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 .
Status of the Claims
Claims 1-2, 4-5, 13-16, 18, 20, 23, 26, 28-29, 35, 44, 51-52, 54, 60 and 62-65 are pending in the instant application and subject to examination herein.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/28/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112(b)
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 13-14, 18, 20, 23, 26, 28, 54, 62-63 and 65 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 13 is drawn to a compound of the overall formula “T-L-E”, wherein T is a radical of raltitrexed or 5-MTHF or of an analog of raltitrexed or 5-MTHF, L is a linker, and E is a radical of a TLR7 agonist represented by Formula (IV), shown below:
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Claim 13 specifically limits the scope of substituents R1-R5, X1-X3, and Z, and does not provide for any connection to the linker “L” at any of these positions. Claim 13 is indefinite because a person of ordinary skill in the art, following the limitations provided for a radical of Formula (IV) shown above, would not understand the metes and bounds of the claim given the contradictory requirements that the elements “E” and “L” must be connected but the structure of “E”, as a radical of Formula (IV), does not provide any location for a connection to the linker “L”.
Claims 14, 18, 20, 23, 26 and 28 depend from claim 13 and do not resolve the indefiniteness from the lack of structural connection between a radical of Formula (IV) and the required linker element “L”.
Where applicant acts as his or her own lexicographer to specifically define a term of a claim contrary to its ordinary meaning, the written description must clearly redefine the claim term and set forth the uncommon definition so as to put one reasonably skilled in the art on notice that the applicant intended to so redefine that claim term. Process Control Corp. v. HydReclaim Corp., 190 F.3d 1350, 1357, 52 USPQ2d 1029, 1033 (Fed. Cir. 1999). The term “comprising” in claim 54 is used by the claim to mean “selected from,” while the accepted meaning is “including.” The term is indefinite because the specification does not clearly redefine the term. Claim 54 further limits claim 1, a compound defined by defined by a structural formula with variable substituents, to a compound which is a member of a group of specific structures provided in claim 54; however, the claim is written as “A compound of claim 1 comprising one of the following structures”, which provides for more than one a discrete, single entity. The term “comprising” particularly provides for the claimed compound to be more than one of the structures provided in the claim, but the “more” is unclear from the claim, whether Applicant wishes to include multiple distinct structures as a single compound, or for any of the provided structures to include more than what is shown in claim 54. A person of ordinary skill in the art could not determine the metes and bounds of claim 54 in the context of a compound being more than a structure provided therein. This rejection can be overcome by replacing “comprising” with “selected from” in the claim language.
Claim 62 depends from and further limits either claim 1 or claim 60, regarding a genus of compounds designated as “formula (I)”, to a method of immunomodulating regulatory T cells (Tregs) in a subject comprising administering to the subject an effective amount of a first compound of claim 1 or a first pharmaceutical composition of claim 60. Claim 62 does not disclose any patient population to whom the first compound or first pharmaceutical composition should be administered. The instant Specification discloses a method of immunomodulating regulatory T cells in a subject in need thereof 1 comprising administering an effective amount of a compound of instant formula (I) or a pharmaceutically acceptable salt thereof or a pharmaceutical composition comprising the first compound (paragraph [0049]). The Specification further discusses “Methods of Immunomodulating Tregs” (paragraphs [0304]-[0313]), describing therein that in certain embodiments, the subject to be treated has cancer and the administration of the first compound or pharmaceutical composition thereof alters Tcells’ promotion of tumor growth and metastasis and/or inhibition of anti-tumor immunity (paragraph [0306]), and proceeds to disclose specific cancers in scope of the treatment of cancer by immunomodulation of Tregs (paragraph [0307]). This section of the instant Specification further discloses another embodiment of the invention wherein the subject to be treated with the first compound or first pharmaceutical composition has a fibrotic disease or disorder, with specific fibrotic disease(s)/disorder(s) disclosed (paragraph [0311]), and also discloses an embodiment wherein the subject has an inflammatory disease, with specific inflammatory disease(s) disclosed (paragraph [031]). Beyond the instant Specification, the field of disease treatment in regard to regulatory T cells is exemplified by the teaching of Sharabi (Sharabi, et al.; Nature