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
Claims 1, 2, 4, 5, 6, 8, 9 and 15 is objected to due to the following informalities:
In claim 1, line 5-6, “longitudinally extending along a longitudinal direction of extension” should be corrected to “
In claim 1, lines 7, 8, 10, 11 and 13, “the fluid line” should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 1, line 9, “said fluid line” should be corrected to “said flexibly deformable fluid line” for claim language consistency.
In claim 2, line 3, “the fluid line” should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 2, lines 4 and 5, “the longitudinal direction of extension” should be corrected to “the longitudinal direction” in light of the suggestion made for claim 1.
In claim 4, line 3, “the fluid line” should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 5, line 3, “the fluid line” for both occurrences should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 6, line 2, “the fluid line” for both occurrences should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 8, line 2, “the fluid line” for both occurrences should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 9, line 4, “the fluid line” for both occurrences should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 15, lines 5, 7, 9, 10 and 12, “the fluid line” for both occurrences should be corrected to “the flexibly deformable fluid line” for claim language consistency.
In claim 15, lines 5-6, “longitudinally extending along a longitudinal direction of extension” should be corrected to “
In claim 15, line 10, “said fluid line” should be corrected to “said flexibly deformable fluid line” for claim language consistency.
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(s) 1-16 is/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 1, line 7 recites “a pumping mechanism configured to interact with the fluid line” and line 8 recites “the pumping mechanism being configured to act onto the fluid line”. It is unclear if the “interact” of line 7 and “act” of line 8 are intended to refer to the same action or introduce two different actions. For the sake of examination, it is being interpreted that the “interact” of line 7 and “act” of line 8 are intended to refer to the same action. Therefore, Applicant is suggested to amend claim 1 to recite “a pumping mechanism configured to interact with the fluid line,
Claim 1, line 10 recites “a fixation of a longitudinal portion of the fluid line”. The term “fixation” can be interpreted as action being performed by the infusion device. However, line 9 recites the term “and” at the end and imply that the “fixation” is a structure since the claim recites in lines 1-2 “an infusion device……comprising” followed by “a housing” in line 3, “a receptacle” in line 4 and “a pumping mechanism” in line 7. Therefore it is unclear whether “fixation” in line 10 refers to an action being performed by the infusion device or a structure of the infusion device. For the sake of examination, based on claims 3 and 4, it can be interpreted that “a fixation” in line 10 is intended to refer to an action being performed by the infusion device. Therefore, Applicant is suggested to amend claim 1 by adding the term “and” at the end of line 6, removing the term “and” from the end of line 9, and further amend claim 1 to recite “wherein the infusion device is configured to provide a fixation of a longitudinal portion of the fluid line”.
Claim 1, line 11 recites “an operative state”. However, it is unclear if this operative state is for the infusion device, the fluid line or the housing section, since the placing of this term after the fluid line and the housing section makes this term ambiguous. In light of the Specification, the Examiner is interpreting the operative state of line 11 as being referred to as “an operative state” of the infusion device. Therefore, Applicant is suggested to amend claim 1 to recite “an operative state of the infusion device” to overcome rejection.
Claims 2-14 are rejected by virtue of their dependency on claim 1.
In claim 15, lines 8-9 recites “a pumping mechanism of the infusion device configured to interact with the fluid line” and lines 9-10 recites “the pumping mechanism being configured to act with the fluid line for causing a fluid flow” and therefore suffers from the same issues as claim 1. Therefore, Applicant is suggested to amend claim 15 to recite “a pumping mechanism of the infusion device configured to interact with the fluid line,
Claim 15, line 14 recites “an operative state”. However, it is unclear if this operative state is for the infusion device, the fluid line or the housing section and therefore suffers from the same issues as claim 1. Applicant is suggested to amend claim 15 to recite “an operative state of the infusion device” to overcome rejection.
Claim 16, is directed to an infusion line for use in the infusion device of claim 4, and therefore claim 16 can be interpreted to be directed to “an infusion line” only and does not include any components of “the infusion device” of claim 4. However claim 4 sets forth that “the fixation device” is a part of the “infusion device”, and claim 16, recites “the infusion line comprises the fluid line and, at least in part, the fixation member”. It is unclear how “the fixation member” is a part of the “infusion line” as set forth by claim 16, if “the fixation member” is already a part of the “infusion device” as set forth by claim 4, when the “infusion line” itself is not a part of the “infusion device”. Applicant is therefore suggested to amend claim 16 to overcome rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Meng et al. (US 20220133994 A1, herein Meng).
