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 8/14/2026 has been entered. Claims 1-16 are pending in the application. Applicant’s amendments to the Specification and Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 4/16/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 and 15-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to include the limitation of “the intermediate portion of the evacuation path extends continuously from the lower portion to the upper portion of the evacuation path”. This limitation is not supported by the original disclosure and is considered as new matter. A vent is provided between the intermediate portion and the upper portion of the evacuation path (vent 26, [0066] & Fig. 2). Vent 26 creates a discontinuity between the intermediate portion and the upper portion. Vent 26 is not disclosed as part of either the intermediate portion or the upper portion, but as a separate part of the evacuation path (“purge valve 22 seals a vent 26 between the intermediate portion 17b and the upper portion 17c of the evacuation pat”, [0066]; “gas enters the evacuation path through the entrance 20, then travels along the lower portion 17a of the evacuation path, then along the intermediate portion 17b of the evacuation path, then through the vents 26 and finally along the upper portion 17c”, [0076] & Fig. 2).
Further, a passage is provided between the intermediate portion and the lower portion of the evacuation path (passage 38, [0078] & Fig. 2). Passage 38 creates a discontinuity between the intermediate portion and the lower portion. Passage 38 is disclosed as “forming the boundary between the lower portion 17a and the intermediate portion 17b of the evacuation path. The passage 38 is arranged at the top of the cavity 36.” ([0078]; also see [0084]). The specification does not support the intermediate portion extending continuously from the lower portion to the upper portion.
Claim Rejections - 35 USC § 103
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 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) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lum (US 20110224610 A1) in view of Martell (US 4373535 A).
Regarding claim 1, Lum discloses an injection device for injecting into a medical tubing a medical liquid from a medical liquid container (medical device 200 for injecting a liquid medication from a vial 50 into a needle cannula 284, [0161] and [0183]-[0184] & Fig. 14-25; needle cannula 284 is a long, hollow cylinder of metal, and can be interpreted as medical tubing), said injection device comprising:
- a body defining an inner space extending in a longitudinal direction between an upper end of the body and a lower end of the body (sidewall 214 of syringe barrel 210 defining a chamber 218 extending in a longitudinal direction between a proximal end 219 and a distal end 211, [0161] & Fig. 14 and 17), the lower end of the body comprising a medical tubing interface through which the medical liquid can penetrate the inner space from the medical liquid container and can exit said inner space to be injected into the medical tubing (distal end 211 includes tip 220 and fitting 288 for attaching cannula 284, or a needle hub holding cannula 284, through which liquid medication enters chamber 218 from vial 50 and exit chamber 218 to be injected into cannula 284, [0161], [0187], and [0190] & Fig. 14-24),
- a piston arranged within the inner space and configured for travelling within the inner space along the longitudinal direction (stopper assembly including stopper 260 and stopper hub 250 attached to plunger rod 240 and configured to travel in chamber 218, [0160]-[0161] & Fig. 14-17 and 23-24), said piston delimiting an upper space and a lower space of the inner space, said lower space configured to receive the medical liquid (the stopper assembly delimiting a lower portion of chamber 218 configured to receive liquid medication, which is being interpreted as a lower space (see Fig. 22-23B), and an upper portion of chamber 218 that includes recess 292 and body 242, [0180] & Fig. 17 and 22-23B),
- an evacuation path, said evacuation path traversing the piston in the longitudinal direction from the lower space to the upper space of the inner space (path 276, stopper cavity 266, and recess 292 are being interpreted as an evacuation path, [0163], [0169], [0180], and [0188] & Fig. 16-17, 21, and 23B; path 276, cavity 266, and recess 292 traverse stopper 260 and stopper hub 250 in the longitudinal direction from the lower portion of chamber 218 to the upper portion of chamber 218, Fig. 21-23B),
