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 without traverse of Group I, claims 34-46, in the reply filed 6/26/2023, and in the election of species requirement, applicant stated that claims 34-43, 45 and 46 read upon the elected species.
Thus, claim 44 is withdrawn from further consideration by the Examiner as being drawn to a non-elected invention.
Therefore, the restriction/election is hereby made FINAL.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 34-43, 45, 46 and 54-67 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by KR 1020160015174 (of record).
KR teaches that Eragrostis extracts have antioxidant activity and are extracted using ethanol from the plant (Eragrostis), see entire reference, especially pages 2, 4, 6. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, KR teaches the claimed method since the Eragrostis is extracted with ethanol and the same extract will inherently have the same compounds in it (compound of Formula (I) and n-trans-feruloyltyramine-claim 46). Note carrier on page 6 (gel). Note oral administration with capsule or the drink (liquid) medicine, under “Description of the embodiments”. Note that all mammals are in need of improved digestive function in an effort to maintain optimal health. Inherently, the compound of Formula (I) comprises between 10 % to 99 % w/w of the oral composition.
Applicant argues that the pending claims do not recite an extract, which the KR reference allegedly teaches according to applicant.
KR does not provide evidence that a compound of Formula (1) is “necessarily and always” present, nor does it inevitably result between “10% to 99% w/w of the oral composition”, according to applicant.
This makes no sense on its face and is not agreed with by the examiner. As stated above, KR teaches that Eragrostis extracts have antioxidant activity and are extracted using ethanol from the plant (Eragrostis), see entire reference, especially pages 2, 4, 6. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, KR teaches the claimed method since the Eragrostis is extracted with ethanol and the same extract will inherently have the same compounds in it (compound of Formula (I) and n-trans-feruloyltyramine-claim 46).
Therefore, there will inherently be the same amount as the claimed amount of the claimed compound used in the method.
Applicant argues that allegedly the present application targets the regulation of gut permeability in mammals which reads on anyone thus clearly the claimed invention is still met by KR.
Applicant argues that allegedly KR does not teach significant levels of n-trans-feruloyltyramine but the claims do not require any amount of n-trans-feruloyltyramine thus it can read on ANY amounts.
Note that the carrier can be an excipient which clearly is taught in the reference.
Claim 34 states, “the compound of Formula (I) comprises between 10% to 99% w/w of the oral composition”. Applicant argues that this is not taught by KR, but the problem lies in the way that applicant has claimed it. The compound DOES NOT comprise the composition, the composition comprises the compound. Secondly, through applicant’s amendment the “oral composition” is now “an oral nutraceutical or dietary supplement in a dosage form for prolonged action”, so in fact, it’s not “an oral composition” but now “an oral nutraceutical or dietary supplement in a dosage form for prolonged action”. Whatever “prolonged action” means. In fact, this is a relative and subjective term thus meaning nothing.
Applicant argues that allegedly KR is directed to a pharmaceutical and food composition for providing antioxidant activity to prevent or treat diseases caused by oxidative stress, such as skin aging, pigmentation, skin cancer, and arteriosclerosis. Applicant argues that allegedly the entire focus of KR is on isolating total phenols and flavonoids to achieve this antioxidant effect. However, the pending claims are directed to a method of regulating gut permeability using 10-99% w/w of a specific compound of Formula (I) according to applicant.
Once again, “regulating gut permeability” reads on anyone since anyone is in need of regulating their gut permeability.
This compound is a tyramine-derived hydroxycinnamic acid amide, which KR ’174 does not isolate, quantify, or even disclose by name or structure according to applicant.
As already noted on the record, the compound is inherently in the “composition”. Applicant argues that this is not taught by KR, but the problem lies in the way that applicant has claimed it. The compound DOES NOT comprise the composition, the composition comprises the compound. Therefore, the whole limitation is confusing and thus is so vague and indefinite that the extract of KR still reads on the claimed invention.
Notably, the assertion that the compound of Formula (1) would be present in the claimed range of 10% to 99% w/w of the final oral composition is facially (sp?) contradicted by the data in KR ‘174, according to applicant. Table 3 of KR ’174 reports the total phenol and flavonoid content of its extracts according to applicant. For Eragrostis japonica, the most potent species identified, the total phenol content was only 10.63 mg/g (1.06%) and the total flavonoid content was a mere 2.83 mg/g (0.28%) of the dry weight of the extract according to applicant.
