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
This application was filed on and is a U.S. national Stage application under 35 U.S.C. 371 of International Patent Application No. PCT/US19/64771 filed 12/05/2019, which claims the benefit of the priority of US Provisional application 62/775,800 filed 12/05/2018.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Claims 61-83 are being examined on the merits in this office action.
Response to Amendment
The Affidavit under 37 CFR 1.132 filed 12/29/2025 is insufficient to overcome the rejection of claims 61-83 based upon 35 U.S.C. 102 and 103 as set forth in the last Office action because the cited references read on the instant invention.
Applicant Arguments
Applicant argues that Sletten does not teach that glycopolymers that are heparanase inhibitors are effective in treating cancer. Applicant argues that Ramani only teaches the use of heparanase inhibitor SST0001 in combination with anti-myeloma drugs has the potential to reduce chemoresistance and improve therapeutic outcome. Moreover, SST0001 is structurally different from the heparanase recited in the claims. Further, Ramani does not teach or suggest that all inhibitors of heparan sulfate-binding proteins are effective as anti-cancer agents and can effectively treat myeloma (Page 3 of the Affidavit).
Applicant argues that the results provided in Singh (Singh et al. manuscript) demonstrate that the compounds recited in the claims are effective in treating cancer. In Fig. 5, the results show that GPM2 (the glycopolymer with n=12) has a IC50 of 0.1 ± 0.036 nM indicating that GPM2's potency is at least comparable to or even higher than heparin (IC50 of 0.54 ± 0.028 nM) and SST0001 (IC50 of 0.53 ± 0.08 nM). In Fig. 7a, the results demonstrate that GPM2 at 30 μM decreased the CAG myeloma cell count to 15%. However, SST0001 and natural heparin, at the same concentration, only decreased the cell count to 80%, indicating that GPM2 has superior anti-proliferative capacity (Page 3-4 of the Affidavit).
Examiner’s Response
The arguments are unpersuasive because the structures of the cited references read on the instant heparanase inhibitors recited in claims 68 and 72. Specifically, for instance, Sletten teaches glycopolymers such shown below and that n is 8 (Scheme 3 on Page 3393).
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Examiner notes that the structure of Sletten shows X is O, L is (CH2CH20-)n1, Ra is a saccharide or disaccharide comprising OS03, Y is O, Q is NHSO3, W is OSO3, Z1 and Z2 are OH, n is 5, 9, or 18. This is exactly what is claimed in the instant claims. Applicant’s assertion that the structure of Loka and Sletten is different from what is claimed in unpersuasive.
Further, Loka teaches an anti-heparanase inhibitor shown below
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Wherein W is OSO3, Z1 is OH, Z2 is OH, Q is NHSO3, X is the structure, Y is CH2, R1 is O, n is 12. Loka further teaches that the compounds are viable for cancer therapeutics (Page 9166, left col., last paragraph). Loka further teaches an anti-heparanase inhibitor shown below, wherein n=5, 9 or 12 (See Table 1 on Page 9165). Thus Loka suggests the use of the compounds to treat cancer. Further, Ramani teaches using heparanase inhibitors to target myeloma (Pages 1-2, results and conclusion section). Examiner notes that one of ordinary skill in the art would be motivated to use the heparanase inhibitor compounds to treat other cancers such as myeloma. The use of heparanase inhibitors to treat cancer is known in the art. Thus, Examine notes that when the teachings of the cited references are combined, the instant invention is rendered obvious.
With regards to Applicant arguments on the Smith reference, Examiner acknowledges the arguments made concerning the Smith and further notes that the current rejection does not include the Smith reference. Additionally, the Smith reference was published after the effective filing date. Examiner notes that even if the data of Smith with regards to the IC50 was to be considered, the arguments are unpersuasive because the data of Smith regarding the potency of the glycopolymers where n = 12, is already known in the art. Specifically, Loka teaches the heparanase inhibitor shown below where n=12.
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Further, Loka teaches that such heparanase inhibitors for treatment of cancer generally. Examiner notes the only data that the instant invention provides for the treatment of cancer is Example 9 wherein the inhibitor wherein n = 12 is compared with heparin. The instant invention shows that heparin consistently reduced the size of the metastasized lung tumor by half, while the GlcNS(6S)α(1,4)GlcA glycopolymer C5A (DP=12), presented almost no metastatic spread into the lungs, an effect that similar to that exerted by Roneparstat (SST0001) (See [0175] of the Disclosure).
Examiner notes that the heparanase inhibitor in Fig. 9 is shown below, which is exactly the same as the inhibitor taught by Loka.
