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 .
Response to Amendment
The amendment filed 6/23/2026 has been entered. Claims 1-2, 6, 12, 14-22, 24-25, 32, and 34 are pending in the application. Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Non-Final Office Action mailed 2/23/2026.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-2, 6, 12, 14-22, 24-25, 32, and 34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 has been amended to recite “an identification part extending from the mounting part to… guide a repeated drug administration point”. This limitation is not supported by the original disclosure and is considered as new matter. The specification discloses that “The identification part 157 has an upper part that protrudes in the form of a curved surface, so that an implantation position of the drug injection device 100 can be identified.” ([0051]) and that “The main body fixing part 150 having the fixing hole 150a formed at the central part thereof may include the identification part 157 for identifying an implantation position when viewed from the outside.” ([0112]). However, the identification part is not disclosed to guide a repeated drug administration point.
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.
Claims 1, 12, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), and further in view of Sheetz (US 20100069743 A1).
Regarding claim 1, Parmer discloses a drug injection device that is fixedly implanted between a skull and a scalp of a patient to inject a drug (Fig. 2, [0124] and [0014]) comprising: a main body that is fixedly implanted in contact with the skull (mounting seat 1402 being the bottom portion of two-piece base 210 which is operable to attached to the skull of a patient, [0079], [0117], and Fig. 2, 14a and 14b);
a main body fixing part (collar 1404 which is the top portion of two-piece base 210, [0117] & Fig. 14a and 14b) is fixedly coupled to the main body to face the main body (collar 1404 having an internal hole, Fig. 14a-14b, and seat 1402 coupled together with collar 1404 with screws 1406, [0117] & Fig. 14a and 14b);
a movable part (movable member 220, [0117] & Fig. 14a and 14b) that is positioned between the main body and the main body fixing part (member 220 positioned inside of the two-piece base 210, situated inside of collar 1404 and seat 1402, [0117] & Fig. 14a and 14b), has a drug injection hole at a central part thereof (opening 222, [0080] & Fig. 5b), and is able to change a direction of the movable part toward a target point (member 220 capable of swiveling to align with a target point, [0013], [0017], & Fig. 2);
a sealing part (stabilizer 227, [0090] & Fig. 5b) that is configured to seal the drug injection hole of the movable part (stabilizer 227 configured to frictionally engage instrument 229; this frictional engagement seals the opening 222, [0095] & Fig. 5f and 5g), into which an injection needle for injecting a drug is inserted (instrument 229, which may be a needle, being inserted into stabilizer 227, [0019], [0095] & Fig. 5f and 5g);
a movable lid part (guide stem 240, [0079] & Fig. 5c and 5d) that is positioned above the sealing part to close and fix the movable part, prevents the sealing part from being separated and escaping an outside (guide stem 240 positioned above stabilizer 227 and operable to prevent stabilizer 227 from escaping or separating, [0093] & Fig. 5c), and
identifies an implantation position of the drug injection device to guide a point for repeated administration (via “a surgical instrument or observational tool can be inserted into the opening 242 of the guide stem 240 and passed through the passage in the movable member 220 and then further inserted into the patient a selected distance to the target 270,” [0080] & Fig. 2 and 5e); and
at least two fastening members (screws 1406, [0117] & Fig. 14a) that fasten an upper part of the main body and an upper part of the main body fixing part to the skull (via “collar 1404 includes a coupler, such as countersunk holes for receiving screws 1406 that detachably engage internally threaded receptacles 1408 in base 1402,” [0117] & Fig. 14a and 14b), wherein the main body includes a support part (flange with bone screw holes, [0117] & Fig. 14a and 14b) and
an insertion part extending vertically from the support part (bottom portion of seat 1402 below the flange with bone screw holes, [0117] & seen in Fig. 14b) with a movable part accommodating hole (hemispherical recess in seat 1402, [0117] & Fig. 14a and 14b, which is disclosed and illustrated with respect to the one-piece embodiment of base 210: “an opening in the base 210 having a first end which terminates at the seat 218 and another end which terminates at the bottom of the base 210.”, [0081]-[0082] & Fig. 6a and 6f; see [0098] for disclosure of base 1400 simply being a two-piece embodiment of base 210 in which one of ordinary skill in the art would understand to contain synonymous structures), an outer diameter of the support part is greater than an outer diameter of the movable part (the diameter of the flange of 1402 encompassing the entire member 220, Fig 14a), and
the main body and the main body fixing part are adjacently coupled to each other to accommodate and fix the movable part (via the two-piece base 210, seat 1402 and collar 1404, coupled together with screws 1406 and receiving the movable member 220, [0117] & Fig. 14a and 14b),
wherein the main body fixing part has a central hole formed through a center thereof to allow an injection needle to pass toward the movable part (collar 1404 having a central hole formed through a center to allow instrument 229 to pass toward movable member 220, [0117] & Fig. 14a-14b and 5d-5g), and comprises:
a mounting part secured to the main body (the outer flange of collar 1404, comprising the countersunk holes for receiving screws 1406, is being interpreted as a mounting part, [0117] & Fig. 14a-14b).
