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 .
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract uses the phrase “The invention relates to” which is considered as an implied phrase. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
The reference characters should be used in a “Detailed description of invention” instead of “Brief Description of Drawings” (see MPEP 608.01).
Appropriate correction is required.
Claim Objections
Claims 9, 13, 17 and 19 are objected to because of the following informalities:
Regarding claim 9, line 1, the recitation “the first and the second sealed tray” appears to be amended to recite either “the first and second sealed trays” or “the first sealed tray and the second sealed tray” to correctly identify “a first sealed tray” and “a second sealed tray” previously recited in claim 1.
Regarding claim 13, last line the recitation “the first and the second sealed tray” appears to be amended to recite either “the first and second sealed trays” or “the first sealed tray and the second sealed tray” to correctly identify “a first sealed tray” and “a second sealed tray” previously recited in claim 13.
Regarding claim 17, line 1, the recitation “the first and the second sealed tray” appears to be amended to recite either “the first and second sealed trays” or “the first sealed tray and the second sealed tray” to correctly identify “a first sealed tray” and “a second sealed tray” previously recited in claim 13.
Regarding claim 19, line 10, the recitation “setup tra layer” appears to be amended to recite “setup tray layer” to correct the spelling error.
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 1-12, 15, 14 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.
Regarding claim 1, line 4, the recitation “a needle” renders the claim indefinite because the claim is unclear if “a needle” is a part of “at least one needle” recited in claim 1, line 3 or additional. For examination purposes, examiner construes “a needle” as being a part of “at least one needle”.
Claims 2-12 being dependent on claim 1 are also rejected.
Regarding claim 2, the recitation “the implanted pump is an intrathecal baclofen pump” renders the claim indefinite because the claim is unclear if “the implanted pump” is positively claimed as a part of the claimed invention. For examination purposes, examiner construes that “the implanted pump” is not positively claimed as a part of claimed invention and therefore, a kit is configured to be used for refilling an intrathecal baclofen pump.
Regarding claim 4, the recitation of “two 5 ml ampules” renders the claim indefinite because the claim is unclear if “two 5 ml ampules” refers to “at least one ampule” recited in claim 1 or additional. For examination purposes, examiner construes that “two 5 ml ampules” are part of “at least one ampule” recited in claim 1.
Regarding claim 5, the recitation of “one 20 ml ampule” renders the claim indefinite because the claim is unclear if “one 20 ml ampule” refers to “at least one ampule” recited in claim 1 or additional. For examination purposes, examiner construes that “one 20 ml ampule” are part of “at least one ampule” recited in claim 1.
Regarding claim 7, the recitation “two needles” renders the claim indefinite because the claim is unclear if “two needles” are part of “at least one needle” recited in claim 1 or additional. For examination purposes, examiner construes that “two needles” are part of “at least one needle”.
Regarding claim 15, the recitation “2 needles” renders the claim indefinite because the claim is unclear if “2 needles” are part of “at least one needle” recited in claim 13, line 3 or additional. For examination purposes, examiner construes that “2 needles” are part of “at least one needle” recited in claim 13, line 3.
Regarding claim 14, the recitation “the implanted pump is an intrathecal baclofen pump” renders the claim indefinite because the claim is unclear if “the implanted pump” is positively claimed as a part of the claimed invention. For examination purposes, examiner construes that “the implanted pump” is not positively claimed as a part of claimed invention and therefore, a kit is configured to be used for refilling an intrathecal baclofen pump.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 14 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim limitation “the implanted pump” is not positively claimed as a part of claimed invention and further recitation of “an intrathecal baclofen pump” does not impose any structural limitation on the claimed invention and therefore, claims 2 and 14 fails to further limit the scope of the claimed invention. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 2 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Massengale et al. (US 7,993,326 B2) in view of Mabold (US 2022/0409322 A1) and further in view of Scott et al. (US 6,832,703 B1).
