DETAILED ACTION
This office action is in response to applicant’s filing dated October 23, 2025.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on October 23, 2025 has been entered.
Status of Claims
Claims 1, 2, 4 and 6-14 are pending in the instant application. Acknowledgement is made of Applicant's remarks and amendments filed October 23, 2025. Acknowledgement is made of Applicant's cancelation of claims 3 and 5, and addition of new claims 13 and 14.
Priority
The present application is a 371 of PCT/US2019/037458 filed on June 17, 2019, which is a CIP of US Application No. 16/123,729 filed on September 6, 2018 and claims benefit of US Provisional Application No. 62/685,450 filed on June 15, 2018.
Objections and/or Rejections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Objections and/or Rejections) or newly applied (New Objections and/or Rejections, Necessitated by Amendment or New Objections and/or Rejections, NOT Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Maintained Objections and/or Rejections
Claim Rejections - 35 USC § 103
The rejection of claim 3 under 35 U.S.C. 103 as being unpatentable over Chen et al (WO 2016/130800 A2, hereinafter referred to as Chen ‘800, cited in a previous Office Action) has been rendered moot in view of the cancelation of claim 3. Thus, the rejection has been withdrawn.
Modified Objections and/or Rejections
Modifications Necessitated by Claim Amendment
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 6, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (US 2017/0369408 A1, cited in the IDS filed June 2, 2022, hereinafter referred to as Chen ‘408).
Regarding claims 1 and 4, Chen ‘408 teaches a method of treating a disease in a mammal comprising the step of delivering to the mammal a therapeutically effective amount of the pharmaceutical composition comprising octadeca-9, 12-dienoic acid 4-isopropenyl-cylcohex-1-enylmethyl ester (linoleoyl ester of POH), wherein the therapeutically effective amount of octadeca-9, 12-dienoic acid 4-isopropenyl-cylcohex-1-enylmethyl ester (linoleoyl ester of POH) is administered before, during or after radiation treatment (claim 30); further comprising delivering to the mammal a chemotherapeutic agent (claim 13); wherein the composition is administered by topical application (claim 32), wherein the disease is cancer (claim 33), wherein the cancer is skin cancer (claim 34).
Regarding claims 6 and 13, Chen ‘408 teaches the monoterpene derivative treatment may be before, during and/or after chemotherapy [0072]. Administering the monoterpene derivative treatment before, during and/or after chemotherapy reads on inflammation induced by chemical irritant is within seven days.
Thus, Chen ’408 teaches a method of treating melanoma (skin cancer) comprising topical administration of linoleoyl ester of POH further comprising administering a chemotherapeutic.
Chemotherapeutic agents reads on chemical irritant as evidenced by Behan et al (Curr. Treat. Options in Oncol., 2016; 17:60, pp. 1-17). Behan teaches management of skin cancers include topical chemotherapeutics and common adverse effects include skin irritation, edema, and hypersensitivity (page 9, 2nd paragraph).
The prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant” However: “treating inflammation of the skin induced by contact with a chemical irritant” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant,” by practicing the method taught by the prior art: “the administration of linoleoyl ester of POH to a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic,” one will also be “treating inflammation of the skin induced by contact with a chemical irritant,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage “treating inflammation of the skin induced by contact with a chemical irritant”) of the method taught by the prior art (“the administration of linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Thus, the teachings of Chen ‘408 anticipates the method of claims 1, 4, 6, and 13.
Claims 1, 4, 6, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (WO 2012/027693 A2, hereinafter referred to as Chen ‘693, cited in a previous Office Action).
Regarding claims 1 and 4, Chen ‘693 teaches a method of treating a disease such as cancer comprising the step of delivering to a patient a therapeutically effective amount of the derivative of monoterpene; the route includes transdermal (Abstract); the derivatives of monoterpene include esters of the monoterpene; monoterpene alcohols may be derivatized to esters (page 8, lines 17-18); esters of the monoterpene alcohol include carboxylic acid esters such as linoleate ester (page 10, lines 5-7); a specific example of a monoterpene that may be used in the present invention is perillyl alcohol (commonly abbreviated as POH) (page 10, lines 12-13); the derivatives of perillyl alcohol included perillyl alcohol esters; and in certain embodiments perillyl alcohol derivative is perillyl alcohol fatty acid ester such as linoleoyl ester of POH (page 11, lines 6-8). Chen ‘693 teaches the monoterpene (or sesquiterpene) derivative may also be used alone or in combination with other chemotherapeutic agents via topical application for the treatment of localized cancers such as melanomas (page 31, lines 27-29). Thus, Chen ‘693 teaches a method of treating melanoma (skin cancer) comprising topical administration of linoleoyl ester of POH further comprising administering a chemotherapeutic.
