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 Objections
Claim 2 is objected to because of the following informalities:
Claim 2 line 6, “hollow needle” should read “hollow needle”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4 and 6 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 4 line 2 recites “the protruding portion has a tapered cross section”. This limitation is unclear as the recitation in claim 4 suggests that there is only one protruding portion, however in claim 2 line 9 (which claim 4 depends upon), the limitation had been introduced as “one or more protruding portions”.
Claim 6 line 7 recites “a liquid medicine”. It is unclear if the “liquid medicine” recited in line 7 is the same “liquid medicine” introduced in line 4, or of this is a second/alternative “liquid medicine”. For purposes of interpretation, the limitation in line 7 is being interpreted as “the liquid medicine”.
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 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toh et al. (US 20200078581 hereinafter “Toh”) in view of Kriheli (US 20180161245) and Burkholz et al. (US 20170120028 hereinafter “Burkholz”).
Regarding Claim 1, Toh teaches (Figs 1a-1e) A liquid medicine administration device comprising:
a needle unit (12) configured to be inserted into and placed on a living body (see [0053] teaching insertion of 12 and 15 into vasculature of patient);
a liquid medicine supply device (20) provided separately from the needle unit (12) and configured to deliver a liquid medicine (26) filled inside from a distal portion;
a tube (16) configured to allow the liquid medicine to flow, the tube having a distal end connected to the needle unit; and
a connector (18) to which are attachable the liquid medicine supply device (20),
wherein: the connector (18) comprises:
a valve body (34), the valve body being open during delivery of the liquid medicine or the priming solution to allow the liquid medicine supply device or the priming solution delivery device to communicate with the tube (see [0040]).
Toh does not specify the connector comprising a hollow needle having a needle hole that is formed inside the hollow needle and that communicates with the tube, the hollow needle protruding toward the liquid medicine supply device or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device, and the valve being disposed distal to the hollow needle; and the connector comprises an uneven portion formed along an axial direction in an uneven shape on a surface that contacts the valve body
Kriheli teaches (Figs 5a-5b) a connector (14) that comprises a hollow needle (40; see [0010] teaching 40 is a liquid conduit) having a needle hole (56) that is formed inside the hollow needle and that communicates with the tube (See [0035] teaching that 56 is pushed through 34 creating an open fluid pathway), the hollow needle (40) protruding toward the liquid medicine supply device (12; see Fig 5b, 40 has a proximal end protruding towards 12) or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device (See [0011] teaching how 40 is in communication with the inertial of the syringe 12), and the valve (54, 34) being disposed distal to the hollow needle (40; see Figs 5a-5b); and the connector (14) comprises an uneven portion (distal portion of 14 surrounding 35) formed along an axial direction in an uneven shape on a surface that contacts the valve body (See Fig 5b, the connector has an uneven/protruded shape close to the surface 35 of the valve 54,34).
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 connector of Toh such that the connector comprises a hollow needle having a needle hole that is formed inside the hollow needle and that communicates with the tube, the hollow needle protruding toward the liquid medicine supply device or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device, and the valve being disposed distal to the hollow needle; and the connector comprises an uneven portion formed along an axial direction in an uneven shape on a surface that contacts the valve body as taught by Kriheli. One of ordinary skill in the art would have been motivated to do so in order to provide a contamination free transfer of drugs (Kriheli [0005]).
The combination does not specify the connector attachable both (i) the liquid medicine supply device, and (ii) a priming solution delivery device configured to deliver a priming solution filled inside from a distal portion.
While Toh teaches [0034] that the adapter 18 could be connected to fluid storage 20 and that may be facilitating priming of catheter system 10. It does not specify two separate devices connecting to the connector.
Burkholz teaches (Fig 24) a connector (102) that is connected to two separate syringes (2300, 2400). Burkholz also teaches [0040] that the system is provided for the infusion of medical fluid including saline solution and a liquid medication. It is interpreted that in the embodiment of Fig 24, one syringe 2300 could comprise a liquid medication and another syringe 2400 could comprise the saline solution.
