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 .
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.
Claim Objections
Claims 9 and 28 are objected to because of the following informalities:
Claims 9 and 28 should read “wherein the composition is topically applied for between 12 days and 20 days”. Appropriate correction is required.
Claim Rejections - 35 USC § 112, Second Paragraph
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 8-13, 16, 20, 24, 27-30, 32, 36, and 40 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.
Claims 8 and 27 are indefinite because they recite that the method does not involve treatment with a topical calcineurin inhibitor or other pharmaceutical active. The phrase “other pharmaceutical active in the claims is indefinite because it is not clear how the atopic dermatitis can be treated without a pharmaceutical active, especially as independent claims 2 and 4 (from which claims 8 and 27 depend) requires the use of pharmaceutical actives such as a polyhydroxy acid and a zinc salt of its conjugate base. To overcome this rejection, the term “other pharmaceutical active” can be removed from the claims.
Regarding broad to narrow limitation, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claims 9 and 28 recite the broad recitation “12 days and 20 days”, and the claims also recite “for example, about 14 days” which is the narrower statement of the range/limitation.
Claims 10 and 29 recite “is at least 6” and the claims also recite “preferably between 6 and 12, for example, between 6 and 10” which is the narrower statement of the range/limitation”.
Claims 11 and 30 recite the broad recitation “is at least 6”, and the claims also recite “more preferably between 6 and 12” which is the narrower statement of the range/limitation.
Claims 16 and 32 recite the broad recitation “between 3.0 and 4.0”, and the claims also recite “more preferably from 3.0 to 3.5, and even more preferably about 3.2” which is the narrower statement of the range/limitation.
Claims 20 and 36 recite the broad recitation “comprising a ceramide”, and the claims also recite “preferably wherein the ceramide is present in an amount from 0.5 to 1.5 w/w of the composition” which is the narrower statement of the range/limitation.
Claims 24 and 40 recite the broad recitations “partition coefficient enhancer”, “diffusion coefficient enhancer”, “emollient”, “surfactant”, “humectant”, “co-surfactant”, “ceramide”, “cholesterol”, “fatty acid”, “a PEG-240/HDI copolymer bis-decyltetradeceth-20 ether”, a acrylates/C10-C30 alkyl acrylates copolymer”, and “preservative” and the claims also recite “preferably” language after each of these limitations which is followed by the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. In each case, the Examiner is interpreting the narrower statement of the range/limitation to not be a required feature of the claim. To overcome each of these rejections, “for example” and “preferably” language can be removed from the claims.
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 2, 6-8, 10, 16, and 18-20 are rejected under 35 U.S.C. 102 as being as being anticipated by Hammond et al. (US 2020/0222438 A1) and as evidenced by “SCORAD”.
Regarding claim 2 Hammond discloses a method of treating atopic dermatitis (eczema) [abstract] with a polyhydroxy acid and a zinc salt of its conjugate base, wherein the polyhydroxy acid is lactobionic acid, the partition coefficient enhancer, propylene glycol, and the diffusion coefficient enhancer, myristyl alcohol [0132]. The composition does not include steroids. The composition is topically applied to the skin twice a day (claim 34). Hammond teaches that the composition is used to treat severe dry skin and eczema [abstract] [0260].
While Hammond does not explicitly disclose the pH of the composition taught at [0132], a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the prior art teaches a composition with the same components (i.e., lactobionic acid and a zinc salt of its conjugate base, propylene glycol, and myristyl alcohol), the properties the applicant discloses and/or claims (pH within the claimed range) are reasonably expected to be necessarily present, especially as Hammond teaches that generally, the pH of the compositions is around 3.2 [0116] [0209].