Regarding claims 6 and 13, Chen ‘693 teaches the pharmaceutical compositions may be administered before, during or after the administration of a chemotherapeutic agent (page 3, lines 16-17). Administering the monoterpene derivative treatment before, during and/or after chemotherapy reads on inflammation induced by chemical irritant is within seven days.
Chemotherapeutic agents reads on chemical irritant as evidenced by Behan et al (Curr. Treat. Options in Oncol., 2016; 17:60, pp. 1-17). Behan teaches management of skin cancers include topical chemotherapeutics and common adverse effects include skin irritation, edema, and hypersensitivity (page 9, 2nd paragraph).
The prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant” However: “treating inflammation of the skin induced by contact with a chemical irritant” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant,” by practicing the method taught by the prior art: “the administration of linoleoyl ester of POH to a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic,” one will also be “treating inflammation of the skin induced by contact with a chemical irritant,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage “treating inflammation of the skin induced by contact with a chemical irritant”) of the method taught by the prior art (“the administration of linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Thus, the teachings of Chen ‘693 anticipates the method of claims 1, 4, 6, and 13.
Claims 1, 2, 4, 6, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al (WO 2016/130800 A2, hereinafter referred to as Chen ‘800, cited in a previous Office Action).
Regarding claims 1 and 4, Chen ‘800 teaches perillyl alcohol derivatives (title) for treating a condition or disease of a patient, e.g., cancer (abstract). Chen ‘800 teaches perillyl alcohol (POH) is a naturally occurring monoterpene (page 2, 2nd paragraph) and a perillyl alcohol derivative which is conjugated to linoleate (page 37, 3rd paragraph):
PNG
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729
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Thus, Chen ‘800 teaches a perillyl alcohol conjugated with linoleic acid for treating cancer. Chen teaches a test mouse was topically treated with TPL (50 mM TPL working solution was reconstituted in 45% Glycerol + 45% Ethanol, and 100 µl (25 mg/kg) was applied topically on the skin which covers the whole tumor) (page 39, 2nd paragraph). Moreover, Chen ‘800 teaches a method of treating a disease in a mammal comprising administering POH-TMZ-Linoleate (claims 3 and 4), wherein the disease is skin cancer (claims 5, 8, and 9).
Moreover, Chen ‘800 teaches the monoterpenes derivative may be administered alone or in combination with additional chemotherapeutic agents (page 29, 1st full paragraph).
Thus, Chen ‘800 teaches a method of treating skin cancer comprising topical administration of linoleoyl ester of POH further comprising administering a chemotherapeutic.
Regarding claims 6 and 13, Chen ‘800 teaches the monoterpene derivative treatment may be before, during and/or after chemotherapy (page 29, 3rd paragraph). Administering the monoterpene derivative treatment before, during and/or after chemotherapy reads on inflammation induced by chemical irritant is within seven days.
Chemotherapeutic agents reads on chemical irritant as evidenced by Behan et al (Curr. Treat. Options in Oncol., 2016; 17:60, pp. 1-17). Behan teaches management of skin cancers include topical chemotherapeutics and common adverse effects include skin irritation, edema, and hypersensitivity (page 9, 2nd paragraph).
The prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant” However: “treating inflammation of the skin induced by contact with a chemical irritant” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant,” by practicing the method taught by the prior art: “the administration of linoleoyl ester of POH to a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic,” one will also be “treating inflammation of the skin induced by contact with a chemical irritant,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage “treating inflammation of the skin induced by contact with a chemical irritant”) of the method taught by the prior art (“the administration of linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic”).
MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
Thus, the teachings of Chen ‘800 anticipates the method of claims 1, 2, 4 and 6.