- a selector (porous portion 290 disposed adjacent path 276 on the inside surface 264 of the stopper is being interpreted as a selector, [0164]-[0165] & Fig. 14-15 and 21) arranged within the evacuation path between a lower portion of the evacuation path and an intermediate portion of the evacuation path (porous portion 290 arranged within path 276 between cavity 266, which is being interpreted as an intermediate portion of the evacuation path, and the lower portion of path 276, which is being interpreted as a lower portion of the evacuation path, [0165] and [0169] & Fig. 16 and 22-23B; the Examiner notes that the drawings of Lum illustrate porous portion 290 as “integrally formed or disposed on the distal face 272, adjacent to the opening 274”, but “the porous portion 290 may extend from the distal face 272 into the path 276…. the distal face 272 may include a pocket (not shown) for holding and securing the porous portion 290 adjacent to the distal face 272 and the opening 274.” [0167]; portion 290 is being interpreted as extending “from the distal face 272 into the path 276” with the portion of path 276 below portion 290 being interpreted as the lower portion of the evacuation path), said lower portion of the evacuation path being connected to the lower space (path 276 connected to the lower portion of chamber 218, [0163] & Fig. 17-23B), wherein
the selector is configured for being in contact with the medical liquid received in the lower space and for selectively allowing gas to go through said selector and to travel along the evacuation path from the lower portion to the intermediate portion of the evacuation path, while selectively preventing the medical liquid from going through said selector and from travelling along the evacuation path from the lower space to the upper space of the inner space (“the porous portion 290 is air permeable and liquid impermeable.”, [0164]; “As shown in FIGS. 23A-B, as liquid fills the chamber 218, any remaining air rises to the top of the aspirated liquid or between the liquid and the distal face 272 of the stopper 260. This remaining air permeates through the porous portion 290 and the liquid is prevented from passing through the porous portion 290 into the stopper cavity 266. The porous portion may be formed from hydrophobic filter… In embodiments which include a porous portion including a hydrophobic filter or membrane, the hydrophobic filter prevents liquid from permeating through the porous portion 290 and entering the stopper cavity 266. FIG. 23B illustrates a syringe barrel 210 filled with liquid and no air.”, [0188]; also see [0186]; portion 290 allows for gas to travel from the lower portion of path 276 to cavity 266 while preventing liquid from traveling past),
- a purge valve arranged in the evacuation path between the intermediate portion of the evacuation path and an upper portion of the evacuation path (one-way check valve 238 arranged between cavity 266 and recess 292, which is being interpreted as an upper portion of the evacuation path, [0176] and [0189] & see Fig. 23B-24) and configured for moving between a blocking configuration in which the purge valve closes the evacuation path (“The expansion of the pump cavity 258 creates a vacuum within the pump cavity 258, which causes the valve 238 to close, as shown more clearly in FIGS. 20 and 21.”, [0185]; “The valve 238 remains closed and the vacuum within the pump cavity 258 is maintained and continues to draw any air present in the chamber 218 into the pump cavity 258.”, [0187]) and a passing configuration in which the purge valve keeps open said evacuation path (“To expel the fluid, a distally directed force is applied to the plunger rod 240 and the stopper hub 250 move with the stopper 260 in the distal direction... The compressed wall 254 causes the valve 238 to open and allows the air within the pump cavity 258 to escape through the outlet 237 instead of through the porous portion 290.”, [0190]), wherein the passing configuration of the purge valve requires an overpressure in the intermediate portion of the evacuation path caused by the piston travelling towards the lower end of the body (see [0187]-[0190]), wherein the intermediate portion of the evacuation path extends continuously from the lower portion to the upper portion of the evacuation path (cavity 266 extends continuously from the lower portion of path 276 to recess 292 as a gas can continuously move from the lower portion of path 276, to cavity 266, to recess 292, [0188]-[0190] & see in Figs. 19 and 24-25).
Lum teaches that “The stopper 260 may be formed from an elastomeric material, polymeric material or other suitable material known in the art… the sealing portion 270 may be formed from a material suitable for forming a fluid-tight seal with the interior surface 216 of the syringe barrel and may include the same or different material utilized to form the stopper 260.” ([0162]) but fails to explicitly disclose wherein the intermediate portion of the evacuation path is rigid.
