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 .
DETAILED ACTION
This is the first office action in response to the above identified patent application filed on 07/28/2023. Claims 1-18 are currently pending and being examined.
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 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.
Claim Objections
Claim 18 is objected to because of the following informalities: Claim 18 recites “after the moving” in line 12. However, there is a lack of antecedent basis for this limitation. Furthermore examiner believes this is a simple cut and paste mistake and is not meant to be there as the container is dry filled so there is not much use in compressing the medicament with the seal. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claim 18 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blondino (USPAP 2018/0304018).
In reference to dependent claim 18, Blondino discloses an apparatus, comprising:
a housing (1100, fig 25) having an inner wall that defines a medicament cavity (1141);
a medicament container assembly (1200, fig 25) at least partially disposed within the medicament cavity (1141) of the housing (1100), the medicament container assembly (1200) containing a dose of a medicament (1227); and a carrier (1260) configured to move within the medicament cavity (1141) from a first carrier position (shown in fig 25) to a second carrier position (62) in response to an actuation force , the carrier (1260) including a side wall (wall of 1200 that encircles the medicament container 1210) that includes a retention portion (general area of 1215) and defines a coupling volume,
the carrier (1260) coupled to a needle (1240) having a proximal tip that extends into the coupling volume (top end of 1240),
the retention portion (1265) of the carrier (1260) configured to retain a distal end portion of the medicament container assembly (1200) in a first container position (seen in fig 25),
the distal end portion of the medicament container assembly (1200) fluidically isolated from the proximal tip of the needle when the medicament container assembly is in the first container position (shown in fig 25 the cartridge is fluidically isolated from the needle 1240),
the distal end portion of the medicament container assembly (1200) configured to move to a second container position in response to the actuation force (fig 62 shows a position of the assembly in the second position with the drug delivering position, although fig 62 is the sixth configuration it is descriptive of what the second configuration would look like in the second position, as it relates to the described components),
the distal end portion of the medicament container assembly (1200) being fluidically coupled to the proximal tip of the needle (1240) when the medicament container assembly is in the second container position (fig 62 shows the drug in 1227 delivered thru the needle 1240),
wherein the inner wall of the housing (1100) and the side wall of the carrier (1260) are configured to limit deformation of the retention portion (general area of 1215) to prevent the medicament container assembly (1200) from moving to the second container position when the carrier is in the first carrier position (the lower portion of 1200, in the general area of 1265, prevents the medicament cylinder from moving down and moving into the second position).
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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, 6-10,12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (USPAP 2016/0184521) in view of Edwards (USPAP 2013/0317477, hereafter Edwards 477).
In reference to independent claim 1, Edwards discloses a method of producing a medicament container assembly (assembly made in fig 135-142) that contains a dry medicament (11241) and a solvent (11244), the medicament container assembly including a container body (11210),
a first elastomeric member (11221), a second elastomeric member (11225), and a distal seal (11242), the first elastomeric member disposed within a proximal end portion of the container body (11221 is located on the proximal side of 11210 in fig 142), the second elastomeric member (11225) disposed within the container body (11210) distally from the first elastomeric member (11225 is distal to 11221),
the first elastomeric member (11221), the second elastomeric member (11225), and a portion of the container body (11210) collectively defining a first volume (volume that holds the diluent 11244), the second elastomeric member (11225) and a distal end portion of the container body (bottom of 11210 in fig 142) defining a second volume (volume that holds the medicament 11241), the method comprising:
conveying the dry medicament (11240/11241) into the second volume via a distal end opening of the container body (fig 1), the second elastomeric member (11225) being within the container body (11210) at a first distance from a distal end portion (11213) of the container body during the conveying (seen in fig 138);
sealing, after the moving, the distal end opening by installing the distal seal (11242) about the distal end opening (seen in fig 139);
conveying the solvent (11244) into the first volume (volume above 11225) via a proximal end opening; and
inserting the first elastomeric member (11221) into the container body (11210) via the proximal end (11212) opening to seal the solvent within the first volume (shown in fig 142), however
Edwards does not teach moving, after the conveying the dry medicament, the second elastomeric member distally within the container body to a second distance from the distal end portion of the container body, the second distance being less than the first distance.
Edwards 477 teaches moving, after the conveying the dry medicament, the second elastomeric member distally within the container body to a second distance from the distal end portion of the container body, the second distance being less than the first distance (para 0079 discloses “movement of the second elastomeric member 3225 compresses the lyophilized medicament” Edwards 477 discloses moving the second elastomeric member to compress the dry medicament).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the dry medicament compression method as taught in Edwards 477 in the method of Edwards so “the volume of the lyophilized medicament is reduced” para 0079, Edwards. By compressing the dry medicament the size of the device as a whole can be shrunk.
