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 .
Specification
The disclosure is objected to because of the following informalities: please also insert the patent number of the patent application cited in the Cross Reference to Related Applications section.
Appropriate correction is required.
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 4, 16, 17 and any of their dependent claims 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.
Claim 4 recites the limitation “the cap” on lines 1 & 2. There is no antecedent basis for this limitation in the claim. It is also unclear if this limitation is supposed to be the same as “the sensor cap” as earlier recited in Claim 1, or later in Claim 4.
Clam 16 recites the limitation “a dialysis device” on line 6. It is not clear if this limitation is the same limitation as “a dialysis device” as in Claim 1, or not. Examiner interprets it to be the same.
Claim 17 recites the limitation “an associated dialysis device” on lines 3-4. It is not clear if this limitation is the same limitation as “a dialysis device” as in Claim 1, 16, or not. Examiner interprets it to be the same.
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 1, 7 & 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11,958,016, (Hereinafter ‘016). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 1 of ‘016 discloses Claims 1, 7 & 8 of the instant application because all of the limitations recited in these claims are recited in their entirety in Claim 1 of ‘016.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1, 2, 7, 8 & 10-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al., (“Lura”, US 2018/0073991), in view of Smith et al., (“Smith”, US 4,995,402).
Regarding Claims 1, 2, 7 & 10-18, Lura discloses a sensor cap system, comprising: a sensor cap, (Sensor Card 109 inserted into port/Slot 102 of Apparatus 101 with Slot Cover 201, See Figure 1A-F & 2, See paragraphs [0147] & [0148], Lura), comprising a body having a closed end, (Cover 201 has “closed end” at Handle 204, See Figure 2, See paragraph [0163]), and an attachment mechanism coupled to the body and configured to provide haptic feedback when the sensor cap forms a tight association with a dialysis device, (Slot Cover 201 and Sensor Card109 into Slot 102 is locked using a Bevel 127, and when inserted can only be inserted in an intended configuration/fixing it, See Figures 1A, 1C and 2, See paragraphs [0163], Examiner interprets the physical insertion of card/cover into Apparatus 101 via Slot 102 being inserted in only an intended manner and fixed to read upon ‘haptic’ since it registers a physical, “touching” sensation).
Lura does not explicitly disclose that the attachment mechanism also provides aural feedback.
Smith discloses a sensor with an attachment mechanism that provides aural feedback, (See column 23, lines 40-45, Smith).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor cap system of Lura by incorporating that the attachment mechanism also provides aural feedback as in Smith in order to indicate “an audible signal when the...sensors...is properly inserted into the instrument’, (See column 23, lines 42-44, Smith), resulting in an analyzer that is “simple to use” and “produces significant sensitivity and accurate test results in an instrument which is error free in its operation’, (See column 4, lines 22-32, Smith).
Additional Disclosures Included:
Claim 2: The sensor cap system of claim 1, wherein the tight association comprises a hermetic seal, (See paragraph [0004], [0160], Lura; See column 23, lines 19-23, Smith).
Claim 7: The sensor cap system of claim 1, wherein the attachment mechanism comprises a channel defined by a sidewall of the sensor cap, the channel configured in size and shape to receive a pin disposed on an exterior surface of the dialysis device, (Rod 205 on Apparatus 101 into hole in Cover 201, See Figure 2 and 1A, See paragraph [0163], Lura).
Claim 8: The sensor cap system of claim 7, wherein the sidewall further defines a pressure ridge configured to (i) resist rotation of the sensor cap about the pin, (ii) to allow the pin to pass into a locking portion of the channel in response to a locking force, and (iii) to release the pin from the locking portion of the channel in response to an unlocking force, (Bevel 127 works with Rod 205 on Apparatus 101 regarding Cover 201 and Card 109 when inserting to lock and then remove after use, See Figure 1A-F and 2, See paragraph [0163], Lura).
Claim 10: The sensor cap system of claim 1, further comprising: one or more processors, (Sensor Card 109 with Cover 201 in communication with Processors, See Figures 1A-F & 2, and See paragraph [0158] & [0154], Lura); a probe at least partially disposed within the body of the sensor cap and in electrical communication with the one or more processors, the probe being configured to measure a property of a fluid, (Sensor Card 109 is inserted/disposed within Cover 201 in communication with Processors, See Figures 1A-F & 2, and See paragraph [0158] & [0154] & [0153], Lura); a transmitter, (See paragraph [0158], Lura); and a power supply in electrical communication with the one or more processors, the probe, and the transmitter, (Electronics 107, or LEDs, See Figure 1A-F, See paragraph [0158] & [0155], Lura), wherein the body of the sensor cap forms a fluid-tight seal around a cavity comprising the one or more processors, the transmitter, and the power supply, (Cover 201 over Apparatus 101, See Figure 1A-F, 2, and See paragraph [0158], [0163], Lura).
Claim 11: The sensor cap system of claim 10, wherein the property measured by the probe comprises one or more of pH, conductivity, dissolved oxygen concentration, electrical resistance, temperature, protein concentration, UV absorbance, redox potential, or turbidity, (See paragraph [0150], Lura).