Regarding the claimed limitation of a method of treating moderate atopic dermatitis with a local SCORAD score of at least 6, Hammond teaches that the composition is used to treat severe dry skin and eczema [abstract] [0260]. As evidenced by “SCORAD”, severe eczema has a SCORAD score of greater than 50 (pg. 1, bottom). Therefore, using the composition to treat severe dry skin and eczema as disclosed by Hammond would necessarily mean the patient having a local SCORAD score of at least 6. While Hammond discloses treating severe dry skin and eczema, the composition of Hammond would be reasonably expected to also treat the milder form of eczema “moderate atopic dermatitis”, as claimed.
Claim 6 is anticipated because Hammond discloses that the composition is applied twice a day (claim 34).
Claims 7 and 8 are anticipated because the composition is free of topical calcineurin inhibitors [0132].
Claim 10 is anticipated because using the composition to treat severe dry skin and eczema as disclosed by Hammond [abstract] [0260] would necessarily mean the patient having a local SCORAD score at the start of treatment of at least 6 as previously discussed.
Claim 16 is anticipated because the pH within the claimed range is reasonably expected to be necessarily present for the composition taught at [0132] as previously discussed, especially as Hammond teaches that generally, the pH of the compositions is around 3.2 [0116] [0209].
Claim 18 is anticipated because Hammond discloses the partition coefficient enhancer (propylene glycol) is present in an amount of 20 wt.% [0132]. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. See MPEP 2131.03.
Claim 19 is anticipated because Hammond discloses the diffusion coefficient enhancer (myristyl alcohol) is present in an amount of 1.50 wt.% [0132]. If the prior art discloses a point within the claimed range, the prior art anticipates the claim. See MPEP 2131.03.
Claim 20 is anticipated because Hammond discloses the compositions include ceramide [0132].
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2, 6-8, 10, 16-21, and 24 are rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) and as evidenced by “SCORAD”.
Hammond is believed to anticipate claims 2, 6-8, 10, 16, and 18-20 as described above, but in the interest of completeness of prosecution, purely arguendo, and for the purposes of this ground of rejection only, Hammond will be interpreted as if it is not anticipatory.
In that case, Hammond could be construed as not clearly and unequivocally disclosing the claimed invention or directing those skilled in the art to the claimed invention without any need for picking, choosing and combining various disclosures not directly related to each other by the teachings of the cited reference. Namely, one skilled in the art would need to choose to apply the composition taught at [0132] twice a day as taught at claim 34, to treat severe dry skin and eczema [abstract] [0260].
In that case, claims 2, 6-8, 10, 16, and 18-20 are rendered prima facie obvious over the teachings of Hammond, because it is prima facie obvious to combine prior art elements according to known methods, to yield predictable results. In the instant case, all the claimed elements (e.g., claimed composition, applying twice a day, to treat severe dry skin and eczema) were known in the prior art (e.g., Hammond) and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielding nothing more than predictable results to one of ordinary skill in the art. MPEP 2143.A.
Claim 2 is rendered prima facie obvious because Hammond discloses a method of treating atopic dermatitis (eczema) [abstract] with compositions including a polyhydroxy acid and a zinc salt of its conjugate base, wherein the polyhydroxy acid is lactobionic acid, the partition coefficient enhancer, propylene glycol, and the diffusion coefficient enhancer, myristyl alcohol [0132] [0023]-[0025]. The compositions are topically applied to the skin twice a day [0114] (claim 34) and have a pH of about 3.2 [0086] [0209]. The compositions do not require the use of steroids (whole document). Hammond teaches that the composition is used to treat severe dry skin and eczema [abstract] [0260].
Regarding the claimed limitation of a method of treating moderate atopic dermatitis with a local SCORAD score of at least 6, Hammond teaches that the composition is used to treat severe dry skin and eczema [abstract] [0260]. As evidenced by “SCORAD”, severe eczema has a SCORAD score of greater than 50 (pg. 1, bottom). Therefore, using the composition to treat severe dry skin and eczema as disclosed by Hammond would necessarily mean the patient having a local SCORAD score of at least 6. While Hammond discloses treating severe dry skin and eczema, the composition of Hammond would be reasonably expected to also treat the milder form of eczema “moderate atopic dermatitis”, as claimed.