Reviews/Drug Discovery, v17, pp823-844; 2018). Sharabi provides a review of the modulation of T cells in the treatment of diseases and other conditions, including not only cancer and inflammatory diseases, but also autoimmune diseases and patients receiving transplanted organs (Abstract). Sharabi teaches that two main subsets of mature Treg cells have been defined on the basis of distinctive phenotypes and gene expression, which are resting or naive Treg (nTreg) cells and activated or effector Treg (eTreg) cells, including tissue-resident Treg cells. The eTreg cells differ critically from nTreg cells in that the former often express increased levels of immunosuppressive molecules, particularly IL‑10, and have increased surface expression of tissue-seeking chemokine receptors. This property, in conjunction with downregulation of CC-chemokine receptor 7 (CCR7) and L-selectin (also known as CD62L), promotes the migration of highly functional Treg cells into tissues. T cell receptor repertoire analysis has shown numerous major clonotype expansions in eTreg cells from deep tissue draining lymph nodes; these clonotypes are absent or reduced in activated memory Treg cells from superficial lymph nodes and in nTreg cell populations, further suggesting that eTreg cells actively control autoimmunity. Thus, eTreg cells exhibit characteristics important for re-establishing tolerance in autoimmune-inflamed tissues. Correspondingly, Treg cell-based therapies that promote eTreg cells are likely to be more efficacious in tissues that are undergoing an immune or autoimmune attack (pages 824-825, bridging paragraph). Sharabi further teaches that administration of IL‑2 to mice (alone or as an IL‑2–anti‑IL‑2 antibody complex to increase its bioavailability) promotes the proliferation of Treg cells in the periphery. This indicates that IL‑2 is a potent growth factor for Treg cells and raises the possibility that it can be used as a means to directly expand these suppressive cells in the context of autoimmune diseases (page 826). Sharabi discusses the role of dysfunctional Treg cell populations in specific autoimmune diseases, for example how in patients with psoriasis, Treg cells, particularly those that express CCR52 and are present in the skin or the bone marrow, display poor function, and the local skin inflammatory milieu promotes Treg cell plasticity and differentiation into cells that produce IL-17, a pro-inflammatory cytokine, and further how in myasthenia gravis, a muscle-wasting autoimmune disease, the expression of CTLA43, which has been linked to myasthenia gravis in genome-wide studies, is reduced on Treg cells from patients with this disease (page 827). Regarding organ transplantation, Sharabi teaches that in transplanted organs, where the active alloimmune responses take place, Treg cells that develop in response to antigen presented directly by the donor APCs4 or by self APCs expand and gradually infiltrate the transplanted organ. Yet, early after transplantation, Treg cells fail to suppress the alloimmune inflammatory response. Inhibition of mTOR5 can improve the ability of Treg cells to control the inflammatory response (page 828). Thus, Sharabi shows that patients who may be in need of immunomodulation of Treg cells are not limited to the conditions disclosed in the instant Specification. Claim 62 is indefinite because a person of ordinary skill in the art would not know the metes and bounds of the claimed method in the absence of a specified patient population.
Claim 63 depends from claim 62 and does not resolve the indefiniteness of claim 62 that arises from an undefined patient population.
Claim 65 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential elements, such omission amounting to a gap between the elements. See MPEP § 2172.01. The omitted element is the “second therapeutic agent” of the claimed method. Claim 65 depends from claim 64, itself a further limitation of claim 62 discussed above, to wherein the subject has cancer (a defined patient population) and the “E” moiety of the compound to be administered is a radical of a TLR7 agonist. Claim 65 further limits the method of claim 64 discussed above, which through the limitations of claim 62 requires administering a “first compound of claim 1”, to wherein the method of claim 65 must further comprise administering a “third therapeutic agent”, that is an anti-cancer agent. However, none of claims 62, 64, or claim 65 discloses any “second compound” or “second therapeutic agent”. Claim 63, which depends directly from and further limits claim 62, claims a “second compound”; however, claim 65 does not depend directly or indirectly from claim 63, therefore the “second compound” of claim 63 cannot be attributed to the method of claim 65. Claim 65 is indefinite because a person of ordinary skill in the art would not understand the metes and bounds of the claim without knowledge of the required “second therapeutic agent” that must be administered.
Claim Rejections - 35 USC § 112(d)
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.
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.
