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 Objections
Claims 9-10 are objected to because of the following informalities:
Regarding claim 9, the last limitation “to the printed circuit broad” should read “to the printed circuit board”.
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.
Claims 1-14 and 17-18 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.
Regarding claim 1, the limitation “the mechanical interface configured such that an air flow rate measured using the sensor is within 2% of an air flow rate measured at the opening of the mouthpiece” renders the claim indefinite. The limitation reads as positively or implicitly requiring a discrete measurement taken at the mouthpiece of the inhaler despite the cap containing the sensor. This appears to be contrary to what applicant intends to claim, as clearly the measurements are to be taken only at the cap and the sensor of the cap is the only recited structure capable of taking measurements. A potentially better phrasing of the limitations would be to clarify that measurements taken at the cap are approximate to that which would be hypothetically measured at the mouthpiece. Thus, it is suggested to amend the claim to indicate “…of an air flow rate which would be measured at the opening of the mouthpiece”, or similar phrasing. Otherwise, applicant should positively recite additional structure necessary to obtain sensing at the mouthpiece, if supported by the specification.
Similar arguments can be made for claim 17.
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.
Claims 1-3, 8, 13-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Biswas (U.S 2016/0144141 A1).
Regarding claim 1, Biswas discloses an inhaler (MDI 18, Fig. 3 and Paragraph 0059) comprising:
a housing comprising medicament (Paragraph 0029, 0059; The MDI delivers dry powder and thus must include the medicament within the inhaler), a mouthpiece (Fig. 3 and Paragraph 0065; The inhaler has a mouthpiece), and a vent (Fig. 3-4 and Paragraph 0065, air vents 3), wherein the mouthpiece comprises an opening (Fig. 3 and Paragraph 0065; The mouthpiece conveys the air/medicament drawn through the device to the user and thus includes an opening), and wherein an air flow path is provided between the vent and the opening of the mouthpiece (Paragraph 0065, air enters through vent 3, travels through the inhaler body and out the mouthpiece); and
a cap housing an electronics module (electronic cap 1, Figs. 3-4 and Paragraph 0064-0065), the electronics module comprising a processor (Paragraph 0073, processing unit 20 is included within to convey with sensors/electrical components; also see Claim 19 regarding processor), a battery (Paragraph 0062 and 0070, rechargeable battery pack 12), a wireless communication circuit (Paragraph 0070-0071, wireless chipset 11), and a sensor, wherein the sensor is configured to sense airflow resulting from a patients inhalation or exhalation at the mouthpiece (pressure sensor 8, see Paragraphs 0025, 0060 and 0064; The pressure sensor senses airflow drawn through the device for the processor to calculate a flow rate from the measured pressure); and
wherein a mechanical interface exists between the housing and the cap (Paragraph 0025, the cap is detachably connected to the top of an inhaler and thus is mechanically affixed to the housing).
Biswas is silent regarding specifically wherein the mechanical interface configured such that an air flow rate measured using the sensor is within 2% of an air flow rate measured at the opening of the mouthpiece.
However, Biswas teaches that the air resistance through the cap is to be minimized to allow unhindered inhalation while still allowing sensing of pressure differentials (Paragraph 0031, 0060 and 0064-0065) and furthermore Biswas teaches that the air flow rate measured at the cap is representative of inspiration flow rates which would be measured at the mouthpiece (Paragraph 0065). The determination of a flow rate in the cap which is substantially representative of the patient inspiratory rate and flow rate through the inhaler body thus must be approximately equal to what would be measured at the mouthpiece to assess inhalation upstream at the cap. It is noted again in the 112(b) section above that the claims appear to be directed towards a hypothetical measurement at the mouthpiece, as opposed to positively requiring a separate measurement/sensor assembly positioned in/at the mouthpiece.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Biswas to minimize air resistance such that airflow rate measured at the sensor is within 2% of the air flow rate measured at the mouthpiece, such as that taught by Biswas, since the air flow measured at the sensor is meant to be representative of the flow drawn by the user during inhalation (Paragraph 0065) and since the air resistance is advantageously minimized to allow ease of inhalation (Paragraph 0031, 0060 and 0064-0065).
Regarding claim 2, Biswas discloses the device of claim 1.
