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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/6/2025 has been entered.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objects are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Allowable Subject Matter
Claims 1-4, 7-11, 14 and 32 are allowed. The closest prior art is WO2012/019145A1 to Goodrich. Although Goodrich discloses a polymer composition wherein L11 is ester or amide (Page 8, Lines 1-14, ...LIl is ester of amide; Page 10, Line 19-Page 11, Line 25; Page 16, Lines 1-12, see Formulas 15-17 for the iodinated monomers, where R11 is C2 alkylene, L1I is ester and Ar-is C6 aryl with 3 to 5 iodine). R11 is C2-C6 alkylene or - Ch2Ch2SCH2CH2-(Page 8, Lines 1-14; Page 10, Line 19-Page 11, Line 25; Page 16, Lines 1-12, see Formulas 15-17 for the iodinated monomers, where R11 is C2 alkylene, LI is ester and Ar is C6 aryl with 3 to 5 iodine). Goodrich discloses the polymer composition of claim 18, wherein the structure of the first monomer is given by Formula 13-A, and at least three of X1-X 5 are iodine and n is an integer from 1 to 8 (Page 8, Lines 1-14; Page 10, Line 19-Page 11, Line 25; Page 16, Lines 1-12, see Formula 17 for the iodinated monomers, where n is 1 and each of X1-XS is iodine). Goodrich discloses a polymer composition comprising a crosslinked network (Abstract; Page 7, Lines 13-26; Claim 1), the network comprising: a) a first repeating unit represented by Formula 1; R 1 is substituted or unsubstituted C2-C36 alkylene, C2-C36 cycloalkylene, C2-C36 alkenylene, C2-C36 cycloalkenylene, C2-C36 alkynylene, C2-C36 arylene, or C5-C36 heteroarylene; L 1 is a single bond, - (CH2)n-, -(HCCH)n-, -O-, -S-, -SO-, -S02, -S03, -OSO2-, -NR2-, -CO-, -COO-, -OCO-, -OCOO-, -CONR3-, - NR4CO-, -OCONRS-, -NR6COO-, or -NR7CONR8-; Arl is a C5-C30 aryl or C5-C30 heteroaryl that is substituted with three or more I, Br or Bi atoms; each of R2 - R8 is independently hydrogen or C1-C10 alkyl; and nis an integer selected from the range of 1 to 16 (Page 8, Lines 1-14; Page 16, Lines 1-12, see Formulas 15-17 for the iodinated monomers, where R11 is C2 alkylene, LI is ester and Ar is C6 aryl with 3 to 5 iodine; Page 7, Lines 13-26, ...first repeating unit derived from a multifunctional iodinated monomer...); and b) a second repeating unit represented by Formula 2: wherein R9 is substituted or unsubstituted C2-C35 alkylene, C2-C35 cycloalkylene, C2-C36 alkenylene, C2-C36 cycloalkenylene, C2- C36 alkynylene, C2-C36 arylene, C2-C36 heteroarylene, an oligomeric polyester, an oligomeric polycarbonate, an oligomeric polyurethane, Formula 3, or Formula 4, or Formula 4-A; wherein R10 is C4-alkynylene, C2-C36 arylene, C2-C36 heteroarylene, aromatic group, silicon-containing group, polyalkyl siloxane group, polyether group, polyester group, polycarbonate group or a combination of linear or branched aliphatic groups and aromatic groups and R16 is ether group, silicon-containing group, polyalkyl siloxane group, polyether group, polyester group, polycarbonate group, C3-C20 alkylene, aliphatic group, substituted or unsubstituted C2-C36 alkylene, C2-C36 cycloalkylene, C2-C36 alkenylene, C2-C36 cycloalkenylene, C2- C36 alkynylene, C5-C36 arylene, C2-C36 heteroarylene, or aromatic group, or a combination of aliphatic groups and aromatic groups and ns is an integer from 1 to 50 (Page 8, Line 16-Page 9, Line 11), it fails to teach or fairly suggest the presently claimed structures.
Claims 1-4, 7-11, 14 and 32 directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 15 and 17-19, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claims 21-25, directed to the invention(s) of does not require all the limitations of an allowable product claim, and has NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between groups (I, II) and (III) as set forth in the Office action mailed on 5/12/2022 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 15 and 17-19 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 15 recites “a device feature.” The term “a device feature” is not a term of art, nor is there a description of this term in the application. As the term “a device feature” is not a term of art, nor is there a description of this term in the application, there is insufficient written description for this term in the application. Further, claim 17 recites “[t]he device of claim 15, for purposes of an indwelling, permament implant to provide the function of… providing…. complete lumen occlusion for any physiological fluid or gas flow or for an applied therapeutic fluid or gas flow.” The recitation includes physiological gases or fluids at any pressure, temperature, or composition (that is a physiological gas or fluid), which includes very caustic materials such as gastic acid. Forming a seal within a lumen that will withstand gastric acid is highly challenging due to the extreme acidity (pH 1-2) and the presence of digestive enzymes. Further, at the high pressures and temperatures encompassed by the claim, it is very difficult to occlude a lumen completely. There is no description in the application of how the invention can be used to completely occlude a lumen across the scope of the claimed invention, specifically creating a complete occlusion using caustic materials and high temperatures and high pressures. There is no description in the application of how to prepare the present composition to occlude a lumen under the scope of what is claimed, which includes a complete seal of a lumen under the scope of all pressures, temperatures, and physiological fluid or gases, which requires a material forming the lumen and the occlusion mechanism to be robust enough to withstand the immense forces involved. Claim 17 further recites “support of an anatomical structure to assist in therapeutic restoration of an… “or other skeletal or function.” “Other skeletal or function” is not a term of art, it is not something that can be supported, and the application does not describe “other skeletal or function” or how this term can be used in the invention. The recitation “for purposes of an indwelling, permanent implant to provide the function of…” is not described in the application. There is no description of how to use the device of claim 15 “for purposes of an indwelling, permanent implant to provide the function of.” There is no description of what is meant by “maintaining an open anatomical lumen.” To maintain has a variety of definitions, and it’s not described in the application what aspect of the open anatomical lumen must be maintained in order to satisfy the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 15 and 17-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The recitation in claim 15 “said device or a device feature.” There is insufficient antecedent basis for “said device or a device feature” as there is no “device feature” previously recited in the claim. Further, claim 18 recites “a temporarily indwelling device… a limited time therapeutic benefit-left indwelling for a period of time-and subsequently removed when the therapeutic period is complete.” As no therapeutic period is previously recited in the claim, there is insufficient antecedent basis for this limitation in the claim. Further, the terms “temporarily” and “limited time” are relative terms that are not defined by the claim, and the artisan would not be apprised of what time intervals are and are not encompassed by the claimed “temporarily” and “limited time.”
Notes and Comments
In the interest of expedited prosecution, a telephone call was placed on 11/25/2025 to Caitlin Hyland to propose cancelling claims 15 and 17-19. The proposal was declined.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL W DICKINSON whose telephone number is (571)270-3499. The examiner can normally be reached on M-F 9 AM to 7:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached on 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL W DICKINSON/Primary Examiner, Art Unit 1618
November 26, 2025