 0-5 wt% of betanin and/or 0-20 wt% of anthocyanins.
One of ordinary skill in the art would have been motivated to vary the amount of vinegar, ascorbic acid and carnosol and /or carnosic acid based on the desired Clostridium perfringens inhibiting effect and microbial stability of the meat product.
Further in regard to the concentration recitations, it is noted that:
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) (MPEP 2144.05, II A).
In response to Applicant’s arguments regarding “experimental results at pages 45-51 of the present application”, it is noted that it is not clear how the “experimental results at pages 45-51 of the present application” demonstrate unexpected results.
Further in response to this argument, it is noted that Applicant’s limited data is not persuasive of unexpected results for multiple reasons. First, it compares the results to a Blend 2 (Rosemary Flavor 13.4% (6% carnosic acid), acerola juice powder 9.4% (with a content of ascorbic acid of 34%)) instead of the closest prior art. The improvement over the combination of carnosic acid and ascorbic acid would have been expected based on the prior art teaching. Thus, Applicant has not shown that the difference would have been unexpected. Second, the limited data does not show criticality at the ends of any of the claimed ranges. Further, no comparison is made to the closest prior art. Even if Appellant demonstrates a difference compared to the closest prior art, it is not enough that the results demonstrated are different, because they also must be shown to be unexpected. See In re Klosak, 455 F.2d 1077, 1080 (CCPA 1972) ("[I]t is not enough to show that results are obtained which differ from those obtained in the prior art: that difference must be shown to be an unexpected difference.") (emphasis omitted). Thus, if less trim content in the brine would be expected to result in a lower retention, such results would be expected rather than unexpected.
Applicants’ attention is further directed to the following passages in the MPEP:
Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense").
The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."); Ex parte C, 27 USPQ2d 1492 (Bd. Pat. App. & Inter. 1992) (Applicant alleged unexpected results with regard to the claimed soybean plant, however there was no basis for judging the practical significance of data with regard to maturity date, flowering date, flower color, or height of the plant.). See also In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977) and In re Eli Lilly, 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990) as discussed in MPEP § 716.02(c).
Evidence of unexpected properties may be in the form of a direct or indirect comparison of the claimed invention with the closest prior art which is commensurate in scope with the claims. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) and MPEP § 716.02(d) - § 716.02(e). See In re Blondel, 499 F.2d 1311, 1317, 182 USPQ 294, 298 (CCPA 1974) and In re Fouche, 439 F.2d 1237, 1241-42, 169 USPQ 429, 433 (CCPA 1971) for examples of cases where indirect comparative testing was found sufficient to rebut a prima facie case of obviousness.
Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).
Where the unexpected properties of a claimed invention are not shown to have a significance equal to or greater than the expected properties, the evidence of unexpected properties may not be sufficient to rebut the evidence of obviousness. In re Nolan, 553 F.2d 1261, 1267, 193 USPQ 641, 645 (CCPA 1977).
Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980).
An affidavit or declaration under 37 CFR 1.132 must compare the claimed subject matter with the closest prior art to be effective to rebut a prima facie case of obviousness. In re Burckel, 592 F.2d 1175, 201 USPQ 67 (CCPA 1979). "A comparison of the claimed invention with the disclosure of each cited reference to determine the number of claim limitations in common with each reference, bearing in mind the relative importance of particular limitations, will usually yield the closest single prior art reference." In re Merchant, 575 F.2d 865, 868, 197 USPQ 785, 787 (CCPA 1978) (emphasis in original). Where the comparison is not identical with the reference disclosure, deviations therefrom should be explained, In re Finley, 174 F.2d 130, 81 USPQ 383 (CCPA 1949), and if not explained should be noted and evaluated, and if significant, explanation should be required. In re Armstrong, 280 F.2d 132, 126 USPQ 281 (CCPA 1960) (deviations from example were inconsequential).
The totality of the record must be considered when determining whether a claimed invention would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, evidence and arguments directed to advantages not disclosed in the specification cannot be disregarded. In re Chu, 66 F.3d 292, 298-99, 36 USPQ2d 1089, 1094-95 (Fed. Cir. 1995) (Although the purported advantage of placement of a selective catalytic reduction catalyst in the bag retainer of an apparatus for controlling emissions was not disclosed in the specification, evidence and arguments rebutting the conclusion that such placement was a matter of "design choice" should have been considered as part of the totality of the record. "We have found no cases supporting the position that a patent applicant’s evidence or arguments traversing a § 103 rejection must be contained within the specification. There is no logical support for such a proposition as well, given that obviousness is determined by the totality of the record including, in some instances most significantly, the evidence and arguments proffered during the give-and-take of ex parte patent prosecution." 66 F.3d at 299, 36 USPQ2d at 1095.). See also In re Zenitz, 333 F.2d 924, 928, 142 USPQ 158, 161 (CCPA 1964) (evidence that claimed compound minimized side effects of hypotensive activity must be considered because this undisclosed property would inherently flow from disclosed use as tranquilizer); Ex parte Sasajima, 212 USPQ 103, 104 - 05 (Bd. App. 1981) (evidence relating to initially undisclosed relative toxicity of claimed pharmaceutical compound must be considered).
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 VERA STULII whose telephone number is (571)272-3221. The examiner can normally be reached Monday-Friday 5:30AM-3:30PM.
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/VERA STULII/Primary Examiner, Art Unit 1791
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