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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 4/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 11-21 are 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.
Claims 11-21 are 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). Claims 11 and 19 both recite “a substrate comprising mammalian skin” which includes positively reciting the human body.
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 1-21 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.
In regard to claim 1, the reference to “the second major surface” on lines 6-7 is unclear because the discontinuous base layer and first rotationally distinct segment are both recited as having second major surfaces. For the purposes of this action, it assumed that the correct reference it to the second major surface of the first rotationally distinct segment but amendments are required. The same issues exist throughout the claims where the surface is not properly identified.
The dependent claims are rejected at least for their dependency on the rejected independent claim.
Claims 11 and 19 have the same issue and are rejected for the same reasons.
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.
Claim(s) 1, 4-5, 9-11, 14, 17, and 19-21 are rejected under 35 U.S.C. 103 as being unpatentable over Bertollo et al. (US 2019/0314012; hereafter Bertollo) in view of Kitotech Medical Inc (WO 2017/151806;hereafter Kitotech).
In regard to claim 1, Bertollo discloses a composite medical article (610; see Figs. 20a-20e) comprising: an attachment article comprising: a discontinuous base layer (see bottom of 610) comprising distinct segments with a first major surface and a second major surface (any of the surfaces can be characterized in this way as no particular structural limitation is implied); a first rotationally distinct segment (614), where the first rotational segment is circular or semicircular (shown as circular in Fig. 20a), has a first major surface and a second major surface (any of the surfaces can be characterized in this way as no particular structural limitation is implied), wherein the second major surface is attached to a portion of a segment of the discontinuous base layer (all of the surfaces are part of 610 and therefore can be considered attached), and wherein the first major surface comprises a first sequential circular or semi-circular array of angled microneedles (626); a second rotationally distinct segment (616), where the second rotational segment is circular or semicircular (shown as circular in Fig. 20a), has a first major surface and a second major surface (any of the surfaces can be characterized in this way as no particular structural limitation is implied), and wherein the second major surface is attached to a portion of a segment of the discontinuous base layer (all of the surfaces are part of 610 and therefore can be considered attached), and wherein the first major surface comprises a second sequential circular or semi-circular array of angled microneedles (628); and a communication member (the surfaces between 614 and 616 that allow for relative rotation between 614 and 616; see par. [0130])) disposed between and at least in contact with the first rotationally distinct segment and the second rotationally distinct segment, and a device (40) attached to at least a portion of the first major surface of the base layer of the attachment article.
Bertollo does not expressly disclose wherein the angle of a microneedle of the first array of microneedles, relative to a point on the first major surface of the first rotational segment is such that the point, the point of attachment of the microneedle to the first major surface of the first rotational segment, and the tip of the microneedle forms an angle of 40-80°, and the angle of a microneedle of the second array of microneedles, relative to the same point on the first major surface of the first rotational segment is such that the point, the point of attachment of the microneedle to the first major surface of the second rotational segment, and the tip of the microneedle forms an angle of 140-100°. The angle of one set of microneedles is clearly less than 90°, whilst the angle of the other set of microneedles is clearly greater than 90° and less than 180°. There are however no angles specified in Bertollo.
It would however be obvious to the skilled person based on their technical knowledge to provide microneedles within the given angle ranges, both of which constitute a wide range of 40°, at least 10° beyond the vertical (90°) in both cases. The skilled person would realize such angles in the concentric rings of Bertollo, and would arrive at the subject matter of claims 1 and 19 without inventive activity.
The instant disclosure describes the parameters of the microneedle angles as being merely preferable, and does not describe the microneedle angles as contributing any unexpected results to the system. As such, parameters such as the predetermined distance are considered to be matters of design choice, well within the skill of the ordinary artisan, obtained through routine experimentation in determining optimum results. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention that the limitation of the microneedle angles would be dependent on the actual application of the system and, thus would be a design choice based on the actual application.
In a similar art, Kitotech discloses, in particular paragraphs 262, 263, 265 and 267 together with Fig. 18 for example, in which an anchoring mechanism is disclosed, albeit as part of a wound closure device, having opposing microneedle arrays having angles within the claimed ranges in claim 1 of the current application. As such the skilled person, should they need such an additional motivation, would receive this from the teaching of Kitotech.
In regard to claim 4, Bertollo discloses, wherein the device (40) comprises a sensor, a monitor, tubing, a vascular access device, a drainage catheter, a drive line device, or a wearable medical device (see par. [0130]).
