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 .
DETAILED ACTION
Specification
The disclosure is objected to because of the following informalities: on page 7, line 3, “radially0entending gap 7” appears to be in error for “radially extending gap 7”.
Appropriate correction is required.
Claim Objections
Claim 36 is objected to because of the following informalities: “the substate” is apparently in error for “the substrate”. Appropriate correction is required.
Claim 44-46 are objected to because of the following informalities: “at least some light sources” is apparently in error for “at least some of the light sources”; “from skin” is apparently in error for “from the skin”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 38-39 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim repeats limitations from claim 31. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 31-48 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 claim 31, “a flexible substrate” (line 5) is indefinite because it is unclear if it is the same or different from the previously defined flexible substrate; “the aperture” lacks antecedent basis; “a needle” (line 12) is indefinite because it is unclear if it is the same or different from the previously defined needle; “a patient’s skin” (line 16) is indefinite because it is unclear if it is the same or different from the previously defined patient’s skin.
In claim 34, “an exposed adhesive” is indefinite because it is unclear if it is the same or different from the “adhesive” of claim 31; “a patient’s skin” (line 2) is indefinite because it is unclear if it is the same or different from the previously defined patient’s skin.
In claim 35, “the adhesive layer” lacks antecedent basis.
In claim 36, “the distal side, and “the proximal side” lack antecedent basis.
In claim 38-39, “an interface” is indefinite because it is unclear if it is the same or different from the “interface” of claim 31; “an electrical lead” is indefinite because it is unclear if it is the same or different from the “electrical lead” of claim 31.
In claim 47, “the light source emitted radiation” and “the body” lack antecedent basis.
Allowable Subject Matter
Claims 31-48 would be allowed if all 112 rejections and claim objections were overcome.
The following is a statement of reasons for the indication of allowable subject matter: US 2016/0242649 teaches a substrate comprising LED light sources arranged around an opening, the substrate being generally annular and having a radial gap (Fig 1). US 2020/0324061 teaches LED light sources on a substrate, and a driver with physical and electrical engagement through an interface, the interface including an electrical lead (Fig 4; driver 17, lead 18, light sources 16). US 2023/0191042 and US 2016/0287814 teach LED light sources on a flexible substrate. However, the references fail to teach a transparent membrane extending across an opening of the flexible substrate and said membrane is configured to be punctured by a needle, wherein the membrane has adhesive on a distal skin-facing surface, the adhesive allowing the membrane to adhere the membrane to a patient's skin surrounding a the needle in use to provide a hygienic environment around a puncture site, and wherein the substrate is peelable from the membrane after the membrane has adhered to a patient's skin, the membrane being of elastomeric material. WO 2014035588 teaches a flexible substrate and a transparent membrane extending across an opening, the membrane comprising an adhesive (Fig 4-5; substrate 1260, membrane 1262), but fails to teach a plurality of surface mounted LED light sources arranged in a pattern on the flexible substrate near an edge of the substrate. WO 2007106068 teaches a transparent membrane around a puncture site being made of elastomeric material (abstract) but fails to teach a generally annular flexible substrate or a plurality of surface mounted LED light sources arranged in a pattern on the flexible substrate near an edge of the substrate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW NGUYEN whose telephone number is (571)270-5063. The examiner can normally be reached 8 am - 4 pm, Monday-Friday.
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/ANDREW H NGUYEN/Primary Examiner, Art Unit 3741