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-10-2020-0106990, filed on 08/25/2020.
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 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Henderson (US 20040087906).
Regarding claim 5 Henderson discloses a pre-filled medicinal liquid pumping assembly comprising: a chamber having an internal space (Fig. 1: internal chamber space of 1) filled with a medicinal liquid (para. [0019], sentence 2) and an injection port connected to the internal space (Figs. 1 and 2: port 11+211); a plunger (Fig. 1: 7+8) configured to be movable inside the chamber such that a volume of the internal space is reduced (para. [0019], sentence 3, plunger slides withing barrel and defines its internal space, reducing that space as it is advanced); and a leak-proof cap (Fig. 4: cap 3) coupled to the chamber to block the injection port (Fig. 1: cap assembly coupled to 11/2).
Regarding claim 6 Henderson discloses the pre-filled medicinal liquid pumping assembly of claim 5, as described above, wherein the chamber comprises: an injection port formation portion in which the injection port is formed and which protrudes outward (Fig. 2: formation portion 211); a circumferential extension extending in a circumferential direction while being spaced apart from the injection port formation portion in an outer radial direction (Fig. 2: 212) to form a gap with the injection port formation portion (Fig. 2: gap between 211 and 212); and a gap base surface defining the gap in a direction opposite to a protruding direction of the injection port formation portion (Fig. 2: gap base between 211 and 212 extends transversely and in the opposite direction to the extensions of 211 and 221), wherein the leak-proof cap comprises a partition that surrounds a periphery of the injection port formation portion and is inserted into the gap (Fig. 4: 32; para. [0021], second-to-last sentence).
Regarding claim 7 Henderson discloses the pre-filled medicinal liquid pumping assembly of claim 6, as described above, wherein the leak-proof cap comprises a flange extending along the gap base surface in the outer radial direction from the partition (Fig. 4: outwardly extending foot/flange of the bottom base of 32, seen in the gap base in Figs. 9 and 10).
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.
Claims 1-4 are rejected under 35 U.S.C. 103 as being unpatentable over Gyure (US 6093175) in view of Denenburg (US 20190117514).
Regarding claim 1 Gyure discloses a method for manufacturing a pre-filled medicinal liquid pumping assembly comprising a chamber (Fig. 1: chamber within barrel 12) and a plunger (Fig. 1: plunger 22 including 24+26), the method comprising: a plunger disposing step in which a lubricant is applied to an inner surface of the chamber (Fig. 1: lubricant 34; col. 2, line 67 – col. 3, line 2) that defines an internal space connected to an injection port (Fig. 1: port 16) and the plunger is disposed inside the chamber such that the internal space has a predetermined volume (Fig. 1: the plunger creates the internal space within 12, shown in white, having a volume predetermined by the plunger placement). However, Gyure does not explicitly state that the internal space of the chamber is filled after the plunger is disposed.
Denenburg teaches an analogous method of manufacturing a pre-filled syringe assembly, with a medicinal liquid pre-filling step in which the internal space of the chamber (Fig. 9A: chamber within 10A) is filled with a medicinal liquid (Fig. 9B: 36) after the plunger disposing step (Figs. 9A-B: plunger 21 is disposed in 10A prior to 36 being filled). Denenburg teaches this step in order to create a sealed internal space for the liquid to fill, such that the syringe can be filled with the liquid without requiring the plunger to be drawn back in order to provide the most accurate calibration of the pumping assembly (para. [0007], sentence 2). 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 Gyure method by incorporating the teaching of Denenburg to place the plunger within the chamber prior to filling it, in order to ensure the Gyure lubricant is properly placed between the chamber body and the plunger, but also to allow for more accurate calibration and precise filling, as taught by Denenburg (para. [0007], sentence 2).
Regarding claim 2 Gyure in view of Denenburg teaches the method of claim 1, as described above, wherein, in the medicinal liquid pre-filling step, the internal space is filled with the medicinal liquid in a state in which the plunger is disposed at a position defining the internal space by the predetermined volume such that the plunger does not slide on the inner surface of the chamber (Denenburg: para. [0041], last sentence; Figs. 9A-B; para. [0007], sentence 2).
