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 .
Election/Restrictions
Applicant's election with traverse of Group I, claims 1-13 in the reply filed on 4/28/2025 is acknowledged. The traversal is on the ground(s) that applicant feels that there is no other way to produce the claimed invention. This is not found persuasive because clearly through genetic engineering other ways can be used to produce the claimed invention.
Therefore, claims 14-20 are withdrawn from further consideration by the Examiner as being drawn to non-elected inventions.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claims 1-3, 5, 9-11, 21-30 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 1 is still confusing, indefinite and vague. It is impossible to quantify the amount of unsaturated and saturated lipids in the claimed composition since chocolate has both of these in them. How does one of ordinary skill in the art factor that in when calculating the fat content in the ”composition”? Therefore, the amounts to unsaturated fat and saturated fat are meaningless since they are inherently in chocolate.
What does “final selected serving size and form” mean? The claims are to a product which by definition is final.
The language, “and is free of any chocolate flavoring other than the chocolate component” is totally confusing. How does one even start to understand how to quantify this? This is even more evidence that the amounts are meaningless and carry no patentable weight because they are impossible to actually quantify.
It is noted that, “less than 0.25%” reads on zero. It is confusing what “substantially homogenous” means. It either is or it is not.
It is also noted that “palm oil” is in both of components C and D of claim 1, making the amounts even more confusing, vague and meaningless.
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 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.
Claims 1-3, 5, 9-11, 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over CA 3089910 (same as WO 2019/153070).
CA teaches a dough composition suitable for a ketogenic diet, see abstract, table 8. The composition contains psyllium powder in an amount of 0%-30%, coconut oil (0-40%), chocolate chip (which inherently contains saturated fat and unsaturated fat, 0-10%), and chia seeds (0-20%), see table 8.
CA does not teach the exact amounts of the components of the composition as claimed, that the psyllium does not absorb more than about 33% of its water holding capacity, that the psyllium has a mesh size value of at least 33, that the composition contains less than 1 wt. % water, that the composition does not contain glycerin, and that the texturizing element has a density of at least about 0.2 g/cm3 (g/cc).
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
It would have been obvious to one of ordinary skill in the art to prepare a psyllium containing composition and to modify the amounts of psyllium, the chocolate component, coconut oil, chia seeds, because these are all result effective variables (as shown in table 8) at the time the invention was made. Clearly being in table 8, they are important components and clearly are result effective variables since they are very clearly identified to be in the composition of CA.
The ordinary artisan would have understood to include and adjust the amount of psyllium, coconut oil, chocolate, chia seeds, with the expectation of success and to modify the amount of the other components to provide the instantly claimed ratios of ingredients and to provide psyllium in the claimed amounts. Therefore, an ordinary artisan would have been motivated to use the claimed amounts of psyllium, coconut oil, chocolate and chia seeds to provide a psyllium composition for managing regularity and dietary matters based upon the beneficial teachings of CA.
Therefore, clearly the psyllium, chocolate, unsaturated fat, saturated fat, grain based texturizing element are result effective variables and to use them at the claimed amounts is merely a choice of the ordinary artisan in an effort to optimize the desired results.
It also would have been obvious to one having ordinary skill in the art that the psyllium does not absorb more than about 33% of its water holding capacity, absent evidence to the contrary, especially since it is not clear what the 33% is in relation to, thus making the limitation meaningless, that the psyllium has a mesh size value of at least 33 (whatever that means), absent evidence to the contrary, that the composition contains less than 1 wt. % water, since chocolate, psyllium, chia seeds are ALL dry, that the composition does not contain glycerin, since glycerin is never mentioned, and that the texturizing element has a density of at least about 0.2 g/cm3 (g/cc), absent evidence to the contrary and since inherently the chia seeds will have this density because they are chia seeds clearly indicated in CA.
It also would have been obvious to one of ordinary skill in the art to use cocoa butter since that is routinely used by one of ordinary skill in the art to make chocolate.
Applicant argues that allegedly the dough compositions in CA are not “finished”. While this is interesting, it is not clear what this means? The composition of CA can be seen as finished.
Applicant argues that the claims exclude water which they do not since claim 1 still allows for less than 1% water which is still water, thus the argument is moot.
Applicant next states that there is no emulsion ingredient which is not true since acacia gum (which is an emulsifier) is taught, see paragraph 4.
Applicant next argues that CA allegedly does not claim the amount of total unsaturated lipid and total saturated lipid. While this is noted, it is also noted that the amount of total unsaturated lipid and total saturated lipids is confusing and hard to determine or quantify since they are both in chocolate. Therefore, the amounts of chocolate, total unsaturated lipid and total saturated lipids are very hard to determine.
Applicant argues that allegedly the reduction of psyllium hydration element is not taught by CA. This has already been addressed on the record. Such a property, is inherent to the psyllium.
The water content in CA can be 0%, see Table 6.
Dr. Lang’s declaration and that of Mr. Gouleete and Mr. Hirt have been carefully considered.
Dr. Lang argues that allegedly the dough compositions in CA are not “finished”. While this is interesting, it is not clear what this means? The composition of CA can be seen as finished.
