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 . Claims 1-3, 5, 7-9, 11 and 13-15 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 01/20/2026 is acknowledged.
Claim Rejections - 35 USC § 102
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 1-2, 5 and 7-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hong Li CN 106963767 A. Cited reference teaches the following four compounds that are the same as applicants when applicant’s Formula 1 has the following substituents: R1 = H, methyl; and R2 = methyl-substituted phenyl; cyclopentyl, cyclohexyl, and substituted alkyl.
PNG
media_image1.png
640
1629
media_image1.png
Greyscale
PNG
media_image2.png
175
1607
media_image2.png
Greyscale
PNG
media_image3.png
462
946
media_image3.png
Greyscale
PNG
media_image4.png
562
1600
media_image4.png
Greyscale
PNG
media_image5.png
545
1567
media_image5.png
Greyscale
Since said the four prior art compounds are the same as applicants, a 102(a)(1) rejection is proper.
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.
Claims 1-3, 5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Li, Hong CN-106963767 A. Cited reference teaches the following two compounds that are almost the same as applicants when applicant’s Formula 1 has the following substituents: R1 = H, methyl; and R2 = methyl-substituted phenyl; and substituted alkyl.
PNG
media_image4.png
562
1600
media_image4.png
Greyscale
PNG
media_image1.png
640
1629
media_image1.png
Greyscale
Applicants are claiming compounds of Formula I-2, Formula 1-7, Formula 1-10 and Formula 1-12.
PNG
media_image6.png
223
489
media_image6.png
Greyscale
PNG
media_image7.png
214
488
media_image7.png
Greyscale
PNG
media_image8.png
210
478
media_image8.png
Greyscale
PNG
media_image9.png
211
482
media_image9.png
Greyscale
The two prior art compounds shown above are almost the same as applicants except the presence or absence of a methylene group (see for example Formula 1-2 and the first prior art compound); or the presence or absence of a methyl substituent (see for example Formula 1-7, Formula 1-12 and the first prior art); or the position of a methyl substituent on the phenyl ring (see for example Formula 1-10 and the second prior art compound).
Compounds that differ only by the presence or absence of an extra methyl group or two are homologues. Homologues are of such close structural similarity that the disclosure of a compound renders prima facie obvious its homologue. The homologue is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing homologues. Of course, these presumptions are rebuttable by the showing of unexpected effects, but initially, the homologues are obvious even in the absence of a specific teaching to add or remove methyl groups. See In re Wood, 199 USPQ 137; In re Hoke, 195 USPQ 148; In re Lohr, 137 USPQ 548; In re Magerlein, 202 USPQ 473; In re Wiechert, 152 USPQ 249; Ex parte Henkel, 130 USPQ 474; In re Fauque, 121 USPQ 425; In re Druey, 138 USPQ 39. In all of these cases, the close structural similarity between two compounds differing by one or two methyl groups was itself sufficient show obviousness. See also MPEP 2144.09, second paragraph.
It is well established that position isomers are prima facie structurally obvious even in the absence of a teaching to modify. The isomer is expected to be preparable by the same method and to have generally the same properties. This expectation is then deemed the motivation for preparing the position isomers. This circumstance has arisen many times. See: Ex parte Englehardt, 208 USPQ 343, 349; In re Mehta, 146 USPQ 284, 287; In re Surrey, 138 USPQ 67; Ex Parte Ullyot, 103 USPQ 185; In re Norris, 84 USPQ 459; Ex Parte Naito, 168 USPQ 437, 439; Ex parte Allais, 152 USPQ 66; In re Wilder, 166 USPQ 545, 548; Ex parte Henkel, 130 USPQ 474; Ex parte Biel, 124 USPQ 109; In re Petrzilka, 165 USPQ 327; In re Crownse, 150 USPQ 554; In re Fouche, 169 USPQ 431; Ex parte Ruddy, 121 USPQ 427; In re Wiechert, 152 USPQ 249, In re Shetty, 195 USPQ 753.
For example, “Position isomerism has been used as a tool to obtain new and useful drugs” (Englehardt) and “Position isomerism is a fact of close structural similarity” (Mehta, emphasis in the original). See also MPEP 2144.09, second paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 1, 3, 5 and 7-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 and claims dependent thereon are rejected because the phrase “a substituted” is indefinite. In the absence of the specific moieties intended to effectuate modification by the “substitution” or attachment to the chemical core claimed, the term “substituted” renders the claims in which it appears indefinite in all occurrences wherein applicants fails to articulate by chemical name, structural formula or sufficiently distinct functional language, the particular moieties applicants regards as those which will facilitate substitution, requisite to identifying the composition of matter claimed.
Claims 7-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Applicants recite in claim 5 a pharmaceutical composition with a pharmaceutical carrier and an intended use that has no patentable weight. Pharmaceutical composition claims 7-9 depend from claim 5 and recite different diseases that are improperly dependent on claim 5. Claims 7-9 fail to narrow the claim limitation of a pharmaceutical composition claim 5. Claims 7-9 are simply duplicates of claim 5. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements. In order to overcome this rejection, the examiner recommends that applicants amend claim 5 as a proper pharmaceutical composition claim by deleting the intended use “for treating……..” and delete claims 7-9 that are duplicates of claim 5.
Information Disclosure Statement
13. Applicant’s Information Disclosure Statement, filed on 12/10/2024 and 02/15/2024 has been acknowledged. Please refer to Applicant’s copies of the 1449 submitted herewith.
Conclusion
14. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kahsay Habte Ph.D. whose telephone number is (571)272-0667. The examiner can normally be reached on 8:30 - 5:00 PM.
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, JEFFREY MURRAY can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Kahsay Habte/
Primary Examiner, Art Unit 1624