Regarding claim 3 Gyure in view of Denenburg teaches the method of claim 1, as described above, wherein, in the plunger disposing step, the plunger is disposed inside the chamber after the lubricant is applied to the inner surface of the chamber (Gyure: col. 3, lines 27-29 and 42-50).
Regarding claim 4 Gyure in view of Denenburg teaches the method of claim 1, as described above, further comprising: a leak-proof cap coupling step in which a leak-proof cap is coupled to the chamber to block the injection port (Denenburg: Fig. 2: cap 17+18 coupled to port at 13; para. [0033], line 2). 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 also incorporated the leak-proof cap taught by Denenburg into the Gyure-Denenburg combination, in order to seal the port of the syringe and prevent leakage of the medicinal liquid from it.
Claims 8, 9, 11, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Henderson (US 20040087906) in view of Denenburg (US 20190117514).
Regarding claim 8 Henderson discloses the pre-filled medicinal liquid pumping assembly of claim 5, as described above, wherein the leak-proof cap comprises: an injection port insertion portion (Fig. 4: 4) inserted into the injection port of the chamber (Fig. 9: 4 inserted into 211). Henderson does not, however, explicitly disclose a membrane withing the central portion of the injection port.
Denenburg teaches an analogous pre-filled medicinal injection apparatus (Fig. 9A: 10A), and a membrane disposed in a central portion of the injection port insertion portion (Fig. 2: septum 17 disposed at 13) and configured to allow an external spike (Fig. 9B: spike 59) to penetrate therethrough (Figs. 9A-B). 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 Henderson apparatus by incorporating the membrane element taught by Denenburg into the central injection port portion (4) of the Henderson cap, such that the spike of the connection cap would penetrate the injection port portion (4) of the Henderson cap, in order to be able to connect to and fill the syringe in a way that is sealed from outside contaminants and which also allows for more accurate calibration of the apparatus (Denenburg: para. [0007], sentence 2).
Regarding claim 9 Henderson in view of Denenburg teaches the pre-filled medicinal liquid pumping assembly of claim 8, as described above, wherein the chamber comprises an injection port formation portion in which the injection port is formed and which protrudes outward (Henderson: Fig. 2: injection port formation portion 211 of 2 protruding outward from chamber), and wherein the leak-proof cap has a protruding end insertion groove (Henderson: Fig. 4: 32) which is formed along a periphery of the injection port insertion portion and into which a protruding end of the injection port formation portion is inserted (Henderson: 32; para. [0021], second-to-last sentence).
Regarding claim 11 Henderson discloses a pre-filled medicinal liquid injection apparatus comprising: a pre-filled medicinal liquid pumping assembly according to claim 5, as described above, but fails to explicitly disclose a connection cap for penetrating the cap.
Denenburg teaches an analogous pre-filled medicinal injection apparatus (Fig. 9A: 10A), and a connection cap (Fig. 4: 40A) including a spike (Figs. 4 and 8: spike 59 at 57) configured to be capable of penetrating the leak-proof cap to be inserted into the injection port (Fig. 2: penetrates leak-proof cap 17+18 at port 13; Fig. 9A) and having a connection flow path which forms an upstream end at a protruding end of the spike (Fig. 9A: 56), wherein the connection cap is configured to be capable of coupling to the medicinal liquid pumping assembly (Fig. 9A: 40A coupled to 10A). 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 Henderson apparatus by incorporating the connection cap taught by Denenburg, such that the spike of the connection cap would penetrate the injection port portion (4) of the Henderson cap, in order to be able to connect to and fill the syringe in a way that is sealed from outside contaminants and which also allows for more accurate calibration of the apparatus (Denenburg: para. [0007], sentence 2).
Regarding claim 13 Henderson in view of Denenburg teaches the pre-filled medicinal liquid injection apparatus of claim 11, as described above, wherein the connection cap is configured to be capable of coupling to the chamber while covering the leak-proof cap (Denenburg: Fig. 9A: connection cap 40A is coupled to the chamber by virtue of being coupled to and penetrating the leak-proof cap).