In reference to dependent claim 2, Edwards in view of Edwards 477 discloses the method of claim 1, Edwards wherein: the dry medicament is a lyophilized medicament (lyophilized in step 12008 fig 143); and the conveying the dry medicament includes: conveying a liquid medicament into the second volume (step 12006, fig 143), and lyophilizing the liquid medicament to produce the lyophilized medicament (step 12008, para 0326 discloses “The method 12000 can include moving the medicament container 12210 into the dehydration station 13002. The method 12000 includes lyophilizing the medicament 12240 (the lyophilized medicament is designated 12241 at 12008, see e.g., FIG. 145)”).
In reference to dependent claim 3, Edwards in view of Edwards 477 discloses the method of claim 2, Edwards 477 further discloses a method wherein: the lyophilized medicament within the container body at a first distance from the distal end produces a lyophilized cake (compressing the medicament makes a “cake”); and the moving the second elastomeric member distally within the container body to the second distance reduces the size of the lyophilized cake (para 0079 discloses “movement of the second elastomeric member 3225 compresses the lyophilized medicament” Edwards 477 discloses moving the second elastomeric member to compress the dry medicament).
In reference to dependent claim 6, Edwards in view of Edwards 477 discloses the method of claim 1, Edwards 477 further discloses a method wherein: the moving the second elastomeric member causes a gas within the dry medicament (3237) to be expelled from the second volume via the distal end opening (para 0079 discloses “the air portion of the lyophilized medicament can be vented through the needle”).
In reference to dependent claim 7, Edwards in view of Edwards 477 discloses the method claim 1, Edwards 477 further discloses a method wherein: the moving the second elastomeric member causes a size of the second volume to be decreased by at least fifty percent (para 0079 discloses “the air portion of the lyophilized medicament can be vented through the needle”, previously in para 0079 it is stated that “the lyophilized medicament can be formulated to include air (e.g., as much as 50% air by volume, as much as 60% air by volume, as much as 70% air by volume, as much as 80% air by volume, as much as 90% air by volume, approximately 93% air by volume)” so on the far end if “the air” is removed then the volume will decrease by at least 50%”).
In reference to dependent claim 8, Edwards in view of Edwards 477 discloses the method of claim 1, however
Edwards and Edwards 477 is silent to wherein the moving the second elastomeric member causes a size of the second volume to be less than 1 mL.
However Edwards 477 does disclose in para 0079 that “the air portion of the lyophilized medicament can be vented through the needle”, previously in para 0079 it is stated that “the lyophilized medicament can be formulated to include air (e.g., as much as 50% air by volume, as much as 60% air by volume, as much as 70% air by volume, as much as 80% air by volume, as much as 90% air by volume, approximately 93% air by volume)” so on the far end if “the air” is removed then the volume will decrease by at least 50%”, Edwards clearly discloses controlling for the volume.
It would have been obvious matter of design choice to make the size of the second volume 1mL, since such a modification would have involved a mere change in the size of a component, especially since the prior art shows varying the final volume. A change is size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237, (CCPA 1955).
In reference to dependent claim 9, Edwards in view of Edwards 477 discloses the method of claim 1, Edwards further discloses the method wherein the distal end portion of the container body includes a neck (neck in the distal portion 11213) and the second volume includes a neck portion (neck in 11213, fig 135), the method further comprising:
inserting, after the conveying the dry medicament and before the moving the second elastomeric member (at step pictured in fig 139, it is installed with the seal 11242),
Edwards does not teach, but Edwards 477, combined above, discloses a portion of a bleed fixture (3254 & 3216) into the neck portion (distal end portion 3212) of the second volume via the distal end opening, the bleed fixture configured to allow a gas within the dry medicament to be expelled from the second volume via the distal end opening while limiting the movement of the dry medicament into the neck portion of the second volume (para 0079 discloses “the volume of the lyophilized medicament is reduced and the third plunger is moved beyond the bypass 3220. In addition, because the proximal end portion 3217 of the needle 3216 is in fluid communication with the void volume 3238, the air portion of the lyophilized medicament can be vented through the needle 3216 prior to the insertion of the needle 3216 into the patient”).
In reference to dependent claim 10, Edwards in view of Edwards 477 discloses the method of claims 1, Edwards further discloses a method wherein: the container (11210) body includes a bypass channel (11220, fig 135) configured to fluidically couple the first volume (volume of 11244) and the second volume (volume of 11241) when the second elastomeric member (11225) is at least partially aligned with the bypass channel; and the second elastomeric member is located proximally from the bypass channel (11220) when the second elastomeric member (11225) is within the container body at the first distance and the second distance (para 0320 discloses “the second elastomeric 11225 can be moved in the distal direction such that at least a proximal surface of the second elastomeric member 11225 is proximal to the bypass 11220”).
