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
Applicant's election with traverse of Group I, claims 95-104 and 108, in the reply filed on 2/18/2026 is acknowledged. The traversal is on the ground(s) that Groups II and VII should be joined with Group I because the species of Group VII read on the homo-bivalent linker compounds of Group I and the search for Group I will likely reveal prior art that reads on the multi-conjugates of Group II. This is found persuasive; Groups II and VII are hereby rejoined with Group I for examination herein.
Applicant’s election without traverse of the species Structure 4: X----NH-(CH2)-CO-NH-(CH2)-CO----X, wherein X is maleimide and <--> as recited in Structure I of claim 1 is absent, in the reply filed on 2/18/2026 is acknowledged.
Claim Status
Claims 95-114 are pending. Claims 97, 104, and 110-113 are withdrawn as non-elected inventions (claims 110-113) and non-elected species (97 and 104). Claims 100 and 114 are currently amended. Claims 1-94 are cancelled.
Priority
The instant application is the 371 national stage entry of PCT/US2021/055085, filed 10/14/2021, which claims priority to the provisional application 63/093,062, filed 10/16/2020. The priority date of 10/16/2020 is acknowledged.
Information Disclosure Statement
The IDS filed on 10/11/2023 is under consideration.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
1. Specific deficiency - This application fails to comply with the requirements of 37 CFR 1.821 - 1.825 because it does not contain a "Sequence Listing" as a separate part of the disclosure or a CRF of the “Sequence Listing.”.
Required response - Applicant must provide:
A "Sequence Listing" part of the disclosure; together with
An amendment specifically directing its entry into the application in accordance with 37 CFR 1.825(a)(2);
A statement that the "Sequence Listing" includes no new matter as required by 37 CFR 1.821(a)(4); and
A statement that indicates support for the amendment in the application, as filed, as required by 37 CFR 1.825(a)(3).
If the "Sequence Listing" part of the disclosure is submitted according to item 1) a) or b) above, Applicant must also provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
If the "Sequence Listing" part of the disclosure is submitted according to item 1) c) or d) above, applicant must also provide:
A CRF in accordance with 37 CFR 1.821(e)(1) or 1.821(e)(2) as required by 1.825(a)(5); and
A statement according to item 2) a) or b) above.
2. Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
More specifically, see Example 4, [00140], Example 8, [00144], Example 12, [00148], Example 14, Example 15, [00150-00153], all of which refer to a “glycine-glycine-valine-lysine” linker; note that [00152] recites the sequence of both HIV-TAT as well
3. Specific deficiency - The Incorporation by Reference paragraph required by 37 CFR 1.821(c)(1) is missing or incomplete. See item 1) a) or 1) b) above.
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required incorporation-by-reference paragraph, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Claim Objections
Claims 102, 104, and 107 are objected to because of the following informalities:
Regarding claim 102, the claim is objected to because it is difficult to comprehend Structure 3 due to the use of unconventional symbols. For improved clarity and readability, it is suggested that the recycling symbols and half-shaded circles be substituted for more conventional symbols.
Regarding claims 102 and 104, both claims recite “spacer group ---” (see Pg 4, line 13 of 102 and line 2 of 104). However, both claims ultimate depend from claim 95, which recites that the spacer group is “< --- >”. For consistency and clarity, amend claims 102 and 104 such that they recite “spacer group < --- >”.
Regarding claim 107, line 2 recites that the biological moiety can be selected from a peptide or a protein. Amend the claim such that one or the other is recited but not both. Appropriate correction is required.
Claim Interpretation
Claim 95 recites that X is a “function group,” which is being interpreted as equivalent to a “functional group” wherein a functional group is defined as a group of atoms within a molecule that have specific characteristic properties.
Claim 105 recites a multi-conjugate comprising two or more biological moieties joined together by covalent bonds, wherein at least one covalent bond within the multi-conjugate is formed by reaction with the homo-bivalent linker compound of claim 95. The claim is being interpreted as having one biological moiety covalently linked to the homo-bivalent linker, which is then covalently linked to a second biological moiety, wherein additional biological moieties can be further linked in any other relative orientation so long as the linkage is a covalent bond.