This is only one part out of many parts of KR. For example, on page 5, right column, it is stated that “the pharmaceutical composition according to the present invention, preferably, phenol and/or the flavonoid which is the active ingredient separated from the Eragrostis inside plant extract is included about the pharmaceutical composition total weight to 0.005 through 85 weight% with 0.0001 through 90 weight% and the pharmaceutical composition formulates in the form of the formulation or the injection liquid of the granule agent, refinement, capsule, cream, gel, patch, ointments, suspension, emulsion, syrup, the aerosol propellant (the aerosol etc.) and the formulation can be manufactured”.
Therefore, at least 10% is taught by KR.
According to applicant, it is speculative and factually unsupportable to suggest that a single, specific, and unmentioned compound within that extract would necessarily and always be present at a concentration of 10% to 99% of a final composition according to applicant. This concentration is an order of magnitude higher than the total amount of the classes of compounds KR ’174 was trying to isolate according to applicant. KR does not provide evidence of an extract comprising of a single compound of 10% or more according to applicant. The law is clear that inherency cannot be established by probabilities or possibilities but must be shown to be a necessary result of the disclosure according to applicant. Accordingly, an extract containing approximately 1% total phenols cannot inherently contain a single component at 10% or more according to applicant. For at least these reasons, KR ‘174 fails to disclose, either expressly or inherently, each and every limitation of the pending claims, particularly the specific compound of Formula (I) at the claimed concentration and its use for improving digestive health, according to applicant.
Claims 34-43, 45, 46 and 54-67 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Okombi et al. (US 2007/0183996-of record)
Okombi teaches that n-trans-feruloyltyramine can be found in Hibiscus and extracted using ethanol, see entire reference, especially paragraphs 16, 21, 131, 139. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, Okombi teaches the claimed method since the Hibiscus is extracted with ethanol and the same extract will inherently have the same compounds in it, namely the compound of Formula (I) and n-trans-feruloyltyramine. Note the carriers in paragraph 131, namely excipients, and tablet form which inherently is a pressed powder. Note that all mammals are in need of improved digestive function in an effort to maintain optimal health.
Applicant argues that allegedly Okombi is limited to topical use. Applicant state in their response that, “Example 41 of Okombi is directed to Tablets. However, pharmaceutical preparations of tablets for topical use is known in the art” as are topical being an interchangeable alternative mode of administration with oral in light of these arguments.
Applicant argues that allegedly Okombi does not teach the use of the claimed compound for gut permeability in a mammal which is nonsense since the claims read on anyone.
Applicant argues that allegedly Okombi does not teach significant levels of n-trans-feruloyltyramine but the claims do not require any amount of n-trans-feruloyltyramine thus it can read on ANY amounts.
Note that the carrier can be an excipient which clearly is taught in the reference.
According to applicant, this rejection mischaracterizes the explicit teachings of Okombi. Okombi is unambiguously directed to, and expressly limited to, cosmetic and dermatological compositions for topical application according to applicant. The title, abstract, and claims are all focused on using the disclosed compounds as depigmenting, free-radical-scavenging, or anti-inflammatory agents when applied to the skin according to applicant. The Examiner’s assertion that topical and oral administration are “interchangeable” is an improper generalization according to applicant. While Okombi mentions “tablets,” these are in the context of topical administration, and the Examiner’s assertion that topical and oral administration are interchangeable is unsupported by evidence and legally insufficient according to applicant. There is no express or inherent disclosure in Okombi to use the disclosed compounds for gut health, gut permeability regulation, or oral nutraceutical use according to applicant.
Fact is, the “tablets” of Okombi are just that, tablets which are well known to be orally administered. There is no way to topically administer a tablet, thus applicant’s arguments are moot.
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.
Claims 34-43, 45, 46 and 54-67 are rejected under 35 U.S.C. 103 as being unpatentable over KR 1020160015174.
KR teaches that Eragrostis extracts have antioxidant activity and are extracted using ethanol from the plant (Eragrostis), see entire reference, especially pages 2, 4, 6. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, KR teaches the claimed method since the Eragrostis is extracted with ethanol and the same extract will inherently have the same compounds in it (compound of Formula (I) and n-trans-feruloyltyramine-claim 46). Note carrier on page 6 (gel). Note oral administration with capsule or the drink (liquid) medicine, under “Description of the embodiments”. Note that all mammals are in need of improved digestive function in an effort to maintain optimal health.
