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 . 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.
Priority
The instant application is a continuation of US application no. 17/116,977 filed on 12/09/2020, which claims domestic benefit to US provisional application no. 62/945,622 filed on 12/09/2019.
Status of the Claims
The claim amendments and remarks filed on 09/26/2025 is acknowledged. Claims 1-2, 4, 6, 8, and 10 are amended. Claim 9 is cancelled. Claims 18-19 are newly added. Claims 1-8 and 10-19 are pending.
The declaration by Dr. Hien Nguyen filed on 09/26/2025 is acknowledged, and the contents
are discussed in the response to argument section below.
Claims 11-17 were previously withdrawn in the office action dated 11/15/2024 from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Newly added claims 18-19 are drawn to the elected method of using claims (claims 1-8 and 10).
Accordingly, claims 1-8, 10, and 18-19 are being examined on the merits herein.
Withdrawn Rejections
The 35 USC 112(b) rejection over claims 2-5, 8, and 10 are withdrawn in view of the “optionally” term being removed.
The cancellation of claim 9 renders the nonstatutory double patenting rejections for claim 9 and 35 USC 103 rejection for claim 9 moot.
The nonstatutory double patenting rejection over US Patent No. 11,524,026 for instant claims 1-10 are withdrawn in view of the Terminal Disclaimer that was filed and approved on 09/30/2025.
The following grounds of rejections are maintained from the previous Office Action dated 05/27/2025 with amendments to address the newly added claims.
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.
Claims 1-6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Loka et al (Chem Comm., 2017 in IDS filed on 12/02/2022) in view of Ziolkowski et al. (J. Clin. Invest., 2012 in PTO-892 dated 11/15/2024).
Loka et al. teaches heparanase sulfate (HS)-mimicking glycopolymers for inhibiting heparanase activity (see Abstract). The glycopolymers, as seen in Table 1 on page 9165, are identical to the claimed compounds of the instant application such as the compound shown below from Loka et al.
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Furthermore, Loka et al. teaches that the heparanase enzyme plays a key role in tumor progression and diseases such as nephrological diseases and diabetes (see page 9163, first paragraph). Loka et al. further teaches that heparanase plays a key role in type 1 diabetes since it destroys heparan sulfate (HS) chains with the insulin-producing β cells to cause their death (see page 9163, first paragraph). Loka et al. also teaches that inhibitors of heparanase are anticancer therapeutics, with carbohydrate mimetics being advanced to clinical trials (see page 9163, second paragraph). However, Loka et al. discloses that these mimetics can lead to unforeseen adverse effects and discloses several examples such as the heparanase inhibitor PI-88 causing antibody-induced thrombocytopenia. Loka et al. teaches that there is therefore an urgent need to identify structurally defined, potent and specific heparanase (see page 9163 right column). Loka discloses that their glycopolymers can be an alternative to other heparinase inhibitors because of advantages such as lack of coagulant activity (see page Abstract). Loka et al. demonstrates that compound 22 (12 repeating units) was both the most potent heparin inhibitor and exhibited no anticoagulant activity (see Abstract and page 9166 left column).
The difference between Loka et al. and the claimed invention is that Loka et al. does not expressly disclose that their compounds can be administered to a subject in a therapeutically effective amount to treat diabetes.
Ziolkowski et al. teaches that HS is critical to the survival of islet β cells, and that HS degradation is a mechanism for β cell destruction (see Abstract). Ziolkowski et al. further teaches that the administration of a heparanase inhibitor, PI-88 at 10 mg/kg (see page 138, left column), preserves intraislet HS and protected NOD mice from type 1 diabetes (NOD mice being a model for type 1 diabetes in humans) (see Abstract and page 133 and 139, right column). Lastly, Ziolkowski teaches that heparanase inhibition can be a therapeutic strategy for protecting β cells from HS depletion and type 1 diabetes progression (see page 133, right column).
