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 .
Priority
The present application, filed January 13, 2023, is a national stage application of PCT/CN2021/105899, filed July 13, 2021, and claims priority to foreign priority application PCT/CN2020/102115, filed July 15, 2020.
Status of the Application
Applicant’s amendment, received March 30, 2026, wherein claims 1, 67, 72, 73, 75, 76, 78, and 79 are amended and claims 63, 65, 71, and 74 are canceled, is acknowledged.
Claims 1, 64, 66-70, 72, 73, and 75-81 are pending and examined on the merits herein.
Withdrawn Objections
Applicant’s amendment, received March 30, 2026, with respect to the objections to claims 1 and 79 for minor informalities, has been fully considered and found to be persuasive to remove the objections because claims 1 and 79 are amended to remove these informalities. Therefore the objections are withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the objection to claim 78 for minor informalities, has been fully considered and found to be persuasive to remove the objection because claim 78 is amended to include replacement figures that correct the informalities. Therefore the objection is withdrawn.
Withdrawn Rejections
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claim 78 under 35 USC § 112(b) as indefinite, has been fully considered and found to be persuasive to remove the rejection because claim 78 is amended define “n” and to remove the undefined asterisks from the structures in the claim. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claim 65 under 35 USC § 112(d) for failing to include all the limitations of the claim upon which it depends, has been fully considered and found to be persuasive to remove the rejection because claim 65 is canceled. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claim 79 under 35 USC § 112(d) for limit the subject matter of the claim upon which it depends, has been fully considered and found to be persuasive to remove the rejection because claim 79 is amended to require the drug delivery system of claim 79 is formulated for local administration, which thus requires the drug delivery system in a specific form and further limits the claim upon which it depends. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 63, 65, 66, 67, 68, 69, 71, 74, and 80 under 35 USC § 102 as anticipated by Yousefpour, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the therapeutic agent of the drug delivery system is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib, which Yousefpour does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 63, 65, 66, 67, 68, 69, 71, 74, and 79-81 under 35 USC § 102 as anticipated by Kato, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the therapeutic agent of the drug delivery system is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib, which Kato does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 63, 65-70, 74, and 79-81 under 35 USC § 102 as anticipated by Harada, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the therapeutic agent of the drug delivery system is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib, which Harada does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 65, 66, 68, 69, 71, 72, 74, and 79-81 under 35 USC § 102 as anticipated by Lin, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the therapeutic agent of the drug delivery system is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib, which Lin does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 66, 68, 69, 71, 72, 74, and 80 under 35 USC § 102 as anticipated by Norbedo, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the therapeutic agent of the drug delivery system is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib, which Norbedo does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 66, 68, 69, 71, 73, 74, and 79-81 under 35 USC § 102 as anticipated by Liu, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the therapeutic agent of the drug delivery system is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib, which Liu does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 63, 65-69, 74, 75, and 77 under 35 USC § 102 as anticipated by Gardner, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the biopolymer is hyaluronic acid or chondroitin sulfate, which Gardner does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the rejection of claims 1, 63, 66, 67, 68, 69, 70, 74, 75, 76, and 80 under 35 USC § 102 as anticipated by Karnthaler-Benbakka, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the biopolymer is hyaluronic acid or chondroitin sulfate, which Karnthaler-Benbakka does not teach. Therefore the rejection is withdrawn.
Applicant’s amendment, received March 30, 2026, with respect to the provisional nonstatutory double patenting rejection of claims 1, 63-73, and 79-81 as unpatentable over the claims of co-pending U.S. patent application 18/692340, has been fully considered and found to be persuasive to remove the rejection because claim 1 is amended to require the therapeutic agent of the drug delivery system is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib, which 18/692340 does not claim. Therefore the rejection is withdrawn.
Claim Interpretation
The limitation “for locally delivering a therapeutic agent at a controlled rate” recited in claim 1 is interpreted herein as an intended use of the drug delivery system of claim 1.
MPEP 2111.02 at II states: “During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. …To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim.” In this instance, claim 1 interpreted as satisfied by a drug delivery system that satisfies the structural limitations recited in claim 1, even if that drug delivery system is not expressly used for locally delivering a therapeutic agent at a controlled rate.
In addition, claim 78 depends from claim 1 and requires the drug delivery system is selected from the group consisting of the structures shown in the claim, wherein n is in the range of 20 to 5,300. The structures recited in claim 78 each show two monosaccharide monomers that together form the hyaluronic acid or chondroitin sulfate biopolymer. This claim thus requires one of every two monosaccharides is derivatized with a therapeutic agent, including wherein all carboxyl groups or all C6-OH groups of hyaluronic acid are derivatized, and wherein all carboxyl groups of chondroitin sulfate are derivatized. A hyaluronic acid or chondroitin sulfate biopolymer having the therapeutic agent present at a lower degree of derivatization (for example, wherein the therapeutic agent is conjugated to only some, not all hyaluronic acid carboxyl groups) is herein interpreted as not satisfying the requirements of claim 78.
Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 requires BG2 is an amine group. However, claim 78, which depends from claim 1, includes embodiments of sunitinib in which BG2 is an amide (lactam) nitrogen group, and the conjugation via an amide nitrogen is herein interpreted as satisfying the requirements of claim 1. For the purposes of promoting clarity in the claims, please amend claim 1 to reflect that BG2 may be nitrogen that is part of another function (e.g., an amide), and does not strictly require BG2 is an amine group.
Appropriate correction is required.
The following are new and/or modified grounds of rejection, necessitated by Applicant’s amendments received March 30, 2026.
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 64 is 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 64 depends from claim 63. However, claim 63 is canceled, and thus the drug delivery system of claim 63 recited in claim 64 lacks antecedent basis. For the purposes of expedited prosecution, claim 64 is interpreted herein as depending from claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 73 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 73 depends from claim 1 and requires the biopolymer is chondroitin. However, claim 1 requires the biopolymer is hyaluronic acid or chondroitin sulfate, and thus claim 73 fails to include all limitations of the claim upon which it depends. This rejection may be overcome by amending claim 73 to require the biopolymer is chondroitin sulfate.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 66-69, 72, 75, 77, and 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Wei (Wei, X.; et al. Molecular Pharmaceutics 2018, vol. 15, pp. 3456-3467; cited in IDS received June 11, 2025) in view of Ikeya (U.S. pre-grant publication no. US 20070197465 A1; cited in IDS received March 17, 2025).
Wei teaches that although the Janus kinase (JAK) inhibitor, Tofacitinib (abbreviated as Tofa), is highly effective in treating rheumatoid arthritis (RA), it has dose-dependent toxicities that limit its clinical application (p. 3456, Abstract, lines 1-4). Wei teaches a prodrug design that targets arthritic joints to enhance Tofa’s therapeutic efficacy, which may provide an opportunity for future development of safer Tofa dosing regimens (p. 3456, Abstract, lines 4-8).
Wei teaches their prodrug is a conjugate of Tofa linked to HPMA via an acid-cleavable carbamate linker (p. 3456, Abstract, lines 8-11; structure shown on p. 3457, Scheme 1 and reproduced below). Wei teaches their prodrug activation data demonstrates the carbamate linkage is cleaved under acidic environments (such as during inflammatory acidosis or at lysosomal pH values) (p. 3465, left column, first paragraph, lines 1-8).
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Wei teaches that the therapeutic efficacy of a single dose of P-Tofa was compared to the dose-equivalent daily oral administration of Tofa in an adjuvant-induced arthritis (AA) rat model. Wei teaches that saline treated AA rats and age-matched healthy rats were used as controls, and observational analyses support the superior and sustained efficacy of a single dose P-Tofa treatment compared to the dose-equivalent daily Tofa administration in ameliorating joint inflammation (p. 3456, Abstract, lines 10-14). This is interpreted as treating inflammation associated with arthritis.
Wei concludes by stating that an HPMA-based nanoscale prodrug of P-Tofa has the potential to enhance the therapeutic efficacy and widen the therapeutic window of Tofa therapy in rheumatoid arthritis (p. 3456, Abstract, lines 19-21).
Wei does not teach the drug delivery system of the present claims, wherein the biopolymer is hyaluronic acid or chondroitin sulfate, as required by claim 1.
Ikeya teaches a hyaluronic acid (HA)-methotrexate conjugate useful as a therapeutic drug for joint diseases (cover page, Abstract, lines 1-3). Ikeya teaches that HA preparations are becoming more useful as a safer intra-articular injection alternative to steroid preparations for locally treating osteoarthritis (p. 1, [0003], lines 14-16). Ikeya further teaches that a high molecular weight type HA preparation having a molecular weight close to that of HA present in normal synovial fluid is approved in Japan with regard to an indication for the elimination of knee pain associated with rheumatoid arthritis (p. 1, [0005], lines 5-10).
Ikeya teaches it is generally thought that HA preparations reverse the impaired viscosity and elasticity of synovial fluid resulting from the pathologic condition of osteoarthritis or rheumatoid arthritis to eliminate pain (p. 1, [0006], lines 1-4).
Finally, Ikeya teaches that methotrexate (abbreviated as MTX) is a drug that has the advantage of having excellent potency and relatively short time before the exertion of its effect. However, MTX is known to cause, in regions other than the joint which is to be treated, serious side effects (p. 1, [0009], lines 4-9). Ikeya teaches that a means for lessening the systemic side effects of MTX or a means for enabling MTX to exert its action only in the region where the development of the beneficial effect of MTX is required would provide a safer rheumatoid arthritis therapy (p. 2, left column, lines 2-7). Ikeya teaches a large number of HA-MTX conjugates with a variety of linker structures between HA and MTX (e.g., see examples summarized in Table 1, pp. 26-28), and teaches administering them to reduce joint swelling in a collagen-induced arthritis model (p. 32, Table 4).
