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 .
DETAILED ACTION
The preliminary amendment filed 06/07/2024, amended claims 4-9 and 16-17.
Claims 1-17 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
See, for examples, pgs. 32-39.
Claim Rejections - 35 USC § 103
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-11, 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/145356 to Legeai-Mallet (published 2019, IDS of 06/07/2024).
Legeai-Mallet teaches a method of treating a FGFR3-related chondrodysplasia in a patient in need thereof by administering a therapeutically effective amount of (-)-epicatechin (pg. 18, claim 1).
Legeai-Mallet teaches the patient as having a FGFR3-related skeletal disease such as hypochondroplasia, achondroplasia, and severe achondroplasia with developmental delay and acanthosis nigricans, (pg. 18, claim 2).
Regarding claims 1, 9-11, and 13, while Legeai-Mallet teaches a method of treating severe achondroplasia with developmental delay by administering (-)-epicatechin, it differs from that of instant claim 1 in that it does not explicitly teach a method of treating a FGFR3-related cognitive deficit.
Legeai-Mallet additionally teaches its method as preventing, curing, delaying the onset of, reducing the severity of, or ameliorating one or more symptoms of the disorder (pg. 4, lines 28-31).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of Legeai-Mallet for the treatment of FGFR3-related cognitive deficits, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Legeai-Mallet teaches its methods as treating symptoms of the disorder,
-Legeai-Mallet teaches developmental delay as a symptom of a FGFR3-related skeletal disease, and
-Legeai-Mallet teaches a daily dosage of epicatechin as 0.0002mg/kg to about 20mg/kg (pg. 7, lines 7-10), and the instant specification teaches the daily dosage amount of catechin or epicatechin as 0.1-100mg/kg.
As such, an ordinary skilled artisan would have reasonably expected the methods of Legeai-Mallet to treat developmental delay, a cognitive deficit, since it administers the same active ingredient ((-)-epicatechin), in the same therapeutically effective dosage amount, to the same patient population (patients with severe achondroplasia with developmental delay and acanthosis nigricans), as that taught by the instant specification and claims. See also MPEP 2112.02.
Regarding claim 2, since Legeai-Mallet teaches its methods as treating developmental delays, the subject is a child. Moreover, Legeai-Mallet teaches its dosages in an amount “per adult per day” (pg. 7, lines 3-4).
Regarding claims 3-5, the instant specification defines FGFR3 gain-of-function mutation as synonymous to constitutively active FGFR3 receptor variant, constitutively active mutant of the FGFR3, or mutant FGFR3 displaying a constitutive activity (pg. 4, Specification). Legeai-Mallet teaches FGFR3-related chondrodysplasia as a skeletal disease caused by an abnormal increased activation of FGFR3, in particular by expression of a constitutively active mutant of the FGFR3 receptor which exhibits a biological activity which is higher than the biological activity of the corresponding wild-type receptor. N540K, K650N, K650Q, N540S, and A391E are taught as such mutations (pgs. 2, line 26-pg. 3, line 31).
Regarding claim 6, Legeai-Mallet exemplifies its most effective composition of its methods as one which comprises (-)-epicatechin and (+)-catechin (pg. 13, lines 11-pg. 14, line 8). As such, an ordinary skilled artisan would reasonably expect the compositions of Legeai-Mallet to additionally comprise (+)-catechin since Legeai-Mallet exemplifies its most effective composition as additionally comprising (+)-catechin. Alternatively, an ordinary skilled artisan would have been motivated to select a composition comprising (-)-epicatechin and (+)-catechin for the treatment of the FGFR3 diseases taught by Legeai-Mallet, since Legeai-Mallet exemplifies its most effective composition for treating such diseases as comprising (-)-epicatechin and (+)-catechin.
Regarding claims 7 and 8, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties, MPEP 2144.09(II).
