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 § 102
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 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 1, 8 and 10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Chesney et al. (of record-see IDS filed 6/18/2024 number 484).
Chesney teaches that increased N-desmethylclobazam levels could also account for the increased odds of pneumonia in epileptic patients taking CBD, further indicates that these events only occurred in patients prescribed high doses of CBD (10-20 mg/kg/day), see page 1803, right column. Chesney concludes that the available data from clinical trials suggest that CBD is well tolerated and has relatively few adverse side effects.
The mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. In fact the use of CBD in combination with clobazam for the treatment of epilepsy in children with LGS or TSC is well-known in the art (see above and D4) and the group of patients is identical with the one of the prior art.
Claims 1, 8 and 10 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Gaston et al. (of record-see IDS filed 6/18/2024 number 594).
Gaston teaches that “all patients who had respiratory distress were all taking concomitant clobazam”, see page 73, right column, third paragraph.
The mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. In fact the use of CBD in combination with clobazam for the treatment of epilepsy in children with LGS or TSC is well-known in the art (see above and D4) and the group of patients is identical with the one of the prior art.
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Chesney et al. (of record-see IDS filed 6/18/2024 number 484) in view of Wanleenuwat et al. (herein enclosed)
Chesney teaches that increased N-desmethylclobazam levels could also account for the increased odds of pneumonia in epileptic patients taking CBD, further indicates that these events only occurred in patients prescribed high doses of CBD (10-20 mg/kg/day), see page 1803, right column. Chesney concludes that the available data from clinical trials suggest that CBD is well tolerated and has relatively few adverse side effects.
The mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. In fact, the use of CBD in combination with clobazam for the treatment of epilepsy in children with LGS (Lennox-Gastaut Syndrome) is well-known in the art (as shown by the reference) and the group of patients is identical with the one of the reference.
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, to use the claimed amounts of CBD and clobazam would have been obvious to one having ordinary skill in the art since CBD and the clobazam are clearly result effective variables and clearly it would have been obvious in an effort to optimize the desired results to use the claimed amounts.
It is noted on page 1801, left column that the CBD is pure. Therefore, to use synthetic or a highly purified extract having 95 wt.% of CBD would have been obvious to one having ordinary skill in the art since clearly Chesney knew that the CBD can be pure and whether it was synthetically made or from a plant it was still pure CBD.
Wanleenuwat teaches that the co-administration of antibiotics and antiseizure drugs are known to have beneficial effects, see page 171, right column.
To monitor the patient for incidence of pneumonia is obvious since the mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. Clearly one having ordinary skill in the art would want to monitor the patient for the possibility of pneumonia since pneumonia is a common side effect.
To lower the dose of CBD and/or clobazam is obvious since if after monitoring the patient for incidence of pneumonia it would have been obvious since the mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. Clearly one having ordinary skill in the art would want to monitor the patient for the possibility of pneumonia and if pneumonia occurs then it would be obvious to lower the dose so as to not exacerbate the pneumonia.
To either discontinue the use of CBD or advising the patient of possible side effects from the concurrent therapy, is an obvious response to a negative effect of either the CBD or the concurrent therapy.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gaston et al. (of record-see IDS filed 6/18/2024 number 594) in view of Wanleenuwat et al. (herein enclosed)
Gaston teaches that “all patients who had respiratory distress were all taking concomitant clobazam”, see page 73, right column, third paragraph.
The mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. In fact, the use of CBD in combination with clobazam for the treatment of epilepsy in children with LGS (Lennox-Gastaut Syndrome) is well-known in the art (as shown by the reference) and the group of patients is identical with the one of the reference.
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, to use the claimed amounts of CBD and clobazam would have been obvious to one having ordinary skill in the art since CBD and the clobazam are clearly result effective variables and clearly it would have been obvious in an effort to optimize the desired results to use the claimed amounts.
It is noted in Table 1, that the CBD is pure. Therefore, to use synthetic or a highly purified extract having 95 wt.% of CBD would have been obvious to one having ordinary skill in the art since clearly Gaston knew that the CBD can be pure and whether it was synthetically made or from a plant it was still pure CBD.
Wanleenuwat teaches that the co-administration of antibiotics and antiseizure drugs are known to have beneficial effects, see page 171, right column.
To monitor the patient for incidence of pneumonia is obvious since the mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. Clearly one having ordinary skill in the art would want to monitor the patient for the possibility of pneumonia since pneumonia is a common side effect.
To lower the dose of CBD and/or clobazam is obvious since if after monitoring the patient for incidence of pneumonia it would have been obvious since the mere step of monitoring for the incidence of pneumonia or to apply "caution" when administering CBD in combination with clobazam are not considered technical features which can confer novelty to the subject-matter of the present application, since it does not lead to a new use of the claimed combination. Clearly one having ordinary skill in the art would want to monitor the patient for the possibility of pneumonia and if pneumonia occurs then it would be obvious to lower the dose so as to not exacerbate the pneumonia.
To either discontinue the use of CBD or advising the patient of possible side effects from the concurrent therapy, is an obvious response to a negative effect of either the CBD or the concurrent therapy.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Terry McKelvey can be reached at 571-272-0995. 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