Finally, Ikeya teaches that the HA-MTX conjugate of their invention may be used in the form of a pharmaceutical composition by properly adding, to an effective amount thereof, a pharmaceutically acceptable carrier (p. 8, [0073], lines 1-4).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to substitute the HPMA polymer in the tofacitinib conjugate disclosed by Wei with the hyaluronic acid polymer disclosed by Ikeya. One of ordinary skill in the art would have been motivated to substitute the HPMA polymer in the tofacitinib conjugate disclosed by Wei with the hyaluronic acid polymer disclosed by Ikeya because Ikeya teaches that hyaluronic acid injections reverse the impaired viscosity and elasticity of synovial fluid resulting from the pathologic condition of osteoarthritis or rheumatoid arthritis to eliminate pain, and that injections of hyaluronic acid into the knee joint are widely used as arthritic therapy, and because Wei teaches the HPMA-tofacitinib conjugates as effective for controlling delivery of tofacitinib to arthritic joints. Accordingly, one of ordinary skill in the art would have contemplated substituting the HPMA in the conjugate of Wei for hyaluronic acid, because hyaluronic acid is also known to provide targeted delivery of anti-arthritic agents (e.g., of MTX as taught by Ikeya), and because Ikeya teaches benefits of hyaluronic acid injection for arthritic joints. Therefore, by substituting the HPMA in the conjugate of Wei for hyaluronic acid, one of ordinary skill in the art would have reasonably expected an additional benefit associated with hyaluronic acid injection into arthritic joints when delivering a conjugate comprising tofacitinib.
Regarding the specific functional groups used for conjugation of tofacitinib and hyaluronic acid, because Wei teaches conjugation of the linker structure to tofacitinib through a carbamate, which is cleaved under acidic conditions, and conjugation of the linker to the polymer backbone as an ester, one of ordinary skill in the art would have reasonably considered the same tofacitinib linker structure attached via ester bond to hyaluronic acid. Such a linker would have BG2 as an amine group, V as -OC(=O)-, A, B, and C as direct bond, D as C2 alkyl, and U as O. Alternatively, this linker can be interpreted wherein V is -OC(=O)-, A is alkyl, B, C, and D are direct bond, and U is O. Such a linker would produce a compound that satisfies the requirements of claims 1, 66, 67, 68 (structure Ia, wherein q is 2), 72, 75, and 77. In addition, one of ordinary skill in the art would have contemplated formulating such a conjugate as an injection, which would satisfy the limitations of the formulation of claim 79 and the pharmaceutical composition of claim 80. Finally, because Wei teaches their conjugate as effective for treating inflammation, administration of this conjugate to treat arthritis-associated inflammation, a disorder recited in claim 81, would also have been obvious.
Regarding claim 69, claim 69 depends from claim 68 and further limits group M. Because claim 68 permits groups that do not include variable group M, and the linker of Wei lacks group M, claim 69 is also obvious over Wei in view of Ikeya, because claim 69 further limits an alternative limitation not required by claim 68.
Therefore the invention taken as a whole is prima facie obvious.
Response to Applicant’s arguments: With respect to the previous rejection over Wei in view of Ikeya, Applicant argues that Wei explicitly emphasizes that conjugating Tofa to the HPMA copolymer was challenging due to the poor reactivity of the secondary amine in Tofa's pyrrole ring, which is its only available site for chemical conjugation. Applicant argues that Wei teaches the secondary amine reactivity on Tofa is poor, so it is difficult to conjugate with the linker and further conjugate to the polymer, and a highly specific synthesis method involving the copolymerization process, wherein Tofa was first conjugated to a monomer (HEMA), and then this drug monomer conjugate was copolymerized with other monomers to form the final P-Tofa prodrug.
Applicant argues that Wei's teaching reveals that the selection of Tofa and HPMA
copolymer as an entire system is critical, and the corresponding synthesis strategy is specifically tailored for such system comprising Tofa and the HPMA copolymer. Wei does not suggest that any component (therapeutic agent, linker, polymer) could be readily used in such specific system while maintaining a reasonable expectation of success.
In addition, Applicant argues lkeya does not disclose the claimed drug delivery system as claimed, and that Wei and Ikeya are not obvious to combine because Wei discloses their particular delivery system and method for making this delivery system and Ikeya discloses different conjugates comprising methotrexate, a peptide linkage, and HA prepared by a different method. Applicant argues that with such distinct delivery system and corresponding synthesis strategy, the person skilled in the art would not have been motivated to combine Wei and lkeya with reasonable expectation of successfully obtaining a delivery system having desired
release profile.