In regards to the pH value of the composition, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. See MPEP 2144.05 A.
Claim 6 is rendered prima facie obvious because Hammond discloses that the compositions are applied twice a day [0114] (claim 34).
Claims 7 and 8 are rendered prima facie obvious because the compositions do not require the use of topical calcineurin inhibitors (whole document).
Claim 10 is rendered prima facie obvious because using the composition to treat severe dry skin and eczema as disclosed by Hammond [abstract] [0260] would necessarily mean the patient having a local SCORAD score of at least 6 at the start of treatment as previously discussed.
Claim 16 is rendered prima facie obvious because Hammond discloses the compositions have a pH of about 3.2 [0086] [0209]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claim 17, while the example taught at [0132] of Hammond include propylene glycol as the partition coefficient enhancer [0132] Hammond also discloses butylene glycol as a partition coefficient enhancer [0024]. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Hammond taught both propylene glycol and butylene glycol as partition coefficient enhancers, it is prima facie obvious to select butylene glycol for incorporation into the compositions based on its recognized suitability for the intended use as partition coefficient enhancer, as taught by Hammond.
Claim 18 is rendered prima facie obvious because Hammond discloses the partition coefficient enhancer (propylene glycol) is present in an amount of 20 wt.% [0132]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 19 is rendered prima facie obvious because Hammond discloses the diffusion coefficient enhancer (myristyl alcohol) is present in an amount of 1.50 wt.% [0132]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claim 20 is rendered prima facie obvious because Hammond discloses the compositions include ceramide [0132] [0027].
Regarding claim 21, Hammond discloses methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate are present in an amount of 2.84-4.73 wt.% [0131]. Hammond discloses the combination of methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate acts as a surfactant system which is taught to stabilize the viscosity of the composition [0087]. Where 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. See MPEP 2144.05(II)(A). In this case, the ordinarily skilled artisan would discover the optimum amount of methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate via routine experimentation to stabilize the viscosity of the composition as taught by Hammond [0087].
Examiner’s Note: Claim 24 recites that the composition includes “up to 3% w/w humectant”, this is interpreted by the Examiner to mean a range of 0-3 wt.% (i.e., the composition may include no humectant).
Claim 24 is rendered prima facie obvious because Hammond discloses the composition includes 4.92 wt.% lactobionic acid and 0.10 wt.% of zinc oxide (5.02 wt.% of lactobionic acid and zinc salt of its conjugate base), 20 wt.% of partition coefficient enhancer (propylene glycol), 1.50 wt.% of diffusion coefficient enhancer (myristyl alcohol), 20 wt.% emollient (6 wt.% of cyclopentasiloxane domethicone cross polymer and 14 wt.% of hydrogenated polydecene), 7.26 wt.% surfactants (1.26 wt.% methyl glucose sesquistearate, 2.52 wt.% PEG - 20 methyl glucose sesquistearate, and 3.48 wt.% glyceryl stearate), and 38.32 wt.% of 1% sodium chloride in deionized water [0132]. Hammond discloses that the compositions of the disclosure can comprise from 30-45 wt.% water [0082]. The compositions have a pH of about 3.2 [0086] [0209]. The composition does not include humectant. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
Claims 9 and 14-15 are rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) and as evidenced by “SCORAD” in view of Jang et al. (Journal of Investigative Dermatology, 2016, 136:127-135).
The 35 U.S.C. 103 rejection over Hammond and as evidenced by “SCORAD” was previously discussed.
Regarding claim 9, Hammond does not disclose that the method comprises topically applying the composition for between 12 and 20 days.
Jang discloses that lactobionic acid was applied twice a day for 2 weeks to treat severe atopic dermatitis skin lesions (pg. 130, left column, third paragraph; abstract). Jang teaches that these treatment conditions significantly attenuated eczema symptoms and that scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph).