Regarding claim 2, Chen ‘800 teaches a test mouse was topically treated with TPL (50 mM TPL working solution was reconstituted in 45% Glycerol + 45% Ethanol, and 100 µl (25 mg/kg) was applied topically on the skin which covers the whole tumor) (page 39, 2nd paragraph). Thus, Chen ‘800 teaches a composition comprising a linoleoyl ester of POH further comprising a mixture of glycerol and ethanol.
Thus, the teachings of Chen ‘800 anticipates the method of claims 1, 2, 4, 6, and 13.
Response to Arguments
102(a)(1) in view of Chen ‘408
Applicant argues:
The Examiner appears to be suggesting that by treating cancer, one is also treating the effects of chronic and persistent inflammation. However, as pointed out by the Office Action, Chen ‘408 does not disclose treating any type of inflammation, instead Chen ‘408 is directed to a method of treating a disease such as cancer. Without exploring the biology of whether chronic inflammation and cancer are in fact related, all of the inflammatory conditions disclosed in Allavena deal with chronic inflammation. The chronic inflammatory processes described in Allavena are different from acute inflammation due to contact with a chemical irritant. Moreover, acute inflammation can result in tumor rejection, while chronic inflammation may, in some instances, lead to tumor promotion. Thus, it is Applicant’s position that Chen ‘408 as evidenced by Allavena and Behan does not teach “a method for treating or reducing inflammation of the skin”…”wherein the inflammation of the skin is induced by contact with a chemical irritant.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Behan establishes that it was known in the art that management of skin cancers include topical chemotherapeutics and common adverse effects include skin irritation, edema, and hypersensitivity. Thus, a chemotherapeutic reads on a chemical irritant. As set forth above, Chen ‘408 teaches a method of treating skin cancer comprising topical administration of a composition comprising linoleoyl ester of POH further comprising administering a chemotherapeutic agent. As set forth above, by practicing the method taught by the prior art: “the administration of linoleoyl ester of POH to a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic,” one will also be “treating inflammation of the skin induced by contact with a chemical irritant,” even though the prior art was not aware of it. MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
102(a)(1) in view of Chen ‘693
Applicant argues:
Inflammation does not necessarily result from a chemotherapeutic agent. The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. Inherent anticipation only occurs if it is clear that the missing characteristic, for example here this missing characteristic acute inflammation always causes cancer. If the alleged inherent characteristic can possibly result from a given set of circumstances or was simply a matter of chance and not an inevitable result, there is no anticipation.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, Chen ‘800 teaches a method of treating a disease in a mammal comprising administering POH-TMZ-Linoleate in combination with a chemotherapeutic agent, wherein the disease is skin cancer (claims 5, 8, and 9). As set forth above, chemotherapeutic agents reads on chemical irritant as evidenced by Behan which teaches common adverse effect of chemotherapeutics for treating skin cancer is skin irritation. As set forth above, “treating inflammation of the skin induced by contact with a chemical irritant” will inevitably flow from the teachings of the prior art (see above rejection), since the same compound (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation administered a chemical irritant, a chemotherapeutic). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
102(a)(1) in view of Chen ‘800
Applicant argues:
For the same reasons as explained above with respect to Allavena, Behan, and Appendices A-C, Applicant respectfully submits that one cannot say that just because a chemotherapeutic agent is applied to the skin, that a skin irritation will inevitably occur and therefore chemotherapeutic agents cannot read on chemical irritants, as asserted in the Office Action.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
Applicant has not independently argued the merits of this rejection. Arguments regarding Allavena, Behan, and Appendix A-C have been addressed above. Therefore, the rejection is maintained for the reasons set forth on the record and for those set forth in the response to the arguments above.
Claim Rejections - 35 USC § 103
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 7-12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (WO 2016/130800 A2, hereinafter referred to as Chen ‘800, cited in a previous Office Action) as applied to claims 1-4 and 6 above, and further in view of Dong et al (WO 02/098399 A2).
Regarding claims 7-9, 11, and 12, as set forth above, Chen ‘800 teaches a method of treating a disease such as skin cancer/inflammation comprising administering linoleoyl ester of POH, glycerol, and ethanol.
