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 .
Claims 1-15 are pending.
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.
Claim(s) 10 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WELLER (US 4176153 A).
Re: 10, WELLER teaches of a system for controlling a temperature of a biopharmaceutical product (see parenteral solution, abstract) during blow-fill sealing, comprising:
a blow-fill sealing machine (see apparatus 10, Fig. 1-5, with blowing in Fig. 2, filling in Fig. 3, and sealing in Fig. 4) including a mandrel (filling tube 26, see also teaching of movable composite mandrel 20 for blowing, filling) configured to introduce the biopharmaceutical product (product 34, parenteral solutions, see abstract), and
a mold (see 14, 15) to receive a ribbon of parison (see 12) and form one or more ampoules (see Fig. 1); and
at least one cooling subunit configured and arranged to reduce a temperature of the biopharmaceutical product (see Col. 6, lines 22-28, wherein, the molds can be chilled by circulating a cooling fluid).
Wherein, the cooling subunit is capable of reducing the temperature of the product via the operation of chilling the product through the molds.
Re: 12 (upon 10), wherein the at least one cooling subunit includes a mold cooling subunit including a standalone temperature control unit that supplies a substance to the mold. (see teaching in Col. 6, lines 22-28, wherein, the temperature control unit can also be of the via the product provided the product which is a substance to the mold, and also teaching of the alternative of the cooling fluid that circulates through the molds.)
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) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over WELLER (US 4176153 A), and further in view of WONG (US 2015/0367969 A1).
Re: 1, WELLER teaches of a method of controlling a temperature of a biopharmaceutical product (see parenteral solutions, abstract) during blow-fill sealing (see abstract of form, fill and seal technique, including blow-mold), comprising:
providing a parison (extruded parison 12) to a blow-fill sealing machine (see Figs. 1-5, for blowing in Fig. 2, filling in Fig. 3, and sealing in Fig. 4) for accepting the biopharmaceutical product during the blow-fill sealing; and
applying at least one heat transfer mechanism (see Col. 6, lines 22-28, wherein, the molds can be chilled by circulating a cooling fluid).
WELLER does not specifically state of the heat transfer mechanism “to control the temperature for the biopharmaceutical product”. However, this manner of operations in blow fill systems are known, see
See in WONG of the attempt to control the temperature of the product that is filled into the container, see Fig. 4, and see [0035], and wherein the fill system may employ conventional cooling mechanism for ensuring the product is at a temperature at the fill system, see [0030].
It would have been obvious for one of ordinary skill in the art to modify the process of WELLER with the cooling mechanism of WONG for controlling the temperature of the product that fills a container, see WONG [0035].
Re: 2 (upon 1), wherein the heat transfer mechanism is selected from:
(i) heat transfer from a pre-molded parison and air inside a parison balloon;
(ii) heat transfer between a molded parison and the main mold before, during and/or after introduction of the biopharmaceutical product;
(iii) heat transfer between the molded parison and a mold;
(iv) heat transfer between the molded parison and the biopharmaceutical product during and/or after introduction of the biopharmaceutical product;
(v) heat transfer between a fully formed ampoule after molding and an external environment;
(vi) heat transfer between an ampoule and the biopharmaceutical product during inversion of the ampoule; or
(vii) continued heat transfer between the ampoule and the external environment.
Wherein, the teaching of WELLER and WONG combined can provide heat transfer in most of the options.
Re: 3 (upon 2), wherein heat transfer mechanisms (i) through (vii) are applied. See teaching of WELLER in view of WONG.
Re: 4 (upon 1), further comprising cooling a component of the blow-fill sealing machine to ensure that a temperature of the biopharmaceutical product does not exceed a predetermined threshold. See teaching in WONG concerning the desired finished product being at a particular temperature or less, see [0035].
Re: 5 (upon 4), wherein the predetermined threshold is selected based on a sensitivity of the biopharmaceutical product. See selection of the different thresholds as seen in WONG [0035], Fig. 4, wherein one skilled in the art would recognize of selection based upon the product.
Re: 6 (upon 4), wherein the predetermined threshold is 35° C. See WONG, [0035], see teaching of 35 C.
