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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6/22/26 has been entered.
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) 1, 5-8, 10-14, 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tachikawa et al. (JP2019-63168A, found in IDS, citations taken from English translation attached with previous office action) in view of Moran et al. (US 4,874,385).
With regard to claim 1 and 13, Tachikawa discloses A prefilled syringe (Fig. 3-5) comprising:
a hollow main body part (2, Fig. 3), and a flange part (24) comprising: an outer cylinder flange (24) at a proximal end part of the hollow main body part (see Fig. 3), and an attachment member (6, better seen in Fig. 5) that is attached to a proximal side of the outer cylinder flange (Fig. 3-5), the attachment member comprising a plunger insertion cutout part (Fig. 7, element 62) that extends from a side part to a center part of the attachment member (as shown in Fig. 7); a gasket (31) that is slidably housed in the outer cylinder, the gasket comprising a plunger distal end part attachment part (Fig. 3, within 33), ;a plunger (4) that is attached to the gasket and configured to press the gasket the plunger comprising: a gasket pressing part (Fig. 8, at 71) at a distal end part of the plunger, a shaft part (41) comprising: a plurality of flat plate parts extending in a proximal end direction from the gasket pressing part, and a pressing operation part (47) at a proximal end part of the shaft part; a sealing member (52) that seals a distal end part of the outer cylinder (Fig. 3); and a drug (9) that is housed in the outer cylinder.
However, Tachikawa does not disclose the indicator parts.
Moran teaches a syringe device (Fig. 1) comprising a shaft part comprising: a plurality of flat plate portions (24, 26, 28, 30) extending in a proximal end direction from the gasket pressing part (the flat plate parts extend from a gasket 18 and a pushing part 20) and a plurality of indicator parts (each of notches 57 located on the four radial wings 24, 26, 28, 30 of the plunger shaft) each formed on an outer side surface of a respective one of the flat plate parts and each comprising: a vertex plane portion (see annotated drawing below), and inclined side parts (see annotated drawing below) located on both sides of the vertex plane portion and a pressing operation part (20) at a proximal end part of the shaft part
wherein: when the plunger is in an initial position in which the plurality of indicator parts are aligned with the flange part all of the plurality of indicator parts are covered by the flange part of the outer cylinder and are not visually recognizable by checking an external appearance of the prefilled syringe (The plunger shaft moves distally and proximally within the hollow main body, therefore at a point the notches 57 will be aligned with the flange part of the outer cylinder and would therefore be not visually seen), when the plunger is in a displaced position in which the plunger has moved proximally from the initial position and the plurality of indicator parts are aligned with the attachment member (if the plunger is moved proximally the shaft including the notches 57 would thus come into view if aligned with the attachment member that is taught in Tachikawa because the attachment part of Tachikawa is open on one side), at least one of the plurality of indicator parts is visually recognizable through the plunger insertion cutout part by checking the external appearance of the prefilled syringe (as described above), and a remainder of the plurality of indicator parts are covered by the attachment member and not visually recognizable by checking the external appearance of the prefilled syringe (because the opening of the attachment member of Tachikawa is only open on side and because the notches 57 of Moran are located circumferentially around the entire plunger shaft, not all the notches will be visible, only the notches that are on the side with the open part of the attachment member).
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Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tachikawa to have indicators that may be moved distally or proximally within the outer cylinder such that moving them proximally from a first position would allow a user to view the indicators as taught by Moran for the purpose of providing a visual indication to a user for operation of the syringe device (Col 4, line 66 to Col 5, line 28).
With regard to claim 5 and 16, Tachikawa discloses an indicator part (46). However, neither Tachikawa nor Janish teach the indicator part are in a range of 1 to 6 mm. However, it would be prima facie obvious to optimize the size of the indicator part as doing so would not alter the overall function of the device of allowing a user to visualize the indicator.
With regard to claim 6 and 17, Tachikawa discloses that the indicator part comprises a part that has a shape different from that of another anchor portion of the shaft (46 is a protrusion from the shaft part and thus has a different shape than the cylindrical shaft).
With regard to claim 7 and 18, Tachikawa discloses wherein: the indicator part (46) comprises a part that has a surface state different from that of another portion of the shaft part (46 is considered a protrusion that would have a surface state that extends from the surface of the rest of the shaft).