Regarding claim 1, Meng discloses an infusion device (infusion pump 22 in Fig. 2) for administering a medical fluid (medical fluid administration [0023]) to a patient (infusion pump pumping the contents of the fluid supply to a patient [0010]; fluid is acted upon by the pump to move fluid downstream to the patient [0024]), comprising:
a housing (body 27 in Fig. 2) having a housing section (see housing section annotated Fig. 2 below),
a receptacle (gap 54 in Fig. 2) arranged on the housing for receiving (medical tubing 66 is seen disposed in gap 54 in Fig. 2) a flexibly deformable fluid line (medical tubing 66 in Fig. 2; the medical tubing may be formed from any suitable material, e.g., soft PVC [0029]; it can be interpreted that the medical tubing made of soft PVC can be configured to be flexible and deformable) longitudinally extending along a longitudinal direction of extension (medical tubing 66 extending longitudinally between fluid line 30 and 31 in Fig. 2), and
a pumping mechanism (pumping mechanism 70 in Fig. 2) configured to interact with the fluid line (pumping mechanism 70 acts as the flow control device of the pump to move fluid though the conduit [0024]), the pumping mechanism being configured to act onto the fluid line for causing a fluid flow through said fluid line (pumping mechanism 70 acts as the flow control device of the pump to move fluid though the conduit [0024]), and
a fixation of a longitudinal portion of the fluid line (longitudinal portion of tubing 66 in contact with backing surface 120 in Fig. 4, the backing surface 120 and the tubing 66 keeps the tubing 66 from being pulled out of position (e.g., out of gap 54) [0037]; it is set forth in [0013] that Fig. 4 is an illustration of pump cycle of Fig. 2) with respect to the housing section in an operative state (an infusion pump 22 having a body 27 is shown in perspective view with the front door 50 open, showing the upstream fluid line 30 and downstream fluid line 31 in operative engagement with the pump 22 [0024]) in which the fluid line is received in the receptacle (medical tubing 66 is seen disposed into gap 54 in Fig. 2) for interacting with the pumping mechanism (pumping mechanism 70 acts as the flow control device of the pump to move fluid though the conduit [0024]) to hold the longitudinal portion of the fluid line in place with respect to the housing section (the medical tubing 66 is constrained within a gap 54 [0029]).
PNG
media_image1.png
721
681
media_image1.png
Greyscale
Annotated Fig. 2 of Meng
Regarding claim 2, Meng disclosed all limitations of claim 1. Meng further discloses wherein the fixation is configured to hold the longitudinal portion of the fluid line in place with respect to the housing section along the longitudinal direction of extension and/or along a direction transverse to the longitudinal direction of extension (longitudinal portion of tubing 66 in contact with backing surface 120 in Fig. 4, the backing surface 120 and the tubing 66 keeps the tubing 66 from being pulled out of position (e.g., out of gap 54) [0037]).
Regarding claim 3, Meng disclosed all limitation of claim 1. Meng further discloses wherein said fixation is established by a gluing connection (a rigid tubing interface 130 may be bound to the tubing 66 with an adhesive 135 attached to the backing surface 120 to immobilize movement of the tubing 66 during pumping cycles [0042]; see also Fig. 6).
Regarding claim 4, Meng disclosed all limitations of claim 1. Meng further discloses further comprising a fixation member (backing surface 120 in Fig. 6) for establishing said fixation of the longitudinal portion of the fluid line with respect to the housing section (a rigid tubing interface 130 may be bound to the tubing 66 with an adhesive 135 attached to the backing surface 120 to immobilize movement of the tubing 66 during pumping cycles [0042]).
Regarding claim 5, Meng disclosed all limitations of claim 4. Meng further discloses wherein the fixation member is fixedly connected to a wall section of the fluid line (backing surface 120 connected to wall of tubing 66 via tubing interface 130 in Fig. 6) along said longitudinal portion of the fluid line (backing surface 120 is seen connected to longitudinal portion of tubing 66 in Fig. 4) such that the wall section is held in place with respect to the housing section in said operative state (a rigid tubing interface 130 may be bound to the tubing 66 with an adhesive 135 attached to the backing surface 120 to immobilize movement of the tubing 66 during pumping cycles [0042]; it can be interpreted that the wall section of tubing 66 is also immobilized from movement since tubing 66 is being immobilized by backing surface 120).
