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 .
Response to Amendment
The amendment filed March 09, 2026 has been entered. Claims 1-2, 4, and 7-21 remain pending in the application. Claims 3 and 5-6 were previously cancelled.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-2, 4, 9, 12, 14-17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Silver et al. (USPN 3052240).
Regarding claim 1, Silver discloses a syringe (invention B; Figures 12-18) comprising:
a barrel (main barrel 25) having a cylindrical shape (“a main barrel 25, preferably of cylindrical formation” [Col 2, lines 19-20]) and including a central cavity (chamber 26);
the barrel comprising:
a first output opening (apertured nipple 29) positioned on a distal end thereof (see labeled in Figure 6, for example);
a side opening (passageway 38a) formed in a side of the barrel and spaced from the first output opening (“The receptacle 70 defines an annular chamber 71 therein and the wall of the barrel 25 is provided with a passageway 38a communicating the chambers 26 and 71” [Col 3, lines 50-53]; Figure 14);
a first external structure (receptacle 70 having annular chamber 71) extending outward from a side of the barrel (Figure 14) and forming a funnel shape with a portion of a side of the barrel (Figures 12-14; “The bottom wall 74 of the concentric receptacle 70 slopes with a taper downwardly from a location diametrically opposed to the duct 38a to the duct side of the receptacle 25, so that the lowermost portion of the bottom surface of the bottom wall 74 is directly at the duct 38a. Thus, even with the assemblage B at an angle, during use thereof, all of the diluent will flow from the chamber 71 into the chamber 26.” [Col 3, lines 54-61], wherein “funnel shape” has been interpreted as a shape that narrows at the bottom to guide liquid), wherein the portion of the side of the barrel (outer wall of barrel 25) forms a portion of the funnel shape (Figures 12-14 and 17) and wherein a proximal opening (“The diluent chamber 37 opens at the top thereof” [Col 2, line 68]) of the first external structure is parallel to a first inlet opening of the barrel (at flange 27a; Figure 14); and
a plunger (plunger 41) mounted in the barrel and movable from a retracted position (see Figure 4, for example) where a distal end of the plunger (nipple 50) is positioned in the barrel and above the side opening and the first external structure (“With the syringe held firmly at the barrel 25, the plunger 41 is pulled outwardly. This uncovers the passageway 38 and permits the diluent to rush into the chamber 26 below the nipple 50 until the diluent chamber is empty.” [Col 3, lines 23-27]. The nipple 50 is above the duct 38a and is therefore above at least a portion of the receptacle 70) to a compressed position (see Figures 5-6, for example) wherein the distal end of the plunger (nipple 50) is positioned between the side opening and the first output opening (“the plunger is pushed downward and the nipple 50 returned to the position shown in FIGURE 5. This action discharges the excess air from the barrel through the passageway 38 and through the vent at the top of the chamber 37. Note that the passageway 38 is now blocked…The plunger 41 is then fully depressed for injecting the solution until the barrel chamber 26 is emptied (see FIGURE 6).” [Col 3, lines 31-45]).
Regarding claim 2, Silver discloses the syringe of claim 1, wherein the first inlet opening (at flange 27a) is provided in a proximal end of the barrel (Figures 12-14) wherein a proximal end of the plunger (proximal end of plunger 41) extends through the first inlet opening (Figure 14).
Regarding claim 4, Silver discloses the syringe of claim 1, wherein the first external structure (receptacle 70) tapers from a top portion to a bottom portion (Figures 12-14; “The bottom wall 74 of the concentric receptacle 70 slopes with a taper downwardly from a location diametrically opposed to the duct 38a to the duct side of the receptacle 25, so that the lowermost portion of the bottom surface of the bottom wall 74 is directly at the duct 38a.” [Col 3, lines 54-56]).
