DETAILED ACTION
Claims 1-5, 8, 14, 16-21, 24-25, 31-33 and 35 are current pending. Claims 1-5, 8, 14, 16-20 are currently under examination.
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 .
Withdrawn Rejections
The prior rejection of claim(s) 1, 10, 14, 17 and 19-20 under 35 U.S.C. 102(a)(1) as being anticipated by US 2016/0279401 is withdrawn in light of the amendment to claim 1 to specify the thickness of the base layer and a microneedle layer comprising a plurality of microneedles comprising a biocompatible material which the ‘401 publication does not teach.
Examiner’s Note
Applicant's amendments and arguments filed 01/14/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. In the Applicant’s response, filed 01/14/2026, it is noted that claims 1 and 14 have been amended and no new matter or claims have been added.
Modified Rejection:
The following rejection is modified based on Applicant’s claim amendment.
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.
Claim(s) 1, 8, 14 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0338632 (previously applied).
Regarding claim 1, a biocompatible device comprising a base layer comprising hyaluronic acid or a combination of silk fibroin and hyaluronic acid is met by the ‘632 publication teaching a microneedle or microneedle device includes a microneedle body ending from a base penetrating tip formed from a silk fibroin-based material (abstract). The substrate can be formed of any flexible material and can comprise silk fibroin film integrated with silk fibroin microneedles [0088] wherein blends of materials may be used for the substrate [0086]. The silk fibroin can be mixed with other biocompatible and biodegradable polymer to form mixed polymer microneedles comprising silk fibroin including hyaluronic acid [0099] and the microneedle contains a base and penetrating tip [0168]. Absent a clear definition the “base layer” may be the base of the microneedle and formed of silk fibroin and hyaluronic acid. Additionally, the substrate may be interpreted as the base layer and is taught to be formed of silk fibroin material.
Regarding the limitation of wherein the base layer is from about 0.5 mm to about 4 mm thick is met by the ‘632 publication teaching microneedle body extending from a base to a penetrating tip (abstract) a tip diameter of 50 nm to 40 um ([0011]), wherein the base of the microneedle is attached to the substrate and may have size and or shape with a diameter of 50 nm to 1500 um ([0039]-[0040]). The substrate thickness is taught to be similar thickness to the diameter of the microneedle base. Thus the “base layer” thickness is taught by either the diameter of the base of the microneedle or the thickness of the substrate. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”.
The limitation of comprising a microneedle layer comprising a plurality of microneedles comprising biocompatible material, wherein the biocompatible material is selected from silk fibroin is met by the ‘632 publication teaching microneedles comprising silk fibroin [0099].
Regarding claim 8, the limitation of wherein the base layer further comprises a bioactive macromolecule selected from the group including chitin is met by the ‘632 publication teaching the silk fibroin can be also mixed with other biocompatible and/or biodegradable polymers for form mixed polymer microneedles comprising silk fibroin. One or more biocompatible and/or biodegradable polymers (e.g. two or more) include chitin and hyaluronic acid [0099].
Regarding claim 14, the limitation of wherein the biocompatible material is selected from silk fibroin is met by the ‘632 publication teaching microneedles comprising silk fibroin [0099].
Regarding claims 17-20, the limitation of wherein the device further comprises an active agent, wherein the active agent is embedded throughout the base layer, the microneedle or a combination thereof and wherein the active agent is a vitamin is met by the microneedle can be coated with at least one active agent [0102]. The at least one active agent can be added to the silk fibroin solution to form the silk fibroin microneedles or microneedle devices ([0100], [0121]). Active agents are taught to include vitamins ([0047], [0127]).
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 use the combination of hyaluronic acid and silk fibroin for the substrate as the ‘632 publication teaches the substrate formed of silk fibroin material and additionally teaches the use of a combination of silk fibroin and hyaluronic acid mixtures to form microneedles, thus rendering it obvious to use the combination in the substrate which comprises silk fibroin and blends of materials are taught to be used for the substrate.
