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 .
Remark
The response and amendment filed on 7/14/2026. Claims 1-10 12, Claims 1, 11, 14-15 and have been canceled. Claims 11, 13, 16-18, 20-22 have been amended. are pending and considered.
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.
Claims 11, 13 16-18 , 20-22 are still rejected under 35 U.S.C. 103 as being unpatentable over WO2009/072767A2 to Moon et al. and Erik De. Clercq (Journal of Clinical Virology 30 (2004), 115-133).
Applicants traverse the rejection by asserting that the cited reference does not teach the claimed composition can reduce HBeAg antigen, whereas Applicants found what they observed HBeAg antigen reduction is an unexpected result.
Applicants’ argument has been respectfully considered, however, it is not found persuasive. Applicants’ attention is directed to the case law of In re Sussman, 141 F. 2d 267, 60 U.S.P.Q. 538 (CCPA 1944), which cites "since the steps are the same, the results must inherently be the same unless they are due to conditions not recited in the claims." In the instant case, Applicant(s) is (are) claiming an invention employing the same process steps but the product(s) is(are) alleged to be different. If the claimed products are structurally different, Applicant is required to recite the missing steps to form the alleged different product(s) in view of the above cited decision.
In the instant case, the cited reference teaches using the composition comprising the same components as Applicants claimed to treat same HBV infected patients. Therefore, the results must inherently be the same unless they are due to conditions not recited in the claims.
Regarding this inherency rejection, applicants’ attention is directed to Feit et al. (2003, J. Pat. Trade. Off. Soc., Vol. 85, No. 1, pages 5-21), in that article, Feit et al. teach three criteria for analysis whether the prior art is inherently anticipate a claim(s). (1). The most important criterion is certainty. Citing In re Tomlinson and In re Zierden, Feit et al. state that certainty is established when the reference process necessarily results in the claimed process as opposed to a possibility. (2) The second criterion is chronology; it will always happen. Feit et al. state that the chronological test is forward chronology. Citing Eli Lilly and Co. v Barr Laboratories, Inc., Feit et al. argue that the claimed result must always be obtained based upon the prior art method. 3) The third criterion is the legal standard. Feit et al., citing Continental Can, state that the legal standard is whether the missing descriptive material would be so recognized by a person of ordinary skill in the art as necessarily present in the thing.
In the instant case, if the claimed method using the same composition for treating the same HIB infected patients, whether the understanding was apparent at the time of filing the application in question, or first becomes apparent at a later time.
To this context, the rejection is maintained.
Conclusion
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.
/BAO Q LI/ Primary Examiner, Art Unit 1671
