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 .
Drawings
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Specification
The interlineations or cancellations made in the specification or amendments to the claims could lead to confusion and mistake during the issue and printing processes. Accordingly, the portion of the specification or claims as identified below is required to be rewritten before passing the case to issue. See 37 CFR 1.125 and MPEP § 608.01(q).
A substitute specification excluding the claims is required pursuant to 37 CFR 1.125(a) because the paragraph for cross-reference to related applications that was introduced in the specification amendments submitted January 9th, 2024 is missing for the clean version of the specification amended and submitted September 28th, 2024.
A substitute specification must not contain new matter. The substitute specification must be submitted with markings showing all the changes relative to the immediate prior version of the specification of record. The text of any added subject matter must be shown by underlining the added text. The text of any deleted matter must be shown by strike-through except that double brackets placed before and after the deleted characters may be used to show deletion of five or fewer consecutive characters. The text of any deleted subject matter must be shown by being placed within double brackets if strike-through cannot be easily perceived. An accompanying clean version (without markings) and a statement that the substitute specification contains no new matter must also be supplied. Numbering the paragraphs of the specification of record is not considered a change that must be shown.
Claim Objections
Claims 1, 5, and 9 are objected to because of the following informalities: missing the R1-N bond in Formula 2. Appropriate correction is required.
Claim 7 is objected to because of the following informalities: missing the word “composition” between “pharmaceutical,” and “according,” in line 1 of the claim. Appropriate correction is required.
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 – 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Canadian Patent Application Publication CA 3041985 A1 to Park et. al. (Park’985).
Regarding claims 1 – 9, Park’985 teach novel benzyloxybenzylamine amino acid derivative, a salt and/or a solvate thereof. See page 3. Additionally, Park’985 teach benzyloxybenzylamine amino acid derivatives represented by Formula 1 of structure
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where R4-8 are defined, and (reference) Y can be
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,
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, or
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. See pages 4 – 5. See claims 1, 5, and 9 limitation for a benzyloxybenzylamine amino acid derivative. See claims 2, and 6 limitation where C1-7alkyl is straight, branched, or cyclic C1-7alkyl.
Specifically, Park’985 teach embodiments where the compound of Formula 1 is (R)/(S)-1-((4-((2-(fluorobenzyl)oxy)benzyl)amino)-1-oxobutane-2-aminium chloride (Compound 17); (R)/(S)-1-((4-((3-(fluorobenzyl)oxy)benzyl)amino)-1-oxobutane-2-aminium chloride (Compound 18); (R)/(S)-1-((4-((4-(fluorobenzyl)oxy)benzyl)amino)-1-oxobutane-2-aminium chloride (Compound 19); (R)/(S)-1-oxo-1-((4-((2-(trifluoromethyl)benzyl)oxy)benzyl)amino)butane-2-aminium chloride (Compound 20); (R)/(S)-1-oxo-1-((4-((3-(trifluoromethyl)benzyl)oxy)benzyl)amino)butane-2-aminium chloride (Compound 21);
(R)/(S)-2-(diethylamino)-N-(4-((4-(trifluoromethyl)benzyl)oxy)benzyl)butanamide (Compound 66);
(R)/(S)-N-(4-((3,4-dichlorobenzyl)oxy)benzyl-2-(diethylamino)butanamide (Compound 67);
(R)/(S)-2-(diethylamino)-N-(4-((4-(trifluoromethyl)benzyl)oxy)benzyl)pentanamide (Compound 68); and
(R)/(S)-N-(4-((3,4-dichlorobenzyl)oxy)benzyl-2-(diethylamino)pentanamide (Compound 69). See pages 5 – 9. See claims 3 and 7 limitations for a compound selected from (R)/(S)-1-((4-((2-(fluorobenzyl)oxy)benzyl)amino)-1-oxobutane-2-aminium chloride (Compound 17) to (R)/(S)-N-(4-((3,4-dichlorobenzyl)oxy)benzyl-2-(diethylamino)pentanamide (Compound 69).
Moreover, Park’985 teach that according to the present invention compounds of the disclosure, which includes compounds 17 – 69, may be formulated with a conventional formulation method by being mixed with a conventional carrier, adjuvant, or diluent, and may be prepared in a form suitable for oral administration or parenteral administration. See page 12. See claims 1, 5, and 9 limitation for a pharmaceutical composition benzyloxybenzylamine amino acid derivative. Specifically, Park’985 teach that the compounds of the disclosure, which includes compounds 17 – 69, were used in an MIC experiment against human pathogenic fungi, where 200 µL of solution of each compound was prepared in RPMI-1640 medium. See pages 37 – 41. See page 12. See claims 1, 5, and 9 limitation for a pharmaceutical composition benzyloxybenzylamine amino acid derivative.
