DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 8-24 are pending and currently under consideration for patentability under 37 CFR 1.104
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (PRO 62/320290 filed on 4/8/2016; PRO 62/344852 filed on 6/2/2016; PRO 62/344847 filed on 6/2/2016; PRO 62/402676 filed on 9/30/2016; 15/357885 filed on 11/21/2016; and 16/824624 filed on 3/19/2020) are acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 23 August 2024 and 11 November 2025 has been considered by the examiner.
Claim Rejections - 35 USC § 112B
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 8-24 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 pre-AIA the applicant regards as the invention.
Claim 8 recites:
“the device” in line 1, which is indefinite. Does this refer to medical sensing device previously recited?
“one of the major walls” in lines 7-8, which lack antecedent basis. Should this be changed to –one of the lower major wall or the upper opposing major wall--?
“the other major wall” in line 9, which lacks antecedent basis.
Claims 8-24 recite “sensing device” in the preamble, all of which should be changed to --medical sensing device--.
Claim 9 recites “touching connection” in line 3, which is indefinite. What is touching connection?
Claim 10 recites “the side” in line 4, which lacks antecedent basis.
Claim 11 recites:
“the side” in line 6, which lacks antecedent basis.
“touching connection” in line 8, which is indefinite. What is touching connection?
Clam 13 recites:
“the contacts” in lines 3-5, which lack antecedent basis.
“the strips” in line 3, which is indefinite. Does this refer to the “two strips” previously recited?
Claim 14 recites “the upper and lower walls” in line 4, which is indefinite. Do these refer to lower major walls and upper opposing major wall previously recited in claim 1?
Claim 20 recites “the upper major wall” and “the sensing device”, which should be changed to --the upper opposing major wall-- and --the medical sensing device--, respectively.
Claim 21 recites “the upper major wall” in multiple instances, both of which should be changed to --the upper opposing major wall--.
Claim 24 recites “less than about 1.4 inches by 1 inch by 0.2 inches in size,” which is indefinite as these pertains to the recitation of relative terminology.
Claim Rejections - 35 USC § 102(A)(1)
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 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 8, 10, 12, 15, 16, 20, 21, 23, and 24 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Bernstein et al. (U.S. PG Pub. No. 2016/0015303 A1) (hereinafter “Bernstein”).
Bernstein was cited in applicant’s IDS submitted on August 23, 2024.
With respect to claim 8, Bernstein teaches a medical sensing device for sensing an analyte (see title, abstract), the device comprising: a case (410A in Fig. 4A) having a lower major wall adapted to be mounted against a skin of a patient (bottom of assembly in Fig. 4A adapted to be mounted against a skin in order to advance implantable device to come into contact with patient’s blood), and an upper opposing major wall (upper curved portion of case depicted in Fig. 4A); a sensor extending from the case (401 in Figs. 4-6) and having a distal end sensitive to the analyte to produce an electrical signal (par.0129 “electrical signal path... of the analyte sensor 401”), and a proximal end within the case having electrical contacts (par.0129 “electrical contacts”); a printed circuit board assembly within the case supported by one of the major walls to receive the electrical signal via the electrical contacts (par.0124 “PCB 411”); and an elastomeric pad (par.0138; 510 in Figs. 5, 6) disposed in the case and biased by the other major wall to urge the said proximal end of the sensor into contact with the printed circuit board assembly and maintain an electrical connection between the electrical contacts and the printed circuit board assembly (sensor 401 is urged into contact with PCB 411 as pad 510 is adhered to the sensor; see par.0134).
With respect to claim 10, Bernstein teaches the electrical contacts on the sensor face away from the printed circuit board assembly; the printed circuit board assembly has contact pads displaced to the side of the sensor, and the elastomeric pad includes conductive strips positioned to connect electrically the contact pads of the printed circuit board assembly to respective electrical contacts of the sensor to maintain the electrical connection (see Figs. 5, 6; the contacts on the PCB have to be opposite of the conductive strips 520 and are therefore displaced to the side of the sensor).
With respect to claim 12, Bernstein teaches the elastomeric pad has alternating conductive layers and non-conductive layers along its length such that the elastomeric pad is conductive along its width and height, but not along its length (510 and 520 in Fig. 6; par.0128).
With respect to claim 15, Bernstein teaches a transmitter electrically coupled to the printed circuit board assembly and inside the case, wherein the transmitter is adapted to transmit analyte readings sensed by the sensor (1320 in Fig. 13; par.0164).
With respect to claim 16, Bernstein teaches a battery electrically coupled to the printed circuit board assembly and inside the case (350 in Fig. 3; par.0122).
With respect to claim 20, Bernstein teaches a button in the upper major wall, wherein the button is adapted to activate the sensing device (par.0103).
With respect to claim 21, Bernstein teaches the case comprises an upper housing including the upper major wall and a lower housing including the upper major wall, and wherein the upper housing is connected to the lower housing in a water tight manner (par.0071 “waterproof housing”).
With respect to claim 23, Bernstein teaches the analyte is glucose (par.0083).
With respect to claim 24, Bernstein teaches the case is less than about 1.4 inches by 1 inch by 0.2 inches in size (implicit from par.0117).
Claims 8, 9, 15, and 16 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Pace et al. (U.S. PG Pub. No. 2013/0150691 A1) (hereinafter “Pace”).
Pace was cited in applicant’s IDS submitted on August 23, 2024.
