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 .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 6/26/26 are acknowledged. Any objection or rejection from the 2/26/26 office action that is not addressed below is withdrawn based on the amendments.
Previously, Group 1 and the species as set forth in the reply filed on 12/23/25 were elected.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12/23/25.
As recognized previously by the applicant, claim 15 is drawn to a non-elected species since the elected species contains an acrylate group not one of the groups recited in claim 15.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/23/25.
Claims 1-14 and 16-17 are being examined.
Priority
The priority information is found in the filing receipt dated 8/31/23.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 4/9/26 has been considered by the examiner.
Claim Rejections - 35 USC § 112
Claims were previously rejected under 35 USC 112(b)/2nd. Since the claims have been amended, the rejection is updated to correspond to the instant claims.
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 2-11 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.
Claim 2 refers to carboxylic-acid- or carboxylate-substituted iodinated moiety with respect to the polyamino compound of claim 1. It is unclear if the phrase ‘substituted’ is requiring some type of change and if so it is unclear what the change is in relation to. The elected polyamino compound is in figure 3c. The polyamino compound of figure 3c appears to contain a standard C-terminus of the peptide (i.e. -COOH). It is unclear if such standard C-terminus is to be considered a carboxylic acid substituted moiety. It is unclear if the elected polyamino compound reads on claim 2. None of claims 3-11 which depend on claim 2 clarify the claim scope.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
Response to Arguments – 112
Applicant's arguments filed 8/10/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue that claim 2 is a further limitation, the elected polyamino compound is in figure 3c. The polyamino compound of figure 3c appears to contain a standard C-terminus of the peptide (i.e. -COOH). It is unclear if such standard C-terminus is to be considered a carboxylic acid substituted moiety. It is unclear if the elected polyamino compound reads on claim 2.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since the claims have been amended including the recitation of ‘core region’ the rejection is updated to correspond to the instant claims.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-14 and 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Delaney et al. (US 2021/0060183; cited with IDS 12/11/23; ‘Delaney’) in view of Moncrief et al. (US 2007/0099841; ‘Moncrief’).
Delaney teach compositions with iodine groups (abstract and sections 0008 and 0010) and specifically teach iodine containing therapeutic groups (section 0044). Delaney teach bioerodible injectable hydrogels (section 0003) which are stable in tissue (section 0004). Delaney teach a reaction product of a polymer and multifunctional compound (claim 20). Delaney teach a system comprising a first composition and second composition (claim 12). Delaney teach multi-arm polymers (abstract) specifically PEG methyl ether acrylate (section 0016) which are reactive with the compound (abstract). With respect to the multi-arm polymers, Delaney teach that the polymers comprise a core region and a plurality of arms each having a reactive end group such as an amine-reactive group (section 0055 and figure 1). Delaney shows the reaction of acrylate with an amine (figure 8A and section 0068). With respect to the amine, Delaney specifically teach oligo-lysine compounds including trilysine (sections 0037, 0065 and 0090). Delaney teach a delivery device comprising reservoirs (claims 18-19). Delaney specifically teach double barreled syringes (section 0081). Delaney teach fluids such as water to be added for injection and teach reservoirs (section 0080).
Delaney does not provide a specific example with all of the claim limitations.
Moncrief teach peptide conjugates comprising T3 or T4 (abstract) where T4 is 3:5,3’:5’tetra-iodothryronine (section 0060) which is a known hormone (section 0003) and is known to be administered for particular disorders (section 0002 and Table A) including those that involve various tissues (section 0004). Moncrief teach availability of T4 to target tissues for optimum human health (section 0062). Moncrief specifically suggest T4 conjugates to Lys-Lys-Lys (section 0064). In figure 3, Moncrief shows T3 conjugated to a peptide. Moncrief teach the peptide carrier as protecting the active agent (abstract). Moncrief teach that methods of synthesis were known (examples 2 and 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Delaney based on the specific teachings and suggestions of Delaney. Since Delaney teach compositions with iodine groups (abstract and sections 0008 and 0010) and specifically teach iodine containing therapeutic groups (section 0044) and teach compositions with advantageous properties (sections 0003-0004) one would have been motivated to make and use such compositions using known iodine containing therapeutic groups including the groups suggested by Moncrief. Moncrief teach peptide conjugates comprising T3 or T4 (abstract) where T4 is 3:5,3’:5’tetra-iodothryronine (section 0060) which is a known hormone (section 0003) and is known to be administered for particular disorders (section 0002 and Table A) including those that involve various tissues (section 0004). Moncrief teach availability of T4 to target tissues for optimum human health (section 0062). Moncrief specifically suggest T4 conjugates to Lys-Lys-Lys (section 0064) (trilysine is also taught by Delaney sections 0037, 0065 and 0090) thus one would have been motivated to make such conjugates especially since Moncrief teach the peptide carrier as protecting the active agent (abstract). In figure 3, Moncrief shows T3 conjugated to a peptide. When using the peptide conjugate suggested by Moncrief (Lys-Lys-Lys-T4) one would have been motivated to use the known chemistry taught by Delaney. Delaney teach multi-arm polymers (abstract) specifically PEG methyl ether acrylate (section 0016) which are reactive with the compound (abstract). With respect to the multi-arm polymers, Delaney teach that the polymers comprise a core region and a plurality of arms each having a reactive end group such as an amine-reactive group (section 0055 and figure 1). Delaney shows the reaction of acrylate with an amine (figure 8A and section 0068). In order to carry out such reactions, one would have been motivated to prepare as systems as suggested by Delaney (claims 12 and 18-19). One would have had a reasonable expectation of success since the components and methods of preparing were known. Delaney shows the reaction of acrylate with an amine (figure 8A and section 0068). Moncrief teach that methods of synthesis were known (examples 2 and 7).