Therefore, it would have been prima facie obvious before the effective filing date of the claimed invention to try and administer the glycopolymers of Loka et al. to a subject in a therapeutically effective amount for the treatment of diabetes with a reasonable expectation of success because Loka et al. teaches their glycopolymers can be used as an alternative to other heparanase inhibitors with an added advantage of exhibiting no anticoagulant activity, and Ziolkowski et al provides guidance that administering heparanase inhibitors can have a therapeutic effect in a diabetes animal model by preserving the HS in β cells.
In regards to claim 4, Loka et al. discloses that their glycopolymers are prepared in LiOH (lithium hydroxide) as seen in Table 1, which would be a lithium salted form of their compounds. Therefore, claim 4 is also prima facie obvious.
Claims 7 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Loka et al (Chem Comm., 2017 in IDS filed on 12/02/2022) in view of Ziolkowski et al. (J. Clin. Invest., 2012 in PTO-892 dated 11/15/2024), as applied to claims 1-6 and 10, and further in view of Ferro et al. (US20150065440A1 in PTO-892 dated 05/27/2025).
The combined teachings of Loka et al. and Ziolkowski are as described above.
The difference between the combined teachings of Loka et al. and Ziolkowski et al. and the claimed invention is that the combined teachings of Loka et al. and Ziolkowski et al. do not disclose a sodium salt form.
Ferro et al. discloses novel compounds that have utility as inhibitors of heparan sulfate-binding proteins such as heparanase (see Abstract and paragraph 0002). Ferro et al. discloses that their heparanase inhibitor compounds can include salt forms such as sodium salts (see paragraph 0078 and 0095). Furthermore, Ferro et al. provides a structure of their compounds in which the saccharide units have sodium sulfate groups (see Fig. 11C).
It would have been prima facie obvious before the effective filing date of the claimed invention to have prepared the compounds of Loka et al. in a sodium salt form as disclosed by Ferro et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Loka et al. provides guidance that their glycopolymers can be in a lithium salted form as seen in Table 1 (LiOH), and Ferro et al. provides further guidance that sodium salts are also suitable for forming salts of anti-heparanase compounds with similar saccharide unit structures.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Loka et al (Chem Comm., 2017 in IDS filed on 12/02/2022) in view of Ziolkowski et al. (J. Clin. Invest., 2012 in PTO-892 dated 11/15/2024) and Ferro et al. (US20150065440A1 in PTO-892), as applied to claim 7 above, and further in view of Sletten et al (Biomacromolecules, 2017 in IDS filed on 12/02/2022)
The combined teachings of Loka et al., Ziolkowski, and Ferro are as described above.
The difference between the combined teachings of Loka et al., Ziolkowski, and Ferro and the claimed invention is that the combined teachings of Loka et al., Ziolkowski, and Ferro do not disclose an anti-heparanase compound comprising an additional saccharide unit as shown in instant claims 8 and 9.
Sletten et al. teaches heparanase sulfate-mimicking glycopolymers (see Abstract). Sletten et al. teaches that the degradation of the HS chains has illustrated heparanase to be the regulator of aggressive tumor behavior as well as to play key roles in the progression of kidney related diseases and autoimmune diabetes (see page 3388, first paragraph). Sletten et al. also teaches heparinase inhibition has become a highly pursued clinical target, with the most potent molecules being HS carbohydrate-based mimetics (see page 3388, first paragraph). Lastly, Sletten et al. teaches that their compounds can be used for heparanase inhibition (see page 3395 under section “Heparanase Inhibition”). Sletten et al. discloses monoantennary and diantennary glycopolymer designs, in which the diantennary includes an additional saccharide unit along with the disaccharide unit (see Figure 1). Sletten et al. discloses a structure of their diantennary glycopolymer in Scheme 3 shown below:
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Sletten et al. discloses that monoantennary polymer had less binding affinity than diantennary polymer with the additional saccharide unit (see page 3395 right column). Sletten et al. discloses that he diantennary unit potentially mimics a trisaccharide that binds into the −1/–2/+1 subsites of heparanase, but removes the scissile bond, thereby preventing cleavage by bridging over the catalytic residues (see page 3391, right column).
