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 .
Applicants' arguments, filed March 23, 2026, have been fully considered but they are not deemed to be fully persuasive. The following rejections and/or objections constitute the complete set presently being applied to the instant application.
Claim Interpretation
New claim 32 relates to the intended interaction target for the V portion of the claimed compounds. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim so if the claimed molecule can interact with the Fc region or Fc region of Fc-fusion protein, the compounds meet the limitation of the claims
New claims 33 - 42 reflect changes in the list of possible options for the claimed compounds and do not require the presence of such groups in the claimed compounds.
Claim Objections
Claims 1 and 2 are objected to because of the following informalities: the word “and’ should be added before the last item of the claim. Appropriate correction is required.
Claim 19 is objected to because of the following informalities: “(v)” should be added before the last item in the last line of the claim to match the formatting of all the other possible values for the payload P. Appropriate correction is required.
Claim 35 is objected to because of the following informalities: the word “is” should be inserted before “selected” in line 1 such that the claim makes grammatical sense. Appropriate correction is required.
Claim 43 is objected to because of the following informalities: the word “is” should be inserted before “represented by” to indicate that the peptide must be of either formula (8a’) or (8b’). Appropriate correction is required.
Claim Rejections - 35 USC § 112 – Written Description
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 1 – 4, 6, 7, 16 – 18 and 31 – 43 were 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. This written description rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 23, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that claim 1 has been amended to recite that Y is of formula (6a) to (6l’) and S is either of formula (a2) or (b2). The specification describes the invention in sufficient detail such that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. There is ample description of compounds of claim 1 with over 100 compounds of formula (I) that include various embodiments of variables P, Y, S and V and description of various payloads, reactive moieties, spacers and vectors disclosed.
The claim amendments and arguments are unpersuasive. Depending on the scope of the claims, 100 compounds or more being exemplified in the disclosure as originally filed may or may not constitute a representative number of species within the claimed genus to fully satisfy the written description requirement for the claims. The amendments to the claims have narrowed the scope of the claims but the claims still encompass a very large number of compounds. 38 different structures are permitted for Y, which is narrower than before, but still encompassing a large number of possible compounds. While the scope of (a2) for S is not especially large, (b2) encompasses any peptide 6 – 25 amino acids in length wherein each location is 1 of 9 different amino acids. For the shortest possible peptide of 6 amino acids, over 10 million (69) different sequences are encompassed. The scope of P and V remains very broad and unchanged from the previous claim set. Despite the narrowing the claims by the addition of structures for Y and S, the disclosed structures still do not represent sufficient species to demonstrate possession of the full scope of the claimed compounds and the written description rejection is maintained.
Claim Rejections - 35 USC § 112 – Indefiniteness
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 – 4, 6, 7, 16 – 19 and 31 – 43 were 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. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 23, 2025 and those set forth herein.
Applicants have amended claim 1 and argue that various claim amendments, including formula for Y and S and the removal of language related to preferable and optional features, have been made. Amended claim 1 informs those skilled in the art with reasonable certainty as to the scope of the claimed compounds particularly in view of the numerous examples of suitable payloads, spacer groups, vectors and reactive moieties disclosed in the Application that can be included the claimed compounds [sic]. The terms preferably, such as, such and in particular have been removed.
The claim amendments and arguments do not render the scope of the claims definite. The scope of elements Y and S are now definite in view of the amendments to those elements of the claimed compounds P-Y-S-V. No attempt has been made to address the issue with the definition of payload given in the disclosure as originally filled that may or may not require the presence of an antibody or antibody fragment either by claim amendment or argument. The scope of P and V remain very broad. 38 different structures are now permitted for Y, which is narrower than before, but still encompassing a large number of possible compounds. While the scope of (a2) for S is not especially large, (b2) encompasses any peptide 6 – 25 amino acids in length wherein each location can be 9 different amino acids. When the scope of the compounds encompassed by the amended claims as a whole are evaluated, the breadth of the compounds remains so large that one skilled in the art is still not able to envision all the compounds defined by the Markush group of the claims and therefore the claims also remain indefinite for this reasons (see MPEP 2173.05(h)(I)).
Claim 16 still recites “preferably” in the third line from the end of the claim.
Claim 17 still recites “such as” in line 11 (see first paragraph on p 14 of the amended claim set).
As all the indefiniteness issues with the claims have not been addressed, claim 1 and the rejected claims that depend from claim 1 remain indefinite.
