Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Restriction and Status of the Claims
Applicant’s election with traverse of Group I, comprising claims 1, 12-15, 21-25, and 29-34 is acknowledged. Applicant argues that the limitations,
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are safety and efficacy parameters that make a contribution over the prior art. However, such parameters only describe the effect/results of the method of claim 1, and are not further limiting to the method itself (see the rejections below). Thus, Kraus (US20200147000A1) remains anticipatory of the claims and the restriction requirement is deemed proper. Claims 1, 3, 4, 12-15, 21-27, and 29-34 are pending. Claims 3-4 and 26-27 are withdrawn from further consideration as being directed towards a nonelected invention. Claims 1, 12-15, 21-25, and 29-34 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on April 4th 2025, January 6th 2025, December 6th 2024, November 5th 2024, September 20th 2024, June 5th 2024, and May 23rd 2024 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 112(b)
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, 21-25, and 29, as well as their dependent claims, 12-15 and 30-34 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 and its dependent claims are indefinite for the following phrases,
“wherein the subject maintains a PGA score <2”
“wherein the 1.0% tapinarof topical cream composition does not prolong the QTc interval in the subject while applying the 1.0% tapinarof topical cream”
“wherein the plasma concentration of tapinarof in the subject is below 50 pg/mL while applying the 1.0% tapinarof topical cream”
“wherein no tachyphylaxis occurs when further applying the thin layer of 1.0% tapinarof topical cream composition to the affected areas of the subject once a day for the initial period of time and the further period of time”
because one of ordinary skill in the art could not reasonably determine the metes and bounds of claim 1 from the claim language.
Regarding the phrase, “wherein the subject maintains a PGA score <2,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of treating plaque psoriasis. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. the maintenance of the subject’s PGA score during a break in administration). The claim language is repeated (specification, pg. 17-18) but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. One of ordinary skill in the art therefore could not reasonably determine how the phrase limits the method of treating plaque psoriasis of claim 1.
Regarding the phrase, “wherein the 1.0% tapinarof topical cream composition does not prolong the QTc interval in the subject while applying the 1.0% tapinarof topical cream,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of treating plaque psoriasis. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. the lack of prolongation in the subject’s QTc interval). The claim language is repeated (specification, pg. 21-23) but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. One of ordinary skill in the art therefore could not reasonably determine how the phrase limits the method of treating plaque psoriasis of claim 1.
Regarding the phrase, “wherein the plasma concentration of tapinarof in the subject is below 50 pg/mL while applying the 1.0% tapinarof topical cream,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of treating plaque psoriasis. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. the subject’s low plasma concentration of tapinarof). The claim language is repeated (specification, pg. 17-19), and the described results are demonstrated (specification, pg. 135-136), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. One of ordinary skill in the art therefore could not reasonably determine how the phrase limits the method of treating plaque psoriasis of claim 1.
Regarding the phrase, “wherein no tachyphylaxis occurs when further applying the thin layer of 1.0% tapinarof topical cream composition to the affected areas of the subject once a day for the initial period of time and the further period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of treating plaque psoriasis. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. the subject’s low plasma concentration of tapinarof). The described results are demonstrated (Figure 6), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. One of ordinary skill in the art therefore could not reasonably determine how the phrase limits the method of treating plaque psoriasis of claim 1.
Claim 21 is indefinite for the phrase, “wherein the subject’s itch numeric rating scale is improved by about 1 to 5 points at the end of the initial time period,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s itch numeric rating scale). Said rating scale is described in the specification (specification, pg. 49, paragraph [0139]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 21 further limits the method of claim 1, claim 21 is indefinite.
Claim 22 is indefinite for the phrase, “wherein the subject’s itch numeric rating scale is improved by about 4 points at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s itch numeric rating scale). Said rating scale is described in the specification (specification, pg. 49, paragraph [0139]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 22 further limits the method of claim 1, claim 22 is indefinite.
Claim 23 is indefinite for the phrase, “wherein the subject’s Psoriasis Area and Severity Index (PASI) score is improved by at least 75% at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s PASI score). Said rating scale is described in the specification (specification, pg. 37, paragraph [0110]; specification, pg. 118, paragraph [0359]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 23 further limits the method of claim 1, claim 23 is indefinite.
Claim 24 is indefinite for the phrase, “wherein the subject’s Psoriasis Area and Severity Index (PASI) score is improved by at least 90% at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s PASI score). Said rating scale is described in the specification (specification, pg. 37, paragraph [0110]; specification, pg. 120, paragraph [0361]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 24 further limits the method of claim 1, claim 24 is indefinite.
Claim 25 is indefinite for the phrase, “wherein the subject’s percent body surface area (BSA) affected is decreased,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. a decrease in the affected body surface area). Said improvements are described in the specification (specification, pg. 36, paragraph [0109]; specification, pg. 114, paragraph [0351]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 25 further limits the method of claim 1, claim 25 is indefinite.
