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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “second filter” recited in claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 18 is rejected under 35 U.S.C. 101 because though it is directed to a use of a device, it lacks any method steps. Therefore, it fails to fall into any of the statutory categories under 35 U.S.C. 101.
Claim Rejections - 35 USC § 112
Claims 1-18 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.
Claim 1 recites the limitation “preferably an antiseptic wound-irrigating solution” in lines 1-2. The word "preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the claim will be interpreted such that the solution does not have to be an antiseptic wound-irrigating solution.
Claim 7 recites the limitation “preferably is completely non-pyrogenic” in line 2. The word "preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the claim will be interpreted as reciting “the device is completely sterilized and completely non-pyrogenic”.
Claim 15 recites the limitation “preferably is completely sterilized, and preferably is completely non-pyrogenic” in line 4. The word "preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). For the sake of examination, the limitation will be interpreted as reciting “is completely sterilized, and is completely non-pyrogenic”.
Claim 16 recites the limitation “the active ingredient is dissolved in a liquid and subsequently administered in dissolved form by means of a device according to claim 1 immediately before administration to a patient”. It is unclear how active ingredient can be administered immediately before administration. For the sale of examination, the limitation will be interpreted as reciting “the active ingredient is dissolved in a liquid immediately before administration to a patient and subsequently administered in dissolved form by means of a device according to claim 1”.
Claim 18 recites a use claim without reciting any steps, thus it is indefinite because it merely recites a use without any active, positive steps delimiting how this use is actually practiced. For the sake of examination, the claim will be interpreted as any method of use of the device of claim 1.
Claims 2-6, 8-14, 17 are rejected as depending from a rejected claim.
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 1-6, 8-9, 11-12, 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2007/0249996) in view of Schneller (US 3,734,098) and further in view of Price (US 2024/0058217).
Regarding claim 1, Tennican discloses a device (device of Fig 16A) for producing an active ingredient solution, preferably an antiseptic wound- irrigating solution, having: - a connection element (702, Fig 16A) which is designed and configured for liquid-tight connection to a container (500, Fig 16B); - a mandrel (400e, Fig 16B) designed and configured for piercing a septum of a container (Para 0077, 0115); - a reservoir (102e, Fig 16A) which contains an active ingredient in solid form (“dry form”, Para 0123), and can be connected via an outlet (108e, Fig 16A) of the reservoir in a fluid-conducting manner to the connection element (Para 0119); - a fluidic element (200e, Fig 16A) which is configured to receive a liquid from a container into the reservoir , and/or is configured to dispense a liquid from the reservoir; wherein the device is designed and configured to receive a liquid from a container into the reservoir, to dissolve the active ingredient in the liquid (Para 0119).
Tennican is silent regarding a liquid-permeable filter which is arranged at the outlet of the reservoir, and is configured to retain the active ingredient in solid form in the reservoir and to dispense the dissolved active ingredient to a patient via the connection element.
Schneller teaches an analogous reservoir (112, Fig 1) which contains an active ingredient (117, Fig 1) in solid form and comprises a liquid-permeable filter (153, Fig 1) which is arranged at the outlet of the reservoir, and is configured to retain the active ingredient in solid form in the reservoir (Col 3, line 59 – Col 4, line 4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to include a liquid-permeable filter as taught by Schneller in order to prevent particles from being delivered to the patient (Col 3, line 59 – Col 4, line 4).
The modified invention of Tennican and Schneller disclose all of the elements of the invention as discussed above, however, is silent regarding the device is designed and configured to dispense the dissolved active ingredient to a patient via the connection element.
Price teaches an analogous device comprising a connection element (638, Fig 6D) which is designed and configured for liquid-tight connection to a container (110, Fig 6F); - a mandrel (640, Fig 6D) designed and configured for piercing f a container; - a reservoir (660, Fig 6F) which contains an active ingredient; the device configured to dispense the dissolved active ingredient to a patient via the connection element (Para 0038-0039).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the container to be a blow-fill-seal vial and modify the connection element to be able to be coupled to a nozzle as taught by Price in order to facilitate administration of droplets for administration to the eye or topical administration (Para 0039).
Regarding Claim 2, the modified invention of Tennican, Schneller, and Price discloses the mandrel (400e, Fig 16B -Tennican) has a hollow interior (406, Fig 7 -Tennican) which is configured to receive a liquid from a container into the reservoir (Para 0077-Tennican).
Regarding Claim 3, the modified invention of Tennican, Schneller, and Price discloses the fluidic element (200e, Fig 16A -Tennican) has a plunger which is movably arranged within the reservoir and closes off the reservoir in a liquid-tight manner (Para 0114 -Tennican).
Regarding Claim 4, the modified invention of Tennican, Schneller, and Price discloses a first component (700, Fig 16A -Tennican) and a second component (100e, Fig 16A -Tennican) which can be detachably connected to one another.
Regarding Claim 5, the modified invention of Tennican, Schneller, and Price discloses the first component (700, Fig 16A -Tennican) contains the connection element (702, Fig 16A -Tennican) and the mandrel (400e, Fig 16B -Tennican), and/or wherein the second component (100e, Fig 16A -Tennican) contains the reservoir (102e, Fig 16A -Tennican), the filter (153, Fig 1 -as modified by Schneller), and the fluidic element (200e, Fig 16A -Tennican).
Regarding Claim 6, the modified invention of Tennican, Schneller, and Price discloses the device also has a connection element (708, Fig 16A -Tennican) by means of which the first component can be connected to the second component (Para 0114, Para 0119 -Tennican).
Regarding Claim 8, the modified invention of Tennican, Schneller, and Price discloses the device also has a nozzle (“nozzle”) which is configured to dispense the active ingredient in dissolved form (Para 0039 -Price).