Claim(s) 2-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0338632 as applied to claims 1, 8, 14, 17-20 above, and further in view of US 2015/0306237 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 8, 14, 17-20 are taught by the ‘632 publication.
The ‘632 publication does not specifically teach wherein the hyaluronic acid is conjugated with an antioxidant (claim 2).
The ‘237 publication teaches hyaluronic acid compositions and conjugates comprising antioxidant compounds, pharmaceutical compositions and their medical applications (abstract). Hyaluronic acid conjugates comprising antioxidant compounds or consisting of HA and an Ax ([0008]-[0009]). The invention has resistance to oxidative degradation [0022]. The composition can be used in medical applications such as topical and used for skin treatment [0026]. Protection of hyaluronic acid from the oxidation by covalent grafting of antioxidant moieties is taught [0032]. A preferred antioxidant is taught to be cysteine [0034].
It would have been prima facie obvious to one of ordinary skill in the art before the filing date of the claimed invention to use hyaluronic acid conjugated antioxidant in the microneedle as taught by the ‘632 publication because the ‘632 publication teaches the microneedle to comprise hyaluronic acid and antioxidants and the ‘237 publication specifically teaches the hyaluronic acid conjugated antioxidant to be used in medical devices. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to conjugate the antioxidant to the hyaluronic acid because the ‘237 publication teaches reduced degradation. One of ordinary skill in the art before the filing date of the claimed invention would have a reasonable expectation of success as the ‘237 publication teaches compositions to be used for medical devices transdermally and for skin applications and the ‘632 publication teaches microneedles to be used in the skin.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0338632 and US 2015/0306237 as applied to claims 1-3, 8, 14, 17-20 above, and further in view of US 2016/0058922 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1-3, 8, 14, 17-20 are taught by the ‘632 publication and the ‘237 publication.
The combination of references does not specifically teach wherein the antioxidant comprises the elected methionine (claim 3).
The ‘992 publication teaches microstructure array for delivery of active agents (title). The microstructure array comprising a plurality of dissolving microstructures such as microprojections attached to a base. The microstructures comprise an active agent in a biocompatible and water-soluble matrix (abstract). Microneedle-assisted transdermal delivery of therapeutic agents [0008]. Antioxidants used are taught to be methionine and cysteine used in the matrix of the microstructure ([0015], [0019]).
It would have been obvious to one of ordinary skill in the art to substitute a first antioxidant as taught by the ‘237 publication with a second antioxidant, methionine, as taught by the ‘992 publication with a reasonable expectation of success because the simple substitution of one known element for another would have yielded predictable results to one of ordinary skill in the art at the time of the invention. M.P.E.P. §2144.07 states "The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” When substituting equivalents known in the prior art for the same purpose, an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). M.P.E.P. §2144.06.
One of ordinary skill in the art before the filing date of the claimed invention would have an expectation of success as the ‘237 publication teaches cysteine and the ‘992 publication teaches the interchangeability of cysteine and methionine as antioxidants in microneedle devices.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0338632 as applied to claims 1, 8, 14, 17-20 above, and further in view of US 2015/0057685 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 8, 14, 17-20 are taught by the ‘632 publication.
The ‘632 publication does not specifically teach wherein the silk fibroin is chemically or chemoenzymatically modified (claim 4) such as hydroxylated silk fibroin (claim 5).
The ‘685 publication teaches medical devise to reduce post operative adhesions (abstract). The medical device is taught to be silk [0029]. The device might include hyaluronic acid [0038]. The water soluble or dissolved silk can be prepared by a solubilization of pure silk fibroin. Silk solution may have altered gelation kinetics resulting in differing final gel properties [0077]. The medical device is taught to include hyaluronic acid [0084]. Silk based biomaterial useful as an adhesion barrier is included including silk fibroin solution [0092]. The amino acid composition of silk fibroin shows a low amount of aspartic acid/glutamic acid (carboxylic groups and even lower amount of lysine (amine groups) and ahigh amount of serine (hydroxyl groups) [0093]. Treatment with alcohols induce structural transitions [0102].
