Detailed Action
This is the final office action for US application number 19/175,161. Claims are evaluated as filed on August 24, 2026.
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 Arguments
Applicant's arguments filed August 24, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that Coffeen, O'Halloran, and Plishka teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that Coffeen explicitly states that the proximal end of the plunger is captured within the knob to prevent it from slipping out of the cavity 341 and thus the plunger is incapable of moving within the knob (Remarks p. 9), Examiner notes that disclosure of being captured within the knob does not equate to being incapable of moving within the knob. As clearly shown in Fig. 41, there is space between the surfaces of the knob and the plunger 336 and there are no structures shown that would prevent the plunger from sliding left to right within the knob. Thus, such is capable of moving within the knob/handle 340 as claimed. Further, Examiner has added a rejection in view of Coffeen’s alternate handle of Figs. 43-45 that more expressly discloses the new claim scope, i.e. the alternative plunger and knob of Figs. 43-45 are specifically disclosed with a spring that acts with knob and plunger features to act as a clutch mechanism that specifically involves the plunger moving within the knob as claimed.
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/656,033, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Application No. 62/656,033 fails to provide adequate support for the seal of claim 13, deflectable fingers of claim 14, and the seal of claim 18 and 19.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “drive features” and “driven features” in claim 6, “coupling features” and “complementary coupling features” in claim 13, and “coupling features” and “complementary coupling features” in claim 19.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
(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, 5, 6, 11-13, 15, and 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Coffeen et al. (US 2009/0257306, hereinafter “Coffeen”).
As to claim 1, Coffeen, in an initial embodiment, discloses a system (104, 1-34, 39-42, and 46-49) capable of dispensing curable material (bone cement mixture of ¶96, ¶96), the system comprising: a chamber (302, Figs. 8-10) defining a dispensing volume (open space shown within 302 in Fig. 41, Fig. 41) and an outlet (opening at right end of 302 as shown in Fig. 41, Fig. 41); a lead screw (336, Figs. 39-41) comprising external threads (threads of threaded shaft 336, Fig. 40, ¶100) and defining a translation axis (horizontal as shown in Fig. 41, Fig. 41); a plunger (344, 350, 351, Fig. 41, ¶100) coupled to a distal end of lead screw (Fig. 41, ¶100) and disposed within the dispensing volume (Fig. 41); a handle (340, 342) coupled to the lead screw (Figs. 39 and 41, ¶101) and comprising a control surface (outer surfaces of 340 and 342, Figs. 39-41, ¶101) capable of receiving a rotational input from a user to advance the plunger (Figs. 39 and 41, ¶101), wherein advancement of the plunger compresses the curable material within the dispensing volume (Figs. 39 and 41, ¶s 100 and 101) and dispenses the compressed curable material from the outlet (Figs. 39 and 41, ¶s 100 and 101); and a locking nut (324, 330, 332, Figs. 40 and 41, ¶99) comprising internal threads (338, Fig. 41, ¶100) threadably engaging the external threads of the lead screw (Fig. 41, ¶100), wherein the locking nut is capable of providing for proximal movement of the lead screw along the translation axis for the curable material to at least partially decompress within the dispensing volume (Fig. 41 shows that there are no structures preventing translation of the lead screw in either direction); and wherein the handle further comprises a shaft (wall portion of 340 defining cavity 341 as shown in Figs. 40 and 41, wall of 342 shown in Figs. 40 and 41 defining a bore and holding 336, Figs. 40 and 41) defining a lumen (341, bore shown in 342 in Figs. 40 and 41, open space within 342 and 340 as shown in Fig. 41, Figs. 40 and 41), and wherein a proximal end of the lead screw (right hand portion of 336 as shown in Fig. 40, Figs. 40 and 41) is positioned within the lumen (Figs. 40 and 41) and capable of moving within the handle (due to the shown empty space between the portions of 336 positioned within handle 340 and the structure of the handle 340 in Fig. 41, Fig. 41) capable of permitting axial movement of the lead screw relative to the control surface of the handle (due to the shown empty space between the portions of 336 positioned within handle 340 and the structure of the handle 340 in Fig. 41, Fig. 41).
