DETAILED ACTION
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of t/e previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 7/14/2025 has been entered.
Status of Application
The Examiner acknowledges receipt of the amendments filed on 7/14/2025 wherein claims 5, 10, 15-19 have been amended, claim 2 has been cancelled and claims 20 and 21 have been added.
Claims 1-5, 8, 10 and 14-21 are presented for examination on the merits. The following rejections are made.
Response to 1.132 Declaration
The declaration under 37 CFR 1.132 filed 7/14/2025 is insufficient to overcome the rejection of claims 1, 3, 5, 8, 10 and 14 based upon 35 USC 103 over Spann-Wade et al. (U 2007/0053984), evidenced by Silveira et al. (Quim. Nova., 34(s), 2011, 292-299) as set forth in the last Office action because the rejection does not rely on US2008/0075677.
In regards to the content of the declaration, the document states that xanthan gum is not a galactomannan but instead a heteropolysaccharide. While galatomannans like guar gum and locust bean gum are primarily composed of mannose and galactose units, xanthan gum is not and cannot be said to be a galactomannan. Therefore, a skilled person would not easily substitute the xanthan gum used in Example 1 of US 2008/0075677 to obtain the claimed composition.
Applicant’s declaration is noted and considered persuasive that xanthan gum does not actually contain galactomannan as the Examiner alleged in the Advisory Action mailed 5/27/2025.
The declaration under 37 CFR 1.132 filed 5/14/2025 is insufficient to overcome the rejection of claims 1, 3, 5, 8, 10 and 14 based upon 35 USC 103 over Spann-Wade et al. (U 2007/0053984), evidenced by Silveira et al. (Quim. Nova., 34(s), 2011, 292-299) as set forth in the last Office action.
This declaration demonstrates that compositions comprising lycopene (a known antioxidant) provide improved wound closure capabilities when combined with 0.2% locust bean gum relative to compositions comprising other known antioxidants (e.g. NAC) or compositiosn comprising only locust bean gum. The declaration argues that the concentrations of gelling agents is not obvious because different concentrations of gelling agent result in different wound healing outcomes.
First, while the declaration shows that combinations of locust bean gum and lycopene outperform a control treatment of only locust bean gum (and locust bean gum and NAC), this alone is not sufficient to mitigate the rejection because a proper comparative analysis would require wound closure for both components individually. As of now, Applicant has provided only one. The data does not provide the outcome for wounds treated with only lycopene and/or the outcome for wounds treated with nothing. While the combination of locust bean gum and lycopene outperform locust bean gum alone, this cannot be said to be unexpected without data showing how lycopene performs on its own (or how the wound heals without application of any exogenous composition). Additional data is critical to better understand and asses the claims of unexpectedness.
Second, the data provided by declarant:
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provides the area covered for two related series of data: comparison between 0.1% LBG/0.001% lycopene and a control (0.1% LBG); and 0.01%LBG/0.001%lycopene outperforms the control (0.01% LBG). The 0.1%LBG/0.001%lycopene outperforms that of the comparative control. On its face the 0.01%LBG/0.001%lycopene outperforms the comparative control but taking into account the overlap in reported error, it is not clear that the combination provides any marked improvement relative to the control. This data is not found sufficient to demonstrate that the claimed combination always outperforms the control of only locust bean gum. It is also noted, as pointed out above, that the data does not demonstrate how application of the antioxidant alone would perform in increasing an area covered by cells.
Third, even if the declaration demonstrated that the inventors have identified something unexpected, the claims are not commensurate in scope with that provided by the declaration. Claim 1 is wide open to the concentrations of carotenoid, galactomannan and excipients and if Applicant has indeed found an unexpected outcome for some limited scope within the broader embodiments, then the claims would need to be structured to better reflect the finer points of what results in the unexpectedness.
Response to Applicants’ Arguments
Applicant’s arguments filed 7/14/2025 regarding the rejection of claims 1, 3, 5, 8 and 14 made by the Examiner under 35 USC 103 over Spann-Wade et al. (U 2007/0053984), evidenced by Silveira et al. (Quim. Nova., 34(s), 2011, 292-299) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 1/14/2025.
Applicant’s arguments filed 7/14/2025 regarding the rejection of claims 4, 10 and 15-19 made by the Examiner under 35 USC 103 over Spann-Wade et al. (U 2007/0053984), evidenced by Silveira et al. (Quim. Nova., 34(s), 2011, 292-299) further in view of Stier (US 2003/0091514) have been fully considered but they are not found persuasive and is MAINTAINED for the reasons of record in the office action mailed on 1/14/2025.
In response to the 103 rejections, Applicant asserts the following:
The declarations overcome the rejections of record.
In response to A, the Examiner is not persuaded that the declarations filed on 7/14/2025 and 5/14/2025 overcome the rejection of record. Applicant is directed to sections 4-11 above.
Regarding the rejection of record, Spann-Wade describes a composition that comprises a thickening agent that is useful as an aid to thicken or add structure to the final formulation, impart physical stability and increased viscosity (see [0055]). Exemplified thickeners include various gums and natural polysaccharides, with gum tragacanth specifically mentioned and the thickening agent is to be included in an amount between 0.1-5% (see [0220]). Tragacanth gum is comprised of galactomannans and so the ranges set forth by the instant claims would have been a direct outcome of an obvious composition.
Maintained Rejections, of Record (claims 1, 3-5, 8, 10 and 14-19) and New Rejections, Necessitated by Amendment (claims 20 and 21)
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3, 5, 8, 14 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Spann-Wade et al. (U 2007/0053984; of record), evidenced by Silveira et al. (Quim. Nova., 34(s), 2011, 292-299; of record).