It would have been prima facie obvious to combine Loka et al., Ziolkowski, and Ferro with Sletten et al. by modifying the glycopolymers of Loka et al. to include an additional saccharide unit as disclosed by Sletten et al. to arrive at the claimed invention. One of ordinary skill in the art would have made this modification with a reasonable expectation of success because Sletten et al. discloses that the diantennary glycopolymer containing the disaccharide and saccharide unit had higher binding affinity to heparanase than monoantennary glycopolymers, and that diantennary units may mimic trisaccharides that bind into the −1/–2/+1 subsites of heparanase.
Response to Arguments
Applicant’s arguments and declaration under 35 CFR 1.132 filed on 09/26/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant states neither Loka nor Ziolkowski teach or suggest that the glycopolymers recited in the claims are effective in treating diabetes.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, the combined teachings of Loka and Ziolkowski establish obviousness to use the compounds of Loka for treating diabetes as suggested in Ziolkowski because the compounds of Loka et al. are shown to potently inhibit heparanase activity, and Ziolkowski establishes that inhibiting heparanase activity is a therapeutic strategy for treating diabetes. Therefore, an ordinary skilled artisan could have predictably considered using the compounds of Loka for treating diabetes with a reasonable expectation of success.
Applicant states that the prior arts described above teach away from the claimed subject matter because not all inhibitors of heparanase are effective for treating diabetes as explained in the filed Declaration of Dr. Hien Nguyen. Applicant states that the 103 rejection above relies on Ziolkowski for teaching PI-88, a heparanase inhibitor, which was thought to be effective for treating diabetes. However, Applicant states that PI-88, which is structurally different from the claimed glycopolymers, was found to induce HIT in patients during clinical trials, and further points to the teachings of Nguyen for support.
In response to this argument, the prior art does not teach away from the claimed subject matter because Loka et al. also discloses that PI-88 clinical trials were stopped due to antibody-induced thrombocytopenia, and further discloses that there is an urgent need to identify structurally defined, potent and specific heparanase inhibitors that overcome these limitations. Furthermore, PI-88 is structurally different from the claimed glycopolymers and therefore does not suggest the recited glycopolymers in Loka would cause thrombocytopenia or not effectively treat diabetes. Therefore, there is a still a reasonable expectation of success in administering the glycopolymers of Loka et al. for treating diabetes because although PI-88 was shown to have adverse effects, Loka et al. suggests that their compounds are an alternative to other heparanase inhibitors such as the PI-88 disclosed in Ziolkowski with an added advantage of exhibiting no anticoagulant activity as described above. MPEP 2143.02 I recites “Conclusive proof of efficacy is not required to show a reasonable expectation of success. OSI Pharm., LLC v. Apotex Inc., 939 F.3d 1375, 1385, 2019 USPQ2d 379681 (Fed. Cir. 2019) ("To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success.’") … (reasoning that "the expectation of success need only be reasonable, not absolute")”.
Applicant also states several unexpected results for the claimed method of treating diabetes using the claimed compounds. As described in the Declaration of Dr. Hien Nguyen, Applicant relies on the GPM2 compound of Nguyen, which is a species of the claimed compound when n=12 in the instant claims, to demonstrate the showing of unexpected results. Applicant states that the GPM2 compound was found to be a potent heparanase inhibitor compared to other known heparanase inhibitors such as the PI-88 of Ziolkowski based on GPM2 having an IC value of around 0.10 nM.
Applicant’s unexpected result of the claimed compound being a potent heparanase inhibitor is not persuasive because Loka demonstrates that their compound 22, which is identical to the GMP2 compound, was a potent heparanase inhibitor (see Figure 4 in Loka) and also discloses this compound had an IC value of around 0.10 nM (see second paragraph right column page 9165 in Loka). Therefore, the claimed compounds as being potent heparanase inhibitors is not unexpected.
Applicant further states that GPM2 exhibited no anticoagulant activity against proteases FXa and FIIa, unlike heparin which is known to exhibit high levels of anticoagulant activity against FIIa and FXa.
In response to this alleged unexpected result, Loka et al. also demonstrates their compound 22 (identical to GPM2) exhibited no anticoagulant activity against proteases FXa and FIIa as described above. Therefore, this result is not unexpected.
