DETAILED ACTION 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 Interpretation In claim 1 , the limitation “ an opening in the permanent tube to receive a distal catheter portion that extends into the sleeve, such that the inner lumen of the permanent tube is fluidly connected to a distal inner lumen of the distal catheter portion ” appears to recite the structure of “a distal catheter portion” first in terms of intended use (“ an opening in the permanent tube to receive a distal catheter portion ”), but subsequently positively recites the same structure as interacting with the permanent tube portion (“ the inner lumen of the permanent tube is fluidly connected to a distal inner lumen of the distal catheter portion ”). The examiner’s best reasonable interpretation of the above cited limitation, in view of the specification, is to interpret the phrase “to receive” as meaning “configured to receive” (i.e. having the necessary structure, programming, etc. to perform the receiving function described). As such, both the limitation “a distal catheter portion that extends into the sleeve” and the remainder of the above cited limitation following “such that” are interpreted as part of the claimed receiving function which the permanent tube must be configured to perform. In claims 10 and 20, the directional terms “horizontally” and “vertically” are provided without any system of reference with which to define these directions other than to each other. As such, these terms are interpreted as merely meaning that the permanent tube or permanent catheter portion is in some manner provided in a direction approximately perpendicular to the direction in which the replaceable distal catheter portion is provided. 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. Claims 18 and 19 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 claims 18 and 19 , each comprises the limitation “the medication outlets”, however this limitation lacks antecedent basis within these claims or within claim 14, upon which these claims depend, thereby rendering the claims indefinite in scope. Claim 14 introduces “at least one medication outlet provided in the distal inner lumen”, however this limitation may refer to a single medication outlet only. It is thus unclear whether “the medication outlets” of claims 18 and 19 refers to the “at least one medication outlet”, which may comprise only one outlet or more, or whether “the medication outlets” refers to different medication outlets entirely. Appropriate clarification is required. For example, the limitation “wherein the at least one medication outlet is at least two medication outlets ” would suffice to eliminate the described ambiguity. For examination purposes, the claims are interpreted as requiring that the at least one medication outlet is at least two medication outlets , as appears to be consistent with the context of the claims and specification. 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. Claim 16 is 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. Specifically, claim 16 recites subject matter (“ providing the sleeve with an outer coating that is at least one of: non-inflammatory or preventative of foreign body response ”) identical to subject matter already claimed in claim 14, upon which claim 16 depends (“ providing a permanent catheter portion in a body, the permanent catheter portion including … a sleeve attached to the permanent tube, the sleeve having outer coating that is at least one of: non- inflammatory or preventative of foreign body response ”) . 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 § 101 Section 33(a) of the America Invents Act reads as follows: Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism. Claim 10 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability , 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). Claim 10 includes the limitations “wherein the permanent tube is provided … in a subcutaneous region of a body” and “the replaceable distal catheter portion is provided … in a peritoneal cavity of the body.” When interpreted in context of the specification (wherein “a body” refers to the body of a human organism), it is clear that t hese limitations positively recite portions of a human organism as being integral to the claimed apparatus. Applicant(s) may overcome this rejection by instead using language such as “adapted to” or “configured to” in describing the placement of the apparatus within the human body. For example, “the permanent tube is configured to be provided in a peritoneal cavity of the body.” 