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 .
This is the first office action on the merits in response to Applicant’s election filed on 02/09/2026.
Election/Restrictions
Applicant’s election without traverse of Group I, Species IV (Figs. 5-9), and Subspecies I (Fig. 10) in the reply filed on February 9, 2026 is acknowledged. Applicant’s election withdraws claims 2, 19, and 21-23 from further consideration. An additional claim is hereby withdrawn for the reasons listed below.
Claim 6 is withdrawn as being drawn to a nonelected species.
Regarding claim 6, the limitation “the sensor member and the infusion cannula are spaced apart from each other along a plane of the first surface of the base by less than the first distance” is not shown in the elected species of Figs. 5-9 and 10. Rather, the limitation is believed to be directed to the nonelected species of Fig. 3, which shows a sensor member (30) and an infusion cannula (40) are spaced apart from each other (distance d) along a plane of the first surface of the base (20) by less than the first distance (d’). See also ¶ [0078] of the specification, which states “in the example in FIG. 3 , the length of the infusion cannula 40 is greater than the length of the insertable member of the sensor 30, such that a distance d′ between the insertable member of the sensor 30 and the open distal end of the infusion cannula 40 is greater than the distance d.”
Since the above limitation is not found in the species of Figs. 5-9 and 10, claim 6 is drawn to a nonelected species, and is also withdrawn from further consideration pursuant to 37 CFR 1.142(b).
Claims 1, 3-5, 7-18, and 20 are pending and examined.
Claim Objections
Claims 4 and 9 are objected to because of the following informalities:
Claim 4, line 2: “the second insertable members” is believed to be in error for --the second insertable member-- (see claim 1, line 6)
Claim 9, line 1: “the infusion lumen has fluid flow lumen” is believed to be in error for --the infusion lumen has a fluid flow lumen--
Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 5, 10-11, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Voskanyan (US 2012/0046533 A1: IDS reference).
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;
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;
wherein the first insertable member (24) includes a sensor member (¶ [0075], l. 4: “sensor 22”) for sensing a biological analyte corresponding to a biological condition (¶ [0075], ll. 9-12);
wherein the second insertable member (33) includes an infusion cannula (¶ [0075], l. 5: “cannula 33”) for infusing an infusion media; and
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).
Regarding claim 5, Voskanyan 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 10, Voskanyan 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 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 20, Voskanyan 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 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 3-4, 8, 12, 14, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference).
Regarding claim 3, Voskanyan teaches the invention as claimed and as discussed above for claim 1. However, the current embodiment of Voskanyan (Figure 3) does not teach the first insertable member and the second insertable member are arranged adjacent each other for insertion together in a single insertion location.
Voskanyan teaches another embodiment (Figs. 6A-6F) of the medical device comprising:
a base (see annotated Fig. 6C on next page), a first insertable member (“sensor lumen” – Fig. 6D) secured to the base and including a sensor member (“Sensor”), and a second insertable member (“Infusion lumen” – Fig. 6D) configured to be secured to the base and including an infusion cannula; and further teaches:
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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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 such that the first insertable member and the second insertable member are arranged adjacent each other for insertion together in a single insertion location, 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).
Regarding claim 4, Voskanyan 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 members (infusion lumen) are attached to each other (as shown in Fig. 6D).
Regarding claim 8, Voskanyan teaches the invention as claimed and as discussed above for claim 5, and Voskanyan further teaches (Figure 3) 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 (22) has at least one electrode (¶ [0045], ll. 4-6: “the sensor includes an electrochemical cell that has a working electrode, a reference electrode, and optionally a counter electrode”) on a surface of the sensor member for interfacing with biological fluid or tissue after the sensor member (22) is inserted at the insertion site.
However, the current embodiment of Voskanyan (Figure 3) does not teach the at least one electrode is on the second surface of the sensor member.
Voskanyan teaches another embodiment (Figs. 6A-6F) of the medical device comprising:
a base (see annotated Fig. 6C on previous page), a first insertable member (“sensor lumen” – Fig. 6D) secured to the base and including a sensor member (“Sensor”), and a second insertable member (“Infusion lumen” – Fig. 6D) configured to be secured to the base and including an infusion cannula;
wherein the sensor member has a first surface (Fig. 6D: top surface of Sensor) that faces toward the infusion cannula (infusion lumen) and a second surface (Fig. 6D: bottom surface of Sensor) that faces in an opposite direction as the first surface of the sensor member; and further teaches:
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).
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 such that the at least one electrode is on the second surface of the sensor member, in order to prevent interference due to catheter bending; thus the sensor is less likely to pick up as much of the insulin of other infused fluid, reducing inaccurate sensor readings from that fluid, as taught by Voskanyan (¶ [0076], ll. 6-9).
Regarding claim 12, Voskanyan teaches the invention as claimed and as discussed above for claim 1. 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 7), a first insertable member (“sensor lumen” – Fig. 6D) secured to the base and including a sensor member (“Sensor”), and a second insertable member (“Infusion lumen” – 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 hollow channel along a lengthwise axial dimension of the inserter needle, wherein the sensor member (sensor lumen) and the infusion cannula (infusion lumen) are arranged adjacent each other in the hollow channel of the inserter needle, for insertion together at a single insertion location (¶ [0093], ll. 11-12: “The set can be inserted with a single needle”).
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 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, 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).
Regarding claim 14, Voskanyan teaches the invention as claimed and as discussed above for claim 12, and Voskanyan further teaches (embodiment of Fig. 6D) the inserter needle (Needle) has a slot (where infusion lumen is positioned) along its lengthwise axial dimension, and wherein a portion of the infusion cannula (infusion lumen) extends at least partially into the slot (Fig. 6D shows the infusion cannula is extends fully into the slot).
Regarding claim 16, Voskanyan teaches the invention as claimed and as discussed above for claim 12, 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).
Regarding claim 17, Voskanyan teaches the invention as claimed and as discussed above for claim 16, and Voskanyan further teaches (embodiment of Figs. 6A-6F) 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.
Regarding claim 18, Voskanyan 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”).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Kube (US 2012/0184835 A1).
Regarding claim 7, Voskanyan 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 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 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 Regittnig (US 2014/0288399 A1).
Regarding claim 9, Voskanyan teaches the invention as claimed and as discussed above for claim 1, and Voskanyan further teaches (Figure 3) the infusion cannula (33) has fluid flow lumen (between 33 and 34) along an axial length dimension of the infusion cannula (33).
However, Voskanyan does not teach at least one side wall opening in fluid flow communication with the 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 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 by including at least one side wall opening in fluid flow communication with the 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).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Wolfe (US 2021/0023313 A1).
Regarding claim 13, Voskanyan teaches the invention as claimed and as discussed above for claim 12, 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 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 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.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Voskanyan (US 2012/0046533 A1: IDS reference), in view of Burkholz (US 2017/0274183 A1).
Regarding claim 15, Voskanyan teaches the invention as claimed and as discussed above for claim 12, 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 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 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).
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure: see also attached form PTO-892 “Notice of References Cited”.
Chiu (US 2020/0384197 A1): Fig. 41 teaches a base (722), a first insertable member including a sensor member (716), and a second insertable member including an infusion cannula (706). Figs. 53-55 teach that the first insertable member (1300) and the second insertable member (1301) are attached to each other. Fig. 140 shows the distal end of the first insertable member (1300) being spaced apart from the distal end of the second insertable member (2854).
Conclusion
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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/HENRY NG/Examiner, Art Unit 3741 /DEVON C KRAMER/Supervisory Patent Examiner, Art Unit 3741