However, Martell teaches a syringe with venting means disposed through the piston (abstract & Fig. 1-5) comprising a piston wherein the piston is rigid (enlarged portion 61 formed of hard plastic including O-rings 26 to seal with the interior surface of syringe body 11, col 5 lines 55-68 & Fig. 5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the stopper of Lum with Martell to include the stopper made from a hard plastic since Martell teaches a stopper made of hard plastic to be an art effective configuration for a stopper positioned in a syringe barrel configured to vent air (col 4 line 52-68 of Martell) and is an art effective equivalent to a soft rubbery plastic sealing member (see col 5 lines 43-54 & Fig. 4 of Martell) and would yield the same predictable results pertaining to fluid aspiration and expulsion and sealing.
As modified, stopper 260 of Lum, which includes cavity 266, would be made from a hard plastic. Sealing portion 270 may continue to be formed from a material suitable for forming a fluid-tight seal with the interior surface 216 of the syringe barrel ([0162]) or may also be formed of the hard plastic, with O-rings 26 of Martell being included to facilitate sealing.
Regarding claim 2, Lum, as modified, discloses all the limitations of claim 1. Lum further discloses the injection device wherein the purge valve is configured for being in the blocking configuration when the piston travels towards the upper end of the body (“to actively aspirate the desired amount of liquid into the syringe barrel 210, the user applies a proximally directed force on the plunger rod 240 or, more specifically, the thumbpress 248, which draws the liquid from the vial 50 into the needle cannula 284 and into the chamber 218. The valve 238 remains closed and the vacuum within the pump cavity 258 is maintained and continues to draw any air present in the chamber 218 into the pump cavity 258”, [0187]).
Regarding claim 3, Lum, as modified, discloses all the limitations of claim 1. Lum further discloses the injection device wherein the lower portion of the evacuation path is configured for receiving both medical liquid and a gas (lower portion of path 276, the portion of path 276 below porous portion 290, would be configured to receive liquid medication and gas considering porous portion 290 is proximally positioned to the lower portion of path 276, [0167] and [0187]-[0188] & Fig. 23B), and the intermediate portion and the upper portion of the evacuation path are configured for receiving only gas (cavity 266 and recess 292 are configured to receive only gas, [0188] & Fig. 21-25).
Regarding claim 4, Lum, as modified, discloses all the limitations of claim 1. Lum further discloses the injection device wherein the upper space is configured to be kept at a constant reference pressure and the overpressure in the intermediate portion of the evacuation path corresponds to a gas pressure above the reference pressure (“The valve 238 remains closed as the pressure within the pump cavity 258 remains lower than the pressure outside of the pump cavity 258…. As the pressure within the pump cavity 258 equalizes or, as will be discussed, the user expels the liquid within the chamber 218, the valve 238 opens and vents the evacuated air from within the pump cavity 258.”, [0189]; the overpressure in cavity 266 caused by downward piston travel would necessarily be greater than the pressure in recess 292 to allow for air expulsion; The Examiner notes that Lum discloses that “The body 242 may include a cavity (not shown), which may be in fluid communication with the pump cavity 258.”, [0179]; the Examiner notes that cavity 266 defines cavity 258 when an overpressure is present, Fig. 19 and 24-25).
Regarding claim 5, Lum, as modified, discloses all the limitations of claim 1. Lum further discloses the injection device wherein the piston comprises a lower interface delimiting the lower space of the inner space, said lower interface comprising an entrance of the evacuation path which opens in a highest portion of said lower interface (stopper 260 comprises a distal face 272 which separates the lower portion of chamber 218 from the upper portion of chamber 218, [0163] & Fig. 15 and 23B; distal face 272 includes opening 274 to path 276, [0164] & Fig. 15-16; distal face may be flexible and may flex concavely and convexly, [0163] and [011] and [0152]; opening 274 is positioned in the highest portion of distal dace 272 when distal face 272 is flexed convexly).
Regarding claim 6, Lum, as modified, discloses all the limitations of claim 5. Lum further discloses the injection device wherein the lower interface has a concave surface seen from the lower space of the inner space and the entrance of the evacuation path opens in a middle of said lower interface (distal face 272 having a convex surface seen from the lower portion of chamber 218 when flexed (as illustrated with respect to the embodiment of Figs. 1-13), [0163] & Fig. 15-16; opening 274 seen formed in the middle of distal face 272, see Fig. 15-16).
