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 .
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.
Claim(s) 1, 3-4, 7, 11-12 and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Linde et al. (US 2013/0090665, hereinafter “Linde”).
Referring to claim 1, Linde discloses an emergency airway evacuation device (in paragraphs [0006]-[0008] Linde discloses the device is used to remove tonsil debris and other problems. Examiner contends that the device of Linde is capable for use as an emergency airway evacuation device), comprising:
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a vacuum body adapted for receiving a suctioned volume (FIG. 4 shows suction device 318; para. [0027]);
an actuator (piston 338 and handle 339 as shown in FIG. 4) engaged with the vacuum body for inducing a lowered pressure in the vacuum body; and
an elongated extraction tube 114, the extraction tube fluidically coupled to the vacuum body for transporting the suctioned volume from a respiratory trauma region.
Referring to claim 3, Linde discloses the device of claim 1 wherein the actuator 338 is slidably engaged with an interior of the vacuum body 318, the actuator disposed for drawing a plunger (FIG. 4) in sealing engagement with the interior for inducing a reduced pressure in the vacuum body resulting from volume displacement in the vacuum body (para. [0027]: “In device 310, the suction device 318 comprises a piston type mechanism, in which a piston seal 338 can be pulled down within a piston sleeve in order to create suction at the aperture 20 using a finger pull 339.”).
Referring to claim 4, Linde discloses the device of claim 1 where the extraction tube 114 includes a proximate end adapted to engage the vacuum body 318, and a distal end having a curved, tapered tip for insertion into the respiratory trauma region (FIG. 5 shows the end-view of the extraction tube 114 and side-view of extraction tube 114. The figure shows the end-view of extraction tube has a circular shape, thus, Linde discloses “a distal end having a curved.” The side-view show tip 12A includes a tapered tip that is capable for insertion into the respiratory trauma region).
Referring to claim 7, Linde discloses the device of claim 1, further comprising: a resilient engagement, the resilient engagement securing the vacuum body to the extraction tube for engagement with the vacuum body (examiner notes that applicant fails to clarify or define what is meant by “resilient engagement,” therefore, the limitation of “resilient engagement” has been given a broadest interpretation as an engagement that provide security to the connection between the vacuum body and extraction tube and maintaining fluid seal during usage of the device. In paragraph [0018] Linde discloses “As illustrated, the device 10 includes a hollow tip 12 having an aperture 20 at one end, a hollow arm 14, a central mechanism 16 (e.g., an armature or clip), and a suction device 18. The hollow tip 12, hollow arm 14, central mechanism 16, and suction device 18 can be sequentially attached to one another to provide a fluid (e.g., air or liquid)-tight passage between the suction device 18 and the aperture 20 at the end of the hollow tip 12. Each connection can be made using any permanent or releasable solution for forming a fluid-tight connection between two components including, for example, glue, a screw/thread, a snap fit, a flange, and/or the like..” (emphasis added). Based on the disclosure above one of ordinary skill in the art will understand that the disclosure above also applied to other embodiments.)
Referring to claim 11, Linde discloses the device of claim 1 wherein the extraction tube 114 has a proximate end and a distal end, the proximate end adapted to engage a suction orifice responsive to reduced pressure in the vacuum body, and a distal end adapted for fluidic communication with the respiratory trauma region (the distal end of vacuum body 318 of Linde device inherently has a suction orifice in fluidic communication with the extraction tube 114).
Referring to claim 12, Linde discloses the device of claim 11 further comprising a rake (loop 40C as shown in FIG. 5) defined by a surface adjacent the distal end, the surface having an area adapted for manual manipulation of viscous or solid material. (para. [0031]: “For debris that is difficult to remove, the user can use the tip 12 (or a structure 40A-40C (FIG. 5) located adjacent to the aperture 20) to create surface tension on the debris and/or tonsil to assist in exposing and/or removing the debris.”)
Referring to claim 16, Linde discloses the device of claim 1 wherein the vacuum body 318 has a volume based on a volume of a patient oral cavity (the device of Linde is for removing foreign object in the mouth, thus, the vacuum body 318 has a volume based on a volume of a patient oral cavity).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linde et al. in view of Sibbitt (US 2005/0192543, hereinafter “Sibbitt”).
Referring to claim 5, Linde discloses the device of claim 3 wherein the vacuum body 318 includes cylindrical walls and the plunger 338 has a diameter corresponding to the cylindrical walls (para. [0027]: “In device 310, the suction device 318 comprises a piston type mechanism, in which a piston seal 338 can be pulled down within a piston sleeve in order to create suction at the aperture 20 using a finger pull 339.” FIG. 4 appears to shows piston 338 includes two flanges or O-rings that act as a seal. Furthermore, examiner contends that one of ordinary skill in the art would recognize that the structure of vacuum body and actuator as shown in FIG. 4 is similar to a conventional syringe). Linde fails to disclose the plunger formed from a resilient material for defining the sealing engagement with the interior of the vacuum.
