Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 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 1 recites the limitations in lines 4 “that can be physically manipulated” and line 9, “wherein the one or more topical compounds can be physically moved” which renders the claim indefinite. It is unclear whether the claim requires the positive recitation of physically moved due to the usage of the words “can be” and thus renders the claim indefinite. In an effort to compact prosecution the limitations are interpreted as --configured to be physically manipulated-- and --wherein the one or more topical compounds is configured to be physically moved--.
Claim 10 also recites “wherein the one or more topical compounds can be automatically moved”. It is unclear whether the claim requires the positive recitation of physically moved due to the usage of the words “can be” and thus renders the claim indefinite. In an effort to compact prosecution the limitation is interpreted as --wherein the one or more topical compounds is configured to be automatically moved--
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-15, 18-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Millikin (US 11666741).
Regarding claim 1, Millikin discloses an automated device (200, figure 2) for delivering one or more topical compounds to a surface of mammalian tissue (col 3, lines 34-44 and col 5, lines 25-40), the device comprising: one or more automated portions (pump and control 202, col 5, lines 25-40);
one or more areas (209), on an outer surface of the device, that can be physically manipulated by a user (col 5, lines 25-40); and
a chamber (chamber of 300) configured to hold the one or more topical compounds (col 4, lines 35-47), wherein the physical manipulation of the one or more areas activates the one or more automated portions, and wherein the one or more topical compounds can be physically moved out of the chamber and out of one end of the device, to be delivered to the surface of mammalian tissue (col 4, lines 35-47 and col 5, lines 25-40).
Regarding claim 2, Millikin discloses wherein the one or more areas are selected from the group consisting of: a tab, a lever, a button (col 5, lines 25-40), and combinations thereof.
Regarding claim 3, Millikin discloses wherein the one or more automated portions comprise a plunger and/or ejector (col 5, lines 25-40, pump and control functions as ejector to utilizing the pump to eject fluid).
Regarding claim 4, Millikin discloses wherein the plunger and/or ejector operate under electric power (col 5, lines 25-45).
Regarding claim 5, Millkin discloses wherein the one or more automated portions comprise a connection between the chamber and one or more tip portions that deliver the one or more topical compounds (300 situated between the nozzle assembly 205 and body, col 4, lines 35-47), the usage of the pump connects the nozzle with the chamber, col 5, lines 25-40).
Regarding claim 6, Millikin discloses wherein attachment between the chamber and the one or more tip portions is automated (the usage of the pump is automated, col 5, lines 25-40). .
Regarding claim 7, Millkin discloses wherein detachment between the chamber and the one or more tip portions is automated (col 5, lines 25-45, the power of the pump can be adjusted and powered on or off depending on user and the depressing of button 208).
Regarding claim 8, Millikin discloses further comprising one or more capsules (cartridge 300 that forms the chamber) containing the one or more topical compounds, and wherein removal of the one or more topical compounds from the one or more capsules is automated (col 25, lines 25-35).
Regarding claim 9, Millikin discloses wherein the removal is triggered by the physical manipulation of the one or more areas (col 5, lines 25-35).
Regarding claim 10-11, Millikin discloses wherein the one or more topical compounds is configured to automatically moved from the chamber into one or more tip portions connected to the chamber (col 5, lines 25-35) and wherein the automatic movement is triggered by the physical manipulation of the one or more areas (col 4, lines 35-40).
Regarding claim 12, Millikin discloses wherein a tip portion (211) connected to the chamber is configured to automatically aspirate a liquid and/or solution into the chamber (col 4, lines 55-60).
Regarding claim 13, Millkin discloses wherein the automatic aspiration is triggered by the physical manipulation of the one or more areas (col 4, lines 50-60).
Regarding claim 14, Millkin discloses wherein a plunger and/or ejector is configured to automatically eject air in the chamber before loading of the one or more topical compounds into the chamber (col 5, lines 25-30, the pump can compress air which can naturally occur before displacing material).
Regarding claim 15, Millikin discloses wherein the automatic ejection is triggered by the physical manipulation of the one or more areas (col 4, lines 35-40).
Regarding claim 18, Millikin discloses further comprising one or more locking mechanisms (settings 202-204 are mechanisms that lock the device into a specific operating mode all of which can be triggered) that are triggered by the physical manipulation of the one or more areas (col 4, lines 47-67).
Regarding claim 19, Millikin discloses further comprising a storage area (col 5, lines 50-53, area inside liposome, micelle or phospholipid) within the chamber, wherein release of one or more agents from the storage area is triggered by the physical manipulation of the one or more areas (col 5, lines 25-35, payload delivery includes the encapsulating material).
Regarding claim 20, Millkin discloses further comprising a cover (seal of cartridge, col 5, lines 30-35) that is automatically moveable to cover an area of the device for delivering the one or more topical compounds, wherein the automatic movement is triggered by the physical manipulation of the one or more areas (col 5, lines 25-35).
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 16 is rejected under 35 U.S.C. 103 as being unpatentable over Millikin in view of Riebman (US 2016/0114112).
Regarding claim 16, Millikin does not disclose further comprising one or more automated sensors configured to detect a proximity of the device to the surface of mammalian tissue.
Riebman discloses a syringe for releasing medicaments and teaches the use of one or more automated sensors ([0089]) configured to detect a proximity of the device to the surface of mammalian tissue ([0089]).
Riebman provides sensors in order to prevent undesirable distance placement of the dispenser ([0001]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Millikin with the sensor of Riebman in order to correctly position he device for dispensing material.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Millikin in view of Greenberg (US 2005/0228338).
Regarding claim 17, Millikin does not discloses wherein the chamber further comprises a filter for filtering the one or more topical compounds, and wherein the filtering is triggered by the physical manipulation of the one or more areas.
Greenberg discloses a device for dispensing material and teaches the chamber further comprises a filter ([0039]) for filtering the one or more topical compounds, and wherein the filtering is triggered by the physical manipulation of the one or more areas ([0039], the filter is on the aperture which would be naturally used and triggered upon dispensing from the Millikin device).
Greenberg provides a filter in order to remove impurities of the solution ([0039]). It would have been obvious to a person of ordinary skill in the art at the effective filling date to modify Millikin with the filter of Greenberg in order to remove undesired particles from the dispensed solution.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAI H WENG whose telephone number is (571)272-5852. The examiner can normally be reached M-F 9am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached at (571) 270-5879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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KAI H. WENG
Primary Examiner
Art Unit 3761
/KAI H WENG/Primary Examiner, Art Unit 3781