As to claim 5, Coffeen, in an initial embodiment, discloses that the handle further comprises a grip portion (outer wall portion of 340 and right end of 342 and extending from the shaft and defining the control surface as shown in Fig. 40, Figs. 40 and 41) extending radially outwardly from the shaft (as defined, Figs. 40 and 41) and defining the control surface (as defined, Figs. 40 and 41).
As to claim 6, Coffeen, in an initial embodiment, discloses that the handle further comprises drive features (surfaces of the walls that define the lumen, Figs. 40 and 41) within the lumen (in as much as Applicant’s, Figs. 40 and 41) and capable of engaging with driven features of the lead screw (surfaces of 311, Figs. 40 and 41) capable of preventing relative rotation between the lead screw and the handle (due to the box-like shape, Figs. 40 and 41, ¶101) and permitting the proximal movement along the translation axis (Figs. 40 and 41).
As to claim 11, Coffeen, in an initial embodiment, discloses that the chamber defines an inlet port (314, portion of 330 that defines 325 and 327, Figs. 40 and 41, ¶96) in fluid communication with the dispensing volume (Figs. 40 and 41, ¶96), wherein the inlet port is capable of being removably coupled with a mixing and compression system (via transfer conduit 110, Figs. 3, 4, and 21, ¶96-98) capable of permitting the curable material to pass through the inlet port and into the dispensing volume (Figs. 3, 4, and 21, ¶96-98).
As to claim 12, Coffeen, in an initial embodiment, discloses that the inlet port comprises a neck portion (Figs. 40 and 41) extending from the chamber (Fig. 40) and defines an aperture (opening in 314, Figs. 40 and 41) in communication with the dispensing volume (Figs. 40 and 41, ¶96), wherein the neck portion is tubular in shape (Fig. 40) and comprises ribs (327) capable of cooperating with complementary features of a release assembly (306322, Figs. 40 and 41, ¶97) of the mixing and compression system to draw the inlet port into sealing engagement with an outlet port of the mixing and compression system (¶97).
As to claim 13, Coffeen, in an initial embodiment, discloses a seal (316, 318, 320) at least partially disposed within the neck portion (Fig. 41, ¶96), wherein the seal comprises coupling features (Figs. 40 and 41, ¶96-98) capable of engaging complementary coupling features (Fig. 41, ¶96-98) of the neck portion to axially retain the seal such that another lumen extending through the seal is in selective communication with the dispensing volume (Fig. 41, ¶96-98).
As to claim 1, Coffeen, in an alternate embodiment, discloses a system (104, Figs. 1-34 and 39-49, ¶s 102-104 where ¶s 102-104 discloses that Figs. 43-45 discloses alternate shaft 360 and knob 371) capable of dispensing curable material (bone cement mixture of ¶96, ¶96), the system comprising: a chamber (302, Figs. 8-10) defining a dispensing volume (open space shown within 302 in Fig. 41, Fig. 41) and an outlet (opening at right end of 302 as shown in Fig. 41, Fig. 41); a lead screw (336/360, Figs. 39-41, 43, and 44, ¶s 102-104) comprising external threads (threads of threaded shaft 336/360, Figs. 40 and 44, ¶100) and defining a translation axis (horizontal as shown in Fig. 41, Fig. 41); a plunger (344, 350, 351, Fig. 41, ¶100) coupled to a distal end of lead screw (Fig. 41, ¶100) and disposed within the dispensing volume (Fig. 41); a handle (340/371) coupled to the lead screw (Figs. 39 and 41, ¶101) and comprising a control surface (outer surfaces of 340/372 and 342/384, Figs. 39-41, 43, and 45, ¶s 101-104) capable of receiving a rotational input from a user to advance the plunger (Figs. 39, 41, and 43-45, ¶s 101-104), wherein advancement of the plunger compresses the curable material within the dispensing volume (Figs. 39, 41, and 43-45, ¶s 100 and 101-104) and dispenses the compressed curable material from the outlet (Figs. 39, 41, and 43-45, ¶s 100 and 101-104); and a locking nut (324, 330, 332, Figs. 40 and 41, ¶99) comprising internal threads (338, Fig. 41, ¶100) threadably engaging the external threads of the lead screw (Fig. 41, ¶100), wherein the locking nut is capable of providing for proximal movement of the lead screw along the translation axis for the curable material to at least partially decompress within the dispensing volume (Fig. 41 shows that there are no structures preventing translation of the lead screw in either direction); and wherein the handle further comprises a shaft (wall(s) of 384 shown defining bore 385 and holding 360 and part of 386 as shown in Fig. 43, left hand portion of 384 as shown in Fig. 43, Fig. 43) defining a lumen (385, open space within 384 and 372 as shown in Fig. 43, Fig. 43, ¶103), and wherein a proximal end of the lead screw (right hand portion of 360 as shown in Fig. 44, 362, Figs. 43 and 44, ¶s 102-104) is positioned within the lumen (Figs. 43 and 44, ¶s 102-104) and capable of moving within the handle (Fig. 43, ¶104) capable of permitting axial movement of the lead screw relative to the control surface of the handle (Fig. 43, ¶104).
