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 .
DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I and compound 22a in the reply filed on 3/18/2026 is acknowledged. The traversal is on the ground(s) that the Office has provided no technical analysis, or evidence demonstrating there would be a serious search and/or examination burden if restriction were not required. This is not found persuasive because for the national stage applications filed under 35 USC 371, the applicable standard for restriction is 37 CFR 1.499, where lack of unity is required for restriction. This regulation is silent on search burden. For national applications filed under 35 USC 111(a), the applicable standard is 37 CFR 1.141-1.146, where the criteria is excessive examiner search burden. As applicants have stated on their application data sheet and on their declaration that this application was filed under 35 USC 371, search burden is not the proper criteria for restriction of this application. Furthermore, Groups I-IV do not share a special technical feature a priori, thus the restriction requirement under PCT Rules 13.1-13.2 is proper.
The requirement is still deemed proper and is therefore made FINAL.
Applicants elected species (i.e. compound 22a) was deemed to be free of the prior art. In accordance with Markush Practice, the search was extended to the Markush group/independent claim, and a reference was discovered that anticipated. As a result, claims 1-5 and 7-10 have been examined and claims 6 and 11-19 are withdrawn from consideration. While applicant’s elected species may read on one or more withdrawn claims, they have not been fully examined for patentability, and thus a determination of allowability cannot be made with respect to these claims at this time. This is proper, as MPEP 803.02 states that, in these circumstances, the prior art search, however, will not be extended unnecessarily to cover all nonelected species (MPEP 803.02).
Status of the Claims
Claims 1-19 are pending in this application.
Claims 6 and 11-19 are withdrawn from consideration as being drawn to a non-elected invention.
Claims 1-5 and 7-10 are presently under consideration as being drawn to the elected species/invention.
Improper Markush
Claims 1-5 and 7-10 are rejected under the judicially created basis of improper Markush group of alternatives. See 76 Fed. Reg. 7164-7166 (Feb. 9, 2011); In re Harnish, 631 F.2d 716m 721-22 (CCPA 1980); Ex parte Hosuzmi, 3 USPQ2d 1059m 1060 (Bd. Pat. App. & Int. 1984). For a Markush grouping to be proper the species of the Markush group must share a ‘‘single structural similarity” and must share a common use. Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art recognized class. Here, the claimed compounds do not share a "single structural similarity.” The template portion of the claimed compound contains different molecules that do not belong to the same recognized physical or chemical class and do not belong to the same art recognized class. For instance, the structural requirements of SH (variable Z) are completely different from S-trityl. Similarly, variable Y comprises unrelated molecules (i.e. these molecules do not belong to the same art recognized class). Variable B comprises an a-amino acid and a b-amino acid backbone, which, once again, do not belong to the same art recognized class. The different compounds encompassed by the claims do not belong to the same recognized physical or chemical class and do not belong to the same art recognized class.
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.
Claims 1-5 and 7-10 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.
Regarding claim 1, the phrases "particularly", "more particularly" and "most particularly" render the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 2-5 and 7-10, which depend from claim 1, are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as these claims incorporate by dependency the indefiniteness of claim 1.
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 1-4 and 7-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lokey et al. (US 2007/0275886).
With respect to claims 1 and 7-9, Lokey et al. teach preparing a compound (Fig. 2; depicted below) which corresponds to the instant compound of Formula (I), wherein X is indole-S, L1 is CH2, L2 is CH2, B is an amino acid, A is an amino acid, n is 2, m is 0, and k is 0.
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Lokey et al. teach preparing the compound above by reacting a compound corresponding to instant compound of Formula (II) with I2 (Iodine) (Fig. 2; depicted above).
The compound of Lokey et al. corresponds to Formula (II), wherein L1 is CH2, L2 is CH2, B is an amino acid, A is an amino acid, n is 2, m is 0, and k is 0, Y is indole, and Z is STrt.
With respect to claims 2-3, as shown in Fig. 2 above, the amino acid corresponding to C or D is: connected to a resin; protected on the N-terminus; and is reacted with iodine.
With respect to claim 4, as shown in Fig. 2 above, reaction step (a) is performed in DMF (i.e. a polar solvent).
With respect to claim 10, Lokey et al. teach that the resin is the highly acid labile 2-chlorotrityl resin (para [0045]).
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 1-5 and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Lokey et al. (US 2007/0275886).
The teachings of Lokey et al. with respect to claims 1-4 and 7-10 have been discussed above.
Lokey et al. do not specifically teach the concentration of iodine used.
However, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum concentration of iodine by normal optimization procedures known in the pharmaceutical art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658