Spann describes a topical gel composition comprising a thickening agent comprising gums (see [0055]) such as gum tragacanth (see [0219]) in an amount of between about 0.1-5% of the composition (see [0220]) (see instant claims 1, 10 and 15-21). It is noted that gum tragacanth naturally comprises galactomannan (see evidence to Silveira et al., page 296) as required by instant claims 1 and 8.
The composition may also include antioxidants. Exemplified antioxidants include carotenoids and carotenes such as beta-carotene and lycopene (see [0229]) (see instant claims 1, 3 and 8) wherein the antioxidant is present in an amount of between about 0.001-30% by weight of the composition (see [0230]) (see instant claims 10, 20 and 21).
Spann’s composition is to also include an active-drug that provide anti-inflammatory benefit such as turmeric root (see [0206]) (see instant claims 5 and 8) in an amount of between about 0.001-20% by weight of the composition (see [0208]).
Vitamins such as vitamin E and vitamin C are also contemplated for inclusion (see [0229]) (see instant claim 5).
The composition is to take the form a gel, hydrogel, lotions, solutions and so on (see [0084]) (see instant claim 13) wherein the composition possesses a viscosity of between about 2,000-50,000 cps (see [0029, 0225]) (see instant claim 14). Application of a 50,000 cps viscosity would have been readily envisaged upon the obvious selection of ‘hydrogel’. It is noted that 1 cps equals 1 mPas. See MPEP 2144.05(I) regarding obviousness of overlapping ranges.
Thus, in all, Spann suggests a composition comprising galactomannan (gum tracaganth), beta-carotene and/or lycopene as an antioxidant and turmeric root as an anti-inflammatory.
Regarding the intended use limitations and their outcomes as recited by instant claim 1 (e.g. ‘for use in therapeutic and/or cosmetic treatment of skin lesions in mammals’), the intended use limitations fail to add any structural element to the otherwise complete composition claimed. Instead, the limitations provide a means for which the composition may be used which fails to provide any structural limitation to the claimed composition. See MPEP 2111.02(II).
Regarding the requirement that the instant claims be limited by ‘consisting of’, the claims recite “one or more pharmaceutically acceptable excipient” which broadens the claims to include other materials in the composition such as surfactants, preservatives, dyes, fillers, bidners, etc..
The only difference between Spann and the instant claims is that Spann does not teach the specific combination of components as claimed in a single embodiment, or with sufficient specificity to be anticipatory. The specific combination of features claimed is disclosed within the teaching of Spann, but ‘such ‘picking and choosing’ within several variable does not necessarily give rise to anticipation. However, when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious. See MPEP 2141(I). Consistent with this reasoning, it would have been obvious to have selected each of the claimed agents outlined above from within Spann's disclosure to arrive at stable compositions useful for providing antioxidant and anti-inflammatory benefit.
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Claims 4, 10, 15-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Spann-Wade et al. (U 2007/0053984; of record), evidenced by Silveira et al. (Quim. Nova., 34(s), 2011, 292-299; of record) as applied to claims 1, 3, 5, 8, 14 and 20 above, and further in view of Stier (US 2003/0091514; of record), evidenced by Torr (US 3645836).
From the outset, it is noted that Spann teaches that antioxidants, e.g. beta-carotene and lycopene (see [0229]) are present in an amount of between about 0.001-30% by weight of the composition (see [0230]) and the anti-inflammatory turmeric root (see [0206]) is present in an amount of between about 0.001-20% by weight of the composition (see [0208]).
Spann fails to teach the galactomannan as being obtained from guar gum, Cassia gum, tara gum, mesquite gum, fenugreek gum and locust bean gum wherein the composition comprises between 0.5-3.0% galactomannan.
Steir describes an oral-care composition wherein the oral care composition is in the form of a gel (see claims 7 and 31), the composition comprising a thickening agent such as guar gum, locust bean gum and tragacanth gum (see [0029] and claim 19). It is noted that locust bean gum and guar gum are identified by instant claim 4 as a source of galactomannan. Torr is cited as evidence that guar gum is chemically a galactomannan (see column 1, lines 31-45). Regarding the obviousness of their inclusion in to Spann’s composition, the selection of a known material (guar gum, locust bean gum) based on its suitability for its intended use (thickening agent) is supportive of obviousness. See MPEP 2144.07. See also MPEP 2144.06 which states that the inclusion of equivalents known for the same purpose is strong evidence of obviousness.
Regarding instant claims 15-18, the selection of the obvious locust bean gum thickening agent from Steir for use in Spann’s composition would result in galactomannan being present in an amount between about 0.1-5% by weight (as guar gum is chemically a galactomannan) which would yield a range that overlaps with the ranges set forth by instant claims 15-18. See MPEP 2144.05(I)(A) regarding the obviousness of ranges.
Regarding instant claim 10, the combination of Spann and Stein would suggest a composition comprising locust bean gum (a thickening agent) in an amount of about 0.1-5%, antioxidants, e.g. beta-carotene and lycopene (see [0229]) in an amount of between about 0.001-30% by weight of the composition (see [0230]) and the anti-inflammatory turmeric root (see [0206]) in an amount of between about 0.001-20% by weight of the composition (see [0208]). Each of the suggested components are present in an amount overlapping with instant claim 10. Overlapping, approaching and similar ranges, amounts and proportions are considered obvious. See MPEP 2144.05(I).
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was filed, as evidenced by the references, especially in absence of evidence to the contrary.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE A PURDY whose telephone number is (571)270-3504. The examiner can normally be reached from 9AM to 5PM.
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/KYLE A PURDY/Primary Examiner, Art Unit 1611