As to claim 5, Coffeen, in an alternate embodiment, discloses that the handle further comprises a grip portion (outer wall portion of 372 and right end of 384 and extending from the shaft and defining the control surface as shown in Fig. 43, Fig. 43) extending radially outwardly from the shaft (as defined, Fig. 43) and defining the control surface (as defined, Fig. 43).
As to claim 6, Coffeen, in an alternate embodiment, discloses that the handle further comprises drive features (surfaces of the walls that define the lumen, Figs. 40 and 41) within the lumen (in as much as Applicant’s, Fig. 43) and capable of engaging with driven features of the lead screw (surfaces of 362, Figs. 43, ¶104) capable of preventing relative rotation between the lead screw and the handle (due to the interlocking of projections 364 and 376 in “normal operation” as disclosed in ¶104, Figs. 43-45, ¶s 102-104) and permitting the proximal movement along the translation axis (in “normal operation” as disclosed in ¶104, Figs. 40, 41, and 43, ¶104).
As to claim 11, Coffeen, in an alternate embodiment, discloses that the chamber defines an inlet port (314, portion of 330 that defines 325 and 327, Figs. 40 and 41, ¶96) in fluid communication with the dispensing volume (Figs. 40 and 41, ¶96), wherein the inlet port is capable of being removably coupled with a mixing and compression system (via transfer conduit 110, Figs. 3, 4, and 21, ¶96-98) capable of permitting the curable material to pass through the inlet port and into the dispensing volume (Figs. 3, 4, and 21, ¶96-98).
As to claim 12, Coffeen, in an alternate embodiment, discloses that the inlet port comprises a neck portion (Figs. 40 and 41) extending from the chamber (Fig. 40) and defines an aperture (opening in 314, Figs. 40 and 41) in communication with the dispensing volume (Figs. 40 and 41, ¶96), wherein the neck portion is tubular in shape (Fig. 40) and comprises ribs (327) capable of cooperating with complementary features of a release assembly (306322, Figs. 40 and 41, ¶97) of the mixing and compression system to draw the inlet port into sealing engagement with an outlet port of the mixing and compression system (¶97).
As to claim 13, Coffeen, in an alternate embodiment, discloses a seal (316, 318, 320) at least partially disposed within the neck portion (Fig. 41, ¶96), wherein the seal comprises coupling features (Figs. 40 and 41, ¶96-98) capable of engaging complementary coupling features (Fig. 41, ¶96-98) of the neck portion to axially retain the seal such that another lumen extending through the seal is in selective communication with the dispensing volume (Fig. 41, ¶96-98).