Finally, Applicant argues that the examples recited in the specification reflect the critical elements to achieve the technical results of the present application, that is to provide a flexible drug delivery system for locally delivering a therapeutic agent at a controlled rate, in order to reduce the potential systemic side effects arising from systemic administration via oral/GI absorption or systemic injection (see, e.g., para. 002-004). Applicant argues the data presented in the specification indicate that the drug delivery system of the present application can achieve desirable release rate in a range from 0.01 % to less than 30%, thereby enabling the administration of the pharmaceutical composition at a time interval of a few days, a few weeks, a few months or even longer.
Applicant’s arguments have been fully considered but they are not found persuasive. Regarding the conjugation of tofacitinib via a carbamate, in view of Wei presenting an effective method of conjugating tofacitinib to a linker and teaching the benefits of the carbamate linker’s drug release under acidic conditions, one of ordinary skill in the art would have found conjugation via the carbamate to be a preferred conjugation strategy when preparing the conjugates obvious over Wei in view of Ikeya.
Regarding Applicant’s arguments over the method of synthesis, Wei teaches a different polymer than presently claimed, which may require a different method of synthesis. However, the product of Wei was prepared for the purposes of modifying its pharmacokinetics and biodistribution to favor disposition at arthritic joints. The Office maintains that one of skill in the art, in view of the methods of synthesis of Wei and Ikeya, would reasonably combine the teachings of Wei and Ikeya, because they are each drawn to treating arthritis. Moreover, one of ordinary skill in the art would have recognized that individual elements of each conjugate could be used, because at least each of methotrexate and tofacitinib have been used in their free form. One of ordinary skill would not have considered the components of the conjugates of Wei and Ikeya to be limited for use in each conjugate.
Regarding Applicant’s arguments about the rationale to combine Wei and Ikeya, each of Wei and Ikeya are directed to methods of treating rheumatoid arthritis, and thus one of ordinary skill in the art would have found the components of each conjugate, including the polymer and therapeutic agents, to be relevant to one another. Regarding Applicant’s arguments about the specific method of synthesis, one of ordinary skill in the art, in view of the methods of synthesis of Wei and Ikeya, would identify an effective method to synthesize the tofacitinib-HA conjugate obvious over Wei and Ikeya, because strategies to conjugate therapeutic agents to linkers and linkers to polymers are well known in the prior art. For example, Goodarzi (Goodarzi, N; et al. Carbohydrate Polymers 2013, vol. 92, pp. 1280-1293; cited in PTO-892) reviews polysaccharide cytotoxic drug conjugates (see pp. 1283-1286), teaching multiple hyaluronic acid conjugates that include esters to the hyaluronic acid carboxyl group. Therefore, in view of the methods of preparing the drug-polysaccharide conjugates known in the prior art, the Office maintains that one of ordinary skill in the art would identify an effective method to synthesize the tofacitinib-HA conjugate obvious over Wei and Ikeya, absent a showing of unexpected results associated with preparing such a tofacitinib-HA conjugate.
Regarding Applicant’s arguments about the benefits of the present invention, Wei teaches their conjugates provided superior and long-lasting therapeutic efficacy due to its passive targeting to sites of joint inflammation and synoviocyte-mediated local sequestration and sustained Tofa release (p. 3466, left column, first paragraph, lines 1-5). Ikeya teaches that when administered into the knee joint of OA or RA patients, the HA-MTX conjugate of the invention
exerts a pain-eliminating effect based on the property of HA, as in a conventional HA preparation, while it accumulates in synovial tissue and simultaneously is gradually incorporated
into synovial cells and releases MTX to persistently exert a synovitis-suppressing effect. Ikeya teaches this enables the dose of MTX to be greatly reduced compared to that for the oral administration (p. 5, [0039], lines 1-11). Accordingly, in view of Wei and Ikeya, the local and sustained drug delivery provided by embodiments of the present claims is not unexpected in view of the prior art, and a conjugate obvious over Wei and Ikeya would reasonably be expected to reduce symptoms associated with systemic administration of a therapeutic agent.
Therefore, for the reasons stated above, the present rejection over Wei in view of Ikeya is maintained.
Claims 1, 64, 66-70, 72, 76, and 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Culbertson (U.S. pre-grant publication no. US 20130331425 A1; cited in PTO-892) in view of Stark (Publication no. WO 2020064847 A1; cited in PTO-892).
Stark was published April 2, 2020, and thus is eligible as prior art under 35 U.S.C. 102(a)(1).
Culbertson teaches polymer-sunitinib conjugates that exhibit advantages over sunitinib in an unconjugated form (cover page, Abstract, lines 1-5).
Culbertson teaches that sunitinib is a receptor tyrosine kinase (RTK) inhibitor (p. 1, [0002], lines 1-3). Culbertson teaches Sunitinib inhibits cellular signaling by targeting multiple RTKs, including VEGFRs and PDGF-Rs, both of which play a role in tumor proliferation and angiogenesis (p. 1, [0010], lines 1-4). Culbertson teaches sunitinib's ability to inhibit these targets leads to cancer cell death and reduced tumor vascularization, thereby resulting in tumor shrinkage (p. 1, [00010], lines 4-6). Culbertson teaches sunitinib also inhibits other RTKs, such as KIT, RET, CSF-1R and flt3, thereby potentially making it clinically useful in the treatment of patients suffering from other cancers (p. 1, [00010], lines 6-9).