Since Hammond generally teaches treating severe atopic dermatitis by applying a composition with lactobionic acid twice a day, it would have been prima facie obvious to apply the composition for 2 weeks (14 days), as taught by Jang, because Jang teaches that lactobionic acid is applied twice a day for 2 weeks to treat severe atopic dermatitis skin lesions (pg. 130, left column, third paragraph; abstract). The ordinarily skilled artisan would have been motivated to apply the composition for 14 days because Jang teaches that treatment for 14 days significantly attenuated eczema symptoms and that scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claims 14 and 15 while the method of treatment resulting in a reduction of local SCORAD score of at least 1, wherein the reduction in local SCORAD score is obtained in less than 4 weeks is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the combined teachings of the prior art (Hammond and Jang) teach a method of treating atopic dermatitis by applying a composition twice a day with the same components (i.e., lactobionic acid and a zinc salt of its conjugate base, propylene glycol, and myristyl alcohol), and it would have been prima facie obvious to apply the composition for 14 days as taught by Jang, the properties the applicant discloses and/or claims (i.e., reduction of local SCORAD score of at least 1 in less than 4 weeks) are reasonably expected to be present in the method rendered obvious by the combined teachings of the prior art.
Claims 11 is rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) and as evidenced by “SCORAD” and further in view of Schmitt et al. (J ALLERGY CLIN IMMUNOL, 2013, 132: 1337-1347).
The 35 U.S.C. 103 rejection over Hammond and as evidenced by “SCORAD” was previously discussed.
As discussed, using the composition to treat severe dry skin and eczema as disclosed by Hammond would necessarily mean the patient having a local SCORAD score of at least 6.
Regarding claim 11, Hammond does not disclose that the method involves identifying a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score.
Schmitt discloses that SCORAD is a method used to measure clinical signs of atopic dermatitis and SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract).
Since Hammond generally teaches a treatment method for atopic dermatitis, it would have been prima facie obvious to identify a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score because Schmitt discloses that SCORAD is a method used to measure clinical signs of atopic dermatitis. The ordinarily skilled artisan would have been motivated to use the SCORAD method because Schmitt teaches that SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract).
Claims 12-13 are rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) and as evidenced by “SCORAD” and further in view of Schmitt et al. (J ALLERGY CLIN IMMUNOL, 2013, 132: 1337-1347) and Dong et al. (Scientific reports, 2021, 11:23539).
The 35 U.S.C. 103 rejection over Hammond as evidenced by “SCORAD” and further in view of Schmitt was previously discussed.
Regarding claims 12-13, Hammond does not disclose that the method further comprises measuring the local SCORAD score after a time period to ensure whether further treatment is needed, wherein the time period is less than 4 weeks.
Dong discloses that in a clinical trial for the treatment of atopic dermatitis patients visited the hospital every two weeks and the dermatologist checked their condition each time to determine whether further treatment was needed. Dong teaches that this allowed the dermatologist to determine whether their condition worsened and if so, immediately initiate further treatment (abstract; pg. 6).
Since Hammond generally teaches a treatment method for atopic dermatitis, it would have been prima facie obvious to check the patient after a treatment period of 2 weeks to ensure whether further treatment was needed because Dong teaches that in a clinical trial for the treatment of atopic dermatitis patients visited the hospital every two weeks and the dermatologist checked their condition each time to determine whether further treatment was needed. The ordinarily skilled artisan would have been motivated to check the patient after 2 weeks to determine whether their condition worsened and if so, immediately initiate further treatment (abstract; pg. 6). The ordinarily skilled artisan would have been motivated to measure the SCORAD score to determine whether further treatment is needed because Schmitt teaches that SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract).
Claims 22-23 are rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) and as evidenced by “SCORAD” and further in view of Stebbins et al. (US 2021/0128419 A1).
The 35 U.S.C. 103 rejection over Hammond and as evidenced by “SCORAD” was previously discussed.