Applicant further states that the interaction of heparin and PF4 triggers an autoimmune response to promote heparin-induced thrombocytopenia (HIT) and is the reason that clinical trials for heparin-based heparanase inhibitors were suspended. Therefore, Applicant states that the interaction between GPM2 and PF4 was evaluated and demonstrated that GPM2 had very low affinity for PF4 compared to heparin, which indicates that GPM2 does not bind PF4 and is less likely to cause thrombocytopenia (HIT).
In response to this alleged unexpected result, the result of GPM2 having low affinity for PF4 compared to heparin would be necessarily present for the compound 22 disclosed in Loka because Loka discloses the same GPM2 compound (compound 22 in Loka) exhibiting no anticoagulant activity, and Ziolkowski provides guidance of administering this Loka compound for treating diabetes as described above. MPEP 2112 section I recites "[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable”. Furthermore, MPEP 2112.01 section II recites “Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.”.
Applicant further states that various experiments were performed to confirm that GPM2 protects pancreatic beta cells and suppresses islet inflammation and that treatment with GPM2 alone had no toxic effect on mouse beta-cell growth or colony formation.
In response to this alleged unexpected result, these results here only confirms that GPM2 inhibits a known activity of heparanase on pancreatic beta cells as disclosed in Loka et al. and Ziolkowskiet al. Therefore, these results would naturally flow from the teachings of Loka and Ziolkowski described above because Loka demonstrates the same compound 22 (identical to GPM2) as a potent heparanase inhibitor, and Ziolkowski provides guidance to administer this compound for treating diabetes as described above. MPEP 2145 II recites “The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985) (The prior art taught combustion fluid analyzers which used labyrinth heaters to maintain the samples at a uniform temperature. Although appellant showed that an unexpectedly shorter response time was obtained when a labyrinth heater was employed, the Board held this advantage would flow naturally from following the suggestion of the prior art.). See also Lantech Inc. v. Kaufman Co. of Ohio Inc., 878 F.2d 1446, 12 USPQ2d 1076, 1077 (Fed. Cir. 1989), cert. denied, 493 U.S. 1058 (1990) (unpublished — not citable as precedent) ("The recitation of an additional advantage associated with doing what the prior art suggests does not lend patentability to an otherwise unpatentable invention.").”
Lastly, in response to all of the alleged unexpected results described above, these results are not commensurate in scope of the claimed method as required in MPEP 716.02(d) because there are several other species of the claimed compounds such as shorter or longer repeating unit glycopolymers as well as different functional groups on the disaccharides, and Applicant has not provided evidence that these other claimed compounds would also have the alleged unexpected results. Sletten et al. discloses that different lengths of the claimed glycopolymer can affect the heparanase activity inhibition (see Figure 6), and discloses that the sulfation pattern is of the utmost importance for interactions with heparanase (see page 3388 right column). Therefore, since the different species of the claimed compounds are suggested to exhibit different properties, the showing of the unexpected result is not commensurate with the scope of the claims, as Applicant has only demonstrated evidence for one specific species, GPM2.
Applicant states that the combined teachings of Loka, Ziolkowski, and Ferro do not render claim 7 obvious because Ferro does not teach or suggest the compounds recited in the claims, and does not teach or suggest all heparanase inhibitors are effective in treating diabetes.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, Ferro is relied upon to establish that sodium salts are also suitable for forming salts of anti-heparanase compounds with similar saccharide unit structures. Furthermore, Loka et al. provides guidance that their glycopolymers can be in a lithium salted form as seen in Table 1 (LiOH). Therefore, when viewing the combination of references as a whole, an ordinary skilled artisan could have predictably considered preparing sodium salt forms of the compounds in Loka with a reasonable expectation of success.
Applicant states that the combined teachings of Loka, Ziolkowski, Ferro, and Sletten do not render claims 8-9 obvious because Sletten does not teach or suggest the compounds recited in the claims are effective in treating diabetes.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Here, Sletten is relied upon to demonstrate that diantennary glycopolymer containing the disaccharide and saccharide unit had higher binding affinity to heparanase than monoantennary glycopolymers, and that diantennary units may mimic trisaccharides that bind into the −1/–2/+1 subsites of heparanase. Therefore, when viewing the combination of references as a whole, an ordinary skilled artisan could have predictably considered modifying the glycopolymers of Loka et al. to include an additional saccharide unit as disclosed by Sletten et al. with a reasonable expectation of success.