However, Parmer does not explicitly disclose a drug injection device comprising a diameter of the movable part accommodating hole gradually decreases and increases in a longitudinal direction of the insertion part, thereby tapering an inner side of the insertion part and wherein an outer diameter of the support part is smaller than an outer diameter of the main body fixing part, and
an identification part extending from the mounting part to identify an implantation position of the drug injection device and guide a repeated drug administration point, wherein the identification part comprises a curved surface that protrudes upwards relative to the mounting part to surround the central hole.
However, Ferrara teaches a device (abstract) comprising a diameter of the movable part accommodating hole gradually decreases and increases in a longitudinal direction of the insertion part, thereby tapering the inner side of an insertion part (the diameter of axial passage 34, which is defined by upper compartment 36, inner annular support member 32, and the inside of lower threaded section 24, and being interpreted as a movable part accommodating hole, decreases and increases in a longitudinal direction of the lower threaded section 24, thereby tapering an inner side of section 24, see Col 3 lines 6-16 & Fig. 4).
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 drug injection device of Parmer with Ferrara to include a diameter of the movable part accommodating hole gradually decreases and increases in a longitudinal direction of the insertion part, thereby tapering the inner side of an insertion part,
since such a modification would provide the instrument with greater range of motion and yield predictable results pertaining to movable member retention and instrument guidance while still providing structure to retain a spherical member (see Col 3 lines 7-16 & Fig. 4 of Ferrara). As modified, the lower member of the insertion part of Parmer, as illustrated in annotated Fig. 6f above, would be modified to include the tapered axial passageway 34 of section 24 of Ferrara.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the injection device of Parmer to have the outer diameter of the support part be smaller than an outer diameter of the main body fixing part since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the drug injection device of Parmer would not operate differently with the claimed diameter since the support part and main body fixing part would still be able to be coupled together and would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter is within the claimed ranges ([0048]).
Further, Sheetz teaches a drug injection device (port 10, [0072] & Fig. 1A, 5, 6A, 11 and 14) comprising an identification part extending from the mounting part to identify an implantation position of the drug injection device and guide a repeated drug administration point (upper topography 60, including protruding regions 70, extending from side regions 54 to identify an implantation position of port 10, [0070], [0076], [0078], and [0082] & Fig. 5; topography 60 may help identify septum 18 to help guide repeated drug administration, [0073] and [0076]), wherein the identification part comprises a curved surface that protrudes upwards relative to the mounting part to surround the central hole (protruding regions 70 being a curved surface protruding upward relative to regions 54 and surrounding septum 18, Fig. 4-5; topography 61c includes a plurality of protrusions 80 exhibiting a spherical upper surface, [0087] & Fig. 8, or protrusion 80E including rounded edges 83, [0088] & Fig. 9).
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 drug injection device of Parmer, as modified, with Sheetz to include an identification part extending from the mounting part, wherein the identification part comprises a curved surface that protrudes upwards relative to the mounting part to surround the central hole, since such a modification would provide structure to help identify the location of the drug delivery device after implantation ([0070] of Sheetz).
Regarding claim 12, Parmer, as modified, discloses all the limitations of claim 1. Parmer further disclose the drug injection device wherein the sealing part is configured so that the sealing part and the movable lid part satisfy at least one of the following Conditional Expressions 11 and 12:
<Conditional Expression 11>
1 < D11/D10 ≤ 7.2
<Conditional Expression 12>
0.4 ≤ L7/L6 ≤ 20
where D10 represents an outer diameter of the sealing part, D11 represents an outer diameter of the movable lid part, L6 represents a height of the sealing part, and L7 represents a height of the movable lid part (the outer diameter of stabilizer 227, which is being interpreted as the sealing part, is slightly smaller than the outermost diameter of the guide stem 240, which is being interpreted as the movable lid part, as seen in Figure 5c-5d; this satisfies conditional expression 11).