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 3-6 are rejected under 35 U.S.C. 103 as being unpatentable over Regittnig ( U.S. Pat. Pub. No. 2008/0234563 A1 ) in view of Joseph ( U.S. Pat. Pub. No. 2018/0207356 A1 ). Regarding claim 1 , Regittnig discloses a permanent catheter portion (embodiment of Fig. 8A-8B) for use in an implanted delivery device for subcutaneous insulin infusion ( indwelling catheter device 5 – see Fig. 8A-8B and [0002], [0031], [0034], [0079], and [0084] ) , including: a permanent tube ( attachment element 16 ) with an inner lumen ( see Fig. 6A-6B and 8A-8B, [0045-0046], [0082], ln 1-18, and [0084], wherein an inner lumen extends from a supply tube, depicted as tube 13 in Fig. 6B, to the central cavity 17 of the permanent tube ) ; a sleeve ( porous tube 15 ) attached to the permanent tube ( see Fig. 8A-8B, [0045], [0052], and [0084] ) ; and an opening (hole 26) in the permanent tube configured to receive a distal catheter portion that extends into the sleeve (see Fig. 8A-8B, [0049-0050], and [0084]) , such that the inner lumen of the permanent tube is configured to be fluidly connected to a distal inner lumen of the distal catheter portion ( see Fig. 6A-6B, 8A-8B, [0045-0046], [0082], ln 1-18, and [0084], wherein the inner lumen of the permanent tube is configured to fluidly connect a distal inner lumen 17 of an appropriately configured distal catheter portion, depicted as tube 19 in Fig. 6B and needle 20 in Fig. 8A-8B, with the supply tube, depicted as tube 13 in Fig. 6B ) . Regittnig teaches that the sleeve may be porous, allowing fluid flow therethrough in order to thereby permit insulin that is infused through the distal catheter portion to spread into surrounding subcutaneous tissue ( [0034] and [0045], ln 12-29). Regittnig fails to teach that the sleeve ha s an outer coating that is at least one of: non-inflammatory or preventative of foreign body response. Joseph exhibits an indwelling catheter device for subcutaneous insulin infusion similar to that of Regittnig (see Fig. 1-32 , [0010-0011], and [0057] ), wherein a tube (cannula) for delivering insulin to the patient is implanted within the subcutaneous portion of a body in the same manner to the sleeve and distal catheter portion of Regittnig ( see Fig. 1-32, [0010-0011], and [0057] ) . Joseph teaches that the implantation of such a tube often leads to inflammation of the surrounding tissue, which can act as a mechanical barrier to the absorption of insulin within the tissue ([0006]). To counter such effects, Joseph teaches that such a tube may comprise an outer coating comprising a variety of materials that are non-inflammatory or preventative of foreign body response ( [0112] ), in order to minimize acute immune response (inflammation, foreign body response) to the implanted tube, and thereby increase the rate and precision of insulin absorption achievable by the indwelling catheter device ( [0006] and [0112], ln 16-26). Based on the teachings of Joseph and the intent of Regittnig – to provide an effective i ndwelling catheter device for subcutaneous insulin infusion ([0033]) – it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sleeve of Regittnig to have an outer coating according to a configuration taught by Joseph, such that the outer coating is either non-inflammatory , preventative of foreign body response , or both, in order to minimize acute immune response (inflammation, foreign body response) to the implanted sleeve and distal catheter portion, and thereby increase the rate and precision of insulin absorption achievable by the indwelling catheter device, as described by Joseph ([0006] and [0112], ln 16-26). Regarding claim 3, Joseph further teaches that the outer coating may be dexamethasone ( [0112], ln 10 ). Because an outer coating according to a configuration taught by Joseph is incorporated into the sleeve of Regittnig in the above combination, it follows that the proposed combination also exhibit s that the outer coating may be dexamethasone . Regarding claim 4, Joseph further teaches that the outer coating may be both non-inflammatory and preventative of foreign body response ( see [0112], ln 1-10, wherein the outer coating may comprise dexamethasone, which is described in [0112], ln 1-10, as well as in applicant(s) specification, pg. 3, ln 24-30 and pg. 13, ln 1-2 , as being both non-inflammatory and preventative of foreign body response ) . Because an outer coating according to a configuration taught by Joseph is incorporated into the sleeve of Regittnig in the above combination, it follows that the proposed combination also exhibit s that the outer coating may comprise dexamethasone , and thus be both non-inflammatory and preventative of foreign body response . Regarding claim 5, Regittnig further discloses that the sleeve does not allow cells to pass through it, but does allow proteins and smaller molecules to pass through it ( [0025] and [0036], wherein the pore size of the sleeve may be selected within a range, including pores smaller than the dimensions of cells, based upon the intended substances which art to pass through the sleeve, and see [0034] and [0045], wherein the desired substances – insulin contained within the infused liquid medication and glucose contained within tissue or blood plasma – are smaller than the dimensions of a cell ) . Regarding claim 6, Regittnig further discloses that sleeve allows both insulin and glucose to pass through it ( [0033-0034] and [0045] ) . Claim(s) 2, 7-9, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Regittnig as modified by Joseph according to claim 1, and in further view of Regittnig ‘622 (U.S. Pat. Pub. No. 2009/0312622 A1). Regarding claim 2, Regittnig as modified by Joseph according to claim 1 exhibits the permanent catheter portion of claim 1. In the embodiment of Fig. 8A-8B, Regittnig further discloses a hollow needle (20) which is clearly retractable from the permanent tube (attachment element 16) and sleeve (porous tube 15), and thus is replaceable independently of the permanent tube and sleeve (see Fig. 8A-8B and [0084]), and which forms a distal catheter portion ( here, Merriam Webster defines a catheter as “ a tubular medical device for insertion into body cavities usually to permit injection or withdrawal of fluids ” , such being an accurate description of the hollow needle 20 as used in Fig. 8B of Regittnig ) , including: a distal inner lumen ( cavity 17 ) ; at least one medication outlet ( hole 24 ) provided in the distal inner lumen ( see Fig. 8A-8B and [0084] ) ; wherein the replaceable distal catheter portion is inserted within the opening and the sleeve of the permanent catheter portion, such as to form a closed connection between the inner lumen of the permanent tube and the distal inner lumen ( see Fig. 8A-8B and [0084], wherein the hollow needle 20 is inserted within the opening and the sleeve , and then retracted slightly to align an opening in the side of the needle with the inner lumen of the permanent tube, thus f orm ing a closed connection between the inner lumen of the permanent tube and the distal inner lumen ) . Regittnig further teaches that tissue fluid is withdrawn from the subcutaneous tissue into which the indwelling catheter device is implanted by passing through the sleeve (porous tube 15) and into a drain line (12) (see Fig. 6A-6C, [0045], and [0082]) , whereupon it is fed into an external device which comprises a glucose sensor (35) and a calibrating electrical conductivity measurement sensor (46) for determining the quantity of glucose present in the subcutaneous tissue, thereby enabling a system comprising both the external device and the indwelling catheter device to regulate insulin delivery according to measured glucose concentration ( see Fig. 12, [0059] , and [ 0088 ]). Regittnig , however, fails to teach that at least one chemical sensor may be provided in the distal inner lumen of the distal catheter portion . Regittnig ‘622 exhibits an indwelling catheter device configured for subcutaneous insulin infusion similar to that of Regittnig ( see Fig. 5A-9C and [0127-0135] ), wherein the indwelling catheter device comprises a distal catheter portion ( cannula 22 ) configured to be implanted within the subcutaneous region of a body and comprising a distal inner lumen ( fluidic channel 3 ) configured for introducing insulin into the subcutaneous region of the body in a similar manner to that of Regittnig ( see Fig. 5A-9C, [0034], and [0127-0135] ) . Like Regittnig, the indwelling catheter device of Regittnig ‘622 may also be incorporated into a system to regulate insulin delivery according to measured glucose concentration ([0034-0062]). Regittnig ‘622 , however, teaches that a glucose sensor (7) and a calibrating electrical conductivity measurement sensor (5) may be provided in the distal inner lumen ( Fig. 7A- 7C , [0054-005 5 ], and [0131-013 2 ]) , rather than within an external device, as is done in Regittnig, in order to thereby enable the insulin pump/infusion system to be implemented in a smaller, more efficient, and cheaper manner ( [0052-0056] ). Based on the teachings of Regittnig ‘622 , it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the replaceable distal catheter portion of Regittnig ‘622 to include a glucose