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 § 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.
Claim 9 is 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 9 recites “wherein the slip-assisting unit formed with a communicating space through which inside and outside communicate, in at least a part between the outer surface of the cylinder and the user's body”. It is unclear what “inside and outside communicate” refers to, if it is the inside of the cylinder and outside of the cylinder (in other words the slip-assisting unit is an aperture/hole on the outer surface of the cylinder), or inside of the slip assisting unit and outside of the cylinder, or between the inside of the user’s body and the outside of the slip assisting unit or cylinder.
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) 1, 2, 4 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swick (US Patent Pub. 20070129668) in view of Fedler (US Patent Pub. 20170209640).
Regarding Claim 1, Swick teaches (Figs 1-2) a drug injection module, comprising:
a cylinder (14), which is formed long, has a storage space capable of storing a drug (46)therein, has a discharge port (36) for discharging the drug (46) formed at a front end (24; see [0019] teaching 24 is a distal section), and has an open rear end (28; see [0019] teaching open end 28 in proximal section 22) ;
a piston (16) that is inserted into the storage space through the rear end (28) of the cylinder (14; see Fig 2) and slides in a longitudinal direction to discharge the drug (see Fig 2 and Fig 5; also see [0025]).
Swick does not specify a slip-assisting unit that is at least partially formed to protrude or depress from an outer surface of the cylinder to form an uneven cross-sectional shape, and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body.
Fedler teaches (fig 4) a cylinder (150) with a slip-assisting unit (153) that is at least partially formed to protrude or depress from an outer surface of the cylinder (150) to form an uneven cross-sectional shape (see [0029] teaching 153 are ribs on the exterior surface of 150), and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body (See [0029] teaching that the ribs 153 are useful for gripping the cavity of the body, such as the anal cavity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the outer surface of the cylinder of Swick such that it includes a slip-assisting unit that is at least partially formed to protrude or depress from an outer surface of the cylinder to form an uneven cross-sectional shape, and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body as taught by Fedler. One of ordinary skill in the art would have been motivated to do so in order to provide structure that will help the device grip/secure itself within the cavity of the body (Fedler [0029]).
Regarding Claim 2, the combination of Swick and Fedler teaches the drug injection module according to claim 1, wherein the slip-assisting unit (Fedler 150) is formed long with a constant length along the longitudinal direction of the cylinder (see Fedler [0029] teaching “Ribs 153 may be oriented around the exterior of shaft 151 in any direction and have any size.”, therefore it is interpreted that the ribs could be longitudinal in direction rather than lateral as shown in Fig 4 of Fedler).
Regarding Claim 4, the combination of Swick and Fedler teaches the drug injection module according to claim 1, wherein at least one or more of the slip-assisting units (Felder ribs 153 in Fig 4) is formed to protrude along the outer surface of the cylinder (Fedler 150, or in modified Swick, the outer surface of cylinder 14), and makes a peripheral shape of the cylinder uneven (See Fedler Fig 4, the outer surface is uneven).
Regarding Claim 10, the combination of Swick and Fedler teaches the drug injection module according to claim 1, wherein the slip-assisting unit has a pattern on the outer surface of the cylinder (See Fig 4 Fedler), and a plurality of protrusions (Fedler 153) are formed to protrude adjacent to each other (See Fig 4 Fedler).
Claim(s) 1, 3 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swick (US Patent Pub. 20070129668) in view of O’Neill et al. (US Patent 5395331 hereinafter “O’Neill”).
Regarding Claim 1, Swick teaches (Figs 1-2) a drug injection module, comprising:
a cylinder (14), which is formed long, has a storage space capable of storing a drug (46)therein, has a discharge port (36) for discharging the drug (46) formed at a front end (24; see [0019] teaching 24 is a distal section), and has an open rear end (28; see [0019] teaching open end 28 in proximal section 22) ;
a piston (16) that is inserted into the storage space through the rear end (28) of the cylinder (14; see Fig 2) and slides in a longitudinal direction to discharge the drug (see Fig 2 and Fig 5; also see [0025]).
Swick does not specify a slip-assisting unit that is at least partially formed to protrude or depress from an outer surface of the cylinder to form an uneven cross-sectional shape, and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body.
O’Neill teaches (Fig 11) a cylinder (402) with a slip-assisting unit (404, 406, 408) that is at least partially formed to protrude or depress from an outer surface of the cylinder to form an uneven cross-sectional shape (See Fig 11; Col 12 lines 15-26), and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body (See Col 11 lines 26-27 teaching ribs are used to frictionally engage the sinus; also see Col 12 lines 15-26 teaching the device of Fig 11 is similar to the device of Fig 10, therefore it is interpreted that the ribs of Fig 11 will have the same functionality as the ribs of Fig 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cylinder of Swick such that it includes a slip-assisting unit that is at least partially formed to protrude or depress from an outer surface of the cylinder to form an uneven cross-sectional shape, and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body as taught by O’Neill. One of ordinary skill in the art would have been motivated to do so in order to allow the device to frictionally engage the sinus or cavity which the device is inserted to (O’Neill Col 11 lines 26-27), and as such help secure the device in place.
