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 .
Claim Status
Applicants’ amendments and arguments filed 09/03/2025 have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claims 4, 6, and 14 are canceled.
Claims 1-6, 5, 7-11, and 13 are amended.
Claim 15 is newly added.
Claims 1-3, 5, 7-13, and 15 are examined on the merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Newly submitted claim 15 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 15 is directed towards a different group of invention, specifically a method for treating or preventing inflammation or pain using a patch, while the remaining claims are directed towards a patch composition. The inventions can be shown to be distinct if either or both of the following can be shown: (1) the process for using the product as claimed can be practiced with another materially different product or (2) the product as claimed can be used in a materially different process of using that product. See MPEP § 806.05(h). In the instant case the originally presented claims directed towards a patch which may be used in a different method such as a method for treating a wound.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 15 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
New Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 112
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.
Claim 5 is 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 5 recites the limitation of ketoprofen is an amount of 0.1-10% by weight and zinc oxide is in an amount of 0.03-0.5% by weight which calculates to a ratio range of 1:0.003 to 1:5 ketoprofen to zinc oxide. Claim 5 is dependent upon claim 1 which recites the limitation of 1:0.03 to 1:0.1 ketoprofen to zinc oxide. Therefore, claim 5 is further broadening the ratio of ketoprofen to zinc oxide thus making the claims unclear and indefinite.
For the purpose of moving prosecution forward, Examiner broadly interprets the weight ratio range of claim 1 to meet the concentration value limitations of ketoprofen and zinc oxide in claim 5.
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 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, and 7-13 are rejected under 35 U.S.C. 103 as being unpatentable over Miura et al. (US20120004306A1, published 01/05/2012, hereafter Miura) in view of Kobayashi et al. (JP2013095749A, published 05/20/2013, hereafter Kobayashi), and in view of Tsujimoto et al. (JP2002226366A, published 08/14/2002, referenced in the instant specification and IDS filed on 07/21/2023, English translation via Google, hereafter Tsujimoto).
Miura teaches an external preparation comprising a non-steroidal analgesic/anti-inflammatory agent also referred to as component A, polyhydric alcohol, and at least one selected from the group consisting of polyoxyalkylene alkyl ether and a polyoxyalkylene alkenyl ether (title and claim 1; according to the claim limitations of the instant claim 1). Miura teaches that non-steroidal anti-inflammatory analgesic agents, like amfenac, is used for relieving inflammation and pain (paragraph 0002; according to the claim limitations of the instant claim 1). Claim 15 of Miura claims the preparation to be a patch (according to the claim limitations of the instant claim 1). Claim 13 of Miura claims the analgesic/anti-inflammatory agent to be ketoprofen (according to the claim limitations of the instant claims 1). Claim 7 of Miura claims the composition further comprises a least one terpene (according to the claim limitations of the instant claim 1). Claim 8 of Miura claims the terpene to be menthol and paragraph 0040 teaches the terpene to preferably be L-menthol (according to the claim limitations of the instant claim 1). Furthermore, Miura teaches the known problem of the reaction between the carboxyl group of the non-steroidal analgesic/anti-inflammatory agent and menthol produces a menthol ester form resulting in a reduced context of non-steroidal analgesic/anti-inflammatory agent in the preparation (paragraph 0048; according to the claim limitations of the instant claim 1). Miura addresses this problem by the addition of a metal oxide, specifically zinc oxide (paragraph 0048; according to the claim limitations of the instant claim 1). Miura further teaches the addition of zinc oxide as a filler (paragraph 0065; according to the claim limitations of the instant claim 1). Miura teaches an example of various technologies for improving the percutaneous absorbability of a non-steroidal analgesic/anti-inflammatory agent is a ketoprofen ointment prepared with an oily base composed of fatty acid ester, waxes, surfactants, and hydrocarbons (paragraph 0005; according to the claim limitations of the instant claim 1). Miura provides a list of fatty acid esters to include: hexyl laurate, isopropyl myristate, cetyl myristate, isocetyl myristate, myristyl myristate, octyldodecyl myristate, isopropyl palmitate, ethylhexyl palmitate, cetyl palmitate, ethyl stearate, isocetyl stearate, stearyl stearate, ethyl isostearate, isopropyl isostearate, hexyldecyl isostearate, isostearyl isostearate, ethyl oleate, decyl oleate, oleyl oleate, ethyl linoleate, and isopropyl linoleate (paragraph 0046; according to the claim limitations of the instant claims 1-3). Miura teaches the composition further comprising excipients such as a plasticizer, a tackifier resin, a filler, an ultraviolet ray absorber, a percutaneous absorption enhancer, an antioxidant, and a water-soluble/water swellable polymer (paragraph 0062; according to the claim limitations of the instant claims 1-3, 7-8 and 11).