Regarding claim 22, Hammond does not disclose that the composition includes PEG-240/HDI copolymer bis-decyltetradeceth-20 ether.
Regarding claim 23, Hammond does not disclose that the composition includes an acrylates/C10-C30 alkyl acrylate copolymer.
Stebbins discloses a composition for the skin with thickeners such as PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer [abstract] [0012] [0079] [0082]. Stebbins teaches that PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer act as thickeners in the composition to afford good sensory properties and so that the composition remains in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
Since Hammond generally teaches a composition for the skin, it would have been prima facie obvious to one of ordinary skill in the art to include PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and/or acrylates/C10-C30 alkyl acrylate copolymer, within the teachings of Hammond, because Stebbins teaches a composition for the skin with thickeners such as PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and/or acrylates/C10-C30 alkyl acrylate copolymer. An ordinarily skilled artisan would be motivated to use PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer within the teachings of Hammond because Stebbins teaches that these polymers act as thickeners in the composition to afford good sensory properties and to remain in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
Claims 4-5, 25-28, 31-37, and 40 are rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) in view of Jang et al. (Journal of Investigative Dermatology, 2016, 136:127-135).
Regarding claim 4, Hammond discloses a method of treating atopic dermatitis (eczema) [abstract] with compositions including a polyhydroxy acid and a zinc salt of its conjugate base, wherein the polyhydroxy acid is lactobionic acid, the partition coefficient enhancer, propylene glycol, and the diffusion coefficient enhancer, myristyl alcohol [0132] [0023]-[0025]. The compositions are topically applied to the skin twice a day [0114] (claim 34) and have a pH of about 3.2 [0086] [0209]. The compositions do not require the use of steroids (whole document). Hammond teaches that the composition is used to treat severe dry skin and eczema [abstract] [0260].
Hammond does not disclose that the method comprises topically applying the composition on the skin for between 10 and up to 28 days.
Jang discloses that lactobionic acid is applied twice a day for 2 weeks to treat severe atopic dermatitis skin lesions (pg. 130, left column, third paragraph; abstract). Jang teaches that these treatment conditions significantly attenuated eczema symptoms and that scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph).
Since Hammond generally teaches treating severe atopic dermatitis by applying a composition with lactobionic acid twice a day, it would have been prima facie obvious to apply the composition for 2 weeks (14 days), as taught by Jang, because Jang teaches that lactobionic acid is applied twice a day for 2 weeks to treat severe atopic dermatitis skin lesions (pg. 130, left column, third paragraph; abstract). The ordinarily skilled artisan would have been motivated to apply the composition for 14 days because Jang teaches that treatment for 14 days significantly attenuated eczema symptoms and scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claim 5, Hammond teaches that the composition is used to treat severe dry skin and eczema [abstract] [0260]. The composition of Hammond would be reasonably expected to also treat the milder form of eczema “moderate atopic dermatitis”, as claimed.
Claim 25 is rendered prima facie obvious because Hammond discloses that the compositions are applied twice a day [0114] (claim 34).
Claims 26 and 27 are rendered prima facie obvious because the compositions do not require the use of topical calcineurin inhibitors (whole document).
Claim 28 is rendered prima facie obvious because it would have been obvious to apply the composition of Hammond, for 14 days, as taught by Jang as previously discussed.
Regarding claim 31, while the method of treatment resulting in a reduction of local SCORAD score of at least 1 is not explicitly disclosed, a chemical composition and its properties are inseparable. MPEP 2112.01 II. Therefore, because the combined teachings of the prior art (Hammond and Jang) disclose a method of treating atopic dermatitis by applying a composition twice a day with the same components (i.e., lactobionic acid and a zinc salt of its conjugate base, propylene glycol, and myristyl alcohol), and it would have been prima facie obvious to apply the composition for 14 days as taught by Jang, the properties the applicant discloses and/or claims (i.e., reduction of local SCORAD score of at least 1) are reasonably expected to be present in the method rendered obvious by the combined teachings of the prior art.