sensor and a calibrating electrical conductivity measurement sensor provided in the distal inner lumen of the distal catheter portion, as taught by Regittnig ‘622, rather than external sensors, in order to thereby enable the insulin pump/infusion system incorporating the indwelling catheter device of Regittnig to be implemented in a smaller, more efficient, and cheaper manner, as described by Regittnig ([0052-0056]). Such a modification does not negate the advantages presented by the porous sleeve (15) of Regittnig, which is able to withdraw tissue fluid for transport to an external device for analysis (see [0034] and [0045]). While providing a glucose sensor within the distal catheter portion itself rather than externally to the device may mitigate the need to withdraw tissue fluid from the patient for glucose concentration measurement, one of ordinary skill in the art would still find the porous sleeve (15) of Regittnig to be valuable in allowing for easy sampling of tissue fluid for other analysis/diagnostic purposes, as well as for providing a means of confirming that the values measured by the glucose sensor provided within the distal catheter portion remain accurate over time. Regarding claim 7 , Regittnig ‘622 further teaches that the chemical sensor (s) may be of an optical or electrochemical type ([0083]) . Because one or more c hemical sensor s according to a configuration taught by Regittnig ’622 is incorporated into the distal catheter portion of Regittnig in the above combination, it follows that the proposed combination also exhibits that the that the chemical sensor (s) may be of an optical or electrochemical type . Regarding claim 8, Regittnig ‘622 further teaches that the chemical sensor (s) may be a glucose sensor ( [0110] and [0131] ) . Regarding claim 9, Regittnig further discloses that the replaceable distal catheter portion further includes a tip ( proximate tip of needle 20 ) that protrudes above the opening in the permanent tube to sit proud above the permanent tube ( see Fig. 8A-8B ) . Regarding claim 11, Regittnig fails to teach that the at least one medication outlet is at least two medication outlets, and wherein the medication outlets are of different sizes or different restrictiveness to provide an equal flow rate from the medication outlets , however, Joseph further teaches that such a distal catheter portion (cannula 100) may comprise an array of medication outlet s (holes 105) along the length thereof (see Fig. 1 and [0058]), wherein the medication outlets are of different sizes and wherein the distal inner lumen may be much less restrictive than the medication outlets (see Fig. 1-2, wherein it is clear that the distal inner lumen is of greater diameter, and thus lesser restrictiveness, than the medication outlets) in order to thereby provide an equal flow rate from the medication outlets (a “uniform cylinder pattern” – see [0061], ln 10-13), thereby ensuring a uniform infusion of insulin to the surrounding subcutaneous tissue, as is desirable to improve absorption (see Fig. 1-2, [0057], [0059], and [0061], wherein the diameter of the outlet holes 105 and the distal inner lumen may be optimized as described in order to thereby create a uniform pressure differential between the distal inner lumen and the surrounding subcutaneous tissue of the patient over the length of the distal catheter portion 100, thereby driving a uniform flow rate through the outlet holes over the length of the distal catheter portion 100 and about it within the subcutaneous tissue plane – i.e. a “uniform cylinder pattern). For this reason , it would have been obvious to one of ordinary skill in the art to modify the distal catheter portion of Regittnig to include an outlet configuration of the kind taught by Jospeh, including an array of medication outlet s along the length thereof , wherein the medication outlets are of different sizes to provide an equal flow rate from the medication outlets (a “uniform cylinder pattern”) , as taught by Joseph. Regarding claim 12, Joseph further teaches that the distal inner lumen is much less restrictive than the medication outlets (see in re claim 11 ). This being a feature of the outlet configuration taught by Joseph and incorporated into Regittnig in the above modification in re claim 11, it follows that the proposed combination of Regittnig, Regittnig ‘622, and Jospeh according to claim 11 also exhibits this feature. Regarding claim 13, Joseph further teaches that the distal inner lumen and the medication outlets are configured to have equal pressure at (see [0059] – a “substantially uniform pressure