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 1-8, 10, and 18-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 61-76 of copending Application No. 17/311,088 (‘088) in view of Loka et al (Chem Comm., 2017 in IDS filed on 12/02/2022) and Ziolkowski et al. (J. Clin. Invest., 2012 in PTO-892 dated 11/15/2024).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘088 recite a method to treat cancer by administering the claimed anti-heparanase compound. The claimed anti-heparanase compounds of ‘088, for example in claims 66, 69, 70, 73, and 76 of ‘088, are identical to the compounds described in claims 1-8, 10, and 18-19 of the instant application.
However, the difference between the instant application and the claims of ‘088 is that the claims of ‘088 are related to a method of treating cancer and not diabetes.
The independent teachings of Loka and Ziolkowski are as described above.
It would have been prima facie obvious to combine the claims of ‘088 with Loka et al. and Ziolkowski et al. by using the same anti-heparanase compounds claimed in ‘088 for treating diabetes as suggested by the combined teachings of Loka et al. and Ziolkowski et al. to arrive at the claimed invention. One of ordinary skill in the art would have further applied the compounds of ‘088 for treating diabetes with a reasonable expectation of success because Loka et al. teaches that these anti-heparanase compounds can be used as an alternative to other heparanase inhibitors with an added advantage of no anticoagulant activity, and Ziolkowski et al. teaches that administering a heparanase inhibitor can have a therapeutic effect in a diabetes model by preserving the HS in β cells.
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 and declaration under 35 CFR 1.132 filed on 09/26/2025 have been fully considered in so far as they apply to the rejections of the instant office action, but were not persuasive.
Applicant traverses the provisional nonstatutory double patenting rejection over ‘088 because the claims of ‘088 are directed toward a method of treating cancers and not diabetes. Applicant further states that neither Loka nor Ziolkowski teach or suggest using glycopolymers recited in the claims for treating diabetes. Applicant points to Otsuka Pharmaceuticals Co., in which there must be a reason or motivation to modify the reference compound to arrive at the claimed compound in a nonstatutory double patenting rejection.
In response to these arguments, Applicant’s remarks were not found persuasive because even though the claims of ‘088 do not recite a method of treating diabetes as pointed out, the teachings of Loka et al. and Ziolkowski et al. provide guidance that the compounds of ‘088, which are identical to the compounds of Loka, can be used to treat diabetes as described above. Therefore, when the claims of ‘088 is viewed in light of the teachings of Loka and Ziolkowski and taken as a whole, it would be obvious to apply the compounds of ‘088 for treating diabetes.
Applicant states that the Applicants and the inventors of ‘088 are different from the instant application. Applicant further states if both of the claims were submitted in the same application, the Office would require Applicant to elect one of the methods in response to a restriction requirement and submit the other method in a divisional application and therefore would the Office would not issue a double patenting rejection. Applicant further states that the claims of the instant application, which are directed toward a method of treating diabetes, do not unjustly extend the patent term of the claims of ‘088, which are directed toward methods of treating cancer.
In response to these arguments, Applicant’s remarks were not found persuasive because MPEP 1504.06 recites “Double patenting rejections are based on a comparison of the claims in a patent and an application or between two applications which have at least one common inventor, common applicant…”. Therefore, ‘088 and the instant application share at least one common inventor and so the double patenting rejection over ‘088 is proper. Additionally, the instant application is not a divisional application as a result of a restriction requirement of ‘088. Therefore, the non-statutory double patenting rejection is still proper. Lastly, there is a prima facie obviousness case to arrive at the instant invention from the claims of ‘088 in view of Loka and Ziolkowski as described above. Therefore, the non-statutory double patenting rejection is also still proper.
Conclusion
No claim is found allowable.
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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/D.H.C./Examiner, Art Unit 1693
/SCARLETT Y GOON/Supervisory Patent Examiner, Art Unit 1693