youDETAILED 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 .
Receipt is acknowledged of Applicant’s Arguments and Request for Continued Examination filed on 09/26/2025.
Claims 1, 2, 5, 9, 10, and 12-17, 19-21 are pending and presented for examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 09/26/2025 has been entered.
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.
Claim 9 and 17 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 9, recites “ wherein at least one R comprises a mannose-binding C-type lectin receptor targeting moieties is attached to the blocking compound backbone”. However, according to claim 1, blocking compound specifically does not contain a therapeutic or diagnostic agent and the “C-type lectin receptor targeting moieties” are rather highly therapeutic targets acting as crucial immune sensors for pathogens, cancer, and inflammation with potential applications. Thus, this limitation contradicts the recitation in the base claim and therefore is confusing and the metes and bounds of the claim cannot be determined.
Claim 17 recites the limitation "the effective dose" in line 1. There is insufficient antecedent basis for this limitation in the claim. It is noted that claim 1 recites “effective amount” and it is unclear if the effective amount is the same as the effective dose.
The dependent claims fall herewith.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 2, 5, 9, 10, 12-17 and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Cope et al. (US 2015/0023876) in view of Lanza et al. (US 2008/1093372)
Cope discloses method of diagnosing and treating CD206 expressing cell-related disorders comprising the steps of: (a) administering a pharmaceutical composition to a subject, said composition including a carrier molecule having a detectable moiety attached thereto, said carrier molecule comprising: i) a dextran backbone; and ii) at least one receptor substrate conjugated, directly or indirectly, to said dextran backbone, said at least one receptor substrate chosen so as to specifically bind to CD206; (b) detecting the presence of said detectable moiety at a location in the subject other than a sentinel lymph node (abstract and claim 1). Each receptor substrate attached to the dextran backbone comprises one or more residues selected from the group consisting of mannose, fucose, n-acetylglucosamine, D-galactose, n-acetylgalactoseamine (0038). In some embodiments, the dextran backbone has a MW of between about 1 kDa and about 50 kDa. The MW of the dextran backbone may be selected based upon the particular disorder to be diagnosed, evaluated, or treated, as well as whether the macromolecular construct is to be used for treatment, diagnosis, or evaluation (0036). In some embodiments a plurality of amino-terminated leashes is attached to the majority of the glucose moieties, wherein the amino-terminated leashes comprise -O(CH2)3S(CH2)2NH2 such that a hydroxyl group of the glucose residue of the dextran backbone is replaced by the amino-terminated leash (0042-0043). In some embodiments, the carrier molecules include a therapeutic agent which is attached to the carrier molecule-either in place of a detectable moiety or in conjunction therewith, the therapeutic agent comprises a high energy killing isotope, cytostatic agents, alkylating agent and for diagnostic purposes, a detectable moiety such as 99mTc or 68Ga is attached to the carrier molecule (e.g. to a DTPA or DOTA chelator), (0062-0067 and 0102). The CD206 expressing cell-related disorder is an inflammatory disorder, an angiogenic disorder, is cancer, Kaposi's sarcoma (0027 and claims 22-24). Additional disclosure includes that the diagnostic methods include not only detecting the presence or absence of a disorder, but also tracking the progress of treatment for a disorder such as by detecting CD206 expressing cells at a predetermined target location at a first time, administering treatment (or the treatment methods described herein or other treatment methods), and detecting CD206 expressing cells at a predetermined target location at a later second time.
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 (a) is the same mannosylated carbohydrate compound in step (b), but without the added therapeutic/diagnostic moiety.
Lanza teaches the prior art had known of enhancing the delivery of targeted composition to the desired location in a subject (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. Using the method, it has been possible to achieve successful targeting in the range of 10% of the labeled targeted composition whereas without the method of the invention, only 2% or more typically only 1% or less of the targeted particles actually reach the target (0023). For example, in attempting to label tumors with radionuclides, the radionuclides have been coupled to antibodies (Note, antibodies read on “targeting moieties”) 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”) which then, presumably, saturate the liver and spleen, permitting the labeled antibodies to progress without dilution by the RES to the target area” (0006). Lanza demonstrate this in Example 2 (see 0078).
Lanza’s invention differs 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, with respect to administering the blocking compound is followed by a time interval of at least zero to 60 minutes before the administering the mannosylated dextran therapeutic or diagnostic compound, Lanza discloses a decoy inactive carrier composition is administered simultaneously with a targeted composition containing vehicles for delivering a desired enhances the delivery of the targeted composition to the desired location in a subject (abstract). Further, Lanza discloses that simultaneous administration is meant that active composition and the inactive carrier are administered so that their initial bio-distribution will be co-extensive,--i.e., the active composition and the inactive carrier are administered within five minutes of each other, 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. Further it would have been obvious to optimize the amount of time between the blocking agent and the therapeutic or diagnostic agent to determine the optimal time depending on both the specific blocking agent and the specific therapeutic or diagnostic agent in order to achieve the desired result of the blocking agent and thereby enhancing the therapeutic/diagnostic.
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 method to deliver targeted agents for diagnostic or therapeutic use.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 5, 9, 10, and 12-17, 19-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-6 and 8-17 of copending Application No. 18/189,658 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are directed to a method for increasing target specificity of a mannosylated dextran therapeutic or diagnostic compound comprising:
(a) administering at least one blocking compound comprising a dextran backbone and one or more CD206 targeting moieties attached thereto, wherein the blocking compound does not contain a therapeutic or diagnostic agent; and (b) administering an effective amount of the mannosylated dextran therapeutic or diagnostic compound comprising a dextran backbone and one or more CD206 targeting moieties and one or more therapeutic or diagnostic agents attached thereto. The subject matter claimed in the instant application is fully disclosed in the referenced copending application and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter as delineated above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 5, 9, 10, and 12-17, 19-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,178,829. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent recites a method of increasing target specificity of a mannosylated carbohydrate polymeric therapeutic or diagnostic compound in a subject comprising: administering a blocking compound comprising a carbohydrate backbone, one or more mannose-binding C-type lectin receptor targeting moieties attached thereto, and one or more negatively charged or neutral moieties attached thereto, wherein the one or more negatively charged or neutral moieties comprises an acidic group, a mannose moiety, galactose, or fucose; and administering an effective amount of the mannosylated carbohydrate polymeric therapeutic or diagnostic compound comprising a carbohydrate polymer backbone and one or more CD206 targeting moieties and one or more therapeutic or diagnostic agents attached thereto, wherein the blocking compound is polyanionic and thereby negatively charged, or neutral; and wherein the mannosylated carbohydrate polymeric therapeutic or diagnostic compound is polycationic and thereby positively charge (see claim 11), wherein the blocking compound is a compound of Formula (Il) (see claim 13).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Conclusion
No claims allowed at this time.
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/J.R.S/Examiner, Art Unit 1618
/Michael G. Hartley/Supervisory Patent Examiner, Art Unit 1618