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 .
Terminal Disclaimer
The terminal disclaimer filed on 6/2/2026 disclaiming the terminal portion of any patent granted on this application has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 103
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.
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tseng et al. (US 2013/0226549) in view of Shenkin et al. (US 2009/0287465).
Tseng et al. discloses a method of screening potential lead compounds for suitability as a candidate for a pharmaceutical application, the method comprising the steps of:
inputting information about an initial lead compound into a computer system (paragraph [0055]: docking a lead compound into a target molecule to obtain the information of the lead compound and its binding site);
providing a first database of known chemical reactions for access by the computer system (paragraph [0007]: The reaction database);
providing a second database of known compound fragments for access by the computer system (paragraph [0031]: Fragment database. Paragraph [0073]: The library of potential substitution fragments);
partitioning, using the computer system, the initial lead compound into fragments (paragraph [0056]: Decomposing the docked lead compound to form fragments), wherein the initial lead compound is partitioned using a computational retrosynthetic analysis of the initial lead compound based on information from the first database (paragraph [0007]: Retrosynthetic transformations automatically is generated from the reaction database);
generating, using the computer system, a plurality of potential lead compounds each having a respective one of a plurality of alternative fragments from the second database (paragraph [0048]: Potential compounds with various combinations of fragments are generated with stronger potency);
calculating, using the computer system, a difference in binding free energy between the partitioned lead compound and each potential lead compound; and predicting, using the computer system, and based on the difference in binding free energy between the partitioned lead compound and each potential lead compound whether each potential lead compound will bind to the biomolecular target; and reporting, by the computer system, a predicted active set of potential lead compounds based on the prediction (paragraph [0031]: The newly proposed compounds are ranked on the basis of a calculated binding free energy).
Tseng et al. however is silent wherein the partitioning partitions the initial lead compound into atoms defining a partitioned lead compound comprising a lead compound core and atoms defining a lead compound non-core, wherein the plurality of alternative fragments from the second database is for replacing the lead compound core in the initial lead compound wherein the reference compound, and wherein the initial lead compound being known to bind to a biomolecular target involved in a metabolic or signaling pathway associated with a disease condition or pathology or to an infectivity or survival of a microbial pathogen.
Shenkin et al. discloses a method of deriving an optimized compound from a reference compound by replacing its core with a new core (Abstract), wherein the reference compound
being known to bind to a biomolecular target involved in a metabolic or signaling pathway associated with a disease condition or pathology or to an infectivity or survival of a microbial pathogen (paragraphs [0083]-[0084]: Reference compound and biological target) and being partitioned into atoms defining a partitioned lead compound comprising a lead compound core and atoms defining a lead compound non-core (paragraphs [0010], [0088], [0089]: The reference compound comprises its core and the side chains (non-core) defined as the peripheral molecular fragments).
Therefore, it would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify Tseng’s method to partition the initial lead compound into a core and a non-core and replace its core with a new core in order to generate an optimized compound as taught by Shenkin et al. (Abstract).
Allowable Subject Matter
Claims 5-6 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Regarding to claim 5: The primary reasons for the indication of the allowability of the claim is the inclusions therein, in combination as currently claimed, of the limitation that wherein the generation of at least one potential lead compound comprises creating an additional covalent bond or annihilating an existing covalent bond, or both creating an additional first covalent bond and annihilating an existing second covalent bond different from the first covalent bond is neither disclosed nor taught by the cited prior art of record, alone or in combination.
Claim 6 is allowed because they depend directly/indirectly on claim 5.
Response to Arguments
Applicant's arguments filed 6/3/2026 have been fully considered but they are not persuasive.
In response to Applicant’s Remarks about the motivation to combine of the references, the Examiner cites that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Furthermore, “The reason for motivation to modify the reference may often suggest what the invention has done, but for a different purpose or to solve a difference problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant” (MPEP 2144 RATIONAL DIFFERENT FROM APPLICANT’S IS PERMISSIBLE).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAM S NGUYEN whose telephone number is (571)272-2151.
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, DOUGLAS RODRIGUEZ, can be reached on 571-431-0716. 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 http://pair-direct.uspto.gov. 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.
/LAM S NGUYEN/ Primary Examiner, Art Unit 2853