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 .
Election/Restrictions
Applicant’s election of nodular basal cell carcinoma, actinic keratosis, a fatty ointment,
guar gum, and lactose in the reply filed on 09/08/2025 is acknowledged. Because applicant did
not distinctly and specifically point out the supposed errors in the restriction requirement, the
election has been treated as an election without traverse (MPEP § 818.01(a)).
Priority
The instant application filed on 04/14/2023 is a 371 of PCT/IL2021/051227 filed on
10/18/2021, which claims priority to U.S. Provisional Application 63/093,312 filed on
10/19/2020. PRO 63/093,312 finds support for the instant application; therefore, the effective
filing date of the instant application is 10/19/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 07/10/2023, 11/14/2023, and
11/13/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information
disclosure statement is being considered by the examiner.
Withdrawal of Rejections
The response and amendments filed on 12/14/2025 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous rejections under 35 U.S.C. 102 for anticipation have been withdrawn. The previous rejections under 35 U.S.C. 103 for obviousness have been withdrawn.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.
Claim Rejections - 35 USC § 112(b), Indefiniteness
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.
Claims 36-55 are rejected under 35 U.S.C. 112(b) 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.
Claims 36, 38, 41, and 55 recite “(EC 3.4.22.32)” in parentheses; however, it is unclear if this is part of the claimed invention, or a preferred embodiment. For the purposes of applying prior art, the Examiner has interpreted this to be a preferred embodiment and not part of the claimed invention.
Claims 38 and 41 recite “preventing recurrence thereof”; however, the claims go on to recite “topically applying to a skin lesion”; therefore the scope of the claims is unclear. It is unclear how one would apply the composition to a skin lesion if the skin lesion has been cleared.
Claim 42 recites “at least about”; however, it is unclear if this duration is about 4 hours, which would include time less than and greater than 4 hours, or if this duration is at least 4 hours, which would only include time that is 4 hours or greater. Moreover, the instant specification defines “about” as “a value which is 10% above or below the indicated value” (see, e.g., instant specification, pg. 18, line 31); however, it is unclear from this definition if the claimed time is at least 3 hours and 36 minutes (10% below) or at least 4 hours and 24 minutes (10% above).
Claim 54 recites a table, which is only permitted under certain circumstances when there is no way of claiming the subject matter (see, e.g., MPEP 2173.05(s)); therefore, it is recommended that the table be removed from the claim.
Claims 37, 39-40, 42, and 43-53 are included in this rejection for depending on independent claim 36 and failing to rectify the noted deficiencies.
Examiner’s Response to Arguments
Applicant’s arguments filed on 12/14/2025 pertaining to the 35 U.S.C. 112(b) rejections set forth in the non-final office action mailed on 11/25/2025 are not persuasive.
Regarding Applicant’s argument regarding EC 3.4.22.32 (remarks, page 7), this argument is not persuasive because it is unclear if what is recited in parentheses is part of the claimed invention or a preferred embodiment. The Examiner understands from the instant specification that EC 3.4.22.32 is an official enzyme class; however, this rejection is maintained because it is still unclear if this enzyme class is part of the claimed invention, or a preferred embodiment, since it is in parentheses. Applicant’s arguments that the EC 3.4.22.32 is a “particular” stem material bromelain from pineapple is noted; however it is unclear if EC 3.4.22.32 is a narrower embodiment of the broader recitation of “stem bromelain” or all stem bromelain fall into this class. The examiner will withdraw this rejection once applicant clarifies the above inquiry on record.
Regarding Applicant’s argument regarding “at least about” (remarks, page 8), this argument is not persuasive because based on the definition of “about” in the instant specification (see, e.g., instant specification, pg. 18, line 31), it is unclear if the lower time boundary is 10% above or 10% below the indicated value. More specifically, 10% below the indicated 4 hour value would be 3 hours and 36 minutes; however, 10% above the indicated 4 hour value would be 4 hours and 24 minutes. Therefore, it is unclear if the lower time boundary is 3 hours and 36 minutes or 4 hours and 24 minutes based on the definition set forth in the instant specification. Thus, it is unclear at what time interval one would infringe; i.e. at 3 hours and 36 minutes (which would refer to the ‘about’ recitation) or at 4 hours and 24 minutes (which would refer to the ‘at least’ recitation). The examiner suggests removing the term ‘at least.’