differential” between the distal inner lumen and the adjacent subcutaneous tissue) , and equal flow from (by virtue of equal pressure differential across the outlets, local pressure differential governing the flow rate through each outlet) , all of the medication outlets (see Fig. 1-2, [0059], and [0061] ). This being a feature of the outlet configuration taught by Joseph and incorporated into Regittnig in the above modification in re claim 11, it follows that the proposed combination of Regittnig, Regittnig ‘622, and Jospeh according to claim 11 also exhibits this feature. Claim(s) 14- 16 and 18- 19 are rejected under 35 U.S.C. 103 as being unpatentable over Regittnig in view of Joseph and Regittnig ‘622 (U.S. Pat. Pub. No. 2009/0312622 A1). Regarding claim 14, Regittnig discloses a method of delivering medication from an implanted catheter, comprising: providing a permanent catheter portion in a body ( see in re claim 1 and [0084], ln 1-12 ) , the permanent catheter portion including a permanent tube with an inner lumen and a sleeve attached to the permanent tube (see in re claim 1) ; providing a replaceable distal catheter portion ( needle 20, see in re claim 2) , the replaceable distal catheter portion including a distal inner lumen (see in re claim 2) , and at least one medication outlet provided in the distal inner lumen (see in re claim 2) ; and inserting the replaceable distal catheter portion in the permanent catheter portio n to form a combined catheter ( see Fig. 8A-8B and [0084], ln 1-12 ) . Regittnig fails to teach that the sleeve has an outer coating that is at least one of: non- inflammatory or preventative of foreign body response , however, Regittnig may be modified according to the teachings of Joseph as described above in re claim 1, whereupon the proposed combination exhibits that the sleeve may have an outer coating that is non- inflammatory , preventative of foreign body response , or both (see in re claims 1 and 3-4). Regittnig also fails to teach that the chemical sensor (s) is provided in the distal inner lumen , however, Regittnig may be modified according to the teachings of Regittnig ‘622 as described above in re claim 2, whereupon the proposed combination exhibits that the chemical sensor(s) is provided in the distal inner lumen. Regarding claim 15, Regittnig further discloses connecting the permanent catheter portion to a pump (34) ( see Fig. 12 and [0088] ), and dispensing a medication from the pump, through the combined catheter, into the body ( see Fig. 12, [0032-0034], and [0088] ). Regarding claim 16, as described above, Regittnig may be modified according to the teachings of Joseph as described above in re claim 1, whereupon the proposed combination exhibits that the sleeve may have an outer coating that is non-inflammatory , preventative of foreign body response , or both (see in re claims 1 and 3-4) . Regarding claim 18, Joseph further teaches that such a distal catheter portion (cannula 100) may comprise an array of medication outlet s (holes 105) along the length thereof (see Fig. 1 and [0058]), wherein the medication outlets are of different sizes and wherein the medication outlets on the distal catheter portion are less restrictive near the tip of the distal catheter portion ( by virtue of larger diameter - see Fig. 1-2 , [0058-0059], and [0061] , wherein the outlet holes 105 may increase in diameter near the tip of the distal catheter portion , and thus decrease in restrictiveness ) in order to thereby provide an equal flow rate at each of the medication outlets (a “uniform cylinder pattern” – see [0061], ln 10-13), thereby ensuring a uniform infusion of insulin to the surrounding subcutaneous tissue, as is desirable to improve absorption (see Fig. 1-2, [0057], [0059], and [0061], wherein the diameter of the outlet holes 105 may be varied as described in order to thereby create a uniform pressure differential between the distal inner lumen and the surrounding subcutaneous tissue of the patient over the length of the distal catheter portion 100, thereby driving a uniform flow rate through the outlet holes over the length of the distal catheter portion 100 and about it within the subcutaneous tissue plane – i.e. a “uniform cylinder pattern). For this reason, it would have been obvious to one of ordinary skill in the art to modify the distal catheter portion of Regittnig to include an outlet configuration of the kind taught by Jospeh, including an array of medication outlet s along the length thereof, wherein the medication outlets are of different sizes and wherein the medication outlets on the distal catheter portion