Regarding claim 9, Silver discloses the syringe of claim 1, further comprising a filter element (venting assemblage C: “The receptacle 52 forms an air block to prevent the diluent from readily passing from the compartment 37 into the compartment 53, and the openings 54 and 56 are so small that due to surface tension the diluent will not enter the body of the sterilized cotton nor pass into the container 55 even when the syringe is placed in horizontal position.” [Col 3, line 14-20]; “the top wall is provided with a venting assemblage C with is of the same construction as the venting assemblage C shown in I'IGURE 12a for the form of invention A.” [Col 3, lines 67-69]) positioned in a flow path extending between the first external structure (receptacle 70), the side opening (passageway 38a) and the central cavity (chamber 26; wherein air can flow between the venting assemblage C, chamber 71, duct 38a, and chamber 26; Figure 14) and configured to allow air and liquid to pass into and out of the barrel (wherein duct 38a allows liquid to pass into and out of the barrel and air can pass into and out of the barrel through vent opening 58: “the removal of the plug 59 permits air to pass through the vent opening 58 and through the sterilized cotton into the chamber 37.” [Col 3, line 28-30] and “the plunger is pushed downward and the nipple 50 returned to the position shown in FIGURE 5. This action discharges the excess air from the barrel through the passageway 38 and through the vent at the top of the chamber 37.” [Col 3, line 33-37]).
Regarding claim 12, Silver discloses the syringe of claim 2, wherein the proximal end of the plunger (flange 42) remains outside of the barrel (Figures 12-14) and includes a flat surface configured for contact with a user's finger to aid the user in manipulating the plunger (“A pistonlike plunger 41 is slidably disposed in the chamber 26, having an upper palm engaging flanged end 42, which is rather broad and preferably flat at the top.” [Col 2, lines 40-42]).
Regarding claim 14, Silver discloses the syringe of claim 12, wherein the distal end of the plunger moves within the barrel (see Figures 3-6, for example) and includes a seal element (nipple 50).
Regarding claim 15, Silver discloses the syringe of claim 14, wherein the seal element (nipple 50) engages an inner wall of the central cavity (Figure 14) such that the plunger stays in place in the barrel when no force is applied by a user to the plunger (“It is in the shape of an inverted cap and has annular spaced ribs thereon, as shown in the drawings, of a size to snugly but slidably engage the internal walls of the chamber 26 and provide a leakproof fit.” [Col 2, line 53-56]; see [Col 3, lines 21-46] disclosing the plunger must be pulled or pushed by the user to move the plunger within the barrel).
Regarding claim 16, Silver discloses the syringe of claim 15, wherein the seal element (nipple 50) is movable along the inner wall of the central cavity when the user applies pressure to the plunger (“With the syringe held firmly at the barrel 25, the plunger 41 is pulled outwardly.” [Col 3, line 23-25]; “the plunger is pushed downward and the nipple 50 returned to the position shown in FIGURE 5.” [Col 3, line 33-34]).
Regarding claim 17, Silver discloses the syringe of claim 14, wherein the seal element (nipple 50) is made of an elastomeric material (“This nipple is of rubber, "neoprene" or similar material not capable of being affected by either the medicament or its solvent, and is preferably of 35 durometer” [Col 2, lines 50-53]).
Regarding claim 20, Silver discloses the syringe of claim 1, wherein a distal end of the barrel (sloping bottom wall 28) tapers in an area surrounding the first output opening (Figure 14; “a main barrel 25…at the bottom thereof, it has a sloping bottom wall 28, terminating in an apertured nipple 29” [Col 2, lines 19-24]).
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 7 is rejected under 35 U.S.C. 103 as being unpatentable over Silver et al. (USPN 3052240) in view of Hasegawa et al. (US 20110004185).
Regarding claim 7, Silver discloses the syringe of claim 1.
Silver fails to explicitly disclose the first external structure further comprises a puncture structure including: a base; a pointed protrusion extending upward from the base; an opening formed in the base and in fluid communication with the side opening.
