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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/10/2026 was filed after the mailing date of the non-final on 11/10/2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Status of the Claims
Claims 1, 4-9, 28-35, and 37-41 are pending in this application. Claims 2-3, 10-27, and 36 have been cancelled by applicant.
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.
Claims 1, 4-9, 28-35, and 37-41 are rejected under 35 U.S.C. 103 as being unpatentable over Kotian et al. (WO 2018/232094 A1 – cited in the IDS – previously cited) (“Kotian”).
Regarding claims 1, 6, and 41, Kotian discloses the compound below, which is the same compound present in the claimed oral dosage form. Kotian discloses their compounds as ALK2 kinase inhibitors (abstract) and discloses methods of inhibiting ALK2 kinase comprising administration of their compounds (page 4, lines 13-15). Kotian further discloses that their compounds and pharmaceutically acceptable salts thereof may be administered orally in combination with acceptable diluents or edible carriers (reading on oral dosage form) (page 81, para. 2). Kotian teaches that a suitable dose will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound (page 83, last 2 para.). Kotian further claims pharmaceutical compositions comprising their compounds and pharmaceutically acceptable excipients (Kotian’s claim 105).
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(claim 50, page 698, row 2, col. 2)
Therefore, regarding claim 1, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a pharmaceutical composition comprising about 10 mg to about 30 mg of Kotian’s compound and a pharmaceutically acceptable carrier. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Kotian discloses their compound above as an ALK2 kinase inhibitor for the treatment of fibrodysplasia ossificans progressive (FOP; see Kotian’s claim 107), and further teaches suitable dose will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound.
Regarding claims 6 and 41, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Kotian’s ALK2 inhibitor to a subject in need in order to inhibit ALK2 kinase. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Kotian discloses their ALK2 kinase inhibitor and pharmaceutical compositions thereof, specifically for oral administration (as claimed), and that suitable doses will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound. Furthermore, Kotian claims a method of inhibiting ALK2 kinase and of treating fibrodysplasia ossificans progressive (FOP; see Kotian’s claims 106-107). Kotian also discloses their desired doses may be presented in a single or divided dose, to be administered at appropriate intervals of two, three, or more times a day. Thus, if the dose is presented as a single dose, this reads on administration once daily (sentence bridging pages 83-84). Thus, one of ordinary skill would have been motivated to administer Kotian’s ALK2 inhibitor once a day, with a reasonable expectation of success.
Regarding the instantly claimed ranges of 10 mg to about 30 mg in the oral dosage forms, as recited in claims 1, 6, and 41, Applicant is advised that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05-II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Regarding claims 4-5 and 33-34, Kotian discloses that their oral dosage form may be a soft gelatin capsule (page 81, para. 2, line 4).
Regarding claims 7-9, Kotian discloses that an R206H mutation within the kinase domain of one the four bone morphogenetic protein (BMP) receptors has been linked to disorders of secondary bone formation, leading to fibrodysplasia ossificans progressive (FOP). Kotian discloses that in addition to R206H, other dysregulation mutations have been identified in ACVR1/ALK2 that lead to variants of FOP, and that compounds effective in regulating BMP signaling, based on their ability to inhibit ALK2, have been shown to inhibit kinases from multiple signaling pathways (page 1, background). Kotian also claims a method of treating FOP comprising administration of their oral dosage form containing the instantly claimed compounds (Kotian’s claim 108).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Kotian’s ALK2 inhibitors to a subject wherein the ALK2 kinase comprises a mutation, like R206H. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Kotien’s disclosure that their compounds are ALK2 inhibitors, useful in methods for the treatment of FOP, which is a condition caused by an R206H mutation within the kinase domain of one of the four BMP receptors (like ALK2).
Regarding claims 28-32, Kotian discloses long-term release implants of their compounds, that can deliver active compound for at least 30-60 days, may be desirable (page 84, para. 3, last 4 lines) (reading on long term treatment of more than 30 days). Kotian also discloses that their compounds and pharmaceutically acceptable salts thereof may be administered orally in combination with acceptable diluents or edible carriers (page 81, para. 2).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer Kotian’s oral dosage forms for 30 to 60 days, as needed. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of Kotian’s disclosure of long-term implants which can administer active compound for 30-60 days, and Kotian’s disclosure of oral forms of administration, which one of ordinary skill would administer for 30-60 days in an implant is not desired for the subject.
Regarding the instantly claimed time ranges of 1 day to 6 months, or 7, 14, 21, or 28 days, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Regarding claims 35, Kotian claims a method of treating fibrodysplasia ossificans progressive comprising administration of their oral dosage form containing the instantly claimed compound – shown above (Kotian’s claim 108).