Regarding claim 1, preamble for preventing or treating inflammatory disease; the preamble does not recite structural limitations and as such the preamble is an intended use statement. See MPEP 2111.02 (I) and (II). Accordingly, the only required component of the pharmaceutical composition as recited in claim 1 is the benzyloxybenzylamine amino acid derivative represented by Formula 1. Thus given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present the prior art teachings of Park’985 of compositions comprising benzyloxybenzylamine amino acid derivative represented by Formula 1 anticipates claim 1.
Moreover, regarding claim 1, clause wherein the composition regulates intracellular signaling pathway mediated by cytokine thymic stromal lymphopoietin (TSLP), TSLP receptor (TSLPR), and IL-7Rα; the clause does not limit the composition to a particular structure or component. See MPEP 2111.04 (I). Thus as stated above, the only required component of the pharmaceutical composition as recited in claim 1 is the benzyloxybenzylamine amino acid derivative represented by Formula 1. Thus given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present the prior art teachings of Park’985 of compositions comprising benzyloxybenzylamine amino acid derivative represented by Formula 1 anticipates claim 1.
Nevertheless, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01 (I). Additionally, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01 (II). Furthermore, given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present and anticipates claim 1; the compositions of Park’985 would inherently be useful in preventing or treating inflammatory disease and regulating intracellular signaling pathway mediated by cytokine thymic stromal lymphopoietin (TSLP), TSLP receptor (TSLPR), and IL-7Rα.
Regarding claim 5, preamble for preventing or treating cancer; the preamble does not recite structural limitations and as such the preamble is an intended use statement. See MPEP 2111.02 (I) and (II). Accordingly, the only required component of the pharmaceutical composition as recited in claim 5 is the benzyloxybenzylamine amino acid derivative represented by Formula 1. Thus given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present the prior art teachings of Park’985 of compositions comprising benzyloxybenzylamine amino acid derivative represented by Formula 1 anticipates claim 5.
Moreover, regarding claim 5, clause wherein the composition regulates intracellular signaling pathway mediated by cytokine thymic stromal lymphopoietin (TSLP), TSLP receptor (TSLPR), and IL-7Rα; the clause does not limit the composition to a particular structure or component. See MPEP 2111.04 (I). Thus as stated above, the only required component of the pharmaceutical composition as recited in claim 5 is the benzyloxybenzylamine amino acid derivative represented by Formula 1. Thus given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present the prior art teachings of Park’985 of compositions comprising benzyloxybenzylamine amino acid derivative represented by Formula 1 anticipates claim 5.
Nevertheless, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01 (I). Additionally, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01 (II). Furthermore, given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present and anticipates claim 5; the compositions of Park’985 would inherently be useful in preventing or treating cancer and regulating intracellular signaling pathway mediated by cytokine thymic stromal lymphopoietin (TSLP), TSLP receptor (TSLPR), and IL-7Rα.
Regarding claim 9, preamble for preventing or treating allergic diseases, itching or Th2 immune-mediated disorders; the preamble does not recite structural limitations and as such the preamble is an intended use statement. See MPEP 2111.02 (I) and (II). Accordingly, the only required component of the pharmaceutical composition as recited in claim 9 is the benzyloxybenzylamine amino acid derivative represented by Formula 1. Thus given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present the prior art teachings of Park’985 of compositions comprising benzyloxybenzylamine amino acid derivative represented by Formula 1 anticipates claim 9.
Moreover, regarding claim 9, clause wherein the composition regulates intracellular signaling pathway mediated by cytokine thymic stromal lymphopoietin (TSLP), TSLP receptor (TSLPR), and IL-7Rα; the clause does not limit the composition to a particular structure or component. See MPEP 2111.04 (I). Thus as stated above, the only required component of the pharmaceutical composition as recited in claim 9 is the benzyloxybenzylamine amino acid derivative represented by Formula 1. Thus given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present the prior art teachings of Park’985 of compositions comprising benzyloxybenzylamine amino acid derivative represented by Formula 1 anticipates claim 9.
Nevertheless, where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01 (I). Additionally, "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. See MPEP 2112.01 (II). Furthermore, given that the prior art of Park’985 teach specific embodiments where the benzyloxybenzylamine amino acid derivative represented by Formula 1 is present and anticipates claim 9; the compositions of Park’985 would inherently be useful in preventing or treating allergic diseases, itching or Th2 immune-mediated disorders and regulating intracellular signaling pathway mediated by cytokine thymic stromal lymphopoietin (TSLP), TSLP receptor (TSLPR), and IL-7Rα. Thus the prior art of Park’985 anticipates claims 1 – 9; thus claims 1 – 9 are rejected under 35 U.S.C. 102(a)(1).