Claim 32 is rendered prima facie obvious because Hammond discloses the compositions have a pH of about 3.2 [0086] [0209]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Regarding claim 33, while the example taught at [0132] of Hammond include propylene glycol as the partition coefficient enhancer [0132] Hammond also discloses butylene glycol as a partition coefficient enhancer [0024]. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, since Hammond taught both propylene glycol and butylene glycol as partition coefficient enhancers, it is prima facie obvious to select butylene glycol for incorporation into the compositions based on its recognized suitability for the intended use as partition coefficient enhancer, as taught by Hammond.
Claims 34 is rendered prima facie obvious because Hammond discloses the partition coefficient enhancer (propylene glycol) is present in an amount of 20 wt.% [0132]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 35 is rendered prima facie obvious because Hammond discloses the diffusion coefficient enhancer (myristyl alcohol) is present in an amount of 1.50 wt.% [0132]. A prima facie case of obviousness exists because of overlap, as previously discussed.
Claims 36 is rendered prima facie obvious because Hammond discloses the compositions include ceramide [0132] [0027].
Regarding claim 37, Hammond discloses methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate are present in an amount of 2.84-4.73 wt.% [0131]. Hammond discloses the combination of methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate acts as a surfactant system which is taught to stabilize the viscosity of the composition [0087]. Where 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. See MPEP 2144.05(II)(A). In this case, the ordinarily skilled artisan would have discovered the optimum amount of methyl glucose sesquistearate and PEG-20 methyl glucose sesquistearate via routine experimentation to stabilize the viscosity of the composition as taught by Hammond [0087].
Examiner’s Note: Claim 40 recites that the composition includes “up to 3% w/w humectant”, this is interpreted by the Examiner to mean a range of 0-3 wt.% (i.e., the composition may include no humectant).
Claim 40 is rendered prima facie obvious because Hammond discloses the composition includes 4.92 wt.% lactobionic acid and 0.10 wt.% of zinc oxide (5.02 wt.% of lactobionic acid and zinc salt of its conjugate base), 20 wt.% of partition coefficient enhancer (propylene glycol), 1.50 wt.% of diffusion coefficient enhancer (myristyl alcohol), 20 wt.% emollient (6 wt.% of cyclopentasiloxane domethicone cross polymer and 14 wt.% of hydrogenated polydecene), 7.26 wt.% surfactants (1.26 wt.% methyl glucose sesquistearate, 2.52 wt.% PEG - 20 methyl glucose sesquistearate, and 3.48 wt.% glyceryl stearate), and 38.32 wt.% of 1% sodium chloride in deionized water [0132]. Hammond discloses that the compositions of the disclosure can comprise from 30-45 wt.% water [0082]. The compositions have a pH of about 3.2 [0086] [0209]. The composition does not include humectant. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 A.
Claim 29 is rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) in view of Jang et al. (Journal of Investigative Dermatology, 2016, 136:127-135) and as evidenced by “SCORAD”.
The 35 U.S.C. 103 rejection over Hammond in view of Jang was previously discussed.
Regarding claim 29, while Hammond does not explicitly disclose the local SCORAD score of the atopic dermatitis is at least 6 at the start of treatment, Hammond teaches that the composition is used to treat severe dry skin and eczema [abstract] [0260]. As evidenced by “SCORAD”, severe eczema has a SCORAD score of greater than 50 (pg. 1, bottom). Therefore, using the composition to treat severe dry skin and eczema as disclosed by Hammond would necessarily mean the patient having a local SCORAD score of at least 6 at the start of treatment.
Claim 30 is rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) in view of Jang et al. (Journal of Investigative Dermatology, 2016, 136:127-135) and further in view of Schmitt et al. (J ALLERGY CLIN IMMUNOL, 2013, 132: 1337-1347) and as evidenced by “SCORAD”.
The 35 U.S.C. 103 rejection over Hammond in view of Jang was previously discussed.