Chen ‘800 does not teach the chemotherapeutic agent is 12-O-tetradecanoylphorbol-13-acetate (asTPA).
However, Dong teaches a method of treating melanocarcinoma (claims 5, 36) comprising administering a pharmaceutical composition comprising a phorbol compound (claim 1), wherein the phorbol compound is 12-O-tetradecanoylphorbol-13-acetate (claim 8), wherein the composition is administered topically (claim 14). Melanocarcinoma reads on melanoma/skin cancer.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teachings of the references so as to administer a combination comprising linoleoyl ester of POH for treating skin cancer to further administer 12-O-tetradecanoylphorbol-13-acetate. One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be useful for treating skin cancer. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining linoleoyl ester of POH with 12-O-tetradecanoylphorbol-13-acetate, one would have achieved a combination useful for treating skin cancer.
The prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate.” However: “treating inflammation of the skin induced by contact with a chemical irritant, 12-O-tetradecanoylphorbol-13-acetate” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compounds (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation also administered a chemical irritant/chemotherapeutic, 2-O-tetradecanoylphorbol-13-acetate). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate,” by practicing the method made obvious by the prior art: “the administration of linoleoyl ester of POH and 12-O-tetradecanoylphorbol-13-acetate to a patient suffering from skin cancer,” one will also be “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate.”) of the method made obvious by the prior art (“the administration of linoleoyl ester of POH and 12-O-tetradecanoylphorbol-13-acetate to a patient suffering from skin cancer”).
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Taken together, all this would result in the practice of the method of claims 7-9, 11, and 12 with a reasonable expectation of success.
Regarding claim 10, the combination of Chen ‘800 and Dong suggest a method of treating a disease such as skin cancer/inflammation comprising administering a combination comprising 12-O-tetradecanoylphorbol-13-acetate linoleoyl ester of POH, glycerol, and ethanol.
Chen ‘800 teaches a test mouse was topically treated with TPL (50 mM TPL working solution was reconstituted in 45% Glycerol + 45% Ethanol, and 100 µl (25 mg/kg) was applied topically on the skin which covers the whole tumor) (page 39, 2nd paragraph). Thus, Chen ‘800 teaches a composition comprising a linoleoyl ester of POH further comprising glycerol and ethanol in a weight ratio of 45:45.
Regarding claim 14, Chen ‘800 teaches the monoterpene derivative treatment may be before, during and/or after chemotherapy (page 29, 3rd paragraph). Administering the monoterpene derivative treatment before, during and/or after chemotherapy reads on inflammation induced by chemical irritant is within seven days.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of ethanol and glycerol and dosing regimen taught by Chen ‘800 as a starting point for optimizing the ethanol and glycerol utilized to formulate a composition comprising a 12-O-tetradecanoylphorbol-13-acetate linoleoyl ester of POH, glycerol, and ethanol and optimize the dosing regimen of the formulation, since Chen ‘800 teaches ethanol and glycerol are useful for formulating a composition comprising a linoleoyl ester of POH, glycerol and ethanol and because excipient ratio and dosing regimen is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts and ratios would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed ratio, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the practice of the method of claims 10 and 14 with a reasonable expectation of success.
Claims 7, 8, 11, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2017/0369408 A1, cited in the IDS filed June 2, 2022, hereinafter referred to as Chen ‘408, cited in a previous Office Action) in view of Dong et al (WO 02/098399 A2).
As set forth above, Chen ’408 teaches a method of treating melanoma (skin cancer) comprising topical administration of linoleoyl ester of POH further comprising administering a chemotherapeutic. Chen ‘408 does not teach the chemotherapeutic agent is 12-O-tetradecanoylphorbol-13-acetate (asTPA).
However, Dong teaches a method of treating melanocarcinoma (claims 5, 36) comprising administering a pharmaceutical composition comprising a phorbol compound (claim 1), wherein the phorbol compound is 12-O-tetradecanoylphorbol-13-acetate (claim 8), wherein the composition is administered topically (claim 14). Melanocarcinoma reads on melanoma/skin cancer.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teachings of the references so as to administer a combination comprising linoleoyl ester of POH for treating skin cancer to further administer 12-O-tetradecanoylphorbol-13-acetate. One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be useful for treating skin cancer. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining linoleoyl ester of POH with 12-O-tetradecanoylphorbol-13-acetate, one would have achieved a combination useful for treating skin cancer.
The prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate.” However: “treating inflammation of the skin induced by contact with a chemical irritant, 12-O-tetradecanoylphorbol-13-acetate” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compounds (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation also administered a chemical irritant/chemotherapeutic, 2-O-tetradecanoylphorbol-13-acetate). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate,” by practicing the method made obvious by the prior art: “the administration of linoleoyl ester of POH and 12-O-tetradecanoylphorbol-13-acetate to a patient suffering from skin cancer,” one will also be “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate.”) of the method made obvious by the prior art (“the administration of linoleoyl ester of POH and 12-O-tetradecanoylphorbol-13-acetate to a patient suffering from skin cancer”).
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Taken together, all this would result in the practice of the method of claims 7, 8, 12, and 14 with a reasonable expectation of success.
Regarding claim 14, Chen ‘408 teaches the monoterpene derivative treatment may be before, during and/or after chemotherapy [0072]. Administering the monoterpene derivative treatment before, during and/or after chemotherapy reads on inflammation induced by chemical irritant is within seven days.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the dosing regimen taught by Chen ‘408 as a starting point for optimize the dosing regimen of the formulation, since the prior art teaches a combination comprising linoleoyl ester of POH, ethanol, and glycerol is useful for treating skin cancer and because dosing regimen is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts and ratios would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed ratio, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the practice of the method of claim 14 with a reasonable expectation of success.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (US 2017/0369408 A1, cited in the IDS filed June 2, 2022, hereinafter referred to as Chen ‘408) in view of Dong et al (WO 02/098399 A2) as applied to claims 1, 4, 6-8, and 11-14 above, and further in view of Chen et al (WO 2016/130800 A2, hereinafter referred to as Chen ‘800, cited in a previous Office Action).
As set forth above, the combination of Chen ’408 and Dong teaches a method of treating melanoma (skin cancer) comprising topical administration of linoleoyl ester of POH further comprising administering a 12-O-tetradecanoylphorbol-13-acetate, and administering POH and 12-O-tetradecanoylphorbol-13-acetate would result in POH inhibiting chemical irritation induced by 12-O-tetradecanoylphorbol-13-acetate, since both agents are administered. Chen ‘408 further teaches the pharmaceutical compositions comprising one or more monoterpene derivative may be mixed with a pharmaceutical acceptable carrier, adjuvant and/or excipient; and excipients include glycerol and ethanol [0078]. Chen ‘408 does not explicitly teach the composition further includes glycerol and ethanol mixture in the ratio of instant claim 9.
However, Chen ‘800 teaches a test mouse was topically treated with TPL (50 mM TPL working solution was reconstituted in 45% Glycerol + 45% Ethanol, and 100 µl (25 mg/kg) was applied topically on the skin which covers the whole tumor) (page 39, 2nd paragraph). Thus, Chen ‘800 teaches a composition comprising a linoleoyl ester of POH further comprising a mixture of glycerol and ethanol.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of ethanol and glycerol taught by Chen ‘800 as a starting point for optimizing the ethanol and glycerol utilized to formulate a composition comprising a linoleoyl ester of POH, glycerol and ethanol since Chen ‘800 teaches ethanol and glycerol are useful for formulating a composition comprising a linoleoyl ester of POH, glycerol and ethanol and because excipient ratio is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts and ratios would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed ratio, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the practice of the method of claims 9 and 10 with a reasonable expectation of success.
Claims 7, 8, 11, 12, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (WO 2012/027693 A2, hereinafter referred to as Chen ‘693, cited in a previous Office Action) in view of Dong et al (WO 02/098399 A2).
Chen ‘693 teaches a method of treating melanoma (skin cancer) comprising topical administration of linoleoyl ester of POH further comprising administering a chemotherapeutic.
Chen ‘693 does not teach the chemotherapeutic agent is 12-O-tetradecanoylphorbol-13-acetate (asTPA).