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 connector of Toh such that it allows for the connection of two supply devices as taught by Burkholz. This would allow for the connector to be attachable to both a liquid medicine supply device and priming solution delivery device configured to deliver a priming solution filled inside from a distal portion. One of ordinary skill in the art would have been motivated to do so in order to deliver/provide first and second fluids intermittently or in combination for a patient via the output of the connector (Burkholz [0080]).
Regarding Claim 6, Toh teaches (Figs 1a-1e) a liquid medicine administration device comprising:
a needle unit (12) configured to be inserted into and placed on a living body ((see [0053] teaching insertion of 12 and 15 into vasculature of patient));
a tube (16) configured to allow a liquid medicine (26) to flow, the tube (16) having a distal end connected to the needle unit (12); and
a connector (18) to which are attachable a liquid medicine supply device (20) configured to deliver a liquid medicine (26) filled inside from a distal portion, wherein:
the connector (18) comprises:
a valve body (34), the valve body being open during delivery of the liquid medicine or the priming solution to allow the liquid medicine supply device or the priming solution delivery device to communicate with the tube (See [0040]).
Toh does not specify the connector comprising a hollow needle having a needle hole that is formed inside the hollow needle and that communicates with the tube, the hollow needle protruding toward the liquid medicine supply device or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device, and the valve being disposed distal to the hollow needle; and the connector comprises an uneven portion formed along an axial direction in an uneven shape on a surface that contacts the valve body
Kriheli teaches (Figs 5a-5b) a connector (14) that comprises a hollow needle (40; see [0010] teaching 40 is a liquid conduit) having a needle hole (56) that is formed inside the hollow needle and that communicates with the tube (See [0035] teaching that 56 is pushed through 34 creating an open fluid pathway), the hollow needle (40) protruding toward the liquid medicine supply device (12; see Fig 5b, 40 has a proximal end protruding towards 12) or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device (See [0011] teaching how 40 is in communication with the inertial of the syringe 12), and the valve (54, 34) being disposed distal to the hollow needle (40; see Figs 5a-5b); and the connector (14) comprises an uneven portion (distal portion of 14 surrounding 35) formed along an axial direction in an uneven shape on a surface that contacts the valve body (See Fig 5b, the connector has an uneven/protruded shape close to the surface 35 of the valve 54,34).
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 connector of Toh such that the connector comprises a hollow needle having a needle hole that is formed inside the hollow needle and that communicates with the tube, the hollow needle protruding toward the liquid medicine supply device or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device, and the valve being disposed distal to the hollow needle; and the connector comprises an uneven portion formed along an axial direction in an uneven shape on a surface that contacts the valve body as taught by Kriheli. One of ordinary skill in the art would have been motivated to do so in order to provide a contamination free transfer of drugs (Kriheli [0005]).
The combination does not specify the connector attachable both (i) the liquid medicine supply device, and (ii) a priming solution delivery device configured to deliver a priming solution filled inside from a distal portion.
While Toh teaches [0034] that the adapter 18 could be connected to fluid storage 20 and that may be facilitating priming of catheter system 10. It does not specify two separate devices connecting to the connector.
Burkholz teaches (Fig 24) a connector (102) that is connected to two separate syringes (2300, 2400). Burkholz also teaches [0040] that the system is provided for the infusion of medical fluid including saline solution and a liquid medication. It is interpreted that in the embodiment of Fig 24, one syringe 2300 could comprise a liquid medication and another syringe 2400 could comprise the saline solution.
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 connector of Toh such that it allows for the connection of two supply devices as taught by Burkholz. This would allow for the connector to be attachable to both a liquid medicine supply device and priming solution delivery device configured to deliver a priming solution filled inside from a distal portion. One of ordinary skill in the art would have been motivated to do so in order to deliver/provide first and second fluids intermittently or in combination for a patient via the output of the connector (Burkholz [0080]).
Claim(s) 2 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toh (US 20200078581) in view of Kriheli (US 20180161245) and Burkholz (US 20170120028) as applied to claim 1 above, and further in view of Nakagami et al. (US 20190262599 hereinafter “Nakagami”).
Regarding Claim 2, the combination of Toh, Kriheli and Burkholz teaches all elements of claim 1 as described above. The combination further teaches the uneven portion has one or more protruding portions protruding toward the valve body (See Kriheli, the distal portion of 14 has a protruding portion extending toward valve body 35).
