DETAILED ACTION
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 and Response to Amendments
The amendments filed on March 02, 2026 have been acknowledged and entered. Claims 1-4, 9, 12-14, and 16-29 are pending. Claims 5-8, 10-11, and 15 are cancelled.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/EP2022/051786, filed on January 26, 2022. This application also claims the benefits of foreign priority to PCTEP2021051983, filed on January 28, 2021.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant's amendments and/or remarks.
----------------------------------- Added Rejections -----------------------------------
Claim Rejections - 35 USC § 112(a) – 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 14 and 22-29 are 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.
The breadth of the claims
The claims are broad insofar as they encompass methods of treating numerous distinct diseases that are pathologically diverse which include diseases classified as an (auto-) immune/ inflammatory mediated disorder (e.g., psoriasis), pulmonary disorder (e.g., asthma), infectious disease (e.g., influenza), fibrotic disorder (e.g., liver cirrhosis), neurodegenerative disorder (e.g., Alzheimer’s disease), and tumor disease (brain tumor; see instant claim 14 for full list of disorders).
The presence or absence of working examples
The instant specification only provides characterization data for the instantly claimed COMPOUND (see tables 1 through 3). The instant specification does not provide any in vitro or in vivo experimental data demonstrating that the claimed COMPOUND possesses therapeutic efficacy for any of the diseases recited in claim 14.
State of the prior art
Prior art referenced:
Caroff et al. (Caroff) (WO2016113344A1; published July 21, 2016)
Caroff provides the earliest disclosure of the instant compound (herein, referred to as COMPOUND; see Caroff, pg. 50, example 35). Caroff also provides data on COMPOUND from various biological assays (i.e., in vitro experimentation demonstrating CXCR3 receptor modulation; see information pertaining to FLIPR assay starting on pg. 52 of Caroff). No in vivo results were provided by Caroff.
Prior art referenced:
Pease (Pease, J. E. Designing small molecule CXCR3 antagonists. Expert Opinion on Drug Discovery. 2017, 12, 159-168.)
Pease discloses that:
AMD 487 is a CXCR3 antagonist (i.e., a modulator of the CXCR3 receptor) (see pg. 161, left col., 1st full paragraph, 4th sentence).
“Amgen pressed ahead with a phase II trial of AMD 487 in patients suffering with psoriasis” (pg. 161, left col., 1st full paragraph, 1st sentence).
“It was… surprising that AMD 487 failed to show efficacy in psoriasis and the trial was terminated” (pg. 161, left col., 1st full paragraph, 3rd sentence).
Therefore, Pease does not demonstrate that modulating the CXCR3 receptor necessarily translates into efficacy for the treatment of psoriasis. Note: the instant application discloses the instantly claimed COMPOUND to be a CXCR3 receptor modulator (see abstract).
Prior art referenced:
Christen et al. (Christen) (Christen, S. et al. Small molecule CXCR3 antagonist NIBR2130 has only a limited impact on type 1 diabetes in a virus-induced mouse model. Clinical and Experimental Immunology 2011, 165, 318-328.)
Even though previous studies have shown CXCR3 antagonist, NIBR2130, exhibiting “the highest CXCR3 binding affinity among structurally related compounds” (see Christen, pg. 319, left col., paragraph right before “Material and methods”), the data provided by Christen “indicate that the bioactivity of NIBR2130 is not sufficient to block CXCR3 to a degree that persistently abrogates T1D [i.e., type 1 diabetes – see abstract]” (pg. 323, right col., 1st paragraph, 4th to last sentence).
Therefore, Christen also does not demonstrate that modulating the CXCR3 receptor necessarily translates into efficacy for the treatment of T1D.
The instant specification does not demonstrate that the inventor(s), at the time the application was filed, had possession of the claimed invention
According to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
The instant specification does not reasonably convey to one of ordinary skill in the art that the inventor(s) were in possession, as of the effective filing date, of methods for treating the full scope of the pathologically diverse diseases recited in instant claim 14.
Although Caroff demonstrates that COMPOUND modulates the CXCR3 receptor in vitro (see information pertaining to FLIPR assay starting on pg. 52 of Caroff), the state of the prior art establishes that CXCR3 receptor modulation alone was not reasonably predictive of therapeutic efficacy across different diseases. For example, Pease disclosed that the CXCR3 antagonist, AMD 487, failed to demonstrate efficacy in psoriasis despite exhibiting CXCR3 antagonistic activity, while Christen demonstrates that the CXCR3 antagonist, NIBR2130, is not sufficient to block CXCR3 to a degree that persistently abrogates type 1 diabetes despite having high binding affinity for the CXCR3 receptor. Thus, the prior art establishes that CXCR3 receptor modulation does not necessarily translates into efficacy for the treatment of diseases associated with the CXCR3 pathway such as those listed in instant claim 14.
