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 .
Response to Amendments
Applicant’s amendments to the claims of December 23, 2025, in response to the Office Action of September 26, 2025, are acknowledged.
Response to Arguments
The examiner notes that the claimed subject population includes sunburn which is a radiation-induced skin damage (claim 19) and it includes those receiving radiation for cancer who experience radiation dermatitis as a result, among other conditions. Symptoms of sunburn include redness, inflammation, swelling and potentially blisters. This can include cracking and bleeding.
Jesch teaches Plectranthus amboinicus for treating skin conditions and skin wounds. See par. 2. This includes treating itching, irritation, cracking, and a burn. See par. 7. Sunburn can be treated and the composition promotes rapid healing. See par. 141.
Jesch teaches more than this. Treatment of PA was used to successfully treat hot spots characterized by rawness, irritation, lesions, and even bleeding. See par.’s 93 and 94. Human with rashes, itching, irritations, cracking and bleeding of the skin were also treated. See par. 100.
Jagetia teaches Centella asiatica (CA) was shown to reduce the adverse effect of low dose irradiation in rats.
Penn teaches radiotherapy is part of cancer treatment for two-thirds of cancers patients in the United States and 90 percent of those patients will experience radiation dermatitis, which is a rash or burn on the skin.
Chen teaches treating burn, cancer, with a compound comprising PA and CA, and that it has a positive effect on endothelial cell proliferation and migration. See Example 1. This includes increased rate of replacement for tissue layers, e.g. See par. 71. It also increased keratinocyte proliferation. See Example 2.
If a subject has itching, burning, irritation secondary to any type of radiation-induced disorder, or experiences radiotherapy for cancer, or has a sunburn or other burn on the skin, they would be administered the composition taught by Chen. The composition is taught to include PA and CA, which has salvigenin and asiaticoside for topical use. It can further comprise cirsimaritin. The claimed combination renders obvious the treatment of sunburn, burn, low dose radiation, cancer, itching, cracking, and irritation. The compositions are taught to have a positive effect on endothelial cell proliferation and migration. including increased the rate of replacement for tissue layers, e.g.
The specification defines ‘radiation-induced skin disorder’ to include “any skin disorder associated with exposure to radiation.” See Spec. @ p16. Moreover, common symptoms taught to be associated with radiation dermatitis include: redness, itching, flaking, peeling, soreness, blistering, scarring, ulcers. See Spec. @ p16-17. These are also symptoms of sunburn, as taught by the prior art, including redness, blistering, flaking, peeling, itching, and more. See par. 147, 139, 140, of Jesch. Thus, the same symptoms that characterize radiation dermatitis are taught be treated by Jesch.
Applicant argues that the experimental data shows that PA extract comprising salvigenin is effective in treating radiation induced skin conditions.
The examiner notes that this is not unexpected as the prior art renders this obvious.
Applicant argues that unexpected results can be used to overcome a rejection of obviousness. Further, the invention is alleged to yield unexpectedly improved properties not present in the prior art. Applicant argues that the PA extract will treat and show effectiveness against radiation-induced skin conditions. The combination of CA and PA is taught to play an essential role.
Applicant attaches Ko for treating other skin conditions that do not include radiation-induced skin conditions.
The examiner notes that Ko is merely used to provide a method of preparing a composition comprising a PA extract that includes salvigenin and crismaritin, e.g. Ko is not required to provide the subject population being taught, although even Ko teaches treating a variety of skin conditions, including dry skin. The claimed combination would be expected to treat wounds, burns, irritation, cracks, inflammation, and other problems associated with the skin especially induced by radiation, including sunburn and low dose radiation as is specifically taught. In view of this, it is not clear that anything is unexpected nor non-obvious in view of the cited prior art. A POSA would understand and find a reasonable and predictable expectation of success in treating an injury of any kind to the skin by reducing inflammation, dryness, burns, and well as wounds in light of the prior art.
Status of the Claims
Claims 1-20 are pending and examined.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al., (US2018/0015133), as evidenced by and in view of Penn Medicine, “Cancer patients can now use skin creams during radiation therapy, “October 18, 2018.