The combination does not specify the liquid medicine administration device wherein: the valve body is formed of an elastic material, and has a disk shape in which a dimension along an axial direction of the hollow needle is smaller than a dimension in a radial direction of the hollow needle, the valve body has an opening/closing hole that is formed in a central part and that has a slit shape.
Nakagami teaches [0093] a valve body (16) that is formed of an elastic material (see [0093] teaching 16 is formed of rubber or elastomer), and has a disk shape (See [0093] teaching 16 is a disc valve) in which a dimension along an axial direction of the hollow needle is smaller than a dimension in a radial direction of the hollow needle (See annotated Fig 3), the valve body (16) has an opening/closing hole (88) that is formed in a central part (86) and that has a slit shape (see [0093] teaching 88 is a slit).
PNG
media_image1.png
389
514
media_image1.png
Greyscale
Annotated Fig 3 (Nakagami)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the valve of Toh such that is a valve formed of an elastic material, and has a disk shape in which a dimension along an axial direction of the hollow needle is smaller than a dimension in a radial direction of the hollow needle, the valve body has an opening/closing hole that is formed in a central part and that has a slit shape as taught by Nakagami. One of ordinary skill in the art would recognize this as an alternative design of a valve that provides the same expected results of opening and closing to allow for fluid flow due to pressing force on the valve (See Nakagami [0003]). Furthermore, it has been held that “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”.
Regarding Claim 4, the combination of Toh, Kriheli, Burkholz and Nakagami teaches all elements of claim 2 as described above. The combination does not specify the liquid medicine administration device wherein the protruding portion has a tapered cross-sectional shape that is tapered toward the valve body, and the one or more protruding portions comprise a plurality of the protruding portions that are substantially parallel to each other.
Nakagami teaches a connector (43) with a protruding portion (43a and 52) that is a tapered cross-section shape (See Fig 3, 43a is a tapered shape) that is tapered towards the valve body (16) and the one or more protruding portions (43a and 52) comprise a plurality of the protruding portions that are substantially parallel to each other (See Fig 3, the two sections of 43a and 52 in the cross-sectional view of Fig 3 are parallel to each other).
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 connector of Toh such that the protruding portion has a tapered cross-sectional shape that is tapered toward the valve body, and the one or more protruding portions comprise a plurality of the protruding portions that are substantially parallel to each other as taught by Nakagami. One of ordinary skill in the art would have been motivated to do so in order to reduce and prevent pain the patient may feel if that portion of the connector contacts the patients skin (Nakagami [0079]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toh (US 20200078581) in view of Kriheli (US 20180161245) and Burkholz (US 20170120028) as applied to claim 1 above, and further in view of Hyer et al. (US 20170120001 hereinafter “Hyer”).
Regarding Claim 3, the combination of Toh, Kriheli and Burkholz teaches all elements of claim 1 as described above. The combination further teaches the liquid medicine administration device wherein: the hollow needle (Kriheli 40) has: a first opening (Kriheli opening on proximal end of 40 towards 12) formed on a proximal side and communicating with the inside of the liquid medicine supply device (Kriheli 12), a second opening (56) formed on a distal side and communicating with the tube (with the modification done in claim 1, the port 56 would communication with tube 16 of Toh).
The combination of Toh and Kriheli does not specify intermediate opening that opens between the first opening and the second opening and communicates with the tube.
Hyer teaches (Fig 13a-13f) different embodiments of needles that include intermediate openings (1311, 1321, 1331, 1361; also see [0082]).
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 needle of Kriheli such that the needle includes an intermediate opening as taught by Hyder. One of ordinary skill in the art would recognize these are alternative needle designs well known in the art used to help achieve desired mechanical strength at the areas of the notch/opening (see Hyer [0082]).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toh et al. (US 20200078581 hereinafter “Toh”) in view of Kriheli (US 20180161245), Burkholz (US 20170120028) and Maseda et al. (US 20150320976 hereinafter “Maseda”).