Claims 15-16 and 29 are 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. Claim 15 further limits claim 14, which itself provides a radical of Formula (IVA) to represent the element “E” in the structure of Formula (I) which is represented in parent (independent) claim 13 as “T-L-E”, as shown below:
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Claim 15 further limits claim 14 to wherein the compound of Formula (I) is represented by either Formula (IVB) or Formula (IVC), shown below:
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Formulae (IVB) of claim 15 includes the variables X1, X2 and X3, whereas claim 14, from which claim 15 depends, allows only Nitrogen atoms at these positions in Formula (IVA), as shown above. Claim 15 further provides that for the elements Z2 and Z3 of Formulae (IVB) and (IVC), respectively, these elements may include a connection to the element “L” directly or indirectly, and through “L”, further connect to the element “T”, whereas neither claim 14 nor its parent claim 13 provides for any connection to the elements “T-L” anywhere at the radical of Formula (IV) or of Formula (IVA) (see 112(b) section above). Thus, claim 15 does not include all of the limitations of its parent claim 14.
Claim 16 depends from claim 15 and also fails to include all of the limitations of claim 14 in that claim 16 provides connection to the element “L” directly or indirectly, and through “L”, further connect to the element “T”, whereas neither claim 14 nor its parent claim 13 provides for any connection to the elements “T-L” anywhere at the radical of Formula (IV) or of Formula (IVA) (see 112(b) section above).
Claim 29 depends from claim 28, which in turn depends from claim 23 and further limits the structure of the radical Formula (IV) of claim 23, and fails to include all the limitations of claim 28 because claim 29 provides an overall formula (V) to represent the full structure of a compound of Formula (I) of parent claim 13, including a connection between the structure corresponding to a radical of Formula (IV) and the elements “L-T”, whereas claims 13, 23 and 28 do not provide any connection between the structure of a radical of Formula (IV) and the elements “L-T” (see 112(b) section above).
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.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 are anticipated by Guzik.
Claims 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Guzik (Guzik, et al.; European Journal of Nuclear Medicine and Molecular Imaging, v48, pp972-983; 2021)6.
Claim 1 is drawn to a compound of a genus defined by “formula (I)”, wherein the formula is defined by three elements, T, L and E, arranged as “T-L-E”, wherein:
T is a radical of raltitrexed or 5-methyltetrahydrofolate (5-MTHF), or an analog of either of these compounds, wherein the term “analog” is not specifically defined in the instant Specification;
L is a linker, wherein the term “linker” is not specifically defined in the instant Specification, but is elaborated into subtypes (e.g., releasable and non-releasable) and exemplary classes (e.g., alkyl, hydroxyl);
E is a radical of a therapeutic agent.
Guzik teaches a study in the preclinical evaluation of 5-MTHF radioconjugates, wherein each separate enantiomer of 5-MTHF, differentiated at the 6-position and designated as 6R-RedFol-1 or 6S-RedFol-1, is connected by a linker to a tetraazacyclododecane macrocycle in which is chelated an ion of Lutetium 177 (Lu177), a radioactive isotope, as shown in the figure below alongside a corresponding folate radioconjugate designated as “OxFol-1” (Abstract, page 972 and Figure 1, page 974):
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Guzik teaches that the folate receptor (FR) is frequently overexpressed in a variety of tumor types and, hence, an interesting target for radionuclide therapy, which is accomplished by the chelated Lu177 moiety, thus defining it as a therapeutic agent.
Thus, claim 1 is anticipated by the teaching of Guzik.
Claim 2 further limits claim 1 to a narrower genus of compounds that is met by the 6R-RedFol-1 and 6S-RedFol-1 compounds taught by Guzik.
Thus, claim 2 is anticipated by the teaching of Guzik.
Claims 1-2, 35, 44 and 51 are anticipated by CAS 1218757-22-2.
Claims 1-2, 35, 44 and 51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1218757-22-2 (Chemical Abstracts Services, Registry Number 1218757-22-2, originally catalogued 12Apr2010).
The limitations of claims 1-2 are discussed in the rejection above and hereby incorporated into the instant rejection.
CAS 1218757-22-2 discloses a compound bearing a radical of raltitrexed (circled at right) and a radical of Mitomycin C, a known therapeutic agent (circled at left), connected by a linker, as shown in the image below:
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Thus, claim 1 is anticipated by the disclosure of CAS 1218757-22-2.
Claim 2 further limits claim 1, to wherein the “T” element is a radical of raltitrexed or of an analog of raltitrexed, or a radical of 5-MTHF or of an analog of 5-MTHF, and is met by the disclosure of CAS 1218757-22-2, which includes a radical of raltitrexed, as shown above.
