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 .
Notice of Amendment
In response to the amendment filed on 8/11/2026, amended claims 1, 3, 5, 9, 11, 13, 19-20, 23-24, and 36 and cancelled claims 8, 10, 16-18, and 25-35 are acknowledged. Claims 1-7, 9, 11-15, 19-24, and 36 are currently pending.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
No claim limitation has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 13-15 and 22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 13 depends from claim 11 and recites the unclear limitation “a second needle cap” in line 2. A “first needle cap” is only recited in claim 5, from which claim 13 does not depend. As such, it is unclear how many “needle caps” are required by the scope of the claim.
Claim 22 recites the limitation "the collection tube needle" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is noted a “collection tube needle” is only previously recited in claims 11-13 and 19, but claim 22 does not depend from any of these claims.
Claims 14-15 are rejected based on their dependence from claim 13.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-7, 20, 24, and 36 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kopperschmidt et al. (US Patent No. 11,744,959 B2).
Regarding claim 1, Kopperschmidt et al. discloses a cannula set loading unit to load a cannula set into a cannula insertion system, comprising:
a cannula set having at least one patient needle (220) for introduction into a patient (see col. 17, lines 20-25 – “FIG. 1A depicts a side view of a cannula 220 with an example embodiment of the cannula holder 200 according to the invention. A longitudinal axis 212 of the cannula 220 extends from the proximal end 224 to the distal end 222 of the cannula 220. The cannula has a beveled tip at its distal end 222 for inserting into tissue”); and
a cartridge (200) having a predefined location for holding the patient needle in a fixed position with respect to the cartridge (see col. 20, lines 53-67 – “Further preferential is for at least one gripper element, in particular exactly one gripper element, of the at least two gripper elements 110, 112 to be rigid relative to the connecting device 170; i.e. in particular immovable by the moving device 160, whereby the relative position and/or orientation of the cannula with cannula holder is/are advantageously predefined by this rigid gripper element. This advantageously enables in particular simplifying the motion control of a robotic tool arm, to which the gripper apparatus 100 is connected by means of the connecting device 170, because with the known position and/or orientation of the tool arm, and thereby connecting device 170 and thus the at least one gripper element, also the position and/or orientation of the cannula holder as well as cannula is known”).
Regarding claim 2, Kopperschmidt et al. discloses the patient needle comprises a patient needle hub (100, 110, 112) to connect the patient needle to a cannula insertion device of the cannula insertion system (see col. 18, lines 29-32 – “The gripper apparatus 100 comprises two gripper elements 110, 112 which are movable relative to one another and interact to grip the cannula holder 200” and col. 26, lines 11-16 – “The cannulation robot 300 is thereby designed to move the gripper apparatus 100 toward the patient's body parts by means of the tool arm device 350 such that a blood vessel of said body part can be cannulated by means of a cannula gripped by the gripper apparatus 100”).
Regarding claim 5, Kopperschmidt et al. discloses a first needle cap configured to receive at least a portion of the patient needle (see col. 13, lines 48-55 – “Preferably, the protective cover is not removed until directly before cannulation; i.e. in the present case, directly before blood vessel puncturing, or at least not removed until after grasping or in the gripping state. In addition, the cannulation robot or the gripper apparatus can comprise a means for removing the protective cover, in particular a removal means—for instance additional gripper elements for grabbing and pulling off the protective cover”).
Regarding claim 6, Kopperschmidt et al. discloses the cannula set comprises the first needle cap (see col. 13, lines 48-55 – “Preferably, the protective cover is not removed until directly before cannulation; i.e. in the present case, directly before blood vessel puncturing, or at least not removed until after grasping or in the gripping state. In addition, the cannulation robot or the gripper apparatus can comprise a means for removing the protective cover, in particular a removal means—for instance additional gripper elements for grabbing and pulling off the protective cover”).
Regarding claim 7, Kopperschmidt et al. discloses the first needle cap is releasably coupled to the cartridge (see col. 13, lines 48-55 – “Preferably, the protective cover is not removed until directly before cannulation; i.e. in the present case, directly before blood vessel puncturing, or at least not removed until after grasping or in the gripping state. In addition, the cannulation robot or the gripper apparatus can comprise a means for removing the protective cover, in particular a removal means—for instance additional gripper elements for grabbing and pulling off the protective cover”).
Regarding claim 20, Kopperschmidt et al. discloses the cannula set comprises a tube (250), wherein the patient needle is coupled to a first end of the tube (see Figure 2A and col 19, lines 44-54 – “The cannula holder 200 is connected to the cannula 220 at the proximal end of the cannula as well as fluidly connected to a tube 250, in particular an infusion tube, whereby the cannula holder 200 creates a fluid connection between the tube 250 and the cannula 220. To connect the cannula holder 200 to the tube 250, the cannula holder 200 can preferably comprise a connector part. This connector part can in particular comprise or consist of an element for a luer lock connection so that the tube 250 and the cannula holder 200 can be screwed together”).