are less restrictive near the tip of the distal catheter portion in order to provide an equal flow rate from the medication outlets (a “uniform cylinder pattern”) that is beneficial for insulin absorption into the subcutaneous tissue , as taught by Joseph. Regarding claim 19, Joseph further teaches that such a distal catheter portion (cannula 100) may comprise an array of medication outlet s (holes 105) along the length thereof (see Fig. 1 and [0058]), wherein the medication outlets are of different sizes and wherein the distal inner lumen may be much less restrictive than the medication outlets (see Fig. 1-2, wherein it is clear that the distal inner lumen is of greater diameter, and thus lesser restrictiveness, than the medication outlets) in order to thereby provide an equal flow rate from each of the medication outlets (a “uniform cylinder pattern” – see [0061], ln 10-13), thereby ensuring a uniform infusion of insulin to the surrounding subcutaneous tissue, as is desirable to improve absorption (see Fig. 1-2, [0057], [0059], and [0061], wherein the diameter of the outlet holes 105 and the distal inner lumen may be optimized as described in order to thereby create a uniform pressure differential between the distal inner lumen and the surrounding subcutaneous tissue of the patient over the length of the distal catheter portion 100, thereby driving a uniform flow rate through the outlet holes over the length of the distal catheter portion 100 and about it within the subcutaneous tissue plane – i.e. a “uniform cylinder pattern). For this reason, it would have been obvious to one of ordinary skill in the art to modify the distal catheter portion of Regittnig to include an outlet configuration of the kind taught by Jospeh, including an array of medication outlet s along the length thereof, wherein the medication outlets are of different sizes and wherein the distal inner lumen may be much less restrictive than the medication outlets in order to provide an equal flow rate from the medication outlets (a “uniform cylinder pattern”) that is beneficial for insulin absorption into the subcutaneous tissue, as taught by Joseph. Claim(s) 17 is rejected under 35 U.S.C. 103 as being unpatentable over Regittnig as modified by Joseph and Regittnig ‘622 according to claim 14, and in further view of Martinez (U.S. Pat. Pub. No. 2008/0234563 A1) and Joseph . Regarding claim 17, Regittnig as modified by Joseph and Regittnig ‘622 according to claim 14 exhibit s the method of claim 17 . While the implanted /indwelling catheter device of Regittnig is clearly configured to allow the distal catheter portion (needle 20) to be retracted and replaced with another similar distal catheter portion (see Fig. 8A-8B and [0084], wherein the needle 20 is both insertable into and retractable from the permanent tube 16 and sleeve 15 without necessitating any change or removal of the permanent tube and sleeve), Regittnig fails to teach the method step of, at defined time intervals, replacing the replaceable distal catheter portion with a new replaceable distal catheter portion, but leaving the permanent catheter portion unchanged. Martinez exhibits an indwelling catheter device similar to that of Regittnig, the indwelling catheter device comprising an implanted permanent tube (tubular body 10) with attached sleeve (catheter conduit 26) and a replaceable distal catheter portion in the form of a flexible tube (catheter 30) inserted through a hole within the top of the implanted permanent tube and sealed therein by a cover structure (see Fig. 1-3 and Col. 4, ln 16 – Col. 5, ln 26). Martinez teaches that the method step of replacing the replaceable distal catheter portion with a new replaceable distal catheter portion, but leaving the permanent catheter portion unchanged , is often necessary due to the tendency of indwelling catheters to become clogged (Col. 6, ln 32-45), and teaches that configurations which allow easy removal of the distal catheter portion without disturbance to the implanted permanent tube and sleeve, such as is present in Regittnig and Martinez, help to avoid the need for surgical operations in replacing clogged catheters (Col. 6, ln 32-45). While Martinez does not teach a specific defined time interval for replacing the distal catheter portion, it is well known within the art that the typical distal catheter portion is only effective for a period of about 2-3 days ( see Joseph, [0005] ) or in optimized cases up to 30 days ( Joseph, [0057] ) before replacement is needed. As such, based upon these teachings, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Regittnig to include, at defined time intervals, replacing the replaceable distal catheter portion with a new replaceable distal catheter portion, but leaving the permanent catheter portion unchanged , as the indwelling catheter device of Regittnig Fig. 8A-8B is configured to do, in order to thereby mitigate the detrimental effects of clogging within the distal catheter portion, as described by Martinez ( Col. 6, ln 32-45 ) . Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Regittnig as modified by Joseph and Regittnig ‘622 according to claim 14, and in further view of Poirier (U.S. Pat. No. 4,668,222) , Regittnig, and Martinez ( U.S. Pat. No. 4,781,693 ) . Regarding claim 20, Regittnig as modified by Joseph and Regittnig ‘622 according to claim 14 exhibits the method of claim 14, wherein a permanent catheter portion in the form of the permanent tube and sleeve of Fig. 8A-8B of Regittnig, the sleeve being modified by Joseph as described above, is provided, and wherein the replaceable distal catheter portion of Fig. 8A-8B of Regittnig, being needle 20, is also provided. While Regittnig teaches that each of the permanent tube and sleeve of Fig. 8A-8B extend into subcutaneous tissue (2) of the body into which they are implanted ( see Fig. 8A-8B and [0084] ), it is clear from Fig. 8A-8B of Regittnig that these features are provided predominantly vertically within the subcutaneous region of the body (in the same direction as the direction in which the replaceable distal catheter portion is provided – see above claim interpretation). It is also clear that the replaceable distal catheter portion of Fig. 8A-8B of Regittnig, being needle 20, is provided vertically but solely within the subcutaneous region of the body. Regittnig thus fails to teach that the permanent catheter portion is provided substantially horizontally in a subcutaneous region of a body, and the replaceable distal catheter portion is provided substantially vertically in a peritoneal cavity of the body. In regards to the permanent cathe t e r portion, Poirier exhibits an implanted catheter device ( PAD 20 ) similar to that of Regittnig, comprising a permanent catheter portion in the form of a permanent base/tube ( hub/neck 24 ) implanted into the subcutaneous tissue of a body ( see Fig. 1-3 and Col. 1, ln 62 – Col. 2, ln 4 ), and a replaceable distal catheter portion in the form of an insertable/retractable (and thereby replaceable) tube (30) inserted to extend vertically through the permanent base/tube (see Fig. 2-4 ) . Poirier teaches that the permanent base/tube may comprise a skirt (22) portion which extends horizontally within the subcutaneous tissue in order to anchor the permanent base/tube securely to the skin of the patient ( see Fig. 1-3, Col. 1, ln 62 – Col. 2, ln 4, and Col. 2, ln 46 – Col. 3, ln 33 ), such a feature causing the permanent catheter portion to be provided substantially horizontally within the subcutaneous region of the body while still receiving the vertically extending distal catheter portion within the vertically oriented inner lumen 28 of the permanent base/tube. Based on the teachings of Poirier , it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the permanent base/tube of Regittnig to further include a skirt portion of the kind taught by Poirier, which extends horizontally within the subcutaneous tissue, thereby causing the permanent catheter portion to be provided substantially horizontally within the subcutaneous region of the body while still receiving the vertically extending distal catheter portion within the vertically oriented inner lumen 17 of the permanent base/tube, in order to anchor the permanent base/tube securely to the skin of the patient, as described by Poirier (see Fig. 1-3, Col. 1, ln 62 – Col. 2, ln 4, and Col. 2, ln 46 – Col. 3, ln 33). In regards to the replaceable distal catheter portion, w hile in the embodiment of Fig. 8A-8B the hollow needle 20 forms the distal catheter portion, Regittnig teaches in other embodiments that the distal catheter portion may be formed instead as a stiff or flexible tube (inlet tube 19) (see embodiment of Fig. 6A-6B and [0082], and embodiment of Fig. 7A-7B and [0083]). Considering that Regittnig envisions the insertion of one form of distal catheter portion - needle 20 - through a hole (26) in the permanent tube (see Fig. 7A-8B and [0083-0084]), and also envisions the use of other forms of distal catheter portions which are not needles, including more traditional rigid or flexible tubes (albeit not inserted in the same manner), it would follow that the embodiment of Fig. 8A-8B would also function appropriately