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 .
Claim Status
Claims 5-7, 9, and 26 are rejected.
Claims 1-3, 11-12, and 14-21 are withdrawn.
No claims are allowable.
Modified 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1. Claims 5-7, 9, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al., (US 2014/0276248 A1, Sept. 18, 2014) (hereinafter Hall).
Hall discloses a system for delivering light and/or ultrasound across a skin surface (Abstract). The light and/or ultrasound emitted from the device cause transdermal transport of a therapeutic or cosmetic composition through the skin surface including one or more of large or small molecular weight hyaluronic acid or its derivative (i.e., one or more glycosaminoglycans) ([0009]) having a high molecular weight HA (greater than 1×106 Da) (i.e., 1,000 kDa), low molecular weight HA (less than about 1×106 Da) (i.e., 1,000 kDa), or some combination thereof ([0144]). The device can be used for transdermal drug delivery, cosmetic applications, and skin/wound healing ([0026]). The therapeutic and/or cosmetic composition may be contained in a pad such as a gel pad or hydrogel pad and may be applied prior to treatment with the device, or after treatment with the device ([0136]). Ultrasound exposures to the treatment site are typically for a period of between about 1 and 15 minutes (e.g., about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 minutes) and application time may be varied to achieve sufficient enhancement of transdermal transport ([0093]). Ultrasound application time is a parameter that may be readily determined by those skilled in the art ([0103]). The therapeutic and/or cosmetic composition may comprise an antioxidant ([0143]). For the treatment or prevention of skin aging and fine lines and wrinkles, ultrasound and active therapeutic and/or cosmetic agents, like hyaluronic acid, act in a synergistic fashion and are complimentary ([0161]). The device may be used in a number of treatment sessions that together result in an overall treatment time (i.e., meeting applying a further ultrasound treatment to the skin surface) ([0183]).
Hall discloses a system for delivering ultrasound across a skin surface (Abstract) that causes transdermal transport (i.e., delivery) of hyaluronic acid (i.e., one or more glycosaminoglycans) ([0009]) applied after treatment with the device ([0136]) (i.e., topically administering of one or more glycosaminoglycans) and wherein treatment sites are typically exposed to ultrasound for a period of between about 1 and 15 minutes ([0093]). Together this would provide a method as claimed instantly. The prior art is not anticipatory insofar as this combination must be selected from various lists/locations in the reference. It would have been obvious, however, to make the combination since all the claimed elements were known in the prior art 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 to one of ordinary skill in the art. See MPEP 2143(I)(A).
Regarding the limitation of claim 5 reciting topically administrating to the ultrasound-treated skin surface a further amount of one or more GAGs, as discussed above, Hall teaches that the therapeutic composition comprising hyaluronic acid (i.e., one or more GAGs) may be applied after treatment with the device and the device may be used in a number of treatment sessions that together result in an overall treatment time. Accordingly, it would have been obvious to one of ordinary skill in the art to have topically administered to the ultrasound-treated skin surface, a further amount of hyaluronic acid (i.e., one or more GAGs) since it is applied after treatment with the device and the device may be used in multiple treatments, as taught by Hall.
Response to Applicant’s Arguments
Applicant argues that Hall does not disclose, suggest, or motivate a skilled artisan to perform these steps in the claimed sequence or describe any functional relationship between repeated ultrasound exposure and repeated topical administration.
Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, Hall discloses a device that delivers ultrasound across a skin surface and teaches that the therapeutic composition comprising hyaluronic acid (i.e., one or more GAGs) may be applied after treatment with the device and the device may be used in a number of treatment sessions that together result in an overall treatment time. Thus, since the hyaluronic acid (i.e., one or more GAGs) is applied after treatment with the device and the device delivers ultrasound treatment, it would have been obvious that the hyaluronic acid (i.e., one or more GAGs) is applied to ultrasound treated skin.
Further, as discussed above, Hall teaches that for the treatment or prevention of skin aging and fine lines and wrinkles, ultrasound and active therapeutic and/or cosmetic agents, like hyaluronic acid, act in a synergistic fashion and are complimentary. The device may be used in a number of treatment sessions that together result in an overall treatment time. Accordingly, since the hyaluronic acid (i.e., one or more GAGs) acts synergistically and complementary with the device that delivers ultrasound treatment, it is obvious that the functional relationship is a synergistic and complementary relationship that Hall teaches may be applied repeatedly. However, regardless of whether or not Hall teaches such a relationship, the claims as currently written do not recite a functional relationship between repeated ultrasound exposure and repeated topical administration.
Applicant argues that Hall's disclosure that its device may be used in multiple treatment sessions does not teach or suggest the claimed method in which ultrasound treatment and topical administration are iteratively coordinated within a defined protocol.
Applicant’s argument has been fully considered but found not to be persuasive. The Examiner is not persuaded that one of ordinary skill in the art would consider multiple treatment sessions to be different than iteratively coordinated within a defined protocol. Further, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art. See MPEP 2123. As discussed above, Hall discloses a system for delivering ultrasound across a skin surface that causes transdermal transport (i.e., delivery) of hyaluronic acid (i.e., one or more glycosaminoglycans) which is applied after treatment with the device and wherein treatment sites are typically exposed to ultrasound for a period of between about 1 and 15 minutes (i.e., a defined protocol) in a number of treatment sessions that together result in an overall treatment time. Therefore, one of ordinary skill in the art would have derived the claimed method according to the teachings of Hall.
