DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 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.
Claim Objections
Claim 3 is objected to because of the following informalities: line 1 should be amended to -wherein the at least one C-glycoside or derivative thereof comprises at least one-. Appropriate correction is required.
Claim 4 is objected to because of the following informalities: line 1 should be amended to - wherein the at least one C-glycoside or derivative thereof is chosen from-. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: line 1 should be amended to - wherein the at least one C-glycoside or derivative thereof is chosen-. Appropriate correction is required.
Claim 8 is objected to because of the following informalities: line 3 should be amended to - applying a composition comprising the at least one C-glycoside or derivative thereof-. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: line 3 should be amended to - applying a composition comprising the at least one C-glycoside or derivative thereof-. Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations
skin modification stimulus (claims 1, 13, 17 and 23-26)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
stimulus (skin modification stimulus - claims 1, 13, 17 and 23-26)
coupled with functional language
treating the scar tissue with (claims 1 and 13), treating uninjured skin with (claim 17) and treating uninjured skin and/or scar tissue with (claims 23-26) (skin modification stimulus - claims 1, 13, 17 and 22-26)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1, 13, 17 and 23-26 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
laser, plasma, radiofrequency, a high- intensity focused ultrasound, an electrical field, heat, a low-level light device, a needle, a microneedle, an abrasive element, a chemical agent such as a chemical exfoliating agent, or the like (¶0045 of the specification)(skin modification stimulus - claims 1, 13, 17 and 23-26)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 22:
The limitation “and(c) instructions for using (a) and (b) in combination to treat scar tissue or to reduce scar tissue formation from a predicted skin injury” in the final lines of the claim is considered new matter. There is nothing in the original disclosure (specification, claims or drawings) that indicate instructions are included with the kit and the remarks fail to indicate where the support for this limitation is in the original disclosure. For this reason the limitation is considered new matter.
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.
Claim(s) 1-4, 6-12, 17-19 and 21-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012131623 A2 to Hirt et al. (Hirt) in view of KR 20140010430 A to Gurtner et al. (Gurtner)(see English language machine translation attached to this or a previous office action).
Regarding claim 1:
Hirt discloses:
A method for improving an appearance of scar tissue (method for the product/kit shown in figures 1-2), comprising:
(a) treating the tissue (“skin” as discussed on page 27, lines 19-25) by applying at least one skin modification stimulus to the tissue to modify or damage the tissue (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and
(b) applying at least one C-glycoside (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10) or derivative thereof to the tissue.
Hirt fails to disclose:
(a) treating the scar tissue by applying at least one skin modification stimulus to the scar tissue to modify or damage the scar tissue, and
(b) applying at least one C-glycoside or derivative thereof to the scar tissue.
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Regarding claim 2:
Hirt discloses:
The method of claim 1, wherein step (b) occurs within about 24 hours before and/or after step (a) (see step d on page 28, line 29- page 29, line 10 which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 24 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 3:
Hirt discloses:
The method of claim 1, wherein the at least one C-glycoside comprises at least one C-xylopyranoside or derivative thereof (Pro-Xylane® (C-beta-D-xylopyranoside-2-hydroxypropane); page 19, lines 20-25).
Regarding claim 4:
Hirt discloses:
The method of claim 1, wherein the at least one C-glycoside is chosen from C1 3-D- xylopyranoside-n-propan-2-one; Ca-D-xylopyranosidepropan-2-one; C1 3-D- xylopyranoside-2-hydroxypropane; Ca-D-xylopyranoside-2- hydroxypropane; 1 -(C1 3- D-fucopyranoside)-propane-2-one; 1 -(Ca-D-fucopyranoside)- propan-2-one; 1 -(C1 3- L-fucopyranoside)-propan-2-one; 1 -(Ca-L-fucopyranoside)- propane-2-one; 2-one,1 - (C1 3-D-fucopyranoside)-2-hydroxypropane, 1 -(Ca-D- fucopyranoside)-2- hydroxypropane; 1 -(C1 3-L-fucopyranoside)-2-hydroxypropane; 1- (Ca-L- fucopyranoside)-2-hydroxypropane; 1 -(C1 3-D-glucopyranosyl)-2- hydroxylpropane; 1- (Ca-D-glucopyranosyl)-2-hydroxylpropane; 1 -(C1 3-D- galactopyranosyl)-2- hydroxylpropane; 1 -(Ca-D-galactopyranosyl)-2-hydroxylpropane-1-(C13-D- fucofuranosyl)propan-2-one; 1-(Ca-D-fucofuranosyl)- propan-2-one; 1-(C13-L- fucofuranosyl)-propan-2-one; 1-(Ca-L-fucofuranosyl)- propan-2-one; C13-D- maltopyranoside-n-propan-2-one-Ca-D-maltopyranoside-n- propan-2-one-C13-D- maltopyranoside-2-hydroxypropane; Ca-D- maltopyranoside-2-hydroxypropane; derivatives thereof (see “C-beta-D-xylopyranoside-2-hydroxypropane” on page 13, lines 5-10), or combinations thereof.
