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 .
Response to Amendment
The examiner acknowledges the reply filed on 07/11/2025 in which claims 1, 4, 8, and 9, were amended. Currently, claims 1-11 are pending for examination in this application.
Response to Arguments
Applicant's arguments filed 07/11/2025 have been fully considered but they are not persuasive. Applicant’s representative asserts that the prior art of record does not disclose the invention as claimed.
The examiner has fully considered the applicant’s arguments but they are not persuasive. It is the examiner’s position that given a careful reading, the claims do not distinguish over the prior art of record.
First, applicant’s representative makes inaccurate remarks regarding the claim interpretation under 35 U.S.C. 112(f). A review of the non-Final (mailed 2/11/2025) shows that the examiner merely placed the claim interpretation under 35 U.S.C. 112(f) on the record for the limitations of “spring-loaded mechanism” and “retraction mechanism” in claim 11. This in no way indicates these limitations as indefinite or unsupported by the specification. (The examiner notes claim 11 was rejected under 112(b) for reasons other than 112(f) interpretation). As such, applicant’s representative’s arguments are moot.
Next, applicant’s representative makes arguments relative to the standing 35 U.S.C. 112(b) rejections of claim 1. Regarding claim 1, it is argued that the “cannula” and “introducer needle” are explicitly recited in the claim. The examiner respectfully disagrees. First, the examiner notes that the “introducer needle” was never asserted to be part of a functional limitation. As stated in the standing rejection, the “cannula” and “sensor” are introduced in the preamble of the claim as part of a functional limitation (“for inserting a cannula and a sensor into a user”). As such, both the structure of the “cannula” and the “sensor” are not positively recited claim limitations. The claim in then made indefinite by the recitation of “an introducer needle disposed in at least a portion of the cannula.” Applicant’s representative has not responded to the issue raised by the examiner, but has merely added the limitation of “sensor” to another functional limitation (“configured to move a cannula and a sensor”). Given this, the “cannula” and “sensor” remain as functional limitations and the claim remains indefinite as stated above.
Regarding claims 2-4 and 6-11, applicant’s representative has either not addressed the issues identified in the standing 112(b) rejections or has merely summarized said rejections. Further, no amendments have been made which address and/or resolve the issues raised by the examiner.
Next, applicant’s representative makes arguments relative to the standing 35 U.S.C. 101 rejection of claim 8. Applicant’s representative asserts the newly filed amendments to the claim address the concern raised in the standing rejection. Again, the examiner respectfully disagrees. The additional added limitation changing “wherein the introducer needle initially penetrates the skin” to “wherein the introducer needle initially penetrates the skin of the user” does not remedy the fact that skin of the user (directed to a human organism) is still positively recited. The examiner suggests the limitation be amended to a functional limitation indicating the introducer needle is “configured to penetrate” the skin of the user.
Finally, applicant’s representative asserts the prior art to Griffin fails to teach the limitations as claimed. Specifically, applicant’s representative argues Griffin does not “teach or disclose a needle retraction mechanism having a distinct retraction spring that operates automatically post-insertion, independent of the insertion spring.” Again, the examiner respectfully disagrees. As best understood by the examiner, it would appear applicant’s representative’s remarks inaccurately characterize the apparatus taught by Griffin, as well as rely on functionality not currently recited in the pending claims. As indicated in the standing rejection below, Griffin discloses both a “cannula insertion spring” (figures 7/8, item 155), as well as a “needle retraction spring” (figures 7/8, item 156). Furthermore, although functionally not presently required by the claims, the needle retraction spring taught by Griffin clearly automatically retracts post-insertion (paragraphs [0098], [0099]). Given this, applicant’s representative’s arguments are found to be unpersuasive.
In light of the above remarks and standing rejection below, the examiner asserts the prior art of record teaches all elements as claimed and these elements satisfy all structural, functional, operational, and spatial limitations currently in the claims. Therefore, the standing rejections are proper and maintained.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-11 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 1] The claim recites the functional limitation of “for inserting a cannula and a sensor into a user” in the preamble of the claim. As such, the “cannula” and “sensor” are not positively recited limitations in the claim. However, the claim further recites “an introducer needle disposed in a least a portion of the cannula.” The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim intends to positively recite the “cannula” or not. For purposes of examination, it is interpreted that the cannula has not been positively recited.