Regarding claim 1, Massengale discloses a kit (figures 5 and 7, column 7, lines 52-56, a kit could be used for refilling an implanted pump) for refilling an implanted pump comprising:
a carton 12;
a first sealed tray 24 (sealed by elements 23 and 14) contained in the carton, the first tray 24 containing a drape 28;
at least one needle 66, 68, 89, a first syringe 86, 88, a needle 89, a filter 102 and clampable tubing 96; and
a second sealed tray 26 (sealed by elements 23 and 14) contained in the carton 12, the second tray 26 containing a second syringe 72, 74) at least one ampule of medication 80, 76, 78, and aspiration tubing 84, wherein the second sealed tray is molded to have a recess (recess in which elements 80, 76, 78 is present) that securely holds the at least one ampule 80, 76, 78 in both a horizontal position and in a vertical position (elements 80, 76, 78 could be hold in horizontal and vertical position by appropriately moving element 26 in horizontal and vertical position).
Massengale is silent regarding a drape being a fenestrated drape. However, Mabold teaches a design of a kit (figure 2) comprising a drape wherein the drape is a fenestrated drape 24 (figure 2) for the purpose of using a well-known alternative drape to create a sterile field over the patient (paragraph 0018, lines 15-17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the drape of Massengale to incorporate a fenestrated drape as taught by Mabold for the purpose of using a well-known alternative drape to create a sterile field over the patient (paragraph 0018, lines 15-17).
Massengale is silent regarding including an ampule opener.
However, Scott teaches a design of kit (figure 1) including an ampule opener 10 for the purpose of opening and accessing the contents inside the ampule in a safe and simple manner (column 2, lines 14-17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the kit to include the ampule opener as taught by Scott for the purpose of opening and accessing the contents inside the ampule in a safe and simple manner (column 2, lines 14-17).
Massengale discloses a single tray containing all the syringes and needles and therefore, Massengale is silent regarding the first tray containing at least one needle, a first syringe, a needle, a filter and clampable tubing and the second tray containing an ampule opener. However, according to MPEP 2144.04 (VI)(C), it is obvious for one of ordinary skill in the art to rearrange the components if the rearrangement does not change the mode of operation. Placing at least one needle, a first syringe, a needle, a filter and clampable tubing in the first tray and an ampule opener in the second tray does not change the operation of the device and would have a reasonable expectation of success in making such modification therefore, is construed as an obvious matter of design choice.
Regarding claim 2, Massengale discloses the implanted pump is an intrathecal baclofen pump (the kit of Massengale is capable to work with an intrathecal baclofen pump).
Regarding claim 6, Massengale discloses wherein the at least one needle is a 22 gauge needle (column 7, lines 31).
Regarding claim 7, Massengale discloses having two needles 66, 68 but does not explicitly state wherein the first sealed tray comprises two needles.
However, according to MPEP 2144.04 (VI)(C), it is obvious for one of ordinary skill in the art to rearrange the components if the rearrangement does not change the mode of operation. Placing two needles in the first tray does not change the operation of the device and would have a reasonable expectation of success in making such modification therefore, is construed as an obvious matter of design choice.
Claim(s) 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Massengale et al. (US 7,993,326 B2) in view of Mabold (US 2022/0409322 A1) in view of Scott et al. (US 6,832,703 B1) as applied to claim 1 above, and further in view of Wasan et al. (US 2022/0328198 A1).
Regarding claims 3-5, Massengale/Mabold/Scott (hereinafter referred as “modified Massengale”) discloses the claimed invention substantially as claimed, as set forth above in claim 1. Massengale further discloses the use of more than one ampoule and to have any other type of drugs (column 7, lines 49-51) but is silent regarding at least one ampule of medication is a 5 ml ampule comprising 2000 mcg/ml baclofen or two 5 ml ampules comprising 2000 mcg/ml baclofen or 20 ml ampule comprising 2000 mcg/ml baclofen.