In reference to dependent claim 12, Edwards in view of Edwards 477 discloses the method of claim 1, wherein the solvent is aqueous (para 0352 discloses “The lyophilized formulations of the present invention may be reconstituted by any suitable diluent or combination of diluent, including, but not limited to, water, sterile water, glycerin, or hydrochloric acid.”, aqueous means “made from, with, or by water” https://www.merriam-webster.com/dictionary/aqueous).
In reference to dependent claim 15, Edwards in view of Edwards 477 discloses an apparatus, comprising: a medicament container (assembly made in fig 135-142) produced according to the method of claim 1 (see the rejection above).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Edwards (USPAP 2016/0184521) in view of Zeng (USPAP 2010/0326437).
In reference to dependent claim 16, Edwards discloses a method of producing a medicament container assembly (assembly made in fig 135-142) that contains a dry medicament (11241) and a solvent (11244), the medicament container assembly including a container body (11210), a first elastomeric member (11221), a second elastomeric member (11225), and a distal seal (11242), the first elastomeric member (11221) disposed within a proximal end portion of the container body (see fig 142), the second elastomeric member (11225) disposed within the container body (11210) distally from the first elastomeric member (11221),
the first elastomeric member (11221), the second elastomeric member (11225), and a portion of the container body (11210) collectively defining a first volume (volume that holds 11244, in fig 142), the second elastomeric member (11225) and a distal end portion of the container body (11210) defining a second volume (volume that holds 11241), the method comprising:
filling the medicament into the second volume via a distal end opening of the container body (fig 137 and 138),
the second elastomeric member (11225) being within the container body (11210) at a first distance from a distal end portion (11213) of the container body during the conveying;
sealing, after the moving (examiner believes this is a cut and paste error objected to above), the distal end opening by installing the distal seal about the distal end opening (fig 139 shows installing the seal 11242);
conveying the solvent into the first volume via a proximal end opening (fig 141 shows filling the first volume with solvent 11244); and
inserting the first elastomeric member (11221) into the container body (11210) via the proximal end opening to seal the solvent within the first volume (fig 142 shows installing the first elastomeric member in the proximal end of the body 11210), however
Edwards does not teach dry filling the medicament.
Zeng, a similar medicament delivery device, teaches dry filling the medicament (para 0026 discloses “dry powder composition may be metered and filled into capsules”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the filling process taught in Zeng in the method of Edwards in view of Edwards 477 so “The appropriate particle size may be provided by the lyophilisation process described hereinabove although further micronisation may be performed by grinding in a mill, e.g. an air jet, ball or vibrator mill, by sieving, by crystallization, by spray-drying or by further lyophilisation” para 0021, Zeng. By using a dry fill process the size of the particles can be better controlled.
Claims 4, 5, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (USPAP 2016/0184521) in view of Edwards (USPAP 2013/0317477, hereafter Edwards 477) in reference to claim 1 above and further in view of Zeng (USPAP 2010/0326437).
In reference to dependent claim 4, Edwards in view of Edwards 477 discloses the method of claim 1, however
Edwards and Edwards 477 are silent to wherein the conveying the dry medicament into the second volume is performed via a dry fill process.
Zeng, a similar medicament delivery device, teaches conveying the dry medicament into a volume performed via a dry fill process (para 0026 discloses “dry powder composition may be metered and filled into capsules”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the filling process taught in Zeng in the method of Edwards in view of Edwards 477 so “The appropriate particle size may be provided by the lyophilisation process described hereinabove although further micronisation may be performed by grinding in a mill, e.g. an air jet, ball or vibrator mill, by sieving, by crystallization, by spray-drying or by further lyophilisation” para 0021, Zeng. By using a dry fill process the size of the particles can be better controlled.
In reference to dependent claim 5, Edwards in view of Edwards 477 discloses the method of claim 4, Zeng further discloses a method wherein the dry medicament is produced by any of a spray drying process or a micronizing process (para 0021 discloses “The appropriate particle size may be provided by the lyophilisation process described hereinabove although further micronisation may be performed by grinding in a mill, e.g. an air jet, ball or vibrator mill, by sieving, by crystallization, by spray-drying or by further lyophilisation”).
In reference to dependent claim 17, Edwards in view of Edwards 477 discloses the method of claim 16, however
Edwards and Edwards 477 are silent to the dry medicament is produced by any of a spray drying process or a micronizing process.