Regarding claim 6:
Hirt discloses:
The method of claim 1, wherein the at least one skin modification stimulus is chosen from one or more of a laser (see the “laser” on page 23, lines 15-20), plasma, radiofrequency, a high-intensity focused ultrasound, an electrical field, heat, a low-level light device, a needle, a microneedle, an abrasive element, or a chemical agent.
Regarding claim 7:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Hirt and Gurtner:
The method of claim 1, wherein the step (a) of treating the scar tissue (see the application of the method of Hirt to scar tissue as taught by Gurtner) by applying the at least one skin modification stimulus to the scar tissue comprises subjecting the scar tissue to one or more of an ablative laser procedure (see “the fractional laser is non-ablative”; page 23, lines 15-20 as taught by Hirt), a non-ablative laser procedure, a microneedling procedure, a high-intensity focused ultrasound procedure, an electroporation procedure, a dermabrasion procedure, a microdermabrasion procedure, a plasma skin rejuvenation procedure, or a chemical exfoliation procedure.
Regarding claim 8:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 1 by Hirt and Gurtner:
The method of claim 1, wherein step (b) comprises:
applying a composition comprising at least one C-glycoside or derivative thereof (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ) and at least one carrier to the scar tissue (see the application of the skin treatment method to scar tissue as taught by Gurtner incorporated into Hirt),
wherein the total amount of C-glycosides and derivatives thereof present in the composition ranges from about 0.1% to about 30% by weight, relative to the total weight of the composition (Hirt indicates the C-glycosides can be the cosmetic composition (page 16, lines 20-30) can be 5 to 50% of the total weight of the composition (page 17, lines 28-32)).
Regarding claim 9:
Hirt discloses:
The method of claim 1, wherein: step(a) occurs before step (b) (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and step (b) occurs no more than about 6 hours after step (a) (see step d on page 28, line 29- page 29, line 10 which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 6 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 10:
Hirt discloses:
The method of claim 9, wherein step (b) is repeated at least one time at least about 12 hours after the first application (see step d on page 28, line 29- page 29, line 10 after the first application outlined in step C which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 12 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 11:
Hirt discloses:
The method of claim 10, wherein step (b) is repeated at least one time at least about 36 hours after the first application (see step d on page 28, line 29- page 29, line 10 after the first application outlined in step C which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 36 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 12:
All limitations of the claim are taught by the 35 USC 103 rejection of claim 9 by Hirt and Gurtner:
The method of claim 9, wherein step (b) comprises:
applying a composition comprising at least one C-glycoside or derivative thereof (see Hirt 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10)and at least one carrier (Hirt “water”, see page 8, lines 19-21 which indicate water can be applied to the sheet material 10 to impregnate it) to the scar tissue (see the application of the method to scar tissue as taught by Gurtner and incorporated into Hirt),
wherein the total amount of C-glycosides and derivatives thereof present in the composition ranges from about 0.1% to about 30% by weight,relative to the total weight of the composition (reference indicates the C-glycosides can be the cosmetic composition (page 16, lines 20-30) can be 5 to 50% of the total weight of the composition (page 17, lines 28-32)).
Regarding claim 17:
Hirt discloses:
A method for reducing the formation of scar tissue from a predicted skin injury (method for the product/kit shown in figures 1-2), comprising:
(a) treating uninjured skin (“skin” as discussed on page 27, lines 19-25) by applying at least one skin modification stimulus to the uninjured skin (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and
(b) applying at least one C-glycoside or derivative thereof to the uninjured skin (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10).
