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 .
DETAIL ACTION
This office action is a response to the following:
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As filed, claims 1-8 are pending.
Information Disclosure Statement
The information disclosure statements (IDS)s submitted on 3/21/2025 have been considered by the Examiner.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No.16/346,028, filed on 4/29/2019.
Claim Interpretation
With regards to the intended use statements, such as “for preventing or treating mycosis”, in claim 3; “wherein the mycosis is selected from encephalomeningitis . . .” in claim 5 (because such claim is dependent of claim 3); “for preventing or treating an animal pathogenic fungal infection” in claim 6; and “for preventing or treating a phytopathogenic fungal infection” in claim 7, they have not been accorded patentable weight for prior art purpose because such statement fails to limit the structure of the compound of instant formula (1).
The Examiner finds that any prior art compound having the same structure as the compound of instant formula (1) would be capable of performing the intended use, according to the guidance in MPEP 2111.02(II).
With regards to the phrases, such as “which has antimicrobial activity against fungi . . ." in claim 4, the Examiner finds such phrase as simply stating an inherent property within the structure of instant formula (1). See MPEP 2111.02(II) and MPEP 2112.
Accordingly, as the prior art teaches the instant compounds, the result would most necessarily to have the same antimicrobial activity against fungi, specifically in the claimed compound(s) taught by the prior art (see rejection below).
With regards to the preamble phrase, such as “A cosmetic composition or human body cleansing composition" in claims 8, the Examiner finds “cosmetic” or “human body cleansing” as simply stating purpose or use within the structure of instant formula (1). See MPEP 2111.02(II).
Accordingly, this phrase is not considered a limitation and is of no significance to the claims. In addition, as the prior art teaches the instant compounds, the result would most necessarily to have the same purpose or use as recited above, specifically in the claimed compound(s) taught by the prior art (see rejection below).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over by “Primary Amino Acid Derivatives: Substitution of the 4’-N’-Benzylamide Site in (R)-N’-Benzyl 2-Amino-3-methylbutanamide, (R)-N’-Benzyl 2-Amino-3,3-dimethylbutanamide, and (R)-N’-Benzyl 2-Amino-3-methoxypropionamide Provides Potent Anticonvulsants with Pain-Attenuating Properties”, hereinafter King. See IDS filed 3/21/2025.
Regarding claims 1-8:
Determining the scope and contents of the prior art:
King, for instance, teaches the following HCl salt or pharmaceutical composition thereof as anticonvulsant (see abstract).
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(pg. 6424, Table 3, compound (R)-28)
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714
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(pg. 6428, right column, compound (R)-28)
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(structure of the abovementioned HCl salt)
Wherein: one of instant variable R5 or R7 are F and the other is H; instant variables R4, R6, and R8 are H; instant variable Y is formula 2; instant variables R1 and R3 are H; and instant variable R2 is H.
The Examiner finds that one of ordinary skill in the art would have recognized that the abovementioned compound was placed in a pharmaceutical composition when it was tested for its pharmacological activity in mice.
According to MPEP 2112(I) and (II), the Examiner finds that the antimicrobial or antifungal activity of the instant compounds is an inherent feature or property of the structure of instant formula (I), which needs not be recognized by King at the time of invention. In addition, the structure of instant formula (I) does not become patentable upon the discovery of the abovementioned antimicrobial or antifungal property.
Ascertaining of the difference between the prior art and the claim at issue:
In the abovementioned compound, King, for instance, did not explicitly teach ethyl at the location shown by box below and did not explicitly teach the 3-fluoro group (shown by box below) at the 2- or 4-position of the phenyl group (indicated by the arrow below).
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Finding of prima facie obviousness --- rationale and motivation:
Although the abovementioned compound, as taught by King, teaches methyl at the location shown above, the difference to the instant compound is only by a methylene group (i.e. oxobutane vs. oxopropane). Such structural similarity makes the instant compound a homologue of the compounds as taught by King. With regards to the substitution of one lower alkyl for another, MPEP 2144.08.II.A.4(c) states, “…consider teachings of a preferred species within the genus. If such a species is structurally similar to that claimed, its disclosure may motivate one of ordinary skill in the art to choose the claimed species or subgenus from the genus, based on the reasonable expectation that structurally similar species usually have similar properties.”
To those skilled in the chemical art, one homologue is not an advance over a member of a homologous series. The reason for this is that one of ordinary skill, knowing the properties of one member of series, would know what properties to expect in homologous members. In re Henze, 85 USPQ 261 (1950), In re Wood, 199 USPQ 137 (CCPA 1978), and In re Lohr, 137 USPQ 548, 549 (CCPA 1963).
Applicant’s attention is also respectfully referred to MPEP 2141. The Supreme Court, in the KSR decision, quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.’" KSR, 550 U.S. at ___, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
The motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds would possess similar activity (i.e. they would be pharmacologically active as anticonvulsants, etc.).
Thus, it would have been prima facie obvious at the time the invention was made for one of ordinary skill in the art to produce homologues of the abovementioned HCl salt taught by King by selecting the particular homologous substitution with a reasonable expectation of success.