CA according to Dr. Lang does not include an emulsion which is incorrect, as noted above.
It is also noted that “palm oil” is in both of components C and D of claim 1, making the amounts even more confusing, vague and meaningless.
Claims 1-3, 5, 9-11, 21-30 are rejected under 35 U.S.C. 103 as being unpatentable over Ervin (US 2010/0278981).
Ervin teaches a composition suitable for controlling food cravings, see abstract, paragraphs 17, 30-45, 88-91, 93, the examples and the claims. The composition contains psyllium, coconut oil, chocolate (which inherently contains saturated fat and unsaturated fat), and chia seeds, see paragraphs 17, 30-45, 88-91, 93, the examples and the claims.
Ervin does not teach the exact amounts of the components of the composition as claimed, that the psyllium does not absorb more than about 33% of its water holding capacity, that the psyllium has a mesh size value of at least 33, that the composition contains less than 1 wt. % water, that the composition does not contain glycerin, and that the texturizing element has a density of at least about 0.2 g/cm3 (g/cc).
MPEP 2144.05, subsection II.
II. ROUTINE OPTIMIZATION
A. Optimization Within Prior Art Conditions or Through Routine Experimentation
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) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 ("The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages."); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997); Smith v. Nichols, 88 U.S. 112, 118-19 (1874) (a change in form, proportions, or degree "will not sustain a patent"); In re Williams, 36 F.2d 436, 438 (CCPA 1929) ("It is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions."). See also KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (identifying "the need for caution in granting a patent based on the combination of elements found in the prior art.").
B. There Must Be an Articulated Rationale Supporting the Rejection
In order to properly support a rejection on the basis that an invention is the result of "routine optimization", the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017 ("Absent some articulated rationale, a finding that a combination of prior art would have been ‘common sense’ or ‘intuitive’ is no different than merely stating the combination ‘would have been obvious.’"); Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362, 119 USPQ2d 1822 (Fed. Cir. 2016) ("[R]eferences to ‘common sense’ … cannot be used as a wholesale substitute for reasoned analysis and evidentiary support … .").
The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘[o]bvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under §103."). Thus, after KSR, the presence of a known result-effective variable would be one, but not the only, motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
It would have been obvious to one of ordinary skill in the art to prepare a psyllium containing composition and to modify the amounts of psyllium, the chocolate component, coconut oil, chia seeds, because these were all result effective variables at the time the invention was made. Note chocolate used at 56% in paragraph 31, protein crisps used at 15% in paragraph 42, coconut oil used at 3 % in paragraph 42 but it is impossible to determine the actual amount of coconut oil in the claims since they are only part of the saturated and unsaturated fats which are also impossible to determine since they are both in the chocolate, and psyllium used as a fiber at 15%, see paragraph 44.
It would have been obvious for the ordinary artisan to include and adjust the amount of psyllium, coconut oil, chocolate, chia seeds (or protein crisps), with the expectation of success and to modify the amount of the other components to provide the instantly claimed ratios of ingredients and to provide psyllium in the claimed amounts. Therefore, an ordinary artisan would have been motivated to use the claimed amounts of psyllium, coconut oil, chocolate and chia seeds to provide a psyllium composition for managing regularity and dietary matters based upon the beneficial teachings of Ervin.
Therefore, clearly the psyllium, chocolate, unsaturated fat, saturated fat, grain based texturizing element are result effective variables and to use them at the claimed amounts is merely a choice of the ordinary artisan in an effort to optimize the desired results.
It also would have been obvious to one having ordinary skill in the art that the psyllium does not absorb more than about 33% of its water holding capacity, absent evidence to the contrary, especially since it is not clear what the 33% is in relation to, thus making the limitation meaningless, that the psyllium has a mesh size value of at least 33 (whatever that means), absent evidence to the contrary, that the composition contains less than 1 wt. % water, since chocolate, psyllium, chia seeds are ALL dry, that the composition does not contain glycerin, since glycerin is never mentioned, and that the texturizing element has a density of at least about 0.2 g/cm3 (g/cc), absent evidence to the contrary and since inherently the chia seeds will have this density because they are chia seeds clearly indicated in Ervin.
It also would have been obvious to one of ordinary skill in the art to use cocoa butter since that is routinely used by one of ordinary skill in the art to make chocolate.
Applicant argues that allegedly Ervin teaches water but applicant’s claims still allow for less than 1% water, thus the argument is moot.
Applicant argues that allegedly the reduction of psyllium hydration element is not taught by CA. This has already been addressed on the record. Such a property, is inherent to the psyllium.
An emulsifier is taught in claim 23 of Ervin.
Dr. Lang’s declaration and that of Mr. Gouleete and Mr. Hirt have been carefully considered.
Lang argues that allegedly Ervin does disclose high fiber compositions comprising an emulsion component but does not exclude water but it is noted that the claimed invention also does not exclude water.
Applicant argues that there is glycerin in Ervin but this cannot be found.
It is also noted that “palm oil” is in both of components C and D of claim 1, making the amounts even more confusing, vague and meaningless.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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, Anand Desai can be reached at 571-272-0947. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/Primary Examiner, Art Unit 1655
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