Regarding claim 16, Legeai-Mallet teaches a composition comprising the epicatechin and at least one pharmaceutically acceptable excipient (pg. 18, claim 3).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/145356 to Legeai-Mallet (published 2019, IDS of 06/07/2024), as applied to claims 1-11, 13 and 16 above, and further in view of MU Hypochondroplasia (published 09/16/2021, Missouri University, PTO-892).
Legeai-Mallet is applied as discussed above and incorporated herein.
Regarding claim 12, while Legeai-Mallet teaches a method of treating hypochondroplasia, it differs from that of instant claim 1, in that it does not specifically teach treating cognitive deficits of hypochondroplasia.
MU teaches cognitive disabilities as affecting 10-12 percent of children with hypochondroplasia, and learning disabilities as impacting half of children with hypochondroplasia (pg. 2).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of Legeai-Mallet for the treatment of the cognitive deficits in hypochondroplasia, to arrive at instant claim 12. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Legeai-Mallet teaches its methods as treating symptoms of hypochondroplasia,
-MU teaches hypochondroplasia as causing cognitive and learning disabilities in some patients, and
-Legeai-Mallet teaches a daily dosage of epicatechin as 0.0002mg/kg to about 20mg/kg (pg. 7, lines 7-10), and the instant specification teaches the daily dosage amount of catechin or epicatechin as 0.1-100mg/kg.
As such, an ordinary skilled artisan would have reasonably expected the methods of Legeai-Mallet to treat the cognitive and learning disabilities of patients with these hypochondroplasia symptoms, since Legeai-Mallet administers the same active ingredient, in the same therapeutically effective dosage amount, to the same patient population as that taught by the instant specification and claims. See also MPEP 2112.02.
Claims 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/145356 to Legeai-Mallet (published 2019, IDS of 06/07/2024), as applied to claims 1-11, 13 and 16 above, and further in view of Johns Hopkins Craniosynostosis (published 12/11/2021, PTO-892).
Legeai-Mallet is applied as discussed above and incorporated herein.
Regarding claims 14-15, while Legeai-Mallet teaches a method of treating Crouzon syndrome with acanthosis nigricans, it differs from that of instant claim 14, in that it does not specifically teach treating cognitive deficits of Crouzon syndrome with acanthosis nigricans.
Johns Hopkins teaches craniosynostosis as causing developmental delays in children (pgs. 2-3).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of Legeai-Mallet for the treatment of cognitive deficits in Crouzon syndrome with acanthosis nigricans, to arrive at instant claims 14-15. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-Legeai-Mallet teaches its methods as treating symptoms of Crouzon syndrome with acanthosis nigricans, a craniosynostosis,
- Johns Hopkins teaches craniosynostosis as causing developmental delays in children, and
-Legeai-Mallet teaches a daily dosage of epicatechin as 0.0002mg/kg to about 20mg/kg (pg. 7, lines 7-10), and the instant specification teaches the daily dosage amount of catechin or epicatechin as 0.1-100mg/kg.
As such, an ordinary skilled artisan would have reasonably expected the methods of Legeai-Mallet to treat the developmental delays of patients with the craniosynostosis that causes developmental delays in children, since Legeai-Mallet administers the same active ingredient, in the same therapeutically effective dosage amount, to the same patient population as that taught by the instant specification and claims. See also MPEP 2112.02.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2019/145356 to Legeai-Mallet (published 2019, IDS of 06/07/2024), as applied to claims 1-11, 13 and 16 above, and further in view of Tagami (3D printing of gummy drug formulations composed of gelatin and an HPMC-based hydrogel for pediatric use, published 02/01/2021, PTO-892).
Legeai-Mallet is applied as discussed above and incorporated herein.
Instant claim 17 differs from that of the methods of Legeai-Mallet in that it does not teaches its compositions as food compositions.
Tagami teaches preparing gummy drug formulations with various shapes in different colors for pediatric patients, to improve drug adherence (abstract; pg. 7, Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the compositions of Legeai-Mallet to gummy drug formulations, to arrive at instant claim 17. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because
-Legeai-Mallet teaches the treatment of patients with developmental delays, i.e., children, and
-Tagami teaches that gummy drug formulations in various shapes and colors for pediatric patients, improves drug adherence in patients.
