FINAL 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 .
This is the second office action on the merits. This office action is in response to the amendment filed on 06/05/2026. Applicant has amended claims 1, 4, 9, 12-17, and 23. Claims 2, 6, 19, and 21-23 remain withdrawn from further consideration. Claims 1, 3-5, 7-18, and 20 are pending and examined.
Claim Objections
Claims 3 and 14 are objected to because of the following informalities:
Claim 3, lines 2-3: “a single insertion location” is believed to be in error for --the single insertion location-- (see claim 1, line 16)
Claim 14, line 4: “a width of sensor member” is believed to be in error for --a width of the sensor member--
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-5, 8, 10-12, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Mastrototaro (US 5,951,521).
Regarding claim 1, Voskanyan teaches (Figure 3) a medical device comprising:
a base (40) having a first surface (bottom surface of 40) configured to be secured to a patient's skin (¶ [0008], ll. 9-10);
a first insertable member (24) secured to the base (40) and having a length portion extending from the first surface of the base (40) to a distal end of the first insertable member (24), for insertion through the patient's skin at an insertion site when the first surface of the base (40) is secured to the patient's skin, the first insertable member (24) including a sensor member (¶ [0075], l. 4: “sensor 22”) for sensing a biological analyte corresponding to a biological condition (¶ [0075], ll. 9-12); and
a second insertable member (33) configured to be secured to the base (40) and having a length portion extending from the first surface of the base (40) to a distal end of the second insertable member (33), for insertion through the patient's skin at the insertion site when the first surface of the base (40) is secured to the patient's skin, the second insertable member (33) including an infusion cannula (¶ [0075], l. 5: “cannula 33”) for infusing an infusion media;
wherein the distal end of the first insertable member (24) and the distal end of the second insertable member (33) are spaced apart by a first distance of at least 5 mm (¶ [0065], ll. 24-26: “the infusion site and the sensor electrode are separated by at least 3, 4, 5, 6 or 7, 8 or 9 millimeters of tissue”), for reducing interference (¶ [0065], ll. 3-5: “to avoid or inhibit sensor interference”) of the infusion media from the infusion cannula (33) with an operation of the sensor member (22).
However, the current embodiment of Voskanyan (Figure 3) does not teach an inserter needle having a hollow channel along a lengthwise axial dimension of the inserter needle, wherein the sensor member and the infusion cannula are arranged adjacent each other in the hollow channel of the inserter needle, for insertion together at a single insertion location.
Voskanyan teaches another embodiment (Figs. 6A-6F) of the medical device comprising:
a base (see annotated Fig. 6C on page 8), a first insertable member (“sensor lumen 210” – Fig. 6D) secured to the base and including a sensor member (“Sensor”), and a second insertable member (“Infusion lumen 210” – Fig. 6D) configured to be secured to the base and including an infusion cannula; and further teaches:
an inserter needle (Needle – Figs. 6A-6D) having a single hollow channel (see annotated Fig. 6D on next page) along a lengthwise axial dimension of the inserter needle, wherein the sensor member (Sensor) and the infusion cannula (infusion lumen 210) are arranged adjacent each other, for insertion together at a single insertion location (¶ [0093], ll. 11-12: “The set can be inserted with a single needle”), wherein the inserter needle (Needle) has two adjacent terminating ends and a slot defined therebetween along the lengthwise axial dimension (see annotated Fig. 6D on next page), and wherein a portion of the infusion cannula (infusion lumen 210) extends from the single hollow channel through the slot between the two adjacent terminating ends.
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It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the Figure 3 embodiment of Voskanyan by including an inserter needle having a single hollow channel along a lengthwise axial dimension of the inserter needle, wherein the sensor member and the infusion cannula are arranged adjacent each other, for insertion together at a single insertion location, wherein the inserter needle has two adjacent terminating ends and a slot defined therebetween along the lengthwise axial dimension, and wherein a portion of the infusion cannula extends from the single hollow channel through the slot between the two adjacent terminating ends, in order to allow the sensor and infusion catheter to be built into a single set, which greatly improves comfort and convenience for the patient by reducing both the amount of hardware the patient has to wear on their body and the number of needle sticks required for use, as taught by Voskanyan (¶ [0061], ll. 5-10).
However, Voskanyan does not teach the sensor member and the infusion cannula are arranged adjacent each other in the single hollow channel of the inserter needle.
