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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. KR 20200106990, filed on 08/25/2020.
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.
Claims 1-8 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the phrase “an internal space which is not filled with a medicinal liquid,” however, the claims and drawings disclose the chamber as filling with a medicinal liquid for administration. It is unclear from this limitation in claim 1 if the chamber is not initially filled with a medicinal liquid, or is never filled with a medicinal liquid. For the purposes of examination, Examiner interprets this limitation to mean that the chamber is not initially filled with a liquid medicine.
Additionally, claims 2-8 are rejected because any claims that depend on a rejected claim inherit the subject matter of their parent claims.
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 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (US 20190192775).
Regarding claim 1, Kim discloses a medicinal liquid pumping apparatus comprising: a chamber having an internal space (Fig. 1: chamber space 114), which is not filled with a medicinal liquid (para. [0045], sentence 1, 114 is not initially filled until the liquid medicine is introduced through 111), and an injection port connected to the internal space (Fig. 1: 111); and a plunger (Fig. 1: 140) disposed inside the chamber such that the internal space has a predetermined volume (Fig. 1: 140 establishes the space 114 within cylinder 110).
Regarding claim 2, Kim discloses the medicinal liquid pumping apparatus of claim 1, as described above, further comprising a pressing actuator (Fig. 1: 130 and 131) configured to be capable of pressing the plunger such that the volume of the internal space is reduced (para. [0048], sentence 3), wherein the pressing actuator is configured to be capable of pressing the plunger by a pressure of a gas generated in the pressing actuator (para. [0048], sentences 2-4).
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.
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 20190192775) in view of Gyure (US 6093175).
Regarding claim 3, Kim discloses the medicinal liquid pumping apparatus of claim 1, as described above, but fails to disclose a lubricant on the inner surface of the chamber.
Gyure teaches an analogous medicinal liquid pumping syringe further comprising: a lubricant applied to an inner surface of the chamber (col. 2, lines 65-67) in which the plunger is configured to be slidable while moving (col. 3, lines 13-16; col. 2, lines 3-8). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Kim assembly by incorporating the inner chamber surface lubricant taught by Gyure into the inside surface of 110 of Kim, in order to reduce the friction between the plunger and cylinder of Kim to create smoother and more precise movement of the plunger with a medical-grade and unharmful oil (Gyure: col. 35-45).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 20190192775) in view of Wong (US 9265880).
Regarding claim 4, Kim discloses the medicinal liquid pumping apparatus of claim 1, as described above, but fails to disclose separate ports for the inflow and outflow of the liquid medicine.
Wong teaches an analogous medicinal liquid pump wherein an inflow port (Fig. 5A: 73; col. 5, lines 32-36), which is connected to the internal space and is different from the injection port (Fig. 5A: 73 connected to grey internal space), is formed in the chamber (Fig. 5A: 73 formed in chamber body 40), and wherein the medicinal liquid pumping apparatus further comprises: a one-way valve disposed in the inflow port (col. 4, lines 6-8) and configured to allow a flow of the medicinal liquid moving from an outside to the internal space and block a flow of the medicinal liquid moving from the internal space to the outside (col. 5, lines 32-36). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Kim apparatus by incorporating the separate one-way inflow port taught by Wong, in order to have separate inflow and outflow and outflow port, to minimize the steps and intervention needed to refill the chamber through only a single port as Kim teaches, and additionally help reduce contamination (Wong: col. 5, lines 30-41).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 20190192775) in view of Wong (US 9265880) in further view of Ma (US 20190366004).
Regarding claim 5, Kim in view of Wong teaches the medicinal liquid pumping apparatus of claim 4, as described above, but fails to explicitly teach a venting hole for discharging air from the chamber.
Ma teaches an analogous medicinal liquid pumping syringe wherein a vent hole is formed in the chamber (Figs. 8A-B: vent holes 380 in chamber 322), and wherein the medicinal liquid pumping apparatus further comprises: a hydrophobic filter (Figs. 8A-B: 390; para. [0079], last sentence) configured to allow passage of air discharged from the internal space to the outside through the vent hole and block passage of a liquid (para. [0079], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Kim-Wong apparatus by incorporating the filtered venting holes into the sides of the chamber, as taught by Ma, in order to safely and effectively purge the air in the chamber such that air does not enter the injected medicinal fluid and the medicinal fluid cannot leak out of the venting holes (Ma: para. [0079], last sentence; para. [0800], sentences 2-4).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (US 20190192775) in view of Ma (US 20190366004).
Regarding claim 6, Kim discloses the medicinal liquid pumping apparatus of claim 1, as described above, but fails to explicitly teach a venting hole for discharging air from the chamber.
Ma teaches an analogous medicinal liquid pumping syringe wherein a vent hole is formed in the chamber (Figs. 8A-B: vent holes 380 in chamber 322), and wherein the medicinal liquid pumping apparatus further comprises: a hydrophobic filter (Figs. 8A-B: 390; para. [0079], last sentence) configured to allow passage of air discharged from the internal space to the outside through the vent hole and block passage of a liquid (para. [0079], last sentence). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Kim apparatus by incorporating the filtered venting holes into the sides of the chamber, as taught by Ma, in order to safely and effectively purge the air in the chamber such that air does not enter the injected medicinal fluid and the medicinal fluid cannot leak out of the venting holes (Ma: para. [0079], last sentence; para. [0800], sentences 2-4).
