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 Request for Continued Examination and Amendment filed on 01/27/2026.
Claims 1, 4-6 have been amended.
Claims 1-6, 8-23 are pending in the instant application.
Claims 18-23 have been previously withdrawn from consideration.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/27/2026 has been entered.
Claim Rejections - 35 USC § 112, 2nd paragraph
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 1-6, 8-17- 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 recites in step (a) “administering to the subject an effective amount of the mannosylated carbohydrate polymeric therapeutic and/or diagnostic compound comprising a carbohydrate polymeric backbone, one or more CD206 receptor targeting moieties, and one or more therapeutic, diagnostic, or theranostic agents attached thereto”. Mannosylated (specie) is recited in the preamble of the claim, but is not recited in the body of the claim. The body of the claim recites “CD206 receptor targeting moieties” (genus), which is the genus and is broader in scope than “mannosylated”.
Applicant’s claims do not recite mannose until claim 6, and claim 6 recites mannose in a Markush group with other moieties, such as fucose and n-acetylglucosamine. Thus, mannose is not specifically required in any claims.
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 Cope fails to teach, suggest, or provide any reason for a method for using a blocking group. Instead, Cope lacks any teaching of a blocking group. As a result, Cope does not teach, suggest, or provide any reason for the method of claim I as claimed. Lonza fails to remedy the deficiencies of Cope. That is, Lonza also fails to teach, suggest, or provide any reason for a method for using a blocking group and a therapeutic/diagnostic compound wherein both compounds specifically bind to a CD206 receptor. Lanza fails to remedy the deficiencies of Cope. That is, Lanza also fails to teach, suggest, or provide any apparent reason for diluting the labeled imaging or therapeutic agent with unlabeled agent to increase localization to sites of pathological inflammation. Lanza is relied on in the Office Action solely for describing competitive blocking at a particular location, but there is no specific binding of the blocking group to the targeted receptor. In paragraph 78 of Lanza, Lanza uses an unlabeled targeted construct to compete with a labeled (targeted) construct for non-specific binding to the liver. The unlabeled construct competitively blocked the labeled construct from localizing to the liver. Lanza does not disclose how competitive blocking of the liver increased localization of the labeled targeted construct to other anatomical sites. Competitive blocking of the liver is not the Applicant's invention. The invention is using competitive blocking of the liver to increase localization to other anatomical sites.
The Examiner finds this argument unpersuasive, because in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As discussed in the rejection above, COPE in view of LANZA teaches Applicant’s invention. Additionally, Applicant argument pertaining to the secondary reference LANZA using a non-specific binding is unpersuasive, because the primary reference COPE is using mannose and a moiety that specifically binds to CD206 receptors.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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/JAKE M VU/Primary Examiner, Art Unit 1618