In relation to the iodinated polyamino of claim 1a and 2-11, Moncrief specifically suggest T4 conjugates to Lys-Lys-Lys (section 0064) resulting in Lys-Lys-Lys-T4 for example. Moncrief teach T4 is 3:5,3’:5’tetra-iodothryronine (section 0060) which is an amino acid and contains iodinated aromatic and a hydroxyl. Delaney specifically teach oligo-lysine compounds including trilysine (sections 0037, 0065 and 0090). As noted above the instant claims are unclear. The instant claims (claim 23-29) show an amino acid or peptide conjugated to T4 on the C-terminal side. Figure 3 of Moncrief shows a peptide that when read from right to left can correspond to 3 amino acids conjugated to T3. Lys-Lys-Lys-T4 as discussed above contains the iodinated moiety on the C-terminal side of the peptide. Further, there are a finite number of locations for the conjugation.
In relation to the multi-arm polymer of claims 1b and 12-14, Delaney teach multi-arm polymers (abstract) specifically PEG methyl ether acrylate (section 0016) which are reactive with the compound (abstract). With respect to the multi-arm polymers, Delaney teach that the polymers comprise a core region and a plurality of arms each having a reactive end group such as an amine-reactive group (section 0055 and figure 1).
In relation to the system of claims 16-17, Delaney teach a delivery device comprising reservoirs (claims 18-19). Delaney specifically teach double barreled syringes (section 0081). Delaney teach fluids such as water to be added for injection and teach reservoirs (section 0080).
Response to Arguments - 103
Applicant's arguments filed 8/10/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that Delaney introduces radiopacity by attaching iodinated groups to a portion of the polymer arms, the instant claims are not drawn to methods of introducing radiopacity. Further, claim 1 recites the open ended language ‘comprises’ (line 1) and refers to a polymer.
Although applicants argue that Delaney does not teach or suggest an unsaturated end group, Delaney teach multi-arm polymers (abstract) specifically PEG methyl ether acrylate (section 0016) which are reactive with the compound (abstract). PEG methyl ether acrylate is specifically recited in instant claim 13. With respect to the multi-arm polymers, Delaney teach that the polymers comprise a core region and a plurality of arms each having a reactive end group such as an amine-reactive group (section 0055 and figure 1).
Although applicants argue about figure 8, the instant rejection is not based solely on figure 8. Delaney teach multi-arm polymers (abstract) specifically PEG methyl ether acrylate (section 0016) which are reactive with the compound (abstract). With respect to the multi-arm polymers, Delaney teach that the polymers comprise a core region and a plurality of arms each having a reactive end group such as an amine-reactive group (section 0055 and figure 1). Figure 8 shows the known chemistry of an acrylate reacting with an amine.
Although applicants argue that Moncrief relates to methods of treating thyroid disorders while Delaney relates to radiation therapy, the instant claims are product claims and are not drawn to methods of treating. MPEP 2144 IV recognizes that the reason or motivation to modify a reference can be for a different purpose from applicants.
Although applicants argue that based on the teachings of Delaney one would have attached the compounds of Moncrief to the polymer arms, such argument appears to support the instant rejection.
Although applicants argue about crosslinking capacity without sacrificing radiopacity, the instant claims are drawn to products. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., crosslinking capacity without sacrificing radiopacity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
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 1-14 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/103,932 (reference application; ‘932’). Although the claims at issue are not identical, they are not patentably distinct from each other.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
932 recites a system for forming a hydrogel comprising a first composition that comprises a polyiodinated polyamino compound and a second composition that comprises a multi-arm polymer that have reactive groups that are reactive with amino groups of the polyiodinated polyamino compound (claim 1). 932 recites that the hydrophilic polymer arms comprise PEG methyl ether acrylate (claim 11). 932 recites details about the polyamino group (claims 9-10) and specifically recites polylysine (claim 8). 932 recites aromatic polyiodinated groups that contain hydroxyl (claim 6). 932 recites a syringe and barrels (claims 15-16).
In relation to the iodinated polyamino of claim 1a, 932 recites a system for forming a hydrogel comprising a first composition that comprises a polyiodinated polyamino compound and a second composition that comprises a multi-arm polymer that have reactive groups that are reactive with amino groups of the polyiodinated polyamino compound (claim 1).
In relation to the polyamino of claims 2-7, 932 recites aromatic polyiodinated groups that contain hydroxyl (claim 6). As noted above certain claims are unclear. Due to the lack of clarity of the claims, possible additional embodiments are addressed herein. Since 932 recites a polyamino compound (claim 1) specifically polylysine (claim 8) and recognize linkage to a polyiodinated group one would have been motivated to attach group at one of the finite number of locations including the C-terminal end of polylysine.
In relation to the polyamino of claims 8-10, 932 recites details about the polyamino group (claims 9-10) and specifically recites polylysine (claim 8).
In relation to the multi-arm polymer of claims 1b and 12-14, 932 recites that the hydrophilic polymer arms comprise PEG methyl ether acrylate (claim 11). Claim 11 expressly recites one or more.
In relation to the system of claims 16-17, 932 recites a syringe and barrels (claims 15-16). Since 932 recites a reaction and a hydrogel (claims 1 and 18) one would have been motivated to include agents appropriate for such use.
Response to Arguments – Double Patenting
Applicant's arguments filed 8/10/26 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants refer to condition for allowance or clear that no further amendments will be made, nothing has been done to overcome the rejection so it remains of record.
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 RONALD T NIEBAUER whose telephone number is (571)270-3059. The examiner can normally be reached M - F 6:30 - 2:30 EST.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658
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