Hasegawa teaches a fluid delivery device (connection tool 3) comprising a main body comprising a first external structure surrounding a side opening (barrel attaching unit 31; Figure 10), the first external structure further comprises a puncture structure including: a base (liquid valve 322); a pointed protrusion (first needle 331) extending upward from the base (Figure 10); an opening (along liquid hole 334 to liquid hole 333) formed in the base and in fluid communication with the side opening (“When liquid holes 334 and 333 of first and second needles 331 and 33 are communicated with each other to transfer toxic drug solution T from barrel 1 to infusion container C by a pressure, and this pressure opens liquid valve 322.” [0082]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the first external structure of Silver to include a puncture structure based on the teachings of Hasegawa to form a liquid tight connection between the external structure and an attached fluid source in a manner that allows fluid flow to fill the external structure while also preventing flow in the reverse direction (Hasegawa [0082-0083]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Silver et al. (USPN 3052240) in view of Ishikawa (USPN 4435176).
Regarding claim 8, Silver discloses the syringe of claim 1.
Silver fails to explicitly discloses a filter element positioned in the side opening and configured to allow air and liquid to pass into and out of the barrel.
Ishikawa teaches a syringe (syringe 26 and needle assembly 10) having a barrel (barrel 28) comprising a side opening (snout 36 and small pipe 40b; Figure 3), further comprising a filter element (filter 48) positioned in the opening (Figure 3) and configured to allow air and liquid to pass into and out of the barrel (“The filter 48 can remove impurities from the liquid medicine. Various kinds of filters including not only a plate-like filter such as a membrane filter or a sintered plastics filter but also any other filter such as a filter made of a pile of fibers or hollow fibers, can be provided at the area which communicates with the needle bore and, in turn communicates with the small pipe in the needle holder 14b.” [Col 3, lines 58-65], wherein the air/liquid can pass into and out of the barrel 28 via filter 48; Figure 3).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the syringe of Silver to include a filter element positioned in the side opening and configured to allow air and liquid to pass into and out of the barrel based on the teachings of Ishikawa to remove impurities from the fluid (Ishikawa [Col 3, line 58-59]) as it is being delivered from the external structure into the barrel.
Claims 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Silver et al. (USPN 3052240) in view of Hyun et al. (US 20120232524).
Regarding claims 10 and 11, Silver discloses the syringe of claim 1, further comprising a lid (top wall of receptacle 70; Figure 14) attached to a top of the first external structure (Figure 14).
Silver fails to explicitly disclose the lid is movable between a first position in which the side opening is exposed and a second position in which the side opening is covered, as required by claim 10, and wherein the lid further comprises a hydrophobic filter, as required by claim 11.
Hyun teaches a syringe (syringe 10) having a barrel (barrel 20) comprising an opening (entrance 18; Figure 2) comprising a lid (cap 16) movable between a first position in which the opening is exposed (Figure 3) and a second position in which the side opening is covered (Figure 1), and wherein the lid further comprises a hydrophobic filter (hydrophobic member 26 25; Figure 3; “The aperture 24 is covered with a hydrophobic member 26 (see FIG. 3) to provide a liquid barrier between the interior of the barrel 20 and an environment 28 yet allow gas to pass therethrough.” [0028]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the lid of the syringe of Silver to be movable between a first position and a second position, as required by claim 10, based on the teachings of Hyun to prevent contamination of the contents of the syringe while also allowing access to the internal space when necessary (Hyun [0009]) and to further modify the lid of Silver to include a hydrophobic filter, as required by claim 11, based on the teachings of Hyun to prevent reflex of the contents of the syringe while still permitting venting of air from the syringe (Hyun [0009]).
Claims 13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Silver et al. (USPN 3052240) in view of Davis (US 20170246087).
Regarding claim 13, Silver discloses the syringe of claim 12.
Silver fails to explicitly disclose the flat surface further comprises a hanger opening configured to receive a protrusion to support the syringe.
Davis teaches a syringe (syringe S) comprising a plunger (plunger 10) having a proximal end (proximal end 14) with a flat surface (contact face 20), wherein the flat surface further comprises a hanger opening (opening 56 of flange portion 50) configured to receive a protrusion (hanging support H) to support the syringe (Figure 2).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the flat surface of the proximal end of the plunger of Silver to include a hanger opening based on the teachings of Davis to allow the syringe to be hung and adapted for gravity feed applications (Davis [0052]).
Regarding claim 21, Silver discloses the syringe of claim 1.
Silver fails to explicitly teach a distal end of the syringe surrounding the first output opening is structured for connection with an enteral tube.