In the event it is seen that the compound of Formula (I) does not inherently contain between 10 % to 99 % of the oral composition (which is NOT being admitted) then it would have been obvious to one having ordinary skill in the art to do so since 10 % to 99 % is a very broad range. Clearly, it would have been well within the purview of the ordinary artisan in an effort to optimize the desired results to use such an amount as the range of 10 % to 99 % is so broad and encompasses amounts which are routinely used in the art. Note that the compound of Formula (I) is clearly a results effective variable and it was clearly obvious at the time the invention was made for one of ordinary skill in the art to use an amount from such a broad range as claimed.
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.
Applicant argues that KR does not provide evidence that a compound of Formula (1) is “necessarily and always” present, nor does it inevitably result between “10% to 99% w/w of the oral composition”. But as evidenced by applicant themselves from their own specification as noted above, 10% to 99 % is an extremely broad range and in the very least was a result effective variable and would have been obvious to use the compound in the amount of the compound to use in the claimed method.
This makes no sense on its face and is not agreed with by the examiner. As stated above, KR teaches that Eragrostis extracts have antioxidant activity and are extracted using ethanol from the plant (Eragrostis), see entire reference, especially pages 2, 4, 6. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, KR teaches the claimed method since the Eragrostis is extracted with ethanol and the same extract will inherently have the same compounds in it (compound of Formula (I) and n-trans-feruloyltyramine-claim 46).
Therefore, there will inherently be the same amount as the claimed amount of the claimed compound used in the method or in the very least would have been obvious to use in an effort to optimize the desired results.
Applicant argues that allegedly the present application targets the regulation of gut permeability in mammals which reads on anyone thus clearly the claimed invention is still met by KR.
Clearly to use the claimed amounts in the very least would have been obvious to one having ordinary skill in the art in an effort to optimize the desired results since clearly the compound of Formula I is a result effective variable.
Applicant argues that allegedly KR does not teach significant levels of n-trans-feruloyltyramine but the claims do not require any amount of n-trans-feruloyltyramine thus it can read on ANY amounts.
Note that the carrier can be an excipient which clearly is taught in the reference.
The Examiner’s “routine optimization” argument fails because KR ’174 not only fails to disclose the compound of Formula (I), its data would not lead a one skilled in the art from the pending claims, according to applicant. KR ‘174 identifies that the total phenol content of its most promising extract is merely 1.06% of the dry weight according to applicant. One skilled in the art seeing that the entire class of phenolic compounds is present at such a low level, would have no reasonable expectation of success in isolating a single, unidentified compound from that class and concentrating it to a level at least ten times higher (i.e., 10% or more) for any purpose according to applicant. The data in KR ‘174 would discourage a POSA from pursuing such a path, as it suggests that no single compound could possibly be present in the high concentrations claimed according to applicant. Therefore, arriving at the claimed concentration would require more than routine optimization; it would require one to ignore the explicit quantitative teachings of the reference according to applicant. Furthermore, a person skilled in the art cannot routinely optimize a variable that has not been recognized in the art for the claimed purpose according to applicant. Since the compound of Formula (I) is absent from KR ’174, and the reference is silent as to the problem of digestive health, one skilled in the art would have had no starting point from which to conduct any “routine optimization” for regulating gut permeability according to applicant. There is simply no motivation in KR ’174 to optimize any compound claimed compound for this purpose according to applicant. One skilled in the art seeking to build upon KR ’174 would have been motivated to enhance its antioxidant effects for skin health, not to investigate an entirely new and unrelated utility in digestive health according to applicant. The fields of invention are different, and the therapeutic objectives are fundamentally different according to applicant.
This is only one part out of many parts of KR. For example, on page 5, right column, it is stated that “the pharmaceutical composition according to the present invention, preferably, phenol and/or the flavonoid which is the active ingredient separated from the Eragrostis inside plant extract is included about the pharmaceutical composition total weight to 0.005 through 85 weight% with 0.0001 through 90 weight% and the pharmaceutical composition formulates in the form of the formulation or the injection liquid of the granule agent, refinement, capsule, cream, gel, patch, ointments, suspension, emulsion, syrup, the aerosol propellant (the aerosol etc.) and the formulation can be manufactured”.
Therefore, at least 10% is taught by KR.
According to applicant, it is speculative and factually unsupportable to suggest that a single, specific, and unmentioned compound within that extract would necessarily and always be present at a concentration of 10% to 99% of a final composition according to applicant. This concentration is an order of magnitude higher than the total amount of the classes of compounds KR ’174 was trying to isolate according to applicant. KR does not provide evidence of an extract comprising of a single compound of 10% or more according to applicant. The law is clear that inherency cannot be established by probabilities or possibilities but must be shown to be a necessary result of the disclosure according to applicant. Accordingly, an extract containing approximately 1% total phenols cannot inherently contain a single component at 10% or more according to applicant. For at least these reasons, KR ‘174 fails to disclose, either expressly or inherently, each and every limitation of the pending claims, particularly the specific compound of Formula (I) at the claimed concentration and its use for improving digestive health, according to applicant.