Biswas further discloses wherein the electronics module is configured to correlate a measured change at the sensor with an air flow rate through the air flow path (Paragraph 0025, 0060 and 0064; The measured pressure is used to calculate a flow rate through the flow path/device).
Regarding claim 3, Biswas discloses the device of claim 1.
Biswas further discloses wherein the sensor comprises a pressure sensor (Paragraph 0025, 0060 and 0064, the sensor is a pressure sensor).
Regarding claim 8, Biswas discloses the device of claim 1.
Biswas further discloses wherein the electronics module comprises a printed circuit board that comprises the processor, the wireless communication circuit, and the sensor (Paragraph 0062 and Figs. 5-6; The electronics cap includes a PCB 6 which includes microcontroller 10, wireless chipset 11, pressure sensor 8); and wherein the inhaler further comprises a battery holder configured to be secured to the printed circuit board, wherein the battery holder is configured to ensure the battery maintains an electrical connection with the printed circuit board when holding the battery (Paragraph 0062, the PCB includes rechargeable battery pack 12 and thus must have a retainer for the battery to maintain connection to the PCB).
Regarding claim 13, Biswas discloses the device of claim 1.
Biswas further discloses wherein the cap is configured to be removably attached to the housing of the inhaler (Paragraph 0025 and Claim 1; The cap is removable on the inhaler).
Regarding claim 14, Biswas discloses the device of claim 1.
Biswas is silent regarding wherein the cap is permanently attached to the housing of the inhaler.
However, Biswas teaches wherein the cap can be recharged without removal (Paragraph 0070) and further that it has been found that when the only difference between the prior art is one-piece or unitary construction, it is an obvious matter of design choice without any unexpected results (MPEP 2144.04 (V)(B)). In this case, applicant indicates that the cap may be removable or permanently affixed to the inhaler body without any suggestion of advantage or unexpected results from making the cap permanently fixed to the housing. The airflow in Biswas would remain unchanged upon making the device integral, as the flow path would be substantially the same and the airflow is intended along the same dedicated pathway without leaks. Thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Biswas to include a cap integral with the inhaler body, since it has been held that one-piece or integral construction is an obvious matter of design choice without unexpected results.
Regarding claim 15, Biswas discloses a housing comprising medicament (Paragraph 0029, 0059; The MDI delivers dry powder and thus must include the medicament within the inhaler), a mouthpiece (Fig. 3 and Paragraph 0065; The inhaler has a mouthpiece), and a vent (Fig. 3-4 and Paragraph 0065, air vents 3), wherein the mouthpiece comprises an opening (Fig. 3 and Paragraph 0065; The mouthpiece conveys the air/medicament drawn through the device to the user and thus includes an opening), and wherein an air flow path is provided between the vent and the opening of the mouthpiece (Paragraph 0065, air enters through vent 3, travels through the inhaler body and out the mouthpiece); and a cap housing an electronics module (electronic cap 1, Figs. 3-4 and Paragraph 0064-0065), the electronics module comprising a processor (Paragraph 0073, processing unit 20 is included within to convey with sensors/electrical components; also see Claim 19 regarding processor), a battery (Paragraph 0062 and 0070, rechargeable battery pack 12), a wireless communication circuit (Paragraph 0070-0071, wireless chipset 11), and a sensor, wherein the sensor is configured to sense airflow resulting from a patients inhalation or exhalation at the mouthpiece (pressure sensor 8, see Paragraphs 0025, 0060 and 0064; The pressure sensor senses airflow drawn through the device for the processor to calculate a flow rate from the measured pressure); and wherein a mechanical interface exists between the housing and the cap (Paragraph 0025, the cap is detachably connected to the top of an inhaler and thus is mechanically affixed to the housing) that is sufficient to permit the sensor to sense airflow measurements within the housing resulting from a patients inhalation at the opening of the mouthpiece Paragraph 0031, 0060; The airflow pathway is conveyed from the vents in the cap, past the sensor to measure the flow, and then conveyed to the MDI body and out the mouthpiece).
Regarding claim 16, Biswas discloses the device of claim 15.
Biswas further discloses wherein the sensor comprises a pressure sensor, and wherein the mechanical interface between the housing and the cap enables the processor to properly correlate pressure changes measured by the pressure sensor with an air flow rate through air flow path of the inhaler (Paragraph 0025, 0060 and 0064, the sensor is a pressure sensor and the cap/inhaler housing are attached such that the fluid pathway through the cap and to the mouthpiece is detected by the pressure sensor for calculation of air flow rate).