Regarding Applicant’s argument regarding the table in claim 54 (remarks, pages 8-9), this argument is not persuasive because, as discussed above, tables are only permitted under certain circumstances when there is no way of claiming the subject matter (see, e.g., MPEP 2173.05(s); emphasis added). The pharmaceutical formulation recited in the table in claim 54 can be written in a claim without use of a table; therefore, the Applicant has multiple ways of claiming this subject matter that does not require a table. The fact that using a table is an easier method for claiming the subject matter is not a persuasive reason. Therefore, this rejection is maintained.
Claim Rejections - 35 USC § 103, Obviousness
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 36-37, 39-40, and 42-55 are rejected under 35 U.S.C. 103 as being unpatentable over Lozinsky (US 2019/0142910; Date of Publication: May 16, 2019 – cited in the IDS filed on 07/10/2023) in view of Fein (US 2003/0026794; Date of Publication: February 6, 2003 – cited in the IDS filed on 07/10/2023).
Lozinsky’s general disclosure relates to methods of wound debridement, wherein wounds are topically administered a debriding formulation comprising a proteolytic enzyme mixture from bromelain and a water-soluble gelling agent (see, e.g., Lozinsky, abstract). Additionally, Lozinsky discloses that the formulation contains an anti-aggregation agent and a pH adjusting agent (see, e.g., Lozinsky, [0025]). Moreover, Lozinsky discloses applying the formulation is a hydrogel and should be administered to the wound site up to ten times over a four week period in order to achieve debridement of the wound (see, e.g., Lozinsky, abstract).
Regarding claims 36 and 55 pertaining to the pharmaceutical formulation, Lozinsky teaches a method of debriding a wound, wherein a dried or lyophilized composition comprising: (i) bromelain EC 3.4.22.32, (ii) a water-soluble gelling agent, (iii) an anti-aggregation agent, (iv) a pH adjusting agent, and (v) water (see, e.g., Lozinsky, [0031]). Moreover, Lozinsky teaches admixing the water with the composition comprising: (i) bromelain EC 3.4.22.32, (ii) a water-soluble gelling agent, (iii) an anti-aggregation agent, (iv) a pH adjusting agent to form a debriding formulation characterized by being a homogenous hydrogel having a pH in the range of about 6.0 to about 8.0 (see, e.g., Lozinsky, [0031]). Additionally, Lozinsky teaches that the amount of proteins in the debriding formulation ranges from about 0.5% (w/w) to about 7% (w/w) of the total weight of the debriding formulation (see, e.g., Lozinsky, [0031]) (see, e.g., MPEP 2131.03). Furthermore, Lozinsky teaches that the composition can be applied to treat chronic wounds, such as “a diabetic ulcer, a venous stasis ulcer, an arterial insufficiency ulcer, a pressure ulcer, a post-operative and a post trauma wound” (see, e.g., Lozinsky, [0037]). Additionally, Lozinsky provides an example comprising a gel formulation, wherein the formulation comprises a proteolytic enzyme mixture obtained from bromelain, guar gum (i.e., gelling agent), lactose (i.e., anti-agglomeration agent), potassium phosphate dibasic and monobasic (i.e., pH adjusting agent), and water (see, e.g., Lozinsky, Example 1, pg. 10). Moreover, within Example 1, Lozinsky teaches that the amount of bromelain can be 0.1%, 0.5%, 1%, and 2% (see, e.g., Lozinsky, Example 1, pg. 10).
Regarding claim 42 pertaining to applying the pharmaceutical formulation, Lozinsky teaches “applying the debriding formulation of the presenting invention onto chronic wounds up to 10 times, while maintaining the debriding formulation on the wound site for about 24 hours per application” (see, e.g., Lozinsky, [0023]).
Regarding claim 43 pertaining to the amount of application of the pharmaceutical formulation, Lozinsky teaches “According to additional embodiments, applying the debriding formulation is performed in a regimen of up to 10 applications, wherein the debriding formulation is maintained in contact with the wound site for about 4-24 hours, such as for about 6 hours, for about 8 hours, for about 10 hours, for about 12 hours, for about 16 hours, for about 24 hours, or for any integer in between per application per day. Each possibility represents a separate embodiment of the invention. According to a certain embodiment, the debriding formulation is maintained in contact with the wound site for about 24 hours per application for up to 10 applications, alternatively for up to 8 applications. According to an exemplary embodiment, the debriding formulation is applied daily for about 24 hours per application for 10 consecutive days” (see, e.g., Lozinsky, [0038]).