Claim 29 is indefinite for the phrase, “wherein the subject’s Dermatology Life Quality Index (DLQI) score is improved from baseline at the end of the initial period of time,” because one of ordinary skill in the art could not reasonably determine how the phrase further limits the method of claim 1. Specifically, the phrase does not limit the subject receiving the drug, the method of administration, the drug administered, the composition in which it is contained, the amount administered, or any other limiting aspect of the method, but only the results of the method (i.e. an improvement on the subject’s DLQI score). Said rating scale is described in the specification (specification, pg. 39, paragraph [0112]; specification, pg. 121, paragraph [0365]), but the specification provides no indication as to what aspect of the method would have to be further limited in order to achieve said results. As one of ordinary skill in the art could not reasonably determine how claim 29 further limits the method of claim 1, claim 29 is indefinite.
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, 12, 21-25, and 29-30, and 32-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kraus (US20200147000A1 effectively filed on November 13th 2018).
Claim 1 is directed towards a method for treating plaque psoriasis comprising a three-step process of:
Applying a thin layer of about 1.0% topical tapinarof cream once a day for about 12-52 weeks, until the subject has a PGA score of 0
Stopping treatment for a period of 1-7 months wherein the PGA score stays below 2
Applying the treatment once daily until the subject has a PGA score of 0
Claim 1 further defines conditions for the treatment wherein:
The 1.0% tapinarof cream does not prolong the QTc interval in the subject
The plasma concentration of tapinarof in the subject is below 50 pg/mL while applying the cream
No tachyphylaxis occurs when applying the cream
Kraus teaches a method for treating mild to moderate plaque psoriasis in a subject comprising topically administering a topical composition containing about 1.0% tapinarof to the affected areas once a day, wherein Physician Global Assessment (PGA) score is improved by 2 grades or has improved to a score of 0 or 1 (Kraus, claim 1). Kraus additionally teaches a 12-week treatment period (Kraus, pg. 12, paragraph [0114]). Kraus thereby anticipates step A of claim 1. Regarding step B, Kraus teaches that the PGA score of 0 is maintained for 4 weeks (i.e. one month) after administration (Kraus, pg. 30, claim 19). Regarding step C, Kraus teaches additional dosing cycles up to 12 weeks apart (Kraus, pg. 10, paragraph [0096]). Kraus thereby anticipates all three steps of claim 1.
Regarding applicant’s further conditions, Kraus satisfies condition (ii) in that Kraus teaches that the systemic exposure of tapinarof in the subject is below the limit of detection (Kraus, pg. 30, claim 20). An undetectable level would necessarily be below the measured amount described by applicant, and Kraus thereby anticipates condition (ii). Regarding condition (iii), that is, no tachyphylaxis occurring over the application period, Kraus teaches that the effectiveness of the treatment is maintained over the 12-week treatment period (Kraus, pg. 17, Table 4). As tachyphylaxis is defined as the decrease in response to successive doses of the drug and the effectiveness is maintained over the course of the treatment taught by Kraus, Kraus anticipates applicant’s condition (iii).
Regarding all three of conditions (i), (ii), and (iii), the conditions are not further limiting on the method itself (see the above 112(b) rejection for claim 1). Furthermore, these parameters described by applicant describe only results of the method and do not further limit any aspect of the method itself. These results would at best be considered a “new property” of the described method, and thus would be inherent in the method itself. See MPEP 2112(I):
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004), the court held that the claimed promoter sequence obtained by sequencing a prior art plasmid that was not previously sequenced was anticipated by the prior art plasmid which necessarily possessed the same DNA sequence as the claimed oligonucleotides. The court stated that "just as the discovery of properties of a known material does not make it novel, the identification and characterization of a prior art material also does not make it novel."
Thus, as Kraus is anticipatory of all of steps a-c of claim 1, Kraus anticipates claim 1.
Claim 12 limits the plaque psoriasis in claim 1 to moderate or severe plaque psoriasis. Kraus teaches the treatment of moderate plaque psoriasis (Kraus, pg. 30, claim 1), anticipating claim 1.
Claim 21 requires that, in the method of claim 1, the subject’s itch numeric rating scale (NRS) is improved by 1-5 points. Kraus teaches a significant portion (73%) of patients having an NRS improvement of greater than or equal to 4 points (Kraus, pg. 24, Table 6), anticipating claim 21.
Claim 22 requires that, in the method of claim 1, the NRS is improved by about 4 points. Kraus teaches a significant portion (73%) of patients having an NRS improvement of greater than or equal to 4 points (Kraus, pg. 24, Table 6), anticipating claim 21.
Claim 23 and 24 require that, in the method of claim 1, the subject’s Psoriasis Area and Severity Index (PASI) score is improved by at least 75% and 90%, respectively. Kraus teaches a large portion (40%) of patients having PASI score improvement of at least 90% (Kraus, pg. 24, Table 6). Kraus thereby anticipates claims 23 and 24.