As to claim 15, Coffeen discloses a system (104, Figs. 1-34 and 39-49, ¶s 102-104 where ¶s 102-104 discloses that Figs. 43-45 discloses alternate shaft 360 and knob 371) capable of dispensing curable material (bone cement mixture of ¶96, ¶96), the system comprising: a chamber (302, Figs. 8-10) defining a dispensing volume (open space shown within 302 in Fig. 41, Fig. 41), an outlet (opening at right end of 302 as shown in Fig. 41, Fig. 41), and an inlet port (314, portion of 330 that defines 325 and 327, Figs. 40 and 41, ¶96) capable of being removably coupled with a mixing and compression system (via transfer conduit 110, Figs. 3, 4, and 21, ¶96-98) capable of permitting the curable material to pass through the inlet port and into the dispensing volume (Figs. 3, 4, and 21, ¶96-98); a lead screw (336/360, Figs. 39-41, 43, and 44, ¶s 102-104) comprising external threads (threads of threaded shaft 336/360, Figs. 40 and 44, ¶100); a plunger (344, 350, 351, Fig. 41, ¶100) coupled to a distal end of lead screw (Fig. 41, ¶100) and disposed within the dispensing volume (Fig. 41); a handle (340/371) comprising a control surface (outer surfaces of 340/372 and 342/384, Figs. 39-41, 43, and 45, ¶s 101-104) coupled to the lead screw (Figs. 39 and 41, ¶101) and capable of receiving a rotational input from a user to advance the plunger (Figs. 39, 41, and 43-45, ¶s 101-104), wherein advancement of the plunger compresses the curable material within the dispensing volume (Figs. 39, 41, and 43-45, ¶s 100 and 101-104) and dispenses the compressed curable material from the outlet (Figs. 39, 41, and 43-45, ¶s 100 and 101-104), wherein a proximal end of the lead screw (right hand portion of 360 as shown in Fig. 44, 362, Figs. 43 and 44, ¶s 102-104) is disposed within the handle (Figs. 43 and 44, ¶s 102-104) and is capable of moving relative to the control surface (Fig. 43, ¶104); and a locking nut (324, 330, 332, Figs. 40 and 41, ¶99) comprising internal threads (338, Fig. 41, ¶100) threadably engaging the external threads of the lead screw (Fig. 41, ¶100).
As to claim 20, Coffeen discloses a system (104, Figs. 1-34 and 39-49, ¶s 102-104 where ¶s 102-104 discloses that Figs. 43-45 discloses alternate shaft 360 and knob 371) capable of dispensing curable material (bone cement mixture of ¶96, ¶96), the system comprising: a chamber (302, Figs. 8-10) defining a dispensing volume (open space shown within 302 in Fig. 41, Fig. 41) and an outlet (opening at right end of 302 as shown in Fig. 41, Fig. 41); a lead screw (336/360, Figs. 39-41, 43, and 44, ¶s 102-104) comprising external threads (threads of threaded shaft 336/360, Figs. 40 and 44, ¶100); a plunger (344, 350, 351, Fig. 41, ¶100) coupled to a distal end of lead screw (Fig. 41, ¶100) and disposed within the dispensing volume (Fig. 41); a handle (340/371) comprising a control surface (outer surfaces of 340/372 and 342/384, Figs. 39-41, 43, and 45, ¶s 101-104) coupled to the lead screw (Figs. 39 and 41, ¶101) and capable of receiving a rotational input from a user to advance the plunger (Figs. 39, 41, and 43-45, ¶s 101-104), wherein advancement of the plunger compresses the curable material within the dispensing volume (Figs. 39, 41, and 43-45, ¶s 100 and 101-104) and dispenses the compressed curable material from the outlet (Figs. 39, 41, and 43-45, ¶s 100 and 101-104), wherein a proximal end of the lead screw (right hand portion of 360 as shown in Fig. 44, 362, Figs. 43 and 44, ¶s 102-104) is capable of moving positioned within the handle (Figs. 43 and 44, ¶s 102-104); and a locking nut (324, 330, 332, Figs. 40 and 41, ¶99) comprising internal threads (338, Fig. 41, ¶100) threadably engaging the external threads of the lead screw (Fig. 41, ¶100) capable of providing a system (Figs. 39-41) capable of backdriving (Fig. 41 shows that there are no structures preventing translation of the lead screw in either direction) in which axial movement of the lead screw relative to the control surface of the handle is permitted (Figs. 39-41 and 43-45, ¶s 100-104).
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 of this title, 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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Coffeen.
As to claim 7, Coffeen, in an initial embodiment, discloses the invention of claim 6 as well as that the drive features comprise the lumen being box-shaped (Figs. 40 and 41, ¶101), and wherein the driven features include the proximal end of the lead screw being at least substantially box-shaped (Figs. 40 and 41, ¶101) and sized to the lumen (Figs. 40 and 41, ¶101).
Coffeen is silent to the box-shape being rectangular.
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to construct the box-shape of the shaft lumen and the proximal end of the lead screw of Coffeen to be rectangular, since Applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of receiving the proximal end of the lead screw in the lumen such that as the user rotates the handle that defines the control surface, the lead screw also rotates (Coffeen ¶101).