Hirt fails to disclose:
(a) treating uninjured skin that is to be subjected to the predicted skin injury, prior to the predicted skin injury, by applying at least one skin modification stimulus to the uninjured skin, and
(b) applying, prior to the predicted skin injury, at least one C-glycoside or derivative thereof to the uninjured skin.
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery (predicted skin injury) as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Regarding claim 18:
Hirt discloses:
The method of claim 17, wherein step (b) occurs within about 24 hours after step (a) (see step d on page 28, line 29- page 29, line 10 which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 24 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 19:
Hirt discloses:
The method of claim 18, wherein step (b) is repeated at least one time at least about 12 hours after the first application (see step d on page 28, line 29- page 29, line 10 after the first application outlined in step C which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 12 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 21:
Hirt discloses:
A method for improving the appearance of skin tissue and/or scar tissue that has been modified with at least one skin modification stimulus, the method comprising:
(a) identifying the skin tissue (identify the tissue for 2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10); and
(b) applying at least one C-glycoside or derivative thereof to the skin tissue (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10).
Hirt fails to disclose:
(a) identifying the modified skin tissue and/or a modified scar tissue; and
(b) applying at least one C-glycoside or derivative thereof to the modified skin tissue and/or modified scar tissue .
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery (predicted or identified skin injury and/or scar tissue) as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Regarding claim 20:
Hirt discloses:
The method of claim 19, wherein step (b) is repeated at least one time at least about 36 hours after the first application (see step d on page 28, line 29- page 29, line 10 after the first application outlined in step C which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 36 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 23:
Hirt discloses:
A method for reducing a conversion of fibroblasts to myofibroblasts in uninjured skin and/or scar tissue, comprising:
(a) treating uninjured skin with at least one skin modification stimulus (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and
(b) applying at least one C-glycoside or derivative thereof to reduce the conversion of fibroblasts to myofibroblasts (inherent function of the application of C-glycoside or derivative thereof) in the uninjured skin and/or scar tissue (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10.
Hirt fails to disclose:
(a) treating uninjured skin that is to be subjected to a predicted skin injury and/or scar tissue formed following a skin injury with at least one skin modification stimulus, and
(b) applying at least one C-glycoside or derivative thereof to the uninjured skin and/or scar tissue to reduce the conversion of fibroblasts to myofibroblasts in the uninjured skin and/or scar tissue.
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery (predicted skin injury and/or scar tissue) as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Regarding claim 24:
Hirt discloses:
A method for increasing an expression level of DKK-1 in uninjured skin and/or scar tissue, comprising:
(a) treating uninjured skin with at least one skin modification stimulus (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and
(b) applying at least one C-glycoside or derivative thereof to increase the expression level of DKK-1 (inherent function of the application of C-glycoside or derivative thereof) in the uninjured skin and/or scar tissue (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10).
Hirt fails to disclose:
(a) treating uninjured skin that is to be subjected to a predicted skin injury and/or scar tissue formed following a skin injury with at least one skin modification stimulus, and
(b) applying at least one C-glycoside or derivative thereof to the uninjured skin and/or scar tissue to increase the expression level of DKK-1 in the uninjured skin and/or scar tissue.
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery (predicted skin injury and/or scar tissue) as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Regarding claim 25:
Hirt discloses:
A method for increasing a phosphorylation of P-catenin in uninjured skin and/or scar tissue, comprising:
(a) treating uninjured skin with at least one skin modification stimulus (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and
(b) applying at least one C-glycoside or derivative thereof to increase the phosphorylation of p-catenin (inherent function of the application of C-glycoside or derivative thereof) in the uninjured skin and/or scar tissue (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10).
Hirt fails to disclose:
(a) treating uninjured skin that is to be subjected to a predicted skin injury and/or scar tissue formed following a skin injury with at least one skin modification stimulus, and
(b) applying at least one C-glycoside or derivative thereof to the uninjured skin and/or scar tissue to increase the phosphorylation of p-catenin in the uninjured skin and/or scar tissue.