[Claim 2] The claim recites the limitation of “further comprising a tri-lumen structure” in the 1st line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear what portion of the “cannula and sensor insertion mechanism” is intended to have a “tri-lumen structure.” For purposes of examination, it is interpreted that the “tri-lumen structure” is describing the functionally recited “cannula.” As such, the examiner notes the “tri-lumen structure” is interpreted as not being a positively recited claim limitation.
[Claim 3] The claim recites the limitation of “a sensor” in the 2nd line of the claim. The examiner is unable to determine the metes and bounds of the claims, since it is unclear if “a sensor” refers to the previously functionally recited “sensor” in the 1st line of claim 1, or if an additional sensor is intended to be claimed. For purposes of examination, it is interpreted that “a sensor” refers to the previously functionally recited “sensor” recited in the 1st line of claim 1. As such, “a sensor” recited in claim 3 is not a positively recited claim limitation.
[Claim 4] The claim recites the limitation of “wherein the introducer needle is disposed within the cannula and remains flush with a bottom surface of a base housing of the cannula and sensor insertion mechanism.” The examiner is unable to determine the meets and bounds of the claim, since it is unclear how this is possible if the “introducer needle” is intended to be inserted into a user. For purposes of examination, it is interpreted that the limitation only refers to a pre- or post-insertion state of the introducer needle, wherein the introducer is not inserted into a user.
[Claim 6] The claim recites the limitation of “the bottom surface of the base housing” in the 2nd line of the claim. There is a lack of antecedent basis for these limitations in the claims. Further, it is unclear how these structures are associated with “the cannula, the introducer needle, and the sensor.” For purposes of examination, it is interpreted that a base housing fully contains “the cannula, introducer needle, and the sensor” in a pre-insertion state, but allows for extension “beyond a bottom surface” in a post-insertion state.
[Claim 7] The claim recites the limitation of “a needle retraction spring” in the 2nd line of the claim. The examiner is unable to determine the metes and bounds of the claims, since it is unclear if “a needle retraction spring” refers to the “needle retraction spring” recited in claim 1, or if an additional spring is intended to be claimed. For purposes of examination, it is interpreted that “a needle retraction spring” recited in claim 7 refers to the previously recited “needle retraction spring” recited in claim 1.
[Claim 8] The claim recites the limitation of “the skin” in the 2nd line of the claim. There is a lack of antecedent basis for this limitation in the claims. For purposes of examination, it is interpreted that “the skin” refers to a skin of the user.
[Claim 9] The claim recites the limitation of a “method of inserting a cannula and a sensor into a user” in the preamble of the claim. In addition, the claim recites the limitation of “a cannula” in the 3rd line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if “a cannula” in the 3rd line of the claim refers to the previously recited cannula, or if an additional cannula is being introduced into the claim language. For purposes of examination, it is interpreted that “a cannula” in the 3rd line of the claim refers to the previously recited cannula.
[Claim 10] The claim recites the limitation of “a sensor” in the 1st and 2nd lines of the claim. However, claim 9, upon which claim 10 directly depends, recites the limitation of a “method of inserting a cannula and a sensor into a user” in the preamble of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if “a sensor” refers to the previously recited sensor, or if an additional sensor is being introduced into the claim language. For purposes of examination, it is interpreted that “a sensor” refers to the previously recited sensor.
[Claim 11] The claim recites the limitation of “configured to insert a cannula and a sensor into a user” in the 1st line of the claim. In addition, the claim recites the limitation of “a spring-loaded mechanism that pushes a cannula and a sensor into the user” in the 2nd line of the claim. The examiner is unable to determine the metes and bounds of the claim, since it is unclear if the claim recites multiple cannulas and sensors, or if only one cannula and sensor are intended to be recited. For purposes of examination, it is interpreted that only one cannula and sensor are intended to be recited.
[Claims 2-8 and 10] The claims are rejected based upon their dependency from independent claims 1 and 9.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 8 is rejected under 35 U.S.C. 101 because 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 8 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). The claim recites “wherein the introducer needle initially penetrates the skin of the user.” As this is not functionally recited, the recitation is interpreted to encompass a human organism.
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 1-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Griffin (PGPub 2008/0051738).