Referring again to claim 5, however, Sibbitt discloses a syringe (FIGS. 1-4; para. [0032]) that permits injection and aspiration of fluids or gases using one hand, with applications in health care research, animal husbandry and the industry (para. [0029]). Sibbitt discloses the syringe includes a syringe plunger 21 and a stopper 23 made from rubber or other flexible or tight sealing material at the distal end of the plunger 21 (para. [0032]). Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have made the flanges or O-rings of Linde with rubber or other flexible material to provide a tight seal between the piston 338 and interior wall of vacuum body 318 to ensure that there is no loss of vacuum when the piston is pulled in a proximal direction.
Claim(s) 7-10 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linde et al. in view of Campau (US 6,257,626, hereinafter “Campau”).
Referring to claims 7-8, Linde discloses the device of claim 7 and the connection between the extraction tube and the vacuum body can be any permanent or releasable solution for forming a fluid-tight connection between two components including, for example, glue, a screw/thread, a snap fit, a flange, and/or the like (emphasis added)(para. [0018]). Linde fails to discloses wherein the resilient engagement includes an annular bushing disposed in a groove at an exit orifice of the vacuum body.
Referring again to claims 7-8, Campau discloses a connector for joining fluid flow passageways in a fluid handling system (FIG. 8, which is reproduced and annotated below). The connector includes an elastomer annular bushing 66 disposed inside a cavity/groove of adapter 68. Distal end of tube 62 includes barbs or tapered collar for engaging with resilient bushing to form a secure and leak tight seal connection between the tube 62 and adapter 68 (col. 5, ln 10-35: “The barbed connector size adapter can be pushed over the barbed connector 62 by hand even though the I.D. of the resilient liner 66 is smaller than the O.D. of the barbed connector. The rigid wall 68 surrounding the resilient liner resists expansion and thus creates a uniform radial compression loading on the barbed connector. The resilient liner, normally an elastomer, conforms to the barbs to provide high friction for retention and to form a leak tight seal.”).
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Referring still to claims 7-8, in view of Campau’s teaching it would have been obvious to one of ordinary skill in the art, before the effective filling date of the application, to have provided a connection as suggested by Campau to the connection between tube 114 and vacuum body 318 of Linde to provide a secure and leak tight seal connection.
Referring to claim 9, Linde as modified by Campau discloses the device of claim 8 further comprising a tapered collar at a proximate end of the extraction tube, the tapered collar having a sloped diameter for deformable engagement with the annular bushing (Linde as modified by Campau would have barb at the proximal end of tube 114. See FIGS. 8-9 of Campau reference).
Referring to claim 10, Linde as modified by Campau discloses the device of claim 9 wherein the tapered collar includes a flat lip (see FIGS. 8-9 of Campau reference), the annular bushing compressively engaging the flat lip for locking the tapered collar against the annular bushing. (col. 5, ln 10-35: “The barbed connector size adapter can be pushed over the barbed connector 62 by hand even though the I.D. of the resilient liner 66 is smaller than the O.D. of the barbed connector. The rigid wall 68 surrounding the resilient liner resists expansion and thus creates a uniform radial compression loading on the barbed connector. The resilient liner, normally an elastomer, conforms to the barbs to provide high friction for retention and to form a leak tight seal.”).
Referring to claim 15, Linde as modified by Campau discloses the device of claim 10, wherein the flat lip engages a complementary flat surface on the annular bushing for enforcing a single use locking attachment (FIG. 8, which is reproduced and annotated above, shows bushing 66 includes a complementary flat surface. Examiner notes that the limitation of “enforcing a single use locking attachment” has been interpreted in view of specification (para. [0021] of the publication discloses “Once engaged, the flat lip 116 is prevented from withdrawal against the flat ridge, thereby ensuring that the device cannot be refolded and reused after possible contamination from gastric contents.”) as the connection is strong and secure to prevent the user from uncoupling the proximal end of the extraction tube from the annular bushing. Linde also suggested using glue at the connection between tube 114 and vacuum body 318. Thus, the combination of glue with the connection of Campau would prevent the decoupling of the connection between tube 114 and vacuum body 318).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Linde et al.
Referring to claim 13, Linde discloses the device of claim 12 wherein the rake 40C is formed of molded plastic (para. [0029]: “In an embodiment, each structure 40A-40C is formed of a metal, such as stainless steel. However, various structures can be formed as part of the tip (e.g., part of a molded plastic tip).” (emphasis added)). Linde fails to disclose the structure 40C has a deformability for nonabrasive contact with tissue and a resiliency for manipulation of solids and semi-solids. However, examiner contends that one of ordinary skill in the art, before the effective filling date of the application, will appreciate that selecting a plastic material to provide rigidity and flexibility of the molded plastic tip to allow the user to scrap loose and embedded tonsil stone and tonsil debris without injuring the tonsil (para. [0004]) is known by the skill person. “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).” See §MPEP 2144.07.
Allowable Subject Matter
Claims 2, 6, 14 and 17 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.
Conclusion
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/TUAN V NGUYEN/Primary Examiner, Art Unit 3771