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 .
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 12 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.
Claim 12 recites “the subcutaneous sensor” in line 3. There is insufficient basis for this limitation in the claim. The lack of antecedent basis causes the meaning of the claim to be unclear. A lack of clarity arises because it is unclear if it refers to “the subcutaneous sensor system” in claim 11 or if it is a new element. For the purposes of examination, the limitations are interpreted as not referring to any earlier recited elements.
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)(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 1-6 and 9-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Donnay (US 20110319729 A1).
With respect to claim 1, Donnay discloses a medical device (see Fig. 1 and see paragraph 0111-0112, insertion device #200), comprising:
a body part that is attachable to a body of a patient (see paragraph 0011-0112 and Fig. 1, inserter #200 has body electronics #1110 and adhesive layer #218 with includes analyte sensor #14 all within a housing #202), the body part having a receiving opening through which a functional element can be reversibly introduced into the body of a patient by an inserting device (see Figs. 4-6 and 16-17 and see paragraph 0156-0159 and 0168, there is a central aperture #220 and hole in #110 and #122 through which a sharp #224 can be introduced into the body of a patient via a needle hub #236 where [0140] discloses that the sharp is inserted into the skin of a patient); and
wherein the body part comprises a seal adapted to seal at least a part of the receiving opening after removal of the inserting device (see Fig. 4-6 and paragraph 0156-0159, housing #202 has a proximal cover #206 which is a sheet of material such as a foil sheet through which has an central aperture opening #220).
With respect to claim 2, all limitations of claim 1 apply in which Donnay further discloses wherein the seal comprises a self-sealing material that is adapted to seal or partially seal an opening in the self-sealing material caused by an inserting device, when or after the inserting device is removed (see Fig. 4-6 and paragraph 0156-0159, housing #202 has a proximal cover #206 which is a sheet of material such as a foil sheet through which has an central aperture opening #220 where applicant’s specification [0018]-[0019] discloses that the self-sealing material comprises a foil or foam or preformed material that is flexible in shape).
With respect to claim 3, all limitations of claim 2 apply in which Donnay further discloses wherein the self-sealing material comprises a foil or a foam or a preformed material (see Fig. 4-6 and paragraph 0156-0159, housing #202 has a proximal cover #206 which is a sheet of material such as a foil sheet through which has an central aperture opening #220 where applicant’s specification [0018]-[0019] discloses that the self-sealing material comprises a foil or foam or preformed material that is flexible in shape).
With respect to claim 4, all limitations of claim 1 apply in which Donnay further discloses wherein the seal comprises a sealing element configured to be introduced into the receiving opening (see paragraph 0173-0174 and Fig. 19-21, resilient member #70 may be introduced through recess #72).
With respect to claim 5, all limitations of claim 4 apply in which Donnay further discloses wherein the sealing element comprises a stopper that adapts to the form of the receiving opening (see paragraph 0173-0174 and Fig. 19-21, resilient member #70 may be introduced through central aperture where #70 may be formed from any elastomeric material including rubber, nitrile, vitron, urethane etc. and formed in any shape to fit recess #72).
With respect to claim 6, all limitations of claim 1 apply in which Donnay further discloses wherein the seal comprises a movable element that can be moved, by an inserting device, into an open position when the inserting device is inserted through the receiving opening and/or into a closed position when the inserting device is retracted from the receiving opening (see paragraph 0177 and Fig. 7, spring #246 is positioned within a recess #244 of housing #202 which is movable when needle hub #236 moves from a semi-compressed state initially to either fully compressed or extended).
With respect to claim 9, all limitations of claim 1 apply in which Donnay discloses wherein: the seal comprises an electrically insulating material so that a flow of electrical current through the receiving opening is prevented when the seal seals at least a part of the receiving opening after removal of an inserting device (see paragraph 0157, a recess may retain a silica gel where a silica gel is an electrically insulating material); and/or the seal is made from or comprises an electrically conductive material and the electrically conductive material is conductively connectable to the skin of a patient when the device is attached to a body of a patient.
With respect to claim 10, all limitations of claim 1 apply in which Donnay further discloses further including the functional element (see Figs. 4-6 and 16-17 and see paragraph 0156-0159 and 0168, sharp #224 can be introduced into the body of a patient via a needle hub #236 where [0140] discloses that the sharp is inserted into the skin of a patient), wherein the functional element comprises a subcutaneous sensor (see Figs. 4-6 and 16-17 and see paragraph 0156-0159 and 0168, sharp #224 carries sensor #14 with it into the skin of the subject), a subcutaneous drug infusion cannula or a combined subcutaneous drug infusion cannula with a subcutaneous sensor.