Furthermore, Miura teaches a diethylene glycol which is a fatty acid monoester and isopropyl myristate which is a fatty acid diester as plasticizers which can be used in combination with each other (paragraph 0063; according to the claim limitations of the instant claim 1). Miura teaches the tackifier resin includes rosin, hydrogenated rosin glycerol ester, ester gum, maleated rosin glycerol ester, terpene resin, petroleum resin, alicyclic saturated hydrocarbon resin, and aliphatic hydrocarbon resin (paragraph 0064; according to the claim limitations of the instant claims 8-9). Miura teaches the addition of a synthetic rubber adhesive to include styrene-isoprene-styrene block copolymer and polybutene (paragraph 0058 and paragraph 0060; according to the claim limitations of the instant claims 7-8 and 10).
Miura teaches the antioxidant to be dibutylhydroxytoluene (paragraph 0047; according to the claim limitations of the instant claim 12). Lastly, Miura teaches a sample patch composition comprising: 30g styrene-isoprene-styrene block copolymer (14.9%), 24g terpene resin (12.0%), 20.0g polybutene (9%), 17.0g liquid paraffin (8.5%), 0.5g dibutylhydroxytoluene (0.25%), (Example 1, paragraphs 0081-0083; according to the claim limitations of the instant claim 7-13).
Miura further teaches the concentration of the analgesic/anti-inflammatory agent to be from 0.001-20% by mass, or more preferably 0.01-10% by mass (paragraph 0025; according to the claim limitations of the instant claims 1 and 5). Miura teaches the concentration of the terpene, L-menthol as taught above, to be 0.0001-20%, or more preferably 0.005-10% by mass (paragraph 0041; according to the claim limitations of the instant claim 5). Additionally, the sample patch composition taught by Miura further comprises 1.0g L-menthol (0.5%), and 1.0g amfenac sodium (non-steroidal analgesic/anti-inflammatory listed in claim 13; 0.5%) (Example 1, paragraphs 0081-0083; according to the claim limitations of the instant claims 1 and 5).
Miura fails to teach the patch as a pasty preparation as claimed by instant claims 1, 10-11, and 13. Miura fails to teach the concentration of the fatty acid ester as in claim 5.
Kobayashi teaches a patch for external use comprising a support and a plaster layer laminated on the support (title and claim 1; according to the claim limitations of the instant claim 1). Kobayashi teaches the support is a polyurethane film and the external patch is a paste layer containing a drug, monoterpenes, and an adhesive (claim 1; according to the claim limitations of the instant claims 1, 10-11, and 13). Furthermore, Kobayashi claims the external patch drug to be a non-steroidal anti-inflammatory agent, specifically ketoprofen (claims 7-8; according to the claim limitations of the instant claim 1). Claim 9 of Kobayashi further claims the plaster layer to contain l-menthol and a styrene-isoprene-styrene-block copolymer then claim 6 defines the styrene-isoprene-styrene block copolymer as the rubber based adhesive(according to the claim limitations of the instant claims 1 and 8). Furthermore, Kobayashi teaches the addition of dibutylhydroxytoluene as an antioxidant (page 4, paragraph 2; according to the claim limitations of the instant claims 11-12). Kobayashi teaches the addition of fatty acid esters such as: fatty acid esters such as isopropyl myristate, isopropyl palmitate, diisopropyl adipate, diethyl sebacate, caprylic acid monoglyceride, and caprylic acid triglyceride (page 3, paragraph 8; according to the claim limitations of the instant claims 1-3). Kobayashi teaches the addition of a terpene resin, specifically an alicyclic saturated hydrocarbon resin, as a tackifier (page 3, paragraph 9; according to the claim limitations of the instant claims 7-9). Kobayashi teaches the addition of liquid paraffin as a plasticizer and the concentration to be from 20-60% of the composition (page 3, paragraph 10; according to the claim limitations of the instant claims 7-10). Lastly, Kobayashi provides external patch preparation examples in which the concentrations of styrene-isoprene-styrene block copolymer are from 30-32%, concentrations of dibutylhydroxytoluene are from 0.2-0.5%, the concentrations of terpene resin are from 16-19%, and the concentrations of liquid paraffin are from 27.33-43.5% (page 4-5, examples; according to the claim limitations of the instant claims 10 and 12). The ketoprofen Kobayashi example composition further teaches the concentration of the fatty acid ester, specifically diethyl sebacate, to be 0.5% (page 4, second example; according to the claim limitations of the instant claim 5). The same example of Kobayashi teaches the concentration of ketoprofen to be 2% and L-menthol to be 2.0% (page 4, second example; according to the claim limitations of the instant claim 5).
Both Miura and Kobayashi fail to teach the concentration of zinc oxide and ratio of zinc oxide to ketoprofen as claimed by the instant claims 1 and 6.
