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 .
Response to Arguments
Applicant's arguments filed 0 have been fully considered but they are not persuasive. From the examiner’s understanding, the applicant presents two arguments; 1) Deangelo fails to teach the newly amended limitation of the lyophilizate having a water activity of less than .05 and 2)the previous rejection of Deangelo specifically states that moisture is allowed in only direction through the membrane not water vapor. Regarding argument 1), while the applicant sites paragraph 0046 of Deangelo, arguing that Deangelo teaches water activities of .01 to about .9, the examiner notes that this this citation is not accurate to the disclosure. Paragraph 0046 of Deangelo states that the water activity is less than .9 and then gives further ranges. Therefore it is interpreted that any product with a water activity of less than .9 would fall under the disclosure of Deangelo. As such the claim value of less than .05 is within the prior art range of .9 and Deangelo reads to the claimed limitation.
Regarding argument 2) the examiner notes that while the argument is nonpersuasive, to advance prosecution, the examiner cites paragraph 0101 of Deangelo, where one example of the invention the multilayer barrier film comprises materials to act as a gas and water vapor barrier layer. The examiner further notes that per the previously cited paragraph 0046 and 0025, the device comprises a material (barrier membrane para. 0046) and where partitioning material may comprise a membrane or series of membranes…ill permit the passage of moisture and/or liquid out of the compartment containing the material of interest being processed (Compartment 2), but will prevent the passage of moisture and/or other material or liquid into the compartment containing the material of interest being dehydrated. Therefore even though Deangelo references that the partitioning membranes allow moisture (and other substances) out but not in, Deangelo clearly describes an example embodiment in which the device comprises a water vapor barrier layer. As such it is interpreted that the partitioning materials (comprising a series of membranes) may include at least a water vapor barrier layer, thus allowing water vapor (or moisture or other liquids) out of the device while preventing said substances from re-entering the dehydrated chamber. The rejection of claim 1 below has been updated to include this citation.
In a further effort to achieve compact prosecution, the examiner provides a further rejection of claim 1 in view of Jones and Todt.
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)(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.
(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.
Claim(s) 1-2,12,15-18 is/are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by DeAngelo et al. US 2005/0186183, provided in the IDS, hereafter Deangelo.
Regarding claim 1, Deangelo discloses
A lyophilisate container comprising (Fig. 1, device (1)) a compartment (first and second compartment (2 and 3)) a wall limiting the compartment (partitioning material (4)); and a lyophilizate arranged inside the compartment (para. 0027-0028, see claim 1 of Deangelo)), wherein at least a portion of the wall is semipermeable allowing water vapour permeation in one direction out of the compartment through the wall and preventing water vapour permeation in an opposite direction into the compartment through the wall (para. 0025), thus allowing lyophilization inside the compartment as well as secure storage and preservation of the lyophilisate inside the compartment until its administration (para. 0026-0027). The examiner notes that should applicant disagree with this rejection, per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Deangelo teaches container for holding a lyophilizate where a semi permeable membrane allows moisture or liquid to flow only in one direction into the chamber with the lyophilizate where lyophilization may then occur (para. 0107-0110), and the securing of the lyophilizate inside the compartment until administration is interpreted to be functional language, Deangelo therefore reads to the claimed invention.
Per the amendments filed 08/01/25 Deangelo further discloses where the lyophilizate has a water activity of less than .05. Paragraph 0046 of Deangelo states that the water activity is less than .9 and then gives further ranges. Therefore it is interpreted that any product with a water activity of less than .9 would fall under the disclosure of Deangelo. As such the claim value of less than .05 is within the prior art range of .9 and Deangelo reads to the claimed limitation.
The examiner notes that as detailed under the response to argument sections, paragraph 0101 of Deangelo, discloses one example of the invention the multilayer barrier film comprises materials to act as a gas and water vapor barrier layer. The examiner further notes that per the previously cited paragraph 0046 and 0025, the device comprises a material (barrier membrane para. 0046) and where partitioning material may comprise a membrane or series of membranes…ill permit the passage of moisture and/or liquid out of the compartment containing the material of interest being processed (Compartment 2), but will prevent the passage of moisture and/or other material or liquid into the compartment containing the material of interest being dehydrated (para. 0025). Therefore even though Deangelo references that the partitioning membranes allow moisture (and other substances) out but not in, Deangelo clearly describes an example embodiment in which the device comprises a water vapor barrier layer. As such it is interpreted that the partitioning materials (comprising a series of membranes) may include at least a water vapor barrier layer, thus allowing water vapor (or moisture or other liquids) out of the device while preventing said substances from re-entering the dehydrated chamber.