Claim(s) 1-3 is/are rejected under 35 U.S.C. 103 as being unpatentable over O'Halloran et al. (US 2011/0306983, hereinafter “O'Halloran”) in view of Coffeen.
As to claims 1-3, O'Halloran discloses a system (Figs. 8-12) capable of dispensing curable material (bone filler material of ¶30, ¶30), the system comprising: a chamber (18, Figs. 8-10) defining a dispensing volume (open space shown within 18 in Figs. 8 and 10, Figs. 8 and 10) and an outlet (opening at 70 as shown in Figs. 8 and 10, Figs. 8 and 10); a lead screw (portion of 12 comprising threads 28 and to the right of threads 28 as shown in Figs. 8 and 10, Figs. 8 and 10) comprising external threads (28) and defining a translation axis (horizontal as shown in Fig. 8, Fig. 8); a plunger (portion of 12 to the left of threads 28 as shown in Figs. 8 and 10, Figs. 8 and 10) coupled to a distal end of lead screw (Figs. 8 and 10) and disposed within the dispensing volume (Figs. 8 and 10); a handle (portion of 12 to the right of the threads 28 as shown at the right end in Figs. 8 and 10, Figs. 8 and 10) coupled to the lead screw (Figs. 8 and 10) and comprising a control surface (surface of the enlarged portion of 12 shown at the right end in Figs. 8 and 10, Figs. 8 and 10) capable of receiving a rotational input from a user to advance the plunger (¶30), wherein advancement of the plunger compresses the curable material within the dispensing volume (Figs. 8 and 10, ¶30) and dispenses the compressed curable material from the outlet (¶30 discloses ejecting material); and a locking nut (102) comprising internal threads (110, 112, Figs. 11 and 12, ¶31) threadably engaging the external threads of the lead screw (Fig. 11, ¶s 31 and 33), wherein the locking nut is capable of providing for proximal movement of the lead screw along the translation axis for the curable material to at least partially decompress within the dispensing volume (Fig. 10 shows that there are no structures preventing translation of the lead screw in either direction, Fig. 12 shows the locking nut pivoted and the threads disengaged from the lead screw and allowing axial translation of the lead screw without rotation as described in ¶34, ¶34); and wherein the handle further comprises a shaft (unthreaded portion of 12 between the threaded portion and the enlarged portion as shown in Fig. 8 Fig. 8). As to claim 2, O'Halloran discloses that the lead screw is capable of being substantially free from rotation with the proximal movement along the translation axis (Fig. 10 shows that there are no structures preventing translation of the lead screw in either direction, Fig. 12 shows the locking nut pivoted and the threads disengaged from the lead screw and allowing axial translation of the lead screw without rotation as described in ¶34, ¶s 34 and 35, where ¶35 discloses that the lead screw can be axially pushed back). As to claim 3, O'Halloran discloses a lever (104, Figs. 8, 11, and 12, ¶s 31, 32, 34, and 35) defining a second control surface (surface of 104, Figs. 8-12) and pivotably coupled to a housing (73, pivotably coupled at fulcrum/pins 114, Figs. 8, 11, and 12, ¶s 31 and 35); and a biasing member (106) biasing the lever pivotably away from the housing (Figs. 8, 10, and 11, ¶s 31 and 33) to a disengaged position in which the locking nut is permitted to rotate about the translation axis (if one so chooses to rotate 102 and 14 about the translation axis, i.e. relative to 12).
O'Halloran is silent to the shaft defining a lumen, and wherein a proximal end of the lead screw is positioned within the lumen and configured to move within the handle to permit axial movement of the lead screw relative to the control surface of the handle.