Tsujimoto claims an external patch comprising a non-steroidal anti-inflammatory analgesic, L-menthol, and a metal oxide (claim 1; according to the claim limitations of the instant claim 1). Tsujimoto teaches when a non-steroidal anti-inflammatory drug having a carboxylic acid group in the molecule is used, l-menthol ester is often formed by reaction with L-menthol, and the amount of the main drug decreases (page 1, paragraph [0003]). Tsujimoto solves this problem with the addition of a small amount of metal oxide which prevents the esterification reaction between the non-steroidal anti-inflammatory drug and L-menthol (page 2, paragraph [0006]). Tsujimoto further claims the weight ratio of the metal oxide to the non-steroidal anti-inflammatory drug is 0.01 to 2 (claim 2; according to the claim limitations of the instant claims 5-6). Tsujimoto claims the metal oxide to be selected from a group to include zinc oxide (claim 4; according to the claim limitations of the instant claim 1). Tsujimoto further claims the non-steroidal anti-inflammatory drug to be selected from a list to include ketoprofen (claim 6; according to the claim limitations of the instant claim 1). Tsujimoto further provides an example patch composition in which the concentration of the zinc oxide is 0.01 parts out of 100 parts (page 4, example 19). Lastly, Tsujimoto teaches a patch example in which the composition is prepared by creating a paste (page 4, example 19; according to the claim limitations of the instant claim 1).
It would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a patch composition comprising ketoprofen, L-menthol, zinc oxide, and a fatty acid ester as outlined by Miura with the ready for improvement with the known technique of making the patch composition a paste preparation and adjusting the concentration of the fatty acid ester as outlined by Kobayashi. Making a pasty preparation of a patch composition comprising ketoprofen, L-menthol, zinc oxide, and a fatty acid ester as claimed by instant claims 1, 10-11, and 13 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Furthermore, adjusting the forementioned components of a patch composition comprising ketoprofen, L-menthol, zinc oxide, and a fatty acid ester as claimed by instant claims 1 and 6 would yield predictable results thus making them of obviousness as modification of a known product with a known technique is within the purview of the skilled artisan. Lastly, it would be obvious to one skilled in the art before the effective filing date of the claimed invention to claim a patch composition comprising ketoprofen, L-menthol, zinc oxide, and a fatty acid ester as outlined by Miura with the ready for improvement with the known technique of adjusting the concentration of the fatty acid ester as outlined by Kobayashi and adjusting the concentration of zinc oxide to a desired concentration and ratio to ketoprofen as outlined by Tsujimoto.
Response to Applicant’s Arguments
Applicant’s arguments and amendments filed on 09/03/2025 have been considered by the Examiner.
In regards to the 35 USC § 103 rejections of record, Applicant first argues the specification, specifically page 8, lines 8-14, states “When the weight ratio of the contained amount of the zinc oxide relative to the ketoprofen is less than 0.03, the effect for suppressing crystal precipitation and esterification reaction becomes insufficient.” Applicant supports this assertion with data referencing example 2 which demonstrates a weight ratio of ketoprofen to zinc oxide of 1:0.06 and comparing it comparative example 2 which is absent of zinc oxide. Applicant further compares comparative example 2 to comparative example 1 claiming these demonstrate a difference in precipitation after 3 and 6 months.
It is first noted that instant claim 1 is directed towards a composition comprising ketoprofen, L-menthol, and 2 fatty acid esters solely while in comparison the provided examples are directed towards composition also comprising SIS, alicyclic saturated hydrocarbon resin, polybutene, liquid paraffin, BHT, and the specific esters diisopropyl adipate and isopropyl myristate. Therefore, the data is not commensurate with the instant claim 1 as it is uncertain if the unclaimed components have physical or chemical effects on the instantly claimed invention. Additionally, the instant specification examples 16-18 (pages 37-38, table 7) demonstrate that not all ester combinations have the same functionality, such as example 16 which shows a decrease in skin permeation. Furthermore, it is noted that Applicant’s examples demonstrating the variation in the concentration ratio of ketoprofen to zinc oxide are directed towards a specific concentration of the remaining components. The importance of these concentrations is further noted in Applicant’s examples 10-12 (page 36, table 5) which demonstrate that both the presence/absence and/or amount of alicyclic saturated hydrocarbon resin, terpene resin, hydrogenated rosin glycerol ester, and/or polybutene effect both the menthol production and skin permeation at the same weight ratio of ketoprofen to zinc oxide. Therefore, Applicant’s claim 1 is not enabled for any amount of the forementioned components as claimed by claim 1. Lastly, it is further noted that the amounts of paraffin varies from example to example, therefore it is unclear if the paraffin or the zinc is resulting in the change.
In summary, Examiner is not persuaded by Applicant’s argument towards the data as the data is not commensurate with the claims and further he 35 USC § 103 rejections are modified herein to account for the amendments.
Conclusion
No claims allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDRA NICOLE ISNOR whose telephone number is (703)756-5561. The examiner can normally be reached Monday-Friday 5:30am-3pm PST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/A.N.I./Examiner, Art Unit 1611