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 .
Status of Claims
Receipt of Applicant’s response, dated 06/26/2025, is acknowledged.
Claims 1-4, 8-13, and 15-18 are pending.
Claims 5-7 and 14 are canceled.
Claims 1-2, 11, and 13 are amended.
Claims 15-18 are new.
Claims 8-10 remain withdrawn from further consideration as being drawn to a nonelected invention.
Claims 1-4, 11-13, and 15-18 are under consideration in the instant Office action to the extent of the elected species, i.e., the encapsulation shell is polymers, the phenolic compound is methyl salicylate, and the polymer is beta-cyclodextrin.
OBJECTIONS/REJECTIONS WITHDRAWN
Objections to the Specification
The objections to the abstract and to the specification set forth in the Office action dated 04/28/2025 are hereby withdrawn in light of Applicant’s amendment to the abstract and to the specification.
Claim Objections
The objections to claims 1-2, 5, and 11 set forth in the Office action dated 04/28/2025 are hereby withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112(b)
The indefiniteness rejections of claims 2-7 and 12-14 set forth in the Office action dated 04/28/2025 are hereby withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 112(d)
The rejections of claims 5-6 for being of improper dependent form set forth in the Office action dated 04/28/2025 are hereby withdrawn in light of Applicant’s amendment to the claims.
Claim Rejections - 35 USC § 103
The obviousness rejections of claims 1-7 and 11-14 over Trinh et al and of claims 1-6 and 12-13 over Preslar et al set forth in the Office action dated 04/28/2025 are hereby withdrawn in light of Applicant’s amendment to the claims and in favor of the new grounds of rejection set forth below as necessitated by Applicant’s amendment.
REJECTIONS MAINTAINED AND MADE AGAIN
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 1-4 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Filippa et al (J. Pharm. Biomed. Anal., 2008, 48, 969-973, published 06/14/2008, cited in Notice of References Cited dated 04/28/2025).
Filippa et al teach the formation of methyl salicylate inclusion complexes with beta-cyclodextrin in an aqueous methanolic solution, wherein methyl salicylate is encapsulated in beta-cyclodextrin (e.g., Title, Abstract, Page 4 Discussion, Conclusion, Figure 3).
The solution of methyl salicylate-beta-cyclodextrin inclusion complexes reads on instant claims 1-4 and 12-13.
Regarding the preamble of instant claim 1, per MPEP 2111.02, a recitation of the preamble must result in structural difference to limit the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation (Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). Thus, the recitation of “for activating a plant’s natural defense mechanisms to extend the shelf life of its produce and preserve its quality” is a statement that does not structurally limit the claim and merely recite intended use or purpose of the composition.
Further regarding instant claim 1, because the solution of Filippa et al is the same as the composition of the instant claims, i.e., comprises methyl salicylate encapsulated by beta-cyclodextrin, the solution of Filippa et al necessarily slows down the ethylene biosynthesis pathway and restricts the microbial growth on it. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Claims 1-4 and 12-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nelson et al (US 5,945,087, published 08/31/1999, cited in Notice of References Cited dated 04/28/2025).
Nelson et al teach oral rinse and dentifrice compositions comprising a phenolic compound, including methyl salicylate, and a cyclodextrin, including beta-cyclodextrin, wherein the phenolic compound occupies the cavity of the cyclodextrin (e.g., Abstract, Col. 4 Lines 18-28). Each of examples 1-2 and 4-5 contain an exemplified dental rinse composition comprising methyl salicylate and beta-cyclodextrin (e.g., Col. 6 Line 65-Col. 9 Line 22).
The composition of Nelson et al comprising methyl salicylate and beta-cyclodextrin reads on instant claims 1-4 and 12-13.
Regarding the preamble of instant claim 1, per MPEP 2111.02, a recitation of the preamble must result in structural difference to limit the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation (Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). Thus, the recitation of “for activating a plant’s natural defense mechanisms to extend the shelf life of its produce and preserve its quality” is a statement that does not structurally limit the claim and merely recites intended use or purpose of the composition.