However, Dong teaches a method of treating melanocarcinoma (claims 5, 36) comprising administering a pharmaceutical composition comprising a phorbol compound (claim 1), wherein the phorbol compound is 12-O-tetradecanoylphorbol-13-acetate (claim 8), wherein the composition is administered topically (claim 14). Melanocarcinoma reads on melanoma/skin cancer.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teachings of the references so as to administer a combination comprising linoleoyl ester of POH for treating skin cancer to further administer 12-O-tetradecanoylphorbol-13-acetate. One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be useful for treating skin cancer. Moreover, the instant situation is amenable to the type of analysis set forth in In re Kerkhoven, 205 USPQ 1069 (CCPA 1980) wherein the court held that it is prima facie obvious to combine two agents each of which is taught by the prior art to be useful for the very same purpose. The idea of combining them flows logically from having been individually taught in the prior art. Applying the same logic to the instant claims, one of ordinary skill in the art would have been imbued with at least a reasonable expectation of success that by combining linoleoyl ester of POH with 12-O-tetradecanoylphorbol-13-acetate, one would have achieved a combination useful for treating skin cancer.
The prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate.” However: “treating inflammation of the skin induced by contact with a chemical irritant, 12-O-tetradecanoylphorbol-13-acetate” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compounds (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation also administered a chemical irritant/chemotherapeutic, 2-O-tetradecanoylphorbol-13-acetate). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
In other words, even though the prior art is silent regarding “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate,” by practicing the method made obvious by the prior art: “the administration of linoleoyl ester of POH and 12-O-tetradecanoylphorbol-13-acetate to a patient suffering from skin cancer,” one will also be “treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate,” even though the prior art was not aware of it.
Apparently, Applicant has discovered a new property or advantage (“treating inflammation of the skin induced by contact with a chemical irritant/chemotherapeutic, 12-O-tetradecanoylphorbol-13-acetate.”) of the method made obvious by the prior art (“the administration of linoleoyl ester of POH and 12-O-tetradecanoylphorbol-13-acetate to a patient suffering from skin cancer”).
MPEP 2145 II states: "The fact that Applicant has recognized another advantage which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious". Ex parte Obiaya, 227 USPQ 58, 60. (FP 7.37.07, MPEP 707.07(f)).
Taken together, all this would result in the practice of the method of claims 7, 8, 12, and 12 with a reasonable expectation of success.
Regarding claim 14, Chen ‘693 teaches the pharmaceutical compositions may be administered before, during or after the administration of a chemotherapeutic agent (page 3, lines 16-17). Administering the monoterpene derivative treatment before, during and/or after chemotherapy reads on inflammation induced by chemical irritant is within seven days.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the dosing regimen taught by Chen ‘693 as a starting point for optimize the dosing regimen of the formulation, since the prior art teaches a combination comprising linoleoyl ester of POH, ethanol, and glycerol is useful for treating skin cancer and because dosing regimen is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts and ratios would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed ratio, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the practice of the method of claim 14 with a reasonable expectation of success.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al (WO 2012/027693 A2, hereinafter referred to as Chen ‘693, cited in a previous Office Action) in view of Dong et al (WO 02/098399 A2) as applied to claims 1, 4, 6-8, 11, and 12 above, and further in view of Chen et al (WO 2016/130800 A2, hereinafter referred to as Chen ‘800, cited in a previous Office Action).
As set forth above, the combination of Chen ’693 and Dong teaches a method of treating melanoma (skin cancer) comprising topical administration of linoleoyl ester of POH further comprising administering a 12-O-tetradecanoylphorbol-13-acetate, and administering POH and 12-O-tetradecanoylphorbol-13-acetate would result in POH inhibiting chemical irritation induced by 12-O-tetradecanoylphorbol-13-acetate, since both agents are administered. Chen ‘693 further teaches the pharmaceutical compositions comprising one or more monoterpene derivative may be mixed with a pharmaceutical acceptable carrier, adjuvant and/or excipient (page 27, lines 12-14); and excipients include glycerol and ethanol (page 27, lines 20-21). Chen ‘693 does not explicitly teach the composition further includes glycerol and ethanol mixture in the ratio of instant claim 3.