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery (predicted skin injury and/or scar tissue) as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Regarding claim 26:
Hirt discloses:
A method for downregulating a signal transduction of TGF-P in uninjured skin and/or scar tissue, comprising:
(a) treating uninjured skin with at least one skin modification stimulus (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and
(b) applying at least one C-glycoside or derivative thereof to the uninjured skin and/or scar tissue to downregulate the signal transduction of TGF-p (inherent function of the application of C-glycoside or derivative thereof) in the uninjured skin and/or scar tissue (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10).
Hirt fails to disclose:
(a) treating uninjured skin that is to be subjected to a predicted skin injury and/or scar tissue formed following a skin injury with at least one skin modification stimulus, and
(b) applying at least one C-glycoside or derivative thereof to the uninjured skin and/or scar tissue to downregulate the signal transduction of TGF-p in the uninjured skin and/or scar tissue.
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery (predicted skin injury and/or scar tissue) as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012131623 A2 to Hirt et al. (Hirt) in view of KR 20140010430 A to GURTNER et al. (Gurtner)(see English language machine translation attached to this or a previous office action) as applied to claim 1 above, and further in view of FR 3009957 A1 to Devie (see English language machine translation attached to this or a previous office action).
Regarding claim 5:
Hirt fails to disclose:
The method of claim 1, wherein the at least one C-glycoside is chosen from C13-D- xylopyranoside-2-hydroxypropane, Ca-D-xylopyranoside-2-hydroxypropane, or combinations thereof.
Devie teaches:
A cosmetic composition that includes different derivatives of C-glycoside (see page 7 of the translation). The reference further teaches that one of the derivatives that can be used is C13-D-xylopyranoside-2-hydroxypropane (see ¶4 of page 7 of the translation).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to replace the C-glycoside with the C-glycoside derivative C13-D-xylopyranoside-2-hydroxypropane as taught by Devie. This is a simple substitution of one known element (C-glycoside as taught by Hirt) for another (C13-D-xylopyranoside-2-hydroxypropane Devie) to obtain predictable results (healing and improvement of the skin). Devie already teaches that C13-D-xylopyranoside-2-hydroxypropane Devie is a derivative of C-glycoside (Devie, ¶4 of page 7 of the translation) and Hirt teaches that C-glycoside derivatives can be used (Hirt, page 16, line 25).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012131623 A2 to Hirt et al. (Hirt) in view of KR 20140010430 A to Gurtner et al. (Gurtner)(see English language machine translation attached to this or a previous office action) and FR 3009957 A1 to Devie (see English language machine translation attached to this or a previous office action).
Regarding claim 13:
Hirt discloses:
A method for improving the appearance of scar tissue, comprising:
(a) treating the tissue (“skin” as discussed on page 27, lines 19-25) by applying at least one skin modification stimulus to the skin to produce modified tissue (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ), and
(b) applying a composition comprising composition comprising C-glycoside or derivative (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10) to the modified tissue within about 24 hours after step (a) (see step d on page 28, line 29- page 29, line 10 which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 24 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)) within about 24 hours after step (a) (see step d on page 28, line 29- page 29, line 10 which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 24 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)), is present in the composition in an amount ranging from about 0.1% to about 30% by weight, relative to the total weight of the composition (reference indicates the C-glycosides can be the cosmetic composition (page 16, lines 20-30) can be 5 to 50% of the total weight of the composition (page 17, lines 28-32)).
Hirt fails to disclose:
(a) treating the scar tissue by applying at least one skin modification stimulus to the scar tissue to produce modified scar tissue, and
(b) applying a composition comprising C13-D-xylopyranoside-2-hydroxypropane to the modified scar tissue.
Gurtner teaches:
A method for improving scar tissue (see page 5, ¶4). The method teaches that skin (scar tissue) treatments such as the one of this claim can be applied before or after surgery for scar correction (page 5, ¶4; “For pretreatment or preconditioning of the skin before or after surgery, for example for scar correction, wound incision…”).
Devie teaches:
A cosmetic composition that includes different derivatives of C-glycoside (see page 7 of the translation). The reference further teaches that one of the derivatives that can be used is C13-D-xylopyranoside-2-hydroxypropane (see ¶4 of page 7 of the translation).
