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 .
Receipt is acknowledged of Applicant’s Amendment filed on 09/09/2026.
Claims 1-2, 5, 8-11, 13 have been amended.
Claims 1-6, 8-23 are pending in the instant application.
Claims 18-23 have been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
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.
Claim(s) 1-6, 8-17 are is/are rejected under 35 U.S.C. 103 as being unpatentable over COPE et al (US 2019/0022259) in view of LANZA et al (US 2008/0193372).
COPE teaches a method of imaging (see claim 62) comprised of: administering a compound comprised of dextran backbone (see claim 1 and Fig. 8), such as mannosylaminodextran (see [0055]) which is a species that reads on the genus of carbohydrate polymeric backbone and has an amino group resulting in a positive charge; a CD206 targeting moiety (see claim 62), such as mannose (see Fig. 8), which is a species that reads on the genus of C-type lectin receptor targeting moieties; and a diagnostic moiety (see claim 62), such as Gallium (see claim 77), wherein dextran backbone is 10kDa (see [0072]; [0087]) and multiple doses can be given (see [0028]), which reads on Applicant’s step (a) which requires a diagnostic agent. Additional disclosure include: Fig. 8, which reads on most of applicant’s dependent claims pertaining the compound, such as DTPA chelating agent, linking/leash formula; kidney (see [0154]); colorectal cancer (see [0148]). Note, dependent claims 10-14 do not appear to have any active steps, but rather what will inherently occur when independent claim 1 is met, unless proven otherwise.
COPE does not teach using a blocking compound that does not contain a therapeutic/diagnostic moiety and administering the blocking compound before or simultaneously with the therapeutic/diagnostic compound. Note, Applicant’s blocking compound in step (b) is the same mannosylated carbohydrate compound in step (a), but without the added therapeutic/diagnostic agent.
LANZA teaches the prior art had known of enhancing the delivery of targeted composition to the desired location in a subject (see abstract), such as a “two-step efforts to saturate the RES (liver and spleen) capacity to clear particulates with unlabeled carrier or other related materials followed later by administering an active imaging and/or therapeutic agent. For example, in attempting to label tumors with radionuclides, the radionuclides have been coupled to antibodies (Note, antibodies read on “targeting moieties” and radionuclides read on “diagnostic agent”) or fragments that bind to tumor associated antigens. However, in order to avoid massive doses, subjects have first been administered unlabeled antibodies (Note, antibodies read on “targeting moieties” and unlabeled reads on “does not contain a diagnostic agent”) which then, presumably, saturate the liver and spleen, permitting the labeled antibodies to progress without dilution by the RES to the target area” (see [0006]). LANZA demonstrate this in Example 2 (see [0078]).
LANZA’s invention differ from the prior art’s “two-step efforts” by using a “decoy” approach, wherein LANZA suggests solving this problem by employing a probability-based approach--i.e., a non-targeted agent of similar physical character is co-administered, i.e., simultaneously, with targeted agent, to facilitate the evasion of the RES system by the targeted complex, which provides improved uptake at the desired site. Since the dosage of agent required for efficacy at the targeted site is small in comparison to the amount cleared by the RES system, the use of decoys often allows the total dose of active agent to be lower than what would otherwise be required to compensate for RES losses (see [0007]). LANZA demonstrated the decoy approach in Example 1 (see [0074]-[0077]).
Note, it would have been obvious to use the prior art’s “two-step efforts” disclosed in LANZA, which is the same approach used by Applicant, because this “two-step efforts” was known to increase/enhance the delivery of the targeted composition.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate using a blocking compound that does not contain a therapeutic/diagnostic moiety and administering the blocking compound before or simultaneously with the therapeutic/diagnostic compound, as taught by the prior art in LANZA’s disclosure of the “two-step efforts”. The person of ordinary skill in the art would have been motivated to make those modifications, because it would enhance the delivery of the targeted composition, and reasonably would have expected success because both references dealt in the same field of endeavor, such as methods to deliver targeted agents for diagnostic or therapeutic use.
The references do not specifically teach adding the ingredients, such as blocking agent, in the amounts claimed by Applicant. The amount of a specific ingredient in a composition is clearly a result effective parameter that a person of ordinary skill in the art would routinely optimize. Optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ and reasonably would expect success. It would have been customary for an artisan of ordinary skill to determine the optimal amount of each ingredient to add in order to best achieve the desired results, such as competitively blocking/saturating the liver and spleen. Thus, absent some demonstration of unexpected results from the claimed parameters, this optimization of ingredient amount would have been obvious at the time of Applicant's invention.
Response to Arguments
Applicant argues that the Office's position is not that the skilled artisan would not have modified Cope to include steps from Lanza' s disclosed method. Rather, the Office alleges that based on Lanza, the skilled artisan would have allegedly modified Cope based on Lanza' s description of prior "two step efforts to saturate the RES capacity to clear particulates with unlabeled carrier or other related materials followed later by administering [an] active imaging and/or therapeutic agent." See Lanza, [0006]. However, without conceding the propriety of the Office's interpretation of Lanza, Applicant submits that this allegation cannot form the basis of a proper prima facie case of obviousness given that Lanza explicitly teaches away from the alleged modification to Cope. Indeed, to the extent that Lanza discloses "two-step efforts to saturate the RES capacity to clear particulates with unlabeled carrier or other related materials," the reference immediately goes on to disclose that "the RES is not readily saturated without inducing symptoms associated with liver or splenic congestion, including discomfort, nausea or vomiting. Thus, the potential decrease in efficacy in combination with adverse clinical effects appears to account for the failure of the previous approaches." See Lanza, [0007] (emphasis added). In that regard, Applicant respectfully submits that "[it] is impermissible within the framework of section 103 to pick and choose from any one reference only so much of it as will support a given position, to the exclusion of other parts necessary to the full appreciation of what such reference fairly suggests to one of ordinary skill in the art." In re Wesslau, 353 F.2d 238 (CCPA 1965). Here, the skilled artisan could have only been motivated by Lanza to modify Cope to include a blocking compound "comprising a dextran backbone and one or more CD206 receptor targeting moieties attached thereto" by excluding the overwhelming majority of Lanza' s disclosure. Indeed, in addition to criticizing, discrediting, and otherwise discouraging the disclosure relied on by the Office (as discussed above), Lanza's disclosed process fundamentally differs from claim 1. Specifically, Lanza utilizes a "decoy" that is comprised of its drug delivery vehicle without a receptor targeting moiety. Indeed, per Lanza, "[t]he invention relies on concurrent administration of untargeted 'carrier' or 'decoy' vehicles to reduce the premature RES clearance of targeted vehicles." See Lanza, [0021] (emphasis added). In this way, the decoy competes with Lanza' s targeted drug delivery vehicle for binding and uptake by low specificity scavenging receptors in the liver but cannot compete with the targeted vehicle in tumors, where low specificity scavenging receptors are not expressed. Given the above, for the skilled artisan to expect success from modifying Cope to include a blocking compound "comprising a dextran backbone and one or more CD206 receptor targeting moieties attached thereto," the artisan would be required to disregard Lanza' s teaching away from prior two-step efforts and further disregard Lanza' s disclosure that its successful process relies on the use of untargeted decoys. This is clearly improper.
The Examiner finds this argument unpersuasive, because as discussed in the rejection, LANZA teaches the prior art before LANZA’s invention had known of the two-step effects, which is the same blocking method used by Applicant, to increase/enhance delivery of the targeted composition.
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.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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