Culbertson teaches their invention provides a compound comprising a Sunitinib
residue covalently attached via a releasable linkage-containing spacer moiety to a water-soluble, non-peptidic polymer (p. 1, [0013], lines 1-4). Culbertson teaches the water-soluble, non-peptidic polymer can be understood as a series of repeating monomers, and provides exemplary monomers include carbohydrates, such as monosaccharides (p. 7, [0092], lines 1-5 and lines 11-12). Accordingly, in view of Culbertson, one of ordinary skill in the art would have contemplated a conjugate of sunitinib with a polymer of monosaccharides as the water-soluble, non-peptidic polymer.
In one specific embodiment, Culbertson teaches sunitinib is conjugated at the amide nitrogen group to a linker via a carbamate, and the linker is subsequently conjugated to a polyethylene glycol polymer by an amide (p. 41, [0247], right column; see structures below). In this example, BG2 is the amide nitrogen group (herein interpreted as an amine), V is -OC(=O)-, A, B, and C are direct bond, D is C3 alkyl, and U is -N(R1), wherein R1 is hydrogen. Alternatively, this linker can be interpreted wherein V is -OC(=O)-, A is alkyl, B, C, and D are direct bond, and U is -N(R1), wherein R1 is hydrogen. The sunitinib and linker in this embodiment satisfy the requirements of claims 1, 66, 67, 68 (wherein q is 3), and has the structure of
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, with q as 3, as shown in claim 70. Moreover, this structure has the therapeutic agent sunitinib, as required by claim 76.
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In addition, Culbertson teaches their invention may include other linkers, providing an embodiment of the structure shown below (p. 34, structure 3c). In this embodiment, sunitinib is conjugated at the amide nitrogen group to a linker via a urea group, and the linker is subsequently conjugated to a polyethylene glycol polymer by an amide. In this example, BG2 is an amide nitrogen group (herein interpreted as an amine), V is -OC(=O)-, A is C2 alkyl, B, C, and D are direct bond, and U is
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. The sunitinib and linker in this embodiment satisfy the requirements of claims 1, 64, 66, 67, and 68 (structure Ik, wherein q is 0, u is 2, and M is heterocyclyl). Moreover, this structure has the therapeutic agent sunitinib, as required by claim 76.
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Culbertson teaches that their invention includes pharmaceutical preparations comprising a compound as provided therein in combination with a pharmaceutical excipient (p. 26, [0172], lines 1-3). Culbertson teaches the pharmaceutical compositions can take any number of forms, and exemplary preparations are most preferably in a form suitable for oral administration, such as a tablet (p. 27, [0184], lines 1-4).
Finally, Culbertson teaches a method of treating diseases mediated by abnormal protein kinase activity in a patient, comprising administering to said patient a pharmaceutical composition comprising a compound of the invention, and that such diseases include, for example, cancer (p. 28, [0196], lines 1-10).
Culbertson does not teach the required biopolymer as hyaluronic acid or chondroitin sulfate, as required by present claim 1.
Stark teaches conjugates comprising crosslinked hyaluronic acid to which a plurality of drug moieties are covalently and reversibly conjugated (cover page, Abstract, lines 1-2). Stark teaches that hydrogels can be used for many applications, such as for the sustained release of drug molecules, and such drug molecules may either be non-covalently embedded or covalently and reversibly attached to the hydrogel. Stark teaches hyaluronic acid, an anionic, non-sulfated
glycosaminoglycan, is a useful polymer for such hydrogels, because it occurs naturally in
connective, epithelial and neural tissue and is thus well tolerated within the human and is also biodegradable (p. 1, lines 13-18).
Stark teaches their conjugates may comprise a plurality of connected units selected from general formula Z1, Z2, or Z3 (p. 2, lines 1-2), wherein D as shown in these structures is a drug moiety. In example Z2, D is conjugated with hyaluronic acid via a linker, connecting to the carboxyl group of the hyaluronic acid.
Stark teaches the drug moiety may be a chemotherapeutic agent (p. 115, line 1) and suggests the chemotherapeutic agent may be sunitinib (p. 115, line 16). Stark teaches that approved TKIs for cancer therapy include, for example, sorafenib and sunitinib (p. 118, lines 19-20). This is interpreted as teaching that the invention of Stark may be used for cancer therapy when an appropriate therapeutic agent is selected.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to substitute the non-peptidic polymer in a conjugate taught by Culbertson for the hyaluronic acid polymer taught by Stark. One of ordinary skill in the art would have been motivated to substitute the non-peptidic polymer in a conjugate taught by Culbertson for the hyaluronic acid polymer taught by Stark because Culbertson teaches their conjugates include non-peptidic polymers for treating diseases including cancer, suggesting polymers comprising monosaccharides, and because Stark teaches conjugates comprising sunitinib and hyaluronic acid for the same application, treating diseases that include cancer. Accordingly, because Culbertson suggests many non-peptidic polymers may be used in their conjugates, and because Stark teaches hyaluronic acid based polymers conjugated to therapeutic agents, including conjugated to sunitinib, one of ordinary skill in the art would have contemplated replacing the non-peptidic polymer taught by Culbertson with hyaluronic acid taught by Stark. Moreover, because each of Culbertson and Stark teach conjugation of the therapeutic agent via a releasable linker, substitution of the non-peptidic polymer of Culbertson for hyaluronic acid taught by Stark would reasonably be expected to produce a conjugate capable of treating a disease such as cancer.