Regarding claim 2, Deangelo discloses
The lyophilisate container of claim 1, wherein the wall comprises a semipermeable membrane (para. 0025, line 1) which is water vapour permeable in the one direction and water vapour tight in the opposite direction (para. 0025).
Regarding claim 12, Deangelo discloses
The lyophilisate container of claim 1, wherein the lyophilisate is a lyophilised drug formulation (para. 0108 discloses storage of a lyophilized virus, where para. 0077 disclose that device is capable of storing/preserving other material, such as a drug). Should the applicant disagree with this interpretation of the prior art, that per the MPEP section 2114 section II “"[A]pparatus claims cover
what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464,
1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with
respect to the manner in which a claimed apparatus is intended to be employed does not differentiate
the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural
limitations of the claim.” Therefore as Deangelo teaches a bag for storing and mixing a lyophilized component and therefore teaches the same structure as the claimed invention (See rejection of claim 1), it is interpreted that Deangelo would be capable of holding a lyophilized drug or any other lyophilized material.
Regarding claim 15, Deangelo discloses
A method of preparing a lyophilisate container according to-claim 1, comprising: positioning a moist substance inside a compartment of the lyophilisate container (para. 0024, where a stabilized product (partially dehydrated) is retained in a separated compartment of the device after preparation) limited by a wall limiting the compartment (wall (4) per rejection of claim 1), wherein at least a portion of the wall is semipermeable allowing water vapour permeation in one direction out of the inside of the compartment through the wall and preventing water vapour permeation in an opposite direction into the inside of the compartment through the wall (para. 0025); closing the compartment of the lyophilisate container (para. 0088, where the system is disclosed as a closed system); and lyophilising the moist substance in the compartment such that water vapour permeates out of the inside of the compartment through the wall (para. 0025, where the partially dehydrated material is processed (dehydrated) fully).
Per the amendments filed 08/01/25 Deangelo further discloses where the lyophilizate has a water activity of less than .05. Paragraph 0046 of Deangelo states that the water activity is less than .9 and then gives further ranges. Therefore it is interpreted that any product with a water activity of less than .9 would fall under the disclosure of Deangelo. As such the claim value of less than .05 is within the prior art range of .9 and Deangelo reads to the claimed limitation.
The examiner notes that as detailed under the response to argument sections, paragraph 0101 of Deangelo, discloses one example of the invention the multilayer barrier film comprises materials to act as a gas and water vapor barrier layer. The examiner further notes that per the previously cited paragraph 0046 and 0025, the device comprises a material (barrier membrane para. 0046) and where partitioning material may comprise a membrane or series of membranes…ill permit the passage of moisture and/or liquid out of the compartment containing the material of interest being processed (Compartment 2), but will prevent the passage of moisture and/or other material or liquid into the compartment containing the material of interest being dehydrated (para. 0025). Therefore even though Deangelo references that the partitioning membranes allow moisture (and other substances) out but not in, Deangelo clearly describes an example embodiment in which the device comprises a water vapor barrier layer. As such it is interpreted that the partitioning materials (comprising a series of membranes) may include at least a water vapor barrier layer, thus allowing water vapor (or moisture or other liquids) out of the device while preventing said substances from re-entering the dehydrated chamber.
Regarding claim 16, Deangelo discloses
A method comprising the steps of: obtaining a lyophilisate container according to claim 1, reconstituting the lyophilisate of the lyophilisate container in a liquid inside the compartment of the lyophilisate container (para. 0024), and filtering the liquid solution comprising the reconstituted lyophilisate through the wall of the compartment. The examiner notes that as vapour created by the reconstituted process would exit through the semipermeable membrane where the solution would be blocked, thus filtering the liquid solution.