Regarding the limitation “(a) treating the scar tissue by applying at least one skin modification stimulus to the scar tissue to produce modified scar tissue, and”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to apply the skin treatment method of Hirt to the skin before or after a surgery (surgery resulting in scar tissue) as taught by Gurtner to minimize scaring (Gurtner, page 5, ¶4; “Other uses for these skin treatment devices include, but are not limited to, for example, alleviation or prevention of scar formation…”).
Regarding the limitation “(b) applying a composition comprising C13-D-xylopyranoside-2-hydroxypropane to the modified scar tissue”
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to replace the C-glycoside with the C-glycoside derivative C13-D-xylopyranoside-2-hydroxypropane as taught by Devie. This is a simple substitution of one known element (C-glycoside as taught by Hirt) for another (C13-D-xylopyranoside-2-hydroxypropane Devie) to obtain predictable results (healing and improvement of the skin). Devie already teaches that C13-D-xylopyranoside-2-hydroxypropane Devie is a derivative of C-glycoside (Devie, ¶4 of page 7 of the translation) and Hirt teaches that C-glycoside derivatives can be used (Hirt, page 16, line 25).
Regarding claim 14:
Hirt discloses:
The method of claim 13, wherein step (b) is repeated at least one time at least about 12 hours after the first application (see step d on page 28, line 29- page 29, line 10 after the first application outlined in step C which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 12 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 15:
Hirt discloses:
The method of claim 14, wherein step (b) is repeated at least one time at least about 36 hours after the first application (see step d on page 28, line 29- page 29, line 10 after the first application outlined in step C which indicates the biocellulose mask can be applied between a few hours to 15 days (includes within 36 hours) and the reference indicates the mask may include the active agent as well (page 8, lines 15-20) which can include C-glycoside (page 13, lines 24-26)).
Regarding claim 16:
Hirt discloses:
The method of claim 13, wherein the C13-D-xylopyranoside-2- hydroxypropane is present in the composition in an amount ranging from about 0.5% to about 10% by weight, relative to the total weight of the composition (reference indicates the C-glycosides can be the cosmetic composition (page 16, lines 20-30) can be 5 to 50% of the total weight of the composition (page 17, lines 28-32)).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2012131623 A2 to Hirt et al. (Hirt) in view of US 20030233138 A1 to Spooner.
Regarding claim 22:
Hirt discloses:
A kit comprising:
(a) a skin modification stimulus (2 or 20, “laser” or “laser treatment”; further see step b of the method described on page 28, line 29- page 29, line 10 ),
(b) a composition comprising at least one C-glycoside or derivative thereof (see 10 and 30 that can include bio cellulose and an active agent; page 26, line 30 – page 27, line 5; the reference further teaches that anti-wrinkle agents that may be used with these components can include C-glycoside compounds (page 13, lines 24-26) and C-glycoside derivatives (page 16, lines 24-26); further see step c of the method described on page 28, line 29- page 29, line 10) and at least one carrier (“water”, see page 8, lines 19-21 which indicate water can be applied to the sheet material 10 to impregnate it), wherein the total amount of C-glycosides and derivatives thereof present in the composition ranges from about 0.1% to about 30% by weight, relative to the total weight of the composition (reference indicates the C-glycosides can be the cosmetic composition (page 16, lines 20-30) can be 5 to 50% of the total weight of the composition (page 17, lines 28-32)).
Hirt fails to disclose:
(c) instructions for using (a) and (b) in combination to treat scar tissue or to reduce scar tissue formation from a predicted skin injury.
Spooner teaches:
A method for skin treatment (¶0039, ¶0044). Further, the method or kit (see figure 1) includes instructions for the method (22, ¶0047).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hirt to further include a instruction in the kit as taught by Spooner to properly use the system (Spooner, ¶0047, “and may include data useful for operation of system 10”).
Response to Arguments
Applicant’s arguments, see remarks, filed 1/12/26, with respect to the rejection(s) of claim(s) 1-26 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of WO 2012131623 A2 to Hirt et al. (Hirt) in view of KR 20140010430 A to Gurtner et al. (Gurtner).
Regarding the 35 USC 112(b) claim rejections:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn.
Conclusion
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 WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
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