However, Chen ‘800 further teaches a test mouse was topically treated with TPL (50 mM TPL working solution was reconstituted in 45% Glycerol + 45% Ethanol, and 100 µl (25 mg/kg) was applied topically on the skin which covers the whole tumor) (page 39, 2nd paragraph). Thus, Chen ‘800 teaches a composition comprising a linoleoyl ester of POH further comprising a mixture of glycerol and ethanol.
It would have been prima facie obvious to one of ordinary skill in the art to utilize the amounts of ethanol and glycerol taught by Chen ‘800 as a starting point for optimizing the ethanol and glycerol utilized to formulate a composition comprising a linoleoyl ester of POH, glycerol and ethanol since Chen ‘800 teaches ethanol and glycerol are useful for formulating a composition comprising a linoleoyl ester of POH, glycerol and ethanol and because excipient ratio is a result-effective variables, i.e. a variable that achieves a recognized result. Therefore, the determination of the optimum or workable amounts and ratios would have been well within the practice of routine experimentation by the skilled artisan. Furthermore, absent any evidence demonstrating a patentable difference between the compositions and the criticality of the claimed ratio, the determination of the optimum or workable dosing regimen given the guidance of the prior art would have been generally prima facie obvious to the skilled artisan. Please see MPEP 2144.05 [R-2](II)(A) and In re Aller, 220 F. 2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). ("[W]here the general conditions of claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.").
Taken together, all this would result in the practice of the method of claims 9 and 10 with a reasonable expectation of success.
Response to Arguments
Applicant argues:
Dong teaches that TPA is used to treat certain cancers; the TPA is used to induce skin inflammation. Even if one to disregard that using the TPA in Dong and in pending claims are using it for opposite goals, one is used to treat an ailment and one is used to induce an ailment, even then because TPA is specific chemical irritant that induces acute inflammation. Dong does not teach treating or reducing inflammation of the skin.
Examiner's response:
The above argument has been carefully considered and has not been found persuasive.
As set forth above, a method of treating melanoma (skin cancer) comprising topical administration of linoleoyl ester of POH further comprising administering a chemotherapeutic is taught by the cited art. As set forth above, Dong teaches a method of treating melanocarcinoma comprising administering a pharmaceutical composition comprising 12-O-tetradecanoylphorbol-13-acetate, wherein the composition is administered topically. As set forth above, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to combine the teachings of the references so as to administer a combination comprising linoleoyl ester of POH for treating skin cancer to further administer 12-O-tetradecanoylphorbol-13-acetate. One would have been motivated to do so because of each of the compounds have been individually taught in the prior art to be useful for treating skin cancer. As set forth above, “treating inflammation of the skin induced by contact with a chemical irritant, 12-O-tetradecanoylphorbol-13-acetate” will naturally flow from the teachings of (or method made obvious by) the prior art (see above rejection), since the same compounds (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from skin cancer/inflammation also administered a chemical irritant/chemotherapeutic, 2-O-tetradecanoylphorbol-13-acetate). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claim 1-11 of copending Application No. 17/313,258 (reference application)
Claim 1-3 7, and 9-17 of copending Application No. 17/573,693 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to a method of treating inflammation of the skin comprising administering a perillyl alcohol (POH) conjugated with linoleic acid, wherein the inflammation of the skin is induced by contact with a chemical irritant, while the claims of the copending application are directed to a method of treating a disease comprising administering linoleoyl ester of POH wherein the disease is cancer, wherein the cancer is melanoma, further comprising delivering a chemotherapeutic agent, wherein the composition is administered by topical application. A chemotherapeutic agent reads on a chemical irritant.
It is well known in the art that inflammation and cancer are interconnected. “Treating inflammation induced by contact with a chemical irritant” will inevitably flow from the method of the copending claims, since the same compound (linoleoyl ester of POH) is being administered to the same subjects (a subject suffering from cancer/inflammation further administered a chemical irritant, chemotherapeutic agent). In other words, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. MPEP 2112 I states: “[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer.” Atlas Powder Co. v. Ireco Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977).”
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
With regard to the double patenting rejection, applicant's request for this rejection to be held in abeyance until all other rejections are overcome has been acknowledged. The double patenting rejection is maintained and held in abeyance.
Conclusion
Claims 1-4 and 6-12 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
Prosecution Insights