Claim 31 is 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. There is insufficient antecedent basis for the limitation "the reaction moiety" in line 1 of the claim. Please clarify.
Claim 36 is 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 36 recites the limitation "the chelating moiety" in line 1. There is insufficient antecedent basis for this limitation in the claim as claim 3 recites a chelating agent that is a moiety derived from (emphasis added) one of the listed compounds so it is not clear if the underlined language is part of the scope of claim 36 due to the difference in wording. Please clarify.
Claim 37 is 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 37 recites the limitation "the chelating is a moiety derived from" in line 1. There is insufficient antecedent basis for this limitation in the claim. Please clarify.
Claim Rejections - 35 USC § 112 – Failure to Further Limit
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 19 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. All of the formulas in claim 19 use the variable P, which is connected via an amine to a –(CH2)2-O-(CH2)2 group and then a carbonate functional group, which must correspond to the Y portion of the P-Y-S-V compounds of claim 1. However, none of the structures set forth in claim 1 for Y comprise a –(CH2)2-O-(CH2)2 group before the carbonate group that is attached to the payload (denoted by ** in the formulas for Y). Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Improper Markush Group
Claims 1 – 4, 6, 7, 16 – 18 and 31 – 43 were rejected on the basis that it contains an improper Markush grouping of alternatives. This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 23, 2025 and those set forth herein.
Applicants traverse this rejection on the grounds that the relatedness of P, Y, S and V be considered and when that is done, there is a core structure of a payload conjugated to a vector through a reactive moiety and a spacer of defined structure and the claims do not contain [an] improper Markush grouping of alternatives.
The claim amendments and arguments are insufficient to result in the rejected claims being drawn to a proper Markush grouping. The requirements for a proper Markush group were discussed in greater detail on p 15 – 17 of the December 23, 2025 Office Action. The claims are still not drawn to the same physical, chemical or art recognized class of compounds. Therefore, the claimed compounds must share a single structural similarity and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature to be considered a proper Markush grouping. In looking at the 38 possible structures for the reactive moiety Y, the one common structural feature the Examiner could identify is a carbonyl group. When considered in the context of the claimed compounds, this is not a substantial structure feature and there does not appear to be any common use that flows from the carbonyl group. In looking at the possibly structures of S, the amino acids and formula 7 could share a carbonyl (although amino acids contain a carboxylic acid that contains a carbonyl group and not just a C=O group) or an amine as the only possible common structural feature. When considered in the context of the claimed compounds, this is not a substantial structure feature and there does not appear to be any common use that flows from the carbonyl group or amine group. Therefore even as amended, the claims are not drawn to a proper Markush grouping of compounds and the rejection is MAINTAINED.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 – 4, 6, 7 and 31 – 43 are rejected under 35 U.S.C. 103 as being unpatentable over Ito et al. (CA 3023520) in view of Strop et al. (WO 2012/059882), Hammer et al. (J Cont Rel, 2014) optionally further in view of Choe et al. (Materials, 2016).
Ito et al. discloses IgG-binding peptides containing a ligand which can be bound to a radioactive metal nuclide (whole document, e.g., abstract). The IgG binding peptide can be site-specifically modified with a crosslinking agent, reading on the reactive moiety of the instant claims, (e.g., ¶ [0007]). Conjugates of the peptide and IgG are claimed (e.g., claim 22) so the material is capable of reacting with the side chain of an amino acid. Amongst the possible sequences for the IgG-binding peptide portion is
PNG
media_image1.png
105
527
media_image1.png
Greyscale
(¶ [0038]). ¶ [0012] exemplified ligands capable of binding a radioactive metal nuclide and include the well-known chelators diethylenetriaminepentaacetic acid (DTPA), 4,7,10-tetraazacyclododecane-1,4,7,10-tetraacetic acid (DOTA), 1,4,7-triazacyclononane-1,4,7-triacetic acid (NOTA) and ethylenediaminetetraacetic acid (EDTA). ¶ [0013] exemplifies various radionuclides including 111In, 89Zr, 64Cu, 67/68Ga and 99mTc and the radionuclides are preferably bound to the IgG-binding peptide via a ligand such as a chelating agent (¶ [0014]).
The presence of a linker or spacer in the conjugate as required by the amended claims is not explicitly disclosed.