Regarding claim 15 Henderson in view of Denenburg teaches the pre-filled medicinal liquid injection apparatus of claim 11, as described above, wherein the chamber comprises an injection port formation portion in which the injection port is formed and which protrudes outward (Henderson: Fig. 2: injection port formation portion 211 of 2 protruding outward from chamber), wherein the leak-proof cap comprises: a partition surrounding a periphery of the injection port formation portion (Henderson: Fig. 4: 32; para. [0021], second-to-last sentence); and a flange extending from the partition in an outer radial direction along a surface of the chamber (Henderson: Fig. 4: outwardly extending foot/flange of the bottom base of 32, seen in the gap base in Figs. 9 and 10), and wherein the connection cap comprises a circumferential cover portion surrounding a periphery of the partition (Denenburg: Fig. 5: 53 surrounds periphery of paired cap, seen in Fig. 9A) and configured to press the flange in a direction toward the surface of the chamber when the connection cap is coupled to the chamber (Henderson: Fig. 9: flange is pushed in, towards the chamber; upon the combination, connection cap of Denenburg pushes the cap inwards with the spike).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson (US 20040087906) in view of JP-5333850.
Regarding claim 10 Henderson discloses the pre-filled medicinal liquid pumping assembly of claim 5, as described above, but fails to explicitly disclose a spike insertion groove recess.
JP-5333850 teaches an analogous syringe apparatus and connection cap assembly, wherein the leak-proof cap has a spike insertion groove recessed in a direction of insertion into the injection port (Fig. 1: “V” shaped groove/recess in 13/13b). 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 Henderson-Denenburg apparatus by incorporating the “V” shaped spike insertion groove, taught by JP-5333850, in order to provide a clear and precise spot for the spike to engage with, making the point more clear and easier to penetrate.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson (US 20040087906) in view of Denenburg (US 20190117514) in further view of Oda (US 20200093699).
Regarding claim 12 Henderson in view of Denenburg teaches the pre-filled medicinal liquid injection apparatus of claim 11, as described above, but fails to disclose a hanger.
Oda teaches an analogous syringe pumping apparatus, further comprising: a hanger (Fig. 32: hanger 13200) coupled to a predetermined position of the pre-filled medicinal liquid injection apparatus such that the injection port is directed upward by gravity when the hanger is hung outside (Fig. 13: 13200 and 13202 couples to predetermined portions of the syringe 13201 in order to hold the syringe upright). 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 Henderson-Denenburg apparatus by incorporating the hanger taught by Oda in order to keep the syringe apparatus in a secured and upright position while in use with the connection cap for being filled and administering its contents.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Henderson (US 20040087906) in view of Denenburg (US 20190117514) in further view of JP-5333850.
Regarding claim 14 Henderson in view of Denenburg teaches the pre-filled medicinal liquid injection apparatus of claim 13, as described above, but fails to explicitly disclose a screw connection between the chamber and the connection cap.
JP-5333850 teaches an analogous syringe apparatus and connection cap assembly, wherein the connection cap comprises a first screw (Fig. 1: 32a), wherein the chamber comprises a second screw (Fig. 1: 12a-c) configured to guide the first screw when the connection cap is coupled to the chamber (page 3 of translation, last sentence of third paragraph from the bottom), wherein one of the chamber and the connection cap has an engagement groove recessed in a direction transverse to a direction of rotation in which the first screw is guided by the second screw (Fig. 1: recess seen below 32a, transverse to the direction of screw rotation), and wherein the other one of the chamber and the connection cap includes an engagement portion (Fig. 1: 13a and 13b) protruding to be engaged with the engagement groove in a state in which the spike penetrates the leak-proof cap (Figs. 4a-e). 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 Henderson-Denenburg apparatus by incorporating the threaded engagement/screws of the chamber to the connection cap, taught by JP-5333850, in order to create a tighter and more secure connection between the syringe/chamber and the connection cap.
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
/NATHAN R PRICE/Primary Examiner, Art Unit 3783