Regarding claim 14, Parmer, as modified, discloses all the limitations of claim 1. Parmer further discloses the drug injection device wherein the movable lid part includes an injection needle accommodating part that is formed with a hole (opening 242, [0095] & Fig. 5c) into which the injection needle is injected at a central part thereof (instrument 229, which is being interpreted as the injection needle, being inserted into opening 242, [0095] & Fig. 5d), a position indicating part that includes the injection needle accommodating part therein and is positioned outside the movable part (threads on the outer section of the top of guide stem 240, Fig. 15a) and a movable fastening member that is connected to the position indicating part, is formed with a screw-thread on an outside thereof, and is screw-coupled with the drug injection hole (external threads 241, which are being interpreted as the movable fastening member, being screwed into internal threads 225 of member 220, [0093] & Fig. 5a and 5b; the threads on the outer section of the top of guide stem 240 seen in Fig. 15a, which are being interpreted as the position indicating part, are not the same threads as threads 241, which are being interpreted as the movable fastening member).
The combination of the two embodiments above, embodiment of Figure 5 and embodiment of Figure 15, is suitable since it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009. The prior art also indicates “like reference numerals describe substantially similar components throughout the several views,” [0023].
Regarding claim 16, Parmer, as modified, discloses all the limitations of claim 14. Parmer further discloses the drug injection device wherein the position indicating part satisfies the following Conditional Expression 14:
<Conditional Expression 14>
0.4 ≤ L7a/L7 < 1
where L7 represents a total height of the movable lid part, and L7a represents a height of the position indicating part.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Parmer to have the dimensions of the movable lid part and position indicating part since it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Parmer places no criticality on the dimensions of the guide stem 240. The guide stem of Parmer would be able to operate under the conditions of the claimed ratio.
Regarding claim 17, Parmer, as modified, discloses all the limitations of claim 1. Parmer further discloses the drug injection device wherein the fastening member includes a body part that is fixedly implanted in the skull (portion of screw 1406 threaded into the skull, [0117] & Fig. 14b), and a head part that is connected to the body part (head of screw 1406 that remains in countersunk hole on collar 1404, [0117] & Fig. 14a) and the body part and the head part satisfy at least one of the following Conditional Expressions 15 and 16:
<Conditional Expression 15>
1 < D12/D11 ≤ 50
<Conditional Expression 16>
1 < L9/L8 ≤ 100
where D11 represents an outer diameter of the body part, D12 represents an outer diameter of the head part, L9 represents a length of the body part, and L8 represents a length of the head part (the length of the head of screw 1406 is substantially smaller than the length of the portion of screw 1406 threaded into the skull which satisfies conditional expression 16, Fig. 14a and 14b).
Regarding claim 18, Parmer, as modified, discloses all the limitations of claim 17. Parmer further discloses the drug injection device wherein the head part includes a horizontal groove (head of screw 1406 having a horizontal groove, Fig. 14a), and an identification groove that is formed to be identifiable in a cross shape with reference to the horizontal groove (the second horizontal groove on the head of screw 1406 creating the shape of a cross, Fig. 14a), and the horizontal groove and the identification groove satisfy the following Conditional Expression 17:
<Condition 17>
0.06 ≤ D13/L8a ≤ 12
where L8a represents a depth of the identification groove, and D13 represents an outer diameter of the horizontal groove.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the injection device of Parmer to have the depth of the identification groove and an outer diameter of the horizontal groove within the claimed ratio since it has been held that claimed ratios were obvious as being reached by routine procedures and producing predictable results, Merck & Co. Inc. v. Biocraft Lab. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1848 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See MPEP 2144.05 II A. In the instant case, the drug injection device of Parmer would not operate differently with the claimed ratio since the ratio includes dimensions that are essentially necessary for operation of a screw, like the screw 1406 of Parmer.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), in view of Sheetz (US 20100069743 A1), and further in view of Yoo (WO 2018199592 A1).
Regarding claim 2, Parmer, as modified, discloses all the limitations of clam 1. Parmer further discloses the drug injection device wherein the main body further includes an insertion part that is inserted into the skull (portion of seat 1402 below the flange with screw holes, [0117] & Fig. 14b). However, Parmer fails to expressly disclose the drug injection device wherein the insertion part satisfies at least one of the following Conditional Expressions 1 and 2:
<Conditional Expression 1>
1 < D1/D2 ≤ 3
<Conditional Expression 2>
2 ≤ L1 ≤ 7 [mm]
where D1 represents an outer diameter of the insertion part, D2 represents an inner diameter of the movable part accommodating hole, and L1 represents an insertion height of the insertion part.