However, Wasan teaches a system and method for training a treatment prediction model wherein Wasan teaches the use of 2000 mcg/ml baclofen (see table 6, under “specific medications/procedure orders” category corresponding to category “Pain Treatment Category”, “Baclofen 10,000 mcg/20 ml (500 mcg/ml), 40,000 mcg/20 ml (2,000 mcg/ml) intrathecal solution”) for the purpose of providing muscle relaxant medication as needed based on medication condition (see table 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the drug of at least one ampule of modified Massengale to incorporate 2000 mcg/ml baclofen as taught by Wasan for the purpose of providing muscle relaxant medication as needed based on medication condition (see table 6).
Modified Massengale and Wasan is silent regarding specifics of having at least one ampule of medication is 5 ml ampule or two 5 ml ampules or 20 ml ampule. There is no evidence of record that establishes that changing the number or volume of vial would result in a difference in function of the kit of modified Massengale. Further, a person having ordinary skill in the art, being faced with modifying the quantity and volume of ampules of modified Massengale would have a reasonable expectation of success in making such a modification and it appears the kit would function as intended being given the claimed quantity and volume. Lastly, applicant has not disclosed that the claimed range solves any stated problem, indicating that the quantity and volume of the ampules “may” be within the claimed range, and offering other acceptable ranges (specification at paragraph 0010) and therefore there appears to be no criticality placed on the range as claimed such that it produces an unexpected result.
Therefore, it would have been obvious having ordinary skill in the art before the effective filing date of the claimed invention to modify the quantity and volume of the ampules of modified Massengale to incorporate at least one ampule of medication is 5 ml ampule or two 5 ml ampules or 20 ml ampule as an obvious matter of design choice within the skill of the art.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Massengale et al. (US 7,993,326 B2) in view of Mabold (US 2022/0409322 A1) in view of Scott et al. (US 6,832,703 B1) as applied to claims 1 and 7 above, and further in view of Kapural (US 2017/0049989 A1).
Regarding claim 8, modified Massengale discloses the claimed invention substantially as claimed, as set forth above in claims 1 and 7. Massengale further discloses wherein one needle is 22 gauge needle with 1.5 inches and but is silent regarding second needle is 22 gauge needle with 2 inches.
However, Kapural teaches a design of a kit comprising a 22 gauge needle with 2 inches (paragraph 0065, lines 1-4) for the purpose of delivering drug subcutaneously under the skin (paragraph 0065, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the second needle of modified Massengale to incorporate 22 gauge needle with 2 inches as taught by Kapural for the purpose of delivering drug subcutaneously under the skin (paragraph 0065, lines 1-4). Thus, modified Massengale modified in view of Kapural will result in having two needles are 22 gauge needles with 1.5 inch and 2 inch length. One of ordinary skill in the art will be motivated to perform modification of modified Massengale in view of Kapural because Massengale discloses the use of additional number/size/diameters of the needles in addition to the disclosed number/size/diameter of the needles (column 7, lines 32-35 in Massengale) and Kapural further provides purpose for using the 22 gauge needle with 2 inches length.
Claim(s) 9-15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Massengale et al. (US 7,993,326 B2) in view of Mabold (US 2022/0409322 A1) in view of Scott et al. (US 6,832,703 B1) as applied to claim 1 above, and further in view of Garth (US 2,947,415).
Regarding claim 9, modified Massengale discloses the claimed invention substantially as claimed, as set forth above in claim 1. Massengale further discloses the first and second sealed trays are sealed with a film 14 but is silent regarding a film being a polyethylene-based film.
However, Garth teaches a medical procedure in packing a kit wherein the kit is sealed with a polyethylene based film (column 2, lines 15-16) for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Therefore, it would have been prima facie obvious to one of ordinary to modify the film of modified Massengale to incorporate a polyethylene based film as taught by Garth for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Regarding claim 10, modified Massengale discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Massengale is silent regarding wherein the polyethylene based film is compatible with commonly used sterilization methods selected from the group consisting of sterilization with ethylene oxide, gamma rays, and electron-beam.