Claim(s) 7-8 and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lum (US 20110224610 A1), in view of Martell (US 4373535 A), and further in view of Williams (US 4424817 A).
Regarding claim 7, Lum, as modified, discloses all the limitations of claim 1. However, Lum fails to explicitly disclose the injection device wherein the selector is a float configured for floating on the medical liquid and arranged in a cavity, said cavity comprising at least a passage which belongs to the evacuation path, wherein said float is configured for travelling within said cavity along the longitudinal direction between a blocking configuration in which the float obturates the passage, thereby closing the evacuation path, and an open configuration in which the float is spaced apart from the passage, thereby letting open the evacuation path.
However, Williams teaches an injection device (syringe device 10 configured for drawing blood but capable of drawing and delivering medicament, abstract and Col 1 lines 14-29) wherein the selector is a float configured for floating on the medical liquid and arranged in a cavity (buoyant spherical ball valve 10 configured to float on liquid and arranged in hollow portion 72’ between insert 81 and bore 68, col 8 lines 9-30 & Fig. 5),
said cavity comprising at least a passage which belongs to the evacuation path (insert 81 including bore 69, Col 8 lines 9-25 & Fig. 1 and 5), wherein said float is configured for travelling within said cavity along the longitudinal direction between a blocking configuration in which the float obturates the passage, thereby closing the evacuation path, and an open configuration in which the float is spaced apart from the passage, thereby letting open the evacuation path (ball 80 is configured for travelling within hollow portion 72’ along the longitudinal direction between a configuration in which bore 69 is sealed by ball 80 and a configuration in which ball 80 is spaced apart from bore 69 letting air escape, Col 8 lines 9-25 & Fig. 1, 3, and 5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the selector of Lum with Williams to include the selector being a float configured for floating on the medical liquid and arranged in a cavity, said cavity comprising at least a passage which belongs to the evacuation path, wherein said float is configured for travelling within said cavity along the longitudinal direction between a blocking configuration in which the float obturates the passage, thereby closing the evacuation path, and an open configuration in which the float is spaced apart from the passage, thereby letting open the evacuation path, since Williams teaches a buoyant ball valve to be an art effective configuration for a selective valve positioned in a piston configured to allow air evacuation while preventing liquid travel (Col 8 lines 9-25 of Williams) and is an art effective equivalent to a porous, hydrophobic filter or swellable polymer (see Col 3 lines 39-49, Col 7 line 58-Col 8 line 2, and Col 8 lines 31-49 & Fig. 1 and 4-6 of Williams), like the porous plug 290 of Lum (see [0188] of Lum).
As modified, porous plug 290 of Lum would be substituted with buoyant ball valve 80 of Williams. Path 276 of Lum would be modified to include bores 68 and insert 81 of Williams to facilitate proper valve activation.
Regarding claim 8, Lum, as modified, discloses all the limitations of claim 7. Lum further discloses the injection device wherein the float has at least one obturating part and a floating part (the top third of ball 80 of Williams is being interpreted as an obturating part and the bottom two-thirds of ball 80 is being interpreted as a floating part, Col 8 lines 9-24 & Fig. 5), said obturating part configured to obturate the passage (top third of ball 80 is capable of obstructing, or obturating, the passage, Col 8 lines 9-24), wherein the floating part has an enlarged section with respect to a widest section of the obturating part (the bottom two-thirds of ball 80 includes the largest diameter portion of ball 80, Col 8 lines 9-24 & Fig. 5).
Regarding claims 15-16, Lum, as modified, discloses all the limitations of claim 1. Lum further discloses the injection device wherein the selector is arranged in a cavity (“the distal face 272 may include a pocket (not shown) for holding and securing the porous portion 290 adjacent to the distal face 272 and the opening 274.”, [0167]; the pocket in which porous portion 290 is arranged and a section of path 276 proximal to the pocket is being interpreted as a cavity; the Examiner again notes that portion 290 is also being interpreted as extending “from the distal face 272 into the path 276”, [0167]),
wherein the evacuation path includes a vent between the intermediate portion and the upper portion of the evacuation path (outlet 237 between cavity 266 and recess 292, [0176]-[0177] & Fig. 16, 19, 21, and 24-25), said vent being sealed by the purge valve in the blocking configuration and left open by the purge valve in the passing configuration (“The compressed wall 254 causes the valve 238 to open and allows the air within the pump cavity 258 to escape through the outlet 237”, [0190] & 19 and 24-25; “the valve 238 closes during expansion of the wall 254 and seals the outlet 237 from the socket 235”, [0178] & Fig. 20-23B; also see [0184]), and wherein said vent is narrower than the intermediate portion of the evacuation path (outlet 237 is narrower than cavity 266, see Fig. 16 and 23B).