As such, an ordinary skilled artisan would have been motivated to make such a modification to predictably arrive at a formulation that improves pediatric drug adherence and hence treatment of the disease.
See pgs. 14-16 of the instant specification for the definition of a “food composition.”
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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 1-2, 8-9, 10-15-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,951,090 (PTO-892) in view of WO 2019/145356 to Legeai-Mallet (published 2019, IDS of 06/07/2024).
‘090 claims
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While ‘090 claims a method of treating FGFR3-related chondrodysplasia by administering (-)-epicatechin, it differs from that of instant claim 1 in that it does not explicitly teach a method of treating a FGFR3-related cognitive deficit.
Legeai-Mallet is applied as discussed above.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of ‘090 for the treatment of FGFR3-related cognitive deficits, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because:
-‘090 teaches its methods as treating FGFR3-related chondrodysplasia,
-Legeai-Mallet teaches its methods as treating FGFR3-related chondrodysplasia, wherein the FGFR3-related chondrodysplasia is a developmental delay as a symptom of FGFR3-related skeletal disease,
-Legeai-Mallet teaches a daily dosage of epicatechin as 0.0002mg/kg to about 20mg/kg (pg. 7, lines 7-10), and the ‘090 teaches the daily dosage amount of epicatechin as 0.1-100mg/kg.
As such, an ordinary skilled artisan would have reasonably expected the methods of ‘090 to treat developmental delay, a cognitive deficit, in a FGFR3-related chondrodysplasia (severe achondroplasia with developmental delay and acanthosis nigricans) since it administers the same active ingredient, in the same therapeutically effective dosage amount, to the same patient population as that taught by the instant specification and claims. See also MPEP 2112.02.
Regarding claim 2, since a child or adult encompasses most living ages, the recitation of “patient” in ‘090 meets this limitation.
Regarding claim 8, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties, MPEP 2144.09(II).
Regarding claims 12 and 14-15, while ‘090 does not explicitly teach “treating a FGFR3-related cognitive deficit” in patients with hypochondroplasia or Crouzon syndrome with acanthosis nigricans, it is reasonable to assume that method of ‘090 would have the same properties since it is administered for the same purpose (treating a FGFR3-related chondrodysplasia, i.e., the hypochondroplasia and Crouzon syndrome with acanthosis nigricans, FGFR3-related chondrodysplasias taught by Legeai-Mallet) in the same dosage amount, to the same patient population as that taught by the instant specification and claims. Thus, while the ‘090 does not explicitly teach treating a FGFR3-related cognitive deficit, an ordinary skilled artisan would reasonably expect the methods of ‘090 to treat cognitive deficits in patients with hypochondroplasia and Crouzon syndrome with acanthosis nigricans since it is taught as treating the disease. See MPEP 2112.02.
Claims 1-2, 8-9, 10-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,257,232 (PTO-892) in view of WO 2019/145356 to Legeai-Mallet (published 2019, IDS of 06/07/2024).
‘090 claims
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While ‘232 does not teach treating a FGFR3-related cognitive deficit, as instantly claimed, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of ‘232 for the treatment of achondroplasia cognitive deficits, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because ‘232 claims its methods as treating FGFR3-related chondrodysplasia such as severe achondroplasia with developmental delay and acanthosis nigrans.
As such, an ordinary skilled artisan would have reasonably expected the methods of ‘232 to treat the developmental delay, a cognitive deficit of severe achondroplasia, since it administers the same active ingredient, in therapeutically effective dosage amounts to treat the disease, to the same patient population (patients with severe achondroplasia with developmental delay and acanthosis nigrans) as that taught by the instant specification and claims. See also MPEP 2112.02.
Regarding claim 2, since a child or adult encompasses most living ages, the recitation of “patient” in ‘232 meets this limitation.
Regarding claim 8, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties, MPEP 2144.09(II).