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Further, Loka teaches that the inhibitor where n=12, was the most potent inhibitor with an IC50 value of 0.10 ± 0.036 nM. Examiner notes that this is the same potency taught by the Smith reference. Further, Loka teaches that the heparanase inhibitors are for treating cancer and Ramani teaches the use of heparanase inhibitors to target cancers including the instant melanoma. One of ordinary skill in the art would be motivated to use the instant inhibitors taught by Loka to treat melanoma and would have had a reasonable expectation of success. The arguments are unpersuasive.
Claim Rejections - 35 USC § 112 - Withdrawn
The rejection of claim 61, 71-83 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in view of the claim amendments.
Claim Rejections - 35 USC § 102 – Modified and Maintained
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim Interpretations
With regards to the limitation recited in instant claim 72, the Examiner is interpreting instant claim 72 includes all the limitations of instant claim 71 with further limitation of the salt recited in instant claim 71. Therefore, instant claim 72 is interpreted as the followings:
An anti-heparanase compound or salt thereof having the structure of
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, wherein the salt of the anti-heparanase compound is a sodium salt, a calcium salt, a magnesium salt, a lithium salt, a potassium salt, a cesium salt, or a triethylammonium salt, and optionally wherein the salt of the anti-heparanase compound is a sodium salt.
Claims 71-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sletten et al. (Biomacromolecules 2017, 18, 10, 3387–3399 - cited and enclosed in the previous office action).
Regarding claims 71-72, Sletten teaches anti-heparanase compounds that are glycopolymers endowed with heparan sulfate(HS) disaccharides were established to inhibit the glycosidase (Abstract). Sletten teaches that the glycopolymers are hydrolytic stable toward heparanase and that longer polymer length provides greater inhibition (Abstract). Sletten teaches glycopolymers such shown below and that n is 8 (Scheme 3 on Page 3393).
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Examiner notes that the structure of Sletten shows X is O, L is (CH2CH20-)n1, Ra is a saccharide or disaccharide comprising OS03, Y is O, Q is NHSO3, W is OSO3, Z1 and Z2 are OH, n is 5, 9, or 18.
Regarding claims 73, Sletten teaches glycopolymers such shown below and that n is 5, 9, or 18. (Scheme 1 and 2 on Page 3392).
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Examiner notes that the compound of Sletten reads on the instant compound.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant argues that Sletten does not teach the compounds of claim 71.
The arguments are unpersuasive because Sletten indeed teaches the compound of claim 71.
Claims 71-73 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Loka et al. (Chem. Commun., 2017, 53, 9163 - cited and enclosed in the previous office action).
Regarding claim 71-73, Loka teaches that compound with the structure
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(See Table 1 on Page 9165). Wherein n=12, X is
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, Y is CH2, R1 is O, W is OSO3, Z1 and Z2 is OH, and Q is NHSO3.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant argues that Figure 2 of Loka discloses heparan sulfate mimicking monomer compounds whose rings are closed and that the claimed compounds of claims 71-73 have undergone ring-opening metathesis polymerization and thus, the compounds of Figure 2 of Loka are structurally different from the compounds claims 71-73.
The arguments presented above have ben fully considered but are unpersuasive. Examiner notes that Loka teaches the exact compound of the instant Fig. 10 as shown below (see instant compound is same as the compound of Loka).
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The arguments are unpersuasive.
Claim Rejections - 35 USC § 103 - Maintained
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 61-83 remain rejected under 35 U.S.C. 103 as being unpatentable over Loka et al. (Chem. Commun., 2017, 53, 9163 - cited and enclosed in the previous office action) in view of Ferro et al. (US20150065440A1 – hereinafter “Ferro”- cited and enclosed in the previous office action), Sletten et al. (Biomacromolecules 2017, 18, 10, 3387–3399 - cited and enclosed in the previous office action) and Ramani et al. (Clinical Lymphoma Myeloma and Leukemia, Vol. 15, Suppl. 3, 2015, Pages 212-213- cited and enclosed in the previous office action).
Loka teaches an anti-heparanase inhibitor shown below
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Wherein W is OSO3, Z1 is OH, Z2 is OH, Q is NHSO3, X is the structure, Y is CH2, R1 is O, n is 12. Loka further teaches that the compounds are viable for cancer therapeutics (Page 9166, left col., last paragraph). Loka further teaches an anti-heparanase inhibitor shown below, wherein n=5, 9 or 12 (See Table 1 on Page 9165).