Regarding claim 17, Deangelo discloses
The lyophilizate container of claim 12, wherein the lyophilizate is a highly potent drug formulation (para. 0108 discloses storage of a lyophilized virus, where para. 0077 disclose that device is capable of storing/preserving other material, such as a drug). Should the applicant disagree with this interpretation of the prior art, that per the MPEP section 2114 section II “"[A]pparatus claims cover
what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464,
1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with
respect to the manner in which a claimed apparatus is intended to be employed does not differentiate
the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural
limitations of the claim.” Therefore as Deangelo teaches a bag for storing and mixing a lyophilized component and therefore teaches the same structure as the claimed invention (See rejection of claim 1), it is interpreted that Deangelo would be capable of holding a lyophilized drug or any other lyophilized material.
Regarding claim 18, Deangelo discloses
The lyophilizate container of claim 12, wherein the lyophilised drug formulation comprises a biological component (para. 0108, where a virus is interpreted as a biological component). Should the applicant disagree with this interpretation of the prior art, that per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Deangelo teaches a bag for storing and mixing a lyophilized component and therefore teaches the same structure as the claimed invention (See rejection of claim 1), it is interpreted that Deangelo would be capable of holding a lyophilized drug or any other lyophilized material.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,8,9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snieder US 4591357, hereafter Snieder, in view of Deangelo.
Regarding claim 1 and 2, Snieder discloses
A lyophilisate container comprising (Fig. 1) a compartment (Fig. 2 (24)) a wall limiting the compartment (Fig. 2 (28)) and a lyophilizate arranged inside the compartment (column 3, lines 1-10)). Snieder further discloses that the defined wall (28) comprises a film barrier (52) preventing liquid from entering the drug formulation within the compartment. However it is not disclosed that at least a portion of the wall is semipermeable allowing vapour permeation in one direction out of the compartment through the wall and preventing vapour permeation in an opposite direction into the compartment through the wall.
Deangelo discloses a lyophilizate container and is thus considered analogous to the claimed invention. Deangelo discloses a partitioning material (Fig. 1 (4)), where said material is configured to allow moisture, liquids and other materials out of the drug storage compartment and block moisture, liquids and other material from going into said compartment thus allowing lyophilization inside the compartment as well as secure storage and preservation of the lyophilisate inside the compartment until its administration (para. 0026-0027). Therefore as Snieder discloses that the film barrier (52) prevents liquid from entering the compartment and interacting with the drug formulation, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide to use membrane of Deangelo for the film barrier of Snieder as both barriers are configured to prevent liquid, moisture inflow, and Deangelo teaches that the taught barrier allow moisture out of the container for dehydration purposes is beneficial in the processing step of the composition, and helps prevent by-product contamination (see para. 0025 of Deangelo). Should the applicant disagree that the device of the combination does not allow lyophilization inside the compartment as well as secure storage and preservation of the lyophilisate inside the compartment until its administration. The examiner notes that should applicant disagree with this rejection, per the MPEP section 2114 section II “"[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim.” Therefore as Deangelo teaches container for holding a lyophilizate where a semi permeable membrane allows moisture or liquid to flow only in one direction into the chamber with the lyophilizate where lyophilization may then occur (para. 0107-0110), and the securing of the lyophilizate inside the compartment until administration is interpreted to be functional language, Snieder in view of Deangelo therefore reads to the claimed invention.
The examiner further notes that as detailed under the response to argument sections, paragraph 0101 of Deangelo, discloses one example of the invention the multilayer barrier film comprises materials to act as a gas and water vapor barrier layer. Per Deangelo paragraph 0046 and 0025, the device comprises a material (barrier membrane para. 0046) and where partitioning material may comprise a membrane or series of membranes…ill permit the passage of moisture and/or liquid out of the compartment containing the material of interest being processed (Compartment 2), but will prevent the passage of moisture and/or other material or liquid into the compartment containing the material of interest being dehydrated (para. 0025). Therefore even though Deangelo references that the partitioning membranes allow moisture (and other substances) out but not in, Deangelo clearly describes an example embodiment in which the device comprises a water vapor barrier layer. As such it is interpreted that the partitioning materials (comprising a series of membranes) may include at least a water vapor barrier layer, thus allowing water vapor (or moisture or other liquids) out of the device while preventing said substances from re-entering the dehydrated chamber.