However, Garth teaches wherein the polyethylene based film is compatible with commonly used sterilization methods selected from the group consisting of sterilization with ethylene oxide (column 2, lines 26-50), gamma rays, and electron-beam for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the film of modified Massengale to incorporate wherein the polyethylene based film is compatible with commonly used sterilization methods selected from the group consisting of sterilization with ethylene oxide, gamma rays, and electron-beam as taught by Garth for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Regarding claim 11, modified Massengale discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Massengale is silent regarding wherein the polyethylene based film is compatible to sterilization with ethylene dioxide.
However, Garth teaches wherein the polyethylene based film is compatible to sterilization with ethylene dioxide (column 2, lines 26-50, since Garth discloses that polyethylene based film is compatible to sterilization with ethylene dioxide, the polyethylene based film is compatible to sterilization with ethylene dioxide) for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the film of modified Massengale to incorporate wherein the polyethylene based film is compatible to sterilization with ethylene dioxide as taught by Garth for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Regarding claim 12, modified Massengale discloses the claimed invention substantially as claimed, as set forth above in claim 1. Modified Massengale is silent regarding wherein the first tray and the second tray are sterilized after sealing such that the ampule, the first syringe, and the second syringe remain sterile during refilling of the implanted pump.
However, Garth teaches wherein the medical kit is sterilized after sealing such that the medical kit remain sterile during the medical procedure (column 2, lines 26-50) for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the sterilizing of the first tray and the second tray of modified Massengale to incorporate sterilizing after sealing as taught by Garth for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50). Thus, modified Massengale modified in view of Garth will result in having wherein the first tray and the second tray are sterilized after sealing such that the ampule, the first syringe, and the second syringe remain sterile during refilling of the implanted pump.
Regarding claim 13, Massengale discloses a kit (figures 5 and 7, column 7, lines 52-56, a kit could be used for refilling an implanted pump) for refilling an implanted pump comprising:
a carton 12;
a first sealed tray 24 (sealed by elements 23 and 14) contained in the carton, the first tray 24 containing a drape 28;
at least one needle 66, 68, 89, a first syringe 86, 88, a filter 102 and clampable tubing 96; and
a second sealed tray 26 (sealed by elements 23 and 14) contained in the carton 12, the second tray 26 containing a second syringe 72, 74) at least one ampule of medication 80, 76, 78, and aspiration tubing 84.
Massengale is silent regarding a drape being a fenestrated drape. However, Mabold teaches a design of a kit (figure 2) comprising a drape wherein the drape is a fenestrated drape 24 (figure 2) for the purpose of using a well-known alternative drape to create a sterile field over the patient (paragraph 0018, lines 15-17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, to modify the drape of Massengale to incorporate a fenestrated drape as taught by Mabold for the purpose of using a well-known alternative drape to create a sterile field over the patient (paragraph 0018, lines 15-17).
Massengale is silent regarding including an ampule opener.
However, Scott teaches a design of kit (figure 1) including an ampule opener 10 for the purpose of opening and accessing the contents inside the ampule in a safe and simple manner (column 2, lines 14-17).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the kit to include the ampule opener as taught by Scott for the purpose of opening and accessing the contents inside the ampule in a safe and simple manner (column 2, lines 14-17).
Massengale discloses a single tray containing all the syringes and needles and therefore, Massengale is silent regarding the first tray containing at least one needle, a first syringe, a needle, a filter and clampable tubing and the second tray containing an ampule opener. However, according to MPEP 2144.04 (VI)(C), it is obvious for one of ordinary skill in the art to rearrange the components if the rearrangement does not change the mode of operation. Placing at least one needle, a first syringe, a needle, a filter and clampable tubing in the first tray and an ampule opener in the second tray does not change the operation of the device and would have a reasonable expectation of success in making such modification therefore, is construed as an obvious matter of design choice.
Massengale is silent regarding wherein each of the first and the second sealed tray is sterilized after sealing.
However, Garth teaches wherein the medical kit is sterilized after sealing (column 2, lines 26-50) for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the sterilizing of the first tray and the second tray of Massengale to incorporate sterilizing after sealing as taught by Garth for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50). Thus, Massengale modified in view of Garth will result in having wherein the first tray and the second tray are sterilized after sealing.