Regarding claim 17, Biswas discloses the device of claim 16.
Biswas is silent regarding specifically wherein the mechanical interface configured such that an air flow rate measured using the sensor is within 2% of an air flow rate measured at the opening of the mouthpiece.
However, Biswas teaches that the air resistance through the cap is to be minimized to allow unhindered inhalation while still allowing sensing of pressure differentials (Paragraph 0031, 0060 and 0064-0065) and furthermore Biswas teaches that the air flow rate measured at the cap is representative of inspiration flow rates which would be measured at the mouthpiece (Paragraph 0065). The determination of a flow rate in the cap which is substantially representative of the patient inspiratory rate and flow rate through the inhaler body thus must be approximately equal to what would be measured at the mouthpiece to assess inhalation upstream at the cap. It is noted again in the 112(b) section above that the claims appear to be directed towards a hypothetical measurement at the mouthpiece, as opposed to positively requiring a separate measurement/sensor assembly positioned in/at the mouthpiece.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Biswas to minimize air resistance such that airflow rate measured at the sensor is within 2% of the air flow rate measured at the mouthpiece, such as that taught by Biswas, since the air flow measured at the sensor is meant to be representative of the flow drawn by the user during inhalation (Paragraph 0065) and since the air resistance is advantageously minimized to allow ease of inhalation (Paragraph 0031, 0060 and 0064-0065).
Regarding claim 20, Biswas discloses the device of claim 16.
Biswas further discloses wherein the housing comprises one or more orifices in a top surface of the housing that allow airflow between the air flow path of the inhaler and the sensor of the electronics module (see vents 3, Figs. 3-4, the inhaler housing includes an opening which connects with the cap to form an airflow pathway across/through the sensor of the cap; also see Paragraph 0031, 0060).
Claims 4 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Biswas (U.S 2016/0144141 A1), as applied to claims 1, 3 15-17, in view of Smutney (U.S 2010/0197565 A1).
Regarding claim 4, Biswas discloses the device of claim 3.
Biswas is silent regarding wherein an air flow resistance associated with the air flow path is within the range of 0.020 kilopascal per liters per minute (kPa0.5/LPM) to 0.042 kPa0.5/LPM and wherein an air flow rate associated with the air flow path is within the range of 50 LPM to 80 LPM when a pressure drop of 4.0 kPa is applied across the air flow path.
However, Smutney teaches wherein a high flow resistance inhaler has a resistance of 0.065 to 0.2 kPA/LPM (Paragraph 0025) and wherein air flow rates through the inhaler may be in the range of 7 to 70 LPM for a pressure drop between 2 and 20 kPA (Paragraph 0025).
Additionally, Biswas teaches that the air resistance through the cap is to be minimized to allow unhindered inhalation while still allowing sensing of pressure differentials (Paragraph 0031, 0060 and 0064-0065). Thus, for an intended low resistance inhaler, the resistance should be below the ‘high’ range of 0.065, or between 0.02 to 0.042 kPa/LPM.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have an air resistance in the range of 0.02 to 0.042 kPa/LPM, and wherein the air flow rate is between 50-80 LPM at 4 kPA, such as that taught by Smutney and Biswas, in order to provide a known effective flow rate through the inhaler under standard applied pressure from the patient (Paragraph 0025 of Smutney) and because minimization of resistance allows for unhindered inhalation while keeping sensing capability (Paragraph 0031, 0060 and 0064-0065 of Biswas).
Regarding claim 18, Biswas discloses the device of claim 17.
Biswas is silent regarding wherein an air flow resistance associated with the air flow path is within the range of 0.020 kilopascal per liters per minute (kPa0.5/LPM) to 0.042 kPa0.5/LPM and wherein an air flow rate associated with the air flow path is within the range of 50 LPM to 80 LPM when a pressure drop of 4.0 kPa is applied across the air flow path.
However, Smutney teaches wherein a high flow resistance inhaler has a resistance of 0.065 to 0.2 kPA/LPM (Paragraph 0025) and wherein air flow rates through the inhaler may be in the range of 7 to 70 LPM for a pressure drop between 2 and 20 kPA (Paragraph 0025).
