NON-FINAL REJECTION
This application, filed Mar. 22, 2024, claims benefit of priority to Provisional Application 63/454,382, filed Mar. 24, 2023.
Claims 1-23, as amended, are pending.
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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Aug. 19, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 U.S.C. § 112(b) – Indefiniteness
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 7-13, 17, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 is drawn to:
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Dependent claims 7-10 and 17 recite the term "about" in relation to the frequency of application; and dependent claims 11-13 and 18 recite the term "about" in relation to the period of time (duration or interval) over which the compositions are administered:
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However, the term "about" is a term of degree which is defined in the specification only in relation to the weight (percentage or concentration) of retinoid in the claimed compositions:
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As recognized by MPEP § 2173.05(b)(I), "[i]f the specification does not provide some standard for measuring that degree, a determination must be made as to whether one of ordinary skill in the art could nevertheless ascertain the scope of the claim (e.g., a standard that is recognized in the art for measuring the meaning of the term of degree). . . . The claims, when read in light of the specification and the prosecution history, must provide objective boundaries for those of skill in the art")."
For example, it is unclear whether "about once every other day," as recited by claim 7, encompasses, e.g., once every third day; or whether "at least from about 5 days to about 12 days," as recited by claim 11, encompasses a period of, e.g., 4 days, or 14 days.
Thus, the scope and meaning of the term "about" is ambiguous. The specification does not provide a standard for ascertaining the requisite degree, such that one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Because infringing methods cannot be distinguished from non-infringing methods, the term "about" renders the metes and bounds of the claims 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 1-6, 14-16, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Truchuelo et al. (J Clin Exp Dermatol Res. 13:606 (2022), cited on PTO-892).
Truchuelo et al. report the results of a 12-week study in which progressive use of high concentrations of retinol (0.5% and 1%) was effective and well-tolerated by most patients (abstract). Since one of the main adverse effects of retinoids is irritant dermatitis, it is especially useful to identify a treatment regimen with high-concentration retinoids that also ensures optimal tolerability.
The aim of the study was to determine the efficacy and tolerability of a protocol using different concentrations of retinol (0.5% and 1%). The compositions were applied to the face at night with increasing frequency and at increasing retinol concentrations (p. 2, right col.), according to the schedule shown in Table 2 (p. 3):
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In addition to retinol, participants applied the transition moisturizer day and night throughout the study, accompanied by applying SPF 50 sun protection in the morning. Evaluations took place on days 0, 15, 50, 70, and 90 (D0, D15, D50, D70 and D90) (p. 3).
As shown in Table 2, the retinization protocol of Truchuelo et al. comprises the steps of
(1) D0: topically applying to the skin a first composition comprising 0.5% retinol at a first frequency (twice per week) for a first period of time (two weeks);
(2) D15: topically applying to the skin the first composition comprising 0.5% retinol at a second frequency (four times per week) for a second period of time (two weeks);
(3) D70: topically applying to the skin a second composition comprising 1% retinol at a third frequency (twice per week) for a third period of time (three weeks); and
(4) D90: topically applying to the skin the second composition comprising 1% retinol at a fourth frequency (three times per week) for a fourth period of time (two weeks),
as recited by claims 1, 2, 14, and 15.
The first composition comprises 0.5% retinol, which falls within the range of about 0.01 to about 1.2 wt. % retinoid by total weight of the composition, as recited by claim 3.
The second composition comprises 1% retinol, which falls within the range of about 0.75 to about 2.5 wt. % retinoid by total weight of the composition, as recited by claim 4.
As shown in Table 2, the first frequency (twice per week) is lower than the second frequency (four times per week), as recited by claim 5.
As shown in Table 2, the third frequency (twice per week) is lower than the fourth frequency (three times per week), as recited by claim 6.
The retinization protocol of Truchuelo et al. administers the same concentration of retinol (0.5%) for 7 weeks: 2x/week during weeks 1-2; 4x/week during weeks 3-4; and 5x/week during weeks 5, 6, and 7 (Table 2), which reads on a method in which the first and second compositions and the first and second concentrations are the same, as recited by claim 16.
As noted above, the retinization protocol of Truchuelo et al. further comprises topically applying to the skin a composition comprising a moisturizer that is substantially free of a retinoid, as recited by claim 22.
For the foregoing reasons, Truchuelo et al. anticipates claims 1-6, 14-16, and 22.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Truchuelo et al. (J Clin Exp Dermatol Res. 13:606 (2022)) in view of Meyers et al. (USPN 5,401,517); Santhanam et al. (USPN 10,123,954); and Mellody et al. (Int J Cosmet Sci. 44: 625–635 (2022)) (all cited on PTO-892).