Regarding claim 6, Meng disclosed all limitation of claim 5. Meng further discloses wherein said longitudinal portion of the fluid line comprises a length (see length in annotated Fig. 4 below) measured along the longitudinal direction of extension, wherein the fixation member is fixedly connected to said wall section by means of a connection (binding contact interface 110 in Fig. 4; it is set forth in [0042] that 110 is rigid tubing interface 130) formed along said length (binding contact surface 110 runs along the length of longitudinal portion in Fig. 4).
PNG
media_image2.png
371
555
media_image2.png
Greyscale
Annotated Fig. 4 of Meng
Regarding claim 7, Meng disclosed all limitations of claim 6. Meng further discloses wherein the connection formed along said length is formed by a gluing connection, a welding connection, a positive-fit connection, or a force-fit connection (a rigid tubing interface 130 may be bound to the tubing 66 with and adhesive 135 attached to the backing surface 120 to immobilize movement of the tubing 66 during pumping cycles [0042]).
Regarding claim 8, Meng disclosed all limitations of claim 4. Meng further discloses wherein the fluid line comprises a connection element (rigid tubing interface 130 in Fig. 6) connected to said longitudinal portion (binding contact interface 110 in contact with longitudinal portion of tubing 66 in Fig. 4; it is set forth in [0042] that 110 is rigid tubing interface 130) and engaging with the fixation member (rigid tubing interface 130 in connection with backing surface 120 in Fig. 6) for forming a positive-fit connection between the longitudinal portion and the fixation member (tubing 66 is seen in Fig. 6 to have a positive-fit connection with rigid tubing interface 130, and therefore can be interpreted to have a positive-fit connection with backing surface 120 via rigid tubing interface 130).
Regarding claim 9, Meng disclosed all limitations of claim 4. Meng further discloses wherein the fixation member is formed by a rigid member extending longitudinally along said longitudinal portion of the fluid line (backing surface 120 is seen as a rectangular object extending longitudinally along the tubing 66 in Fig. 4).
Regarding claim 10, Meng disclosed all limitations of claim 9. Meng further discloses wherein said rigid member is formed by a bar element (backing surface 120 is seen to have a rectangular side in Fig. 4, and a rectangular face in Fig. 6, therefore it can be interpreted that the backing surface 120 has a bar shape) to be received in a fixation receptacle (gap 54 in Fig. 2) of said housing section for fixing the bar element to said housing section (the backing surface 120 and the tubing 66 keeps the tubing 66 from being pulled out of position (e.g., out of gap 54) [0037]).
Regarding claim 11, Meng disclosed all limitations of claim 4. Meng further discloses wherein the fixation member comprises a connection face (see connection face in annotated Fig. 6 below) to which said longitudinal portion is connected (the connection face in annotated Fig. 6 can be interpreted to be in connection with the longitudinal portion of tubing 66 in Fig. 4, since it is set forth in [0042] that 110 is rigid tubing interface 130).
PNG
media_image3.png
511
352
media_image3.png
Greyscale
Annotated Fig. 6 of Meng
Regarding claim 12, Meng disclosed all limitations of claim 11. Meng further discloses wherein the fixation member comprises at least one bounding element (see bounding element annotated Fig. 6 above) protruding with respect to said connection face (bounding elements in annotated Fig. 6 can be interpreted to protrude from connection face) and bounding said connection face when viewed in a direction transverse to the longitudinal direction of extension (connection face is bounded to tubing 66 in transverse direction from the longitudinal direction in Fig. 6).
Regarding claim 13, Meng disclosed all limitations of claim 1. Meng further discloses wherein the housing comprises a closure element (front door 50 in Fig. 2) which is pivotable (it can be interpreted from annotated Fig. 2 above that the front door 50 is hinged to the front face of body 27, and therefore pivotable) with respect to a front face (see front face annotated Fig. 2 above) of the housing, the closure element forming said housing section (it can be interpreted from the annotated Fig. 2 that the projections on the back face of front door 50 fits into the housing section, therefore forming the shape for the housing section).
Regarding claim 14, wherein the receptacle is formed on the front face (gap 54 is located on front face in annotated Fig. 2 above) for receiving the fluid line between the front face and the closure element (the medical tubing 66 is compressed when the pump door 50 is closed. With the pump door 50 closed, the medical tubing 66 is constrained within a gap 54 [0029]).