if subsequent to placement of the device within the patient using a needle (as described in [0049-0050], [0083-0084], and depicted in Fig. 8A), the needle were then fully retracted through hole 26 and replaced with an inserted flexible tube catheter similar in structure to that of needle 20 or inlet tube 19 as shown in Fig. 6A-6B, inserted through hole 26 in the same manner as needle 20 in Fig. 8A-8B, and sealed within the permanent tube by placement of cover 21, as described in [0083] and depicted in Fig. 7B. Indeed, Regittnig teaches that the use of a flexible tube, such as inlet tube 19, rather than a rigid needle, provides the benefit of improved patient comfort ([0083], ln 1-5). Further, insertion of a traditional flexible tube type catheter through a top hole formed in an implanted permanent tube and sleeve, rather than a needle, is well known within the art. Such is taught by Martinez, which exhibits an indwelling catheter device similar to that of Regittnig, and teaches that the implanted permanent tube (tubular body 10) and sleeve (catheter conduit 26) of such a device may be configured to receive a replaceable distal catheter portion in the form of a flexible tube (catheter 30) inserted through a hole within the top of the implanted permanent tube and sealed therein by a cover structure (see Fig. 1-3 and Col. 4, ln 16 – Col. 5, ln 26). Based, therefore, on the additional teachings of Regittnig in the embodiments of Fig. 6A-7B and on the example of Martinez, it would have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to modify the device of embodiment 8A-8B of Regittnig by providing an inserted (and similarly replaceable) flexible tube catheter in place of the needle 20 of embodiment 8A-8B, the flexible tube catheter being of similar form to needle 20 in regards to distal inner lumen, medication outlet, and fluid communication with the permanent tube, and being inserted through hole 26 in the same manner as needle 20 in Fig. 8A-8B, which may be retracted upon placement of the device within the patient (as described in [0049-0050], [0083-0084], and depicted in Fig. 8A), and being sealed within the permanent tube by placement of cover 21, in order to thereby provide the benefit of improved patient comfort in comparison to a rigid needle ([0083], ln 1-5). Such a flexible tube catheter being similar in form to the needle 20, it would exhibit all claimed limitations exhibited by the needle 20 in the same manner. Martinez further teaches that such a flexible tube catheter (30) may extend vertically in to a peritoneal cavity (portion below peritoneal wall 18 in Fig. 1-3) of the body (see Fig. 1 and 3, and Col. 2, ln 1-49 ) in order to provide intro-peritoneal delivery of insulin ( Col. 1, ln 24-35 ). Intro-peritoneal delivery of insulin mimics the physiologic rout of insulin released by the pancreas, provid ing additional advantages of insulinizing the liver without peripheral hyperinslinization, predictable insuli n absorption, and reduced blood clotting at the tip of the catheter ( Col. 1, ln 24-35 ). Based on the teachings of Martinez, it would further have been obvious to one of ordinary skill in the art prior to the filing date of the claimed invention to provide an extended flexible tube distal catheter portion of Regittnig as modified above in re itself and Regittnig ‘622 , such the extended distal catheter portion it is provided substantially vertically extending in to a peritoneal cavity of the body in order to thereby permit advantageous intro-peritoneal delivery of insulin to the patient, such a technique providing distinct advantages of insulinizing the liver without peripheral hyperins u linization, predictable insulin absorption, and reduced blood clotting at the tip of the catheter, as taught by Martinez (Col. 1, ln 24-35). Such an extended flexible tube distal catheter portion could still comprise medication outlets within the subcutaneous tissue portion for insulin delivery in both locations, or could comprise outlets solely within the peritoneal cavity, whereupon one of ordinary skill in the art would still find the porous sleeve (15) of Regittnig to be valuable in allowing for easy sampling of tissue fluid for analysis/diagnostic purposes. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT Eric A Lange whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-9202 . The examiner can normally be reached on FILLIN "Work Schedule?" \* MERGEFORMAT M-F 8:30 am-noon and 1pm- 5:30 pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ERIC A LANGE/ Examiner, Art Unit 3745 /CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783