With regard to claim 8 and 19, Tachikawa discloses wherein the indicator part (46) is a protrusion part formed on an outer surface of the shaft part.
With regard to claim 20, Tachikawa discloses the claimed invention except for the indiator part being of a different color.
Moran teaches wherein each indicator part (57) comprises a part that is a different pattern from that of the flat plate part (57 is a notch and thus considered a different pattern than the flat plate part).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tachikawa to have indicators that may be moved distally or proximally within the outer cylinder such that moving them proximally from a first position would allow a user to view the indicators as taught by Moran for the purpose of providing a visual indication to a user for operation of the syringe device (Col 4, line 66 to Col 5, line 28).
With regard to claim 10, Tachikawa discloses the claimed invention except for a surface roughness of the indicator part.
Moran teaches wherein each indicator part (57) comprises a part (57) that has a roughness higher than that of the flat plate part (57 is a notch or cutout and therefore would be rougher than the smooth flat plate).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tachikawa to have indicators that may high a higher roughness as taught by Moran for the purpose of providing a visual indication to a user for operation of the syringe device (Col 4, line 66 to Col 5, line 28).
With regard to claim 11 and 20, Tachikawa discloses wherein: the indicator part comprises a patterned part that has a pattern different from that of another portion of the shaft part (protrusion 46 can be considered a pattern as it breaks from the normal part of the shaft).
With regard to claim 12, Tachikawa discloses wherein: the indicator part comprises a part (46) that has a surface state and a shape different from those of another portion of the shaft part (46 protrudes from the surface of the shaft and thus creates a different surface state and shape that is different than the rest of the shaft).
With regard to claim 14, Tachikawa discloses wherein: the flange comprises a plurality of recesses (Fig. 6, elements 26a-d), and the prefilled syringe comprises an attachment member (6) that is attached to a proximal side of the flange and comprises: a plate shaped part (body of 6), and a plurality of protrusions (63a-d) that fit into the recesses of the flange (as shown in Fig. 4 and 5).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tachikawa et al. (JP2019-63168A, found in IDS, citations taken from English translation attached with previous office action) in view of Moran et al. (US 4,874,385) and in further view of Ogawa (US 2016/0001017 A1).
With regard to claim 2, Tachikawa/Moran teach the claimed invention except for a label.
Ogawa teaches a syringe having a label ([0011]) that is pasted on an outer surface of the outer cylinder, wherein the gasket is not visually recognizable by checking an external appearance of the prefilled syringe due to the label (label has opaque portions and thus the gasket would not be able to be viewed at these portions, [0050]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tachikawa/Moran to have a label as taught by Ogawa for the purpose of be able to provide information to the user via the label ([0050]).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tachikawa et al. (JP2019-63168A, found in IDS, citations taken from English translation attached with previous office action) in view of Moran et al. (US 4,874,385) and in further view of Jones (US 9,566,388 A1).
With regard to claim 9, Tachikawa/Moran teaches the claimed invention except for an indicator part with different colors.
Jones teaches a syringe having indicators that can be color-coded (Col 1, lines35-56). The notches of Tachikawa could also be colored in order to more distinctly provide a visual indication.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Tachikawa/Moran to have colored indicia as taught by Jones for the purpose of ease of reference (Col 1, line 35-56).
Response to Arguments
Applicant’s arguments with respect to claim(s) s 1-2, 5-14, 16-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
It is appreciated that Applicant has amended claims to further define the indicator parts which was discussed in the last office action as being a potential path forward. As shown above in the annotated drawing, Moran still appears to teach the claimed amendments. However, it appears looking at the Drawings of the present invention the indicator parts are not grooves cut into the flat plate parts but are formed as angled surfaces along the flat plate parts. The claims as currently recited, don’t necessarily preclude the inclined side parts from being the sides of the cutout notch so further definition of the inclined side parts may help to overcome the current rejection. Further, it is noted that the present invention divides the shaft part into two parts (as shown in Fig. 7), one with the flat plate parts at the distal half and then a proximal part (41f) that is divided with a reinforcement member (46). This type of structure could also be defined in the claims to potentially overcome the current rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/ Primary Examiner, Art Unit 3783
Prosecution Insights