In this instance, the rationales “combining prior art elements according to known methods to yield predictable results” and “simple substitution of one known element for another to obtain predictable results” would apply. Because each of the conjugates of Culbertson and Stark teach or suggest conjugation of sunitinib to a polymer via a releasable linker and are recognized for treating cancer, one of ordinary skill in the art would have considered that the hyaluronic acid taught by Stark may be substituted in the conjugates of Culbertson, with a reasonable expectation that said conjugates would remain effective when treating cancer.
Moreover, because Culbertson teaches conjugation to the non-peptidic PEG polymer using an amide and Stark teaches conjugation of the therapeutic agent via the hyaluronic acid carboxyl group, one of ordinary skill in the art would have contemplated substitution of the non-peptidic polymer for hyaluronic acid with a reasonable expectation of success in preparing such a conjugate.
Regarding claim 69, claim 69 depends from claim 68 and further limits group M. Because claim 68 permits groups that do not include variable group M, and Culbertson teaches an embodiment in which the linker lacks group M, claim 69 is also obvious over Culbertson in view of Stark, because claim 69 further limits an alternative limitation not required by claim 68.
Therefore the invention taken as a whole is prima facie obvious.
Claims 1, 64, 66-70, 73, 76, and 79-81 are rejected under 35 U.S.C. 103 as being unpatentable over Culbertson (U.S. pre-grant publication no. US 20130331425 A1; cited in PTO-892) in view of Liu (Liu, P.; et al. Carbohydrate Polymers 2019, vol. 213, pp. 17-26; cited in previous office action).
Culbertson teaches as described in the above rejection under 35 U.S.C. 103. In addition, Culbertson teaches that treatment with sunitinib, however, is not without drawbacks, including hand-foot syndrome, stomatitis, and other toxicities (p. 1, [0011]), and that a need exists to provide compounds that can exert the same pharmacology sunitinib has in vivo with improved side effect profile (p. 1, [0012], lines 1-3).
Culbertson does not teach the required biopolymer as hyaluronic acid or chondroitin sulfate, as required by present claim 1.
Liu teaches doxorubicin (Dox) is a typical cytotoxic anthracycline antibiotic, which has been clinically used to treat a variety of cancers, and that the most perilous side effect of Dox is dilated cardiomyopathy that leads to congestive heart failure, and thus the cumulative dose of Dox is severely limited in clinical applications (p. 17, Introduction section, first paragraph, lines 1-8). Liu teaches the CD44 antigen is highly overexpressed in aggressive tumors, and is also used to actively target the nanocarriers to the tumors by using hyaluronic acid and chondroitin sulfate (CS) as target ligands (p. 17, Introduction section lines 11-17).
Liu teaches that research has been conducted on the role of CS in targeting cancer cells, and that chitosan-CS nanoparticles bearing Dox have been successfully applied for tumor-targeting drug delivery with improved in vivo efficacy of Dox (p. 17, right column, first full paragraph, lines 3-7). Liu teaches glycoconjugate-assisted nanocrystalline drug delivery showed better tumor targeting via CD44 receptors with significantly less off-tumor cytotoxicity (p. 17, right column, first full paragraph, lines 7-10). Moreover, Liu teaches CS also has direct anti-cancer and anti-osteoarthritis activity, and thus the modification of Dox with CS may improve the CD44 targeting effect of Dox and result in a synergistic effect on anti-cancer properties (p. 17, right column, first full paragraph, line 11 to p. 18, left column, line 5).
Liu teaches preparation of a chondroitin sulphate-doxorubicin conjugate (p. 17, Abstract, line 3; structure shown on p. 18, Figure 1 and reproduced below). Liu teaches preparation of PLGA nanoparticles comprising CS-DOX and PLGA (p. 18, Section 2.3, first paragraph lines 1-10), and Liu teaches administration of these CS-DOX-PLGA nanoparticles to mice for treating xenograft tumors of U251 cells (p. 19, right column, section 2.11, lines 1-4). Liu teaches that the CS-DOX-PLGA nanoparticles slowed tumor growth more effectively than doxorubicin alone (p. 25, Figure 8b).