Regarding claims 37-40, Kotian claims a method of treating cancer comprising administering formulations containing the instantly claimed compounds (Kotian’s claim 109), wherein the cancer is glioma, and wherein the glioma is diffuse intrinsic pontine glioma (Kotian’s claims 110-111).
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, 4-9, 28-35, and 37-41 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-42 of U.S. Patent No. 11,661,426 B2 (US ‘426); in view of Kotian et al. (WO 2018/232094 A1 – cited in the IDS). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claims 1, 6, and 41, US ‘426 claims the instant compound and pharmaceutical compositions comprising pharmaceutically acceptable excipients (reading on the instant oral dosage forms) (US ‘426’s claims 19 and 21).
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(col. 982)
While US ‘426 does not specifically claim: (i) dosage amounts of 10 mg to about 500 mg or 10 mg to about 250 mg (claims 1, 3, 6, and 26); (ii) wherein the dosage is a capsule, or a soft gelatin capsule (claims 4-5 and 33-34); (iii) wherein the ALK2 kinase comprises an activating mutation, wherein the mutation is an activating mutation is R206H (claims 7-9); (iv) wherein the dosage is administered daily (claim 27); (v) wherein the length of administration is 1 day to 6 months, 4, 14, 21, or 28 days (claims 28-32); (vi) a method of treating FOR comprising administration of their compounds (claims 35-36); or (vii) a method of treating cancer, wherein the cancer is glioma, wherein the glioma is diffuse intrinsic pontine glioma (claims 37-40); the teachings of Kotian et al. are relied upon for these disclosures.
Kotian discloses the same ALK2 kinase inhibitor as US ‘426’s (abstract; claim 50, page 698, row 2, col. 2) and discloses methods of inhibiting ALK2 kinase comprising administration of the instantly claimed compounds (page 4, lines 13-15). Kotian teaches that a suitable dose will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound (page 83, last 2 para.). Kotian discloses their desired doses may be presented in a single or divided dose, to be administered at appropriate intervals of two, three, or more times a day. Thus, if the dose is presented as a single dose, this reads on administration once daily (sentence bridging pages 83-84). Kotian discloses long-term release implants of their compounds, that can deliver active compound for at least 30-60 days, may be desirable (page 84, para. 3, last 4 lines) (reading on long term treatment of more than 30 days).
Regarding instant claims 1, 6, and 41, Kotian discloses that a suitable dose will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound (page 83, last 2 para.).
Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Further regarding instant claims 6 and 41, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ‘426’s compounds to inhibit ALK2. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘426’s disclosure of their compounds above; in view of Kotian’s teachings that these compounds are ALK2 inhibitors and their disclosure of methods of inhibiting ALK2 by administering their compounds. Kotian further discloses their desired doses may be presented in a single or divided dose, to be administered at appropriate intervals of two, three, or more times a day. Thus, if the dose is presented as a single dose, this reads on administration once daily (sentence bridging pages 83-84).
Regarding instant claims 4-5 and 33-34, Kotian discloses that their oral dosage form may be a soft gelatin capsule (page 81, para. 2, line 4).
Regarding instant claims 7-9, Kotian discloses that an R206H mutation within the kinase domain of one the four bone morphogenetic protein (BMP) receptors has been linked to disorders of secondary bone formation, leading to fibrodysplasia ossificans progressive (FOP). Kotian discloses that in addition to R206H, other dysregulation mutations have been identified in ACVR1/ALK2 that lead to variants of FOP, and that compounds effective in regulating BMP signaling, based on their ability to inhibit ALK2, have been shown to inhibit kinases from multiple signaling pathways (page 1, background). Kotian also claims a method of treating FOP comprising administration of their oral dosage form containing the instantly claimed compounds (Kotian’s claim 108).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ‘426’s ALK2 inhibitors, as taught by Kotian, to a subject wherein the ALK2 kinase comprises a mutation, like R206H. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘426’s disclosure of their compounds; Kotien’s disclosure that their related ALK2 inhibitors are useful in methods for the treatment of FOP, which is a condition caused by an R206H mutation within the kinase domain of one of the four BMP receptors (like ALK2).
Applicant is advised that similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have very close structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Linter, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972) (see MPEP 2144.08(d)).
Regarding instant claims 28-32, Kotian discloses long-term release implants of their compounds, that can deliver active compound for at least 30-60 days, may be desirable (page 84, para. 3, last 4 lines) (reading on long term treatment of more than 30 days).