Further regarding instant claim 1, because the composition of Nelson et al is the same as the composition of the instant claims, i.e., comprises methyl salicylate encapsulated by beta-cyclodextrin, the composition of Nelson et al necessarily slows down the ethylene biosynthesis pathway and restricts the microbial growth on it. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
NEW GROUNDS OF OBJECTIONS/REJECTIONS
Claim Objections
Claim 16 is objected to because “beta cyclodextrin” in line 2 should be amended to “beta-cyclodextrin” in order to improve the consistency of the claim language (See claim 13).
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 1-4, 11-13, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Trinh et al (ES 2234127 T3, published 06/16/2005, cited in Notice of References Cited dated 04/28/2025) as evidenced by Millipore Sigma (“Methyl salicylate”, cited in Notice of References Cited dated 04/28/2025) and Millipore Sigma (“β-Cyclodextrin”, cited in Notice of References Cited dated 04/28/2025).
Trinh et al teach food cleaning compositions and methods of treating food with the compositions (e.g., Page 1 Par. 6 of English translation). The food cleaning compositions restore the freshness of the food and provide an olfactory signal in the form of a pleasant odor such as a fruit odor that reduces/eliminates unwanted malodor, wherein the pleasant olfactory signal is provided by a non-permanent perfume (e.g., Page 1 Par. 6-7 of English translation). The food cleaning compositions are in solid, powdered, or granulated form and the non-permanent perfume is contained in a water-activated perfume vehicle that dislodges the perfume by diluting the composition with water (e.g., Page 1 Par. 7 of English translation). The foods that are treated include agricultural products, especially fruits and vegetables (e.g. Page 2 Par. 7 of English translation).
The preferred food cleaning composition of Trinh et al is in the form of a solid powder concentrate that can be diluted with water using from 0.1% to 5% of the concentrate, where percentage is by weight of the food cleaning composition. The solid powder concentrate composition comprises at least an effective amount of food-friendly disinfectant to reduce the level of microorganisms, an effective amount of non-permanent, food-friendly perfume wherein all or part of said non-permanent perfume composition is encapsulated, e.g. in cyclodextrin and/or in microcapsules that are activated with moisture, and from 0.1% to 50% by weight of a food suitable detergent surfactant, where the remaining balance is an inert filler (e.g., Page 3 Par. 3-11 of English translation).
The non-permanent perfume may be composed of hydrophilic perfume ingredients, where the most preferred hydrophilic perfume ingredients to be used include methyl salicylate (e.g., Page 7 Par. 3 of English translation).
The composition comprises all or part of the perfume in the form of encapsulated perfume particles suitable for moisture-activated foods. The encapsulated particles act as protective vehicles and reduce the loss of perfume prior to use. It is preferred to use solid perfume encapsulated particles that are not easily breakable, with perfume/cyclodextrin inclusion complexes being especially preferred (e.g., Page 8 Par. 6 of English translation).
It is typically desirable that at least most of the encapsulation material in of the perfume/cyclodextrin complexes be alpha-cyclodextrin, beta-cyclodextrin and/or gamma-cyclodextrin, more preferably beta-cyclodextrin (e.g., Page 9 Par. 5 of English translation).
The non-permanent perfume can be added in very low levels, e.g., up to 0.5%, by weight of the composition (e.g., Page 6 Par. 7 of English translation). The perfume/cyclodextrin complexes can have a perfume/cyclodextrin compound molar ratio of about 1:1 (e.g., Page 9 Par. 4 of English translation).
Trinh et al teach packaging the composition in a container with instructions for use relative to exposure time and suitable dilution to obtain a suitable disinfection/sterilization. Trinh et al teach that the instructions for use will aid the consumer by providing suitable dilution and/or use information to remove/destroy the microorganisms. A special advantage of the product is that it can be used for this purpose at a time of the food production process in which recontamination is minimal (e.g., Page 12 Par. 4 of English translation).
The food cleaning composition of Trinh et al comprising methyl salicylate as the non-permanent perfume and beta-cyclodextrin as the encapsulation material and the packaging of the composition in a container with instructions for use render obvious the composition of instant claims 1-4, 11-13, and 15-18.