Regarding claim 44 pertaining to the application of the pharmaceutical composition, Lozinsky teaches “According to additional embodiments, applying the debriding formulation is performed in a regimen of up to 10 applications, wherein the debriding formulation is maintained in contact with the wound site for about 4-24 hours, such as for about 6 hours, for about 8 hours, for about 10 hours, for about 12 hours, for about 16 hours, for about 24 hours, or for any integer in between per application per day” (see, e.g., Lozinsky, [0038]).
Regarding claim 45 pertaining to the healing composition, Lozinsky teaches administration of Santyl ® ointment to treat chronic wounds (see, e.g., Lozinsky, [0022]). One of ordinary skill in the art would readily recognize that Santyl ® is a fatty ointment because it contains petroleum (see, e.g., Art of Record, Smith+Nephew – A Patient’s Guide Collagenase Santyl Ointment).
Regarding claim 46 pertaining to the amount of the proteolytic enzyme mixture, Lozinsky teaches from about 0.5% (w/w) to about 7% (w/w) of the total weight of the debriding formulation (see, e.g., Lozinsky, [0031]). Moreover, within Example 1, Lozinsky teaches that the amount of bromelain can be 0.1%, 0.5%, 1%, and 2% (see, e.g., Lozinsky, Example 1, pg. 10). Additionally, Lozinsky teaches “The proteolytic enzyme mixture is denoted throughout the specification and claims as the active principal ingredient (API). According to the invention, the amount of proteins, or alternatively the amount of API, in the debriding formulation ranges from about 0.5% (w/w) to about 7% (w/w) of the total weight of the debriding formulation. According to additional embodiments, the amount of proteins or API ranges from about 1% (w/w) to about 5% (w/w) , such as of about 1% (w/w), 2%, 3%, 4%, 5%, 6%, 7% of the total weight of the debriding formulation, or alternatively of about 2% (w/w) of the total weight of the debriding formulation” (see, e.g., Lozinsky, [0116]).
Regarding claim 47 pertaining to the water-soluble gelling agent, Lozinsky teaches “naturally occurring gelling agents, semi-synthetic gelling agents and synthetic gelling agents” (see, e.g., Lozinsky, [0053]).
Regarding claim 48 pertaining to water-soluble naturally occurring gelling agent, Lozinsky teaches “the naturally occurring gelling agent is a naturally occurring polysaccharide such as, for example, galactomannans, glucomannans, natural gums, starches, agar, and pectin” (see, e.g., Lozinsky, [0053]).
Regarding claim 49 pertaining to the galactomannan and guar gum, Lozinsky teaches “the water-soluble naturally occurring gelling agent is guar gum present in an amount ranging from about 0.25 % (w/w) to about 5 % (w/w) of the total weight of the debriding formulation” (see, e.g., Lozinsky, [0053] & Example 1, pg. 10).
Regarding claims 50-51 pertaining to the anti-aggregation agent, Lozinsky teaches “the anti-aggregation agent of the debriding formulation is an oligosaccharide selected from the group consisting of lactose, sucrose, mannitol, and glucose. Each possibility represents a separate embodiment of the invention. According to a certain embodiment, the anti-aggregation agent is lactose present in an amount ranging from about 10 % (w/w) to about 25 % (w/w) of the total weight of the debriding formulation” (see, e.g., Lozinsky, [0054] & Example 1, pg. 10).
Regarding claim 52 pertaining to the pH adjusting agent, Lozinsky teaches “the pH adjusting agent of the debriding formulation is selected from the group consisting of potassium phosphate, potassium carbonate, sodium phosphate, and sodium carbonate. Each possibility is a separate embodiment of the invention. According to a certain embodiment, the pH adjusting agent is a combination of potassium phosphate dibasic and potassium phosphate monobasic present in an amount ranging from about 2% (w/w) to about 10% (w/w) of the total weight of the debriding formulation” (see, e.g., Lozinsky, [0055]).