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 101 and 108 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 claim 101, the claim depends from claim 98, which recites the linking group comprises at least one amide bond formed from the linkage of two amino acids. However, claim 101 recites the at least one amino acid is selected from glycine, alanine, proline, valine, lysine, aspartic acid, citrulline, or beta-alanine. Thus, the scope of the claim is indefinite because there is no prior recitation of at least one amino acid and it is unclear which of the two amino acids “the” at least one amino acid refers to. For purposes of examination, the claim is being interpreted as at least one of the two amino acids recited in claim 98 are selected from the group recited above.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 108 recites the broad recitation at least 75% pure, and the claim also recites 80%, 85%, 90%, 95%, 96%, 97%, 98%, 99%, and 100% pure, which are the narrower statements of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 95-96, 98-103, 105-109, and 114 are rejected under 35 U.S.C. 101 because they are directed to a judicial exception.
The Supreme Court has given a three-part test for patent eligibility (see flowchart of MPEP 2106(III)):
Are the claims drawn to a process, machine, manufacture, or composition of matter?
2a) If the claims pass the first test, are the claims drawn to a judicial exception (a law of nature, a natural phenomenon (product of nature), or an abstract idea)?
2b) If a judicial exception applies, do the claims recite additional elements that amount to significantly more than the judicial exception?
Applying the three-part test to the instant claims:
Regarding 1), the claims are drawn to a composition of matter.
Regarding 2a), the peptide claimed is a product of nature.
The claims are drawn to a homo-bivalent linker comprising the structure
(X)-<-->-□-<--->-(X), wherein X is a functional group, <--> is a spacer that is present or absent, and □ is a linking group comprising at least one amide bond. Wherein a functional group is interpreted as described above (Claim Interpretation) and <--> is present or absent, this reads on any naturally-occurring protein comprising at least four amino acids with a palindromic sequence. For example, Sridhar et al. teaches the palindrome “RALAR” in the blood clotting protein (PBD code:2FZV:A; Analyses of the Sequence and Structural Properties Corresponding to Pentapeptide and Large Palindromes in Proteins. PLoS One. 2015 Oct 14;10(10):e0139568., see Pg 4, “Secondary structure”). In this sequence, the functional group X is R, the spacer <--> is absent, and the linking group □ is “ALA.” Another palindromic sequence taught by Sridhar is “GDNPRPNDG” from the hydrolase protein (PBD code:3B7E:A). In this sequence, the linking group □ is “PRP” and the functional group X is G and the spacer <--> is DN, OR the functional group X is GD and the spacer <--> is N, OR the functional group X is GDN and the spacer <--> is absent. Sridhar further teaches that palindromic sequences are fairly common in naturally-occurring proteins (Pg 1, first paragraph) and provides many other examples (see, for instance, Pg 4, “Secondary structure”).
Regarding 2b), none of the claims above recite features that modify the claimed products such that they are significantly more than the natural products. The claims merely recite elements that continue to read on naturally-occurring peptides with palindromic sequences, such as the presence of an amine group, specific numbers and types of amino acids, the palindromic sequence as part of a larger peptide, and a pharmaceutical composition thereof. As such, they do not contain elements added to the judicial exception sufficient to render the claims significantly more than the exception. Taken together, the claims are drawn to patent ineligible subject matter and are rejected here.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
First rejection
Claim(s) 95 and 98-101 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cellamare et al. (Design, synthesis, and biological evaluation of glycine-based molecular tongs as inhibitors of Abeta1-40 aggregation in vitro. Bioorg Med Chem. 2008 May 1;16(9):4810-22.; cited on ISR and IDS filed 10/11/2023).