Strop et al. discloses engineered polypeptide conjugates such as Fc-containing polypeptide-drug conjugates (whole document, e.g., ¶ [0007]) that can have the structure Fc-containing polypeptide-T-A, wherein T is an acyl donor glutamine-containing tag and A is amine donor agent (¶ [0008]). The amine donor agent can have the formula X-Y-Z where X is an amine donor unit, Y is a linker and Z is an agent moiety (¶ [0011]). Some specific structures for X-Y-Z are shown at ¶ [0147]. The amino donor unit-linker can comprise polymers such as PEG (¶¶ [0011] and [0012]). The linker can be cleavable or non-cleavable and can be peptides, alkyl or PEG linkers (¶ [0127]). The agent moiety Z can be imaging agents (¶ [0013]) and therapeutic radioisotopes or other labels can be incorporated in the agent moiety (¶ [0145]). Biocompatible polymers such as PEG can be conjugated to increase serum half-life and bioactivity and/or to extend in vivo half-lives (¶ [0146]). When the engineered polypeptide conjugate is labeled with a detectable marker, the labels can be attached by spacer arms of various lengths to reduce potential steric hindrance (¶ [0161]).
Hammer et al. discloses the reversible attachment of the protein lysozyme to PEG by a degradable carbamate linkage and the different substituents of phenyl groups were used to control the rate of carbamate hydrolysis and thus protein release (whole document, e.g., abstract). A variety of protein conjugation strategies are discussed on p 67, but a common disadvantage of those stratgegies is that the linker molecules remain attached to the protein even after release from the hydrogel being used for drug delivery (p 67, col 2, ¶ 1). Aromatic succinimidyl carbonates that react with protein amino groups (lysine residues, p 75, ¶ 3) and decompose without leaving any ‘tags’ on the protein were disclosed and studied (¶ bridging p 67 and 68). Linear PEG derivatives are shown in Table 1 and the common structure of
PNG
media_image2.png
28
135
media_image2.png
Greyscale
along with the NH of the substituent R for compounds 2a, 2b and 2c read on S of the instant claim. Each molecule terminates with the succinimidyl group capable of reacts with amines to form a linker and the intervening portion of 2a, 2b and 2c read on formulas 6a, 6h and 6l’ respectively of the instant claims. The rate and mechanism of the linker cleavage are discussed on p 73, with the last paragraph in particular disclosing that the substitution pattern of the generated carbamates controls the cleavage reaction rate (p 75, ¶ 3).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to incorporate a linker into the IgG-binding peptides conjugates of Ito et al. such as the PEG carbamate structures disclosed by Hammer et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because linkers can be used as is known to one of ordinary skill in the art and as disclosed by Strop et al. when preparing constructs containing peptides with an agent such as imaging agent, which includes the metal chelates of Ito et al. Linkers or spacers can be used to provide sufficient space between the IgG-binding peptide and the radiometal nuclide containing portion of the molecule to permit peptide binding to its target (IgG) and for constructs such as those in Strop et al. that can also form a conjugate that will react with an antibody and therefore require the ability to be in a suitable position relative to the antibody for that reaction to occur. The PEG and carbamate linkers disclosed by Hammer et al. result in a cleavable linker whose rate can be controlled based on the substitution pattern on the phenyl ring and when cleaved, is ‘traceless’ in that no tags are left behind on the protein while also providing more space to reduce potential steric hindrance. This would enable targeted delivery of the payload molecule to a desired site based on the protein it was conjugated to that would then be cleaved over time, resulting in release of the payload molecule. PEG is known by those in the art as a hydrophilic group and the number of repeat units of the PEG can be varied and optimized by those of ordinary skill in the art based on factors such as hydrophilicity and optimal linker length based on factors such as the desired reaction and to potential steric hindrance.
SEQ ID NO. 17 from Ito et al. does not have a leucine at position 6 as in the elected species to have a complete sequence of DCAWHLGELVWCT.
Choe et al. reports peptides that bind to the Fc region of antibodies (whole document, e.g., abstract). In vitro selection of different peptides containing a disulfide bond resulted in the 13-mer Fc peptide Fc-III, DCAWHLGELVWCT-NH2 with an unusually high binding affinity toward the Fc region of IgG (p 6, ¶ 3). The internal disulfide bond is important for binding (p 6, ¶ 3 and Table 3).
It would have been obvious to the person of ordinary skill in the art before the effective filing date of the claimed invention to use the Fc-III peptide of Choe et al. as the IgG-binding portion of the conjugates disclosed by Ito et al. The person of ordinary skill in the art would have been motivated to make those modifications and reasonably would have expected success because DCAWHLGELVWCT demonstrates high binding affinity to the Fc region of IgG as taught by Choe et al. Depending on the particular intended use of the compound, different Fc binding peptides may be desired to modulate the binding affinity and DCAWHLGELVWCT is a known, high-affinity peptide sequence for the Fc region of IgG.