Chen teaches topical compositions comprising salvigenin and asiaticoside for wound healing. See Abstract. In some embodiments, the active agent is Plectranthus amboinicus (PA) and Centella asiastica extract. It comprises salvigenin and asiaticoside for topical use. It can further comprise cirsimaritin. See par. 7. The composition can be in form of a cream or topical ointment. See par. 32 and 33. Example of solvents that can be used to produce a PA extract include ethanol and ethyl acetate, ethyl acetate and butanol, ethanol and propanol, methyl acetate and butanol. See par. 46. The solvent is one with a polarity less than 7, including less than 6.5, 6, 5.5, 4.0, etc., including methanol, ethanol, acetone, ethyl acetate, and others. See par.’s 46 and 47. Further, the PA can be extracted one or more times to produce a crude extract. The crude extract can be brought into contact with a suitable resin to allow for binding on the resin, including: DIAION® HP20, DIAION® HP20SS, Sepabeads® SP207, Amberlite™ XAD-2, or Amberlite™ XAD-4. See par. 51. These are example of hydrophobic interaction chromatography. The extract can then be eluted with a solvent having a polarity index below 7 to produce a dried PA extract. See par. 52. Solvents shown to have a lower polarity index than 7 are included in Table 1, which includes solvents with a polarity index of 6.6 and lower. The composition can be applied multiple times day and as little as once every week or every other day. See par. 70. These compositions were shown to have a positive effect on endothelial cell proliferation and migration. See Example 1. This includes increased rate of replacement for tissue layers, e.g. See par. 71. It also increased keratinocyte proliferation. See Example 2. It treats a wound caused by a carcinoma, burn, and atopic dermatitis, e.g. See par. 20. Chen teaches formulations comprising carriers and excipients. See par. 36.
With regard to claim 4, the claim is a method claim wherein the product to be used is defined by a product by process. The product in this claim will be examined based on the structural limitations, absent evidence to the contrary that, e.g., the product produced has different structural limitations/features. See M.P.E.P. § 2113.
Penn Medicine indicates that radiotherapy is part of cancer treatment for two-thirds of cancers patients in the United States and 90 percent of those patients will experience radiation dermatitis, which is a rash or burn on the skin.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of Chen and Penn Medicine. One would have been motivated to do so because the claimed extracts are taught to treat cancer (i.e., carcinoma), burns, and dermatitis, among a number of other skin conditions and the claimed compositions have been shown to increase keratinocyte proliferation and endothelial cell proliferation and migration. In light thereof, a POSA would find a reasonable and predictable expectation of success in treating skin conditions, including burns and dermatitis as well as other wounds of the skin by administering the claimed compositions. This is a result of the claimed active agents being taught to heal skin wounds independent of source of that wound when a composition comprising an extract of PA, salvigenin, asiaticoside, and cirsimaritin are applied topically and by other routes of administration.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ko et al., (US2013/0131159), in view of Chen et al., (US2018/0015133), in view of Penn Medicine, “Cancer patients can now use skin creams during radiation therapy, “October 18, 2018, and in view of Jagetia, “Radioprotective Potential of Plants and Herbs against the Effects of Ionizing Radiation,” J. Clin. Biochem. Nutr.,40, 74-81, March 2007, and in view of Jesch et al., (US2015/0118333).
Ko teaches Plectranthus amboinicus (PA) is effective for treating a variety of skin conditions “such as seborrheic dermatitis, eczema, acne, allergies, dry skin, scalp folliculitis, and significant effects on the skin whitening, fatigue elimination, and removal of a variety of skin ringworm.” See par. 4. Further, PA has efficacy to treat cancer. See par. 6. Other prior art also recognized the ability of PA extract to treat skin disorders and wound healing, particularly in those with diabetes. See par. 8. An absorption peak of cirsimaritin is noted in the PA. See par. 11. Further, absorption peaks were also recognized in salvigenin, carvacrol, and rosmarinic acid. See par.’s 24-30. The composition can be delivered through any route of administration including orally and transdermally. See par. 51. Excipients and carriers are contemplated. See par. 50. The extract can be obtained using alcoholic solutions of ethanol, e.g., and hexane and hexane/ethyl acetate, e.g., can be used as extraction solvent by a chromatography. See prior art claims 6-10. In other pervious applications elution can be performed with numerous solvents that decrease in polarity. See par. 9.