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 – 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 5 of copending Application No. 18/918493 to Park et. al. (reference application; Park’493).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to benzyloxybenzylamine amino acid derivatives represented by Formula 1 of structure
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. In particular, Park’493 recite a method for preparing a benzyloxybenzylamine amino acid derivative represented by the following Formula 1, a salt thereof, or a solvate thereof, Formula 1
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where R4-8 and Y are defined. See reference claim 1. See examined claims 1, 5, and 9. Furthermore, Park’493 recite a compound prepared by the method of (reference) claim 1 or a racemic mixture thereof, wherein the compound is selected from the group consisting of: compounds 17 – 69. See reference claim 5. See examined claims 1 – 9.
However, Park’493 fails to recite a composition as recited in examined claims 1, 5, and 9. See examined claims 1, 5, and 9. Nevertheless, given that the skill level of one of ordinary skill in the pharmaceutical arts is high being that of a MD or Ph.D.; and given the recitation of Park’493, it would have been within the purview of such artisan to formulate the compound as a composition.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 3 of copending Application No. 18/918533 to Park et. al. (reference application; Park’533).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to benzyloxybenzylamine amino acid derivatives represented by Formula 1 of structure
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. Furthermore, Park’533 recite a compound is selected from the group consisting of: compounds 17 – 69. See reference claim 1. See examined claims 1 – 9. Additionally, Park’533 recite a pharmaceutical composition for preventing or treating phytopathogenic fungal infection, comprising the compound or racemic mixture of (reference) claim 1 and a pharmaceutically acceptable carrier. See reference claim 2. See examined claims 1 – 9. Moreover, Park’533 recite a method for preventing or treating phytopathogenic fungal infection, which comprises administering to a subject in need of such prevention or treatment, a pharmaceutically effective amount of the composition of (reference) claim 2. See reference claim 3.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 7 of copending Application No. 18/918511 to Park et. al. (reference application; Park’511).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to benzyloxybenzylamine amino acid derivatives represented by Formula 1 of structure
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. Furthermore, Park’511 recite a compound is selected from the group consisting of: compounds 17 – 69. See reference claim 1. See examined claims 1 – 9. Additionally, Park’511 recite a pharmaceutical composition for preventing or treating mycosis, comprising a conventional carrier and an active ingredient, wherein the active ingredient is the benzyloxybenzylamine amino acid derivative, the salt thereof, or the solvate thereof of claim 1. See reference claims 2 – 4. See examined claims 1 – 9. Moreover, Park’511 recite a method for preventing or treating mycosis, which comprises administering to a subject in need of such prevention or treatment, a pharmaceutically effective amount of the composition of (reference) claim 2. See reference claims 5 – 7.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 8 of copending Application No. 18/918365 to Park et.al. (reference application; Park’365).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to benzyloxybenzylamine amino acid derivatives represented by Formula 1 of structure
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. In particular, Park’365 recite a benzyloxybenzylamine amino acid derivative represented by the following Formula 1, a salt thereof, or a solvate thereof, Formula 1
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where R4-8 and Y are defined. See reference claims 1 – 2. See examined claims 1, 5, and 9. Additionally, Park’365 recite a pharmaceutical composition for preventing or treating mycosis, comprising a conventional carrier and an active ingredient, wherein the active ingredient is the benzyloxybenzylamine amino acid derivative, the salt thereof, or the solvate thereof of (reference) claim 1. See reference claims 3 – 8. See examined claims 1 – 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1 – 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 – 2, 4 – 6, and 13 – 15 of copending Application No. 16/346028 to Park et. al. (reference application; Park’028).
Although the claims at issue are not identical, they are not patentably distinct from each other because both copending applications direct to benzyloxybenzylamine amino acid derivatives represented by Formula 1 of structure
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. In particular, Park’028recite a benzyloxybenzylamine amino acid derivative represented by the following Formula 1, a salt thereof, or a solvate thereof, Formula 1
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where R4-8 and Y are defined. See reference claims 1 – 2. See examined claims 1, 5, and 9. Additionally, Park’028 recite a pharmaceutical composition for preventing or treating mycosis, comprising a conventional carrier and an active ingredient, wherein the active ingredient is the benzyloxybenzylamine amino acid derivative, the salt thereof, or the solvate thereof of (reference) claim 1. See reference claims 4 – 6, and 13 – 15. See examined claims 1 – 9.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 – 9 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAWANNA S WHITE whose telephone number is (703)756-4687. The examiner can normally be reached 7:00 am - 5:00 pm [EST] M - Th.
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/DAWANNA SHAR-DAY WHITE/Examiner, Art Unit 1627
Prosecution Insights