While a new ground of rejection is set forth above, the same references as previously applied are still included. Regarding that rejection, Applicants argue that the cross-linking agent of Ito does not read on the reactive moiety of the instant claims as it is located in a different region compared to the reactive moiety and does not provide the regioselective payload conjugation to an antibody of antibody fragment as in the present claims. This deficiency is not cured either Strop or Choe.
These arguments are unpersuasive. In view of the amendments requiring a particular structure for the reactive moiety Y of the instant claims, the new reference Hammer et al. has been added as discussed in greater detail. The claimed compounds do not necessarily comprise an antibody or antibody fragment, although such compounds could be a payload. The V portion of the molecule must be capable of interacting with the Fc (fragment crystallizable) region of an antibody or fragment but these arguments do not establish that the molecules rendered obvious by the combined teachings of the applied prior are not capable of such an interaction. The peptides of Choe are specifically taught as being to the Fc region of antibodies. 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., regioselective payload conjugation to an antibody) are not recited in the rejected claim(s). The only mention of the regioselectivity located in the claims is in a withdrawn method claims and none of the compound claims under examination contain any language regarding regioselective payload conjugation. 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).
Applicants also argue that there is evidence of unexpected results arising from the placement of the reactive moiety Y between the payload P and the spacer S, that spacer being of length Z so that the vector V is able to interact with the Fc region of antibody or antibody fragment and the reactive moiety Y being able to react with the side chain of an amino acid in the antibody or antibody fragment in regioselective manner of payload conjugation. The Examples of the present application demonstrate this technical effect such as example 5 in which a DOTA containing conjugate yields a conjugate with trastuzumab in excellent yields and in a single step. The produced conjugates effectively bind to adenocarcinoma cells allowing diagnosis, monitoring or imaging or treat [of] diseases such as cancer. None of the cited references teach or suggest compounds that enable regioselective modification of an antibody in a single step as with the presently claimed compounds.
These arguments are unpersuasive. While no such compounds are disclosed in a single prior art reference, as discussed above, the claimed compounds are rendered obvious by the combination of applied prior art when one of ordinary skill in the art takes into account the explicit, implicit and inherent teachings of those documents and their knowledge. The labeling that would occur when the claimed compounds are used in a method are determined by the structure of the claimed compounds. Please see MPEP 716.02 et seq. for a complete discussion of the unexpected results. Applicants bear the burden of explaining the evidence offered in support of alleged unexpected results and part of establishing unexpected results requires a comparison with the closest prior art and there is nothing that indicates a comparison was carried out. The examples show that the limited subset of claimed compounds tested could be used to label the antibody or fragment thereof but that is not sufficient to establish unexpected results. As discussed more extensively in the previous Office previously and also above in view of the claim amendments, the scope of the claimed compounds is still very broad. Even if there is persuasive evidence of unexpected results of record, that evidence must be reasonably commensurate in scope with the claims. Even if the examples in the specification were a comparison with the closest prior art and the actual results obtained were demonstrated to be unexpected in by establishment of the expected results, the results from the specification would not be reasonable commensurate in scope with the claims. Therefore the allegations of unexpected results are insufficient to outweigh the prima facie case of obviousness.
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.
Applicants request reconsideration of the non-statutory double patenting rejections in view of the amended claims and remarks.
The amendments and remarks are not fully persuasive. Since the mailing of the previous Office Action in this case, Application No. 16/764,343 has been abandoned so the provisional non-statutory double patenting rejection over that Application has been withdrawn. The remaining rejection is maintained as detailed below.
Claims 1 – 4, 6, 7, 16 – 18 and 31 – 43 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 - 33 of copending Application No. 18/248,674 (reference application). This rejection is MAINTAINED for the reasons of record set forth in the Office Action mailed December 23, 2025 and those set forth herein.
Claim 15 of US’674 defines the reactive moiety Y with the same formulas that have been added to instant claim 1. The Lxx1 and Lxx2 linked to Y1 and Y2 respectively in claim 16 of US’674 defines the peptide V and that can correspond to the newly amended values for S of the instant claims (S1 of US’764).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 Nissa M Westerberg whose telephone number is (571)270-3532. The examiner can normally be reached M - F 8 am - 4 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at 571-272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Nissa M Westerberg/Primary Examiner, Art Unit 1618
Prosecution Insights