However, Yoo teaches disclose the drug injection device wherein the insertion part satisfies at least one of the following Conditional Expressions 1 and 2:
<Conditional Expression 1>
1 < D1/D2 ≤ 3
<Conditional Expression 2>
2 ≤ L1 ≤ 7 [mm]
where D1 represents an outer diameter of the insertion part, D2 represents an inner diameter of the movable part accommodating hole, and L1 represents an insertion height of the insertion part (via member 200 may be in a range of 6-8 mm which satisfies expression 2, [89] & Fig. 1). 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 device of Parmer, as modified, with Yoo to include the height of the insertion part to be within 2-7 mm since such a modification would limit the size of the inserting part. This modification provides predictable results pertaining to minimizing the amount of bone needed for removal prior to device insertion ([91] of Yoo).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), in view of Sheetz (US 20100069743 A1), and further in view of Mahlin (US 20110106097 A1).
Regarding claim 6, Parmer, as modified, discloses all the limitations of claim 1. However, Parmer fails to explicitly disclose the drug injection device wherein the main body fixing part further comprises a support coupling groove formed a lower part of the mounting part, wherein the support coupling groove has a curved lower part that is concave in shape to match a shape of the support part of the main body, thereby facilitating coupling between the main body and the main body fixing part, and satisfies the following Conditional Expression 6:
<Conditional Expression 6>
5 < R1 ≤ 15 [mm]
where R1 represents a radius of the support coupling groove.
However, Mahlin teaches a drug injection device (abstract & Fig. 2) wherein the main body fixing part further comprises a support coupling groove formed a lower part of the mounting part (the half of assembly 2 comprising a mating depressions/holes, [0036] & Fig. 1A and 2), wherein the support coupling groove has a curved lower part that is concave in shape to match a shape of the support part of the main body (mating depressions/holes seen having a curved lower part that is concave in shape to match a shape of pins 32 on the other half of assembly 2, [0036] & Fig. 1A-2), thereby facilitating coupling between the main body and the main body fixing part (“The assembly is further provided with mating means 32 for fastening and orientating the two halves in relation to each other during assembling. The mating means may comprise a number of extending pins at one half of the assembly and mating depressions/holes at the other half to receive the pins such that a frictional connection is achieved.”, [0036]).
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 drug injection device of Parmer, as modified, with Mahlin to include a support coupling groove formed a lower part of the mounting part, wherein the support coupling groove has a curved lower part that is concave in shape to match a shape of the support part of the main body, since such a modification would provide structure to fasten and orient the main body part and the main body fixing part, the two pieces of the two piece base, ([0036] of Mahlin) and would yield predictable results pertaining to proper component orientation before securement. As modified, one or more pins 32 would be modified onto mounting seat 1402 and one or more corresponding mating depressions/holes would be included on the bottom, or lower part, of collar 1404. The modification would provide structure to help align the holes of collar 1404 and receptacles 1408 of base 1402 (Fig. 14a-14b of Parmer).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the support coupling groove of Parmer, as modified with Mahlin, have the claimed radius since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Parmer, as modified, would not operate differently with the claimed radius since the mating pins 32 are cylindrical (Fig. 1-2 of Mahlin) and would still be able to be coupled to correspondingly sized depressions/holes. One of ordinary skill in the art would be able to size pins 32 and their corresponding depressions/holes to facilitate desired connection. The Examiner notes that claim 1 does not include limitations to the size of the drug injection device; therefore, the radius of pins 32 may be between 5 and 15 mm.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), in view of Sheetz (US 20100069743 A1), and further in view of Nelson (US 20140276416 A1).
Regarding claim 15, Parmer, as modified, discloses all the limitations of claim 14. Parmer fails to expressly disclose the drug injection device wherein the injection needle accommodating part satisfies the following Conditional Expression 13:
<Conditional Expression 13>
A1 ≥ A2
where Al represents an angle of an upper end part of the needle accommodating part, which is an angle on the left and right with reference to a central axis, and A2 represents an angle of a middle portion of the needle accommodating part.