Regarding claim 53 pertaining to the amount of the proteolytic enzyme mixture, the water-soluble gelling agent, the anti-aggregation agent, and the pH adjusting agent, Lozinsky teaches from about 0.5% (w/w) to about 7% (w/w) of the total weight of the debriding formulation (see, e.g., Lozinsky, [0031]). Additionally, Lozinsky teaches “the water-soluble naturally occurring gelling agent is guar gum present in an amount ranging from about 0.25 % (w/w) to about 5 % (w/w) of the total weight of the debriding formulation” (see, e.g., Lozinsky, [0053]). Moreover, the anti-aggregation agent is lactose present in an amount ranging from about 10 % (w/w) to about 25 % (w/w) of the total weight of the debriding formulation” (see, e.g., Lozinsky, [0054]). Furthermore, the pH adjusting agent is a combination of potassium phosphate dibasic and potassium phosphate monobasic present in an amount ranging from about 2% (w/w) to about 10% (w/w) of the total weight of the debriding formulation” (see, e.g., Lozinsky, [0055]).
Regarding claim 54 pertaining to the pharmaceutical formulation, Lozinsky teaches a debriding formulation comprising 2% (w/w) of a proteolytic enzyme mixture, 3.5% (w/w) of guar gum, 18.05% (w/w) of lactose, 2.5% (w/w) of potassium phosphate dibasic, 0.8% (w/w) of potassium phosphate monobasic, 2% (w/w) of PEG-3350, and 71.15% (w/w) of water for injection (see, e.g., Lozinsky, [0101]), The percentage of the proteolytic enzyme mixture (i.e., bromelain), lactose, and PEG-3350 is approaching the claimed percentages of bromelain, lactose, and PEG-3350; therefore, these percentages are prima facie obvious in view of Lozinsky (see, e.g., MPEP 2144.05(I)).
However, Lozinsky does not teach: treating a skin lesion and delaying or preventing recurrence thereof comprising topically applying to a skin selected from the group consisting of a non-melanoma skin cancer, pre-cancerous skin lesions, and benign skin lesions(claims 36 and 55); of wherein the non-melanoma skin cancer is selected from the group consisting of basal cell carcinoma and squamous cell carcinoma (claim 37); or wherein the pre-cancerous skin lesion is actinic keratoses (claim 39); or wherein the benign skin lesion is seborrheic keratosis (claim 40); or wherein the skin lesion is basal cell carcinoma (claim 44).
Fein’s general disclosure relates to “A method of treating skin conditions by providing compositions containing enzymes to selectively remove specific layers of skin. The depth of skin removed (that is, vertical surface treated) is regulated by the type and concentration of enzyme or enzymes in the composition” (see, e.g., Fein, abstract). Moreover, Fein discloses a pharmaceutical composition comprising bromelain to selectively effect an epidermal layer of skin (see, e.g., Fein, [0013]). Furthermore, Fein teaches the treatment of skin conditions with bromelain, wherein the skin conditions are “non-pathological, such as natural or artificial altered skin pigmentation” (see, e.g., Fein, [0029]), or “pathological and more invasive, such as neoplasms affecting the skin” (see, e.g., Fein, [0029]). Within this last group are neoplasms having various degrees of aggressiveness, ranging from the relatively non-aggressive basal cell carcinoma, to the aggressive malignant melanoma” (see, e.g., Fein, [0029]).