[Claims 1, 3, and 8-11] Griffin teaches a system and method comprising a cannula and sensor insertion mechanism (figures 7 and 8) for inserting a cannula (figures 7/8, item 148) and a sensor (paragraph [0060], “the sensor may be included with as a part or along side the infusion cannula and/or needle”; paragraph [0185], “Such sensor(s) may include a hollow needle or cannula and/or a set of micro-needles, as described above, for piercing the patient-user's skin to convey fluid from the patient to the sensor”) into a user, the mechanism comprising:
a cannula insertion spring (spring-loaded mechanism) (figures 7/8, item 155) configured to move a cannula (figures 7/8, item 148) and a sensor (paragraph [0060]) from a first pre-insertion position (figure 7) to a second post-insertion position (figure 8), wherein the cannula insertion spring (figures 7/8, item 155) is used to push a sensor (paragraphs [0060], [0185]) (see 112(b) interpretation above) toward and into the user (figure 8) (paragraphs [0092]-[0094]);
an introducer needle (figures 7/8, item 172) disposed in (figure 7) at least a portion of the cannula (see 112(b) interpretation above) (figures 7/8, item 148) and configured to insert the cannula (figures 7/8, item 148) and the sensor (paragraph [0060]) into a user (figure 8), wherein the introducer needle (figures 7/8, item 172) initially penetrates the skin (see 112(b) interpretation above) (paragraphs [0042], [0100]) to allow the cannula (figures 7/8, item 148) and/or the sensor (paragraphs [0060], [0185]) to be inserted into the user (figures 7 and 8);
a needle retraction spring (retraction mechanism) (figures 7/8, item 156) configured to remove or partially retract the introducer needle (figures 7/8, item 172) from within the cannula (figures 7/8, item 148) after the cannula (figures 7/8, item 148) is inserted into the user (figure 8; paragraph [0095]); and
a trigger arm (figure 7, item 159) configured to hold the cannula insertion spring (figures 7/8, item 155) such that the cannula (figures 7/8, item 148) is in the first pre-insertion position (figure 7) and configured to release the insertion spring (figures 7/8, item 155) such that the cannula (figures 7/8, item 148) moves to the second post-insertion position (figure 8) (figures 7 and 8; paragraphs [0094], [0100]).
[Claim 2] Griffin teaches the limitations of claim 1, upon which claim 2 depends. As noted in the rejections above (see 112(b) interpretation above), the “cannula” is not a positively recited claim limitation. As such, the structure taught by Griffin is functionally capable of comprising a cannula with a tri-lumen structure.
[Claim 4] Griffin teaches the limitations of claim 1, upon which claim 4 depends. Griffin further discloses the introducer needle (figures 7/8, item 172) is disposed within the cannula (figures 7/8, item 148) and remains flush (see 112(b) interpretation above) with a bottom surface (the examiner notes any point on the “surface” of the housing, which is “flush with” the needle, can be considered to meet this limitation) of a base housing (figures 7/8, item 144) of the cannula and sensor insertion mechanism (figures 7/8).
[Claim 5] Griffin teaches the limitations of claim 1, upon which claim 5 depends. Griffin also teaches the trigger arm (figure 7, item 159) is released such that the cannula (figures 7/8, item 148), the introducer needle (figures 7/8, item 172), and the sensor (paragraphs [0060], [0185]) (again, the examiner notes the “sensor” is not a positively recited limitation) move toward and into the user (figures 7 and 8).
[Claim 6] Griffin teaches the limitations of claim 5, upon which claim 6 depends. In addition, Griffin teaches the cannula (figures 7/8, item 148), the introducer needle (figures 7/8, item 172), and the sensor (paragraphs [0060], [0185]) extend beyond the bottom surface (figure 8) of the base housing (figures 7/8, item 144) (see 112(b) interpretation above) (figures 7 and 8).
[Claim 7] Griffin teaches the limitations of claim 1, upon which claim 7 depends. Griffin further discloses a retract trigger (figures 7/8, item 160) contacts a surface of an insertion guide member (figures 7/8, items 146/166) and a needle retraction spring (figures 7/8, item 156) (see 112(b) interpretation above) is allowed to release to retract the introducer needle (figures 7/8, item 172), thereby allowing the cannula (figures 7/8, item 148) and the sensor (paragraphs [0060], [0185]) to remain inserted inside of the user (figure 8) (paragraphs [0097]-[0101]).
Conclusion
THIS ACTION IS MADE FINAL. 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 JASON E FLICK whose telephone number is (571)270-7024. The examiner can normally be reached M-F 7 a.m.-3 p.m. Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JASON E FLICK/Primary Examiner, Art Unit 3783 10/16/2025