However, Nelson teaches the drug injection device wherein the injection needle accommodating part satisfies the following Conditional Expression 13:
<Conditional Expression 13>
A1 ≥ A2
where A1 represents an angle of an upper end part of the needle accommodating part, which is an angle on the left and right with reference to a central axis, and A2 represents an angle of a middle portion of the needle accommodating part (via bore 218 may include “chamfer or radius 240 near the uppermost surface 215 as shown in FIG. 5... to assist with placing the catheter 102 into bore 218, [0107] & Fig. 5; the chamfer creates a greater angle near the top of the bore of the member 214 compared to a lower end of the bore). 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 device of Parmer, as modified, with Nelson to include the upper end part having a greater angle compared to a middle portion since such a modification would assist in placing a medical instrument ([0107] of Nelson). The modification provides predictable results pertaining to safe device use.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), in view of Sheetz (US 20100069743 A1), and further in view of Balfour (US 20080215099 A1)
Regarding claim 19, Parmer, as modified, discloses all the limitations of claim 17. Parmer further discloses the drug injection device wherein the body part is fixedly implanted in the skull (screws 1406 intended to screw into the skull, [0117] & Fig. 2). However, Parmer fails to explicitly disclose the drug injection device wherein the body part is formed with a tapered screw-thread to the end thereof, and is formed with at least one pressure reducing groove that satisfies the following Conditional Expression 18:
<Conditional Expression 18>
1 < L9/L9a ≤ 50
where L9 represents a length of the body part, and L9a represents a length of a portion in which the pressure reducing groove is formed.
However, Balfour teaches the drug injection device wherein the body part is formed with a tapered screw-thread to the end thereof (threaded body 11, [0018] & Fig. 1), and is formed with at least one pressure reducing groove (cutting flute 4, [0017] & Fig. 1; the cutting flute structure is capable of reducing pressure, as is known in the art) that satisfies the following Conditional Expression 18:
<Conditional Expression 18>
1 < L9/L9a ≤ 50
where L9 represents a length of the body part, and L9a represents a length of a portion in which the pressure reducing groove is formed (the cutting flute varies in length to assist in the self-tapping of the screw without jeopardizing the structural characteristics of the thread, [0017] & Fig. 1; therefore, the length can be changed to satisfy the conditional expression 18 above). 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 device of Parmer, as modified, with Balfour to include the body part being formed with a tapered screw-thread to the end, and being formed with at least one pressure reducing groove that satisfies Conditional Expression 18, since such a modification would assist in the self-tapping of the screw. The modification provides predictable results pertaining to improved screw use.
Claim 20-22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable Parmer (US 20040267284), in view of Ferrara (US 4809694 A), in view of Sheetz (US 20100069743 A1), and further in view of Na Duk (KR 20140137308 A).
Regarding claim 20, Parmer, as modified, discloses all the limitations of claim 1. Parmer fails to expressly disclose the drug injection device further comprising a guide tube that is connected to the movable part and is inserted to a position close to the target point, and guides the injection needle for injecting the drug into the target point in the direction of the target point.
However, Na Duk teaches the drug injection device further comprising a guide tube (catheter 140, [0042] & Fig. 6 and 17) that is connected to the movable part (catheter 140 capable of being connected to another part of the drug injection device, such as chamber 130, [0034] & Fig. 5) and is inserted to a position close to the target point (via catheter 140 being inserted into location 12, [0059], [0102] & Fig. 13), and guides the injection needle for injecting the drug into the target point in the direction of the target point (via the needle 181 being inserted into the catheter and injecting stem cells into the location 12, [0064] & Fig. 15).
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 drug injection device of Parmer, as modified, with Na Duk to include the catheter connected to the movable part and inserted to a position close to the target point since such a modification would provide structure to guide the injection needle to a location in need of therapeutic treatment. The modification provides predictable results pertaining to creating a connection to a target point in the brain, such as a lesion ([0034] and [0059] of Na Duk).
Regarding claim 21, Parmer, as modified, discloses all the limitations of claim 20. Parmer fails to explicitly disclose the drug injection device wherein the guide tube further includes a tube connection part that is mounted on a lower end part of the drug injection hole, connects the movable part and the guide tube, and is formed with a hole connected to the inside of the guide tube.