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It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present application to substitute the water-soluble, non-peptidic polymer in a conjugate taught by Culbertson for chondroitin sulfate taught by Liu. One of ordinary skill in the art would have been motivated to substitute the non-peptidic polymer in a conjugate taught by Culbertson for chondroitin sulfate taught by Liu because Culbertson teaches their conjugates include non-peptidic polymers for treating diseases including cancer, and because Liu teaches a conjugate comprising doxorubicin and chondroitin sulfate for treating cancer. Moreover, because Liu suggests that conjugation to chondroitin sulfate may reduce off-target toxicity and improve the anti-cancer activity of doxorubicin, one of ordinary skill in the art would have recognized that substituting the polyethylene glycol polymer in the sunitinib-polymer conjugates embodied by Culbertson may improve the anti-cancer activity of sunitinib and reduce the drawbacks associated with administering sunitinib. Accordingly, one of ordinary skill in the art would have contemplated replacing the non-peptidic polymer taught by Culbertson with chondroitin sulfate.
In this instance, the rationales “combining prior art elements according to known methods to yield predictable results” and “use of known technique to improve similar products in the same way” would apply. Because each of the conjugates of Culbertson and Liu are recognized for treating the same disease, cancer, and because Liu recognizes chitosan sulfate as having anti-cancer activity and teaches that the conjugate of chondroitin sulfate and doxorubicin shows improved anti-cancer activity and may reduce off-tumor toxicity of doxorubicin, one of ordinary skill in the art would have had a reasonable expectation that substitution of the non-peptidic polymer for chondroitin sulfate in the conjugates of Culbertson would be effective for treating cancer and providing the benefits taught by Liu.
Moreover, because Culbertson teaches conjugation to the non-peptidic PEG polymer using an amide and Liu teaches conjugation of doxorubicin to chondroitin sulfate using an amide, one of ordinary skill in the art would have contemplated substitution of the non-peptidic polymer for hyaluronic acid with a reasonable expectation of success in preparing such a conjugate.
Regarding claim 69, claim 69 depends from claim 68 and further limits group M. Because claim 68 permits groups that do not include variable group M, and Culbertson teaches an embodiment in which the linker lacks group M, claim 69 is also obvious over Culbertson in view of Liu, because claim 69 further limits an alternative limitation not required by claim 68.
Therefore the invention taken as a whole is prima facie obvious.
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, 64, 66-70, 72-73, 75, 77, and 79-81 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 52-54, 57, and 59-64 of co-pending U.S. patent application 18/692340 (reference application, hereafter ‘340) ) in view of Wei (Wei, X.; et al. Molecular Pharmaceutics 2018, vol. 15, pp. 3456-3467; cited in IDS received June 11, 2025).
The present application and ‘340 are each assigned to Coval Biopharm (Shanghai) Co., Ltd. and include Hao Zhang, Weijiang Zhang, Lichun Feng, Guolong Wu, and Dafeng Li as inventors.
The amended claims received November 8, 2024 are cited in this provisional nonstatutory double patenting rejection.
Claim 1 of ‘340 claims a drug delivery system for locally delivering a therapeutic agent at a controlled rate as described in the claim. Claim 59 of ‘340 depends from claim 1 claims the structures shown below:
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(p. 10)
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(p. 12)
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(p. 12)
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(p. 12)
These structures have the therapeutic agent triamcinolone acetonide conjugated to a polysaccharide via a linker. In the first structure shown, the polysaccharide is chondroitin sulfate. In the second, third, and fourth structure shown, the polysaccharide is hyaluronic acid.
These structures satisfy all limitations of present claims 1, 64, 66, 67, 68, 69, 70, and 72-73, except for the requirement that the therapeutic agent is tofacitinib, oclacitinib, baricitinib, ruxolitinib, nintedanib, or sunitinib.
In addition, claim 57 of ‘340 claims the biopolymer is chondroitin sulfate. Claim 60 of ‘340 claims the drug delivery system is locally administrated to a subject in need thereof, and claim 61 claims wherein the drug delivery system is locally administered to a subject in need thereof via injection, oral dosage form, via inhalation, implant, or topical application.
Claim 62 of ‘340 claims a pharmaceutical composition comprising the drug delivery system according to claim 1 and a pharmaceutically acceptable excipient.
Claim 63 of ‘340 claims a method of treating a disorder in a subject in need thereof, the method comprising administering to the subject a therapeutic effective amount of the drug delivery system according to claim 1, wherein the disorder is allergic diseases, autoimmune diseases, or inflammatory diseases, and claim 64 depends from claim 63 and claims the disorder is selected from a group that includes, for example, rheumatism, Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema Following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR).
Moreover, claims 52, 53, and 54 of ‘340 claim additional linker structures as shown, several of which are the same of fall within the genus of present claim 68 (e.g., Ia, wherein the subscript value is 5; Ik with an M group recited in claim 53 of ‘340), claim 69 (e.g., the specific M groups listed) and claim 70 (e.g.,
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).