Regarding Claim 5, Toh teaches (Figs 1a-1e and 3a-3b) a liquid medicine administration device comprising:
a needle unit (12) comprising:
a catheter (15),
an inner needle (68; see Fig 3B) passing through an inside of the catheter (15; see [0053]),
a hub (42) that holds a proximal end of the catheter (15), and
a liquid medicine supply device (20) comprising a container (24) configured to store a liquid medicine (26) inside;
a tube (16) configured to receive the liquid medicine (26) from the liquid medicine supply device (20), the tube having a distal end connected to the hub (See Fig 1a); and
a connector (18) to which are attachable the liquid medicine supply device (20), wherein:
the connector (18) comprises:
a valve body (34), the valve body being open during delivery of the liquid medicine or the priming solution to allow the container or the barrel to communicate with the tube (See [0040]).
Toh does not specify the connector comprising a hollow needle having a needle hole that is formed inside the hollow needle and that communicates with the tube, the hollow needle protruding toward the liquid medicine supply device or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device, and the valve being disposed distal to the hollow needle; and the connector comprises an uneven portion formed along an axial direction in an uneven shape on a surface that contacts the valve body
Kriheli teaches (Figs 5a-5b) a connector (14) that comprises a hollow needle (40; see [0010] teaching 40 is a liquid conduit) having a needle hole (56) that is formed inside the hollow needle and that communicates with the tube (See [0035] teaching that 56 is pushed through 34 creating an open fluid pathway), the hollow needle (40) protruding toward the liquid medicine supply device (12; see Fig 5b, 40 has a proximal end protruding towards 12) or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device (See [0011] teaching how 40 is in communication with the inertial of the syringe 12), and the valve (54, 34) being disposed distal to the hollow needle (40; see Figs 5a-5b); and the connector (14) comprises an uneven portion (distal portion of 14 surrounding 35) formed along an axial direction in an uneven shape on a surface that contacts the valve body (See Fig 5b, the connector has an uneven/protruded shape close to the surface 35 of the valve 54,34).
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 connector of Toh such that the connector comprises a hollow needle having a needle hole that is formed inside the hollow needle and that communicates with the tube, the hollow needle protruding toward the liquid medicine supply device or the priming solution delivery device so as to be freely communicable with the inside of the liquid medicine supply device or the inside of the priming solution delivery device, and the valve being disposed distal to the hollow needle; and the connector comprises an uneven portion formed along an axial direction in an uneven shape on a surface that contacts the valve body as taught by Kriheli. One of ordinary skill in the art would have been motivated to do so in order to provide a contamination free transfer of drugs (Kriheli [0005]).
The combination does not specify the connector attachable both (i) the liquid medicine supply device, and (ii) a syringe comprising a barrel configured to store a priming solution inside.
While Toh teaches [0034] that the adapter 18 could be connected to fluid storage 20 and that may be facilitating priming of catheter system 10. It does not specify two separate devices connecting to the connector.
Burkholz teaches (Fig 24) a connector (102) that is connected to two separate syringes barrels (2300, 2400). Burkholz also teaches [0040] that the system is provided for the infusion of medical fluid including saline solution and a liquid medication. It is interpreted that in the embodiment of Fig 24, one syringe 2300 could comprise a liquid medication and another syringe 2400 could comprise the saline solution.
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 connector of Toh such that it allows for the connection of two supply devices as taught by Burkholz. This would allow for the connector to be attachable to both a liquid medicine supply device and syringe comprising a barrel configured to store a priming solution inside. One of ordinary skill in the art would have been motivated to do so in order to deliver/provide first and second fluids intermittently or in combination for a patient via the output of the connector (Burkholz [0080]).
The combination does not specify the needle unit comprising a sealing body configured to affix the hub to a body surface.
Maseda teaches (Fig 1) a sealing body (110) configured to affix the hub (132) to a body surface (See [0051])
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 needle unit of Toh such that it includes a sealing body configured to affix the hub to a body surface as taught by Maseda. One of ordinary skill in the art would have been motivated to do so in order to prevent dislodging of the device from the patient due to any movement by the patient (Maseda [0051]).
Conclusion
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.
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, 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.
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.
/NEERAJA GOLLAMUDI/Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783