Additionally, Biswas teaches that the air resistance through the cap is to be minimized to allow unhindered inhalation while still allowing sensing of pressure differentials (Paragraph 0031, 0060 and 0064-0065). Thus, for an intended low resistance inhaler, the resistance should be below the ‘high’ range of 0.065, or between 0.02 to 0.042 kPa/LPM.
Thus, it would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have an air resistance in the range of 0.02 to 0.042 kPa/LPM, and wherein the air flow rate is between 50-80 LPM at 4 kPA, such as that taught by Smutney and Biswas, in order to provide a known effective flow rate through the inhaler under standard applied pressure from the patient (Paragraph 0025 of Smutney) and because minimization of resistance allows for unhindered inhalation while keeping sensing capability (Paragraph 0031, 0060 and 0064-0065 of Biswas).
Claim 5 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Biswas (U.S 2016/0144141 A1), as applied to claims 1 and 15, in view of Deaton (U.S 2008/0173301 A1).
Regarding claim 5, Biswas discloses the device of claim 1.
Biswas is silent regarding wherein the cap comprises one or more clips or protrusions extending from an inner peripheral surface of the cap, and wherein a top portion of the housing defines one or more recesses that are configured to receive the one or more clips or protrusions to create a seal between the housing and the cap.
However, Deaton teaches an inhaler with cooperating structures to secure a cap to an inhaler housing, wherein the cap comprises one or more clips or protrusions extending from an inner peripheral surface of the cap, and wherein a top portion of the housing defines one or more recesses that are configured to receive the one or more clips or protrusions to create a seal between the housing and the cap (see Fig. 8 and Paragraph 0050; A cap may be secured to an inhaler body via projections 220 of the cap which fit into slots 222 in the inhaler body).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Biswas to include cooperating projections/recesses between the cap and inhaler body, such as that taught by Deaton, in order to provide a known reversible mechanism to secure the cap to the body (Paragraph 0050).
Regarding claim 19, Biswas discloses the device of claim 15.
Biswas is silent regarding wherein the cap comprises one or more clips or protrusions extending from an inner peripheral surface of the cap, and wherein a top portion of the housing defines one or more recesses that are configured to receive the one or more clips or protrusions to create a seal between the housing and the cap.
However, Deaton teaches an inhaler with cooperating structures to secure a cap to an inhaler housing, wherein the cap comprises one or more clips or protrusions extending from an inner peripheral surface of the cap, and wherein a top portion of the housing defines one or more recesses that are configured to receive the one or more clips or protrusions to create a seal between the housing and the cap (see Fig. 8 and Paragraph 0050; A cap may be secured to an inhaler body via projections 220 of the cap which fit into slots 222 in the inhaler body).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Biswas to include cooperating projections/recesses between the cap and inhaler body, such as that taught by Deaton, in order to provide a known reversible mechanism to secure the cap to the body (Paragraph 0050).
However, Deaton teaches an inhaler with cooperating structures to secure a cap to an inhaler housing, wherein the cap comprises one or more clips or protrusions extending from an inner peripheral surface of the cap, and wherein a top portion of the housing defines one or more recesses that are configured to receive the one or more clips or protrusions to create a seal between the housing and the cap (see Fig. 8 and Paragraph 0050; A cap may be secured to an inhaler body via projections 220 of the cap which fit into slots 222 in the inhaler body).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Biswas to include cooperating projections/recesses between the cap and inhaler body, such as that taught by Deaton, in order to provide a known reversible mechanism to secure the cap to the body (Paragraph 0050).
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Biswas (U.S 2016/0144141 A1), as applied to claim 1, in view of Reuven (U.S Publication No. 2014/0322935 A1).
Regarding claim 6, Biswas discloses the device of claim 1.
Biswas further discloses wherein the electronics module comprises a printed circuit board that comprises the processor, the wireless communication circuit, and the sensor (Paragraph 0062 and Figs. 5-6; The electronics cap includes a PCB 6 which includes microcontroller 10, wireless chipset 11, pressure sensor 8).
Biswas is silent regarding wherein the cap comprises a plurality of heat stakes that protrude or extend from a top inner surface of the cap and that are configured to be partially deformed to secure the printed circuit board to the cap.
