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 .
Status of the Application
Claims 190-196, and 268 are pending.
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 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 of this title, 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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 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 190-196, and 268 are rejected under 35 U.S.C. 103 as being unpatentable over Miller (WO 2018/191732 A1).
Determining the scope and contents of the prior art
Miller teaches quinone and hydroquinone compound of formula:
PNG
media_image1.png
160
358
media_image1.png
Greyscale
PNG
media_image2.png
336
941
media_image2.png
Greyscale
PNG
media_image3.png
285
636
media_image3.png
Greyscale
which encompass compound of instant claims; u=1-8 in the instant claims, in prior art R7=R8=C1alkoxy, R9=CH3; R10=R11=H; R12= (CH2)1-8 CF3, and a composition comprising the same for treating diseases associated with oxidative stress (entire application, especially paragraphs 0007, 0094, 0114, 0125, claims 1- 5, 9, 10, 12, 17, 19 and 27). The cited prior art further provides examples, such as
PNG
media_image4.png
552
806
media_image4.png
Greyscale
Similar to species of the instant claims:
PNG
media_image5.png
124
544
media_image5.png
Greyscale
with the difference that the cited prior art didn’t provide example of hydroquinone compound of the instant claims.
Ascertaining the differences between the prior art and the claims at issue
Miller teaches compound, which encompass the compound of the instant claims:
PNG
media_image2.png
336
941
media_image2.png
Greyscale
when u=1-8 in the instant claims, in prior art R7=R8=C1alkoxy, R9=CH3; R10=R11=H; R12= (CH2)1-8 CF3. The cited prior art teaches R7=R8=C1alkoxy, R9=CH3; R10=R11=H; R12= alkyl group substituted with F and further provides examples of quinones, such as
PNG
media_image4.png
552
806
media_image4.png
Greyscale
(claims 1- 5, 9, 10, 12, 17, 19 and 27) with the difference that the cited prior art didn’t provide example of hydroquinone compound of the instant claims.
Resolving the level of ordinary skill in the pertinent art
With regard to the above difference- The cited prior art teaches compound, which encompass the compound of the instant claims:
PNG
media_image2.png
336
941
media_image2.png
Greyscale
when u=1-8 in the instant claims, in prior art R7=R8=C1alkoxy, R9=CH3; R10=R11=H; R12= (CH2)1-8 CF3. The cited prior art teaches R7=R8=C1alkoxy, R9=CH3; R10=R11=H; R12= alkyl group substituted with F and further provides examples of quinones, such as
PNG
media_image4.png
552
806
media_image4.png
Greyscale
Similar to species of the instant claims. The cited prior art teaches compound in quinone or hydroquinone form and also teaches preferable groups for 2 and 3 positions (R7 and R8 of the prior art) as H, methyl and methoxy (claim 5). Since the cited prior art preferable groups for 2 and 3 positions contains a small number of members (H, methyl and methoxy) that, when considered in light of the totality of the circumstances, “one skilled in [the] art would... envisage each member” of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962). Since examples of species or subgenus taught by the cited prior art are structurally similar to that claimed, it would have been obvious to a person 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. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” Thus, based on the guidance provided by Miller, it would have been prima facie obvious to a person of ordinary skill in the art with reasonable expectation of success that a compound selected from the genus of Miller may be useful in treating diseases associated with oxidative stress.
Further, the cited prior art teaches that the compounds may be useful in treating diseases associated with oxidative stress. Therefore, a person of ordinary skill in the art would have been motivated to modify compounds within the genus taught by the cited prior art to identify compounds useful for treating oxidative stress.
Based on the above established facts, it appears that the teachings of above cited prior art read applicants’ compound.
Therefore, all the claimed elements were known in the prior art and one skilled person in the art could have modified the elements as claimed with no change in their respective functions, and the modification would have yielded predictable results to one of ordinary skill in the art at the time of the invention.
Considering objective evidence present in the application indicating obviousness or nonobviousness
To establish a prima facie case of obviousness, three basic criteria must be met: (1) the prior art reference must teach or suggest all the claim limitations; (2) there must be some suggestion or motivation, either in the references themselves or in the knowledge generally available to one of ordinary skill in the art, to modify the reference or to combine reference teachings; and (3) there must be a reasonable expectation of success; and (MPEP § 2143).
In this case, Miller teaches compound, which encompass the elected species.
In KSR International Vo. V. Teleflex Inc., 82 USPQ2d (U.S. 2007), the Supreme Court particularly emphasized “the need for caution in granting a patent based on a combination of elements found in the prior art,” (Id. At 1395) and discussed circumstances in which a patent might be determined to be obvious. Importantly, the Supreme Court reaffirmed principles based on its precedent that “[t]he combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” (Id. At 1395). See MPEP 2143 - Examples of Basic Requirements of a Prima Facie Case of Obviousness [R-9].