Loka does not teach wherein the cancer is mammary carcinoma, mesothelioma, lymphoma, and myeloma.
Ferro teaches a method of treating cancer comprising administering an anti-heparanase compounds (claim 10; [0003, 0039]) and that the compounds can be in form of salts [0095]. Ferro teaches that the compounds had greater potency, improved pharmacokinetic properties and a reduced side effect profile [0006].
Sletten teaches anti-heparanase compounds that are glycopolymers endowed with heparan sulfate(HS) disaccharides were established to inhibit the glycosidase, heparanase, with an IC 50 value in the low nanomolar range(1.05 ± 0.02 nm), a thousand-fold amplification over its monovalent counterpart (Abstract). Sletten teaches that the glycopolymers are hydrolytic stable toward heparanase and that longer polymer length provides greater inhibition (Abstract). Sletten teaches glycopolymers such shown below (Scheme 3 on Page 3393).
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With regards to the specific cancers, Ramani teaches using heparanase inhibitors to target myeloma (Pages 1-2, results and conclusion section). Examiner notes that one of ordinary skill in the art would be motivated to use the anti- heparanase inhibitor compounds to treat other cancers such as myeloma.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Loka, Ferro, Sletter and Ramani and use the anti-heparanase inhibitor compounds or salts thereof to treat cancer such as myeloma since Ferro teaches that such compounds had greater potency, improved pharmacokinetic properties and a reduced side effect profile [0006] and Sletter teaches that the compounds inhibit the glycosidase, heparanase, with an IC50 value in the low nanomolar range(1.05 ± 0.02 nm), a thousand-fold amplification over its monovalent counterpart (Abstract). Further, it would have been obvious to use the anti- heparanase inhibitor compounds to treat other cancers such as myeloma since Ramani teaches using heparanase inhibitors to target myeloma (Pages 1-2, results and conclusion section). One of ordinary skill in the art would be motivated and would have had a reasonable expectation of success in combining the teachings of Loka and Ferro and to prepare a method of treating cancer using the anti-heparanase inhibitor compounds or salts thereof since both references teach that the compounds were effective in treating cancer (claim 10; [0003, 0039]). The disclosures render obvious claims 61-63.
Regarding claims 64 and 72, Ferro teaches salts of the compounds and preferably sodium salts [0078, 0095].
Regarding claim 65, Loka teaches that n=5, 9 or 12 (See Table 1 on Page 9165).
Regarding claims 66 and 70, Loka further teaches an anti-heparanase inhibitor shown below, wherein n=5, 9 or 12 (See Table 1 on Page 9165).
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Regarding claims 67 and 74, Ferro teaches compounds comprising the structure below, wherein X is SO3Na or H (Fig. 11C).
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Regarding claims 68-69 and 75-76, Ferro teaches sodium salt of the anti-heparanase compounds [0078, 0095]. Further, Sletter teaches the compound below that comprises the instant Ra (Scheme 3 on Page 3393).
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Regarding claims 73, Sletten teaches glycopolymers such shown below and that n is 8 (Scheme 3 on Page 3393).
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It would have been obvious to modify Loka and include the compound taught by Sletten.
Regarding claim 77, Ferro teaches pharmaceutical composition of the anti-heparanase compounds with an acceptable carrier or diluent (claim 1; [0092]).
Regarding claims 78-83, Ferro teaches the anti-heparanase compounds have a binding affinity to FGF-1, FGF-2, VEGF (Table 1, [0003, 0243]) and inhibition of thrombin [0004]. Further, MPEP 2111.04 states: claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. In the instant case, the limitations of claims 78-83 expresses the intended result of the compound and is given little patentable weight.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant arguments
Applicant makes similar arguments disclosed in the Declaration. Applicant argues that Sletten does not teach that glycopolymers that are heparanase inhibitors are effective in treating cancer. Applicant argues that Ramani only teaches the use of heparanase inhibitor SST0001 in combination with anti-myeloma drugs has the potential to reduce chemoresistance and improve therapeutic outcome. Moreover, SST0001 is structurally different from the heparanase recited in the claims. Further, Ramani does not teach or suggest that all inhibitors of heparan sulfate-binding proteins are effective as anti-cancer agents and can effectively treat myeloma. Applicant argues that the results provided in Singh (Singh et al. manuscript) demonstrate that the compounds recited in the claims are effective in treating cancer. In Fig. 5, the results show that GPM2 (the glycopolymer with n=12) has a IC50 of 0.1 ± 0.036 nM indicating that GPM2's potency is at least comparable to or even higher than heparin (IC50 of 0.54 ± 0.028 nM) and SST0001 (IC50 of 0.53 ± 0.08 nM). In Fig. 7a, the results demonstrate that GPM2 at 30 μM decreased the CAG myeloma cell count to 15%. However, SST0001 and natural heparin, at the same concentration, only decreased the cell count to 80%, indicating that GPM2 has superior anti-proliferative capacity (Page 28-31 of the Arguments).
