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 .
Specification
The following title is suggested: “PHARMACEUTICAL-PREPARATION-CONTAINING SYRINGE EQUIPPED WITH FILTER”. (the current title includes the words: “title of the invention”)
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
The terms “low and middle” molecular weight in claim 32 are a relative term which renders the claim indefinite. The terms “low and middle” are not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is not clear what it the reference point in order to determine what would be considered a low or middle molecular weight.
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.
Claim(s) 17-20, 22, 32-34, and 36 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McCullough et al. (US 2023/0138654) hereinafter McCullough
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Regarding claim 17, McCullough teaches a pre-filled syringe containing a solution, the syringe comprising:
a cylindrical barrel comprising a chamber (112d) containing the solution, a leading end portion (See figure 2D/2E), and (c) a base end portion, wherein the leading end portion is provided with a nozzle hole for externally ejecting the solution from the chamber; and a filter (120) (see Figure 2d/2e) disposed in the chamber in a position on a base end side of the nozzle hole, the filter comprising a filter membrane with a plurality of pores (122) configured to allow the solution to flow from the chamber, through the plurality of pores, and to the nozzle hole.
Regarding claim 18, McCullough teaches the filter is configured to remove visually detectable particles from the solution as the solution passes through the filter (Refer to paragraph [0036]).
Regarding claim 19, McCullough teaches the filter membrane comprises one or more materials selected from polyether sulfone (PES), polyvinylidene fluoride (PVDF), polysulfone (PS), and an acrylic copolymer (refer to paragraph [0036]).
Regarding claim 20, McCullough teaches a material of the filter membrane is a hydrophobic acrylic copolymer (refer to paragraph [0036]).PVFD)
Regarding claim 22, McCullough teaches a leading end side subspace of the chamber at least partially defined by a leading end side of the filter; and a base end side subspace of the chamber at least partially defined by a base end side of the filter, wherein the nozzle hole has an axial, cross-sectional area that is smaller than an axial, cross-sectional area of the base end side subspace and smaller than an axial, cross-sectional area of the leading end side subspace (see Figure 2d).
Regarding claim 32, McCullough teaches the solution comprises a low molecular weight compound or a middle molecular weight compound (Refer to paragraphs [0073-75]).
Regarding claim 33, McCullough teaches the solution comprises a protein as an active ingredient (Refer to paragraph [0073]).
Regarding claim 34 McCullough teaches the solution comprises an antibody as an active ingredient (Refer to paragraphs [0073-75]).
Regarding claim 36, McCullough teaches a pre-filled syringe containing a solution, the syringe comprising:
a cylindrical barrel (112d) comprising a chamber (112) containing the solution, a leading end portion, and a base end portion, wherein the leading end portion is provided with a nozzle hole for externally ejecting the solution from the chamber; and
a filter (120) disposed in the chamber of the barrel in a position on a base end side of the nozzle hole, the filter comprising a filter membrane with a plurality of pores (122) configured to allow the solution to flow from a base end side of the filter to a leading end side of the filter,
and wherein the filter is configured to remove visually detectable particles from the solution as the solution passes through the filter (refer to paragraphs [0036-0037]).
Claim(s) 17, 23-26, 30, 36-37 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hill et al. (WO 0230494) hereinafter Hill.
Regarding claims 17 Hill teaches,
a pre-filled syringe (Figure 1) containing a solution (Figure1, pointed by 151), the syringe comprising:
a cylindrical barrel comprising a chamber (150) containing the solution, a leading end portion (distal end), and (c) a base end portion (proximal end), wherein the leading end portion is provided with a nozzle hole (141) for externally ejecting the solution from the chamber; and a filter (180) (see Figure 12) disposed in the chamber in a position on a base end side of the nozzle hole, the filter comprising a filter membrane with a plurality of pores (180 has pores that allow the passage of fluid after the powder drug is dissolved in the solution) configured to allow the solution to flow from the chamber, through the plurality of pores, and to the nozzle hole.
Regarding claim 23, a partitioning assembly (160) disposed in the chamber of the barrel and configured for partitioning the chamber into a base end side (side facing 150) space and a leading end side space (side facing 164), wherein the partitioning assembly comprises:
a cylindrical housing (space formed around 163) comprising a close-time engaging portion (portion of 163 contacting 162 before it burst open), wherein the housing sealably contacts an inner surface of the barrel (by means of 161); and an inner plug portion comprising a close-time engaged portion (inner portion of 162 contacting 163 before burst) configured to engage with the close-time engaging portion of the housing, wherein the filter is coupled to a leading end side portion of the housing (by means of container 150).
Regarding claim 24, Hill teaches the inner plug portion is movable between an open position (when membrane 162 burst, see paragraph 0022) in which the base end side space is in fluid communication with the leading end side space, and a closed position (before membrane 162 burst) in which the base end side space is not in fluid communication with the leading end side space.
Regarding claim 25, Hill teaches when the inner plug portion is in the open position, the close-time engaging portion ((portion of 163 contacting 162 before it burst open), and the close-time engaged portion (inner portion of 162 contacting 163 before burst) are disengaged (since the membrane 162 bursts it disengages from the portion of 163), and when the inner plug portion is in the closed position, the close-time engaging portion and the close-time engaged portion are engaged.