Truchuelo et al. report the results of a 12-week study in which progressive use of high concentrations of retinol (0.5% and 1%) was effective and well-tolerated by most patients (abstract). Since one of the main adverse effects of retinoids is irritant dermatitis, it is especially useful to identify a treatment regimen with high-concentration retinoids that also ensures optimal tolerability.
The aim of the study was to determine the efficacy and tolerability of a protocol using different concentrations of retinol (0.5% and 1%). The compositions were applied to the face at night with increasing frequency and at increasing retinol concentrations (p. 2, right col.), according to the schedule shown in Table 2 (p. 3):
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In addition to retinol, participants applied the transition moisturizer day and night throughout the study, accompanied by applying SPF 50 sun protection in the morning. Evaluations took place on days 0, 15, 50, 70, and 90 (D0, D15, D50, D70 and D90) (p. 3).
As shown in Table 2, the retinization protocol of Truchuelo et al. comprises the steps of
(1) D0: topically applying to the skin a first composition comprising 0.5% retinol at a first frequency (twice per week) for a first period of time (two weeks);
(2) D15: topically applying to the skin the first composition comprising 0.5% retinol at a second frequency (four times per week) for a second period of time (two weeks);
(3) D70: topically applying to the skin a second composition comprising 1% retinol at a third frequency (twice per week) for a third period of time (three weeks); and
(4) D90: topically applying to the skin the second composition comprising 1% retinol at a fourth frequency (three times per week) for a fourth period of time (two weeks),
as recited by claims 1, 2, 14, and 15.
The first composition comprises 0.5% retinol, which falls within the range of about 0.01 to about 1.2 wt. % retinoid by total weight of the composition, as recited by claim 3.
The second composition comprises 1% retinol, which falls within the range of about 0.75 to about 2.5 wt. % retinoid by total weight of the composition, as recited by claim 4.
As shown in Table 2, the first frequency (twice per week) is lower than the second frequency (four times per week), as recited by claim 5.
As shown in Table 2, the third frequency (twice per week) is lower than the fourth frequency (three times per week), as recited by claim 6.
The retinization protocol of Truchuelo et al. administers the same concentration of retinol (0.5%) for 7 weeks: 2x/week during weeks 1-2; 4x/week during weeks 3-4; and 5x/week during weeks 5, 6, and 7 (Table 2), which reads on a method in which the first and second compositions and the first and second concentrations are the same, as recited by claim 16.
As noted above, the retinization protocol of Truchuelo et al. further comprises topically applying to the skin a composition comprising a moisturizer that is substantially free of a retinoid, as recited by claim 22.
Truchuelo et al. does not explicitly disclose pausing the application of the first or second composition if irritation on the skin occurs, as recited by claim 19; topically applying a moisturizer to the skin until the irritation subsides, as recited by claim 20; or resuming the method at the step previous to the step when paused, as recited by claim 21.
However, Santhanam et al. disclose methods of treating skin to diminish signs of aging,
comprising topically applying at least two separate compositions, in a sequential, rotating, or alternating fashion to overcome adaptation, tolerance, or sensitization phenomena (abstract).
In particular, Santhanam et al. (claims 1-2) claim methods for diminishing dermatological signs of aging in human skin comprising, in any order, the steps of
(1) topically applying, at least once daily, a first skin treatment composition comprising an effective amount of retinol for 2 to 15 days;
(2) topically applying, at least once daily, a second skin treatment composition comprising a moisturizer, for 2 to 15 days; and
(3) repeating steps (1) and (2) to diminish said dermatological signs of skin aging.
Thus, Santhanam et al. disclose, teach, and suggest a flexible retinization protocol wherein the application of the first or second composition is paused, as recited by claim 19; topically applying a moisturizer to the skin, as recited by claim 20; and resuming application of the retinol composition(s), as recited by claim 21.
Truchuelo et al. differs from claims 7-13, 17, 18, and 23 in the application frequency and duration, as follows:
Claimed Method
Truchuelo et al. (Table 2)
7. the first frequency is about once every other day
Two times per week
8. the second frequency is about once every day
Four times per week
9. the third frequency is about once every other day or twice per day
Two times per week
10. the fourth frequency is about once or twice per day
Three times per week
11. the first, second, and third periods of time are each at least from about 5 days to about 12 days
First interval: 2 weeks (14 days)
Second interval: 2 weeks (14 days)
Third interval: 3 weeks (21 days)
Fourth interval: 2 weeks (14 days)
12. the first, second, and third periods of time are each about 7 days
13. the fourth period of time is at least about 5 days
17. the first frequency is about once every third day, the second frequency is about once every other day, and the third frequency is about once every day
First frequency: twice per week
Second frequency: four times per week
Third frequency: twice per week
Fourth frequency: three times per week
18. the first, second, and third periods of time are each about 2 weeks, and the fourth time period is at least one day
First interval: 2 weeks (14 days)
Second interval: 2 weeks (14 days)
Third interval: 3 weeks (21 days)
Fourth interval: 2 weeks (14 days)
23. the second time period runs concurrently with the third or fourth time periods
Intervals run consecutively, not concurrently
However, retinization protocols employing slightly varying concentrations, frequencies, and durations are well-known in the art.