Coffeen teaches a similar system (104, Figs. 1-34 and 39-49, ¶s 102-104 where ¶s 102-104 discloses that Figs. 43-45 discloses alternate shaft 360 and knob 371) capable of dispensing curable material (bone cement mixture of ¶96, ¶96), the system comprising: a chamber (302, Figs. 8-10) defining a dispensing volume (open space shown within 302 in Fig. 41, Fig. 41) and an outlet (opening at right end of 302 as shown in Fig. 41, Fig. 41); a lead screw (336/360, Figs. 39-41, 43, and 44, ¶s 102-104) comprising external threads (threads of threaded shaft 336/360, Figs. 40 and 44, ¶100) and defining a translation axis (horizontal as shown in Fig. 41, Fig. 41); a plunger (344, 350, 351, Fig. 41, ¶100) coupled to a distal end of lead screw (Fig. 41, ¶100) and disposed within the dispensing volume (Fig. 41); a handle (340/371) coupled to the lead screw (Figs. 39 and 41, ¶101) and comprising a control surface (outer surfaces of 340/372 and 342/384, Figs. 39-41, 43, and 45, ¶s 101-104) capable of receiving a rotational input from a user to advance the plunger (Figs. 39, 41, and 43-45, ¶s 101-104), wherein advancement of the plunger compresses the curable material within the dispensing volume (Figs. 39, 41, and 43-45, ¶s 100 and 101-104) and dispenses the compressed curable material from the outlet (Figs. 39, 41, and 43-45, ¶s 100 and 101-104); and a locking nut (324, 330, 332, Figs. 40 and 41, ¶99) comprising internal threads (338, Fig. 41, ¶100) threadably engaging the external threads of the lead screw (Fig. 41, ¶100), wherein the locking nut is capable of providing for proximal movement of the lead screw along the translation axis for the curable material to at least partially decompress within the dispensing volume (Fig. 41 shows that there are no structures preventing translation of the lead screw in either direction); and wherein the handle further comprises a shaft (wall(s) of 384 shown defining bore 385 and holding 360 and part of 386 as shown in Fig. 43, left hand portion of 384 as shown in Fig. 43, Fig. 43) defining a lumen (385, open space within 384 and 372 as shown in Fig. 43, Fig. 43, ¶103), and wherein a proximal end of the lead screw (right hand portion of 360 as shown in Fig. 44, 362, Figs. 43 and 44, ¶s 102-104) is positioned within the lumen (Figs. 43 and 44, ¶s 102-104) and capable of moving within the handle (Fig. 43, ¶104) capable of permitting axial movement of the lead screw relative to the control surface of the handle (Fig. 43, ¶104); wherein the handle comprises a spring (386) capable of biasing the lead screw into engagement with the control surface under normal operation (Fig. 3, ¶104).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to replace the handle and proximal end of the lead screw as disclosed by O'Halloran the handle and proximal end of the lead screw as taught by Coffeen in order to provide a clutch mechanism that engages during normal operation and is configured to slip when undesired pressures are reached in the delivery device (Coffeen ¶104) thereby preventing further advancement of the plunger until pressure is normalized (Coffeen ¶104).
Claim(s) 15-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Plishka et al. (US 2007/0211565, hereinafter “Plishka”) in view of Coffeen.
As to claims 15-17, Plishka discloses a system (Figs. 1-7) capable of dispensing curable material (curable materials of ¶28, ¶28), the system comprising: a chamber (110, Figs. 2, 4, and 7) defining a dispensing volume (115, Figs. 2, 4, and 7, ¶27), an outlet (opening at left end of 110 as shown in Figs. 2, 4, and 7, Figs. 2, 4, and 7), and an inlet port (140, Figs. 2, 4, and 7, ¶27) capable of being removably coupled with a mixing and compression system (Figs. 2, 4, and 7, ¶s 27, 29, and 31) capable of permitting the curable material to pass through the inlet port and into the dispensing volume (Figs. 2, 4, and 7, ¶s 27, 29, and 31); a lead screw (240, Figs. 1, 4, and 6a-7) comprising external threads (threads of threaded rod 240, Figs. 1, 4, and 6a-7, ¶47); a plunger (210, Figs. 4 and 7, ¶s 21 and 46) coupled to a distal end of lead screw (Figs. 4 and 7, ¶s 21 and 46) and disposed within the dispensing volume (Figs. 4 and 7, ¶s 21 and 46); a handle (portion of 240 to the right of the threads as shown at the right end in Fig. 6b, 246, Figs. 1 and 6b) coupled to the lead screw (Figs. 1 and 6b) and comprising a control surface (surface of 246, Figs. 1 and 6b, ¶46) coupled to the lead screw (Fig. 1, ¶46) and capable of receiving a rotational input from a user to advance the plunger (Fig. 1, ¶46), wherein advancement of the plunger compresses the curable material within the dispensing volume (Fig. 1 and 7, ¶46) and dispenses the compressed curable material from the outlet (Fig. 1 and 7, ¶s 46 and 52), wherein a proximal end of the lead screw (right most portion as shown in Fig. 6b, Fig. 6b) appears to be disposed within the handle (Fig. 6b); and a locking nut (230, Fig. 4, ¶46) comprising internal threads (threads of internal threaded portion 230, Fig. 4, ¶46) threadably engaging the external threads of the lead screw (Fig. 4, ¶46). As to claim 16, Plishka discloses that the inlet port comprises a neck portion (Figs. 2, 4, and 7) extending from the chamber (Figs. 2, 4, and 7) and defining an aperture (145, Figs. 2, 4, and 7, ¶29) in communication with the dispensing volume (Figs. 2, 4, and 7, ¶29), wherein the neck portion is tubular in shape (Figs. 2, 4, and 7) and comprises ribs (revolutions of 143, Fig. 2, ¶31) extending radially outward in a helical arrangement (Fig. 2, ¶31). As to claim 17, Plishka discloses the ribs are capable of cooperating with complementary features of a release assembly of the mixing and compression system to draw the inlet port into sealing engagement with an outlet port of the mixing and compression system (¶s 27 and 31).