Regarding claim 30, Hammond does not disclose that the method involves identifying a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score.
Schmitt teaches that SCORAD is a method used to measure clinical signs of atopic dermatitis and SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract).
Since Hammond generally teaches a treatment method for atopic dermatitis, it would have been prima facie obvious to identify a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score because Schmitt discloses that SCORAD is a method used to measure clinical signs of atopic dermatitis. The ordinarily skilled artisan would have been motivated to use the SCORAD method because Schmitt teaches that SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract).
As evidenced by “SCORAD”, severe eczema has a SCORAD score of greater than 50 (pg. 1, bottom). Therefore, using the composition to treat severe dry skin and eczema as disclosed by Hammond would necessarily mean the patient having a local SCORAD score of at least 6.
Claims 38 and 39 are rejected under 35 U.S.C. 103 as being as being obvious over Hammond et al. (US 2020/0222438 A1) in view of Jang et al. (Journal of Investigative Dermatology, 2016, 136:127-135) and further in view of Stebbins et al. (US 2021/0128419 A1).
The 35 U.S.C. 103 rejection over Hammond in view of Jang was previously discussed.
Regarding claim 38, Hammond does not disclose that the composition includes PEG-240/HDI copolymer bis-decyltetradeceth-20 ether.
Regarding claim 39, Hammond does not disclose that the composition includes an acrylates/C10-C30 alkyl acrylate copolymer.
Stebbins discloses a composition for the skin with thickeners such as PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer [abstract] [0012] [0079] [0082]. Stebbins teaches that PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer act as thickeners in the composition to afford good sensory properties and so that the composition remains in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
Since Hammond generally teaches a composition for the skin, it would have been prima facie obvious to one of ordinary skill in the art to include PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and/or acrylates/C10-C30 alkyl acrylate copolymer, within the teachings of Hammond, because Stebbins teaches a composition for the skin with thickeners such as PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer. An ordinarily skilled artisan would be motivated to use PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and/or acrylates/C10-C30 alkyl acrylate copolymer within the teachings of Hammond because Stebbins teaches that these polymers act as thickeners in the composition to afford good sensory properties and to remain in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 2 and 4-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11,173,172 B2 in view of Hammond et al. (US 2020/0222438 A1), Jang et al. (Journal of Investigative Dermatology, 2016, 136:127-135), Schmitt et al. (J ALLERGY CLIN IMMUNOL, 2013, 132: 1337-1347), Dong et al. (Scientific reports, 2021, 11:23539), and Stebbins et al. (US 2021/0128419 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the method expect for the method comprising topically applying the composition twice a day, for between 12 and 20 days, identifying a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score, that the method further comprises measuring the local SCORAD score after a time period to ensure whether further treatment is needed, wherein the time period is less than 4 weeks, or that the composition includes PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer.
Hammond discloses a method of treating atopic dermatitis (eczema) [abstract] where the compositions are topically applied to the skin twice a day [0114] (claim 34). Hammond teaches that patients prefer a skin care treatment that they need to only apply twice a day [0009].
Jang discloses that lactobionic acid is applied twice a day for 2 weeks to treat severe atopic dermatitis skin lesions (pg. 130, left column, third paragraph; abstract). Jang teaches that these treatment conditions significantly attenuated eczema symptoms and scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph).
Schmitt discloses that SCORAD is a method used to measure clinical signs of atopic dermatitis and SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract).
Dong discloses that in a clinical trial for the treatment of atopic dermatitis patients visited the hospital every two weeks and the dermatologist checked their condition each time to determine whether further treatment was needed. Dong teaches that this allowed the dermatologist to determine whether their condition worsened and if so, immediately initiate further treatment (abstract; pg. 6).