Re: 7 (upon 1), further comprising decreasing a temperature of a mold of the blow-fill sealing machine. See teaching of WELLER above in regards of decreasing the temperature of the mold.
Re: 8 (upon 1), further comprising decreasing a temperature of a mandrel of the blow-fill sealing machine. See teaching of WELLER regarding the flow of the product that includes temperature that would decrease at a lower relative temperature, see Col. 6, lines 22-25, the mandrel 500 being entered into the formed container and allowing for fill, see Fig. 3.
Re: 9 (upon 1), further comprising keeping the mandrel at a temperature below 15° C. While WONG teaches of various temperature ranging from 40 C or less, or 20 C, see [0035], and of the container being capable of being filled at 15-20C, including the product at 10C, see [0038], wherein, the mandrel of WELLER can be set to a lower temperature by the product of WONG as it enters the mandrel for filling.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over WELLER as applied to claim 10 above, and further in view of PRICE (US 2024/0009911 A1) and SCHULZE (US 2004/0156942 A1).
Re: 11 (upon 10), wherein the at least one cooling subunit includes a mandrel cooling subunit that recirculates a substance through an outer annular space of the mandrel.
Wherein, WELLER does not specifically teach of a mandrel cooling subunit.
However, as known in the blow fill seal machine arts, PRICE teaches of mandrels 142 that are coupled to cooling device 144, see [0017], whereby to cool the product [0016]. Wherein SCHULZE teaches of a known cooling method of a mandrel includes a cooling medium that flows through the mandrel, see [0014-0015].
It would have been obvious for one of ordinary skill in the art to have modified the mandrel of WELLER with a cooling device as taught by PRICE to cool the product, and with the use of a cooling substance that flows through the mandrel as taught by SCHULZE as a known manner of cooling a mandrel, see KSR rationale MPEP 2143, as combining prior art elements according to known methods to yield predictable results.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over WELLER as applied to claim 12 above, and further in view of NAGASAKA (US 2007/0063061 A1).
Re: 13 (upon 12), wherein the substance is propylene glycol.
The teaching of WELLER is of introducing of a cooling fluid as a substance to the mold. But does not teach of the particular fluid.
However, it is known in the molding arts of the use of propylene glycol as a temperature regulating fluid, see in NAGASAKA [0040], as a known fluid used in a mold system.
It would have been obvious for one of ordinary skill in the art to modify the cooling fluid of WELLER with the use of propylene glycol as taught by NAGASAKA as a known temperature regulating fluid used in a mold system, see KSR rationale MPEP 2143, as combining prior art elements according to known methods to yield predictable results.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over WELLER as applied to claim 10 above, and further in view of ZOU (US 2023/0264409 A1).
Re: 14 (upon 10), wherein the at least on cooling subunit includes one or more air knives configured to direct a stream of air onto the ribbon of parison.
WELLER does not teach of air knives for the cooling subunit.
ZOU teaches of the use of air knives for cooling of a preform (seen as equivalent to parisons) that is known in the molding arts. Here, preforms are cooled by an air cooling knife, see [0005, 0006, 0011, 0012], wherein, these are known for manner for cooling of the plastic preform.
It would have been obvious for one of ordinary skill in the art to modify the cooling of WELLER with the use of air knives as taught by ZOU as a known manner of cooling parisons in a mold system, see KSR rationale MPEP 2143, as combining prior art elements according to known methods to yield predictable results.
Re: 15 (upon 14), wherein the one or more air knives includes a pair of 12” air knives placed on opposing ends of the ribbon and configured to blow air onto the ribbon and away from the mandrel.
Regarding paired air knives that are on opposing ends of a ribbon, see teaching in ZOU with the opposed air outlets, see [0012] that would be equivalent to the claimed element.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See attached PTO-892 form, most teaching filled sealed containers formed via blow molding.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL S LUK whose telephone number is (571)272-1134. The examiner can normally be reached Monday-Friday 9 to 5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Xiao S Zhao can be reached at 571-270-5343. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL S LUK/Primary Examiner, Art Unit 1744