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the instant application to administer US ‘426’s oral dosage forms, as taught by Kotian, for 30 to 60 days, as needed. One of ordinary skill would have been motivated to do so with a reasonable expectation of success in view of US ‘426’s disclosure of their compounds; Kotian’s teaching of long-term implants which can administer active compound for 30-60 days, and Kotian’s disclosure of oral forms of administration, which one of ordinary skill would administer for 30-60 days in an implant is not desired for the subject.
Regarding the instantly claimed time ranges of 1 day to 6 months, or 7, 14, 21, or 28 days, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Regarding instant claims 35, Kotian claims a method of treating fibrodysplasia ossificans progressive comprising administration of their oral dosage form containing the instantly claimed compound (Kotian’s claim 108).
Regarding claims 37-40, Kotian claims a method of treating cancer comprising administering formulations containing the instantly claimed compounds (Kotian’s claim 109), wherein the cancer is glioma, and wherein the glioma is diffuse intrinsic pontine glioma (Kotian’s claims 110-111).
Response to Arguments
Claims
Claim amendments are acknowledged and have been entered. No new matter has been introduced.
Specification
Amendments to the specification are acknowledged and have been entered. No new matter has been introduced.
Applicant’s arguments, see page 87, filed 03/10/2026, with respect to objections to the specification have been fully considered and are persuasive. The objections to the specification have been withdrawn.
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see page 88, filed 03/10/2026, with respect to 35 USC § 112(b) rejections of the claims have been fully considered and are persuasive. The 35 USC § 112(b) rejections of the claims have been withdrawn.
Claim Rejections - 35 USC § 103
Applicant's arguments filed 03/20/2026 have been fully considered but they are not persuasive.
Applicant argues Kotian doesn’t disclose their compound in an oral dosage form or in a method of inhibiting ALK2 kinase, or the specific amounts or frequencies claimed. Applicant argues Kotian broadly describes oral administration as a potential route, which may apply to any composition. Applicant argues the instant 10-30 mg doses, once a day, would not have been predictable in view of Kotian. Applicant argues that nothing in Kotian teaches or suggests the minimal effective absence of accumulation of the compound in the claimed composition in plasma following administration. Applicant asserts that one of ordinary skill would not have been able to predict once daily oral admin for 1-7 days would yield a dosing regimen that is safe and effective for inhibiting ALK2 kinase and treat FOP or cancer. Applicant argues the “unexpected results associated with once daily administration of the claimed composition are crucial when prescribing therapies, as it can inform potential toxicity side effects.”
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007).
In this case, Kotian specifically discloses the compound below, which is the same compound present in the claimed oral dosage form. Kotian discloses their compounds as ALK2 kinase inhibitors (abstract) and discloses methods of inhibiting ALK2 kinase comprising administration of their compounds (page 4, lines 13-15). Kotian further discloses that their compounds and pharmaceutically acceptable salts thereof may be administered orally in combination with acceptable diluents or edible carriers (reading on oral dosage form) (page 81, para. 2). Kotian teaches that a suitable dose will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound (page 83, last 2 para.). Kotian further claims pharmaceutical compositions comprising their compounds and pharmaceutically acceptable excipients (Kotian’s claim 105). Kotian also discloses their desired doses may be presented in a single or divided dose, to be administered at appropriate intervals of two, three, or more times a day. Thus, if the dose is presented as a single dose, this reads on administration once daily (sentence bridging pages 83-84). Thus, one of ordinary skill would have been motivated to administer Kotian’s ALK2 inhibitor once a day, with a reasonable expectation of success.
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(claim 50, page 698, row 2, col. 2)
Therefore, it would have been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to prepare a pharmaceutical composition comprising about 10 mg to about 30 mg of Kotian’s compound and a pharmaceutically acceptable carrier. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Kotian discloses their compound above as an ALK2 kinase inhibitor for the treatment of fibrodysplasia ossificans progressive (FOP; see Kotian’s claim 107), and further teaches suitable dose will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound.
It would have also been prima facie obvious to one of ordinary skill prior to the effective filing date of the claimed invention to administer Kotian’s ALK2 inhibitor to a subject in need in order to inhibit ALK2 kinase. One of ordinary skill would have been motivated to do so with a reasonable expectation of success because Kotian discloses their ALK2 kinase inhibitor and pharmaceutical compositions thereof, specifically for oral administration (as claimed), and that suitable doses will be in the range of about 0.5 to about 100 mg/kg, and that the compounds can be formulated into unit dosage forms containing about 5 to 1000 mg of the active compound. Furthermore, Kotian claims a method of inhibiting ALK2 kinase and of treating fibrodysplasia ossificans progressive (FOP; see Kotian’s claims 106-107). Kotian also discloses their desired doses may be presented in a single or divided dose, to be administered at appropriate intervals of two, three, or more times a day. Thus, if the dose is presented as a single dose, this reads on administration once daily (sentence bridging pages 83-84). Thus, one of ordinary skill would have been motivated to administer Kotian’s ALK2 inhibitor once a day, with a reasonable expectation of success.