With respect to claim 8, Pace teaches a medical sensing device for sensing an analyte, the device comprising: a case having a lower major wall adapted to be mounted against a skin of a patient, and an upper opposing major wall (device in Figs. 40-46 has upper/lower parts of a casing, of which the lower part of the casing contacts the skin via sensor 4112); a sensor extending from the case and having a distal end sensitive to the analyte to produce an electrical signal (par.0011 “sensor for detecting electrical signals from the sensor”; sensor 4112 produces electrical signals in Fig. 41C), and a proximal end within the case having electrical contacts (par.146 “electrical contacts 4110 of the sensor 4112”); a printed circuit board assembly within the case supported by one of the major walls to receive the electrical signal via the electrical contacts (par.0146 “circuit board 4102”); and an elastomeric pad disposed in the case and biased by the other major wall to urge the said proximal end of the sensor into contact with the printed circuit board assembly and maintain an electrical connection between the electrical contacts and the printed circuit board assembly (par.0146 “the circuit board 4102 includes a socket connector 4104 that has an arrangement of stacked conductive elastomeric O-rings 4106 disposed within the inner diameter of the socket connector 4104. A sensor support 4108 is adapted to hold the electrical contacts 4110 of the sensor 4112 in a corresponding stack facing radially outward… sensor assembly 4100 can be inserted into the socket connector 4104 of the electronics assembly 4102 in any radial/rotational orientation”; see also Figs. 41A-41C).
With respect to claim 9, Pace teaches the electrical contacts on the sensor face the contact pads on the printed circuit board assembly; and the elastomeric pad presses the electrical contacts on the sensor into touching connection with corresponding contact pads on the printed circuit board assembly to maintain the electrical connection (par.0144; Figs. 36, 37; elastomeric backing in 3604 presses the contacts of sensor 3300 onto the contacts of PCB 3706 which are located on a second elastomeric unit inside part 3704).
With respect to claim 15, Pace teaches a transmitter electrically coupled to the printed circuit board assembly and inside the case, wherein the transmitter is adapted to transmit analyte readings sensed by the sensor (par.0081; Fig. 2G).
With respect to claim 16, Pace teaches a battery electrically coupled to the printed circuit board assembly and inside the case (2406 in Fig. 24A).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 11, 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Pace.
With respect to claims 11, 13, and 14 Pace teaches a medical sensing device for sensing an analyte.
However, Pace does not explicitly teach the limitations recited in claims 11, 13, and 14.
With respect to claim 11, Pace renders obvious the proximal end of the sensor has electrical contacts facing both towards and away from the printed circuit board assembly; the printed circuit board assembly has first contact pads touching the contacts facing towards the printed circuit board assembly, and second contact pads displaced to the side of the sensor; the elastomeric pad being disposed to press the electrical contacts on the sensor facing the printed circuit board assembly into touching connection with first contact pads; the elastomeric pad further containing conductive strips positioned to connect electrically the second contact pads of the printed circuit board assembly to respective electrical contacts of the sensor facing away from the printed circuit board assembly (par.0140 last sentence).
With respect to claim 13, Pace renders obvious the sensor comprises two strips of insulative sheet material each having on its surface elongate conductive elements leading from the distal end to the contacts at the proximal end, wherein the strips are arranged back-to-back such that the contacts on one strip face towards the printed circuit board assembly and the contacts on the other strip face away from the printed circuit board assembly (par.0136-0140).
With respect to claim 14, Pace renders obvious the sensor extends from the case via an opening in the lower major wall, there being a seal separating the opening from an internal cavity of a housing of the case of the printed circuit board assembly, said seal being held in compression between the upper and lower walls, wherein the back-to-back strips separate to a side-by-side relationship where they pass through the seal (410A in Fig. 4A).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art when the invention was filed to modify Pace to utilize the structural limitations recited above without involving an inventive step. Furthermore, modifying Pace to incorporate a duplication of parts (e.g. a second contact pad) arranged in the manner recited above would be obvious since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8; and since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70. Lastly, one of ordinary skill in the art when the invention was filed would have had predictable success modifying Pace to utilize the seal arrangement of claim 7 in order to prevent contamination.
Claims 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bernstein/Pace in further view of Saltzstein (U.S. PG Pub. No. 2010/0286607 A1).
Saltzstein was cited in applicant’s IDS submitted on August 23, 2024.
With respect to claims 17-19, Bernstein/Pace teach a medical sensing device for sensing an analyte as established above.
However, Bernstein/Pace do not teach the limitations recited in claims 17-19.
Regarding claim 17, Saltzstein teaches a battery pull tab adapted to break the electrical coupling of the battery from the printed circuit board assembly (par.0051).
Regarding claim 18, Saltzstein teaches battery connector pads that are shorted together to connect the battery to the printed circuit board assembly, a pull tab elastomeric connector biased in a direction to short the battery connector pads; wherein the battery pull tab is adapted to separate the battery connector pads from the pull tab elastomeric connector until it is pulled (par.0051).
Regarding claim 19, Saltzstein teaches the battery connector pads are on the printed circuit board assembly, wherein the printer circuit board assembly further comprises a battery pull tab retaining post, wherein the battery pull tab is affixed to the battery pull tab retaining post (par.0051).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art when the invention was filed to modify Bernstein/Pace to incorporate a pull tab for activating/deactivating a power source as is widely known in medical devices, as evidence by Saltzstein.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Bernstein in view of Pace.
With respect to claim 22, Bernstein teaches a medical sensing device for sensing an analyte as established above.
However, Bernstein does not explicitly teach the limitations recited in claim 22.
Pace teaches the upper housing is ultrasonically welded to the lower housing (par.0018, see last sentence).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art when the invention was filed to modify Bernstein such that the upper housing is ultrasonically welded to the lower housing as a matter of design preference which has been suggested in another analyte sensing systems, as evidence by Pace.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 8-24 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 10,765,369 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because are obvious variants of one another.
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
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