Regarding the preamble of instant claim 1, per MPEP 2111.02, a recitation of the preamble must result in structural difference to limit the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation (Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). Thus, the recitation of “for activating a plant’s natural defense mechanisms to extend the shelf life of its produce and preserve its quality” is a statement that does not structurally limit the claim and merely recite intended use or purpose of the composition.
Further regarding instant claim 1, because the food cleaning composition of Trinh et al is the same as the composition of the instant claims, i.e., comprises methyl salicylate encapsulated by beta-cyclodextrin, the food cleaning composition of Trinh et al necessarily slows down the ethylene biosynthesis pathway and restricts the microbial growth on it. A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present (In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Trinh et al teach that the non-permanent perfume is added up to 0.5% by weight of the composition and that the perfume/cyclodextrin compound molar ratio of about 1:1 (supra). It is reasonable to conclude that the food cleaning composition of Trinh et al comprising equimolar amounts of methyl salicylate and beta-cyclodextrin, the amount being up to 0.5% by weight, diluted with water from 0.1 to 5% to form a 1 L solution renders obvious the requirements of concentration required by the instant claims. The instant claims 15-18 require that a 1 L solution of the composition in water comprises ~0.01 to ~0.03 mol of methyl salicylate and ~0.01 to ~0.03 mol of beta-cyclodextrin (methyl salicylate: (1.0 mL/L x 1 L x 1.174 g/mL x mol/152.15 g ~ 0.01 mol; 3.5 mL/L x 1 L x 1.174 g/mL x mol/152.15 g ~ 0.03 mol; Molecular weight and density evidenced by Millipore Sigma; beta-cyclodextrin: 11 g/L x 1 L x mol/1134.98 g ~ 0.01 mol; 30 g/L x 1 L x mol/1134.98 g ~ 0.03 mol; Molecular weight evidenced by Millipore Sigma). A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
The specific combination of features claimed is disclosed within the broad generic ranges taught by Trinh et al but such “picking and choosing” within several variables does not necessarily give rise to anticipation (Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989)). Where, as here, the reference does not provide any motivation to select this specific combination of variables of non-permanent perfume and encapsulation material in the food cleaning composition of Trinh et al, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen 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” (KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR at 1741). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton” (Id. at 1742).
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected various combinations of various disclosed ingredients of a food cleaning composition from within the prior art disclosure of Trinh et al, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1-4, 12-13, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Preslar et al (WO 2017/143311 A1, published 08/24/2017, cited in Notice of References Cited dated 04/28/2025).
Preslar et al teach a composition comprising a delivery material and at least one active ingredient, for release or controlled-release of the at least one active ingredient (e.g., Page 4 Lines 11-15). Preslar et al teach that the composition can be used to improve the quality and shelf life of produce, where produce means agricultural and horticultural products, including pre- and post-harvest unprocessed and processed agricultural and horticultural products, e.g., fruits, vegetables, flowers, ornamental plants, herbs, grains, seeds, fungi (e.g. mushrooms) and nuts. The quality and shelf life of produce may be improved, for example, by inhibiting the effects of ethylene, promoting the effects of ethylene, enhancing or maintaining shelf life, color, firmness, weight, sweetness, flavor, heat or chill temperature tolerance, resistance to microbes, fungi, or other pathogens, and/or humidity tolerance (e.g., Page 16 Line 25-Page 17 Line 1).
The active ingredient may include volatile plant hormones known to effect plant biological processes for the purpose of improving crop yield, quality, taste, or extending produce shelf-life, including methyl salicylate (e.g., Page 22 Lines 7-9).
The delivery material may comprise a complexing agent, and the interaction between an active ingredient and a complexing agent can be described as "host-guest" chemistry, in which the active ingredient is the guest and the complexing agent is the host, and the complexing agent can be described as a compound that has a lock and key structure whereby a substrate selectively fits into the encapsulation site. The complexing agent may be β-cyclodextrin (e.g., Page 28 Lines 8-9 and 19-23).
Preslar et al teach β-cyclodextrin as the complexing agent in a concentration of 0-20 mol% of the delivery material (e.g., Page 29 Lines 8-9). Preslar et al teach the delivery material comprising 0-99.99 wt% of the composition (e.g., claim 44) and the active ingredient is present in the composition from about 0.01 wt% to 30 wt% (e.g., Page 5 Lines 27-29, claim 88).