Regarding the instantly claimed ranges of 10 mg to about 30 mg in the oral dosage forms, Applicant is reminded that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists. The courts have also found that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art, and one of ordinary skill would have been able to arrive at the instant compositions and methods with a reasonable expectation of success in view of Kotian.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
Applicant cites Figure 10 and pages 75-100 of the specification to point to pharmacokinetic and toxicology studies of the compound in the claimed compositions and methods, however, no comparative data is provided to prove that these results are unexpected. Per MPEP 716.02: Any differences between the claimed invention and the prior art may be expected to result in some differences in properties. The issue is whether the properties differ to such an extent that the difference is really unexpected. In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986) (differences in sedative and anticholinergic effects between prior art and claimed antidepressants were not unexpected). In In re Waymouth, 499 F.2d 1273, 1276, 182 USPQ 290, 293 (CCPA 1974), the court held that unexpected results for a claimed range as compared with the range disclosed in the prior art had been shown by a demonstration of "a marked improvement, over the results achieved under other ratios, as to be classified as a difference in kind, rather than one of degree." Compare In re Wagner, 371 F.2d 877, 884, 152 USPQ 552, 560 (CCPA 1967) (differences in properties cannot be disregarded on the ground they are differences in degree rather than in kind); Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) ("we generally consider a discussion of results in terms of ‘differences in degree’ as compared to ‘differences in kind’ . . . to have very little meaning in a relevant legal sense"). See also UCB, Inc. v. Actavis Labs, UT, Inc., 65 F.4th 679, 693, 2023 USPQ2d 448 (Fed. Cir. 2023) ("A difference of degree is not as persuasive as a difference in kind – i.e., if the range produces ‘"a new property dissimilar to the known property,’" rather than producing a predictable result but to an unexpected extent.").
Per MPEP 716.02(a): "A greater than expected result is an evidentiary factor pertinent to the legal conclusion of obviousness ... of the claims at issue." In re Corkill, 771 F.2d 1496, 226 USPQ 1005 (Fed. Cir. 1985). In Corkhill, the claimed combination showed an additive result when a diminished result would have been expected. This result was persuasive of nonobviousness even though the result was equal to that of one component alone. Evidence of a greater than expected result may also be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately (i.e., demonstrating "synergism"). Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. Ex parte The NutraSweet Co., 19 USPQ2d 1586 (Bd. Pat. App. & Inter. 1991) (Evidence showing greater than additive sweetness resulting from the claimed mixture of saccharin and L-aspartyl-L-phenylalanine was not sufficient to outweigh the evidence of obviousness because the teachings of the prior art lead to a general expectation of greater than additive sweetening effects when using mixtures of synthetic sweeteners.).
It is noted that the response above should not be construed as an invitation to file an after final declaration. See MPEP 715.09.
Double Patenting
Applicant’s arguments, see pages 95-98, filed 03/10/2026, with respect to NSDP rejections over US ‘492 and Copending ‘115 have been fully considered and are persuasive. In light of claim amendments, the NSDP rejections over US ‘492 and Copending ‘115 have been withdrawn.
Applicant's arguments filed 03/20/2026, with respect to NSDP over US ‘426 have been fully considered but they are not persuasive.
Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)).
Applicant argues the compound in the instant compositions is one of over 250 compounds in US ‘426. Applicant further states that Kotian is the PCT application underlying the ‘426 patent, and therefore the analysis used amounts to an impermissible use of the specification of ‘426 in constructing the NSDP rejection. Applicant argues the amended claims are different from ‘426 in the dosage amounts and oral administration dosages, and that while Kotian discloses 5-1000 mg of their compounds, nothing in ‘426 or Kotian provides guidance for electing 10-30 mg doses, or the claimed methods.
This is not persuasive. Kotian et al. (WO 2018/232094A1 – previously cited) is a prior art reference, and therefore, it may be used for all it contains in any rejection (See MPEP 2123). The NSDP rejection over US ‘426 did not rely on the specification of US ‘426, but that of Kotian, and therefore, the rejection is proper and stands. For arguments regarding dosage amounts, methods, etc. see arguments in the 103 section above and to the NSDP rejection of record over US ‘426 in view of Kotian.
Regarding the breadth of US ‘426 and Kotian; Per MPEP 2123: "The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)). Furthermore, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
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.
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/JACKSON J HERNANDEZ/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
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