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 .
Summary
It is noted that there is no IDS filed by applicant, as such applicant is reminded if there are relevant references they should be supplying them to the office. The response filed on 04/30/26 is acknowledged. Claims 1-17 are pending.
Applicants’ response to restriction is acknowledged with Group I claims 1-10 without traverse. Applicant’s election of species for prior art search and examination of drug of palbociclib and subject of child is also acknowledged. As such claims 4-6 and 8-10 are withdrawn as non-elected species. Claims 1-3 and 7 are examined and rejected herein. Claims 4-6, 8-17 are withdrawn.
The election was made without traverse and restriction is made FINAL.
NEW REJECTIONS
In the interest of compact prosecution, the below is made over the ‘generic’ subject:
Generic for subject-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.
Claims 1 and 7 are rejected under 35 U.S.C. 102a(1) as being anticipated by CN 115054724A (‘724, google translation included).
‘724 claims a treatment of arteriovenous malformations with hollow embolic microspheres comprising a pharmaceutical composition including palbociclib (claims 1-19, esp 1, 13 and 19, see too abstract and examples). Further on page 4 of the translation the prior art teaches that the hollow embolic microspheres or pharmaceutical compositions are known to treat arteriovenous malformations.
Species election of child:
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 of this title, 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 1-2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022004859A1 (of which US 2023/0364063 is English equivalent (Tanaka)).
Tanaka teaches the pharmaceutical composition to be administered to a subject in need thereof for therapeutic effects on diseases such as vascular malformations including an active ingredient such as palbociclib or Ibrance® (abstract, [0003, 0017, 0062] Aspect 4, Table 1-1) and according to Tanaka the dosage form can be delivered via various forms including dry syrups which are mainly administered to children [0083].
Tanaka also teaches that administration can be varied by dose or frequency depending on the patient, species, age, weight and condition [0093].
Tanaka does not teach with sufficient specificity to anticipate nor provide a single working embodiment.
However, a reference is analyzed using its broadest teachings. MPEP 2123 [R-5].
“[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Here the prior art Tanaka teaches that vascular malformations are treated via administration to children with various pharmaceutical compositions including those containing palbociclib as well as other drugs.
Claims 1-2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2022004859A1 (of which US 2023/0364063 is English equivalent (Tanaka)) in view of US 20190307897 (‘897).
Tanaka is taught above and does not teach the vascular malformation types in claim 3.
‘897 teaches various vascular diseases and includes arteriovenous malformations (AVM), cavernous malformations, Arnold-Chiari malformations, etc [0386, 0418].
As such it would be obvious to a person of ordinary skill in the art at the time of filing to combine a known method of treating vascular malformations with compositions comprising palbociclib administered to a child/juvenile with ‘897 which teaches known vascular diseases include AVM. Combination of a known method of treatment with compositions comprising palbociclib administered to a child/juvenile with a known type of vascular malformation is within the purview of the skilled artisan and would yield predictable results. As such it is within the purview to combine administration to a child of drug to treat vascular disease including a specific type of vascular disease such as AVM with predictable results.
Claims 1-3 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over CN 115054724A (‘724, google translation included) in view of US 2020/0345665 (‘665).
‘724 claims a treatment of arteriovenous malformations with injection of hollow embolic microspheres comprising a pharmaceutical composition including palbociclib (claims 1-19, esp 1, 13 and 19, see too abstract and examples). Further on page 4 of the translation the prior art teaches that the hollow embolic microspheres or pharmaceutical compositions are known to treat arteriovenous malformations.
‘724 does not specifically teach ‘child’ as a patient but does teach administration of embolic particles comprising palbociclib to patients for treatment of AVM via injection.
‘665 teaches treatments of vascular issues including vascular impediments and cerebrovascular dysfunction (abstract, [0026-0032]) and treats children/juveniles with particles to treat issues of cerebral and venous blood flow with embolism (Ex JAS and [0183-194]).
As such it would be obvious to a person of ordinary skill in the art at the time of filing to combine a known method of using embolic particles of palbociclib to treat AVM of ‘724 with administration to a child/juvenile via injection delivery as taught in ‘665 for resolving vascular impediments. Combination of a known method of treatment of AVM with a known subject i.e. a child, for a similar purpose is within the purview of the skilled artisan and would yield predictable results. As such it is within the purview to administer to children an injection containing a drug to treat vascular disease including AVM with predictable results.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BETHANY BARHAM whose telephone number is (571)272-6175. The examiner can normally be reached on M-F 9:30AM-6pm.
The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
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