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 .
Election/Restrictions
Applicant's election with traverse of Group I and Species A in the reply filed on February 3rd 2026 is acknowledged. The traversal is on the ground(s) that amended claim 1 is novel over Cowan. This is not found persuasive because the restriction in light of the originally presented claims was proper. Applicant arguments are to amended claims which renders the arguments moot. Additionally, as shown below, the features of amended claim 1 are common features and do not include a special technical feature as amended claim 1 does not make a contribution over the prior art of Lum (US 20110224610 A1).
The requirement is still deemed proper and is therefore made FINAL.
Claims 9-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 3rd 2026.
Specification
The disclosure is objected to because of the following informalities: on page 10 line 31, reference “4c” should be corrected to reference “4b”.
Appropriate correction is required.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, 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 periphery of said lower interface”, subject matter of claim 6, must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 3-4 are objected to because of the following informalities:
Regarding claim 3, “a gas” and “only gas” should be corrected to “the gas” and “only the gas” for claim language consistency
Regarding claim 4, “the reference” should be corrected to “the constant reference” for claim language consistency. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lum (US 20110224610 A1).
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, cavity 258, and recess 292 are being interpreted as an evacuation path, [0163], [0169], mad [0180] & Fig. 17, 21, and 23B; path 276, cavity 258, 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 258, 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. 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 “may also be integrally formed and/or disposed adjacent to the path 276 on the inside surface 264 of the stopper”, [0165]; portion 290 is being interpreted as “integrally formed and/or disposed adjacent to the path 276 on the inside surface 264 of the stopper” 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]; portion 290 allows for gas to travel from the lower portion of path 276 to cavity 258 and prevents 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 258 and recess 292, which is being interpreted as an upper portion of the evacuation path, [0176] and [0189] & see Fig. 23B) 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 [0189]-[0190]).
Regarding claim 2, Lum 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 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, [0165] and [0187]-[0188] & Fig. 23B), and the intermediate portion and the upper portion of the evacuation path are configured for receiving only gas (cavity 258 and recess 292 are configured to receive only gas, [0188] & Fig. 21-25).
Regarding claim 4, Lum 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 258 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]).
Regarding claim 5, Lum 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 discloses all the limitations of claim 1. Lum further discloses the injection device wherein the lower interface has a convex 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 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) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lum (US 20110224610 A1) as applied to claim 1 above, and further in view of Williams (US 4424817 A).
Regarding claim 7, Lum 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 681),
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).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Jeng (US 5372591 A), Simpson (US-20050245872-A1), Martell (US-4373535-A), Martell ‘206 (US-4448206-A), Woodford (US-4690154-A), Baidwan (US-5238003-A), and Kvitrud (US-4632672-A).
Jeng teaches a floatable body 32 of spherical construction with a thin ring 33 (Fig. 4) and a floating stopping element 50 with a collar shoulder 53 (Fig. 5).
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 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
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