In addition, the difference to the instant compound is that the abovementioned compound of King is a positional isomer of the instant compound.
Again, the motivation to make the instantly claimed compounds derives from the expectation that structurally similar compounds (i.e. positional isomer) would possess similar activity (i.e. they would be pharmacologically active as anticonvulsants, etc.).
MPEP 2144.09.II. states, “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195USPQ 426 (CCPA 1977).
One of ordinary skill would be motivated, from the disclosure in the prior art, to make the modifications required to arrive at the instant invention with reasonable expectation of success for obtaining a compound with the same utility. The motivation to make the change would be to make additional compound for the quoted purpose.
Thus, the instant claims are prima facie obvious.
Nonstatutory 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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
The instant claims are drawn to a compound of instant formula (I) or pharmaceutical/cosmetic/human body cleansing composition thereof.
Claims 1-8 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
18/918,533
1 and 2
Yes
18/918,493
5
Yes
18/918,511
1-4
Yes
16/346,028
1-7 and 13-15
Yes
In this instance, the analysis employed for the abovementioned nonstatutory obviousness-type double patenting rejection parallels the analysis for anticipation, wherein the instant compounds are anticipated by the compounds, as shown below (in representative examples), and such compounds are disclosed in the abovementioned conflicting claims of the abovementioned co-pending applications.
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(claim 1 of the ‘533 co-pending application and claim 5 of ‘493 co-pending application)
Claims 1-8 are rejected on the ground of nonstatutory obviousness-type double patenting (ODP) as being unpatentable over the conflicting claims of the following U.S. patents or co-pending applications. See Table below.
If the conflicting claims are in a co-pending application, then the rejection is a provisional ODP rejection because the conflicting claims have not in fact been patented.
Co-pending Application No./ U.S. Patent No.
Conflicting Claims
Provisional ODP
(Yes or No)
16/346,028
16-19
Yes
18/918,511
5-7
Yes
18/918,533
3
Yes
The analysis employed for an obviousness-type double patenting rejection parallels the analysis for a determination of obviousness under 35 U.S.C. § 103. See MPEP 804; In re Braat, 937 F.2d 589, 19 USPQ 2d 1290 (Fed. Cir. 1991); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985). For this reason, the factual inquires set forth in Graham v. John Deere Co., 383 U.S. 1, USPQ 459 (1966) are employed herein.
The Graham v. Deere inquires are summarized as follows: (A) Determining the scope and contents of the patent claim relative to a claim in the application at issue; (B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue; (C) Determine the level of ordinary skill in the pertinent art; and, (D) Evaluate any objective indicia of nonobviousness.
(A) Determining the scope and contents of the patent claim relative to a claim in the application at issue – The conflicting claims of the abovementioned co-pending applications are drawn to the instant compounds or composition thereof.
(B) Ascertaining the differences between the scope and content of the patent claim as determined in (A) and the claim in the application at issue - The conflicting claims of the abovementioned co-pending applications described the instant compounds in a method of treatment-type claim.
(C) Determine the level of ordinary skill in the pertinent art - the level of ordinary skill in the art may be found by inquiring into: (1) the type of problems encountered in the art; (2) prior art solutions to those problems; (3) the rapidity with which innovations are made; (4) the sophistication of the technology; and (5) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of those factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983).
Based on the typical education level of active workers in the field of organic chemistry, as well as the high degree of sophistication required to solve problems encountered in the art, the Examiner finds that a person of ordinary skill in the art would have at least a college degree in the field related to medicine, chemistry, and/or the pharmaceutical art and at least four years of work experience, i.e. a masters or doctorate level scientist/clinician.
(D) Evaluate any objective indicia of nonobviousness - none
Conclusion - Although the conflicting claims are not identical, one of ordinary skill in the art would recognize that they are not patentably distinct from each other because they are drawn to the same compound having the same therapeutic utility (e.g. antimicrobials etc.). As a result, an infringer of a patent issuing from the instant claims would also be an infringer of the conflicting claims of the abovementioned co-pending applications.
As recited above, the compound in the conflicting claims of abovementioned co-pending applications is the instant compounds. However, these conflicting claims described the instant compounds in a method of treatment-type claims.
Structural similarity is the touchstone of the nonobviousness inquiry for patents claiming a novel chemical compound. Eisai Co. v. Dr. Reddy's Laboratories, 533 F.3d1353,1356-57 (Fed. Cir. 2008). In this case, the compounds are the same; i.e., they have the same atomic composition and the same atomic connectivity. For this reason, one of ordinary skill in the art would anticipate that this is the same compound.
The unpredictable nature of the chemical arts generally allows an assertion of similarity to be rebutted by a sufficient demonstration of nonobviousness that employs secondary considerations of objective indicia. In this case, there are no indicia of nonobviousness shown to provide evidence that the structure of the abovementioned co-pending applications is excluded as the instant compounds of the instant application. Absent indicia of nonobviousness, the Examiner finds that one of ordinary skill in the art would consider the instant compound forms and that of the conflicting claims of the abovementioned co-pending applications to be equally effective in their objective.
This rejection is in agreement with the judicially created doctrine grounded in public policy 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.
Conclusion
Claims 1-8 are rejected.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
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