Regarding claim 24, Kopperschmidt et al. discloses the cartridge is configured to hold the tube in a predefined, fixed position with respect to the cartridge (see col. 23, lines 32-41 – “FIG. 5A shows the cannula holder 200 together with a cannula 220 and a tube 250 in a side view; also depicted is the longitudinal axis 212 of the cannula 220. The cannula holder 200 is integrally connected to the cannula 220, whereby the lumen of the cannula 220 is fluidly connected to a lumen of the cannula holder 200 and the cannula holder 200 is designed to be mechanically connected to the tube 250 in such a way as to establish a fluid connection between the tube 250, in particular a lumen of the tube, and the lumen of the cannula”).
Regarding claim 36, Kopperschmidt et al. discloses a cannula insertion system to insert a cannula into a human or animal body, comprising:
a cannula insertion device (300, 350) configured to insert the cannula into the human or animal body (see Figure 8 and col. 26, lines 11-16 – “The cannulation robot 300 is thereby designed to move the gripper apparatus 100 toward the patient's body parts by means of the tool arm device 350 such that a blood vessel of said body part can be cannulated by means of a cannula gripped by the gripper apparatus 100”),
at least one cannula set loading unit as claimed in claim 1 (see rejection above), and
a cannula set loading device (100) to load a cannula set from the at least one cannula set loading unit into the cannula insertion system (see Figure 8 and col. 26, lines 20-23 – “The cannulation robot 300 is thereby preferably designed for a cannula with cannula holder to be removed out of the storage device 330 by being grasped by the gripper apparatus 100”).
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.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kopperschmidt et al., further in view of Say (US Publication No. 2011/0270061 A1).
Regarding claim 3, Kopperschmidt et al. discloses a storage device to store multiple cannulas and cartridges (see Figure 8 and col. 26, lines 18-23 – “Preferably, the cannulation robot 300 comprises a storage device 330 designed to store cannula holders, cannulas and/or cannulas with cannula holders. The cannulation robot 300 is thereby preferably designed for a cannula with cannula holder to be removed out of the storage device 330 by being grasped by the gripper apparatus 100”) but does not specifically teach the cartridge is stackable with a second cartridge. However, Say teaches the cartridge (200a) is stackable with a second cartridge (200b) (see Figures 13-19 and [0087] – “In general, the cartridge element 200 includes exterior structures configured to allow a plurality of the cartridge elements 200 to be stacked one on top of the other to form a cartridge assembly 250 (see FIGS. 13-19) or magazine that can be loaded into a monitoring and delivery system (e.g., a glucose monitoring and insulin delivery system) 300 (see FIG. 20) as a unit”). 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 cannula set loading unit of Kopperschmidt et al. to include the cartridge is stackable with a second cartridge, as disclosed in Say, so as to allow a plurality of the cartridge elements to be stacked one on top of the other to form a cartridge assembly (see Say: [0087]).
Regarding claim 4, Say teaches the cartridge comprises one or more snap connection elements (212, 214, 216) to connect the cartridge to the second cartridge (see [0089] – “When a first cartridge element 200a is stacked on top of a second cartridge element 200b, the second rail 214 of the cartridge element 200a fits within the first slot 216 of the second cartridge element 200b. The first rail 212 of the second cartridge element 200b fits within the second slot of the first cartridge element 200a”).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kopperschmidt et al., further in view of Allen et al. (US Publication No. 2012/0323142 A1).
Regarding claim 9, it is noted Kopperschmidt et al. does not specifically teach a tamper indicator between the patient needle and the first needle cap. However, Allen et al. teaches a tamper indicator (191c) between the patient needle and the first needle cap (101c) (see Figures 10-11 and [0178] – “In some embodiments, the blood collection safety device 100c includes a tamper-resistant label 191c. For example, the label 191c can be adhered to the housing 104c and the cap 101c. In some configurations, the label 191c is configured to rip, break, crease, or otherwise provide an indication upon the cap 101c being separated from the housing 104c”). 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 cannula set loading unit of Kopperschmidt et al. to include a tamper indicator between the patient needle and the first needle cap, as disclosed in Allen et al., so as to provide an indication that the cap has been separated from the needle (see Allen et al.: [0178]).
Claim(s) 11-15, 19, and 21-23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kopperschmidt et al., further in view of Higaki et al. (US Publication No. 2006/0009714 A1).
