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 . Claims included in the prosecution are claims 1, 3-15, 17, 19, 20-22 and 24.
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 14 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 14 recites the limitation "the contracture" in the last line. There is insufficient antecedent basis for this limitation in the claim. Claim 14 depends from claim 1, which recites a facial skin injury and does not recite wherein the facial skin injury is a contracture. Therefore, it is not clear if claim 14 is limiting the facial skin injury to contracture or whether the composition is additionally applied to a contracture.
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.
1. Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), and Liang (CN 105560312 A, May 11, 2016).
Whitbourne discloses a composition for skin treatment (¶ [0001]). A skin condition may include burn (¶ [0076]). The composition may be prepared in a variety of manners, in a variety of topical forms, and along with a variety of components and suitable carriers. For example, the composition may take the form of a cream or an ointment (¶ [0069]). The skin treatment composition may include tyrosine kinase inhibitors (¶ [0060]). The composition may comprise muscle relaxants (¶ [0066]). The composition may include more than one therapeutic agent (¶ [0047]). After applying the composition, a wound dressing may be applied (Example 12, ¶ [0145]).
Whitbourne differs from the instant claims insofar as not disclosing wherein the composition comprises nilotinib (i.e., an anti-myogenic agent).
However, Trumbore discloses a composition for topical administration that contains a tyrosine kinase inhibitor, such as nilotinib (abstract).
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. Whitbourne discloses wherein the composition includes a tyrosine kinase inhibitor. Accordingly, it would have been obvious to have incorporated nilotinib (i.e., an anti-myogenic agent) into the composition of Whitbourne since it is a known and effective tyrosine kinase inhibitor as taught by Trumbore.
The combined teachings of Whitbourne and Trumbore do not teach wherein the composition comprises baclofen (i.e., a skeletal muscle relaxant).
However, Kisak discloses a topical formulation (¶ [0002]). The composition may comprise baclofen as a relaxant (¶ [0206]).
Whitbourne discloses wherein the composition includes muscle relaxant. Accordingly, it would have been obvious to have incorporated baclofen (i.e., skeletal muscle relaxant) into the composition of Whitbourne since it is a known and effective muscle relaxant as taught by Kisak.
The combined teachings of Whitbourne, Trumbore, and Kisak do not teach wherein the composition treats a facial skin injury.
However, Liang discloses wherein there is scar contracture after deep burn healing of the face (page 2 of translation, third paragraph).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have treated facial burn with the composition of Whitbourne since the composition treats burns and burns are known to appear on the face as taught by Liang.
2. Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), Liang (CN 105560312 A, May 11, 2016), and further in view of Tan et al. (Current progress in understanding the molecular pathogenesis of burn scar contracture, 2017) (hereinafter Tan) and Akhmetshina et al. (Dual inhibition of c-abl and PDGF receptor signaling by dasatinib and nilotinib for the treatment of dermal fibrosis, 2008) (hereinafter Akhmetshina).
The teachings of Whitbourne, Trumbore, Kisak, and Liang are discussed above. Whitbourne, Trumbore, Kisak, and Liang do not teach wherein the composition is administered during the healing phase after injury to facial tissues, and wherein the composition is administered to reduce contractures associated with existing facial scars resulting from thermal injury to the face.
However, Tan discloses that abnormal wound healing is likely to induce scar formation leading to dysfunction, deformity, and psychological trauma in burn patients. Scar contracture in burn patients remains a challenge. Myofibroblasts play a key role in scar contracture (abstract). Wound healing proceeds through three overlapping stages. The inflammatory stage is triggered by injury. The proliferative stage involves myofibroblast differentiation. In this phase, the myofibroblasts have acquired contractile properties that can contract the wound and promote re-epithelialization. The third healing stage is matrix remodeling, including scar tissue remodeling. During this stage, the persistent activation of myofibroblasts and poor arrangement of newly formed fibers can lead to scar formation (page 1, right column). Myofibroblasts have been demonstrated to play an essential role in the induction and maintenance of scar contracture. In normal acute wound healing, the myofibroblasts are temporally limited and cleared by apoptosis in the third healing phase when tissues are repaired. However, in hypertrophic scars and keloids, these myofibroblasts persist at a high number for long period (page 2, left column, first paragraph).
Akhmetshina discloses wherein nilotinib potently reduces the number of myofibroblasts (abstract).
As discussed above, Liang discloses wherein there is scar contracture after deep burn healing of the face. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have administered the composition of the prior art during the healing phase after facial burn motivated by the desire to reduce scar contracture since scar contracture is developed during the healing process as taught by Tan. One of ordinary skill in the art would have had a reasonable expectation of success since the composition of the prior art comprises nilotinib. Tan discloses wherein myofibroblasts play a key role in scar contracture and during the third healing stage myofibroblast is persistently activated and Akhmetshina discloses wherein nilotinib potently reduces the number of myofibroblasts. Thus, by reducing the number of myofibroblast, which activates during the healing phase and plays a key role in scar contracture, one reduces scar contracture.