Regarding Claim 9, the modified invention of Tennican, Schneller, and Price discloses the nozzle can be detachably connected in a fluid-conducting manner to the connection element (Para 0038 -Price).
Regarding Claim 11, the modified invention of Tennican, Schneller, and Price discloses the connection element has a first feedthrough (706, Fig 16A -Tennican) which is configured to receive a liquid from a container into the reservoir (Para 0114 -Tennican).
Regarding Claim 12, the modified invention of Tennican, Schneller, and Price discloses the connection element has a second feedthrough (712e’, Fig 17 -Tennican) which is configured to dispense a liquid from a container, wherein the dispensing is preferably possible in a state in which the device is connected to the reservoir via the first feedthrough according to claim 11 (Para 0123 -Tennican).
Regarding Claim 16, the modified invention of Tennican, Schneller, and Price discloses an active ingredient for use in a medical treatment method, wherein the active ingredient is dissolved in a liquid immediately before administration to a patient and subsequently administered in dissolved form by means of a device according to claim 1 (Para 0119 -Tennican).
Regarding Claim 17, the modified invention of Tennican, Schneller, and Price discloses the method for producing an active ingredient solution, which comprises the following steps: a) receiving a liquid from a container (500, Fig 16B -Tennican) using a device (device of Fig 16A -Tennican) according to claim 1 into the reservoir (102e, Fig 16A -Tennican) of the device (Para 0119 -Tennican), b) mixing the active ingredient within the reservoir with the liquid received in step a) (Para 0119 -Tennican), c) thereby obtaining an active ingredient solution, d) optionally dispensing the active ingredient solution into the container (Para 0119-Tennican).
Regarding Claim 18, the modified invention of Tennican, Schneller, and Price discloses use of a device according to claim 1 (Para 0119 -Tennican) or a kit for producing an active ingredient solution.
Claims 7 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2007/0249996) in view of Schneller (US 3,734,098) and further in view of Price (US 2024/0058217) and further in view of Liberti (US 2023/0038636).
Regarding Claim 7, the modified invention of Tennican, Schneller, and Price discloses all of the elements of the invention as discussed above, however, is silent regarding the device is completely sterilized, and preferably is completely non-pyrogenic
Liberti teaches a device that is packaged in a sealed, sterile, non-pyrogenic packaging (Para 0024-0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to be package in a sterile and non-pyrogenic package before use to have optimal safety and comfort (Para 0024).
Regarding Claim 15, the modified invention of Tennican, Schneller, and Price discloses kit, having a device according to claim 1 and a container (500, Fig 16B -Tennican) having a medically compatible liquid, wherein the device can be detachably connected to the container (See rejection of claim 1), however, is silent regarding wherein the kit is packed together in a germ-tight manner, preferably is completely sterilized, and more preferably is completely non-pyrogenic.
Liberti teaches a kit that is packaged in a sealed, sterile, non-pyrogenic packaging (Para 0024-0025).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device to be package in a sterile and non-pyrogenic package before use to have optimal safety and comfort (Para 0024).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2007/0249996) in view of Schneller (US 3,734,098) and further in view of Price (US 2024/0058217) and further in view of Epps (US 2019/0117569) as evidenced by Thibault (US 6,003,566).
Regarding Claim 10, the modified invention of Tennican, Schneller, and Price discloses all of the elements of the invention as discussed above, however, is silent regarding the active ingredient is an antiseptic, which is preferably selected from the group consisting of calcium hypochlorite, magnesium hypochlorite, sodium hypochlorite, sodium percarbonate, sodium peroxide, calcium peroxide, urea peroxide, triisocyanuric chloride, sodium-N-chloro-4-methylbenzene sulfonamide, sodium-N-chlorobenzene sulfonamide, octenidine, polyhexanide, and chlorhexidine digluconate.
Epps teaches that chlorhexidine digluconate is a solution used for preventing bacterial growth in a wound or surgical site of a subject (Abstract), wherein the solution is made from a solid or powder that is reconstituted prior to use (Para 0039, 0042).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the active ingredient to be an aseptic such as chlorhexidine digluconate in order to prevent bacterial growth in a wound or surgical site of a subject (Abstract -Epp) while also increasing shelf life of the drug (as evidenced by Thibault in Col 1, lines 18-22).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2007/0249996) in view of Schneller (US 3,734,098) and further in view of Price (US 2024/0058217) and further in view of McKay (US 2010/0228097).
Regarding Claim 13, the modified invention of Tennican, Schneller, and Price discloses all of the elements of the invention as discussed above, however, is silent regarding the reservoir is permeable to gamma rays and/or electron beams.
McKay teaches an analogous reservoir (“syringe”, Para 0128) wherein the reservoir is sterilizable by gamma rays (Para 0186-0187).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to be sterilizable by gamma rays as taught by McKay in order to sterilize the device by means that are highly effective in killing microorganisms, leave no residues, can be employed when the device is in the package, and gamma sterilization does not require high pressures or vacuum conditions, thus, package seals and other components are not stressed (Para 0187).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Tennican (US 2007/0249996) in view of Schneller (US 3,734,098) and further in view of Price (US 2024/0058217) and further in view of Griffiths (US 2004/0138611).
Regarding Claim 14, the modified invention of Tennican, Schneller, and Price discloses all of the elements of the invention as discussed above, however, is silent regarding the reservoir furthermore has a second filter which divides the reservoir into a first region and a second region.
Griffiths teaches an analogous reservoir wherein the reservoir comprises a filter (164, Fig 5A) which divides the reservoir into a first region and a second region (Para 0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoir to have a second filter as part of a seal structure as taught by Griffiths in order to wet the entire surface of the dry medicament for rapid and complete dissolution (Para 0047).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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