Claim 12: The sensor cap system of claim 10, wherein the communication port comprises a Bluetooth or other wireless protocol transceiver, (See paragraph [0158], Lura).
Claim 13: The sensor cap system of claim 12, wherein the communication port comprises a Bluetooth or other wireless protocol transceiver, (See paragraph [0158], Lura).
Claim 14: The sensor cap system of claim 1, wherein the sensor cap is a single use, disposable device, (See paragraph [0166], Lura).
Claim 15: The sensor cap system of claim 10, wherein a portion of the sensor cap is interchangeable or disposable, (See paragraph [0166], Lura).
Claim 16: The sensor cap system of claim 10, further comprising one or more hardware storage devices in electrical communication with the one or more processors, (See paragraph [0127], Lura; “RAM” or “logic circuitry”), the one or more hardware storage devices having stored thereon computer-executable instructions that when executed by the one or more processors, (See paragraph [0127], Lura; “logic circuitry that responds to and processes the basic instructions that drive a computer”), cause the sensor cap to perform at least the following: measure a property of a sample or of a fluid within a sample chamber of a dialysis device associated with the sensor cap; and wirelessly transmit data corresponding to the measured property to a destination computing device, (See paragraph [0158] & [0127], Lura; processor includes a computing system and receives data that is further processed and measured).
Claim 17: The sensor cap system of claim 16, wherein the computer-executable instructions further cause the sensor cap to identify or change a dialysis condition comprising one or more of: a number of uses associated with one or more components of the sensor cap or an associated dialysis device, a stirring speed, a dialysis time, or a temperature, volume, chemistry, or concentration of one or more parts of the fluid within the sample chamber or within a dialysate, (See paragraph [0039], [0077], [0094], [0169], Lura).
Claim 18: The sensor cap system of claim 17, wherein the computer-executable instructions further cause the sensor cap to at least one of (i) send an alert to the destination computing device based on the dialysis condition, (See paragraph [0181], Lura), and (ii) activate one or more of a second visual cue or an aural cue to indicate the dialysis condition, (optional).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al., (“Lura”, US 2018/0073991), in view of Smith et al., (“Smith”, US 4,995,402), in further view of Lanigan et al., (“Lanigan”, US 2014/0107579)
Regarding Claim 3, modified Lura discloses the sensor cap system of claim 1, wherein the aural feedback comprises an audible sound, (See column 23, lines 40-45, Smith), but does not disclose wherein the haptic feedback comprises a sharp increase in an intensity of haptic feedback followed by a sharp decrease in the intensity of haptic feedback.
Lanigan discloses wherein the haptic feedback comprises a sharp increase in an intensity of haptic feedback followed by a sharp decrease in the intensity of haptic feedback, (See paragraph [1347]; a ‘click’ sound that also produces a tactile feedback. By definition, a click is a short sharp sound or sensation which starts and stops quickly (sharp increase/decrease)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor cap of modified Lura by incorporating wherein the haptic feedback comprises a sharp increase in an intensity of haptic feedback followed by a sharp decrease in the intensity of haptic feedback as in Lanigan so that it “is indicative to the user that the…housing assembly…is fully connected…such that it will be maintained…until and unless the user wishes to remove the latching connector”, (See paragraph [1347], Lanigan).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al., (“Lura”, US 2018/0073991), in view of Smith et al., (“Smith”, US 4,995,402), in further view of Tung et al., (“Tung”, US 2005/0106750).
Regarding Claim 4, modified Lura discloses the sensor cap system of claim 1, but does not disclose wherein the cap additionally comprises a visual marker on the body of the cap configured to indicate the tight association of the sensor cap with the dialysis device.
Tung discloses wherein the cap additionally comprises a visual marker on the body of the cap configured to indicate the tight association of the sensor cap with the dialysis device, (See paragraph [0014], Tung).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor cap system of modified Lura by incorporating wherein the cap additionally comprises a visual marker on the body of the cap configured to indicate the tight association of the sensor cap with the dialysis device as in Tung so that “the threads are fully engaged” and “an airtight seal is formed between the cup and lid”, (See paragraph [0014], Tung).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al., (“Lura”, US 2018/0073991), in view of Smith et al., (“Smith”, US 4,995,402), in further view of Alam, (US 6,217,772).
Regarding Claim 5, modified Lura discloses the sensor cap system of claim 1, but does not disclose wherein the attachment mechanism comprises a plurality of threads disposed on an interior surface of the sensor cap.
Alam discloses wherein the attachment mechanism comprises a plurality of threads disposed on an interior surface of the sensor cap, (See column 5, lines 31-40, column 6, lines 27-31, Alam).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor cap of modified Lura by incorporating wherein the attachment mechanism comprises a plurality of threads disposed on an interior surface of the sensor cap as in Alam in order to “make a tight leak proof seal”, (See column 6, lines 40-44, Alam), when “the open ends of both the collection reservoir and the dialysis reservoir [are] connected, engaged, mounted or brought together…by screw mounting”, (See column 1, lines 53-56, Alam).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al., (“Lura”, US 2018/0073991), in view of Smith et al., (“Smith”, US 4,995,402), in further view of Nuotio et al., (“Nuotio”, US 2013/0209333).