Regarding Claim 3, the combination of Swick and O’Neill teaches the drug injection module according to claim 1, wherein the slip-assisting unit (O’Neill 404, 406, 408) is made up of a plurality of pieces along the periphery or the longitudinal direction of the cylinder (See O’Neill Fig 11), and at least one or more of the slip-assisting units is formed differently (See O’Neill Col 12 lines 15-27 teaching how there are raised and non-raised portions which are alternating).
Regarding Claim 10, the combination of Swick and O’Neill teaches the drug injection module according to claim 1, wherein the slip-assisting unit (O’Neill 404, 406, 408) has a pattern on the outer surface of the cylinder (See O’Neill Fig 11), and a plurality of protrusions are formed to protrude adjacent to each other (See O’Neill Col 12 lines 15-27 and Fig 11).
Claim(s) 1, 4, 6 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swick (US Patent Pub. 20070129668) in view of Rentschler et al. (US Patent Pub. 20200276417 hereinafter “Rentschler”).
Regarding Claim 1, Swick teaches (Figs 1-2) a drug injection module, comprising:
a cylinder (14), which is formed long, has a storage space capable of storing a drug (46)therein, has a discharge port (36) for discharging the drug (46) formed at a front end (24; see [0019] teaching 24 is a distal section), and has an open rear end (28; see [0019] teaching open end 28 in proximal section 22) ;
a piston (16) that is inserted into the storage space through the rear end (28) of the cylinder (14; see Fig 2) and slides in a longitudinal direction to discharge the drug (see Fig 2 and Fig 5; also see [0025]).
Swick does not specify a slip-assisting unit that is at least partially formed to protrude or depress from an outer surface of the cylinder to form an uneven cross-sectional shape, and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body.
Rentschler teaches (Fig 1A and 2AC) a device with a balloon (102) comprising a textured area (104) comprising protrusions (200AC, Fig 2AC; see [0129] “the textured portion 104 includes multiple protrusions,”), in order to vary resistance between different direction of the device (See [0163]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cylinder of Swick such that it includes a slip-assisting unit (protrusions) as taught by Rentschler. One of ordinary skill in the art would have been motivated to do so in order to provide desired friction, and varied resistance when the device is inserted, and help anchor the device (See Rentschler [0163]; also see Rentschler [0141] teaching “the textured portions 2204A, 2204B to come into contact with the inner surface of the physiological lumen. Doing so increases friction between the balloon 2202 and the inner surface of the physiological lumen and may be used to anchor or otherwise reduce movement of the balloon 2202 within the physiological lumen.”).
Regarding Claim 4, the combination of Swick and Rentschler teaches the drug injection module according to claim 1, wherein at least one or more of the slip-assisting units (Rentschler Fig 2AC, protrusions 200AC) is formed to protrude along the outer surface of the cylinder, and makes a peripheral shape of the cylinder uneven (See Rentschler Fig 2AC, the surface of cylinder 102 is uneven, with the modification to Swick the outer surface of cylinder 14 would be similarly uneven).
Regarding Claim 5, the combination of Swick and Rentschler teaches the drug injection module according to claim 4, wherein the slip-assisting unit (Rentschler Fig 2AC, protrusions 200AC) comprises a protrusion that protrudes from the outer surface of the cylinder (Rentschler Fig 2AC, protrusions 200AC extend from outer surface 102); and a wing which is formed so that a part thereof is expanded from a protruding end of the protrusion (See annotated Fig 2AC), and forms a separate communicating space (Rentschler 202AB, and space under this surface) with the cylinder.
The combination does not specify the wing is formed to have a width relatively larger than that of the protrusion. Rentschler does teaches [0170] that the height and width of the protrusions may be varied. The instant disclosure describes the parameter of the wing is formed to have a width relatively larger than that of the protrusion as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the wing is formed to have a width relatively larger than that of the protrusion are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the wing is formed to have a width relatively larger than that of the protrusion would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
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Annotated Fig 2AC (Rentschler)
Regarding Claim 6, the combination of Swick and Rentschler teaches the drug injection module according to claim 5, wherein the wing is formed to curve downward towards the cylinder along the periphery toward the edge and is disposed to be spaced adjacent to the surface of the cylinder (See annotated Fig 2AC).