Claim 25 requires that, in the method of claim 1, the subject’s body surface area (BSA) affected is decreased. Kraus teaches a decrease in BSA to less than 20% (Kraus, pg. 30, claim 10), anticipating claim 25.
Claim 29 requires that, in the method of claim 1, the subject’s Dermatology Life Quality Index (DLQI) score is improved. Kraus teaches an improvement in DLQI score (Kraus, pg. 30, Claim 13).
Claim 30 requires that, in the method of claim 1, the further period of time is about 8-16 weeks. Kraus teaches additional application periods of 8 weeks (Kraus, pg. 10, paragraph [0096]), anticipating claim 30.
Claim 32 requires that, in the method of claim 1, the subject has had stable plaque psoriasis for at least 6 months. Kraus teaches subjects with stable plaque psoriasis for at least 6 months (Kraus, pg. 5 paragraph [0066]), anticipating claim 32.
Claim 33 requires that, in the method of claim 1, the subject is between the ages of 18 and 75. Kraus teaches subjects in the age group of 18-65 (Kraus, Figure 14), anticipating claim 33.
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 13-15, 31, and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Kraus.
Claim 13 limits the length of the remittive period in claim 1 is greater than 3 months and up to about 7 months. For the teachings of Kraus as they relate to claim 1, see the above 102 rejection for claim 1. Regarding the length of the remittive period, Kraus teaches a break in administration of 12 weeks (Kraus, pg. 10, paragraph 95). Such a break is approximately the 3 months described by applicant (1 month = approximately 4 weeks), and claim 13 is thereby prima facie obvious.
Claim 14 limits the length of the remittive period in claim 1 is about 4 months. For the teachings of Kraus as they relate to claim 1, see the above 102 rejection for claim 1. Regarding the length of the remittive period, Kraus teaches a break in administration of 12 weeks (Kraus, pg. 10, paragraph 95). Kraus also teaches an embodiment wherein the psoriasis symptoms do not worsen for about 15 or about 16 weeks (i.e. about 4 months) after administration of the composition (Kraus, pg. 10, paragraph [0085]). One of ordinary skill in the art attempting to determine when to begin re-application of the tapinarof composition would reasonably wait until symptoms began appearing again, and would thus have a reasonable expectation of success in beginning reapplication after a 4-month remittive period. Thus, claim 14 is prima facie obvous.
Claim 15 requires that the further period of time in claim 1 (that is, the period of time in step c of claim 1) is less than the initial period of time (the period of time in step a of claim 1). For the teachings of Kraus as they relate to claim 1, see the above 102 rejection for claim 1. Regarding the length of the further period of time, one of ordinary skill in the art would have a reasonable expectation of success in performing a re-treatment that is shorter than the initial treatment, because the effects of the tapinarof composition were determined to have long-lasting effects (Kraus, pg. 9-10, paragraph [0085]). One of ordinary skill in the art would therefore expect the subject at the beginning of the re-treatment phase to have a lower PGA score than at the beginning of the initial phase. As both treatment phases include the same endpoint of “until the subject has a PGA score of 0,” one of ordinary skill in the art would reasonably expect that treatment of a subject with a lower PGA score (i.e. the subject at the beginning of the re-treatment step) would require a shorter treatment period than the same subject with a higher PGA score (i.e. the subject at the beginning of the initial treatment step). The method of claim 15 is therefore prima facie obvious.
Claim 31 requires that the initial period of time in the method of claim 1 is about 40 weeks. For the teachings of Kraus as they relate to claim 1, see the above 102 rejection for claim 1. Regarding the length of the initial period of time, as the end point for all subjects (a PGA score of zero) is the same, the length of the initial treatment would vary from patient to patient. One of ordinary skill in the art would have a reasonable expectation of success in extending the length of the treatment until such an endpoint has been reached. One of ordinary skill in the art would consider such an extension of the initial time period to be routine optimization. See MPEP 2144.05(II)(A):
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.");
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, 4 USPQ 237 (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.").
Claim 31 is thereby prima facie obvious.
Claim 34 limits the length of the remittive period in claim 1 is about 4 months. For the teachings of Kraus as they relate to claim 12, see the above 102 rejection for claim 12. Regarding the length of the remittive period, Kraus teaches a break in administration of 12 weeks (Kraus, pg. 10, paragraph 95). Kraus also teaches an embodiment wherein the psoriasis symptoms do not worsen for about 15 or about 16 weeks (i.e. about 4 months) after administration of the composition (Kraus, pg. 10, paragraph [0085]). One of ordinary skill in the art attempting to determine when to begin re-application of the tapinarof composition would reasonably wait until symptoms began appearing again, and would thus have a reasonable expectation of success in beginning reapplication after a 4-month remittive period. Thus, claim 34 is prima facie obvous.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629