Also, it would have been prima facie obvious to one of ordinary skill in the art to have administered the composition of the prior art comprising nilotinib to reduce contractures associated with existing facial scars since existing scars have a high number of myofibroblasts as taught by Tan and nilotinib potently reduces the number of myofibroblasts as taught by Akhmetshina.
2. Claims 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), Liang (CN 105560312 A, May 11, 2016), and further in view of Mitragotri et al. (US 2018/0251495, Sep. 6, 2018) (hereinafter Mitragotri).
The teachings of Whitbourne, Trumbore, Kisak, and Liang are discussed above. Whitbourne, Trumbore, Kisak, and Liang do not teach wherein the anti-myogenic agent and the skeletal muscle relaxant are administered simultaneously, wherein nilotinib (i.e., anti-myogenic agent) is administered first followed by the administration of baclofen (i.e., skeletal muscle relaxant), wherein the administration of nilotinub is discontinued prior to administration of baclofen, and wherein the administration of nilotinib is continued during the subsequent administration of baclofen.
However, Mitragotri discloses a method of using skin penetrating peptides and pharmaceutical compositions thereof. Typically, one or more skin penetrating peptides is administered to a subject in need thereof in combination with one or more active agents. The combination can be administered either concomitantly (e.g., as an admixture), separately but simultaneously (e.g., via separate intravenous lines into the same subject, or locations of topical administration), or sequentially (e.g., one of the compounds or agents is given first followed by the second) (¶ [0196]).
Accordingly, since the composition of the prior art comprises more than one therapeutic agent, it would have been prima facie obvious to one of ordinary skill in the art to have administered the therapeutic agents concomitantly, simultaneously, or sequentially since these are known and effective methods for administering more than one active agent as taught by Mitragotri.
Regarding instant claim 6 reciting wherein the anti-myogenic agent is administered first, since it was known in the art to administered actives sequentially, one of ordinary skill in the art would have selected any active agent to be administered first absent unexpected results with the order of inclusion.
Regarding instant claim 8 reciting wherein the administration of the anti-myogenic agent is continued during the subsequent administration of the skeletal muscle relaxant, since it was known in the art that actives may be administered sequentially and may be administered separately but simultaneously, it would have been obvious to one of ordinary skill in the art that the combination of the two is also an effective method of administering actives.
3. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), Liang (CN 105560312 A, May 11, 2016), and further in view of Chung et al. (US 2011/0212161, Sep. 1, 2011) (hereinafter Chung).
The teachings of Whitbourne, Trumbore, Kisak, and Liang are discussed above. Whitbourne, Trumbore, Kisak, and Liang do not teach wherein the composition is administered by injection.
However, Chung discloses a composition for treating skin disorders (abstract). The composition can be a cream, an ointment, or an injection solution (¶ [0006]).
As discussed above, Whitbourne discloses wherein the composition treats skin. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of the prior art to be an injection since this is a known and effective form for compositions that treat skin as taught by Chung.
4. Claims 10-12, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), Liang (CN 105560312 A, May 11, 2016), and further in view of Guo et al. (CN 110755272 A, Feb. 7, 2020) (hereinafter Guo).
The teachings of Whitbourne, Trumbore, Kisak, and Liang are discussed above. Whitbourne, Trumbore, Kisak, and Liang do not teach wherein a wound dressing comprising hydrolyzed is applied to the surface of said afflicted tissues after administration of the anti-myogenic agent or skeletal muscle relaxant.
However, Guo discloses a medical biologic repairing dressing (claim 1). The dressing comprising hydrolyzed collagen (claim 4). Hydrolyzed collagen makes the skin recover elasticity, reproduce firmness, reduce sagging, and smooths fine lines and wrinkles (page 5 of translation).
As discussed above, Whitbourne discloses wherein a wound dressing may be applied after administration of the composition. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated hydrolyzed collagen into the wound dressing motivated by the desire to recover elasticity, reproduce firmness, reduce sagging, and smooth fine lines and wrinkles of the skin as taught by Guo.
4. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), Liang (CN 105560312 A, May 11, 2016), Tan et al. (Current progress in understanding the molecular pathogenesis of burn scar contracture, 2017) (hereinafter Tan), Akhmetshina et al. (Dual inhibition of c-abl and PDGF receptor signaling by dasatinib and nilotinib for the treatment of dermal fibrosis, 2008) (hereinafter Akhmetshina), and further in view of
Guo et al. (CN 110755272 A, Feb. 7, 2020) (hereinafter Guo), Chung et al. (US 2011/0212161, Sep. 1, 2011) (hereinafter Chung), and Nguyen et al. (US 2013/0108700, May 2, 2013) (hereinafter Nguyen).
The teachings of Whitbourne, Trumbore, Kisak, Liang, Tan, and Akhmetshina are discussed above. Whitbourne, Trumbore, Kisak, Liang, Tan, and Akhmetshina do not teach wherein a wound dressing comprising hydrolyzed is applied to the surface of said afflicted tissues after administration of the anti-myogenic agent or skeletal muscle relaxant.
However, Guo discloses a medical biologic repairing dressing (claim 1). The dressing comprising hydrolyzed collagen (claim 4). Hydrolyzed collagen makes the skin recover elasticity, reproduce firmness, reduce sagging, and smooths fine lines and wrinkles (page 5 of translation).
