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 .
Specification
The disclosure is objected to because of the following informalities: Page 5 lines 4-7 of the specification recites …with a first coupling, the mixing element moves by assistance of a motor along the axial length of the mixing container without translation of the plunger to mix the bone cement. …with a second coupling, the mixing element and plunger are driven together along the axial length of the mixing container. However, the specification does not disclose the device including two couplings having a first coupling that moves the mixing element and a second coupling that moves the mixing element and the plunger. For example, page 12 lines 4-11 recites …When the plunger 16c is not coupled to the leadscrew 16, rotation of the leadscrew 16 by handle 14 or by geartrain 20a results in the leadscrew merely turning inside a bore of plunger 16c with no (or only limited) motion coupled to plunger 16c. Once the mixing is complete, drive coupling 16b couples the leadscrew 16 to plunger 16c and rotation of leadscrew 16 now advances plunger 16c, mixing paddle 16d, and leadscrew 16 along the axial direction. Therefore, the specification discloses that the device includes the mixing element coupled to the plunger via a single coupling element. Therefore, the specification needs to be clarified regarding the coupling between the mixing element and the plunger, i.e. how many couplings there are and how they are used to couple the mixing element and the plunger.
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 device having a first coupling and a second coupling for the mixing element and the plunger (see claim 1) 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
Claim 1 is objected to because of the following informalities: Claim 1 recites …with a first coupling … with a second coupling …. The specification and drawings disclose the device having a single coupling between the mixing element and the plunger as discussed above. For examination purposes the examiner will treat claim 1 wherein the device is capable of allowing mixing element to move by the motor without translation of the plunger and is capable of allowing the mixing element and the plunger to move together. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: Claim 1 recites … a motor for driving the mixing element along the axial length of the mixing container…. Claim 1 further recites …the mixing element moves, by assistance of a motor….This appears to be a duplicate limitation within the claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the stand" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim 7 recites the limitation “the port” in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites …a handle configured to manually drive the mixing element and the plunger along the axial length of the mixing container for dispensing the bone cement, after detachment of the mixing container from the stand…. The claim is unclear if the detachment of the of the mixing container from the stand occurs as part of the functional limitation stated before, i.e. the handle drive the mixing element and plunger after detaching the mixing container from the stand, or is the detachment of the stand part when the following functions are performed, i.e. the first coupling and the second coupling functions of moving the mixing element and the plunger occur after detaching the mixing container from a stand? Therefore, the examiner will reject the claims as best understood, i.e. the stand being functionally recited in claim 1 and not being part of the invention.
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 1-4, 7-9, and 11-14 are rejected as best understood under 35 U.S.C. 102(a)(1) as being anticipated by Solomon (U.S. Patent 4,277,184).
Solomon discloses a device (for example see Figures 1-5) comprising:
(claim 1) a mixing container (20)
(claim 1) wherein the mixing container is capable of holding a bone cement mixture
(claim 1) wherein the mixing container extends along an axial length
(claim 1) including first end and an opposing second end
(claim 1) the first end comprising a downstream opening (opening of 25) capable of dispensing the bone cement from the mixing container
(claim 7) wherein the mixing container includes a port (21)
(claim 7) wherein the port provides a vent opening for priming a bone cement mixture (column 4 lines 5-10)
(claim 1) a mixing element (46)
(claim 1) wherein the mixing element is movably disposed within the mixing container
(claim 2) wherein the mixing element is coupled to a drive shaft (40) coupled to a motor for rotating the mixing element
(claim 2) wherein the drive shaft passes through a bore (34) in the piston
(claim 4) wherein the mixing element is a rotatable paddle
(claim 14) wherein the mixing container is capable of being detached from a stand and moveable to a place for delivery of bone cement to a patient (column 5 lines 57-66)
(claim 1) a motor (element 50 is an electric drill and includes a motor)
(claim 1) wherein the motor is capable of driving the mixing element along the axial length of the mixing container
(claim 11) wherein the motor includes a control (electric drills include controls such as the power trigger) which controls driving of the at least one of the plunger and the mixing element
(claim 1) a plunger comprising a piston (30)
(claim 1) wherein the plunger is movably disposed within the mixing container
(claim 1) a handle (12)
(claim 1) wherein the handle is capable of manually driving the mixing element and the plunger along the axial length of the mixing container for dispensing bone cement after detaching the mixing container from a stand (for example see Figure 5; for example see column 6 lines 4-66; the paddles of the mixing element are pulled up into the plunger and then the plunger and the mixing element are moved to dispense the bone cement)
(claims 12-13) claims 12-13 are directed to the stand which is not part of the invention. Therefore, the device only needs to be capable of working with a stand that includes these limitations.