Davis teaches a syringe (syringe S) comprising barrel (Figure 18, for example) comprising a first output opening (female connector FC) and a side opening (vent V); wherein a distal end of the syringe surrounding the first output opening (female connector FC) is structured for connection with an enteral tube (“syringe S comprises a female connector FC (see FIGS. 18-19) in the form of an ENFit compatible connector or coupling, for example, which can be connected with another ENFit compatible coupling (which can be connected to a feeding tube FT).” [0052]; Figures 17-19).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the syringe of Silver to include a distal end of the syringe surrounding the first output opening is structured for connection with an enteral tube based on the teachings of Davis to adapt the syringe for enteral feeding administrations, such as via a syringe pump or gravity-feed applications (Davis [0052]; Figures 17-19).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Silver et al. (USPN 3052240) in view of Hartnick et al. (US 20090159086).
Regarding claim 18, Silver discloses the syringe of claim 17, wherein the barrel is made of plastic (“the materials of the hypodermic syringe are inexpensive plastic.” [Col 2, line 28-29]).
Silver fails to explicitly disclose the barrel is made of polypropylene.
Hartnick teaches a syringe (syringe 10) comprising: a barrel (syringe body 100) and a plunger (plunger 300); wherein the barrel (syringe body 100) is made of polypropylene (“Because the syringe body 100 and plunger 300 can be disposable, polymers suitable for use in medical devices (e.g., polypropylene, polyvinyl chloride, polyimide, polyamide, polyamide-imide, acrylic or polycarbonate) can be used in the manufacture of the syringe 10.” [0027]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the barrel of Silver to be made of polypropylene based on the teachings of Hartnick to ensure the barrel is both suitable for medical uses and also disposable (Hartnick [0027]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Silver et al. (USPN 3052240) in further view of Russo (USPN 9656022).
Regarding claim 19, modified Silver teaches the syringe of claim 1.
Modified Silver fails to explicitly disclose a circular ring extending from an inner surface of an inner wall of the central cavity to mark the retracted position of the plunger.
Russo teaches a syringe (device 34; Figure 4) comprising a barrel (barrel 18) and a plunger (piston 23; further comprising a circular ring (stop ring 36) extending from an inner surface of an inner wall of the central cavity (chamber 35) to mark the retracted position of the plunger (Figure 4).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the syringe of Silver to include a circular ring extending from an inner surface of an inner wall of the central cavity based on the teachings of Russo to prevent the plunger from being completely removed from the barrel of the syringe (Russo [Col 5, line 18-22]).
Response to Arguments
Applicant's arguments filed March 09, 2026 have been fully considered but they are not persuasive.
Regarding the argument that Silver (USPN 3052240) does not explicitly disclose “a first external structure extending outward from a side of the barrel and forming a funnel shape with a portion of a side of the barrel, where the portion of the side of the barrel forms a portion of the funnel shape” as required by claim 1 (Remarks, page 5), the examiner respectfully disagrees. As detailed above, Silver discloses a syringe (invention B; Figures 12-18) comprising: a barrel (25) comprising: a first output opening (29); a side opening (38a) formed in a side of the barrel and spaced from the first output opening ([Col 3, lines 50-53]; Figure 14); a first external structure (receptacle 70 having annular chamber 71) extending outward from a side of the barrel (Figure 14) and forming a funnel shape with a portion of a side of the barrel (Figures 12-14; “The bottom wall 74 of the concentric receptacle 70 slopes with a taper downwardly from a location diametrically opposed to the duct 38a to the duct side of the receptacle 25, so that the lowermost portion of the bottom surface of the bottom wall 74 is directly at the duct 38a. Thus, even with the assemblage B at an angle, during use thereof, all of the diluent will flow from the chamber 71 into the chamber 26.” [Col 3, lines 54-61]), wherein the portion of the side of the barrel (outer wall of barrel 25) forms a portion of the funnel shape (Figures 12-14 and 17) and wherein a proximal opening ([Col 2, line 68]) of the first external structure is parallel to a first inlet opening of the barrel (at flange 27a; Figure 14). Applicant presents the argument that “this annular chamber does not form a funnel shape…According to the Britannica Dictionary, a funnel is "a device shaped like a hollow cone with a tube extending from the point." The receptacle 70 is not shape like a hollow cone and does not include a point. The annular chamber 71 is concentric with the barrel 25 and does not come to a point.” (Remarks, page 6). However, the interpretation of “funnel shape” as requiring a hollow cone that comes to a point is narrower than the broadest reasonable interpretation. For example, Cambridge Dictionary defines “funnel” as “an object that has a wide round opening at the top, sloping sides, and a narrow tube at the bottom, used for pouring liquids or powders into containers with narrow necks”. The limitation “the first external structure….forming a funnel shape” has been interpreted as the first external structure has a shape that is wider at the proximal end, narrows from the proximal end to a distal end to guide liquid into another container. The first external structure (receptacle 70 having annular chamber 71) is considered form a funnel shape because the receptacle 70 is wide at the proximal end, and then tapers towards its distal end at duct 38 (Figure 12; [Col 3, lines 54-61]).