Examiner’s Response
The arguments are unpersuasive because the structures of the cited references read on the instant heparanase inhibitors recited in claims 68 and 72. Specifically, for instance, Sletten teaches glycopolymers such shown below and that n is 8 (Scheme 3 on Page 3393).
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Examiner notes that the structure of Sletten shows X is O, L is (CH2CH20-)n1, Ra is a saccharide or disaccharide comprising OS03, Y is O, Q is NHSO3, W is OSO3, Z1 and Z2 are OH, n is 5, 9, or 18. This is exactly what is claimed in the instant claims. Applicant’s assertion that the structure of Loka and Sletten is different from what is claimed in unpersuasive.
Further, Loka teaches an anti-heparanase inhibitor shown below
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Wherein W is OSO3, Z1 is OH, Z2 is OH, Q is NHSO3, X is the structure, Y is CH2, R1 is O, n is 12. Loka further teaches that the compounds are viable for cancer therapeutics (Page 9166, left col., last paragraph). Loka further teaches an anti-heparanase inhibitor shown below, wherein n=5, 9 or 12 (See Table 1 on Page 9165). Thus Loka suggests the use of the compounds to treat cancer. Further, Ramani teaches using heparanase inhibitors to target myeloma (Pages 1-2, results and conclusion section). Examiner notes that one of ordinary skill in the art would be motivated to use the heparanase inhibitor compounds to treat other cancers such as myeloma. The use of heparanase inhibitors to treat cancer is known in the art. Thus, Examine notes that when the teachings of the cited references are combined, the instant invention is rendered obvious.
With regards to Applicant arguments on the Smith reference, Examiner acknowledges the arguments made concerning the Smith and further notes that the current rejection does not include the Smith reference. Additionally, the Smith reference was published after the effective filing date. Examiner notes that even if the data of Smith with regards to the IC50 was to be considered, the arguments are unpersuasive because the data of Smith regarding the potency of the glycopolymers where n = 12, is already known in the art. Specifically, Loka teaches the heparanase inhibitor shown below where n=12.
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Further, Loka teaches that such heparanase inhibitors for treatment of cancer generally. Examiner notes the only data that the instant invention provides for the treatment of cancer is Example 9 wherein the inhibitor wherein n = 12 is compared with heparin. The instant invention shows that heparin consistently reduced the size of the metastasized lung tumor by half, while the GlcNS(6S)α(1,4)GlcA glycopolymer C5A (DP=12), presented almost no metastatic spread into the lungs, an effect that similar to that exerted by Roneparstat (SST0001) (See [0175] of the Disclosure).
Examiner notes that the heparanase inhibitor in Fig. 9 is shown below, which is exactly the same as the inhibitor taught by Loka.
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Further, Loka teaches that the inhibitor where n=12, was the most potent inhibitor with an IC50 value of 0.10 ± 0.036 nM. Examiner notes that this is the same potency taught by the Smith reference. Further, Loka teaches that the heparanase inhibitors are for treating cancer and Ramani teaches the use of heparanase inhibitors to target cancers including the instant melanoma. One of ordinary skill in the art would be motivated to use the instant inhibitors taught by Loka to treat melanoma and would have had a reasonable expectation of success. The arguments are unpersuasive.
Double Patenting - Maintained
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 71-76 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 of U.S. Patent No. 11524026B2. Although the claims at issue are not identical, they are not patentably distinct from each other because even though the claims of the patent recite a method, the method comprises administering the instant heparanase inhibitor. Specifically, the claims of the patent recite a method that comprises administering an anti-heparanase compound of claims 1-7, wherein one of the compound has the structure
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Wherein X is
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Y is CH2, R1 is O, W is OSO3, Z1 is F, Z2 is OH, Q is F and n is an integer of 2 to 12 (claim 1-6).
The claims of the instant application recite an anti-heparanase compound
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(claim 71).
The claims of the patent anticipate the instant claims.
Regarding claims 72, the claims of the patent recite wherein the salt of the anti-heparanase compound is a sodium salt, a calcium salt, a magnesium salt, a lithium salt, a potassium salt, a cesium salt, or a triethylammonium salt, and optionally wherein the salt of the anti-heparanase compound is a sodium salt (claim 5).