As discussed above, Whitbourne discloses wherein a wound dressing may be applied after administration of the composition. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated hydrolyzed collagen into the wound dressing motivated by the desire to recover elasticity, reproduce firmness, reduce sagging, and smooth fine lines and wrinkles of the skin as taught by Guo.
The combined teachings of Whitbourne, Trumbore, Kisak, Liang, Tan, Akhmetshinama and Guo do not teach wherein the composition is an injection and is injected into skin proximal to a facial skin contracture.
However, Chung discloses a composition for treating skin disorders (abstract). The composition can be a cream, an ointment, or an injection solution (¶ [0006]).
Nguyen discloses a composition useful in the treatment of wounds, particularly reducing or preventing scar formation (abstract). The composition can be injected into the area proximal to a wound (¶ [0008]).
As discussed above, Whitbourne discloses wherein the composition treats skin. Accordingly, it would have been obvious to one of ordinary skill in the art to have formulated the composition of the prior art to be an injection since this is a known and effective form for compositions that treat skin as taught by Chung.
As discussed above, it would have been obvious to one of ordinary skill in the art to have administered the composition of the prior art to treat facial scar contracture. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have injected the composition proximal to the facial scar contracture since injecting proximal to a wound is a known and effective method for treating skin wounds with an injection as taught by Nguyen.
5. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), Liang (CN 105560312 A, May 11, 2016), Tan et al. (Current progress in understanding the molecular pathogenesis of burn scar contracture, 2017) (hereinafter Tan), Akhmetshina et al. (Dual inhibition of c-abl and PDGF receptor signaling by dasatinib and nilotinib for the treatment of dermal fibrosis, 2008) (hereinafter Akhmetshina), and further in view of Mitragotri et al. (US 2018/0251495, Sep. 6, 2018) (hereinafter Mitragotri).
The teachings of Whitbourne, Trumbore, Kisak, Liang, Tan, and Akhmetshina are discussed above. Whitbourne, Trumbore, Kisak, Liang, Tan, and Akhmetshina do not teach administering a first composition comprising an anti-myogenic agent but lacking a muscle relaxant followed by the administration of a second composition comprising a muscle relaxant.
However, Mitragotri discloses a method of using skin penetrating peptides and pharmaceutical compositions thereof. Typically, one or more skin penetrating peptides is administered to a subject in need thereof in combination with one or more active agents. The combination can be administered either concomitantly (e.g., as an admixture), separately but simultaneously (e.g., via separate intravenous lines into the same subject, or locations of topical administration), or sequentially (e.g., one of the compounds or agents is given first followed by the second) (¶ [0196]).
Accordingly, since the composition of the prior art comprises more than one therapeutic agent, it would have been prima facie obvious to one of ordinary skill in the art to have administered the therapeutic agents sequentially since this is a known and effective method for administering more than one active agent as taught by Mitragotri.
Regarding instant claim 17 reciting wherein the anti-myogenic agent is administered first, since it was known in the art to administered actives sequentially, one of ordinary skill in the art would have selected any active agent to be administered first absent unexpected results with the order of inclusion.
6. Claims 19-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Whitbourne (US 2012/0077784, Mar. 29, 2012) in view of Trumbore et al. (US 2016/0120865, May 5, 2016) (hereinafter Trumbore), Kisak et al. (US 2011/0028460, Feb. 3, 2011) (hereinafter Kisak), Liang (CN 105560312 A, May 11, 2016), Tan et al. (Current progress in understanding the molecular pathogenesis of burn scar contracture, 2017) (hereinafter Tan), Akhmetshina et al. (Dual inhibition of c-abl and PDGF receptor signaling by dasatinib and nilotinib for the treatment of dermal fibrosis, 2008) (hereinafter Akhmetshina), Mitragotri et al. (US 2018/0251495, Sep. 6, 2018) (hereinafter Mitragotri), and further in view of Guo et al. (CN 110755272 A, Feb. 7, 2020) (hereinafter Guo).
The teachings of Whitbourne, Trumbore, Kisak, Liang, Tan, Akhmetshina, and Mitragotri are discussed above. Whitbourne, Trumbore, Kisak, Liang, Tan, Akhmetshina, and Mitragotri do not teach wherein a wound dressing comprising hydrolyzed is applied to the surface of said afflicted tissues after administration of the anti-myogenic agent or skeletal muscle relaxant.
However, Guo discloses a medical biologic repairing dressing (claim 1). The dressing comprising hydrolyzed collagen (claim 4). Hydrolyzed collagen makes the skin recover elasticity, reproduce firmness, reduce sagging, and smooths fine lines and wrinkles (page 5 of translation).
As discussed above, Whitbourne discloses wherein a wound dressing may be applied after administration of the composition. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated hydrolyzed collagen into the wound dressing motivated by the desire to recover elasticity, reproduce firmness, reduce sagging, and smooth fine lines and wrinkles of the skin as taught by Guo.
Conclusion
Claims 1, 3-15, 17, 19, 20-22 and 24 are rejected.
No claims are allowed.
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/TRACY LIU/Primary Examiner, Art Unit 1614