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to hydroxyl modify silk fibroin as the ‘632 publication teaches a microneedle device comprised of silk fibroin and the ‘685 publication teaches a high amount of serine and thus hydroxyl groups and addition of ethanol. One of ordinary skill in the art before the filing date of the claimed invention would be motivated to use the silk taught by the ‘685 publication for the silk fibroin taught by the ‘632 publication because the ‘685 publication teaches treatment with alcohol for structural transitions and altered gelation kinetics and the ‘632 publication teaches hydrogel.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0338632 as applied to claims 1, 8, 14, 17-20 above, and further in view of US 2011/0293666 (previously applied).
As mentioned in the above 103(a) rejection, all of the limitations of claims 1, 8, 14, 17-20 are taught by the ‘632 publication.
Regarding claim 16, the ‘632 publication teaches the device the device further comprises an adhesive layer (claim 61).
The ‘632 publication does not specifically teach silk fibroin is an adhesive layer.
The ‘666 publication teaches biocompatible adhesive silk fibroin, wherein silk fibroin is a preferred biocompatible adhesive ([0130]-[0131]).
It would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to use silk fibroin as the adhesive taught by the ‘632 publication because the ‘632 publication teaches the device comprises silk fibroin and uses an adhesive layer and the ‘666 publication teaches silk fibroin is an adhesive known to be used on medical devise. Thus it would have been obvious to one of ordinary skill in the art to use a known adhesive as taught by the ‘666 publication on a device comprising an adhesive known to contains silk fibroin.
Response to Arguments:
Applicant’s arguments have been fully considered and are not deemed to be persuasive.
Applicant argues the ‘632 publication alone or in combination with the ‘237, ‘992, ‘685 or ‘666 publications fails to teach or suggest the claim element of the device comprising both a base layer from about 0.5 mm to about 5mm thick and a microneedle layer. The ‘632 publication is directed to microneedles and fails to teach or suggest a base layer. This is illustrated in Figure 2, which shows a plurality of microneedle s as a single layer.
In response, regarding the limitation of wherein the base layer is from about 0.5 mm to about 4 mm thick is met by the ‘632 publication teaching microneedle body extending from a base to a penetrating tip (abstract) a tip diameter of 50 nm to 40 um ([0011]), wherein the base of the microneedle is attached to the substrate and may have size and or shape with a diameter of 50 nm to 1500 um ([0039]-[0040]). The substrate thickness is taught to be similar thickness to the diameter of the microneedle base. Thus the “base layer” thickness is taught by either the diameter of the base of the microneedle or the thickness of the substrate. As MPEP 2144.05 recites “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization”. The substrate can be formed of any flexible material and can comprise silk fibroin film integrated with silk fibroin microneedles [0088] wherein blends of materials may be used for the substrate [0086]. The silk fibroin can be mixed with other biocompatible and biodegradable polymer to form mixed polymer microneedles comprising silk fibroin including hyaluronic acid [0099] and the microneedle contains a base and penetrating tip [0168]. Absent a clear definition the “base layer” may be the base of the microneedle and formed of silk fibroin and hyaluronic acid. Additionally, the substrate may be interpreted as the base layer and is taught to be formed of silk fibroin material. Applicant points to Figure 2 which demonstrates a substrate layer (204) a base needle layer (214} and a penetrating tip (212). Thus demonstrating a substrate containing multiple microneedles and additionally demonstrate a “base layer” base of microneedle” containing a microneedle tip layer, wherein multiple base of microneedles and tips of microneedles are present. The instant claims do not require multiple microneedles to be attached to a single base layer, therefore multiple base layers with a single microneedle layer results in a plurality of microneedles.
Conclusion
No claims are 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.
Examiner Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNDSEY MARIE BECKHARDT whose telephone number is (571)270-7676. The examiner can normally be reached Monday-Thursday 9am to 4pm and Friday 9am to 2pm.
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/LYNDSEY M BECKHARDT/Examiner, Art Unit 1613
/BRIAN-YONG S KWON/Supervisory Patent Examiner, Art Unit 1613