-DETAILED ACTION-
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s response dated May 12, 2026 is acknowledged.
Priority
This application is a CON of 17/184, 152 filed on 02/24/2021 (PAT 11,660,349), which is a is a CON of 16/182,261 filed on 11/06/2018 (PAT 10,933,144), which is a CON of 13/797,531 filed on 03/12/2013 (PAT 10,159,743), which claims benefit in provisional application 61/611,975 filed on 03/16/2012.
Claims Status
Claims 1-18 were canceled. Claims 19 and 31 were amended. Claims 19-36 are pending and examined.
Withdrawn Claim Objections
Objection to claim 31 is withdrawn because the claim was amended by deleting the extra period.
Withdrawn Claim Rejections - 35 USC § 103
Rejections of claims 19 and 21-34 as being unpatentable over Zhang (US 2011/0262490 Al, Published October 27, 2011 - of record in IDS dated 01/09/2025) and rejections of claims 35 and 36 as being unpatentable over Zhang and Robinson (WO 2010/009034 A3 Published January 21, 2010) are withdrawn because claim 19 was amended to require m+n to be greater than 2, which would not have been obvious over Zhang.
Maintained Double Patenting Rejections
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 19-35 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-54 of U.S. Patent No. 9,950,072 B2 in view of Zhang.
Patented claims encompass polymer-drug conjugates. Patented claims do not teach PLA,
PGA, or PLGA as the hydrophobic polymer segment in the conjugate.
The teachings of Zhang are relied upon as summarized in the previous office action.
Patented claims and Zhang are related to polymer-drug conjugates and it would have
been obvious to have combined them because they are in the same field of endeavor.
Instant claim 19 is obvious over patented claims 1-6, 10, and 11 when in patented claim
1: A is a HIF-1 inhibitor, X is a hydrophobic polymer segment that is a polyester, Y is a
branching point selected from compounds in patented claims 10 and 11, Z is a hydrophilic
polymer segment PEG, o is 1, p is 0, q is 0, m is an integer between 1 and 20, n is an integer
between 1 and 20.
It would have been prima facie obvious to a person of ordinary skill in the art at the time
of the claimed invention to have selected PLA, PGA, and PLGA as the hydrophobic polyesters
in patented claims, with a reasonable expectation of success because it was known from Zhang
that diblock copolymers having PEG as the hydrophilic segment and one of PLA, PGA, and
PLGA as the hydrophobic segment is suitable for conjugation with anti-angiogenic drugs. The
selection of a known materials based on its suitability for its intended purpose supports
obviousness.
Instant claim 20 is obvious over patented claims 10 and 11.
Instant claim 21 is obvious because PLA would have been an obvious hydrophobic
polyester in view Zhang.
Regarding claims 22-25, 27-29, and 31-33, it would have been obvious to have modified
patented polymer-drug conjugate by replacing the HIF -1 with an anti-VEGF compounds selected from bevacizumab, sunitinib, and sorafenib; or a tyrosine kinase inhibitor comprising terreic acid, with a reasonable expectation of success because it was known from Zhang that anti-cancer agents including anthracyclines such as doxorubicin (paragraph 1650); Bruton's tyrosine kinase inhibitors comprising terreic acid (paragraph 1664), and VEGF pathway inhibitors comprising bevacizumab, sunitinib, and sorafinib (paragraph 1710) may be formulated in nanoparticles as polymer-drug conjugates where the polymer is a diblock copolymer of PEG (hydrophilic segment) and one of PLA, PGA, orPLGA (hydrophobic segment) where the drug is covalently bonded to the hydrophobic segment terminal. The anthracyclines (HIF-1 inhibitor), Bruton's tyrosine kinase inhibitors, and VEGF inhibitors are equally suitable for conjugation to PEGPLGA and it would have been obvious to modify patented conjugate by replacing the HIF -1 inhibitors with Bruton's tyrosine kinase inhibitors and VEGF inhibitors as taught by Zhang.
The limitations that require an anti-VEGF compound are met by VEGF pathway
inhibitors.
Limitations that require a receptor tyrosine kinase inhibitors are met because sunitinib is
a receptor tyrosine kinase inhibitor, as evidenced by the instant specification.
Limitations that require a tyrosine kinase inhibitor are met by Burton's tyrosine kinase
inhibitors and sorafenib, as evidenced by instant specification.
Instant claim 26 is obvious because Zhang teaches PGA.
Instant claim 30 is obvious because Zhang teaches PLGA.
Instant claim 34 is obvious over patented claim 39.
Instant claim 3 5 is obvious over patented claims 4 7-51.
Claim 36 is rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-54 of U.S. Patent No. 9,950,072 B2 in view of Zhang, as applied to
claims 19-35, and further in view of Robinson (WO 2010/009034 A3 Published January 21,
2010).
The teachings of patented claims and Zhang are relied upon as summarized above. They
do not teach limitations of claim 36.
The teachings of Robinson are relied upon as summarized in the previous office action.
