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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26 June 2026 has been entered.
This Office action is responsive to Applicant’s amendment and remarks, filed 26 June 2026. No claim is amended.
This application is a domestic application, filed 24 Jan 2024; claims benefit as a CON of 17/362,254, filed 29 June 2021, issued as PAT 11,911,412; and claims benefit as a CON of 15/752852, which is a 371 of PCT/US2016/046829, filed 12 Aug 2016, issued as PAT 11,077,135; which claims benefit of provisional application 62/205,408, filed 14 Aug 2015.
Claims 1-8, 27-32, 41-43, and 45-49 are pending in the current application and are examined on the merits herein.
Rejections Withdrawn
Applicant’s remarks, filed 26 June 2026, with respect that claims 1-8, 27-32, 41-43, and 47-49 are rejected under 35 U.S.C. 103 as being unpatentable over the '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, provided by Applicant in IDS filed 29 Jan 2024) in view of the '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, provided by Applicant in IDS filed 29 Jan 2024) has been fully considered and is persuasive, as Applicant’s remarks are persuasive that the combined teachings of the '785 application in view of the '474 application does not provide sufficient guidance to modify the method of '785 in order to treat the disorder by administering the PAAG compound intravenously. For example, '785 at page 12, paragraphs 222-223 teaches the administration of a combination of agents wherein the polyglucosamine or polyglucosamine derivative can be administered topically, intranasally, via pulmonary aerosol or orally, and the second agent can be administered systemically. While the cited teachings of '474 suggest a polyglucosamine or polyglucosamine derivative is capable of being administered intravenously, Applicant’s remarks are persuasive that the combined teachings of the closest prior art do not provide sufficient guidance because '785 taken as a whole teaches the difference between the local administration of the PAAG compound and systemic administration of the second agent, and one of ordinary skill in the art would have reasonably expected intravenous administration in the context of the invention of '785 to be a type of systemic administration. In addition, Applicant notes that the specification describes results of the intravenous administration of the PAAG compound that are not reasonably predicted by the combined teachings of the closest prior art. Therefore the closest prior art does not teach or fairly suggest all limitations of the claimed invention including those properties resulting from the claimed method.
This rejection has been withdrawn.
Applicant’s remarks, filed 26 June 2026, with respect that claims 45-46 are rejected under 35 U.S.C. 103 as being unpatentable over the '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, provided by Applicant in IDS filed 29 Jan 2024) in view of the '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, provided by Applicant in IDS filed 29 Jan 2024) as applied to claims 1-8, 27-32, 41-43, and 47-49 above, and further in view of Mulivor et al. (Am. J. Physiol. Heart Circ. Physiol., 2004, 2, pages H1672-H1680, of record) and Burke-Gaffney et al. (Critical Care, 2012, 16, article 121, 2 pages, of record) has been fully considered and is persuasive, as Applicant’s remarks are persuasive regarding the combined teachings of the '785 application in view of the '474 application, and the further teachings of Mulivor et al. and Burke-Gaffney et al. do not remedy the teachings of '785 in view of the '474 discussed above.
This rejection has been withdrawn.
The following are reiterated grounds of rejection.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 4-8, 27-32, and 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,077,135 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-12 of the reference patent are drawn to a method of treating a disorder of the vascular system, the method comprising intravenously administering a polymer to a subject in need thereof, thereby treating the disorder, wherein the disorder is traumatic brain injury; and wherein the polymer is a compound of the structure recited in claims 1 and 45. The disorder treated of traumatic brain injury is recited in claim 8 and is encompassed within the scope of brain injury or brain damage recited in claim 8. Reference Claims 2-10 of the reference patent correspond to claims 2, 4, 5, 6, 7, 27, 28, 29, and 30, respectively.
Regarding claims 45-46, Reference claims 1 and 5 indicate the disorder of traumatic brain injury is a result of dysfunction of the glycocalyx or loss of structural integrity of the glycocalyx, and Reference claims 3-4 recite the method reduces the permeability or enhances the integrity of the blood brain barrier, implying the method restores glycocalyx structure or integrity.
Claims 3, 41-43, and 47-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,077,135 (reference patent) in view of '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, of record) and '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, of record).
Reference Claims 1-12 of the reference patent recite as above.