Regarding claims 36-37, 39-40, 44, and 55 pertaining to treating a skin lesion by topically applying the formulation to a skin lesion on a subject in need thereof, Fein teaches topically applying a composition that contains a least one protease, wherein the protease can be bromelain, in order to selectively remove at least one epidermal layer of skin containing a skin condition (see, e.g., Fein, [0013]-[0015]). Additionally, Fein teaches “In another embodiment, a method for treating a condition affecting skin is disclosed by applying a composition to the affected skin, where the composition contains at least one enzyme at a concentration selective for regulating the depth of skin treatment, and is applied to an area of skin selective for regulating a radial surface of skin treatment” (see, e.g., Fein, [0018]). Furthermore, Fein teaches that the skin condition to be treated or controlled can be pathological and more invasive, such as neoplasms, wherein the neoplasms can include actinic keratosis, basal cell carcinoma, squamous cell carcinoma, and seborrheic keratosis (see, e.g., Fein, [0029]-[0030]). Additionally, Fein teaches that the composition can be administered to prevent skin conditions in mammals by administering protease-containing formulations (see, e.g., Fein, [0027]-[0028]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Lozinsky’s pharmaceutical composition comprising (i) bromelain EC 3.4.22.32, (ii) a water-soluble gelling agent, (iii) an anti-aggregation agent, (iv) a pH adjusting agent, and (v) water, wherein the composition is administered to treat skin lesions, such as basal cell carcinoma, squamous cell carcinoma, actinic keratosis, and seborrheic keratosis, as taught by Fein. One would have been motivated to do so because Fein teaches that compositions comprising proteolytic enzymes, such as bromelain, can treat a patient having a condition involving the epidermal, and/or dermal, and/or subcutaneous layer of skin (see, e.g., Fein, [0008]). Additionally, Fein teaches that bromelain can be used to treat benign, pre-cancerous, and cancerous skin conditions, such as basal cell carcinoma, actinic keratoses, and seborrheic keratosis (see, e.g., Fein, [0030] & Example 2). Moreover, Lozinsky teaches a method of debridement of chronic wounds through administration of a composition comprising bromelain (see, e.g., Lozinsky, abstract). Additionally, Lozinsky teaches applying the composition containing bromelain to patients having wounds, such as “a diabetic ulcer, a venous stasis ulcer, an arterial insufficiency ulcer, a pressure ulcer, a post-operative and a post trauma wound” (see, e.g., Lozinsky, [0164]). Therefore, Lozinsky also teaches methods of treating skin conditions through application of compositions comprising bromelain. Therefore, based on the teachings of Lozinsky and Fein, it would have been obvious to apply a composition comprising bromelain to treat a skin lesion, wherein the skin lesions are the most common types of malignant, premalignant, or benign skin lesions that can present on the human body. One would have expected success because Lozinsky and Fein both teach skin conditions and treatment of skin conditions.
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Lozinsky (previously cited), Fein (previously cited), and Dourmishev (Clinical variants, stages, and management of basal cell carcinoma; 2013).
The teachings of Lozinsky are discussed above.
Regarding claim 38 pertaining to the pharmaceutical formulation, Lozinsky teaches a method of debriding a wound, wherein a dried or lyophilized composition comprising: (i) bromelain EC 3.4.22.32, (ii) a water-soluble gelling agent, (iii) an anti-aggregation agent, (iv) a pH adjusting agent, and (v) water Moreover, Lozinsky teaches admixing the water with the composition comprising: (i) bromelain EC 3.4.22.32, (ii) a water-soluble gelling agent, (iii) an anti-aggregation agent, (iv) a pH adjusting agent to form a debriding formulation characterized by being a homogenous hydrogel having a pH in the range of about 6.0 to about 8.0 (see, e.g., Lozinsky, [0031]). Additionally, Lozinsky teaches that the amount of proteins in the debriding formulation ranges from about 0.5% (w/w) to about 7% (w/w) of the total weight of the debriding formulation (see, e.g., Lozinsky, [0031]) (see, e.g., MPEP 2131.03). Furthermore, Lozinsky teaches that the composition can be applied to treat chronic wounds, such as “a diabetic ulcer, a venous stasis ulcer, an arterial insufficiency ulcer, a pressure ulcer, a post-operative and a post trauma wound” (see, e.g., Lozinsky, [0037]). Additionally, Lozinsky provides an example comprising a gel formulation, wherein the formulation comprises a proteolytic enzyme mixture obtained from bromelain, guar gum (i.e., gelling agent), lactose (i.e., anti-agglomeration agent), potassium phosphate dibasic and monobasic (i.e., pH adjusting agent), and water (see, e.g., Lozinsky, Example 1, pg. 10). Moreover, within Example 1, Lozinsky teaches that the amount of bromelain can be 0.1%, 0.5%, 1%, and 2% (see, e.g., Lozinsky, Example 1, pg. 10).
However, Lozinsky does not teach: wherein the skin lesion is a basal cell carcinoma that is nodular basal cell carcinoma (claim 38).
The teachings of Fein are discussed above.