Regarding claim 7, Kim in view of Ma teaches the medicinal liquid pumping apparatus of claim 6, as described above, wherein the hydrophobic filter is located on an opposite side to the plunger with reference to the internal space (Ma: para. [0800], sentence 3, as the plunger is advanced, the filters remain on the other side of the plunger from the fluid chamber).
Regarding claim 8, Kim in view of Ma teaches the medicinal liquid pumping apparatus of claim 7, as described above, wherein the chamber is configured such that the internal space has a shape protruding toward the opposite side (Kim and Ma: the cylindrical chamber shape protrudes/extends lengthwise towards the opposite side that the exit/injection port is located), and the hydrophobic filter is located in a portion having the protruding shape of the internal space (Ma: para. [0800], sentence 3, as the plunger is advanced, the filters remain on the other side of the plunger from the fluid chamber, on the opposite extension end of the chamber).
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 9265880) in view of Bakken (US 20200129079) in further view of Sasaki (US 20180015222).
Regarding claim 9, Wong discloses a preparation method for medicinal liquid injection using a medicinal liquid injection apparatus comprising a chamber having an internal space (Figs. 5A-B: chamber 40) and having an injection port (Fig. 5B: 77) and an inflow port (Fig. 5A: 73), which are connected to the internal space and are different from each other (Figs. 5A-B: 73 and 77 connected to space within 40 shown in grey); a plunger (Figs. 5A-B: 45) disposed inside the chamber such that the internal space has a predetermined volume (Fig. 5A: 45 determines the volume shown in grey within 40); a pressing actuator configured to be capable of pressing the plunger such that the volume of the internal space is reduced (101 and 103; col. 5, lines 54-60); and a medicinal liquid flow line having a medicinal liquid flow path connected to the injection port (col. 5, lines 44-45). Wong discloses a method of filling the syringe with medicinal liquid (col. 5, lines 32-36). However, Wong fails to explicitly disclose an additional filling step after the initial filling, as well as a priming step.
Bakken teaches an analogous liquid injection apparatus and method with a chamber (301) and plunger (420), the method comprising: an additional medicinal liquid filling step in which, in a state in which the internal space is filled with a medicinal liquid, additional medicinal liquid is introduced into the internal space through the inflow port such that the plunger moves to increase the volume of the internal space (para. [0034], last sentence, an additional step executed to draw in additional fluid), thereby generating a pressure with which the plunger pushes the medicinal liquid (fluid in the chamber has pressure against the plunger, by which the plunger pushes against the fluid). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Wong method of preparing the syringe by incorporating the additional filling step as taught by Bakken, in order to ensure the chamber is completely filled and to also promote more precise filling of the chamber (para. [0034], last sentence). However, the Wong-Bakken method fails to explicitly disclose a priming step.
Sasaki teaches an analogous liquid injection apparatus and method, including a priming step in which the medicinal liquid is moved by the pressure to fill the medicinal liquid flow path (para. [0057], sentences 1-3). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Wong-Bakken preparation method by incorporating the priming step taught by Sasaki to ensure that all air is removed from the tube prior to fluid delivery to the patient and more accurately deliver the proper medicament dose to the patient (para. [0057], sentences 3-4).
Regarding claim 10, Wong in view of Bakken in further view of Sasaki teaches the preparation method of claim 9, as described above, wherein, in the additional medicinal liquid filling step, the pressure is generated by compressing a closed space on an opposite side to the internal space with reference to the plunger (Wong and Bakken: fluid in the chamber has pressure against the plunger due to the space being closed; the plunger pushes against the fluid due to the space on the other side of the plunger that does not allow the plunger to continue to move such that it would create negative pressure in the liquid).
Regarding claim 11, Wong in view of Bakken in further view of Sasaki teaches the preparation method of claim 9, as described above, wherein an amount of the medicinal liquid filled in the internal space before the additional medicinal liquid filling step is greater than an amount of the medicinal liquid filled in the additional medicinal liquid filling step (Bakken: para. [0034], last sentence, an additional step executed to draw in additional fluid after the chamber is mostly but not completely filled).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Wong (US 9265880) in view of Bakken (US 20200129079) in further view of Sasaki (US 20180015222) in further view of Gyure (US 6093175).
Regarding claim 12, Wong in view of Bakken in further view of Sasaki teaches the preparation method of claim 9, as described above, but fails to teach application of a lubricant to the inner surface of the chamber.
Gyure teaches an analogous medicinal liquid pumping syringe wherein the medicinal liquid injection apparatus further comprises a lubricant applied to an inner surface of the chamber (col. 2, lines 65-67) in which the plunger is configured to be slidable while moving (col. 3, lines 13-16; col. 2, lines 3-8). It would have been obvious for a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified the Wong-Bakken-Sasaki method by incorporating the application of the inner chamber surface lubricant taught by Gyure, in order to reduce the friction between the plunger and cylinder of Kim to create smoother and more precise movement of the plunger with a medical-grade and unharmful oil (Gyure: col. 35-45).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATERINA ANNA WITTLIFF whose telephone number is (703)756-4772. The examiner can normally be reached M-Th: 9-7ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL TSAI can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/K.A.W./Examiner, Art Unit 3783
/SCOTT J MEDWAY/Primary Examiner, Art Unit 3783