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 .
Priority
Acknowledgement is made to Applicant’s claim to priority to National Stage Application No. PCT/TR2021/050860 filed August 26, 2021 and to foreign priority to Turkish Application No. TR2020/13497 filed August 26, 2020.
Status of Claims
This present office action is responsive to the Application filed on January 31, 2022. As directed, claims 1-11 are presently pending in this application.
Claim Objections
Claims 1-11 are objected to because of the following informalities:
Claim 1 recites, “the person” in ln 3, “the drug” in ln 4, “the system” in ln 5 which Examiner suggest amending to read --a patient--, --a drug--, and --the device-- for consistency
Claim 1 recites, “their noses” In 5 which Examiner suggest amending to read --the patient’s nose” for clarity of the person who will use the device rather than children and adults.
Claim 1 recites, “in which all liquid pharmaceutical compositions in the state of the art are applicable, characterized in that; it comprises” in ln 6-7 which Examiner suggest amending to read --in which applicable to liquid pharmaceutical compositions, the nasal treatment device comprises--
Claim 1 recites, “the power that the nebulizer” in ln 15 which Examiner suggest amending to read --a power that a nebulizer--
Claim 1 recites, “the desired particle ratio in the targeting region” in ln 18 which Examiner suggest amending to read --a desired particle ratio in a targeting region--
Claim 1 recites, “the dosage form in the drug chamber (2) (reservoir) to become aerosols droplets” in ln 19-20 which Examiner suggest amending --the liquid form in the drug reservoir (2) to become the aerosol droplets-- for clarity.
Claim 1 recites, “to adjust the patient doses according age, height and weight” in ln 23-24 which Examiner suggest amending --to adjust the patient’s dose according to the patient’s age, height, and weight-- for consistency
Claim 1 recites, “ladybug wings (7) which opens during drug administration to the upper part of the skeletal system and has a structure in the form of a shutter system to close the outer wall of the skeletal system (1) and at the same time prevents aerosol droplets released from the holes (4) from escaping out of the device skeletal system (1)” in ln 25-29 which Examiner suggest amending --ladybug wings (7) having a structure in the form of a shutter system that opens to an upper part of the skeletal system during drug administration configured to close an outer wall of the skeletal system (1) and prevents the aerosol droplets released from the holes from escaping out of the skeletal system (1)--
Claim 2 recites, “according to Claim 1, characterized in that; the shape” in ln 1-2 which Examiner suggest amending to --according to claim 1, wherein a shape--
Claim 3 recites, “according to Claim 1, characterized in that; the skeletal system (1)” in ln 1-2 which Examiner suggest amending to --according to claim 1, wherein the skeletal system (1)--
Claim 4 recites, “characterized in that; the invention can be” in ln 2 which Examiner suggest amending to read --the nasal treatment device configured to be--
Claim 5 recites, “characterized in that; it comprises” in ln 1-2 which Examiner suggest amending to read --the nasal treatment device further comprises--
Claim 6 recites, “according to Claim 1, characterized in that; it comprises the following process steps;” in ln 1-2 which Examiner suggest amending to --according to claim 1, the process comprises the steps:--
Claim 6 recites, “at the resonant frequency determined” in ln 12 which Examiner suggest amending to read --from the determined resonant frequency--
Claim 6 recites, “transferring it to the piezoelectric crystal material by means of the driver circuit” in ln 13-14 which Examiner suggest amending to --transferring the signal to the piezoelectric crystal material by a driver circuit--.
Claim 6 recites, “vibration of piezoelectric crystal material” in ln 15 which Examiner suggest amending to read --vibrating of the piezoelectric crystal material--
Claim 6 recites, “into aerosol droplets in particle size determined" in ln 16-17 which Examiner suggest amending to read --into the aerosol droplets in a particle size--
Claim 7 recites, “the person” in ln 1, “the drug” in ln 2, “the system” in ln 4 which Examiner suggest amending to read --a patient--, --a drug--, and --the device-- for consistency
Claim 7 recites, “their noses” In 3 which Examiner suggest amending to read --the patient’s nose” for clarity of the person who will use the device rather than children and adults.
Claim 7 recites, “in which all liquid pharmaceutical compositions in the state of the art are applicable, characterized in that; it comprises” in ln 6-7 which Examiner suggest amending to read --in which applicable to liquid pharmaceutical compositions, the intranasal treatment device comprises--
Claim 7 recites, “battery (3), which provides the power that the nebulizer” in ln 15 which Examiner suggest amending to read --a battery (3), which provides a power that a nebulizer --
Claim 7 recites, “the desired particle ratio in the targeting region” in ln 18 which Examiner suggest amending to read --a desired particle ratio in a targeting region--
Claim 7 recites, “a nebulizer (5) which allows the dosage form to become aerosols droplets” in ln 19-20 which Examiner suggest amending --the nebulizer (5) which allows a dosage form to become the aerosols droplets-- for clarity.