However, Na Duk teaches the drug injection device wherein the guide tube further includes a tube connection part (protrusion 134, [0042] & Fig. 6 and 17) that is mounted on a lower end part of the drug injection hole (protrusion 134 mounted on a lower end of cap 150, [0042] & Fig. 6, 8, and 19), connects the movable part and the guide tube (protrusion 134 capable of connecting the catheter 140 to another part of the drug injection device, such as chamber 130, [0034] & Fig. 5), and is formed with a hole connected to the inside of the guide tube (hole 137 formed in a central portion of the protrusion 134, Fig. 8).
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 drug injection device of Parmer, as modified, with Na Duk to include the guide tube connection part formed with a hole connected to the inside of the guide tube since such a modification would provide structure to connect the guide tube to the drug injection device ([0034] of Na Duk).
Regarding claim 22, Parmer, as modified, discloses all the limitations of claim 20. Parmer fails to expressly disclose the drug injection device wherein the guide tube satisfies the following Conditional Expression 19:
<Conditional Expression 19>
1 < D14b/D14a ≤ 3.5
where D14a represents an inner diameter of the guide tube, and D14b represents an outer diameter of the guide tube.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Parmer, as modified, to have the inner and outer diameters of the guide tube fall within the claimed ratio since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Parmer, as modified, would not operate differently with the claimed diameters and since the catheter is designed to be implanted into brain tissue and guide an injection needle the device would function appropriately having the claimed diameter.
Regarding claim 24, Parmer, as modified, discloses all the limitations of claim 21. Parmer fails to explicitly disclose the drug injection device wherein the tube connection part satisfies at least one of the following Conditional Expressions 20 and 21:
<Conditional Expression 20>
1 < D15/D16 ≤ 20
<Conditional Expression 21>
0.5 ≤ L10 ≤ 1.5 [mm]
where D15 represents an outer diameter of the tube connection part, D16 represents an inner diameter of the tube connection part, and L10 represents a height of the tube connection part.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Parmer, as modified, to have dimensions of the guide tube connection part fall within the claimed ranges since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Parmer, as modified, would not operate differently with the claimed diameters and since the protrusion is designed to guide an injection needle the device would function appropriately having the claimed diameter.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), in view of Sheetz (US 20100069743 A1), in view of Na Duk (KR 20140137308 A), and further in view of Mokarram-Dorri (US 10493233 B1).
Regarding claim 25, Parmer, as modified, discloses all the limitations of claim 20. Parmer fails to explicitly disclose the drug injection device wherein the guide tube is configured so that at least one drug injection hole is formed on one side or both sides thereof so that the drug flows without accumulation, and the inner and outer diameters of the end part of the guide tube are formed in a curved shape to minimize tissue damage when inserted into the skull.
However, Mokarram-Dorri teaches the drug injection device wherein the guide tube is configured so that at least one drug injection hole is formed on one side or both sides thereof so that the drug flows without accumulation (opening 25 capable of allowing drug to flow without accumulation, Col 5 lines 13-16 & Fig. 4), and the inner and outer diameters of the end part of the guide tube are formed in a curved shape to minimize tissue damage when inserted into the skull (the end of tube 70, the internal and external wall, being formed in a curved shape, Fig. 4).
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 device of Parmer, as modified, with Mokarram-Dorri to include the drug injection hole and the curved inner and outer diameters at an end part since such a modification would allow for the passage of fluid from the catheter to the brain. The modification provides predictable results pertaining to unobstructed fluid delivery to safely accessed brain tissue (Col 3 lines 30-40 & Fig. 4).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), in view of Sheetz (US 20100069743 A1), and further in view of Song (KR 20190099877 A).
Regarding claim 32, Parmer, as modified, discloses all the limitations of claim 1. Parmer further discloses the drug injection device wherein the movable lid part includes a position indicating part having a hole at a center of the position indicating part (threads on the outer section of the top of guide stem 240 and the internal extension of guide stem 240 is being interpreted as the position indicating part, Fig. 5c and 15a; see annotated Fig. 5c below; there being a hole in the center of the top surface of guide stem 240, see Fig. 5a and 15a), and a movable fastening part partially surrounding the position indicating part and configured to have an external screw thread to threadedly be engaged with the drug injection hole of the movable part (external threads 241, which are being interpreted as the movable fastening member, being screwed into internal threads 225 of member 220, [0093] & Fig. 5a and 5b; see annotated Fig. 5c below in which the movable fastening part partially surrounds the position indicating part).