In regard to claim 5, Bertollo discloses wherein the microneedles of the attachment article comprise tapered cones comprising a point (see Fig. 20c).
In regard to claim 9, Bertollo discloses wherein the microneedles of the first and second arrays comprise plastics, metals, absorbable materials, or a combination thereof (see par. [0114], [0132], [0134]).
In regard to claim 10, Bertollo discloses wherein the microneedles of the first or the second arrays or both comprise absorbable materials (see par. [0142]).
In regard to claim 11, Bertollo discloses the medical construction (see rejection of claim 1) and further including a substrate comprising mammalian skin (patient’s skin).
In regard to claim 14, see rejection of claim 4.
In regard to claim 17, see rejection of claim 9.
In regard to claim 19, Bertollo discloses the method of using the medical construction (see rejection of claim 1) and further including a substrate comprising mammalian skin (patient’s skin).
In regard to claims 20-21, the segments are rotatable relative to each other (see par. [0130]).
Claim(s) 2-3 and 12-13 rejected under 35 U.S.C. 103 as being unpatentable over Bertollo and Kitotech in view of D’ Aloiso et al. (US 2017/0157364; hereafter D’Aloiso).
In regard to claims 2-3 and 12-13, the combination fails to teach wherein the communication member comprises a compliant member or a rolling member, wherein the communication member comprises a compliant member selected from a spring or a flexible bar, or a rolling member comprising a ball bearing or a disc.
In a similar art, D’Alosio discloses wherein the communication member comprises a compliant member or a rolling member (95), wherein the communication member comprises a compliant member selected from a spring or a flexible bar, or a rolling member comprising a ball bearing (95) or a disc (see par. [0037]).
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 combination with the ball bearings of D’Alosio in order to provide a means for allowing relative rotation between two rotatable elements.
Claim(s) 6 is rejected under 35 U.S.C. 103 as being unpatentable over Bertollo and Kitotech in view of Evonik Corporation (WO 2019/136033; hereafter Evonik).
In regard to claim 6, the combination fails to teach wherein the microneedles further comprise at least one barb or a stopping portion to limit the depth that the microneedle can penetrate the substrate surface.
In a similar art, Evonik discloses wherein the microneedles (18) further comprise at least one barb (30; Figs. 4A-4G or 134; Figs. 5-6) or a stopping portion to limit the depth that the microneedle can penetrate the substrate surface.
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 device of the combination with the barbs of Evonik in order to provide a microneedle that anchored into the skin of a patient.
Claim(s) 7-8 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Bertollo and Kitotech in view of The Procter & Gamble Company (WO 02/32480; hereafter Procter).
In regard to claims 7 and 15, the combination fails to teach, wherein some of the microneedles in the first array of angled microneedles, the second array of angled microneedles, or both are different from the majority of the angled microneedles, the difference being different in shape, configuration, composition or a combination thereof.
In a similar art, Procter discloses wherein some of the microneedles in the first array of angled microneedles, the second array of angled microneedles, or both are different from the majority of the angled microneedles, the difference being different in shape, configuration, composition or a combination thereof (see page 15, last paragraph and Fig. 30).
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 combination with the different microneedles in order to provide an alternate means for penetrating the skin.
In regard to claims 8 and 16, Bertollo discloses wherein the different microneedles in the microneedle array or arrays are hollow permitting the flow of fluids through the microneedles, are conductive permitting electric monitoring through the microneedle, are bioabsorbable (see par. [0142]), or a combination thereof.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Bertollo and Kitotech in view of Kobayashi et al. (US 2021/023356; hereafter Kobayashi).
In regard to claim 18, the combination further comprising an adhesive article, wherein the adhesive article seals at least a portion of the attachment article of the medical construction from the outside environment, aids in the attachment of the medical construction to the substrate surface, or both.
In a similar art, Kobayashi discloses further comprising an adhesive article, wherein the adhesive article seals at least a portion of the attachment article of the medical construction from the outside environment, aids in the attachment of the medical construction to the substrate surface, or both (see par. [0057] and [0089]).
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 combination with the teachings of Kobayashi in order to provide an article with adhesive securing means for attaching to the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THEODORE J STIGELL whose telephone number is (571)272-8759. The examiner can normally be reached M-F 9-5:30 EST.
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THEODORE J. STIGELL
Primary Examiner
Art Unit 3783
/THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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