The claims of ‘340 do not claim wherein the therapeutic agent is tofacitinib, as required by the present claims.
Wei teaches as described in the above rejection under 35 U.S.C. 103.
It would therefore have been prima facie obvious to substitute the therapeutic agent in a structure recited in claim 59 of ‘340 for tofacitinib because the claims of ‘340 claim a drug delivery system for controlled delivery of a therapeutic agent and a method of treating rheumatism using said agent, and because Wei teaches conjugates comprising tofacitinib covalently linked to another polymer, HPMC, for the purposes of locally treating rheumatoid arthritis. Accordingly, one of ordinary skill in the art would have reasonably contemplated a conjugate claimed by ‘340 with tofacitinib as the active agent for the purposes of locally treating rheumatoid arthritis.
Moreover, it would therefore have been prima facie obvious to one of ordinary skill in the art to substitute a linker of one of the drug delivery system structures claimed by ‘340 above for an alternative linker recited in claims 52, 53, or 54 of ‘340, because claim 59 of ‘340 claims those specific drug delivery structures, and claims 52-54 of ‘340 claim their drug delivery system may include one of those linkers of claims 52-54. Accordingly, one of ordinary skill in the art would have contemplated derivatives of the drug delivery specific drug delivery system structures above with the alternative linker structures recited in claims 52-54 of ‘340, because ‘340 claims these as linkers for their drug delivery system. In addition, following the guidance of Wei, one of ordinary skill in the art would have reasonably selected a linker that includes a carbamate group for conjugation with hyaluronic acid, because Wei teaches successful conjugation via the carbamate and the benefits of release of tofacitinib under acidic conditions.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not been patented.
Response to Applicant’s arguments: With respect to the previous nonstatutory double patenting rejections over 18/692340, Applicant argues it can be seen that the co-pending U.S. patent application 18/692340 does not disclose, teach or suggest the claimed therapeutic agent having -NH- as reactive group BG2 and the specific amide linkages between the claimed therapeutic agent and linker.
Furthermore, as argued above, Wei does not disclose, teach or suggest the claimed delivery system.
Applicant’s arguments have been fully considered but are not found persuasive. Because the claims of ‘340 claim their conjugates for treating rheumatism, and because Wei teaches conjugates comprising tofacitinib for the purposes of treating rheumatoid arthritis, one of ordinary skill in the art would have contemplated a derivative of the conjugate claimed by ‘340 that replaces the therapeutic agent with tofacitinib, because each of tofacitinib and the conjugates claimed by ‘340 are recognized for treating rheumatoid arthritis.
Regarding the specific conjugation between the linker of the conjugate claimed by ‘340 and tofacitinib, in view of Wei teaching conjugation using the amine of tofacitinib to form a carbamate with the linker of Wei, one of ordinary skill in the art would have contemplated the analogous strategy with the linkers claimed by the conjugates of ‘340.
Moreover, the claims of ‘340 provide embodiments in which the hydroxyl group of the therapeutic agent is attached to the linker via a carbonate linkage. Substitution of a therapeutic agent claimed by ‘340 for tofacitinib conjugated to the biopolymer via a carbonate linkage would generate a product with the carbamate linkage taught by Wei.
Therefore, for the reasons described above, the present rejection is maintained.
Allowable Subject Matter
Claim 78 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 78 depends from claim 1 and requires the drug delivery system is selected from the group consisting of the structures shown in the claim, wherein n is in the range of 20 to 5,300.
As described in the above claim interpretation section, the structures recited in claim 78 each show two monosaccharide monomers that together form the hyaluronic acid or chondroitin sulfate biopolymer. Claim 78 thus requires one of every two monosaccharides is derivatized with a therapeutic agent, including wherein all carboxyl groups or all C6-OH groups of hyaluronic acid are derivatized, and wherein all carboxyl groups of chondroitin sulfate are derivatized.
The closest prior art to the structures of claim 78 is considered the combination of Wei and Ikeya, described in the above rejection under 35 U.S.C. 103, which render obvious the structure shown below (see p. 32 of the present claims). However, Ikeya teaches that the conjugation rate is preferably 1.0% or more in view of the exertion of the beneficial effect, and is less than 10% in order to localize the effect of MTX to the administration region and reduce the systemic side effects (p. 7, [0068]). Thus Ikeya teaches away from the very high conjugation rate required by claim 78.
In addition, Ikeya provides examples in which the conjugation rates vary from about 0.5% to 4.4% (for example, see p. 30, Table 3), well below the required conjugation rate of claim 78. Accordingly, one of ordinary skill in the art would not have reasonably considered modifying the conjugate obvious over Wei in view of Ikeya to arrive at a structure of present claim 78.
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Conclusion
Claims 1, 64, 66-70, 72, 73, 75-77, and 79-81 are rejected.
Claim 78 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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/B.M.B./Examiner, Art Unit 1693
/ANDREA OLSON/Primary Examiner, Art Unit 1693
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