Plishka is silent to an express disclosure of the proximal end of the lead screw is disposed within the handle and is silent to the proximal end of the lead screw movable relative to the control surface.
Coffeen teaches a similar system (104, Figs. 1-34 and 39-49, ¶s 102-104 where ¶s 102-104 discloses that Figs. 43-45 discloses alternate shaft 360 and knob 371) capable of dispensing curable material (bone cement mixture of ¶96, ¶96), the system comprising: a chamber (302, Figs. 8-10) defining a dispensing volume (open space shown within 302 in Fig. 41, Fig. 41), an outlet (opening at right end of 302 as shown in Fig. 41, Fig. 41), and an inlet port (314, portion of 330 that defines 325 and 327, Figs. 40 and 41, ¶96) capable of being removably coupled with a mixing and compression system (via transfer conduit 110, Figs. 3, 4, and 21, ¶96-98) capable of permitting the curable material to pass through the inlet port and into the dispensing volume (Figs. 3, 4, and 21, ¶96-98); a lead screw (336/360, Figs. 39-41, 43, and 44, ¶s 102-104) comprising external threads (threads of threaded shaft 336/360, Figs. 40 and 44, ¶100); a plunger (344, 350, 351, Fig. 41, ¶100) coupled to a distal end of lead screw (Fig. 41, ¶100) and disposed within the dispensing volume (Fig. 41); a handle (340/371) comprising a control surface (outer surfaces of 340/372 and 342/384, Figs. 39-41, 43, and 45, ¶s 101-104) coupled to the lead screw (Figs. 39 and 41, ¶101) and capable of receiving a rotational input from a user to advance the plunger (Figs. 39, 41, and 43-45, ¶s 101-104), wherein advancement of the plunger compresses the curable material within the dispensing volume (Figs. 39, 41, and 43-45, ¶s 100 and 101-104) and dispenses the compressed curable material from the outlet (Figs. 39, 41, and 43-45, ¶s 100 and 101-104), wherein a proximal end of the lead screw (right hand portion of 360 as shown in Fig. 44, 362, Figs. 43 and 44, ¶s 102-104) is disposed within the handle (Figs. 43 and 44, ¶s 102-104) and is capable of moving relative to the control surface (Fig. 43, ¶104); and a locking nut (324, 330, 332, Figs. 40 and 41, ¶99) comprising internal threads (338, Fig. 41, ¶100) threadably engaging the external threads of the lead screw (Fig. 41, ¶100); wherein the handle comprises a spring (386) capable of biasing the lead screw into engagement with the control surface under normal operation (Fig. 3, ¶104).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to replace the handle and proximal end of the lead screw as disclosed by Plishka the handle and proximal end of the lead screw as taught by Coffeen in order to provide a clutch mechanism that engages during normal operation and is configured to slip when undesired pressures are reached in the delivery device (Coffeen ¶104) thereby preventing further advancement of the plunger until pressure is normalized (Coffeen ¶104).
Allowable Subject Matter
Claims 4, 8-10, and 14 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims if rewritten as suggested or consistent with the interpretation set forth in this Office action 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 for the base claim and any intervening claims.
Conclusion
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 extension fee 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 date of this final action.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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