Applicant argues that Hall does not teach or suggest ultrasound treatment for a period of about 5 seconds to about 5 minutes and claim 26 further limits the time frame for ultrasound application from 30 sec to 2 min.
Applicant’s argument has been fully considered but found not to be persuasive. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists. See MPEP 2144.05 A. As discussed above, Hall teaches ultrasound exposures to the treatment site are typically for a period of between about 1 and 15 minutes (e.g., about 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, or 15 minutes), which overlaps the claimed ranges. Thus, a prima facie case of obviousness exists.
Applicant argues that the transdermal delivery of large, charged macromolecules such as GAGs, particularly when combined with repeated ultrasound treatment and complex formation, is inherently unpredictable.
Applicant’s argument has been fully considered but found not to be persuasive. Applicant has not provided any objective evidence supporting Applicant’s assertion that it is unpredictable. Therefore, since Applicant’s argument is merely speculative, Applicant’s argument is unpersuasive.
Applicant argues that the claims require a specific, ordered therapeutic method involving short-duration ultrasound treatment, coordinated and optionally repeated topical administration, and, in certain embodiments, GAG-polysaccharide complexes, features not taught or suggested by Hall. These limitations introduce functional interactions and biological effects that are neither disclosed nor predictable from the prior art.
Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above. Additionally, GAG-polysaccharide complexes are optionally formed in instant claim 5. Thus, the presence of GAG-polysaccharide complexes is not required.
2. Claim 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Hall et al., (US 2014/0276248 A1, Sept. 18, 2014) (hereinafter Hall) in view Won et al., (KR 2016/0118146 A, Oct. 11, 2016) (English translation provided by Examiner) (hereinafter Won).
As discussed above, Hall makes obvious the limitations of claims 5 and 7 but does not teach wherein at least one GAG-polysaccharide complex is topically administered.
However, Won discloses a composition for promoting skin regeneration, comprising sodium 2-mercaptoethane sulfonate as an active ingredient (Claim 1). The composition further comprises a biodegradable polymer (Claim 3), such as hyaluronic acid or a derivative thereof (Claim 4). Examples of hyaluronic acid derivatives include hyaluronic acid-chitosan complex (i.e., at least one GAG-polysaccharide complex) (page 4, first paragraph). The composition is suitable for topical application (page 4, eight paragraph).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Hall discloses wherein the composition comprises hyaluronic acid derivatives. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a hyaluronic acid-chitosan complex (i.e., at least one GAG-polysaccharide complex) into the composition of Hall since it is a known and effective derivative of hyaluronic acid for compositions suitable for topical application as taught by Won.
Response to Applicant’s Arguments
Applicant argues that Won does not suggest or even remotely imply that HA-chitosan complexes may serve as transdermally delivered actives. Won does not disclose or suggest ultrasound treatment, sequenced or repeated topical administration, or transdermal delivery facilitated by physical energy.
Applicant’s argument has been fully considered but found not to be persuasive. As this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed above, Hall discloses a system for delivering ultrasound (i.e., physical energy) across a skin surface that causes transdermal transport of hyaluronic acid compositions applied in a number of treatment sessions that together result in an overall treatment time, wherein the composition comprises hyaluronic acid derivatives. Won teaches that a hyaluronic acid-chitosan complex is a known and effective derivative of hyaluronic acid for compositions suitable for topical application. Thus, it would have been obvious to one of ordinary skill in the art to have used the hyaluronic acid-chitosan complex of Won as the hyaluronic acid derivative in the composition of Hall and together the teachings of Hall and Won disclose that HA-chitosan complexes may serve as transdermally delivered actives, ultrasound treatment, sequenced or repeated topical administration, and transdermal delivery facilitated by physical energy.
Applicant argues that the combination of Hall and Won does not cure these deficiencies of each reference individually.
Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above.
Applicant argues that nothing in Won suggests that its compositions should be applied after ultrasound, would benefit from ultrasound, or would remain stable or functional when subjected to ultrasound energy.
Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above. The composition of Won is suitable for topical application and the composition comprises hyaluronic acid derivatives such as hyaluronic acid-chitosan complex. Hall is relied on to teach that these compositions should be applied after ultrasound, would benefit from ultrasound, or would remain stable or functional when subjected to ultrasound energy.
Applicant argues that Neither Hall nor Won teaches or suggests repeated post-ultrasound topical administration of polymer complexes, or that such repetition would enhance delivery or efficacy.
Applicant’s argument has been fully considered but found not to be persuasive for reasons discussed above. Further, the claims as written do not recite wherein the repetition would enhance delivery or efficacy.
Applicant argues that Won does not recognize hyaluronic acid-chitosan complexes as suitable for ultrasound-mediated transdermal delivery nor does it suggest their repeated administration following ultrasound treatment.
Applicant’s argument has been fully considered but found not to be persuasive. As discussed above, Hall discloses a system for delivering ultrasound across a skin surface (i.e., topical) that causes transdermal transport of hyaluronic acid derivatives applied in a number of treatment sessions that together result in an overall treatment time and Won teaches that hyaluronic acid derivatives include hyaluronic acid-chitosan complex and are suitable for topical application. Thus, the combined teachings of Hall and Won disclose that hyaluronic acid-chitosan complexes are suitable for ultrasound-mediated transdermal delivery and suggest their repeated administration following ultrasound treatment.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/S.J.K./ Examiner, Art Unit 1614
/TRACY LIU/ Primary Examiner, Art Unit 1614