However, Parmer fails to explicitly disclose the position indicating part having a funnel shaped hole at a center of the position indicating part. However, Song teaches a drug injection device (abstract) comprising a position indicating part (guide member 60, [0032] & Fig. 11-12) having a funnel shaped hole at a center of the position indicating part (member 60 having a recessed introduction region 64 formed at an upper end of pillar portion 61a forming the start of center guide hole 65, [0032] & Fig. 11-12; “the introduction region 64 may be provided in the form of an inclined groove formed with an inclined surface along the circumference”, [0032]).
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 guide stem of Parmer, as modified, with Song to include the position indicating part having a funnel shaped hole at a center of the position indicating part since such a modification would aid in the retention and insertion of an additional instrument and yield predictable results pertaining to ease of device use (see [0032] of Song).
PNG
media_image1.png
787
440
media_image1.png
Greyscale
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Parmer (US 20040267284), in view of Ferrara (US 4809694 A), and further in view of Mahlin (US 20110106097 A1).
Regarding claim 34, Parmer discloses a drug injection device that is fixedly implanted between a skull and a scalp of a patient to inject a drug (Fig. 2, [0124] and [0014]) comprising: a main body that is fixedly implanted in contact with the skull (mounting seat 1402 being the bottom portion of two-piece base 210 which is operable to attached to the skull of a patient, [0079], [0117], and Fig. 2, 14a and 14b);
a main body fixing part (collar 1404 which is the top portion of two-piece base 210, [0117] & Fig. 14a and 14b) is fixedly coupled to the main body to face the main body (collar 1404 having an internal hole, Fig. 14a-14b, and seat 1402 coupled together with collar 1404 with screws 1406, [0117] & Fig. 14a and 14b);
a movable part (movable member 220, [0117] & Fig. 14a and 14b) that is positioned between the main body and the main body fixing part (member 220 positioned inside of the two-piece base 210, situated inside of collar 1404 and seat 1402, [0117] & Fig. 14a and 14b), has a drug injection hole at a central part thereof (opening 222, [0080] & Fig. 5b), and is able to change a direction of the movable part toward a target point (member 220 capable of swiveling to align with a target point, [0013], [0017], & Fig. 2);
a sealing part (stabilizer 227, [0090] & Fig. 5b) that is configured to seal the drug injection hole of the movable part (stabilizer 227 configured to frictionally engage instrument 229; this frictional engagement seals the opening 222, [0095] & Fig. 5f and 5g), into which an injection needle for injecting a drug is inserted (instrument 229, which may be a needle, being inserted into stabilizer 227, [0019], [0095] & Fig. 5f and 5g);
a movable lid part (guide stem 240, [0079] & Fig. 5c and 5d) that is positioned above the sealing part to close and fix the movable part, prevents the sealing part from being separated and escaping an outside (guide stem 240 positioned above stabilizer 227 and operable to prevent stabilizer 227 from escaping or separating, [0093] & Fig. 5c), and
identifies an implantation position of the drug injection device to guide a point for repeated administration (via “a surgical instrument or observational tool can be inserted into the opening 242 of the guide stem 240 and passed through the passage in the movable member 220 and then further inserted into the patient a selected distance to the target 270,” [0080] & Fig. 2 and 5e); and
at least two fastening members (screws 1406, [0117] & Fig. 14a) that fasten an upper part of the main body and an upper part of the main body fixing part to the skull (via “collar 1404 includes a coupler, such as countersunk holes for receiving screws 1406 that detachably engage internally threaded receptacles 1408 in base 1402,” [0117] & Fig. 14a and 14b), wherein the main body includes a support part (flange with bone screw holes, [0117] & Fig. 14a and 14b) and
an insertion part extending vertically from the support part (bottom portion of seat 1402 below the flange with bone screw holes, [0117] & seen in Fig. 14b) with a movable part accommodating hole (hemispherical recess in seat 1402, [0117] & Fig. 14a and 14b, which is disclosed and illustrated with respect to the one-piece embodiment of base 210: “an opening in the base 210 having a first end which terminates at the seat 218 and another end which terminates at the bottom of the base 210.”, [0081]-[0082] & Fig. 6a and 6f; see [0098] for disclosure of base 1400 simply being a two-piece embodiment of base 210 in which one of ordinary skill in the art would understand to contain synonymous structures), an outer diameter of the support part is greater than an outer diameter of the movable part (the diameter of the flange of 1402 encompassing the entire member 220, Fig 14a), and
the main body and the main body fixing part are adjacently coupled to each other to accommodate and fix the movable part (via the two-piece base 210, seat 1402 and collar 1404, coupled together with screws 1406 and receiving the movable member 220, [0117] & Fig. 14a and 14b),
wherein the support part includes at least one first fastening hole that is positioned at an upper part of the main body (internally threaded receptacles 1408 formed in the flange of seat 1402, [0117] & Fig. 14a and 14b), in which the fastening member is fixedly inserted (via screws 1406 engaging receptacles 1408, [0117] & Fig. 14b).
