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 .
Election/Restrictions
Applicant’s election of Group I in the reply filed on March 25, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 15-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statement (IDS) submitted 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 § 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.
Claim 5 is 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.
Regarding claim 5, the claim is drawn towards a first needle and an analyte sensor and a second needle and cannula which are received by the first and second UV reflectors, respectively. It is unclear if these components are part of the implantable component recited in claim 1 or if these are separate components so that the implant comprises the implantable component in addition to the needle and analyte sensor. For examination purposes, the components of claim 5 are considered to be the implantable component of claim 1 and are also considered to be positively recited elements of the claim since the claim recites that the UV reflector “receives” rather than “is configured to receive”.
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.
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 1-14 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).
Regarding claim 1, it appears that the claim inadvertently positively claims the human body since the claim recites “A minimally invasive implant worn flush against a patient’s skin” in the preamble and “a UV window positioned between the at least one UV reflector and the patient’s skin” in line 18. It is recommended to amend these limitations to recite “configured to be worn flush” and “configured to be positioned between” to overcome the rejection.
Claims 2-14 are also rejected by virtue of being dependent on claim 1.
Allowable Subject Matter
Claims 1-14 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 101, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter:
The closest prior art is Gerber (US 20160082281), Armour (US 20210401537), and Suematsu (US 20230264007).
Regarding claim 1, the prior art fails to fairly teach or suggest a UV window positioned between the at least one UV reflector and the patient's skin such that diverted UV-C light shines through the UV window to sterilize the patient's skin, the UV window comprising an opening configured to allow the implantable component to at least partially pass through the UV window to implant in the patient's skin.
Gerber discloses a minimally invasive implant worn flush against a patient's skin (fig. 1E) comprising:
a UV light emitter configured to emit UV-C light (LED 121 in fig. 1E; paragraph 24 discloses UVC light);
at least one UV reflector configured to receive light from the UV light emitter (reflective surface 109 with window 102 which surrounds opening 111 in fig. 1A), the at least one UV reflector comprising:
an interior cavity (cavity formed by surface 109 in fig. 1A) comprising:
an implant receiving portion running lengthwise along the at least one UV reflector and configured to receive at least some of the implantable component (opening 111 in fig. 1A); and
an angled surface configured to receive UV-C light from at least one light channel perpendicular to a centerline of the interior cavity (faceted surface 119 in figure 2A receives light from LED 121 in coupling 107) and to direct the received UV-C light towards an exit opening of the interior cavity such that the implantable component is sterilized by the UV-C light (paragraph 67 discloses directing light downwards towards the “predetermined location or site”).
Gerber further discloses that the device is intended to be used with an implantable component (paragraph 59 discloses trocars as an example device).
Armour teaches a similar device configured to be worn flush against a patient’s skin (apparatus 1 in fig. 257) and further teaches the device comprises an implantable component configured to at least partially implant into the patient's skin for a period of time of use of the minimally invasive implant (paragraph 431 discloses a catheter).
Suematsu is directed towards a device configured to be worn flush on a patient’s skin (fig. 1) which comprises a ring-shaped adhesive pad (adhesive section 233 in fig. 1) comprising an opening configured to allow an implantable component to at least partially pass through the adhesive to implant in the patient (hole 234 in fig. 1; paragraph 47).
The examiner notes that while PHOSITA may be motivated to modify Gerber with the teachings of Suematsu to include the ring-shaped adhesive on the bottom surface of the shell in order to adhere the shell of Gerber to the patient so that the adhesive would be between the UV reflector and the patient’s skin, it is the examiner’s opinion that the adhesive does not fairly constitute a UV window so that UV-C light can shine through the window to sterilize the patient’s skin, as required by the claim.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to COURTNEY FREDRICKSON whose telephone number is (571)270-7481. The examiner can normally be reached Monday-Friday (9 AM - 5 PM EST).
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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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/COURTNEY FREDRICKSON/ Primary Examiner, Art Unit 3783
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