Regarding claims 12 and 14-15, ‘232 does not teach “treating a FGFR3-related cognitive deficit” in patients with hypochondroplasia or Crouzon syndrome with acanthosis nigricans.
Legeai-Mallet is applied as discussed above.
It is reasonable to assume that method of ‘232 would have the same properties since it is administered for the same purpose (treating a FGFR3-related chondrodysplasia, i.e., the hypochondroplasia and Crouzon syndrome with acanthosis nigricans, FGFR3-related chondrodysplasias taught by Legeai-Mallet) in the same dosage amount, to the same patient population as that taught by the instant specification and claims. Thus, while ‘232 does not explicitly teach treating a FGFR3-related cognitive deficit, an ordinary skilled artisan would reasonably expect the methods of ‘232 to treat cognitive deficits in patients with hypochondroplasia and Crouzon syndrome with acanthosis nigricans, since ‘232 is taught as treating the disease. See MPEP 2112.02.
Regarding claim 17, ‘2343 teaches administration of a pharmaceutical composition and a pharmaceutically acceptable excipient.
Claims 1-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15-18 of copending Application No. 18/717,719 (claim set dated 06/07/2024, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘719 claims a method of treating FGFR-related bond repair and bond formation impairment in a subject comprising administering to the subject a therapeutically effective amount of at least one catechin (claim 1).
Claims 2-7 of ‘719 are identical to those of instant claims 2-3 and 6-9.
Regarding instant claims 2 and 10, ‘719 claims subjects having a gain of function mutation and a FGFR3 related skeletal disease (claims 7-8, 15).
Regarding instant claims 11 and 13, ‘719 claims severe achondroplasia with developmental delay and acanthosis nigrans as a FGFR3 related skeletal disease (claims 9, 11).
Regarding instant claim 16, ‘719 claims a composition comprising a catechin and at least one pharmaceutically acceptable excipient (claim 17).
Regarding claim 17, ‘719 claims a food composition.
While ‘719 does not teach treating a FGFR3-related cognitive deficit, as instantly claimed, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to select the methods of ‘719 for the treatment of achondroplasia cognitive deficits, to arrive at instant claim 1. One of ordinary skill in the art would have been motivated to make such a selection, with a reasonable expectation of success, because ‘719 claims its methods as treating FGFR3 gain of function mutation skeletal diseases, such as severe achondroplasia with developmental delay and acanthosis nigrans.
As such, an ordinary skilled artisan would have reasonably expected the methods of ‘719 to treat the developmental delay, a cognitive deficit of severe achondroplasia, since it administers the same active ingredient, in therapeutically effective dosage amounts to treat the disease, to the same patient population (patients with severe achondroplasia with developmental delay and acanthosis nigrans) as that taught by the instant specification and claims. See also MPEP 2112.02.
Regarding claims 12 and 14-15, while ‘719 does not explicitly teach “treating a FGFR3-related cognitive deficit” in patients with hypochondroplasia or Crouzon syndrome with acanthosis nigricans, it is reasonable to assume that method of ‘719 would have the same properties since it is administered for the same purpose (treating a FGFR3-related skeletal disease due to a FGFR3 gain-of-function mutation) in the same dosage amount (both ‘719 and the instant specification teach therapeutically effective amounts of 0.1-100mg/kg of the catechin (pg. 16 of ‘719 and pg. 12 of the instant specification) to the same patient population (those with hypochondroplasia and Crouzon syndrome with acanthosis nigricans (claims 9-10, 12-13, 16 of ‘719) as that taught by the instant specification and claims. Thus, while the ‘719 does not explicitly teach these treating a FGFR3-related cognitive deficit, an ordinary skilled artisan would reasonably expect the methods of ‘719 to treat cognitive deficits in patients with hypochondroplasia and Crouzon syndrome with acanthosis nigricans, accompanied with cognitive deficits such as developmental delays or learning disabilities. See MPEP 2112.02.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/LAUREN WELLS/Examiner, Art Unit 1622
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