Cellamare teaches a series of N-terminus benzamides of glycine-based symmetric peptides, linked to m-xylylenediamine and 3,4’-oxydianiline spacers, prepared and tested as inhibitors of β-amyloid Aβ1-40 aggregation in vitro (Abstract).
Regarding claim 95, Cellamare teaches the following compounds, A-D:
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where compounds A-D each read on the instant Structure 1 of claim 95 (Scheme 1). Structures A-D meet the limitations of Structure 1 where the functional group X is
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; the spacer <--> is absent; and the linking group □ is
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(Structure A),
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(Structure B),
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(Structure C), or
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(Structure D).
Regarding claim 98, 99, and 101, as shown above, the linking group □ of Structures C and D comprise n glycine residues, where n is 0-3, which reads on one amide bond formed by two amino acids and two amide bonds formed by three amino acids.
Regarding claim 100, as shown above, the amide bonds formed are eupeptide bonds.
Second rejection
Claim(s) 95, 96, 98-103, 105-107, 109 and 114 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Orchard et al. (US20190388571A1, published 12/26/2019), as evidenced by PubChem (Diethylenetriaminepentaacetic acid, accessed from https://pubchem.ncbi.nlm.nih.gov/compound/Diethylenetriaminepentaacetic-acid on 5/14/2026.).
Orchard teaches radioimmunoconjugates for the treatment of bone marrow associated diseases (Abstract).
Regarding claim 95, Orchard teaches the radionuclide is linked to the CD66-binding component via a structure of the formula
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, wherein n is 0 or 1; m is 1-15; p is 0 or 1; R1 and R3 are independently selected from
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, and R2 is selected from
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([0034-0040]). This meets the limitations of claim 1, wherein R1 and R3 are equivalent to the instant functional group X and selected from the group above, where R1 and R3 are the same functional group; R2 is equivalent to the linking group □ and selected from –[NHCHR4CO]y, R4 is selected from the group above and y is at least 2 (amide bond); n is 1; m is 1; and p is 1.
Regarding claim 96, as stated above, Orchard teaches R1 and R3 can be maleimide or amide ([0038]).
Regarding claim 98, as stated above, Orchard teaches R2 can comprise –[NHCHR4CO]y, R4 is selected from the group above, and y is at least 2 (amide bond), which reads on a at least one amide bond formed from the linkage of two amino acids ([0040]).
Regarding claim 99, as stated above, Orchard teaches R2 can comprise –[NHCHR4CO]y, R4 is selected from the group above, and y is 1-20 (amide bond), which reads on at least one amide bond formed by the linkage of two amino acids, two amide bonds formed from the linkage of three amino acids, and three amide bonds formed from the linkage of four amino acids ([0040]).
Regarding claim 100, the amide bond taught by Orchard can be diglycine, when R2 comprises –[NHCHR4CO]y, R4 is H, and y is 2 (amide bond); the bond formed is a eupeptide bond ([0040]).
Regarding claim 101, –[NHCHR4CO]y, wherein R4 is H, Me, and HOOCCH2, reads on Glycine, Alaine, and Aspartic Acid, respectively ([0040]).
Regarding claim 102, Orchard teaches the elected compound wherein R2 is –[NHCHR4CO]y, R4 is selected from H, and y is 2-4 (resulting in 1-3 amide bonds). This reads on Structure 2, R-Aa-Bb-Cc-Dd-R’, wherein R is absent, R’ is absent, at least A and B, and up to A through D, are present (where a, b, and when also present, c, d, are each 1); each of A, B, C, and D independently comprise Structure 3,
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. Within Structure 3, w is 1 and x, y, and z are 0; each of
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are absent;
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is H;
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is OH; and
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I is H, thereby resulting in NH-CH2-COOH (glycine); when the Structure 3 of A and Structure 3 of B, or A-D, are bonded together, an amide bond is formed and two amino acids are linked.
Regarding claim 103, as stated above, Orchard teaches R1 and R3 can be maleimide or amide ([0038]).