Regarding Claim 6, modified Lura discloses the sensor cap system of claim 1, but does not disclose wherein the attachment mechanism comprises a pin disposed on an interior surface of the sensor cap, the pin configured to interface with a horizontal channel formed by an exterior surface of a portion of the dialysis device.
Nuotio discloses a cap system for samples wherein the attachment mechanism comprises a pin disposed on an interior surface of the sensor cap, (Pegs 23/24 on interior of Lid 19, See Figure 1, See paragraph [0034], [0041], Nuotio), the pin configured to interface with a horizontal channel formed by an exterior surface of a portion of the dialysis device, (Peg 24 engages with Knob/Groove 25, See Figure 1, See paragraph [0033], [0034], Nuotio).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor cap system of modified Lura by incorporating wherein the attachment mechanism comprises a pin disposed on an interior surface of the sensor cap, the pin configured to interface with a horizontal channel formed by an exterior surface of a portion of the dialysis device as in Nuotio “in order to improve tightness and sealing ability”, (See paragraph [0041], Nuotio).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al., (“Lura”, US 2018/0073991), in view of Smith et al., (“Smith”, US 4,995,402), in further view of Roussel, (US 2007/0031297).
Regarding Claim 9, modified Lura discloses the sensor cap system of claim 1, but does not disclose wherein the attachment mechanism comprises a hinge joint coupled to the dialysis device, the hinge joint being integrally connected with a flexible stopper configured in size and shape to selectively seal a sample chamber of the dialysis device.
Roussel discloses a cap system for sample application wherein the attachment mechanism comprises a hinge joint coupled to the dialysis device, the hinge joint being integrally connected with a flexible stopper configured in size and shape to selectively seal a sample chamber of the dialysis device, (Hinge 4 with Cover/Stopper 3 sealing to Body 2 which holds samples (chamber for dialysis), See Figure 1, See paragraph [0015] & [0016], Roussel).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor cap system of modified Lura by incorporating wherein the attachment mechanism comprises a hinge joint coupled to the dialysis device, the hinge joint being integrally connected with a flexible stopper configured in size and shape to selectively seal a sample chamber of the dialysis device as in Roussel in order to provide “a cover that is easily opened by the user…without risking contamination”, (See paragraph [0003], Roussel).
Claim(s) 19 & 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lura et al., (“Lura”, US 2018/0073991), in view of Smith et al., (“Smith”, US 4,995,402), in further view of Haney et al., (“Haney ‘225”, US 2009/0200225).
Regarding Claim 19, modified Lura discloses the sensor cap system of claim 1, but does not disclose wherein the dialysis device comprises a frame defined by a plurality of sidewalls that are impermeable to a sample being dialyzed, a pair of dialysis membranes that are each associated with an opposing face of the plurality of sidewalls such that the plurality of sidewalls and the pair of dialysis membranes define a sample chamber, and an outer shell surrounding at least a portion of the pair of dialysis membranes.
Haney ‘225 discloses herein the dialysis device comprises a frame defined by a plurality of sidewalls that are impermeable to a sample being dialyzed, a pair of dialysis membranes that are each associated with an opposing face of the plurality of sidewalls such that the plurality of sidewalls and the pair of dialysis membranes define a sample chamber, and an outer shell surrounding at least a portion of the pair of dialysis membranes, (Membranes 14 & 16 sandwiched between Plates 20, 22, See Figures 1 & 2, and See paragraph [0019]). Additional features of this embodiment are included as part of the overall combination.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the sensor cap of modified Lura by incorporating wherein the dialysis device comprises a frame defined by a plurality of sidewalls that are impermeable to a sample being dialyzed, a pair of dialysis membranes that are each associated with an opposing face of the plurality of sidewalls such that the plurality of sidewalls and the pair of dialysis membranes define a sample chamber, and an outer shell surrounding at least a portion of the pair of dialysis membranes as in Haney ‘225 in order to “improve the dialysis process in terms of reliability and speed, [the device has] been designed to house the dialysis membrane’, (See paragraph [0004], Haney ‘225), resulting in “a high surface to volume ratio” which “results in faster dialysis times”, (See paragraph [0031], Haney ‘225).
Additional Disclosures Included:
Claim 20: The sensor cap system of claim 19, wherein a first sidewall of the frame has a concave curvature with respect to the sample chamber partially defined thereby, (Plate 22 having Ledges 36 or 38 and Raised Areas/Ridges 40, concave portions to accommodate Membranes 14/16 therebetween as shown in Figures 1 & 2, See paragraph [0021], Haney ‘225).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M PEO whose telephone number is (571)272-9891. The examiner can normally be reached M-F, 9AM-5PM.
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/JONATHAN M PEO/Primary Examiner, Art Unit 1779