However, Reuven teaches using a plurality of heat stakes that are configured to be partially deformed to mount and secure a printed circuit board to the rest of the electronics (Paragraph 0065; The PCB may be secured onto the base via mounting pins, which are hot melted into/onto the base; also see Paragraph 0084, the PCB is secured via hot melting guides 234).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the circuit board of Biswas to include heat stakes to secure the board to the base of the cap, such as that taught by Reuven, in order to provide a known alternative for securing a circuit board to the base/housing of a device (Paragraph 0065 and 0084).
Regarding claim 7, Biswas discloses the device of claim 6.
Reuven further teaches wherein the plurality of heat stakes are configured to secure the printed circuit board to the electronics module cap without the use of additional fasteners (Paragraph 0084; guides/heat stakes can be melted to mount and secure the PCB to the base and are thus configured to secure the PCB without additional fasteners; It is noted that the ‘configured to’ language does not necessarily require the heat stakes to be the only securement, merely that the heat stakes alone are sufficient to secure to the PCB).
Claims 9-12 are rejected under 35 U.S.C. 103 as being unpatentable over Biswas (U.S 2016/0144141 A1), as applied to claims 1 and 8, in view of Engelstein (U.S 4,487,820 A).
Regarding claim 9, Biswas discloses the device of claim 8.
Biswas is silent regarding wherein the printed circuit board comprises openings that extend through the printed circuit board; and wherein the battery holder comprises tabs that extend through the openings of the printed circuit board to attach the battery holder to the printed circuit broad.
However, Engelstein teaches a battery holder for a PCB comprising openings that extend through the printed circuit board; and wherein the battery holder comprises tabs that extend through the openings of the printed circuit board to attach the battery holder to the printed circuit board (see Figs. 1-4 and Col. 2 lines 1-40; The circuit board includes openings to allow tips 20 of contacts 12/13 to extend therethrough, the contacts securing a battery within a battery holder base 10; Thus, the battery holder is attached to the PCB).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Biswas to include a battery holder with tabs extending through holes of the PCB, such as that taught by Engelstein, in order to provide a known retention system to retain batteries on a PCB and which allows replacement of the batteries (Col. 2 lines 27-43).
Regarding claim 10, Biswas discloses the device of claim 9.
Engelstein further teaches wherein the tabs are configured to deflect and engage the openings such that the battery holder is removably attached to the printed circuit board (see Figs. 1-4 and Col. 2 lines 1-40; The tabs are inserted into the openings of the PCB and thus engage the openings; Additionally, the tabs at 12/13 deflect against the button cell battery to bias and retain the battery in place; The battery holder can also be removed via disengaging/removal of the tabs from the openings in the PCB).
Regarding claim 11, Biswas discloses the device of claim 8.
Biswas is silent regarding wherein the battery holder comprises a base, two legs, and tabs extending from each leg, wherein the tabs are configured to attached the battery holder to the printed circuit board.
However, Engelstein teaches a battery holder for a PCB, which comprises a base, two legs, and tabs extending from each leg, wherein the tabs are configured to attached the battery holder to the printed circuit board (see Figs. 1-4 and Col. 2 lines 1-40; The battery holder includes a base at 10, two legs/contacts 12/13 which have tabs 20 which extend into holes on the PCB to retain the battery holder against the PCB).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Biswas to include a battery holder with a base, two legs and tabs, such as that taught by Engelstein, in order to provide a known retention system to retain batteries on a PCB and which allows replacement of the batteries (Col. 2 lines 27-43).
Regarding claim 12, Biswas discloses the device of claim 8.
Biswas is silent regarding wherein the battery holder is a through hole type battery holder.
However, Bari teaches a battery holder which is a through hole type battery holder (see Figs. 1-4 and Col. 2 lines 1-40; The battery holder includes a base at 10, two legs/contacts 12/13 which have tabs 20 which extend into holes on the PCB to retain the battery holder against the PCB; Thus, the battery holder is a through hole type as it extends through holes in the PCB).
It would have been obvious to one having ordinary skill in the prior art before the effective filing date of the claimed invention to have modified the device of Biswas to include a through hole type battery holder, such as that taught by Engelstein, in order to provide a known retention system to retain batteries on a PCB and which allows replacement of the batteries (Col. 2 lines 27-43).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS WILLIAM GREIG whose telephone number is (571)272-5378. The examiner can normally be reached Monday - Thursday: 7:30AM - 5:00PM.
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/THOMAS W GREIG/Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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