Regarding claim 8, Snieder and Deangelo teach
The lyophilisate container of claim 2, comprising a rigid body (cap (28) resilient per abstract, column 6, lines 61-69, where said cap is resilient to be retained and snugly engage with other components of the system). The examiner also notes that the cap directly connects to compartment (24), a glass container (column 3, line 5), which is sufficiently rigid. Snieder and Deangelo further teach having a hole opening at one end side of the body and extending from the one end side of the body to another end side of the body (wherein the hole is the channel formed through the cap 28), wherein the hole forms the compartment (wherein the cap opens into the glass compartment 24) and the semipermeable membrane is attached to the body thereby closing the hole at the one end side of the body (where film barrier 52, defined as the semipermeable membrane per rejection of claim 1 using Snieder and Deangelo, is seen to close the hole at one end side.
Regarding claim 9, Snieder and Deangelo teach
The lyophilisate container of claim 8, comprising a non- permeable foil having a high thermal conductivity, wherein the foil is attached to the body thereby closing the hole at the other end side of the body. The examiner notes that should the applicant disagree with this interpretation, a second interpretation is provided. As seen in figure 2 of Snieder, film portion 22 is seen covering the other end of defined body (28), where said layer is impervious to fluids to prevent unwanted escape (column 6, lines 44-46).
The examiner notes that should the applicant disagree with this interpretation, a second interpretation is provided. Per column 4, line 14-18 of Snieder it is disclosed that to further prevent fluid migration it the cap may be provided with an impervious Mylar film. As evidenced by the Laminated Plastics attached PDF data sheet, Mylar is known to have excellent insulating and heat resistance, thus reading to the claim. Therefore it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide a Mylar film to further block off the cap, preventing fluid transfer.
As seen in figure 2 of Snieder, film portion 22 is seen covering the other end of defined body (28), where said layer is impervious to fluids to prevent unwanted escape (column 6, lines 44-46)
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snieder in view of Deangelo in view of Kulle et al. US 4335770, hereafter Kulle.
Regarding claim 10, Snieder and Deangelo teach
The lyophilisate container of claim 8, but fails to disclose wherein the body has a conical lateral area.
Kulle teaches a fluid container and is thus considered analogous to the claimed invention. Kulle teaches that a conical shape of the section (figure 1, section (34)) permits detailed measurements of liquid level and provides further accuracy of administration (column 3, lines 52-68) through ports (20,30). Therefore as Deangelo teaches the movement of treated substance out of ports (See figure 1 of Deangelo) and Kulle teaches that conical shaped areas for said ports provide more accurate administration and measurements, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to provide the lateral area of Deangelo with a conical shape.
Claim(s) 1 is/are rejected under 35 U.S.C. 103 as being unpatentable over Snieder in view of Jones US 5522155 in view of Todt et al. WO 2010/022066, hereafter Jones and Todt, where Todt was previously provided.
Regarding claim 1, Jones discloses a lyophilisate container comprising (Fig. 13) a compartment (empty space within the device) a wall limiting the compartment (93); and a lyophilizate arranged inside the compartment (freeze dried product per column 5 lines 36-40)), wherein at least a portion of the wall is semipermeable allowing water vapour permeation in one direction out of the compartment through the wall (column 3, lines 60-67 and column 4 lines 1-15, where venting media (30) allows this function to happen and is similar to venting media disk (93) per column 5 lines 8-15). However while Jones discloses allowing lyophilization inside the compartment as well as secure storage and preservation of the lyophilisate inside the compartment until its administration (per the above citation), Jones fails to specifically disclose and preventing water vapour permeation in an opposite direction into the compartment through the wall.
Todt teaches materials for keeping material dry and preventing damage to said materials (abstract) and is thus considered analogous to the claimed invention. Todt teaches that as a means to keep articles dry said articles are provided with a film in which water vapor follows a “one way” path, that being out from the article (abstract, para. 0136). Therefore, as Jones teaches a material for removing water vapor from a dry object, and Todt teaches that it is known in the art to provide one-way water vapor films to prevent objects from getting wet and keep dry object dry, it would have been obvious to one having ordinary skill in the art prior to the effective filing date of the claimed invention to use the film of Todt as the venting material of Jones to achieve the predictable result of keeping a dry (lyophilizate) material dry by preventing water vapor from entering the chamber while still allowing water vapor to leave.
Conclusion
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Matthew Wrubleski whose telephone number is (571)272-1150. The examiner can normally be reached M-F 8:00-4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 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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/MATTHEW WRUBLESKI/Examiner, Art Unit 3781
/ARIANA ZIMBOUSKI/Primary Examiner, Art Unit 3781