In view of the state of the prior art, the instant specification’s disclosure of characterization data for COMPOUND, without any experimental evidence demonstrating therapeutic efficacy for any of the numerous diseases recited in claim 14, does not reasonably convey to one of ordinary skill in the art that the inventors were in possession of methods for treating the full breadth of the claimed diseases.
Claims 22-29, which are dependent on claim 14, are also rejected for further requiring and/or reciting non-enabling elements as described above.
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 12-14, and 18-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 13, 15, and 16 of U.S. Patent No. 10,053,457 B2 (‘457B2).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim set from the co-pending application.
Claim 13 of ‘457B2 is directed towards a pharmaceutical composition comprising:
(a) a compound according to claim 1 which encompasses instant COMPOUND and
(b) at least one therapeutically inert excipient.
Even though ‘457B2 does not specify whether COMPOUND is a crystalline or non-crystalline solid, if the inert excipient is a solvent that can dissolve crystalline COMPOUND, the resulting composition would be indistinguishable from a solution prepared from the non-crystalline form of COMPOUND. Under such conditions, claim 13 of ‘457B2 would not be patentably distinct from instant claims 12, 18, and 19. Since a POSITA would understand how to combine a compound with at least one pharmaceutically acceptable carrier material, instant claims 13, 20, and 21 are further rendered obvious and not patentably distinct from claim 13 as disclosed in ‘457B2.
Claims 15 and 16 of ‘457B2 are directed towards a method of treating a disease comprising administering to a subject in need thereof a compound according to claim 1 (which encompasses instant COMPOUND) or a pharmaceutical composition according to claim 13, wherein the disease is an autoimmune disorder, inflammatory disease, infectious disease, transplant rejection, fibrosis, neurodegenerative disorder, or cancer (which encompasses diseases listed in instant claim 14). These claims encompass instant claims 14 and 22-29 which are directed towards a method for the treatment of disorders (which include type 1 diabetes and vitiligo), wherein the method comprises administering a crystalline form of COMPOUND. Although claims 15 and 16 of ‘457B2 do not explicitly require COMPOUND to be in crystalline form, their scope is sufficiently broad to include crystalline forms of COMPOUND. Likewise, although instant claims 14 and 22-29 do not explicitly require administration of COMPOUND with a pharmaceutically acceptable carrier material, the open-ended transitional term “comprising” permits the inclusion of additional steps such as first formulating COMPOUND into a pharmaceutical composition and subsequently administering an effective amount of the pharmaceutical composition as recited in claim 16 of ‘457B2. Accordingly, the claimed methods are not patentably distinct.
----------------------------------- Maintained Rejections -----------------------------------
Note on 35 USC § 102 and § 103 Rejections
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.
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 12, 13, and 18-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Caroff et al. (Caroff) (WO2016113344A1; published July 21, 2016)
Caroff provides the earliest disclosure of the instant compound (herein, referred to as COMPOUND; see Caroff, pg. 50, example 35). Caroff reports that the crude form of COMPOUND was purified by Prep LC-MS (II) followed by Prep LC-MS (IV). Prep LC-MS (IV) requires two elution solvents: solvent A (which consists of water + 0.5% formic acid) and solvent B (which consists of MeCN) (pg. 32, lines 16-18). In other words, Caroff discloses a composition comprising COMPOUND dissolved in water and MeCN.
Note: water and MeCN are known to be excipients. See:
Baldrick, P. Regulatory Toxicology and Pharmacology 2000, 32, 210-218.; pg. 210, right col., middle of 1st paragraph, sentence starts with “Indeed, the 12 most common excipients…” and
Acetonitrile HP; Actylis.
https://www.safic-alcan.com/en/product-catalog/pharmaceuticals/actylis/acetonitrile-hp. (Last accessed October 24, 2025).
Caroff does not disclose the phase state (i.e., solid or liquid) of COMPOUND. It is noted here that, since Caroff does not disclose additional steps necessary to crystallize COMPOUND (as disclosed in the instant application), it is presumed that the purified COMPOUND disclosed in Caroff is non-crystalline. Regardless of the solid-state form of COMPOUND, once a crystalline polymorph is fully dissolved in a liquid carrier such as liquid excipients which include water and/or MeCN, the resulting solution no longer retains any crystalline structure and is indistinguishable from a solution prepared from COMPOUND in an amorphous form. Therefore, Caroff disclosing a composition comprising COMPOUND dissolved in water and MeCN reads on instant claims 12, 18, and 19. Since Caroff also teaches how to purify the crude form of COMPOUND using solvent A and B, Caroff is also disclosing a method of manufacturing a composition comprising COMPOUND dissolved in water and MeCN which reads on instant claims 13, 20, and 21.