Stebbins discloses a composition for the skin with thickeners such as PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer [abstract] [0012] [0079] [0082]. Stebbins teaches that PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer act as thickeners in the composition to afford good sensory properties and so that the composition remains in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
The ordinarily skilled artisan would have been motived to include topically applying the composition twice a day, for between 12 and 20 days, identifying a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score, measuring the local SCORAD score after a time period to ensure whether further treatment is needed, wherein the time period is less than 4 weeks, and include PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer within the claims. The ordinarily skilled artisan would have been motived to apply to composition twice a day because Hammond teaches that patients prefer a skin care treatment that they need to only apply twice a day [0009], would have been motivated to apply the composition for between 12 and 20 days because Jang teaches that treatment for 14 days significantly attenuated eczema symptoms and that scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph), would have been motivated to measure the local SCORAD score because Schmitt teaches that SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract), would have been motivated to measure the local SCORAD after 2 weeks because Dong teaches that checking the patient after 2 weeks allowed the dermatologist to determine whether their condition worsened and if so, immediately initiate further treatment (abstract; pg. 6), and would have been motived to include PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer because Stebbins teaches that they act as thickeners in the composition to afford good sensory properties and so that the composition remains in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
Claims 2 and 4-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of U.S. Patent No. 11,890,294 B2 in view of Jang et al. (Journal of Investigative Dermatology, 2016, 136:127-135), Schmitt et al. (J ALLERGY CLIN IMMUNOL, 2013, 132: 1337-1347), Dong et al. (Scientific reports, 2021, 11:23539), and Stebbins et al. (US 2021/0128419 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other. The claims recite all of the features instantly recited for the method expect for the method comprises topically applying the composition for between 12 and 20 days, identifying a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score, that the method further comprises measuring the local SCORAD score after a time period to ensure whether further treatment is needed, wherein the time period is less than 4 weeks, or that the composition includes PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer.
Jang discloses that lactobionic acid is applied twice a day for 2 weeks to treat severe atopic dermatitis skin lesions (pg. 130, left column, third paragraph; abstract). Jang teaches that these treatment conditions significantly attenuated eczema symptoms and scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph).
Schmitt discloses that SCORAD is a method used to measure clinical signs of atopic dermatitis and SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract).
Dong teaches that in a clinical trial for the treatment of atopic dermatitis patients visited the hospital every two weeks and the dermatologist checked their condition each time to determine whether further treatment was needed. This allowed the dermatologist to determine whether their condition worsened and if so, immediately initiate further treatment (abstract; pg. 6).
Stebbins discloses a composition for the skin with thickeners such as PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer [abstract] [0012] [0079] [0082]. Stebbins teaches that PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer act as thickeners in the composition to afford good sensory properties and so that the composition remains in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
The ordinarily skilled artisan would have been motived to include topically applying the composition for between 12 and 20 days, identifying a patient suffering from moderate atopic dermatitis by measuring the local SCORAD score, measuring the local SCORAD score after a time period to ensure whether further treatment is needed, wherein the time period is less than 4 weeks, and to include PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer within the claims. The ordinarily skilled artisan would have been motived to apply the composition for between 12 and 20 days because Jang teaches that treatment for 14 days significantly attenuated eczema symptoms and that scratching frequency and duration were significantly reduced (pg. 130, left column, third paragraph), would have been motivated to measure the local SCORAD score because Schmitt teaches that SCORAD has adequate validity, responsiveness, interobserver reliability, and interpretability and is internally consistent (abstract), would have been motivated to measure the local SCORAD after 2 weeks because Dong teaches that checking the patient after 2 weeks allowed the dermatologist to determine whether their condition worsened and if so, immediately initiate further treatment (abstract; pg. 6), and would have been motived to include PEG-240/HDI copolymer bis-decyltetradeceth-20 ether and acrylates/C10-C30 alkyl acrylate copolymer because Stebbins teaches that they act as thickeners in the composition to afford good sensory properties and so that the composition remains in place on the keratinous surface to which it is applied so that it does not drip or run [0002]-[0003] [0047]-[0090].
Conclusion
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/ASHLEE E WERTZ/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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