Mastrototaro teaches (Figs. 1-3 and 6-7) a similar medical device (10 – Figs. 1-2) comprising a base (30 – Figs. 1-2), a sensor member (18 – Figs. 2 and 6-7) secured to the base (30), an infusion cannula (10 – Figs. 2 and 6-7) configured to be secured to the base (30); and further teaches:
an inserter needle (14) having a single hollow channel (formed by the round cross-sectional shape as shown by the top of needle 14 in Figs. 1-2, which extends to the open slot portion of needle 14) along a lengthwise axial dimension (shown by Fig. 3) of the inserter needle (14), wherein the sensor member (18) and the infusion cannula (16) are arranged adjacent each other in the single hollow channel of the inserter needle (14) – (as shown by Figs. 2 and 6-7; note that the single hollow channel includes both the fully round portion and the open slot portion of needle 14. Fig. 2 shows both sensor member 18 and infusion cannula 16 within the fully round portion of needle 14; the length of the fully round portion can be seen in Fig. 1), for insertion together at a single insertion location (col. 3, ll. 51-53), wherein the inserter needle (14) has two adjacent terminating ends and a slot defined therebetween along the lengthwise axial dimension (see annotated Fig. 7 on next page), and wherein a portion (48) of the infusion cannula (16) extends from the single hollow channel through the slot between the two adjacent terminating ends (see annotated Fig. 7 on next page).
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In comparison to Voskanyan, it is noted that Mastrototaro’s arrangement of the needle, sensor member, and infusion cannula – as shown in Fig. 7 – has a similar design to Voskanyan’s arrangement shown in Fig. 6D.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Voskanyan by replacing its arrangement of the needle, sensor member, and infusion cannula with an arrangement in which the sensor member and the infusion cannula are arranged adjacent each other in the single hollow channel of the inserter needle, because it has been held that a simple substitution of one known element (in this case, Mastrototaro’s arrangement of the needle, sensor member, and infusion cannula, in which the sensor member and the infusion cannula are arranged adjacent each other in the single hollow channel of the inserter needle) for another (in this case, Voskanyan’s arrangement of the needle, sensor member, and infusion cannula) to obtain predictable results (in this case, to provide a similar interchangeable insertion needle used to facilitate quick and easy subcutaneous placement of the cannula at the subcutaneous insertion site, as taught by Mastrototaro – col. 3, ll. 51-53), was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I) (B).
Regarding claim 3, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (Figs. 6C-6D) the first insertable member (sensor lumen) and the second insertable member (infusion lumen) are arranged adjacent each other (as shown in Fig. 6D) for insertion together in a single insertion location (Figs. 6C and 6F show them as a “dual lumen tube” that is inserted together in a single location).
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Regarding claim 4, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 3, and Voskanyan further teaches (embodiment of Figs. 6A-6F) the length portions of the first insertable member (sensor lumen) and the second insertable member (infusion lumen) are attached to each other (as shown in Fig. 6D).
Regarding claim 5, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (Figure 3) the sensor member (22) has a first length extending from the first surface of the base (40) to the distal end of the sensor member (22), and the infusion cannula (33) has a second length extending from the first surface of the base (40) to the distal end of the infusion cannula (33), and wherein the first length is different than the second length (shown by Fig. 3 – see also ¶ [0031], ll. 2-4: “a sensor and a cannula are placed at different depths in the body of a patient”).
Regarding claim 8, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 5, and Voskanyan further teaches (Figure 3 and 6B) the sensor member (22) has a first surface (right surface of 22) that faces toward the infusion cannula (33) and a second surface (left surface of 22) that faces in an opposite direction as the first surface of the sensor member (22), and the sensor member (Sensor) has at least one electrode (195 – Fig. 6B) on the second surface of the sensor member for interfacing with biological fluid or tissue after the sensor member is inserted at the insertion site (Fig. 6B shows a sensor electrode window 195 that opens to the electrodes of the sensor member. Therefore, these electrodes would be on the second surface, which is the surface that faces away from the infusion cannula).
Regarding claim 10, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (Figure 3) the length portion of at least one of the first and second insertable members (22 and/or 33) extends from the first surface of the base (40) at an oblique angle relative to the first surface of the base (as shown in Figure 3).
Regarding claim 11, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (Figure 3) the length portion of each of the first and second insertable members (22 and 33) extends from the first surface of the base (40) at an oblique angle relative to the first surface of the base (as shown in Figure 3).
Regarding claim 12, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and the combination further teaches (Mastrototaro, Fig. 7) the infusion cannula (16) is disposed within the single hollow channel between the slot and the sensor member (18) – (see annotated Fig. 7 on next page).
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Regarding claim 16, Voskanyan, in view of Mastrototaro as discussed so far, teaches the invention as claimed and as discussed above for claim 1, except for the inserter needle has an inner surface defining the single hollow channel, and wherein the inserter needle defines a gap between the inner surface and the sensor member.