Claim 7 recites, “adjusts patient doses according to their age, height, weight, and/or gender” in ln 22 which Examiner suggest amending --adjusts the patient’s doses according to the patient’s age, height, weight, and/or gender-- for consistency
Claim 7 recites, “ladybug wings (7) which opens during drug administration to the upper part of the skeletal system and has a structure in the form of a shutter system to close the outer wall of the skeletal system (1) and at the same time prevents aerosol droplets released from the holes (4) from escaping out of the device skeletal system (1)” in ln 25-29 which Examiner suggest amending --ladybug wings (7) having a structure in the form of a shutter system that opens to an upper part of the skeletal system during drug administration configured to close an outer wall of the skeletal system (1) and prevents the aerosol droplets released from the holes from escaping out of the skeletal system (1)--
Claim 8-10 recite, “An intranasal treatment device” which Examiner suggest amending to read --The intranasal treatment device--
Claim 8 recites, “Claim 7, characterized in that; nebulizer (5) comprises Bluetooth unit, microprocessor unit, driver circuit” in ln 1-2 which Examiner suggest amending to read --claim 7, the nebulizer (5) comprises a Bluetooth unit, a microprocessor unit, and a driver circuit-- as described in ¶0024 and 0038.
Claim 9 recites, “Claim 8, characterized in that; it further comprises a remote control (6) or a mobile device containing Bluetooth” in ln 1-2 which Examiner suggest amending to read --claim 8, the intranasal treatment device further comprises a mobile device containing a Bluetooth that allows the device to be controlled remotely--
Claim 10 recites, “characterized in that; it further comprises activation button” in ln 2 which Examiner suggest amending to read --the intranasal treatment further comprise an activation button--
Claim 11 recites, “Operating method of the intranasal therapy device according to Claim 10, characterized in that; it comprises the following process steps;” in ln 1-2 which Examiner suggest amending to read --An operating method of the intranasal therapy device according to claim 10, the method comprises the steps:--
Claim 11 recites, “the trigger signal” in ln 7, “the resonance frequency” in ln 9, and “the personal data” in 17 which Examiner suggest amending to read --a trigger signal--, --a resonance frequency--, and --patient’s information--
Claim 11 recites, “at the resonant frequency determined” in ln 11 which Examiner suggest amending to read --from the determined resonant frequency--
Claim 11 recites, “transferring it to the piezoelectric crystal material by means of the driver circuit” in ln 12-13 which Examiner suggest amending to --transferring the signal to the piezoelectric crystal material by the driver circuit--.
Claim 11 recites, “vibration of piezoelectric crystal material” in ln 14 which Examiner suggest amending to read --vibrating of the piezoelectric crystal material--
Claim 11 recites, “into aerosol droplets in particle size determined" in ln 15-16 which Examiner suggest amending to read --into the aerosol droplets in a particle size--
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 1-11 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, “preferably” in ln 2 and 10 renders claim indefinite. It is unclear whether these limitations are required or optional. For examination purposes, claim is understood as the limitations are presented as optional.
Claim 1 recites, “…pentagon etc. form” which renders claim indefinite. It is unclear the metes and bounds of the shape and the difference between the shape of the overall device (¶0028) and the shapes of the skeletal system (¶0060). See MPEP 2173.05(e).
Claim 1 recites, “the mechanism” in ln 10 and 13 which renders claim indefinite. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear whether it is referring to the piezoelectric crystal mechanism as described in ¶0037 or the device or the nebulizer as described in ¶0034.
For the examination purposes, it is understood as --nebulizer--. Examiner suggest amending the claim to read --a skeletal system which has a structure configured to completed cover the nose and surrounds an exterior of a nebulizer--
Claim 1 recites, “battery (3), which provides the power that the nebulizer (5) needs while working” in ln 15-16 and “software that enables the nebulizer (5) to be operated with or without a battery (3) with a mobile phone or different signal sending devices” in ln 22-23 which renders claim indefinite. It is unclear whether the battery (3) is same battery of nebulizer which required to power the nebulizer to be used or different battery associated with the mobile phone.
Further, neither claim nor the specification provide adequate explanation of what Applicant regards as “signal sending device”, and thus it is not possible for one of ordinary skill to ascertain the metes and bounds of the claim.
Claim 1 recites, the limitations, “remote control (6)” in ln 21 and “software” in ln 22 render claim indefinite. The limitations are not recognized in the art as structural terms but rather functional claim language which requires to be supported by the structure that performs the function. See MPEP 2173.05(e). Examiner suggest applicant to further define the structure for the limitation of “software” such as any component(s) holding the software. Applicant is reminded to provide support of amended claim to avoid introducing new matter to the claim.
In regards to the limitation, “remote control”, it is unclear whether this is any other structures capable of “remote control” other than the said mobile device as described in ¶0069.
For the examination purposes, “remote control (6)” is understood as “a mobile phone” as described in ¶0069.