Applicant argues that allegedly KR is directed to a pharmaceutical and food composition for providing antioxidant activity to prevent or treat diseases caused by oxidative stress, such as skin aging, pigmentation, skin cancer, and arteriosclerosis. Applicant argues that allegedly the entire focus of KR is on isolating total phenols and flavonoids to achieve this antioxidant effect. However, the pending claims are directed to a method of regulating gut permeability using 10-99% w/w of a specific compound of Formula (I) according to applicant.
Once again, “regulating gut permeability” reads on anyone since anyone is in need of regulating their gut permeability.
This compound is a tyramine-derived hydroxycinnamic acid amide, which KR ’174 does not isolate, quantify, or even disclose by name or structure according to applicant.
As already noted on the record, the compound is inherently in the “composition”. Applicant argues that this is not taught by KR, but the problem lies in the way that applicant has claimed it. The compound DOES NOT comprise the composition, the composition comprises the compound. Therefore, the whole limitation is confusing and thus is so vague and indefinite that the extract of KR still reads on the claimed invention.
Notably, the assertion that the compound of Formula (1) would be present in the claimed range of 10% to 99% w/w of the final oral composition is facially (sp?) contradicted by the data in KR ‘174, according to applicant. Table 3 of KR ’174 reports the total phenol and flavonoid content of its extracts according to applicant. For Eragrostis japonica, the most potent species identified, the total phenol content was only 10.63 mg/g (1.06%) and the total flavonoid content was a mere 2.83 mg/g (0.28%) of the dry weight of the extract according to applicant.
This is only one part out of many parts of KR. For example, on page 5, right column, it is stated that “the pharmaceutical composition according to the present invention, preferably, phenol and/or the flavonoid which is the active ingredient separated from the Eragrostis inside plant extract is included about the pharmaceutical composition total weight to 0.005 through 85 weight% with 0.0001 through 90 weight% and the pharmaceutical composition formulates in the form of the formulation or the injection liquid of the granule agent, refinement, capsule, cream, gel, patch, ointments, suspension, emulsion, syrup, the aerosol propellant (the aerosol etc.) and the formulation can be manufactured”.
Therefore, at least 10% is taught by KR.
According to applicant, it is speculative and factually unsupportable to suggest that a single, specific, and unmentioned compound within that extract would necessarily and always be present at a concentration of 10% to 99% of a final composition according to applicant. This concentration is an order of magnitude higher than the total amount of the classes of compounds KR ’174 was trying to isolate according to applicant. KR does not provide evidence of an extract comprising of a single compound of 10% or more according to applicant. The law is clear that inherency cannot be established by probabilities or possibilities but must be shown to be a necessary result of the disclosure according to applicant. Accordingly, an extract containing approximately 1% total phenols cannot inherently contain a single component at 10% or more according to applicant. For at least these reasons, KR ‘174 fails to disclose, either expressly or inherently, each and every limitation of the pending claims, particularly the specific compound of Formula (I) at the claimed concentration and its use for improving digestive health, according to applicant.
Claims 34-43, 45, 46 and 54-67 are rejected under 35 U.S.C. 103 as being unpatentable over Okombi et al. (US 2007/0183996)
Okombi teaches that n-trans-feruloyltyramine can be found in Hibiscus and extracted using ethanol, see entire reference, especially paragraphs 16, 21, 131, 139. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, Okombi teaches the claimed method since the Hibiscus is extracted with ethanol and the same extract will inherently have the same compounds in it, namely the compound of Formula (I) and n-trans-feruloyltyramine. Note the carriers in paragraph 131, namely excipients, and tablet form which inherently is a pressed powder. Note that all mammals are in need of improved digestive function in an effort to maintain optimal health.
In the event it is seen that the compound of Formula (I) does not inherently contain between 10 % to 99 % of the oral composition (which is NOT being admitted) then it would have been obvious to one having ordinary skill in the art to do so since 10 % to 99 % is a very broad range. Clearly, it would have been well within the purview of the ordinary artisan in an effort to optimize the desired results to use such an amount as the range of 10 % to 99 % is so broad and encompasses amounts which are routinely used in the art. Note that the compound of Formula (I) is clearly a results effective variable and it was clearly obvious at the time the invention was made for one of ordinary skill in the art to use an amount from such a broad range as claimed.
