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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 28, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 1 – 21 are examined here-in.
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.
(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 – 4, 8, 13, 14, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Allio (US 2016/0256383 A1).
Allio teaches compositions and methods for relief of a cough (abstract, paragraph 0004).
Allio teaches compositions with an inner liquid and a chewy outer layer which is solid, semi-solid, or gelatinous (paragraphs 0009, 0023-0024, 0047, Figure 1). Allio teaches the outer layer may comprise a botanical ingredient, of which marshmallow powder is an example, and the inner portion may comprise an active pharmaceutical ingredient, of which honey is an example (paragraphs 0026 – 0031, 0046 – 0047).
Allio’s teaching for a composition with a chewy outer layer and an inner portion, wherein marshmallow powder is the outer layer (paragraphs 0009, 0026 – 0031, 0047), anticipates instant claim 1.
Allio’s teaching that the outer layer completely encompasses the inner portion, as shown in Figure 1, anticipates instant claim 2.
Allio’s teaching that the inner portion is a liquid (paragraph 0009), anticipates instant claims 3 and 8.
Allio’s teaching that the inner portion is honey (paragraphs 0026 – 0031), anticipates instant claim 4.
Allio teaches the composition may include elderberry, stevia, and thyme, among other ingredients (paragraph 0009), anticipating instant claims 13 and 14.
Allio teaches a method for providing relief for a cough by administering such a composition (paragraphs 0009, 0023 – 0024), anticipating instant claims 19 and 20.
However, in the event that the previous does not have sufficient specificity to rise to anticipation, claims 1 – 4, 8, 13, 14, 19, and 20 are also rejected under 35 U.S.C. 103 below.
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 non-obviousness.
Claims 1 – 20 are rejected under 35 U.S.C. 103 as being unpatentable over Allio (as cited above).
For the purposes of this ground of rejection only, and purely arguendo, the examiner will take the position that Allio does not teach a specific embodiment (i.e., preferred embodiment, working example, etc.) having all of the claimed elements arranged as required by the claim without resorting to some “picking and choosing” within the prior art disclosure. That being said, although Allio thus would not be anticipatory by this interpretation of the facts, it nevertheless does fairly suggest the claimed invention, as shown below.
Allio teaches compositions and methods for relief of a cough (abstract, paragraph 0004).
Allio teaches compositions with an inner liquid and a chewy outer layer which is solid, semi-solid, or gelatinous (paragraphs 0009, 0023-0024, 0047 Figure 1). Allio teaches the composition may include marshmallow powder, honey, elderberry, stevia, and thyme, among other ingredients (paragraph 0009).
Allio teaches the outer layer may comprise a botanical ingredient, of which marshmallow powder is an example, and the inner portion may comprise an active pharmaceutical ingredient, of which honey is an example (paragraphs 0026 – 0031, 0046 – 0047).
Allio teaches that the amount of botanical ingredients and active pharmaceutical ingredients in the composition may be as low as 0.001 ug or as high as 22,000 mg (paragraphs 0070 – 0071). Allio teaches the weight ratio of pharmaceutical to botanical ingredients is in the range of 1:5 to 1:1 (paragraph 0072).
Allio teaches a method for providing relief for a cough by administering such a composition (paragraphs 0009, 0023 – 0024).
Claims 1 – 20 are rendered prima facie obvious over the teachings of Allio, because it is prima facie obvious to combine prior art elements according to known methods, in order to yield predictable results. In the instant case, all the claimed elements (e.g., chewy outer layer, inner liquid portion, marshmallow root, honey ) were known in the prior art (e.g., dosage formulations) 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 yielded nothing more than predictable results (e.g., a composition with a chewy outer layer comprising marshmallow root, inner liquid portion comprising honey) to one of ordinary skill in the art (MPEP 2143(i)(a)).
Allio’s teaching for a composition with a chewy outer layer and an inner portion, wherein marshmallow powder is the outer layer (paragraphs 0009, 0026 – 0031, 0047), reads on instant claim 1.
Allio’s teaching that the outer layer completely encompasses the inner portion, as shown in Figure 1, reads on instant claim 2.
Allio’s teaching that the inner portion is a liquid (paragraphs 0009, 0047, Figure 1), reads on instant claims 3 and 8.
Allio’s teaching that the inner portion is honey (paragraphs 0026 – 0031), reads on instant claim 4.