Claim 35 further limits claim 1 to wherein the linker is a releasable linker (i.e., cleavable) linker. As shown in the image above, the compound disclosed by CAS 1218757-22-2 includes both a disulfide bond, cleavable by reducing agents/conditions, and a hydrazone bond, cleavable by acidic agents/conditions. While CAS 1218757-22-2 does not disclose that these functional groups render the linker cleavable, this property is inherent in the structure of the compound and is known in the art, as evidenced for example, by Reddy (Reddy, et al.; Cancer Chemotherapy and Pharmacology, v58, pp229-236; 2005), who teaches the value of cleavable linkers in folate-drug conjugates (Abstract) and specifically identifies the reducing and acidic cleaving conditions, respectively, of the disulfide and hydrazone groups (page 233) in a folate-Mitomycin C conjugate bearing each of these functional groups in the backbone of the linker (Figure 5, page 233, compound EC118).
Claim 44 further limits the compound of claim 1 to wherein the linker L comprises one or more linker moieties, each independently selected from a Markush group that includes amide, a group that is found in the linker of the compound disclosed by CAS 1218757-22-2.
Claim 51 further limits claim 1 to wherein the linker L can be a bivalent linker or a trivalent linker. As shown above, CAS 1219757-22-2 discloses a compound with a bivalent linker.
Thus, claims 2, 35, 44 and 51 are anticipated by the disclosure of CAS 1218757-22-2.
Claims 1-2, 35, 44 and 51-52 are anticipated by CAS 1218756-92-3.
Claims 1-2, 35, 44 and 51-52 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS 1218756-92-3 (Chemical Abstracts Services, Registry Number 1218756-92-3, originally catalogued 12Apr2010).
The limitations of claims 1-2, 35, 44 and 51 are discussed in the rejection above and hereby incorporated into the instant rejection.
CAS 1218756-92-3 discloses a compound bearing a radical of raltitrexed (circled at bottom left) and a radical of Tubulysin, a known therapeutic agent (circled at right), connected by a linker, as shown in the image below:
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Thus, claims 1 is anticipated by the disclosure of CAS 1218756-92-3.
Regarding claim 2, as shown above, the compound disclosed in CAS 1218756-92-3 has a radical of raltitrexed.
Regarding claim 35, as shown above, the compound disclosed in CAS 1218756-92-3 has a cleavable disulfide bond in the linker.
Regarding claim 44, as shown above, the compound disclosed in CAS 1218756-92-3 has an amide bond.
Regarding claim 51, as shown above, the compound disclosed in CAS 1218756-92-3 has a bivalent linker.
Claim 52 further limits claim 1 to wherein the compound comprises a radical selected from a Markush group that includes peptide group, glycopeptide group and saccharide group. As shown in the image above, the compound disclosed in CAS 1218756-92-3 has a glycopeptide group, wherein multiple amino acids consist of 1-amino-1-deoxy-D-glucitol-γ-glutamate, with one of the pendant amino-deoxy-glucitol side groups circled at top left in the image.
Thus, claims 2, 35, 44 and 51-52 are anticipated by the disclosure of CAS 1218756-92-3.
Claims 1-2, 35, 44, 51 and 60 are anticipated by Leamon.
Claims 1-2, 35, 44, 51 and 60 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 8,546,425 B2 (hereafter referred to as “Leamon”).
The limitations of claims 1-2, 35, 44 and 51-52 are discussed in the prior rejection, and hereby incorporated into the instant rejection.
Leamon discloses conjugates of antifolates, releasable linkers, and drugs, and pharmaceutical compositions containing them (Abstract). Leamon discloses a Markush group of specific embodiments of the invention disclosed therein: “It is to be understood that foregoing processes may be adapted with the appropriate selection of starting materials to prepare additional conjugates described herein, such as the following” (Col. 40, lines 20-23) and includes multiple compounds that anticipate the genus of instant claim 1, including the conjugate shown below, bearing a Mitomycin C moiety, a linker and an antifolate, wherein the iterations includes raltitrexed (“ZD1694”, highlighted below):
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(Leamon, Cols. 43-44, page 34)
The embodiment shown in the image above, with raltitrexed (ZD1694), corresponds to the same compound as disclosed in CAS 1218757-22-2, discussed in the rejection above. The compound has all required structural elements of instant Formula (I) as claimed in instant claim 1.