Zeng, a similar medicament delivery device, teaches the dry medicament is produced by any of a spray drying process (para 0021 discloses “The appropriate particle size may be provided by the lyophilisation process described hereinabove although further micronisation may be performed by grinding in a mill, e.g. an air jet, ball or vibrator mill, by sieving, by crystallization, by spray-drying or by further lyophilisation”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the filling process taught in Zeng in the method of Edwards in view of Edwards 477 so “The appropriate particle size may be provided by the lyophilisation process described hereinabove although further micronisation may be performed by grinding in a mill, e.g. an air jet, ball or vibrator mill, by sieving, by crystallization, by spray-drying or by further lyophilisation” para 0021, Zeng. By using a dry fill process the size of the particles can be better controlled.
Claims 11 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (USPAP 2016/0184521) in view of Edwards (USPAP 2013/0317477, hereafter Edwards 477) in reference to claim 10 above and further in view of Lumkemann (USPN 11,357,914).
In reference to dependent claim 11, Edwards in view of Edwards 477 discloses the method of claim 10, however
Edwards and Edwards 477 are silent to wherein: a proximal end portion of the bypass channel is at a third distance from the distal end portion of the container body, a ratio of the third distance to a length of the container body being less than 0.20.
Lumkemann, a similar two-part syringe with a bypass, teaches in col 4, lines 52-59 that “the bypass arrangement preferably is located adjacent to the distal end side of the body. In this connection the term “adjacent” can be referred to as close to the distal end side as possible or feasible. The closer the bypass arrangement is located at the distal end side the less first pharmaceutical liquid is left in the interior of the body when the second pharmaceutical liquid passes via the bypass arrangement” furthermore fig 5 clearly shows the bypass at the far distal end of the chamber, essentially being at the end, therefore meeting the claim language.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the bypass positioning, as taught in Lumkemann in the method of Edwards in view of Edwards 477 so “less first pharmaceutical liquid is left in the interior of the body when the second pharmaceutical liquid passes via the bypass arrangement” col 4, lines 57-59, Lumkemann.
Furthermore, it has been held that a particular parameter must be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation. In re Antoine, 559 F.2d 618, 195 USPQ 6 (CCPA 1977). See MPEP 2144.05 II(B).
Furthermore, it has been held that “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP 2144.05II(A). Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the bypass position taught by Edwards in view of Edwards 477 because the bypass position from the distal end was recognized as a result-effective variable achieving a particular level of fluid utilization and it would have been a matter of routine experimentation to determine the optimum or workable ranges of the bypass position to achieve a desired fluid utilization.
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Edwards (USPAP 2016/0184521) in view of Edwards (USPAP 2013/0317477, hereafter Edwards 477) in reference to claim 12 above and further in view of Zheng (USPAP 2014/0135343).
In reference to dependent claim 13, Edwards in view of Edwards 477 discloses the method of claim 12, however
Edwards and Edwards 477 are silent to the aqueous solvent includes an alcohol or miscible organic solvent.
Zheng, a multi-part medicament, teaches the aqueous solvent includes an alcohol or miscible organic solvent (para 0013 discloses “The said organic solvent is selected from the acceptable solvents in the pharmaceutical field according to the principle that the solubility of the aripiprazole in this organic solvent is better than that in water, and the water-miscible organic solvent is preferred, such as conventionally used water-soluble alcohols in the pharmaceutical field, like ethanol, propylene glycol, glycerin, isopropyl alcohol and tertiary butyl alcohol etc., preferably one or more among ethanol, propylene glycol and glycerol, and ethanol in particular.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the medicament preparation method taught in Zhen in the method of Edwards in view of Edwards 477 so the final medicament “has a significantly reduced amount of related substances, great solubility, great stability, high bioavailability, reduced individual differences, and enhanced wettability and content uniformity of insoluble medicaments” abstract, Zheng.
In reference to dependent claim 14, Edwards in view of Edwards 477 and Zheng discloses the method of claim 12, Zheng further discloses a medicament wherein the aqueous solution includes a surfactant (para 0014 discloses “surfactants and/or the solubilizers can be added during or after the preparation of the medicament”).
Conclusion
Examiner has cited particular columns and line and/or paragraph numbers in the references applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings of the art and are applied to specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested from the applicant in preparing responses, to fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the Examiner.
The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Egeland (USPAP 2018/0049948) discloses a medicament container for mixing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES W NICHOLS whose telephone number is (571)272-6492. The examiner can normally be reached Monday-Friday 8am-5pm EST.
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/CHARLES W NICHOLS/Examiner, Art Unit 3783