Claim 1 recites the limitations "the upper part" in 25-26 and “the outer wall” in ln 27. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-6 are rejected by virtue of dependency to claim 1.
Claim 4 recites, “the invention can be charged apart from the cell battery via battery, wired or wirelessly” which renders the claim indefinite. It is unclear which battery/cell battery is considered to be charged wired or wirelessly as both nebulizer and mobile phone have a battery.
Claim 5 recites, “a slow and gentle drug release” which renders claim indefinite. Neither claim nor the specification provide adequate explanation of what Applicant regards as “a slow and gentle drug release”, and thus it is not possible for one of ordinary skill to ascertain the metes and bounds of the claim.
Claim 6 is rejected by virtue of dependency to claim 5.
Claim 6 recites, “the activation button” in ln 3, “the smart mobile device and the intranasal treatment device via the Bluetooth unit” in ln 4-5, “the trigger signal generated for this to the microprocessor unit” in ln 7-8, “the resonance frequency of the piezoelectric crystal material” ln 10-11, “the driver circuit” in ln 14 and “the personal data” in ln 16. There is insufficient antecedent basis for these limitations in the claim.
Further, the limitation “by triggering the medicine chamber (2) of the vibrating piezoelectric crystal material” which renders the claim indefinite. It is unclear whether the medicine chamber/reservoir, or the piezoelectric crystal mechanism as described in ¶0037-0038 is triggering the “spraying”. Examiner notes the reservoir is described as a container/storage of the drug (¶0023, 0042, 0071).
Regarding claim 7, “preferably” in ln 8 renders claim indefinite. It is unclear whether these limitations are required or optional. For examination purposes, claim is understood as the limitations are presented as optional.
Claim 7 recites, “the system” in ln 4 which renders claim indefinite. It is unclear whether system is refer skeletal system or the closed structure of the intranasal treatment device.
Claim 7 recites, “the mechanism” in ln 8 and 11 which renders claim indefinite. There is insufficient antecedent basis for this limitation in the claim. Further, it is unclear whether it is referring to the piezoelectric crystal mechanism as described in ¶0037 or the device or the nebulizer as described in ¶0034.
For the examination purposes, it is understood as --nebulizer--. Examiner suggest amending the claim to read --a skeletal system which has a structure configured to completed cover the nose and surrounds an exterior of a nebulizer--
Claims 8-11 are rejected by virtue of dependency to claim 7.
Claim 9 recites, the limitation, “remote control (6)” in ln 2 which renders claim indefinite. It is unclear whether this is any other structures capable of “remote control” other than the said mobile device as described in ¶0069.
Examiner suggest amending the claim to read --the device further comprises, a mobile device containing a Bluetooth unit that allows the nebulizer to be controlled remotely-- as described in ¶0069.
Claim 11 recites, “by triggering the medicine chamber (2) of the vibrating piezoelectric crystal material” which renders the claim indefinite. It is unclear whether the medicine chamber/reservoir, or the piezoelectric crystal mechanism as described in ¶0037-0038 is triggering the “spraying”. Examiner notes the reservoir is described as a container/storage of the drug (¶0023, 0042, 0071).
The following is a quotation of 35 U.S.C. 112(e):
(e) REFERENCE IN MULTIPLE DEPENDENT FORM.— A claim in multiple dependent form shall contain a reference, in the alternative only, to more than one claim previously set forth and then specify a further limitation of the subject matter claimed. A multiple dependent claim shall not serve as a basis for any other multiple dependent claim. A multiple dependent claim shall be construed to incorporate by reference all the limitations of the particular claim in relation to which it is being considered.
Claim 5-6 are objected to under 37 CFR 1.75(c) as being in improper form because claim 5 has dependency to the multiple dependent claim 4. See MPEP § 608.01(n).
Claim 6 is objected by the dependency to claim 5 since it depends from an improper claim.
Accordingly, the claims 5-6 have not been further treated on the merits.
Allowable Subject Matter
Claims 1-11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Reasons for Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding the subject matter of independent claims 1 and 7, the closest identified document of record is Kim et al. (US 20090301472 A1).
Kim et al. discloses, the main components of the closed system nasal treatment device/intranasal therapy device (an assembly of Fig 17) such as a skeletal system (604, Fig 17), a drug reservoir (22, Fig 17), a battery, a nebulizer (¶0111) with holes (40, Fig 17), and a mobile device/phone (¶0121, “provided to allow operating information of the device 900 to be communicated to a general purpose computer (e.g., a laptop, desktop, hand-held, smartphone, etc.) via a cable or a wireless or other connection”), and further discloses a ladybug wing like structure which is a flexible sealing member 608 of Fig 17 which opens during drug administration in function of a check valve/one-way valve (¶0106-0107), but the prior art does not teach or suggest that ladybug wings which opens during drug administration while closing the outer wall of the skeletal system in purpose of preventing aerosol droplets released from escaping.
It is thus found that one of ordinary skills in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
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/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785