In Applicant Remarks (dated March 2, 2026), Applicant asserts that:
“Claim 12 is amended to clarify that the pharmaceutical composition comprises the compound in crystalline form. Claim 13 is amended to recite that the compound is in crystalline form” and accordingly, “Caroff does not anticipate the instant claims” (see Remarks, pg. 14, section VI.)
As recited above and in the previous office action submitted by Examiner:
Regardless of the solid-state form of COMPOUND, once a crystalline polymorph is fully dissolved in a liquid carrier such as liquid excipients which include water and/or MeCN, the resulting solution no longer retains any crystalline structure and is indistinguishable from a solution prepared from COMPOUND in an amorphous form.
Applicant amended claims 12 and 13 to recite that the pharmaceutical composition comprises COMPOUND in crystalline form. However, claims 12 and 13 are directed to a pharmaceutical composition and a method for manufacturing a pharmaceutical composition, respectively, rather than to a crystalline form of COMPOUND. Consequently, where the pharmaceutically acceptable carrier material dissolves the crystalline COMPOUND, the resulting pharmaceutical composition is indistinguishable from a pharmaceutical composition prepared by dissolving amorphous COMPOUND in the same carrier material.
Therefore, Caroff disclosing a composition comprising COMPOUND dissolved in water and MeCN still reads on instant claims 12, 18, and 19. Since Caroff also teaches how to purify the crude form of COMPOUND using solvent A and B, Caroff is also disclosing a method of manufacturing a composition comprising COMPOUND dissolved in water and MeCN which reads on instant claims 13, 20, and 21.
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 12, 14, 18, 19, and 22-26 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-9, 11-21 of U.S. Patent Application No. 19/109,802 (‘802).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim set from the co-pending application.
Claims 1-9 of ‘802 are directed towards a pharmaceutical combination comprising:
(a) the instant COMPOUND as the first active pharmaceutical ingredient (referred to as COMPOUND; note: the claim does not specify that COMPOUND has to be crystalline) and
(b) an anti-CD3 monoclonal antibody as the second active pharmaceutical ingredient.
For embodiments in which COMPOUND is formulated for intravenous administration (as disclosed in claim 5 of ‘802), it is necessary for COMPOUND to be dissolved in a pharmaceutically acceptable excipient suitable for parenteral delivery such as MeCN or water as discussed above. Thus, the scope of claims 1-9 in ‘802 overlap with instant claims 12, 18, and 19 which recite a pharmaceutical composition comprising a crystalline form of COMPOUND and at least one pharmaceutically acceptable carrier. If the carrier used in the instant case is also a solvent suitable for intravenous administration and can dissolve the crystalline form of COMPOUND, then the resulting solution would be indistinguishable from a solution prepared from the non-crystalline form. Thus, under such conditions, the claimed pharmaceutical combination of claims 1-9 in ‘802 would not be patentably distinct from the pharmaceutical composition recited in instant claims 12, 18, and 19. Furthermore, even though the combination disclosed in ‘802 also includes a second active pharmaceutical ingredient, the open-ended term “comprises” in instant claims 12, 18, and 19 indicates that the composition disclosed in the instant case can also include other components such as an anti-CD3 monoclonal antibody as disclosed in ‘802.
Claim 17 of ‘802 is directed towards a pharmaceutical composition comprising COMPOUND and at least one therapeutically inert excipient. As stated previously, even though ‘802 does not specify whether COMPOUND is a crystalline or non-crystalline solid, if the inert excipient is a solvent that can dissolve crystalline COMPOUND, the resulting composition would be indistinguishable from a solution prepared from the non-crystalline form of COMPOUND. Under such conditions, claim 17 of ‘802 would not be patentably distinct from instant claims 12, 18, and 19.
Claims 11-16 and 18-21 of ‘802 are directed towards a method for the prevention and/or treatment of a disease (which includes type 1 diabetes) in a patient in need thereof, wherein the method comprises administering to the patient an effective amount of COMPOUND and an effective amount of an anti-CD3 monoclonal antibody. These claims encompass instant claims 14 and 22-26 which are directed towards a method for the treatment of disorders (which include type I diabetes), wherein the method comprises administering a crystalline form of COMPOUND. Although claims 11-16 and 18-21 of ‘802 do not explicitly require COMPOUND to be in crystalline form, their scope is sufficiently broad to include crystalline forms of COMPOUND. Likewise, although instant claims 14 and 22-26 do not explicitly require co-administration of an anti-CD3 monoclonal antibody, the open-ended transitional term “comprising” permits the inclusion of additional steps such as administering an effective amount of an anti-CD3 monoclonal antibody as recited in claims 11-16 and 18-21 of ‘802. Accordingly, the claimed methods are not patentably distinct.
Allowable Subject Matter
Claims 1-4, 9, 16, and 17 are allowed.
Conclusion
Claims 1-4, 9, 16, and 17 are allowed. Claims 12-14, and 18-29 are rejected. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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