It would have been obvious to have administered patented composition as modified by
Zhang in a method of treating an ocular disorder such as choroid al neovascularization by
administering the composition by intraocular injection, with a reasonable expectation of success
because it was known from Robinson that intraocular injection is a suitable method of
administering an active agent in a method of treating choroid al neovascularization. Combining
prior art elements according to known methods to obtain predictable results supports obviousness
and the selection of a known method based on its suitability for its intended purpose supports
obviousness.
Claims 19-35 are rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-45 of U.S. Patent No. 8,962,577 B2 (of record in IDS dated
01/09/2025) in view of Zhang.
Patented claims encompass polymer-drug conjugates. Patented claims do not teach PLA,
PGA, or PLGA as the hydrophobic polymer segment in the conjugate.
The teachings of Zhang are relied upon as summarized in the previous office action.
Patented claims and Zhang are related to polymer-drug conjugates and it would have
been obvious to have combined their teachings because they are in the same field.
Instant claim 19 is obvious over patented claims 1-6 and 10, when in patented claim 1: A
is a HIF-1 inhibitor, X is a hydrophobic polymer segment that is a polyester, Y is a branching
point selected from compounds in patented claims 1 and 10, Z is a hydrophilic polymer segment
PEG, o is 1, p is 0, q is 0, mis an integer between 1 and 20, n is an integer between 1 and 20.
It would have been prima facie obvious to a person of ordinary skill in the art at the time
of the claimed invention to have selected PLA, PGA, and PLGA as the hydrophobic polyesters
in patented claims, with a reasonable expectation of success because it was known from Zhang
that diblock copolymers having PEG as the hydrophilic segment and one of PLA, PGA, and
PLGA as the hydrophobic segment are suitable for conjugation with anti-angiogenic drugs. The
selection of a known materials based on its suitability for its intended purpose supports
obviousness.
Instant claim 20 is obvious over patented claims 1 and 10.
Instant claim 21 is obvious because PLA would have been an obvious hydrophobic
polyester in view Zhang.
Regarding claims 22-25, 27-29, and 31-33, it would have been obvious to have modified
patented polymer-drug conjugate by replacing the HIF -1 with an anti-VEGF compounds selected from bevacizumab, sunitinib, and sorafenib; or a tyrosine kinase inhibitor comprising terreic acid, with a reasonable expectation of success because it was known from Zhang that anti-cancer agents including anthracyclines such as doxorubicin (paragraph 1650); Bruton's tyrosine kinase inhibitors comprising terreic acid (paragraph 1664), and VEGF pathway inhibitors comprising bevacizumab, sunitinib, and sorafinib (paragraph 1710) may be formulated in nanoparticles as polymer-drug conjugates where the polymer is a diblock copolymer of PEG (hydrophilic segment) and one of PLA, PGA, or PLGA (hydrophobic segment) where the drug is covalently bonded to the hydrophobic segment terminal. The anthracyclines (HIF-1 inhibitor), Bruton's tyrosine kinase inhibitors, and VEGF inhibitors are equally suitable for conjugation to PEGPLGA and it would have been obvious to modify patented conjugate by replacing the HIF -1 inhibitors with Bruton's tyrosine kinase inhibitors and VEGF inhibitors as taught by Zhang.
The limitations that require an anti-VEGF compound are met by VEGF pathway inhibitors.
Limitations that require a receptor tyrosine kinase inhibitors are met because sunitinib is a
receptor tyrosine kinase inhibitor, as evidenced by the instant specification.
Limitations that require a tyrosine kinase inhibitor are met by Burton's tyrosine kinase
inhibitors and sorafenib, as evidenced by instant specification.
Instant claim 26 is obvious because Zhang teaches PGA.
Instant claim 30 is obvious because Zhang teaches PLGA.
Instant claim 34 is obvious over patented claims 29, 31, and 37.
Instant claim 35 is obvious over patented claims 37-42.
Claim 36 is rejected on the ground of nonstatutory double patenting as being
unpatentable over claims 1-45 of U.S. Patent No. 8,962,577 B2 in view of Zhang, as applied to
claims 19-35, and further in view of Robinson (WO 2010/009034 A3 Published January 21,
2010).
The teachings of patented claims and Zhang are relied upon as summarized above. They
do not teach limitations of claim 36.
The teachings of Robinson are relied upon as summarized in the previous office action.
It would have been obvious to have administered patented composition as modified by
Zhang in a method of treating an ocular disorder such as choroid al neovascularization by
administering the composition by intraocular injection, with a reasonable expectation of success
because it was known from Robinson that intraocular injection is a suitable method of
administering an active agent in a method of treating choroid al neovascularization. Combining
prior art elements according to known methods to obtain predictable results supports obviousness
and the selection of a known method based on its suitability for its intended purpose supports
obviousness.
Double patenting rejections are maintained because applicant requested the rejections to be held in abeyance.
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.
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/ALMA PIPIC/
Primary Examiner, Art Unit 1617
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