Regarding claim 14, Massengale discloses the implanted pump is an intrathecal baclofen pump (the kit of Massengale is capable to work with an intrathecal baclofen pump).
Regarding claim 15, Massengale discloses 2 needles 66, 68 but does not explicitly state wherein the first sealed tray comprises 2 needles.
However, according to MPEP 2144.04 (VI)(C), it is obvious for one of ordinary skill in the art to rearrange the components if the rearrangement does not change the mode of operation. Placing two needles in the first tray does not change the operation of the device and therefore, is construed as an obvious matter of design choice.
Regarding claim 17, Massengale discloses the first and second sealed trays are sealed with a film 14 but is silent regarding a film being a polyethylene-based film.
However, Garth teaches a medical procedure in packing a kit wherein the kit is sealed with a polyethylene based film (column 2, lines 15-16) for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Therefore, it would have been prima facie obvious to one of ordinary to modify the film of Massengale to incorporate a polyethylene based film as taught by Garth for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Regarding claim 18, Massengale is silent regarding wherein the polyethylene based film is compatible to sterilization with ethylene dioxide.
However, Garth teaches wherein the polyethylene based film is compatible to sterilization with ethylene dioxide (column 2, lines 26-50, since Garth discloses that polyethylene based film is compatible to sterilization with ethylene dioxide, the polyethylene based film is compatible to sterilization with ethylene dioxide) for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing of the claimed invention to modify the film of Massengale to incorporate wherein the polyethylene based film is compatible to sterilization with ethylene dioxide as taught by Garth for the purpose of sterilizing the medical kit after packing the medical kit (column 2, lines 26-50).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Massengale et al. (US 7,993,326 B2) in view of Mabold (US 2022/0409322 A1) in view of Scott et al. (US 6,832,703 B1) in view of Garth (US 2,947,415) as applied to claims 13 and 15 above, and further in view of Kapural (US 2017/0049989 A1).
Regarding claim 16, modified Massengale/Garth (hereinafter referred as “modified Massengale ‘26”) discloses the claimed invention substantially as claimed, as set forth above in claims 13 and 15. Massengale further discloses wherein one needle is 22 gauge needle with 1.5 inches and but is silent regarding second needle is 22 gauge needle with 2 inches.
However, Kapural teaches a design of a kit comprising a 22 gauge needle with 2 inches (paragraph 0065, lines 1-4) for the purpose of delivering drug subcutaneously under the skin (paragraph 0065, lines 1-4).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the second needle of modified Massengale to incorporate 22 gauge needle with 2 inches as taught by Kapural for the purpose of delivering drug subcutaneously under the skin (paragraph 0065, lines 1-4). Thus, modified Massengale ‘26 modified in view of Kapural will result in having two needles are 22 gauge needles with 1.5 inch and 2 inch length. One of ordinary skill in the art will be motivated to perform modification of modified Massengale in view of Kapural because Massengale discloses the use of additional number/size/diameters of the needles in addition to the disclosed number/size/diameter of the needles (column 7, lines 32-35 in Massengale) and Kapural further provides purpose for using the 22 gauge needle with 2 inches length.
Allowable Subject Matter
Claim 19 would be allowable if rewritten in independent form to overcome each and every objections placed in the current Office Action.
The closest prior art of record, Massengale et al. (US 7,993,326 B2) in view of Mabold (US 2022/0409322 A1) in view of Scott et al. (US 6,832,703 B1) in view of Kapural (US 2017/0049989 A1) discloses a kit to facilitate easy, efficient and sterile refilling of baclofen wherein the sealed setup tray comprises layers including a fenestrated drape, a syringe, a needle, clampable tubing, gauze pad or a gauze roll but is silent regarding the exact order as claimed in claim 19.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NILAY J SHAH whose telephone number is (571)272-9689. The examiner can normally be reached Monday-Thursday 8:00 AM-4:30 PM EST.
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/NILAY J SHAH/Primary Examiner, Art Unit 3783