Thus, claim 1 is anticipated by the disclosure of Leamon.
Regarding claim 2, as shown above, the compound disclosed by Leamon has a radical of raltitrexed.
Regarding claim 35, as shown above, the compound disclosed by Leamon has a cleavable disulfide bond in the linker.
Regarding claim 44, as shown above, the compound disclosed by Leamon has an amide bond.
Regarding claim 51, as shown above, the compound disclosed by Leamon has a bivalent linker.
Claim 60 further limits claim 1 to a pharmaceutical composition further comprising a pharmaceutically acceptable carrier or excipient. Leamon discloses a pharmaceutical composition comprising any of the conjugate compounds disclosed therein and one or more carriers, excipients, diluents, and combinations thereof (Col. 21, lines 20-24).
Thus, claims 2, 35, 44, 51 and 60 are anticipated by the disclosure of Leamon.
Claims 1, 35, 44, 51-52 and 60 are anticipated by Low.
Claims 1, 35, 44, 51-52 and 60 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by U.S. Patent No. 9,629,918 B2 (hereafter referred to as “Low”).
The limitations of claims 1-2, 35, 44 and 51-52 are discussed in the prior rejections, and hereby incorporated into the instant rejection.
Low discloses targeted drug delivery conjugates (Abstract), including multiple compounds that anticipate the genus of instant Formula (I) as claimed in instant claim 1, including the compound shown below, designated by Low as “DMTHF-EC-119-TubH” (Cols. 11-12; Cols. 49-50; and Col. 53, lines 15-36):
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Low’s compound DMTHF-EC-119-TubH has a dimethyltetrahydrofolate radical (circled at top left above) and a radical of Tubulysin B, a known therapeutic agent (in rectangle at bottom right), and these radicals are joined by a linker. Dimethyltetrahydrofolate is an analog of 5-methyltetrahydrofolate, having an additional methyl on the 10-position of the folate scaffold.
Thus, claim 1 is anticipated by the disclosure of Low.
Regarding claim 35, as shown above, the compound disclosed by Low has a cleavable disulfide bond in the linker.
Regarding claim 44, as shown above, the compound disclosed by Low has an amide bond.
Regarding claim 51, as shown above, the compound disclosed by Low has a bivalent linker.
Regarding claim 52, as shown above, the compound disclosed by Low has a peptide group in the linker.
Claim 60 further limits claim 1 to a pharmaceutical composition further comprising a pharmaceutically acceptable carrier or excipient. Low discloses a pharmaceutical composition comprising any of the conjugate compounds disclosed therein and one or more excipients (Cols. 38-39, bridging paragraph).
Thus, claims 2, 35, 44, 51-52 and 60 are anticipated by the disclosure of Low.
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 and 35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7, 14-15 and 20 of U.S. Patent No. 9,629,918 B2 (hereafter referred to as “Low”). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of Low anticipate the instant claims.
The limitations of claims 1 and 35 and the disclosure of Low are discussed in the rejection above and hereby incorporated into the instant rejection.
Low’s claim 1 is drawn to a compound of the overall formula “B-L-D” wherein D is a therapeutic agent or imaging agent, L is a linker, and B is a compound represented by an additional provided structural formula with specific substituents and limitations, shown below:
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Low’s claim 20 further limits Low’s claim 1 to wherein “B” is dimethyltetrahydrofolate, which a person of ordinary skill in the art would at once recognize as an analog of 5-methyltetrahydrofolate.
Low’s claims 2 and 14 each further limit Low’s claim 1 to wherein “D” is a therapeutic agent. Low’s claim 15 further limits Low’s claim 14 to wherein the therapeutic agent is a vinca alkaloid or a tubulysin.
Low’s claim 7 further limits Low’s claim 1 to wherein the Linker includes a releasable linker.
Allowable Subject Matter
Claims 4-5 and 64 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to W. JUSTIN YOUNGBLOOD whose telephone number is (703)756-5979. The examiner can normally be reached on Monday-Thursday from 8am to 5pm. The examiner can also be reached on alternate Fridays.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S. Lundgren, can be reached at telephone number (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/W.J.Y./Examiner, Art Unit 1629
1 Italic emphasis added by Examiner.
2 C-C chemokine receptor 5
3 Cytotoxic T-lymphocyte associated protein 4
4 Antigen presenting cells
5 Mechanistic target of rapamycin
6 Published online 15Oct2020.
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