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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-16 and 20, drawn to a liquid polymeric composition, in the reply filed on 07/21/2026, is acknowledged.
Applicant’s election (species) without traverse of:
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105
505
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(species of radiopaque molecule)
Ethylene vinyl alcohol copolymer (species of polymer)
DMSO (species of solvent)
in the reply filed on 07/21/2026, is acknowledged.
Claims 17-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/21/2026.
Claim Rejections - 35 USC § 112 –
Indefiniteness and Indefinite Language
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 1-16 and 20 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.
Regarding claims 1 and 20, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The Applicant is encouraged to remove the indefinite language from claims 1 and 20.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 1-2, 6-16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (WO 2020/098673 A1), in view of Joseph et al (US 2021/0402051 A1).
Huang taught a liquid polymeric composition (claims 23 -25) comprising: (a) from about 2 to about 20 weight percent of a polymer, such as ethylene vinyl alcohol copolymer (Examples); (b) from about 5 to about 40 weight percent of a radiopaque molecule, such as 2,4,6-triiodophenol, 2,3,5-triiodobenzoic acid [e.g., 715 mg at page 23, section 5 of Example 5], 2,3,5-sodium triiodobenzoate, iodotitanic acid, formazan acid, iododonic acid or iohexol (Examples), with a molecular weight below 2000 g/mol; and, (c) from about 40 to about 93 weight percent of a non-physiological solvent system or solvent system, such as dimethyl sulfoxide or N-methylpyrrolidone (Examples); wherein: (i) the sum of the weight percent of all components in the composition was 100, (ii) the polymer and the radiopaque molecule were both dissolved in the non-physiological solvent or solvent system. The composition was used for embolization by injecting it into a physiological environment, whereby it precipitated and embolized (claim 26).
Specifically, Huang taught
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210
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, where B, C, R, n, p, q and Z were as defined in formula II [bottom of page 12, bridging to page 13], where B was poly(ethylene) or poly(ethyleneoxy)
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53
145
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, C was oxy (-O-), Z was the ethylene-vinyl alcohol copolymer, R was selected from alkyl, cycloalkyl, heterocyclyl, aryl or heteroaryl, the alkyl, cycloalkyl, aryl or heteroaryl and contained multiple iodine atoms, which was one iodine atom, 2 iodine atoms, 3 iodine atoms or 4 iodine atoms [claims].
Huang was silent stability, as recited in claim 1.
Joseph taught a radiopaque, homogeneous polymeric liquid embolic system [title and ¶s 0016 and 0031]. At Examples 3 and 7 [0069 and 0073], it was taught iodo-containing compounds comprising ethylene vinyl alcohol copolymer, dissolved in dimethyl sulfoxide, that were stable at the tested conditions (e.g., 37° C for 3 months). As per Joseph, a low cost, metal powder free, biologically stable liquid embolic system with good clinical handling characteristics is essential for the treatment of clinical conditions [0013-0014 and 0018-0019].
Since Huang generally taught radiopaque polymeric liquid embolic systems, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Huang, stable systems throughout three months, as taught by Joseph. The ordinarily skilled artisan would have been so motivated, because a low cost, metal powder free, biologically stable liquid embolic system with good clinical handling characteristics is essential for the treatment of clinical conditions, as taught by Joseph [0013-0014 and 0018-0019].
The instant claim 1 recites 2-20 weight percent polymer; 5-40 weight percent radiopaque molecule; 40-93 weight percent solvent; precipitate maintained at least 50 % radiopacity during at least 1 hour and lost at least 50 % radiopacity in less than 3 months.
Huang taught about 2 to about 20 weight percent of a polymer, from about 5 to about 40 weight percent of a radiopaque molecule and from about 40 to about 93 weight percent of a non-physiological solvent system or solvent system. Joseph taught stability of the radiopaque molecule throughout three months. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Huang, in view of Joseph, reads on claims 1-2, 6-16 and 20.
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al (WO 2020/098673 A1), in view of Salb et al (US 2001/0031035 A1).
The 35 U.S.C. 103 rejection over Huang was previously described.
Although Huang was generally drawn to visualization agents [abstract], Huang was silent the LogP of the compounds, as recited in claims 3-5.
Salb taught radiographic imaging of tissue using radio-opaque compounds that accumulated intracellularly in tissue [abstract], and had LogP values of 3.28 and 3.77 [Examples 1-2 at ¶s 0158 and 0164, respectively], or 8.09 [Example 6 at ¶ 0207].
Since Huang was generally drawn to visualization agents, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Huang, compounds having a logP of 3-8, as taught by Salb. The ordinarily skilled artisan would have been motivated to accumulate the radiopaque compounds intracellularly, in order to visualize tissue, as taught by Salb [Examples 1-2 and 6].
The instant claim 3 recites a LogP from 2-9.
The instant claim 4 recites a LogP from 2-7.
The instant claim 5 recites a LogP from 4-9.
Salb taught LogP values of 3.28, 3.77 and 8.09. A prima facie case of obviousness exists because of overlap, as discussed above.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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