Mastrototaro further teaches (Figs. 5 and 7) the inserter needle (14) has an inner surface defining the single hollow channel (the inner surface of the ring shown in Fig. 5 defines the single hollow channel), and wherein the inserter needle (14) defines a gap between the inner surface and the sensor member (18 – Fig. 7) – (since the inner surface surrounds sensor member 18, there is an annular gap, between the inner surface and sensor member 18, that also surrounds sensor member 18).
Regarding claim 17, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (embodiment of Figs. 6A-6F) the base has a channel (shown in Figs. 6C and 6F) through which the inserter needle (Needle) extends for insertion of the sensor member (sensor lumen) and the infusion cannula (infusion lumen), wherein the infusion cannula (infusion lumen) is connected in fluid flow communication with the channel in the base (as shown in Figs. 6C and 6F), and wherein the base includes at least one septum (¶ [0200], ll. 16-18: “A block including an insulin channel is inserted, as well as the self-sealing septum for the insulin needle to pierce during insulin delivery”) located adjacent or within the channel in the base, through which the inserter needle (Needle) extends for insertion of the sensor member (sensor lumen) and the infusion cannula (infusion lumen).
Regarding claim 18, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 17, and Voskanyan further teaches (embodiment of Figs. 6A-6F) the at least one septum provides a port on the base for receiving a needle or rigid cannula of an infusion media source that provides infusion media to the infusion cannula (¶ [0200], ll. 15-18: “Next, the sensor cap and sensor are inserted into the base. A block including an insulin channel is inserted, as well as the self-sealing septum for the insulin needle to pierce during insulin delivery”).
Regarding claim 20, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches the biological analyte is at least one of glucose, ketone or lactose (in this case, it is glucose – see ¶ [0062], ll. 6-7: “to monitor body characteristics of that patient (e.g. blood glucose levels)”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Mastrototaro (US 5,951,521), and in further view of Kube (US 2012/0184835 A1).
Regarding claim 7, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 5, and Voskanyan further teaches (shown in Figs. 6A-6F and 14) the first length is greater than the second length (Fig. 14 shows the length of 1501 is greater than the length of 1502 – also discussed in ¶ [0071], ll. 27-30), the sensor member (sensor – Fig. 6D) has a first surface (Fig. 6D: top surface of sensor) that faces toward the infusion cannula (infusion lumen – Fig. 6D) and that is connected to the infusion cannula (as shown in Fig. 6D), and the sensor member has at least one electrode (195 – Fig. 6B).
However, Voskanyan, in view of Mastrototaro, does not teach that the at least one electrode is on the first surface of the sensor member for interfacing with biological fluid or tissue after the sensor member is inserted at the insertion site.
It is noted the Fig. 6B of Voskanyan shows a sensor electrode window 195 that opens to the electrodes of the sensor member. Therefore, these electrodes would be on the surface of the sensor member that faces away from the infusion cannula.
Kube teaches (Figs. 1-3) a similar medical device comprising a sensor member (1 – Fig. 3) and an infusion cannula (5 – Fig. 1), and at least one electrode (2) on a top side of sensor member 1 (as shown in Fig. 2). In addition, Kube also teaches “Said electrodes 2 are arranged on the same side of the substrate in the embodiment shown. However, as a general rule, it is feasible just as well to arrange one or more electrode(s) on the opposite side of the substrate, i.e. its rear side, for example in order to implement a particularly compact design” (¶ [0039], ll. 4-9).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Voskanyan, in view of Mastrototaro, by including at least one electrode on the first surface of the sensor member for interfacing with biological fluid or tissue after the sensor member is inserted at the insertion site, in order to implement a particularly compact design and/or allow a sensor to be generated that has measuring sensitivities that are matched to different concentration ranges or can be used for measurements on different analytes, as taught by Kube (¶ [0039], ll. 8-9 and 12-15).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Mastrototaro (US 5,951,521), and in further view of Regittnig (US 2014/0288399 A1).
Regarding claim 9, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (Figure 3) the infusion cannula (33) has a fluid flow lumen (between 33 and 34) along an axial length dimension of the infusion cannula (33).
However, Voskanyan, in view of Mastrototaro, does not teach at least one side wall opening in fluid flow communication with the fluid flow lumen for expelling infusion media through a side wall of the infusion cannula, and wherein each side wall opening is provided on a side of the infusion cannula that faces away from the sensor member.