Chen teaches topical compositions comprising salvigenin and asiaticoside for wound healing. See Abstract. In some embodiments, the active agent is PA and Centella asiastica extract. It comprises salvigenin and asiaticoside for topical use. It can further comprise cirsimaritin. See par. 7. The composition can be in form of a cream or topical ointment. See par. 32 and 33. Example of solvents that can be used to produce a PA extract include ethanol and ethyl acetate, ethyl acetate and butanol, ethanol and propanol, methyl acetate and butanol. See par. 46. The solvent is one with a polarity less than 7, including less than 6.5, 6, 5.5, 4.0, etc., including methanol, ethanol, acetone, ethyl acetate, and others. See par.’s 46 and 47. Further, the PA can be extracted one or more times to produce a crude extract. The crude extract can be brought into contact with a suitable resin to allow for binding on the resin, including: DIAION® HP20, DIAION® HP20SS, Sepabeads® SP207, Amberlite™ XAD-2, or Amberlite™ XAD-4. See par. 51. These are example of hydrophobic interaction chromatography. The extract can then be eluted with a solvent having a polarity index below 7 to produce a dried PA extract. See par. 52. The composition can be applied multiple times day and as little as once every week or every other day. See par. 70. These compositions had a generic positive effect on endothelial cell proliferation and migration. See Example 1. Chen teaches formulations comprising carriers and excipients. See par. 36.
With regard to claim 4, the claim is a method claim wherein the product to be used is defined by a product by process. The product in this claim will be examined based on the structural limitations, absent evidence to the contrary that, e.g., the product produced has different structural limitations/features. See M.P.E.P. § 2113.
Penn Medicine indicates that radiotherapy is part of cancer treatment for two-thirds of cancers patients in the United States and 90 percent of those patients will experience radiation dermatitis, which is a rash or burn on the skin.
Jagetia teaches ionizing radiation has harmful effects that have been established, including through the use of radiation in diagnosis therapy, air and space travel, industry, and other causes. See p 74. Centella asiatica (CA) was shown to reduce the adverse effect of low dose irradiation in rats by inhibiting radiation-induced weight loss and conditioned taste aversion. See p76. Similarly, Jesch teaches a composition comprising Plectranthus amboinicus for use in treating sunburn and promoting rapid healing in superficial sunburn cases. See par. 141. Treatment with PA can be topical for those with rash, itching, irritation, burn, and other skin conditions. See prior art claims 11-13.
It would have been prima facie obvious to a person having ordinary skill in the art prior to the filing of the instant application to arrive at the claimed methods in view of Ko, Chen, Penn Medicine, Jagetia, and Jesch. One would have been motivated to do so because the claimed extracts are taught to treat cancer (i.e., carcinoma), burns, and dermatitis, among a number of other skin conditions taught by Ko, and the claimed compositions have been shown to increase keratinocyte proliferation and endothelial cell proliferation and migration. In light thereof, a POSA would find a reasonable and predictable expectation of success in treating skin conditions, including burns and dermatitis as well as other wounds of the skin by administering the claimed compositions. Even further, Jagetia explicitly describes the use of CA to reduce adverse events associated with ionizing radiation. Jesch, similar to Ko, also teaches treating skin conditions, including sunburn, irritation, itching, and others.
As such, no claim is allowed.
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 extension fee 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 JARED D. BARSKY whose telephone number is (571)-272-2795. The examiner can normally be reached on Monday through Friday from 8:30 to 5:30. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Amy L. Clark can be reached on 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARED BARSKY/Primary Examiner, Art Unit 1628