However, Parmer does not explicitly disclose a drug injection device comprising a diameter of the movable part accommodating hole gradually decreases and increases in a longitudinal direction of the insertion part, thereby tapering an inner side of the insertion part and wherein an outer diameter of the support part is smaller than an outer diameter of the main body fixing part, and at least one fixing protrusion that is fixedly coupled to the main body fixing part, and satisfies the following Conditional Expression 3:
<Conditional Expression 3>
12 ≤ D3/L2 ≤ 60
where D3 represents the outer diameter of the support part, and L2 represents a height of the support part.
However, Ferrara teaches a device (abstract) comprising a diameter of the movable part accommodating hole gradually decreases and increases in a longitudinal direction of the insertion part, thereby tapering the inner side of an insertion part (the diameter of axial passage 34, which is defined by upper compartment 36, inner annular support member 32, and the inside of lower threaded section 24, and being interpreted as a movable part accommodating hole, decreases and increases in a longitudinal direction of the lower threaded section 24, thereby tapering an inner side of section 24, see Col 3 lines 6-16 & Fig. 4).
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 drug injection device of Parmer with Ferrara to include a diameter of the movable part accommodating hole gradually decreases and increases in a longitudinal direction of the insertion part, thereby tapering the inner side of an insertion part,
since such a modification would provide the instrument with greater range of motion and yield predictable results pertaining to movable member retention and instrument guidance while still providing structure to retain a spherical member (see Col 3 lines 7-16 & Fig. 4 of Ferrara). As modified, the lower member of the insertion part of Parmer, as illustrated in annotated Fig. 6f above, would be modified to include the tapered axial passageway 34 of section 24 of Ferrara.
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the injection device of Parmer to have the outer diameter of the support part be smaller than an outer diameter of the main body fixing part since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the drug injection device of Parmer would not operate differently with the claimed diameter since the support part and main body fixing part would still be able to be coupled together and would function appropriately having the claimed diameter. Further, applicant places no criticality on the range claimed, indicating simply that the diameter is within the claimed ranges ([0048]).
Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Parmer to have the outer diameter of the support part and a height of the support part within the claimed ratio since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Parmer would not operate differently with the claimed dimensions since the flange of the seat is intended to attach the seat to the skull and have a low profile. The device would function appropriately having the claimed dimensions.
Further, Mahlin teaches a drug injection device (abstract & Fig. 2) comprising a support part (the half of assembly 2 comprising pins 32, [0036] & Fig. 1-2), wherein the support part includes at least one fixing protrusion that is fixedly coupled to the main body fixing part (pins 32 fixedly coupled to the other half of assembly 2 upon connection, [0036] & Fig. 1-2).
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 drug injection device of Parmer, as modified, with Mahlin to include at least one fixing protrusion that is fixedly coupled to the main body fixing part since such a modification would provide structure to fasten and orient the main body part and the main body fixing part, the two pieces of the two piece base, ([0036] of Mahlin) and would yield predictable results pertaining to proper component orientation before securement. As modified, one or more pins 32 would be modified onto mounting seat 1402 and one or more corresponding mating depressions/holes would be included on the bottom, or lower part, of collar 1404. The modification would provide structure to help align the holes of collar 1404 and receptacles 1408 of base 1402 (Fig. 14a-14b of Parmer).
Response to Arguments
Applicant's arguments filed 6/23/2026 have been fully considered but they are not persuasive. In response to Applicant’s arguments to claim 12, the Examiner finds that rejection of claim 12 does not rely on In re Aller. The Examiner finds that Parmer teaches the claimed limitations. The outer diameter of stabilizer 227 is slightly smaller than the outermost diameter of the guide stem 240 as seen in Figure 5c-5d. This satisfies conditional expression 11, as D11/D10 is slightly greater than 1.
Applicant’s arguments with respect to independent claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARTIN A RADOMSKI/Examiner, Art Unit 3783 /EMILY L SCHMIDT/Primary Examiner, Art Unit 3783
Prosecution Insights