The composition of Preslar et al comprising beta-cyclodextrin as complexing agent in the delivery material and methyl salicylate as at least one active ingredient renders obvious the composition of instant claims 1-4, 12-13, and 15-16.
The composition of Preslar et al comprising from about 0.01 wt% to 30 wt% of methyl salicylate, from 0-99.99 wt% of the delivery material, the delivery material comprising from 0-20 mol% beta-cyclodextrin, necessarily overlaps the concentrations of methyl salicylate and beta-cyclodextrin of instant claims 15 and 16. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
The specific combination of features claimed is disclosed within the broad generic ranges taught by Preslar et al but such “picking and choosing” within several variables does not necessarily give rise to anticipation (Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989)). Where, as here, the reference does not provide any motivation to select this specific combination of variables of active ingredient and delivery material comprising a complexing agent in the composition of Preslar et al, anticipation cannot be found.
That being said, however, it must be remembered that “[w]hen 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” (KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 U.S.C. 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ” (KSR at 1741). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton” (Id. at 1742).
Consistent with this reasoning, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have selected various combinations of various disclosed ingredients of a composition from within the prior art disclosure of Preslar et al, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Response to Applicant’s Arguments
Applicant’s arguments filed on 06/26/2025 have been considered.
Applicant argues that Filippa et al is just making a reference to beta-cyclodextrin – the host molecule – and methyl salicylate – the guest molecule – with solvents to facilitate complexation and analysis and that Filippa et al do not disclose any active ingredient or excipient carrier but merely describe an HPLC process using methyl salicylate and beta-cyclodextrin.
The above argument has been fully considered by the Examiner but is not found persuasive because Applicant’s claimed composition is merely an active ingredient and an encapsulation shell, i.e., methyl salicylate encapsulated in beta-cyclodextrin, which is identical to the teaching of Flippa et al (see the maintained rejection under 35 USC 102 above), which reads on instant claims 1-4 and 12-13. Applicant is reminded that the intended use of the claimed invention (e.g., instant claim 1 “for activating a plant’s natural defense mechanisms to extend the shelf life of its produce and preserve its quality”) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation (Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). Applicant should focus on distinguishing the structure of the composition from that of Filippa et al.
Applicant argues that Nelson et al uses beta-cyclodextrin to form inclusion complexes with phenolic compounds like thymol, menthol, and methyl salicylate to enhance their solubility and stability in oral care products, and that methyl salicylate is explicitly mentioned as one of the active agents complexed with beta-cyclodextrin to improve delivery and reduce irritation in mouthwashes and toothpastes.
The above argument has been fully considered by the Examiner but is not found persuasive because Applicant’s claimed composition is merely an active ingredient and an encapsulation shell, i.e., methyl salicylate encapsulated in beta-cyclodextrin, which is identical to the teaching of Nelson et al (see the maintained rejection under 35 USC 102 above), which reads on instant claims 1-4 and 12-13. Applicant is reminded that the intended use of the claimed invention (e.g., instant claim 1 “for activating a plant’s natural defense mechanisms to extend the shelf life of its produce and preserve its quality”) must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation (Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997). Applicant should focus on distinguishing the structure of the composition from that of Nelson et al.
Applicant argues that Preslar et al focus on other antimicrobial agents and delivery systems, that methyl salicylate is neither a key active ingredient nor discussed in depth, and that beta-cyclodextrin is used as a complexing agent and not as an encapsulating agent as in the instant application.
Regarding the argument that beta-cyclodextrin is used as a complexing agent and not as an encapsulating agent in the teaching of Preslar et al, as seen above in the new grounds of rejection under 35 USC 103, the complexing agent, which may be beta-cyclodextrin, is described as a compound that has a lock and key structure whereby a substrate, which may be methyl salicylate, selectively fits into the encapsulation site. Regarding the argument that Preslar et al focus on other antimicrobial agents and delivery systems and that methyl salicylate is neither a key active ingredient nor discussed in depth, Applicant is reminded that a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments (Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989)) and that it is well settled that it is a matter of obviousness for one of ordinary skill in the art to select a particular component from among many disclosed by the prior art as long as it is taught that the selection will result in the disclosed effect, even when the possible selections number 1200 or in the thousands (Merck & Co., Inc. v. Biocraft Labs., Inc., 874 F.2d 804, 807 (Fed. Cir. 1989); In re Corkill, 771 F.2d 1496, 1500 (Fed. Cir. 1985)).
