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
Applicant’s election without traverse of Group 1 in the reply filed on 12/23/25 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Applicant’s election of the species as set forth in the reply filed on 12/23/25 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
As recognized 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Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 12/11/23 and 10/25/23 have been considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
Based on the filing date of the instant application sequence compliance is governed by ST.26 and 37 CFR 1.831-1.835.
37 CFR 1.831(a) states that amino acid sequence encompassed by the sequence rules should be disclosed in a sequence listing and 37 CFR 1.831(c) states that the corresponding sequences should be identified by sequence identifier.
In the instant case, page 14 section 0048 of the specification recites numerous peptides with 4 or more specifically identified amino acids including glycylglycyl-L-lysylglycylglycy-L-lysine, L-Lysyl-L-threonyl-L-lysyl-L-lysine, glycylglycyl-L-lysyl-L-lysylglycyl-L-cysteine, L-lysyl-L-arginyl-L-lysyl-L-lysine, L-arginyl-L-lysyl-L-lysyl-L-lysine, L-leucyl-L-lysyl-L-seryl-L-lysyl-L-lysine, L-alanyl-L-methionylglycyl-L-lysyl-L-lysyl-L-lysine, L-lysyl-L-lysyl-L-lysyl-L-arginylL-glutamine, L-seryl-L-isoleucyl-L-lysyl-L-lysyl-Lysyl-L-lysine and L-lysyl-L-lysyl-L-lysyl-L-alanine. However, no sequence listing is of record.
This application contains sequence disclosures that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.831. However, this application fails to comply with the requirements of 37 C.F.R. §§ 1.821-1.825 for the reason(s) set forth on the attached Notice To Comply With Requirements For Patent Applications Containing Nucleotide Sequence And/Or Amino Acid Sequence Disclosures. Applicant must comply with the requirements of the sequence rules (37 CFR 1.821 - 1.825). APPLICANT IS GIVEN THREE MONTHS FROM THE DATE OF THIS LETTER WITHIN WHICH TO COMPLY WITH THE SEQUENCE RULES, 37 C.F.R. §§ 1.821-1.825. Failure to comply with these requirements will result in ABANDONMENT of the application under 37 C.F.R. § 1.821(g). Extensions of time may be obtained by filing a petition accompanied by the extension fee under the provisions of 37 C.F.R. § 1.136. In no case may an applicant extend the period for response beyond the six month statutory period. Direct the response to the undersigned. Applicant is requested to return a copy of the attached Notice to Comply with the response.
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Appropriate correction is required.
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 1-14 and 16-17 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 1a refers to a polymer and then refers to arms having unsaturated end groups. In this context, it is unclear if the plural term ‘groups’ is requiring any given polymer to have more than one unsaturated end group or if the language encompasses multiple polymers which each contain an unsaturated end group resulting in a plurality of end groups. Page 5 section 0021 of the specification refers to figure 4 and refers to ‘acrylate end groups’. However, figure 4 shows a single acrylate group. It is unclear if the compound of figure 4 has the required end groups. None of the dependent claims clarify the claim scope.
Claim 2 refers to carboxy-substituted. Claim 2 depends on claim 1 which merely refers to an iodinated polyamino compound. Claim 1 does not require or recite a carboxy group. Without a carboxy group in claim 1, it is unclear what the substitution of claim 2 and dependent claims 3-11 is in relation to. As such, the scope of the structures encompassed by the claims is unclear. Claims 3 and 6 refer to a carboxylic acid. If a carboxylic acid is present it is unclear what the substitution corresponds to. Claim 10 refers to ‘carboxyl’. It is unclear if the ‘carboxyl’ of claim 10 is the same as the ‘carboxy’ of claim 2.
Claim 13 refers to ‘monomers selected from’ and then recites ‘or PEG methyl ether methacrylate, or PNIPAAM’. The use of multiple ‘or’ within the same group makes it unclear where the group ends and makes it unclear if combinations of monomers are required.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
Claim Rejections - 35 USC § 103
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). 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). 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).
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).
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).
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.
Conclusion
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658