Regittnig teaches (Fig. 4B) a similar medical device comprising a sensor member (427) and an infusion cannula (403), wherein the infusion cannula has fluid flow lumen (461) along an axial length dimension of the infusion cannula (403), and further teaches:
at least one side wall opening (406) in fluid flow communication with the fluid flow lumen (461) for expelling infusion media (433) through a side wall of the infusion cannula (note that Fig. 4B shows the openings being located on both side walls of the infusion cannula).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Voskanyan, in view of Mastrototaro, by including at least one side wall opening in fluid flow communication with the fluid flow lumen for expelling infusion media through a side wall of the infusion cannula, in order to allow the infusion media to exit the lumen of the cannula and also to allow the substance (glucose) within the tissue to enter the lumen of the cannula to get in contact with the detection portion of the sensor system to detect the substance and determine the concentration of the substance within the tissue in the case where the sensor is located within the lumen of the cannula, as taught by Regittnig (¶ [0103], ll. 4-6 and 7-15).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Mastrototaro (US 5,951,521), and in further view of Wolfe (US 2021/0023313 A1).
Regarding claim 13, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (shown in Fig. 6D) the infusion cannula (infusion lumen) has a first side that has a reduced radius or flat surface (bottom side of infusion lumen is flat) facing the sensor member (sensor lumen), and
wherein the infusion cannula is attached to the sensor member along at least a portion of the first side of the infusion cannula (as shown in Fig. 6D).
However, Voskanyan, in view of Mastrototaro, does not teach that the attachment is by one or more of an adhesive or heat staking.
Wolfe teaches (Fig. 4B) a similar medical device comprising a sensor member (200a and 200b) and an infusion cannula (306), and further teaches:
wherein the infusion cannula (306) is attached to the sensor member (200a and 200b) along at least a portion of the first side of the infusion cannula (306) by one or more of an adhesive or heat staking (¶ [0034], ll. 3-5: “the sensors 200 a and 200 b are coupled to the cannula 306 using heat staking, adhesives…”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Voskanyan, in view of Mastrototaro, by attaching the infusion cannula to the sensor member by one or more of an adhesive or heat staking, because it has been held that combining prior art elements (in this case, Voskanyan’s infusion cannula with Voskanyan’s sensor member) according to known methods (heat staking or adhesives, as taught by Wolfe) to yield predictable results (in this case, to attach two structural elements together) was an obvious extension of prior art teachings, KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007), MPEP 2143 (I) (A).
Furthermore, it is noted that heat staking is a manufacturing process, and in this regard, it has been held that “[T]he patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process”; In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985), MPEP 2113.
Regarding claim 14, Voskanyan, in view of Mastrototaro and Wolfe as discussed so far, teaches the invention as claimed and as discussed above for claim 13, except for a width of the first side of the infusion cannula is greater than a width of sensor member and a width of the slot.
Mastrototaro further teaches (Fig. 7) the infusion cannula (16) has a first side (see annotated Fig. 7 on next page) that has a reduced radius or flat surface (in this case, it has a flat surface) facing the sensor member (18),
wherein a width of the first side of the infusion cannula (16) is greater than a width of sensor member (18) and a width of the slot (as shown in annotated Fig. 7 on next page).
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Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Mastrototaro (US 5,951,521), and in further view of Burkholz (US 2017/0274183 A1).
Regarding claim 15, Voskanyan, in view of Mastrototaro, teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (embodiment of Figs. 6A-6F) the inserter needle (Needle) is configured to slide in a direction of its lengthwise axial dimension relative to the sensor member (sensor lumen) and to the infusion cannula (infusion lumen), for selectively withdrawing the inserter needle relative to the sensor member and the infusion cannula (intended use).
However, Voskanyan, in view of Mastrototaro, does not teach at least one of the inserter needle or the infusion cannula includes a coating or layer for reducing friction between the inserter needle and one or both of the infusion cannula and the sensor member.
Burkholz teaches (Fig. 1) a medical device (10) comprising a needle (14) being inserted into an inner housing (18), wherein surfaces of the inner housing (18) that contact the needle (14) include a coating (¶ [0045], ll. 6-7).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Voskanyan, in view of Mastrototaro, by including a coating on at least one of the inserter needle or the infusion cannula, in order to lower friction between the surfaces of the infusion cannula and the needle and/or improve a feel of the needle sliding relative to the surfaces, as taught by Burkholz (¶ [0045], ll. 7-9).
Response to Arguments
Applicant’s arguments regarding the new limitations in claim 1 have been considered but are moot in view of the new ground(s) of rejection, necessitated by Applicant's amendments. To the extent possible, Applicant's arguments have been addressed in the body of the rejections at the appropriate locations.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see attached form PTO-892 “Notice of References Cited”.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY NG whose telephone number is (571)272-2318. The examiner can normally be reached M-F 9:30 AM - 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Devon Kramer can be reached at 571-272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741
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