In this case at least prong (E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success would apply.
The rationale to support a conclusion that the claim would have been obvious is that “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”KSR, 550 U.S. at ___, 82 USPQ2d at 1397. If any of these findings cannot be made, then this rationale cannot be used to support a conclusion that the claim would have been obvious to one of ordinary skill in the art. Further, there is a reasonable expectation of success that a compound selected from the genus of Miller may be useful in treating diseases associated with oxidative stress and can be made by teachings of the above cited prior art.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited references and to make the instantly claimed compound with a reasonable expectation of success.
Response to Arguments
Applicant’s remarks and IDS, filed on 09/30/2025, have been fully considered but not found persuasive.
Applicant argue that compounds of the instant claims have superior activity:
PNG
media_image6.png
692
904
media_image6.png
Greyscale
This is not found persuasive and the instant claims stand rejected. This is because (1) the instant claims are directed to a compound and not to a process; (2) compounds of the instant claims are not quinone but hydroquinone and are different from compound C. Thus, applicant is arguing over a limitation not recited in the instant claims; (3) the comparison is not a true comparison as compounds that applicant compared with compound C are different from class of compounds of the cited prior art used for the rejection.
PNG
media_image7.png
630
1121
media_image7.png
Greyscale
PNG
media_image8.png
770
1115
media_image8.png
Greyscale
vs. cited prior art taught compounds:
PNG
media_image9.png
690
870
media_image9.png
Greyscale
PNG
media_image10.png
291
778
media_image10.png
Greyscale
Applicant argue that the instant claims are not obvious as Miller teaches two broad formula I and formula II and vatiquinone has no activity:
PNG
media_image11.png
180
948
media_image11.png
Greyscale
PNG
media_image12.png
155
703
media_image12.png
Greyscale
PNG
media_image13.png
660
742
media_image13.png
Greyscale
This is not found persuasive and the instant claims stand rejected. This is because Miller teaches compound, which encompasses the compounds of the instant claims:
PNG
media_image2.png
336
941
media_image2.png
Greyscale
when u=1-8 in the instant claims, in prior art R7=R8=C1alkoxy, R9=CH3; R10=R11=H; R12= (CH2)1-8 CF3. The cited prior art teaches R7=R8=C1alkoxy, R9=CH3; R10=R11=H; R12= alkyl group substituted with F and further provides examples of quinones, such as
PNG
media_image4.png
552
806
media_image4.png
Greyscale
Similar to species of the instant claims. The cited prior art teaches compound in quinone or hydroquinone form and also teaches preferable groups for 2 and 3 positions (R7 and R8 of the prior art) as H, methyl and methoxy (claim 5). Since the cited prior art preferable groups for 2 and 3 positions contains a small number of members (H, methyl and methoxy) that, when considered in light of the totality of the circumstances, “one skilled in [the] art would... envisage each member” of the genus. In re Petering, 301 F.2d 676, 681, 133 USPQ 275, 280 (CCPA 1962). Since examples of species or subgenus taught by the cited prior art are structurally similar to that claimed, it would have been obvious to a person 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. See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also Deuel, 51 F.3d at 1558, 34 USPQ2d at 1214. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties.” Thus, based on the guidance provided by Miller, it would have been prima facie obvious to a person of ordinary skill in the art with reasonable expectation of success that a compound selected from the genus of Miller may be useful in treating diseases associated with oxidative stress.
Further, the cited prior art teaches that the compounds may be useful in treating diseases associated with oxidative stress. Therefore, a person of ordinary skill in the art would have been motivated to modify compounds within the genus taught by the cited prior art to identify compounds useful for treating oxidative stress.
Miller’s additional teaching of another compound
PNG
media_image11.png
180
948
media_image11.png
Greyscale
, does not preclude teaching of formula that encompass compound of the instant claims. As mentioned above, compounds of the instant claims are not quinone but hydroquinone and are different from compound C that applicant compared. Thus, applicant is arguing over a limitation not recited in the instant claims. Further, the comparison is not a true comparison as compounds that applicant compared with compound C are different from class of compounds of the cited prior art used for the rejection.
Applicant is suggested to provide true comparative data, wherein hydroquinone compounds encompassed by formula
PNG
media_image2.png
336
941
media_image2.png
Greyscale
are compared with compounds of the instant claims.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Conclusion
No Claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PANCHAM BAKSHI whose telephone number is (571)270-3463. The examiner can normally be reached M-Thu 7-4.30 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Milligan Adam can be reached at 571-2707674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PANCHAM BAKSHI/Primary Examiner, Art Unit 1623