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.
Therefore, there will inherently be the same amount as the claimed amount of the claimed compound used in the method or in the very least would have been obvious to use in an effort to optimize the desired results.
Applicant argues that allegedly the claimed invention is used for a different purpose than that of Okombi but it doesn’t matter since the claimed invention is directed to “regulating gut permeability in a mammal” and “improving digestive function” which read on anyone thus anyone can be seen as reading on the claimed invention.
This makes no sense on its face and is not agreed with by the examiner. As stated above, Okombi teaches that Eragrostis extracts have antioxidant activity and are extracted using ethanol from the plant (Eragrostis), see entire reference, especially pages 2, 4, 6. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, Okombi teaches the claimed method since the Eragrostis is extracted with ethanol and the same extract will inherently have the same compounds in it (compound of Formula (I) and n-trans-feruloyltyramine-claim 46).
Therefore, there will inherently be the same amount as the claimed amount of the claimed compound used in the method or in the very least would have been obvious to use in an effort to optimize the desired results.
Okombi teaches that Eragrostis extracts have antioxidant activity and are extracted using ethanol from the plant (Eragrostis), see entire reference, especially pages 2, 4, 6. Applicant admits on the record in paragraphs 93-100 of the instant specification, that the claimed extract can be made by a simple extraction with ethanol. Thus, the claimed method is taught by the reference.
Applicant argues that allegedly Okombi does not teach the use of the claimed compound for gut permeability in a mammal which is nonsense since the claims read on anyone.
Clearly to use the claimed amounts in the very least would have been obvious to one having ordinary skill in the art in an effort to optimize the desired results since clearly the compound of Formula I is a result effective variable.
Applicant argues that allegedly Okombi does not teach significant levels of n-trans-feruloyltyramine but the claims do not require any amount of n-trans-feruloyltyramine thus it can read on ANY amounts.
Note that the carrier can be an excipient which clearly is taught in the reference.
Applicant alleges that this rejection for obviousness is unfounded due to a clear gap between non-analogous fields of Okombi and the pending claims. Okombi teaches the use of its compounds in the field topical cosmetics for skin depigmentation, according to applicant. The present claims reside in the field of oral dietary supplements for internal digestive health according to applicant. These fields are not analogous according to applicant. The technical problems being solved are entirely different, inhibiting tyrosinase in the skin versus modulating cellular junctions in the gut epithelium according to applicant. One skilled in the art in the cosmetics field would have no reason or motivation to reformulate a topical skin agent for oral ingestion to treat an unrelated internal condition according to applicant. The pharmacokinetics, bioavailability, safety, and mechanism of action of a compound applied topically are known to be entirely different and unpredictable from when that same compound is ingested according to applicant. The Examiner’s reliance on the toxicology study in Example 42 of Okombi is also misplaced according to applicant. This study, which includes oral administration to determine a lethal dose (LD50), underscores the unpredictability and potential danger of oral ingestion according to applicant. A POSA would view this not as a suggestion of therapeutic oral use, but as a standard safety assessment, further reinforcing the boundary between the distinct fields of topical cosmetics and oral nutraceuticals according to applicant. Therefore, since KR teaches away from the claimed concentration and neither reference provides any motivation to use the claimed compound for the claimed purpose, the rejections under § 103 are improper according to applicant.
While all of this is noted, it is also noted that clearly tablets were indeed disclosed and applicant claims that the uses are different but applicant’s claims read on anyone since anyone can benefit from having their gut permeability regulated.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 34-43, 45, 46 and 54-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,173,136. Although the claims at issue are not identical, they are not patentably distinct from each other because 17/828,627 claims a process using the same compound as used in US 11,173,136 and the instant application can be used on anyone thus it is obvious to use the compound in either case.
Applicant did not respond to the rejection other than to say it should be held in abeyance, thus the rejection is maintained for the reasons of record.
Claims 34-43, 45, 46 and 54-67 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,382,880.
Although the claims at issue are not identical, they are not patentably distinct from each other because 17/828,627 claims a process using the same compound as used in US 11, 382,880 and the instant application can be used on anyone thus it is obvious to use the compound in either case.
Applicant did not respond to the rejection other than to say it should be held in abeyance, thus the rejection is maintained for the reasons of record.
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 MICHAEL V MELLER whose telephone number is (571)272-0967. The examiner can normally be reached M-F 9 am-5:30 pm.
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MICHAEL V. MELLER
Primary Examiner
Art Unit 1655
/MICHAEL V MELLER/ Primary Examiner, Art Unit 1655
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