However, Lum fails to explicitly disclose said cavity comprising a passage between the lower portion of the evacuation path and the intermediate portion of the evacuation path, wherein said passage is narrower than the intermediate portion of the evacuation path, wherein the selector is a float configured for floating on the medical liquid, wherein said float is configured for travelling within the cavity along the longitudinal direction between a blocking configuration in which the float obturates the passage, thereby closing the evacuation path, and an open configuration in which the float is spaced apart from the passage, thereby letting open the evacuation path.
However, Williams teaches an injection device (syringe device 10 configured for drawing blood but capable of drawing and delivering medicament, abstract and Col 1 lines 14-29) comprising a cavity (a portion of rearward hollow portion 72’ between bore 68 and insert 81, where ball valve 80 is positioned, col 8 lines 9-30 & Fig. 5) comprising a passage between the lower portion of the evacuation path and the intermediate portion of the evacuation path (portion 72’ comprises insert 81 which includes small bore 69 positioned between bore 68 and a portion of rearward hollow portion 72’ proximal to insert 81, Fig. 5), wherein said passage is narrower than the intermediate portion of the evacuation path (bore 69 is narrower than hollow portion 72’, see Fig. 5), wherein the selector is a float configured for floating on the medical liquid (buoyant spherical ball valve 10 configured to float on liquid, col 8 lines 9-30 & Fig. 5), wherein said float is configured for travelling within the cavity along the longitudinal direction between a blocking configuration in which the float obturates the passage, thereby closing the evacuation path, and an open configuration in which the float is spaced apart from the passage, thereby letting open the evacuation path (ball 80 is configured for travelling within hollow portion 72’ along the longitudinal direction between a configuration in which bore 69 is sealed by ball 80 and a configuration in which ball 80 is spaced apart from bore 69 letting air escape, Col 8 lines 9-30 & Fig. 1, 3, and 5).
Therefore, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the device of Lum, as modified, with Williams to include said cavity comprising a passage between the lower portion of the evacuation path and the intermediate portion of the evacuation path, wherein said passage is narrower than the intermediate portion of the evacuation path, wherein the selector is a float configured for floating on the medical liquid, wherein said float is configured for travelling within the cavity along the longitudinal direction between a blocking configuration in which the float obturates the passage, thereby closing the evacuation path, and an open configuration in which the float is spaced apart from the passage, thereby letting open the evacuation path, since such Williams teaches a buoyant ball valve to be an art effective configuration for a selective valve positioned in a piston configured to allow air evacuation while preventing liquid travel (Col 8 lines 9-25 of Williams) and is an art effective equivalent to a porous, hydrophobic filter or swellable polymer (see Col 3 lines 39-49, Col 7 line 58-Col 8 line 2, and Col 8 lines 31-49 & Fig. 1 and 4-6 of Williams), like the porous plug 290 of Lum (see [0188] of Lum).
As modified, porous plug 290 of Lum would be substituted with buoyant ball valve 80 of Williams. Path 276 of Lum would be modified to include bores 68 and insert 81 of Williams to facilitate proper valve activation.
Response to Arguments
Applicant’s arguments with respect to the claims 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. The Examiner notes that there is no specific structure that defines the bounds of the evacuation path, the evacuation path simply being a space traversing the piston in which fluid can move through.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Baidwan (US 5238003 A) also teaches a piston formed of rigid plastic configured to vent air including a purge valve and a selector (col 3 line 62-col 4 line 36 & Fig. 2).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARTIN ADAM RADOMSKI whose telephone number is (571)272-2703. The examiner can normally be reached Monday-Friday: 7:30-4:30 CT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/MARTIN A RADOMSKI/ Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