Regarding claim 26, Hill teaches the partitioning assembly is configured to move the inner plug portion to the open position when the close-time engaged portion of the inner plug portion moves relative to the close-time engaging portion of the housing in response to a pressing force applied from a base end side of the inner plug portion by a piston (170) inserted into the barrel (Refer to paragraphs 0022 to 0024).
Regarding claim 30, Hill teaches comprising a partitioning assembly (160) for partitioning the chamber of the barrel into a base end side space (proximal end) and a leading end side space (end facing 164), wherein the partitioning assembly comprises a cylindrical housing (see figure 1) configured to sealably contact an inner surface of the barrel (by means of 161), and wherein the filter is coupled to a leading end side portion of the housing (by means of 150).
Regarding claim 36, Hill teaches a pre-filled syringe containing a solution, the syringe comprising:
a cylindrical barrel (150) comprising a chamber (inner area of 150) containing the solution, a leading end portion (portion facing 164), and a base end portion (portion facing 150), wherein the leading end portion is provided with a nozzle hole (opening of 151 in fluid communication with 180) for externally ejecting the solution from the chamber; and
a filter (180) disposed in the chamber of the barrel in a position on a base end side of the nozzle hole, the filter comprising a filter membrane (180) with a plurality of pores (since mixed fluid passes through 180) configured to allow the solution to flow from a base end side of the filter to a leading end side of the filter,
and wherein the filter is configured to remove visually detectable particles from the solution as the solution passes through the filter (the filter is capable of removing particles).
Regarding claim 37, Hill teaches a partitioning assembly (160) for partitioning the chamber of the barrel into a base end side space and a leading end side space, wherein the partitioning assembly comprises a cylindrical housing in sealed contact with an inner surface of the barrel (by means of 161), and wherein the filter (180) is adjacent to a leading end side portion of the housing.
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.
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough in view of Rovinski (US 3757779)
Regarding claim 21, McCullough teaches “it is understood that the openings 122 may be dimensioned as desired in order to properly filter particles of desired sizes from the medicament” (See paragraph [0036]), but fails to explicitly teach the filter membrane has a pore size of 5 µm or less.
Rovinski teaches a filter syringe with a filter of less than 5µm (refer to col. 2, lines 40-46).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have a pore size of 5 µm or less in the filter of McCullough, as taught by Rovinski, to properly filter a specific size of particles from a medicament.
Claim(s) 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill in view of Hill in view of Hiniduma-Lokuge et al. (US 8870848) hereinafter Hiniduma-Lokuge
Regarding claim 27, Hill fails to explicitly teach when the inner plug portion is in the open position, one of the close-time engaging portion and the close-time engaged portion is disposed on a leading end side and a base end side of the other of the close-time engaging portion and the close-time engaged portion. Hiniduma Lokuge et al. teaches a filter (600), an inner plug portion is in the open position (figure 7d) one of the close-time engaging portion and the close-time engaged portion is disposed on a leading end side and a base end side of the other of the close-time engaging portion and the close-time engaged portion (teaches one side of 210 connected in the leading side and a base end side of the other of the close-time engaging portion and the close-time engaged portion). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have one close engaging portion, and engaged portion disposed on a leading end side and a base end side of the close engaging portion and close engaged portion, to allow the solution to move from the base portion to the leading portion.
Claim(s) 28-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill in view of Hill in view of Butts et al. (US 2017/0209648) hereinafter Butts.
Regarding claim 28, Hill fails to teach a material of the inner plug portion is a low density polyethylene (LDPE).
Butts teaches a material of the inner plug portion is a low density polyethylene (LDPE). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the material of the inner plug of Hill to be a linear low density polyethylene as taught by Butts, to protect the plug.
Regarding claim 29, Hill fails to teach a material of the inner plug portion is a linear low density polyethylene (LLDPE). Butts teaches a material of the inner plug portion is a linear low density polyethylene (LLDPE). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to use the material of the inner plug of Hill to be a linear low density polyethylene as taught by Butts, to protect the plug.
Claim(s) 31 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hill in view of Stamps (US 2020/0261659).
Regarding claims 31 and 38, Hills fails to explicitly teach the leading end side space of the barrel has a volume of 150 mm3 or less. Stamps teaches a syringe barrel with a leading end side (section from 0.15mL to the nozzle).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed, to use a 0.15mL leading end space of volume in the syringe of Hill as taught by Stamps to deliver small doses of medication.
Claim(s) 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over McCullough in view of Ashmead et al. (US 20170173267) hereinafter Ashmead.
Regarding claim 35, McCullough fails to explicitly teach the solution comprises emicizumab as an active ingredient. Ashmead teaches a syringe filled with emicizumab (refer to paragraph [0089]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed, that the solution in the device of McCullough to be emicizumab, as taught by Ashmead, to treat hemophilia.
Conclusion
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EDELMIRA BOSQUES
Supervisory Patent Examiner
Art Unit 3762
/EDELMIRA BOSQUES/Supervisory Patent Examiner, Art Unit 3772
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