Regarding claims 73, the claims of the patent recite wherein the anti-heparanase compound or salt thereof has the structure of
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(claim 6).
Regarding claim 74, the claims of the patent recite wherein the anti-heparanase compound or salt thereof has the structure of
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and wherein the salt of the anti-heparanase compound is a sodium salt (claim 6).
Regarding claims 75-76, the claims of the patent recite the compound has the structure
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Wherein X is
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,
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(claims 1-3).
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant’s Arguments
Applicant argues that the claims of the patent are directed to method of treating diabetes and that the compounds are distinct from the instant invention.
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that claim 71-76 of the instant invention are drawn to the compound. In the instant case, claims 1-7 of U.S. Patent No. 11524026B2 are in possession of the compound recited in instant claims 71-76. The arguments are unpersuasive and the rejection is maintained.
Claims 71-83 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-19 of copending Application No. 18/061,323. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application recite a method of treating that comprises administering the instant recited compound and further recites a composition that comprises the instant compound. Specifically, the claims of the copending application recite the compound
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(claims 1-3).
The claims of the instant application recite an anti-heparanase compound
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(claim 71).
The claims of the patent anticipate the instant claims.
Regarding claim 72, the claims of the copending application recite wherein the salt of the anti-heparanase compound is a sodium salt, a calcium salt, a magnesium salt, a lithium salt, a potassium salt, a cesium salt, or a triethylammonium salt, and optionally wherein the salt of the anti-heparanase compound is a sodium salt (claim 4).
Regarding claim 73, the claims of the copending application recite wherein the compound has the structure of
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(claim 6).
Regarding claim 74, the claims of the copending application recite wherein the compound has the structure of
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(claim 7).
Regarding claim 75, the claims of the copending application recite wherein the compound has the structure of
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(claim 8).
Regarding claim 76, the claims of the copending application recite wherein the compound has the structure of
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(claim 9).
Regarding claim 77, the claims of the copending application recite a composition comprising: (i) the anti-heparanase compound or a salt thereof of claim 1 and (ii) a pharmaceutically acceptable carrier, wherein the pharmaceutically acceptable carrier is aqueous or alcoholic and comprises a viscous base (claim 11).
Regarding claim 78, the claims of the copending application recite a composition wherein the binding affinity of the anti-heparanase compound to FGF-1 is more than the binding affinity of heparin to FGF-1 (claim 12).
Regarding claim 79, the claims of the copending application recite a composition wherein the binding affinity of the anti-heparanase compound to FGF-2 is more than the binding affinity of heparin to FGF-2 (claim 13).
Regarding claim 80, the claims of the copending application recite a composition wherein the binding affinity of the anti-heparanase compound to VEGF is more than the binding affinity of heparin to VEGF (claim 14).
Regarding claim 81, the claims of the copending application recite a composition wherein the binding affinity of the anti-heparanase compound to PF4 is more than the binding affinity of heparin to PF4 (claim 15).
Regarding claim 82, the claims of the copending application recite a composition wherein the binding affinity of the anti-heparanase compound to P-Selectin is more than or equal to the binding affinity of heparin to P-Selectin (claim 16).
Regarding claim 83, the claims of the copending application recite a composition wherein the anti-heparanase compound has lower binding affinity to antithrombin III than heparin's binding affinity to antithrombin III (claim 17).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed 12/29/2025 have been fully considered but they are not persuasive.
Applicant’s Arguments
Applicant argues that the present application is earlier filed and that is a double patenting application is the only remaining rejection, the rejection should be withdrawn.
Examiner’s Response
The arguments presented above have been fully considered but are unpersuasive. Examiner notes that claim 71-83 of the instant invention are drawn to the compound. That specific compound is recited by the claims of the co-pending application. Even though the copending application recites a method of use, the method comprises using the instant compound and the compounds contain all the binding affinities as recited in claims 78-83.
Regarding the argument of the restriction requirement, Examiner notes that the claims of the copending application are withdrawn and not canceled thus the rejection is proper.
Regarding the argument of the earlier filed application, Examiner notes that the Double patenting rejection is not the only rejection remaining. Thus the rejection is proper and the rejection is maintained.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Mercy H. Sabila whose telephone number is (571)272-2562. The examiner can normally be reached Monday - Friday 5:00 am - 3:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko G. Garyu can be reached at (571)270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MERCY H SABILA/Examiner, Art Unit 1654
/LIANKO G GARYU/Supervisory Patent Examiner, Art Unit 1654