Regarding Claim 9, the combination of Swick and Rentschler teaches the drug injection module according to claim 1, wherein the slip-assisting unit (Rentschler Fig 2AC) is formed with a communicating space (space between Wall 202AB and outer surface of 102) through which inside and outside communicate, in at least a part between the outer surface of the cylinder and the user's body (this is considered a functional limitation, since Swick and Rentschler teach all structural elements of the claim, they would necessarily meet the functional limitation as well).
Claim(s) 1, 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Swick (US Patent Pub. 20070129668) in view of Rentschler et al. (US Patent Pub. 20200276417 hereinafter “Rentschler”) in an alternative interpretation.
Regarding Claim 1, Swick teaches (Figs 1-2) a drug injection module, comprising:
a cylinder (14), which is formed long, has a storage space capable of storing a drug (46)therein, has a discharge port (36) for discharging the drug (46) formed at a front end (24; see [0019] teaching 24 is a distal section), and has an open rear end (28; see [0019] teaching open end 28 in proximal section 22) ;
a piston (16) that is inserted into the storage space through the rear end (28) of the cylinder (14; see Fig 2) and slides in a longitudinal direction to discharge the drug (see Fig 2 and Fig 5; also see [0025]).
Swick does not specify a slip-assisting unit that is at least partially formed to protrude or depress from an outer surface of the cylinder to form an uneven cross-sectional shape, and generates variations in pressure acting on the surface when coming into contact with a user's body, wherein the slip-assisting unit prevents the pressure of the human body acting along the periphery from becoming uniform and facilitates a slip in a state in which the cylinder is inserted into the human body.
Rentschler teaches (Fig 1A and 2AC) a device with a balloon (102) comprising a textured area (104) comprising depressions (202K, Fig 2K; see [0129] “the textured portion 104 includes multiple protrusions,”), in order to vary resistance between different direction of the device (See [0163]) and help anchor the device to the lumen it is inserted in (See [0141] “the textured portions 2204A, 2204B to come into contact with the inner surface of the physiological lumen. Doing so increases friction between the balloon 2202 and the inner surface of the physiological lumen and may be used to anchor or otherwise reduce movement of the balloon 2202 within the physiological lumen.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the cylinder of Swick such that it includes a slip-assisting unit (depressions) as taught by Rentschler. One of ordinary skill in the art would have been motivated to do so in order to provide desired friction, and varied resistance when the device is inserted, and help anchor the device (See Rentschler [0163]; also see Rentschler [0141] teaching “the textured portions 2204A, 2204B to come into contact with the inner surface of the physiological lumen. Doing so increases friction between the balloon 2202 and the inner surface of the physiological lumen and may be used to anchor or otherwise reduce movement of the balloon 2202 within the physiological lumen.”).
Regarding Claim 7, the combination of Swick and Rentschler the drug injection module according to claim 1, wherein at least one or more of the slip-assisting units (Rentschler Fig 2K, depressions 202K) is formed to be depressed along the outer surface of the cylinder, and makes the peripheral shape of the cylinder uneven (see Rentschler Fig 2K).
Regarding Claim 8, the combination of Swick and Rentschler teaches all elements of claim 7 as described above. the combination does not specify the drug injection module wherein the slip-assisting unit is formed to have a width in an inner direction relatively larger than the surface of the cylinder.
Rentschler does teaches [0170] that the height and width of the protrusions may be varied.
The instant disclosure describes the parameter of the slip-assisting unit is formed to have a width in an inner direction relatively larger than the surface of the cylinder as being merely preferable, and does not describe the parameter as contributing any unexpected results to the system. As such, parameters such as the slip-assisting unit is formed to have a width in an inner direction relatively larger than the surface of the cylinder are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art that the limitation of the slip-assisting unit is formed to have a width in an inner direction relatively larger than the surface of the cylinder would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
Regarding Claim 9, the combination of Swick and Rentschler teaches the drug injection module according to claim 1, wherein the slip-assisting unit (Rentschler Fig 2K) is formed with a communicating space (space from walls 204k) through which inside and outside communicate, in at least a part between the outer surface of the cylinder and the user's body (this is considered a functional limitation, since Swick and Rentschler teach all structural elements of the claim, they would necessarily meet the functional limitation as well).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Todd et al. (US Patent 5423745) teaches a balloon with a plurality of protrusions that are used to help grip the device to the body.
Gerrans et al. (US 20120259217) teaches a balloon with protrusions that are used to help grip the device to the body.
Cho (KR 102040773) teaches a device for injecting liquid in the body with a cylinder and a piston.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/QUYNH-NHU H. VU/Primary Examiner, Art Unit 3783