Reference Claims 1-12 do not specifically recite the disorder is inflammation, swelling and secondary damage of the vascular and lymphatic system. (claim 3) Reference Claims 1-12 do not specifically recite the intravenous administration is by bolus administration, continuous infusion, or intraarterial. (claims 41-43) Reference Claims 1-12 do not specifically recite the time frame after the injury the administration is made. (claims 47-49)
The '785 application teaches as above, particularly with regard to the time frame after the injury the administration is made. The '785 application also teaches in some embodiments the method reduces local or system inflammation.
The '474 application teaches as above, particularly with regard to the types of intravenous administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-12 in view of the '785 application and the '474 application in order to select from within the scope of the reference claims the types of intravenous administration, the time frame after the injury the administration is made, or for the method to treat inflammation. One of ordinary skill in the art would have been motivated to combine Reference claims 1-12 in view of the '785 application and the '474 application with a reasonable expectation of success because all of the references are drawn to therapeutic treatment comprising administering the same chitosan-arginine structure, both Reference claims 1-12 of the reference patent and the '785 application encompass treatment of brain injury comprising administering the same compound and the '785 application provides guidance that one of ordinary skill in the art would select the time frame after the injury the administration is made, and both Reference claims 1-12 and the '474 application encompass intravenous administration of the same compound and the '474 application provides guidance that one of ordinary skill in the art would select the types of intravenous administration.
Claims 1-8, 27-32, 41-43, and 45-46 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,911,412 (reference patent).
Although the claims at issue are not identical, they are not patentably distinct from each other because reference claims 1-16 of the reference patent are drawn to a method of treating hemorrhagic shock, the method comprising intravenously administering a polymer to a subject in need thereof, thereby treating the disorder; and wherein the polymer is a compound of the structure recited in claims 1 and 45. The disorder of hemorrhagic shock is a disorder of the vascular system addressing limitations of claims 1 and 8. Reference Claims 2-10 correspond to limitations of claims 2, 4, 5, 6, 7, 27, 28, 29, and 30, respectively. Reference claims 11-15 correspond to limitations of claims 31, 32, 41, 42, and 43, respectively. Regarding claims 45-46, reference claim 5 recites the hemorrhagic shock is a result of dysfunction of the glycocalyx or loss of structural integrity of the glycocalyx, and reference claims 3-4 recite the method reduces the permeability or enhances the integrity of the blood brain barrier, implying the method restores glycocalyx structure or integrity.
Claim 3 and 47-49 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,911,412 (reference patent) in view of '785 application (Baker et al. US 2014/0080785, published 20 Mar 2014, of record) and '474 application (Baker et al., US 2010/0056474, published 04 Mar 2010, of record).
Reference Claims 1-16 of the reference patent recite as above.
Reference Claims 1-16 do not specifically recite the disorder is inflammation, swelling and secondary damage of the vascular and lymphatic system. (claim 3) Reference Claims 1-16 do not specifically recite the time frame after the injury the administration is made. (claims 47-49)
The '785 application teaches as above, particularly with regard to the time frame after the injury the administration is made. The '785 application also teaches in some embodiments the method reduces local or system inflammation.
The '474 application teaches as above, particularly with regard to the types of intravenous administration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Reference claims 1-16 in view of the '785 application and the '474 application in order to select from within the scope of the reference claims the types of intravenous administration or the time frame after the injury the administration is made. One of ordinary skill in the art would have been motivated to combine Reference claims 1-16 in view of the '785 application and the '474 application with a reasonable expectation of success because all of the references are drawn to therapeutic treatment comprising administering the same chitosan-arginine structure, both Reference claims 1-16 and the '785 application encompass treatment of hemorrhagic shock comprising administering the same compound and the '785 application provides guidance that one of ordinary skill in the art would select the time frame after the injury the administration is made, and both Reference claims 1-16 and the '474 application encompass intravenous administration of the same compound and the '474 application provides guidance that one of ordinary skill in the art would select the types of intravenous administration.
Response to Applicant’s Remarks:
Applicant’s Remarks, filed 26 June 2026, have been fully considered and not found to be persuasive.
Regarding each of the nonstatutory double patenting rejections above, no terminal disclaimer is recorded, therefore it is proper to maintain the rejections.
Applicant’s remarks regarding the teachings of the '785 application and the '474 application are not persuasive regarding the double patenting rejections detailed above because the Reference claims of the reference patents themselves recite intravenously administering the polyglucosamine derivative, providing guidance and a reasonable expectation of success to administering the compound by this route.
Conclusion
No claim is currently in condition for allowance.
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/JONATHAN S LAU/Primary Examiner, Art Unit 1693
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