(claim 8) a dispenser (25) coupled to the downstream opening of the mixing container
(claim 9) wherein the dispenser includes a cannula coupling (the threaded connection in the downstream opening) for connection to a cannula (13) for delivery of the bone cement
(claim 1) wherein
(claim 1) the mixing element moves, by assistance of the motor, along the axial length of the mixing container to mix bone cement without translation of the plunger (for example see Figure 3)
(claim 3) wherein in a first operational state (everything that follows if being interpreted as a functional limitation)
(claim 3) the mixing element moves, by assistance of the motor, along the axial length of the mixing container to mix bone cement without translation of the plunger which is not coupled to the motor (Figure 3; column 5 lines 53-66)
(claim 1) the mixing element and plunger are driven together along the axial length of the mixing container (for example see Figures 4 and 5; for example see column 6 lines 4-66)
(claim 3) wherein in a second operational state (everything that follows is being interpreted as a functional limitation)
(claim 3) both the mixing element and the plunger are coupled to the motor and driven together by the motor along the axial length of the mixing container (column 6 lines 4-66; the motor is capable of performing this function when the mixing element is fully pulled into the plunger)
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.
Claims 5 is rejected under 35 U.S.C. 103 as being unpatentable over Solomon (U.S. Patent 4,277,184) in view of Pilpel (U.S. Publication 2017/0156714).
Solomon discloses the invention as claimed except for the mixing element being a helical-shaped paddle. Pilpel teaches a device (see Figure 1) comprising a mixing container (10), a plunger (17), and a rotatable mixing element (43), wherein the mixing element is a helical-shaped paddle (see Figure 2). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Solomon wherein the mixing element is a helical-shaped paddle in view of Pilpel, since the applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person of ordinary skill in the art would find obvious for the purpose of providing a mixing element. In re Dailey and Eilers, 149 USPQ 47 (1966).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Solomon (U.S. Patent 4,277,184) in view of Sharma (U.S. Patent 10,687,795).
Solomon discloses the invention as claimed except for the cannula coupling comprising a rotatable knob. Solomon discloses the invention as discussed above wherein the dispenser couples to the mixing container via a cannula coupling, i.e. a threaded coupling (see Figure 1 and Figure 4), in order to couple a dispenser to the mixing container. Sharma teaches a device (for example see Figures 1-4) comprising a mixing container (110) and a dispenser (the proximal portion of element 140 that directly connects to element 110), wherein the dispenser includes a cannula coupling comprising a rotatable knob (for example see Figure 4) that seals the cannula coupling to a cannula in order to deliver bone cement mixture. Because both the device of Solomon and the device of Sharma disclose devices including a dispenser coupled to a mixing container via a cannula coupling it would have been obvious to one having ordinary skill in the art at the time the invention was filed to substitute one cannula coupling for the other in order to achieve the predictable results of coupling the dispenser to a mixing container.
Claims 15 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Solomon (U.S. Patent 4,277,184) in view of Plishka (U.S. Patent 7,744,270).
Solomon discloses the invention as claims, see above, except for the mixing container having at least one groove. Plishka teaches a device comprising a mixing container (100) having an inner surface, wherein the inner surface includes at least one groove (195) capable of being disposed on an upright side of the mixing container when the mixing container is inclined in order to allow gas/air to flow around the plunger (column 6 lines 5-9). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to provide the device of Solomon wherein the mixing chamber includes at least one groove in view of Plishka in order to allow gas/air to flow around the plunger.
Allowable Subject Matter
Claims 6 and 17 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 for cited references the examiner felt were relevant to the application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas Woodall whose telephone number is (571) 272-5204. The examiner can normally be reached on Monday-Friday 8am to 5:30pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (571. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS W WOODALL/Primary Examiner, Art Unit 3775