Regarding claims 105 and 106, Orchard teaches the linker compound described links a chelating agent and a CD66-binding component, which reads on two biological moieties ([0031, 0038]).
Regarding claim 107, Orchard teaches the chelating agent may be DTPA ([0041]), which has the following structure and contains a carboxylic acid, as evidenced by PubChem:
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. Orchard further teaches that the CD-66 binding component may be a polypeptide ([0031-0032]).
Regarding claim 109, Orchard teaches a pharmaceutical composition of the above compound (Figure 4, [0084]).
Regarding claim 114, as stated above, Orchard teaches the formula
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. Where R1 and R3 are both maleimide, R2 is –[NHCHR4CO]y, R4 is H, and y is 2; n is 1; m is 1; and p is 1 reads on the elected compound X----NH-(CH2)-CO-NH-(CH2)-CO----X, where X is maleimide and there is no spacer.
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) 95, 96, 98-103, 105-109 and 114 are rejected under 35 U.S.C. 103 as being unpatentable over Orchard et al. (US20190388571A1, published 12/26/2019) in view of Matsuda et al. (Good Manufacturing Practice Strategy for Antibody-Drug Conjugate Synthesis Using Site-Specific Chemical Conjugation: First-Generation AJICAP. ACS Omega. 2019 Nov 26;4(24):20564-20570.).
The teachings of Orchard have been set forth above. Orchard does not expressly teach a compound comprising the homo-bivalent linker substituted on one end by a biological moiety, wherein the other end is unsubstituted, and wherein the compound is at least 75-100% pure.
Matsuda teaches the development of antibody-drug conjugates (ADCs) are in great demand, but challenges still exist in terms of establishing robust and scalable synthetic processes (Abstract). Matsuda teaches a method of generating ADCs, wherein an antibody (biological moiety) is conjugated to a linker that is subsequently conjugated to a small molecule payload (another biological moiety; Scheme 1, Scheme 2). In other words, as an intermediate component, Matsuda teaches the conjugation of one biological moiety to a bivalent linker, wherein the other end of the bivalent linker is not connected to a biological moiety (unsubstituted).
Matsuda further teaches that the synthesis was designed with current Good Manufacturing Practice (cGMP) in mind, where both intermediates and final products underwent purification steps, which reads on the compound being at least 75% pure (Pg 20565, “Results and Discussion”; Pg 20568, “Antibody-Drug Conjugate Synthesis Using Site-Specific Chemical Conjugation).
In light of these teachings, regarding claim 108, it would be prima facie obvious to generate a compound comprising a biological moiety conjugated to one end of the homo-bivalent linker of Orchard while the other end remains unsubstituted. One skilled in the art would recognize that in order to create a bifunctional compound, such as the ADC taught by Matsuda, one would necessarily need to generate intermediate products wherein only one end of a homo bivalent linker is conjugated to a biological moiety; additionally, one would be motivated to do so because it would provide one with the opportunity to make many combinations of bifunctional compounds. One would have a reasonable expectation of success as Matsuda teaches a method for generating compounds comprising bivalent linkers conjugated to different biological moieties at either end using such a stepwise process.
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 95-104, 108, and 114 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 and 12-30 of copending Application No. 17/503,053 (‘053 reference application; claim set filed 12/23/2021). Although the claims at issue are not identical, they are not patentably distinct from each other because they contain overlapping subject matter.
The claims of copending Application No. ‘053 are drawn to a compound comprising a homo-bivalent covalent linker substituted on one end by a substituent X, wherein X comprises a biological moiety other than a nucleic acid, wherein the compound is at least 75% pure. The homo-bivalent linker, moiety X, and purity of the linkers in copending Application No. ‘053 read on the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sara Konopelski Snavely whose telephone number is (571)272-1841. The examiner can normally be reached Monday - Friday 9-6pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa L Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARA E KONOPELSKI SNAVELY/Examiner, Art Unit 1658
/Melissa L Fisher/Supervisory Patent Examiner, Art Unit 1658
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