For example, Meyers et al. disclose methods for improving skin condition through a progressive program to acclimate the skin and minimize potential irritation, by applying retinol or retinoic acid to facial skin in gradually increasing concentrations over time (abstract).
Example 1 of Meyers et al. illustrates a treatment system wherein starter composition 1 (0.01% retinol) is applied to the face daily for two weeks. For a subsequent two weeks, starter composition 2 (0.025% retinol) is applied daily to the face. After the fourth week, starter composition 3 (0.05% retinol) is applied daily to the face for a successive two weeks. Finally, maintenance composition 4 (0.1% retinol) is applied daily to the face beginning at the seventh week and continued for at least two months (Example 1; Table I). In addition, Meyers et al. claim methods wherein the retinoid compositions are applied "separately on a plurality of days" (claims 1-3) without specifying the frequency or duration of application.
Further, Mellody et al. report a study in which cohort 1 (n = 115) applied a formulation containing 0.3% w/w retinol, whilst cohort 2 (n = 103) applied a formulation containing 1% w/w retinol, followed by application of their usual night-time moisturizer every evening (pp. 628-629). Participants applied the formulations to the full face in the evenings, according to the schedule shown in Table 2:
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In addition, Santhanam et al. disclose, teach, and suggest a flexible retinization protocol wherein the first composition (retinol) and the second composition (moisturizer) are applied according to a sample schedule shown in Fig. 3 (below left). In this embodiment, treatment periods "A" and "B" are each 7 days long, as recited by claims 11 and 12. In another embodiment, treatment period "A" is 5 days long and treatment period "B" is 2 days long (col. 20, lines 6-11).
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Further, Figs. 12A and 12B of Santhanam et al. (above right) illustrate embodiments wherein the two compositions are contained in separate reservoirs in a single container. FIG. 12A also has an identifier indicating each day of the week visible on the container's exterior. FIG. 12B illustrates a variant of the embodiment of FIG. 12A in which a circular sticker has been placed on the day of the week on which treatment began (in this case, Monday or “M”) (col. 13, lines 23-36).
Thus, a retinol treatment regimen in which the application freuquency and duration can be tailored to each patient's needs is implicit in the design of the containers themselves.
As this sampling of prior art retinization protocols demonstrates, it would have been predictable to one of ordinary skill in the art as of the filing date to adjust the application frequency of Truchuelo et al., so that:
the first frequency is about once every other day, as recited by claim 7;
the second frequency is about once every day, as recited by claim 8;
the third frequency is about once every other day or twice per day, as recited by claim 9;
the fourth frequency is about once every day or twice per day, as recited by claim 10;
the first frequency is about once every third day, the second frequency is about once every other day, and the third frequency is about once every day, as recited by claim 17;
and to adjust the application intervals of Truchuelo et al., so that:
the first, second, and third periods of time are each independently at least from about 5 days to about 12 days, as recited by claim 11;
the first, second, and third periods of time are each independently about 7 days, as recited by claim 12;
the fourth period of time is at least about 5 days, as recited by claim 13;
the first, second, and third periods of time are each independently about 2 weeks, and the fourth time period is at least one day, as recited by claim 18; and
the second time period runs concurrently with the third or fourth time periods, as recited by claim 23,
with a reasonable expectation of success, because redness and irritation were well-known side effects of topical retinol treatment requiring a personalized balance to achieve treatment benefits while minimizing side effects. This is taught and suggested by all the cited references, which are in the identical field of endeavor as the claimed invention, and solve the identical problem.
Further, adjustments in the frequency and/or duration of application amount to routine optimization of result-effective variables, as this would have an effect similar to increasing or decreasing the applied concentration or dosage over a given period of time. Optimizing drug dosage, frequency, and/or duration based on patient-specific variables is a routine aspect of therapeutic drug monitoring, because those skilled in the art were aware that each patient's response to retinol treatment will be unique.
As recognized by MPEP § 2144.05,
Generally, differences in concentration or tempera-ture will not support the patentability of subject mat-ter 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 dis-cover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Citation of Additional Prior Art
Additional references made of record are considered pertinent to applicant's disclosure:
USPN 9,956,151; USPN 9,968,538; and USPN 10,022,315 (all cited on PTO-892).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARA E. TOWNSLEY whose telephone number is 571-270-7672. The examiner can normally be reached on Mon-Fri from 10:00 am to 6:00 pm (EST). If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Jeff S. Lundgren, can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E. TOWNSLEY/Examiner, Art Unit 1629
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