Instant claims 5 – 7 recite the center fill portion comprises honey in an amount ranging from about 1 to 4 mL, 2 to 3 mL, and 2.5 mL, respectively. Allio teaches that the amount of active pharmaceutical ingredients (which may be the inner portion) in the composition may be as low as 0.001 ug or as high as 22,000 mg (paragraphs 0070 – 0071). Honey has a density of 1.4 g / mL. According to calculations by the Examiner, the range of 0.001 ug to 22,000 mg as taught by Allio converts to a range of up to 15.7 mL. Allio’s teaching for up to 15.7 mL of honey as active pharmaceutical ingredient overlaps on the claimed ranges of 1 to 4 mL, 2 to 3 mL, and 2.5 mL, as recited in instant claims 5 – 7. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i).
Allio’s teaching that marshmallow is in the chewy outer layer, not in the inner portion (paragraphs 0009, 0026 – 0031, 0047), reads on instant claims 9 and 10. Allio’s teaching that marshmallow is in the chewy outer layer rather than the inner portion suggests that the “shell portion comprises at least 51% of the total amount of marshmallow root” as recited in instant claim 10.
Allio does not require the inclusion of high fructose corn syrup, artificial sweeteners, artificial flavors, gluten, or gelatin, reading on instant claims 11, 12, and 15.
Allio’s teaching that the composition may include elderberry, stevia, and thyme, among other ingredients (paragraph 0009), reads on instant claims 13 and 14.
Instant claims 16 – 18 recite the gummy form has a mass ranging from about 1 to 8 grams, 4 to 6 grams, and 5 grams, respectively. As an initial matter, Allio teaches that the amount of botanical ingredients and active pharmaceutical ingredients in the composition may be as low as 0.001 ug or as high as 22,000 mg (paragraphs 0070 – 0071). For an composition including both the botanical and active pharmaceutical ingredients, the total range becomes 0.002 ug to 44 g. This range overlaps the claimed ranges of 1 to 8 grams, 4 to 6 grams, and 5 grams. Claimed ranges that overlap teachings of the prior art are prima facie obvious according to MPEP 2144.05(i). Further, a person of ordinary skill in the art would have the expertise to determine an appropriate mass for the gummy form via routine experimentation. A person of ordinary skill in the art would recognize that a gummy formulation would be most attractive to the consumer in a bite-size form, rather than an extremely small or large amount. With this understanding, and considering the mass of most commercially available gummies, a person of ordinary skill in the art would see 1 to 10 grams as a suitable range to being routine optimization. Optimization within prior art conditions is prima facie obvious according to MPEP 2144.05(ii)(a).
Allio’s teaching for a method for providing relief for a cough by administering such a composition (paragraphs 0009, 0023 – 0024), reads on instant claims 19 and 20.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Allio (as cited above) and further in view of Naidu (US 2013/0064804 A1).
Allio’s teachings are discussed above.
Allio does not teach the gummy formulation includes melatonin.
Naidu teaches a missing element of Allio.
Naidu teaches melatonin is a naturally-occurring compound that modulates sleep patterns (paragraphs 0023 – 0025). Naidu teaches that melatonin is used to treat sleep-associated conditions such as jet lag and insomnia (paragraphs 0058, 0071).
Naidu teaches that coughing is disruptive to sleep (paragraph 0161). Naidu’s teaching that melatonin modulates sleep patterns and can be used to treat sleep-associated conditions (paragraphs 0023 – 0025, 0058, 0071) suggests that melatonin can mitigate sleep disruption resulting from a cough.
The combination of Allio and Naidu’s teachings renders instant claim 21 prima facie obvious according to MPEP 2143(i)(g). A person of ordinary skill in the art would be motivated to include melatonin in the gummy formulation of Allio because Naidu suggests that melatonin can mitigate sleep disruption resulting from a cough. The modification of Allio’s gummy formulation according to Naidu’s teachings is prima facie obvious because Naidu’s teachings would have led one of ordinary skill to modify the prior art reference of Allio to arrive at the claimed invention (MPEP 2143(i)(g)).
Allio’s teaching for a method for providing relief for a cough by administering a composition with a chewy outer layer and an inner portion, wherein marshmallow powder is the outer layer (paragraphs 0009, 0023 – 0024, 0026 – 0031, 0047), reads on instant claims 19 and 20. A person of ordinary skill in the art would be motivated to modify Allio’s gummy formulation to include melatonin because Naidu suggests that melatonin can mitigate sleep disruption resulting from a cough (paragraphs 0023 – 0025, 0058, 0071, 0161). Thus, the combination of Allio’s teaching for a method for providing relief for a cough by administering a gummy formulation, as modified by Naidu’s teaching to include melatonin in a formulation to mitigate sleep disruption, reads on instant claim 21.
Conclusion
All claims are rejected. No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Toriana N. Vigil whose telephone number is (571)270-7549. The examiner can normally be reached Monday - Friday 9:00 a.m. - 5:00 p.m. EST.
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/TORIANA N. VIGIL/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612