Regarding claim 15, Meng discloses a method (medication delivery process 22c in Fig. 4) for setting up an infusion operation using an infusion device (infusion pump 22 in Fig. 2) for administering a medical fluid (medical fluid administration [0023]) to a patient (infusion pump pumping the contents of the fluid supply to a patient [0010]; fluid is acted upon by the pump to move fluid downstream to the patient [0024]), comprising:
arranging a flexibly deformable fluid line (medical tubing 66 in Fig. 2; the medical tubing may be formed from any suitable material, e.g., soft PVC [0029]; it can be interpreted that the medical tubing made of soft PVC can be configured to be flexible and deformable) in a receptacle (gap 54 in Fig. 2; medical tubing 66 is seen disposed in gap 54 in Fig. 2) arranged on a housing of the infusion device (body 27 in Fig. 2; gap 54 is seen located on body 27 in Fig. 2), the fluid line (2) longitudinally extending along a longitudinal direction of extension (medical tubing 66 extending longitudinally between fluid line 30 and 31 in Fig. 2); and
by arranging the fluid line in said receptacle, bringing the fluid line in
operative connection with a pumping mechanism of the infusion device (pumping mechanism 70 in Fig. 2;) configured to interact with the fluid line (pumping mechanism 70 acts as the flow control device of the pump to move fluid though the conduit [0024]), the pumping mechanism being configured to act onto the fluid line (pumping mechanism 70 acts as the flow control device of the pump to move fluid though the conduit [0024]) for causing a fluid flow through said fluid line (fluid is drawn from a fluid supply 38 through the tubing 66 in a fluid flow FF [0030]; see also fluid flow FF in Fig. 4); and
fixing a longitudinal portion of the fluid line (longitudinal portion of tubing 66 in contact with backing surface 120 in Fig. 4, the backing surface 120 and the tubing 66 keeps the tubing 66 from being pulled out of position (e.g., out of gap 54) [0037]; it is set forth in [0013] that Fig. 4 is an illustration of pump cycle of Fig. 2) with respect to a housing section (see housing section annotated Fig. 2 above) of the housing such that the longitudinal portion is held in place with respect to the housing section (longitudinal portion of tubing 66 in contact with backing surface 120 in Fig. 4, the backing surface 120 and the tubing 66 keeps the tubing 66 from being pulled out of position (e.g., out of gap 54) [0037]) in an operative state
(an infusion pump 22 having a body 27 is shown in perspective view with the front door 50 open, showing the upstream fluid line 30 and downstream fluid line 31 in operative engagement with the pump 22 [0024]) in which the fluid line is received in the receptacle (medical tubing 66 is seen disposed in gap 54 in Fig. 2) for interacting with the pumping mechanism (pumping mechanism 70 acts as the flow control device of the pump to move fluid though the conduit [0024]).
Regarding claim 16, Meng discloses an infusion line (it can be interpreted from Fig. 2 that fluid line 30 and 31 forms an infusion line with tubing 66) for conveying a medical fluid (pump 22 may deliver medication or nutrients or other medical fluids into a patient's body in controlled amounts [0029]) for use in an infusion device (infusion pump 22 in Fig. 2) according to one claim 4 (see rejection of claim 4 above) wherein the infusion line comprises the fluid line (tubing 66 is located between fluid line 30 and 31 in Fig. 2) and, at least in part, the fixation member (it can be interpreted that since backing surface 120 is fixed to tubing 66, backing surface 120 is also located between fluid line 30 and 31).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure:
US 20030181866 A1 (Abrahamson et al.) – drawn to an infusion pump with a surface defined on the door to limit movement of tube.
US 12036385 B2 (Slaby et al.) – drawn to an infusion pump with a tube port for receiving an IV tube.
US 20190351138 A1 (Bhandar et al.) – drawn to an infusion pump with a tube guide.
US 20190328963 A1 (Wolff et al.) – drawn to an infusion device with a pump module and delivery line.
US 20180250468 A1 (Paoli et al.) – drawn to an infusion device with a pump module.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAHMOOD FAROOQ whose telephone number is (571)272-7276. The examiner can normally be reached Monday-Friday: 7:30-5:00p EST. 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.
/M.F./Patent Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
Prosecution Insights