Regarding claim 38 pertaining to treating a skin lesion by topically applying the formulation to a skin lesion on a subject in need thereof, Fein teaches topically applying a composition that contains a least one protease, wherein the protease can be bromelain, in order to selectively remove at least one epidermal layer of skin containing a skin condition (see, e.g., Fein, [0013]-[0015]). Additionally, Fein teaches “In another embodiment, a method for treating a condition affecting skin is disclosed by applying a composition to the affected skin, where the composition contains at least one enzyme at a concentration selective for regulating the depth of skin treatment, and is applied to an area of skin selective for regulating a radial surface of skin treatment” (see, e.g., Fein, [0018]). Furthermore, Fein teaches that the skin condition to be treated or controlled can be pathological and more invasive, such as neoplasms, wherein the neoplasms can include actinic keratosis, basal cell carcinoma, squamous cell carcinoma, and seborrheic keratosis (see, e.g., Fein, [0029]-[0030]). Additionally, Fein teaches that the composition can be administered to prevent skin conditions in mammals by administering protease-containing formulations (see, e.g., Fein, [0027]-[0028]).
Dourmishev’s general disclosure relates to basal cell carcinoma and different variants of basal cell carcinoma, such as nodular, cystic, micronodular, superficial, and pigment (see, e.g., Dourmishev, abstract). Moreover, Dourmishev discloses that nodular basal cell carcinoma is the most common variant of basal cell carcinoma (see, e.g., Dourmishev, “Nodular basal cell carcinoma”, pg. 13).
Regarding claim 38 pertaining to nodular basal cell carcinoma, Dourmishev teaches that “Nodular basal cell carcinoma comprises about 60-80% of the cases and occurs most often on the skin of the head. Clinically it is presented by elevated, exophytic pearl-shaped nodules with telangiectasie on the surface and periphery [Figure 1]. Subsequently, nodular BCC can extend into ulcerative or cystic pattern” (see, e.g., Dourmishev, “Nodular basal cell carcinoma”, pg. 13).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce Lozinsky’s pharmaceutical composition comprising (i) bromelain EC 3.4.22.32, (ii) a water-soluble gelling agent, (iii) an anti-aggregation agent, (iv) a pH adjusting agent, and (v) water, wherein the composition is administered to treat skin lesions, wherein the skin lesion is a nodular basal cell carcinoma, which is a variant of basal cell carcinoma, as taught by Fein, and Dourmishev. One would have been motivated to do so because Fein teaches that compositions comprising proteolytic enzymes, such as bromelain, can treat a patient having a condition involving the epidermal, and/or dermal, and/or subcutaneous layer of skin (see, e.g., Fein, [0008]). Additionally, Fein teaches that bromelain can be used to treat benign, pre-cancerous, and cancerous skin conditions, such as basal cell carcinoma, actinic keratoses, and seborrheic keratosis (see, e.g., Fein, [0030] & Example 2). Furthermore, Dourmishev teaches that nodular basal cell carcinoma comprises about 60-80% of the basal cell cases (see, e.g., Dourmishev, “Nodular basal cell carcinoma”, pg. 13). Moreover, Lozinsky teaches a method of debridement of chronic wounds through administration of a composition comprising bromelain (see, e.g., Lozinsky, abstract). Additionally, Lozinsky teaches applying the composition containing bromelain to patients having wounds, such as “a diabetic ulcer, a venous stasis ulcer, an arterial insufficiency ulcer, a pressure ulcer, a post-operative and a post trauma wound” (see, e.g., Lozinsky, [0164]). Therefore, Lozinsky also teaches methods of treating skin conditions through application of compositions comprising bromelain. Therefore, based on the teachings of Lozinsky, Fein, and Dourmishev it would have been obvious to apply a composition comprising bromelain to treat a skin lesion, wherein the skin lesion is nodular basal cell carcinoma, which is the most common basal cell carcinoma variant. One would have expected success because Lozinsky, Fein, and Dourmishev all teach skin conditions and treatment of skin conditions.
Examiner’s Response to Arguments
In response to Applicant’s arguments regarding Lozinsky not teaching a skin lesion and instead treating chronic wounds, as discussed above, the previous 35 U.S.C. 102 rejection in view of Lozinsky has been withdrawn; however, new grounds of rejection are set forth above. Although Lozinsky is cited in the rejection above, it is not cited to teach the limitations pertaining to skin lesions.
Conclusion
Claims 36-55 are rejected. However, claim 41 appears free from the art because the prior art does not teach delaying recurrence of a skin lesion for at least 18-24 months.
No claims are allowed.
Art of Record
Smith+Nephew Collagenase Santyl. “A Patient’s Guide + Collagenase Santyl Ointment”. 2016.
Correspondence Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATALIE IANNUZO whose telephone number is (703)756-5559. The examiner can normally be reached Mon - Fri: 8:30-6:00 EST.
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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