Regarding the argument that Silver does not disclose “a plunger mounted in the barrel and movable from a retracted position where a distal end of the plunger is positioned in the barrel and above the side opening and the first external structure to a compressed position wherein the distal end of the plunger is positioned between the side opening and the first output opening” as required by claim 1 because “The plunger in FIGS. 12-18…includes a stop extension 44 that limits movement of the plunger to keep the opening 38 closed. Thus, the plunger devices in FIGS. 12-18 do not allow the plunger to move to the compressed position wherein the distal end is "positioned between the side opening and the first output opening." (Remarks, pages 5-6), the examiner respectfully disagrees. Both embodiments disclosed by Silver (Invention A in Figures 1-11 and Invention B in Figures 12-18) include a stop extension 44, which is disclosed as “stop extension 44…adapted to engage the top surface of one of the flange extensions 27a in order to close the passageway 38 by means of a nipple or cap 50” [Col 2, lines 44-49]. However, in use, the plunger 41 with the stop extension 44 is rotated in order to allow the plunger 41 to be moved to a compressed position as claimed (“the plunger 41 is then turned for 90° in either direction. This places the extension 44 out of the path of the longer flange extensions 27a. The plunger 41 can then be depressed…The plunger 41 is then fully depressed for injecting the solution until the barrel chamber 26 is emptied (see FIGURE 6).” [Col 3, lines 37-46]). This particular disclosure is in reference to Invention A, but Silver discloses that the corresponding structures function the same (see [Col 3, line 46-65]).
Regarding the argument that Silver as modified by Ishikawa (USPN 4435176) does not disclose or suggest “filter element positioned in the side opening and configured to allow air and liquid to pass into and out of the barrel” as required by claim 8 (Remarks, page 6-7), the examiner respectfully disagrees. As detailed above, Ishikawa teaches a syringe (10 and 26) having a barrel (28) and a filter element (48) positioned in an opening (36 and 40b; Figure 3). The limitation “configured to allow air and liquid to pass into and out of the barrel” is a recitation of intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The filter 48 of Ishikawa described as “The filter 48 can remove impurities from the liquid medicine. Various kinds of filters including not only a plate-like filter such as a membrane filter or a sintered plastics filter but also any other filter such as a filter made of a pile of fibers or hollow fibers, can be provided at the area which communicates with the needle bore and, in turn communicates with the small pipe in the needle holder 14b.” ([Col 3, lines 58-65]), and therefore, the filter 48 is capable of performing the intended use of allowing air and liquid to pass into and out of the barrel. Based on this, it would have been obvious to one having ordinary skill in the art to modify the syringe of Silver to include a filter element positioned in the side opening and configured to allow air and liquid to pass into and out of the barrel based on the teachings of Ishikawa to remove impurities from the fluid (Ishikawa [Col 3, line 58-59]) as it is being delivered from the external structure into the barrel.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEAH J SWANSON whose telephone number is (571)270-0394. The examiner can normally be reached M-F 9 AM- 5 PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LEAH J SWANSON/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
Prosecution Insights