Regarding claim 11, it is noted Kopperschmidt et al. does not specifically teach the cannula set comprises a collection tube needle arranged to connect the cannula set to a blood collection tube. However, Higaki et al. teaches the cannula set comprises a collection tube needle (22) arranged to connect the cannula set to a blood collection tube (see Figure 1 and [0031] – “The needle tubes 21 and 22 of the present invention are hollow tubes, and distal ends 211 and 221 thereof are formed with sharp cutting edges. The distal end 211 is for puncturing a blood vessel via a patient's skin, and the distal end 221 is for puncturing a rubber plug which seals a vacuum blood collection tube”). 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 cannula set loading unit of Kopperschmidt et al. to include the cannula set comprises a collection tube needle arranged to connect the cannula set to a blood collection tube, as disclosed in Higaki et al., so as to puncture a rubber plug which seals a vacuum blood collection tube when it is attached to the collection tube needle (see Higaki et al.: [0031]).
Regarding claim 12, Higaki et al. teaches a distal end (221) of the collection tube needle and a distal end (211) of the patient needle are oriented in opposite directions (see Figure 1).
Regarding claim 13, Higaki et al. teaches a second needle cap (4) configured to receive at least a portion of the collection tube needle (see Figure 1 and [0038] – “The resilient cap 4 to be engaged with the engaging portion 38 of the hub 3 has a bottom cylindrical shape, and has a size sufficient for accommodating the distal end 221 of the needle tube 22”).
Regarding claim 14, Higaki et al. teaches the cannula set comprises the second needle cap (see Figure 1 and [0038] – “The resilient cap 4 to be engaged with the engaging portion 38 of the hub 3 has a bottom cylindrical shape, and has a size sufficient for accommodating the distal end 221 of the needle tube 22”).
Regarding claim 15, Higaki et al. teaches the second needle cap is releasably coupled to the cartridge (see Figure 1 and [0038] – “The resilient cap 4 to be engaged with the engaging portion 38 of the hub 3 has a bottom cylindrical shape, and has a size sufficient for accommodating the distal end 221 of the needle tube 22”).
Regarding claim 19, Higaki et al. teaches the cartridge (3) is configured to hold the collection tube needle in a predefined, fixed position with respect to the cartridge (see [0032] – “The needle tubes 21 and 22 are secured to the hub 3 at the proximal portions 212 and 222 thereof. The hub 3 is a hollow tubular member including internal passages, more specifically, including needle tube holding portions 31 and 32 for inserting the proximal portion 212 of the needle tube 21 and the proximal portion 222 of the needle tube 22, and an internal passage having a void 33 where the later-described valve member is disposed, and a guiding passage 34”).
Regarding claim 21, it is noted Kopperschmidt et al. does not specifically teach the cannula set further comprises a connection element coupled to a second end of the tube opposite the first end of the tube. However, Higaki et al. teaches the cannula set further comprises a connection element (3, 22) coupled to a second end of the tube opposite the first end of the tube (see Figure 1 and [0031] – “The needle tubes 21 and 22 of the present invention are hollow tubes, and distal ends 211 and 221 thereof are formed with sharp cutting edges. The distal end 211 is for puncturing a blood vessel via a patient's skin, and the distal end 221 is for puncturing a rubber plug which seals a vacuum blood collection tube”). 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 cannula set loading unit of Kopperschmidt et al. to include the cannula set comprises a collection tube needle arranged to connect the cannula set to a blood collection tube, as disclosed in Higaki et al., so as to puncture a rubber plug which seals a vacuum blood collection tube when it is attached to the collection tube needle (see Higaki et al.: [0031]).
Regarding claim 22, Higaki et al. teaches the connection element comprises the collection tube needle (see Figure 1 and [0031] – “The needle tubes 21 and 22 of the present invention are hollow tubes, and distal ends 211 and 221 thereof are formed with sharp cutting edges. The distal end 211 is for puncturing a blood vessel via a patient's skin, and the distal end 221 is for puncturing a rubber plug which seals a vacuum blood collection tube”).
Regarding claim 23, Higaki et al. teaches the connection element comprises a connection element hub to manipulate the connection element (see [0032] – “The needle tubes 21 and 22 are secured to the hub 3 at the proximal portions 212 and 222 thereof. The hub 3 is a hollow tubular member including internal passages, more specifically, including needle tube holding portions 31 and 32 for inserting the proximal portion 212 of the needle tube 21 and the proximal portion 222 of the needle tube 22, and an internal passage having a void 33 where the later-described valve member is disposed, and a guiding passage 34”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEVIN B HENSON whose telephone number is (571)270-5340. The examiner can normally be reached M-F 7 AM ET - 5 PM ET.
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/DEVIN B HENSON/Primary Examiner, Art Unit 3791
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