Applicant argues that in the teaching of Trinh et al, beta-cyclodextrin functions as an encapsulating agent and/or complexing agent for volatile compounds such as methyl salicylate, however, methyl salicylate is mentioned as a volatile perfume component and the composition ratios differ significantly from the claimed composition.
The above argument has been fully considered by the Examiner but is not found persuasive because, as seen above in the new grounds of rejection under 35 USC 103, Trinh et al teach a composition comprising an encapsulated non-permanent perfume, wherein the non-permanent perfume may be methyl salicylate and the encapsulation material may be beta-cyclodextrin, which meets the limitations of instant claims 1-4 and 12-13. The teaching that methyl salicylate is mentioned as a perfume component does not conflict with the limitation of methyl salicylate as ‘an active ingredient’ of the instant claims. Regarding the argument that the composition ratios of Trinh et al differ significantly from the claimed composition, this is not found persuasive because, as seen above in the new grounds of rejection under 35 USC 103, Trinh et al teach that the non-permanent perfume is added up to 0.5% by weight of the composition and that the perfume/cyclodextrin compound molar ratio of about 1:1, for which it is reasonable to conclude that the composition of Trinh et al comprising equimolar amounts of methyl salicylate and beta-cyclodextrin, the amount being up to 0.5% by weight, diluted with water from 0.1 to 5% to form a 1 L solution renders obvious the requirements of concentration required by the instant claims. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Applicant argues that the ratios of methyl salicylate to beta-cyclodextrin of 1:0.5, 1:1, 1:2, 1:5, wherein 1:1 gave the best entrapment efficiency, of Trinh et al do not render obvious the ratios of methyl salicylate to beta-cyclodextrin of instant claims 15-16, for which Applicant has converted the concentration ranges recited in instant claims 15-16 to a molar ratio range of methyl salicylate to beta-cyclodextrin of from 1:3.9 to 2.78:1. Specifically, Applicant argues that the molar ratio range of methyl salicylate to beta-cyclodextrin of from 1:3.9 to 2.78:1 of the current application deviates significantly from the ideal 1:1 molar ratio practiced and relied upon in the cited documents and therefore the claimed composition is different from the cited references. Applicant further argues that none of Nelson et al, Preslar et al, nor Filippa et al teach ratios of methyl salicylate to beta-cyclodextrin.
Regarding the argument that the teachings of ratios of methyl salicylate to beta-cyclodextrin of 1:0.5, 1:1, 1:2, 1:5, wherein 1:1 gave the best entrapment efficiency, by Trinh et al do not render obvious the ratios of methyl salicylate to beta-cyclodextrin of instant claims 15-16, for which Applicant has calculated as corresponding to a ratio range of methyl salicylate to beta-cyclodextrin of from 1:3.9 to 2.78:1, this is not found persuasive because the ratios of Trinh et al overlap the ratios calculated from the concentrations of instant claims 15-16. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)). Regarding the argument that none of Nelson et al, Preslar et al, nor Filippa et al teach ratios of methyl salicylate to beta-cyclodextrin, the Examiner first notes that concentration requirements of methyl salicylate and beta-cyclodextrin are limitations recited in instant claims 15 and 16, respectively, and neither the rejections over Filippa et al nor Nelson et al include instant claims 15 or 16. Regarding the argument that Preslar et al does not teach the ratio of methyl salicylate to beta-cyclodextrin, the Examiner disagrees. As seen above in the new grounds of rejection under 35 USC 103, Preslar et al teach a composition comprising from about 0.01 wt% to 30 wt% of methyl salicylate, from 0-99.99 wt% of the delivery material, the delivery material comprising from 0-20 mol% beta-cyclodextrin, which necessarily overlaps the concentrations of methyl salicylate and beta-cyclodextrin of instant claims 15 and 16. A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art (In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003)).
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.E.O./Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619