With respect to claim 11, Donnay discloses an analyte monitoring system (see Fig. 1 and see paragraph 0113-0115, analyte monitoring system #100) comprising a subcutaneous sensor system (see Fig. 1-2 and see paragraph 0113-0115, sensor system #14) and an analyte monitor connected or connectable to the subcutaneous sensor system (see Fig. 1-2 and see paragraph 0113-0115, display device #1200 is connected to #14 via transmission), the subcutaneous sensor system comprising a device according to claim 1 (see Fig. 1 and see paragraph 0111-0112, insertion device #200 is part of analyte monitoring system #100).
With respect to claim 12, all limitations of claim 11 apply in which Donnay further discloses wherein the analyte monitoring system is a continuous analyte monitor (see Fig. 1 and see paragraph 0113-0115, analyte monitoring system #100; and see paragraph 0117, real time analyte measurement; and see paragraph 0128, analyte monitoring system continuously receives and monitors analyte data) and the subcutaneous sensor is adapted to sense glucose in a body fluid of a patient when implanted (see paragraph 0093, in vivo glucose sensor).
With respect to claim 13, Donnay discloses a method of using a medical device (see paragraph 0098-0099, devices, systems, kits and/or methods to monitor analyte levels primarily glucose), comprising retracting an inserting device from a receiving opening of a body part of the medical device, wherein the body part is attached to a body of a patient (see Figs. 4-6 and 16-17 and see paragraph 0156-0159 and 0168, there is a central aperture #220 and hole in #110 and #122 through which a sharp #224 can be introduced into the body of a patient via a needle hub #236 where [0140] discloses that the sharp is inserted into the skin of a patient and further removed as explained in [0234] and [0239]), wherein the method further comprises sealing at least part of the receiving opening with a seal of the body part after retracting the inserting device from the receiving opening (see paragraph 0234-0239, remove inserter which seals the receiving opening).
With respect to claim 14, all limitations of claim 13 apply in which Donnay further discloses further comprising, before retracting the inserting device from the receiving opening, inserting the inserting device through the receiving opening and placing a functional element into the body of the patient (see Figs. 4-6 and 16-17 and see paragraph 0156-0159 and 0168, there is a central aperture #220 and hole in #110 and #122 through which a sharp #224 can be introduced into the body of a patient via a needle hub #236 where [0140] discloses that the sharp is inserted into the skin of a patient and further removed as explained in [0234] and [0239]).
With respect to claim 15, all limitations of claim 13 apply in which Donnay further discloses wherein the medical device is the medical device according to claim 1 (see Fig. 1 and see paragraph 0111-0112, insertion device #200).
With respect to claim 16, Donnay discloses a kit comprising a medical device according to claim 1 (see paragraph 0098-0099, devices, systems, kits and/or methods to monitor analyte levels primarily glucose), a functional element and an inserting device for inserting the functional element into a body of a patient (see Figs. 4-6 and 16-17 and see paragraph 0156-0159 and 0168, there is a central aperture #220 and hole in #110 and #122 through which a sharp #224 can be introduced into the body of a patient via a needle hub #236 where [0140] discloses that the sharp is inserted into the skin of a patient).
With respect to claim 17, all limitations of claim 16 apply in which Donnay further discloses wherein the inserting device comprises a needle (see Figs. 4-6 and 16-17 and see paragraph 0156-0159 and 0168, a needle hub #236 is a needle).
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.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Donnay in view of Chiu (US 20180169322 A1).
With respect to claim 7, all limitations of claim 1 apply in which Donnay does not specifically disclose wherein the seal comprises an absorbent element that is adapted to absorb a fluid and change, upon absorbing the fluid, its form so as to seal at least part of the receiving opening after removal of an inserting device.
Chiu teaches a seal which comprises an absorbent element that is adapted to absorb fluid and seal an opening (see paragraph 0054-0055, self-sealing septum #314 that is configured to fluidly seal a cannula #312 which seals a hole #328).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Donnay with the teachings of Chiu to have utilized a seal with an absorbent element because it would have resulted in the predictable result of sealing an aperture to inhibit leakage of fluid (Chiu: see [0067]-[0068]).
With respect to claim 8, all limitations of claim 7 apply in which Chiu further teaches wherein the absorbent material comprises one or more components that support coagulation of blood (see paragraph 0054, fluidic seal to prevent blood from spilling).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NIDHI PATEL whose telephone number is (571)272-2379. The examiner can normally be reached Mondays to Fridays 9AM-5PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.N.P./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791