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 .
Election/Restrictions
Applicant’s election without traverse of claims 20, 21, 23, 24, 39-46 in the reply filed on 6/29/26 is acknowledged.
Claims 1, 9, 13, 32-35, 38 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/29/26.
Claim Interpretation
35 U.S.C. 101 enumerates four categories of subject matter that Congress deemed to be
appropriate subject matter for a patent: processes, machines, manufactures and compositions of matter.
As explained by the courts, these "four categories together describe the exclusive reach of patentable
subject matter. If a claim covers material not found in any of the four statutory categories, that claim falls
outside the plainly expressed scope of § 101 even if the subject matter is otherwise new and useful," see
MPEP 2106.03. The term "system" is not directly analogous to any of these four categories, but given that
applicant's preamble states "an extrusion blow molding system for forming a plastic container," it can be
inferred that applicant intended the claims to recite a machine. A machine is a "concrete thing,
consisting of parts, or of certain devices and combination of devices." Digitech, 758 F.3d at 1348-49, 111
USPQ2d at 1719 (quoting Burr v. Duryee, 68 U.S. 531, 570, 17 L. Ed. 650, 657 (1863)). This category
"includes every mechanical device or combination of mechanical powers and devices to perform some
function and produce a certain effect or result." Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501
(quoting Corning V. Burden, 56 U.S. 252, 267, 14 L. Ed. 683, 690 (1854))," see MPEP 2106.03. The
examiner further notes that the article worked upon does not limit machine/apparatus claims, see MPEP
2115 and a manner of operating a device does not differentiate the apparatus claim from the prior art, see
MPEP 2114.
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(s) 20, 23, 24, 41, 43 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hart (US 2020/0023397).
As to claim 20, Hart teaches a system comprising: an emulsion supply container for preparing or storing a particle source [0077]; one or more extrusion-based printing nozzles in fluid communication with the emulsion supply container for generating a plurality of droplets of the emulsion including particles having diameters of from 10 nm to 1100 um [0055, 0066-0068, 0070, Fig 8B]; and a collection surface [0015-0017] for receiving the plurality of droplets of the emulsion from the one or more extrusion-based printing nozzles [Fig 1-4A]. The container having an emulsion comprising water, a polymer or a non-polymeric excipient, a solvent, and an active pharmaceutical ingredient phrased the examiner further notes that the article worked upon does not limit machine/apparatus claims, see MPEP 2115 and a manner of operating a device does not differentiate the apparatus claim from the prior art, see MPEP 2114.
As to claim 23, Hart teaches one or more temperature sensors or temperature controllers for monitoring or controlling a temperature of the collection surface [0015]; or a translation stage for generating a relative translation between the one or more extrusion-based printing nozzles and the collection surface [0071]; or one or more pressure sensors or pressure controllers for monitoring or controlling an extrusion pressure associated with the one or more extrusion-based printing nozzles [0066, 0117]; or one or more actuators for monitoring or controlling an extrusion speed associated with the one or more extrusion-based printing nozzles [0109, 0110].
As to claim 24, Hart teaches the collection surface is a moving or translating collection surface [0071, Fig 1-2B, 4A].
As to claim 41, Hart teaches a translation stage for generating a relative translation between the one or more extrusion-based printing nozzles and the collection surface [0071, Fig 1-2B, 4A].
As to claim 43, Hart teaches comprising one or more pressure sensors or pressure controllers for monitoring or controlling an extrusion pressure associated with the one or more extrusion-based printing nozzles [0059, 0043, 0066, 0117].
Claim(s) 20, 23, 24, 41, 42, 44-46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Maggiore (US 2017/0335268).
As to claim 20, Maggiore teaches a system comprising: an emulsion supply for preparing or storing phrased as feed source[0036]; one or more extrusion-based printing nozzles in fluid communication with the emulsion supply container for generating a plurality of droplets of the emulsion including particles having diameters of from 10 nm to 1100 um referred to as “micronized droplets” as micronized means on the micron scale [0027]; and a collection surface [0015-0017] for receiving the plurality of droplets of the emulsion from the one or more extrusion-based printing nozzles [0154, 0163, 0165]. The container having an emulsion comprising water, a polymer or a non-polymeric excipient, a solvent, and an active pharmaceutical ingredient phrased the examiner further notes that the article worked upon does not limit machine/apparatus claims, see MPEP 2115 and a manner of operating a device does not differentiate the apparatus claim from the prior art, see MPEP 2114.
As to claim 23, Maggiore teaches a translation stage for generating a relative translation between the one or more extrusion-based printing nozzles and the collection surface [0154, 0165].
As to claim 24, Maggiore teaches the collection surface is a moving or translating collection surface [0154, 0165].
As to claim 41, Maggiore teaches a translation stage for generating a relative translation between the one or more extrusion-based printing nozzles and the collection surface [0154, 0165].
As to claim 43, Maggiore teaches comprising one or more pressure sensors or pressure controllers for monitoring or controlling an extrusion pressure associated with the one or more extrusion-based printing nozzles [0090, 0091, 0094].
As to claim 42, Maggiore teaches comprising one or more mixing vessels in fluid communication with the emulsion supply container for preparing and providing the emulsion to the emulsion supply container [0110, 0111, 0114-0116].
As to claim 44, Maggiore teaches one or more actuators for monitoring or controlling an extrusion speed associated with the one or more extrusion-based printing nozzles [0090, 0136].
As to claim 45, Maggiore teaches a housing for maintaining at least the one or more extrusion-based printing nozzles and the collection surface in a sterile environment [0154, 0165].
As to claim 46, Maggiore teaches sterilization equipment positioned to sterilize one or more of the emulsion supply containers, the one or more extrusion- based printing nozzles, or the collection surface [0154, 0165].
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.
Claim(s) 21 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Hart (US 2020/0023397) in view of Rubinsky (US 2018/0304537).
As to claims 21 and 39, Hart teaches his system is for use in biomedical/pharmaceutical devices [0063], but does not explicitly state the collection surface is cooled to a temperature of from about -200 °C to about -75 °C, or wherein the system further comprises a cooling or refrigeration system coupled to the collection surface for cooling the collection surface to a temperature of from about -200 °C to about -75 ° C and comprising a cooling or refrigeration system coupled to the collection surface for cooling the collection surface to a temperature of from about -200 °C to about -75 °C.
Rubinsky teaches a method of making biomedical devices [0010] wherein produced structures are rapidly frozen [0013, 0019, 0023] which allows for complex structures [0032]. The freezing step is accomplished by a cooling system utilizing liquid nitrogen (which would have a temperature of approximately -200 C) [0019, 0023-0025, 0044, 0045, 0047, 0070, 0072] which eliminates “thermal stresses” that are a key element in maintaining the integrity and stability of the formed product. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have altered the invention of Hart and included a cooling system coupled to the collection surface for cooling the collection surface to a temperature of -200 C (ie that of liquid nitrogen), as suggested by Rubinsky, in order to produce complex structures with good integrity and stability.
Claim(s) 21 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Maggiore (US 2017/0335268) in view of Rubinsky (US 2018/0304537).
As to claims 21 and 39, Maggiore teaches his system is for use in biomedical/pharmaceutical material including tissue [0002, 0007], but does not explicitly state the collection surface is cooled to a temperature of from about -200 °C to about -75 °C, or wherein the system further comprises a cooling or refrigeration system coupled to the collection surface for cooling the collection surface to a temperature of from about -200 °C to about -75 ° C and comprising a cooling or refrigeration system coupled to the collection surface for cooling the collection surface to a temperature of from about -200 °C to about -75 °C.
Rubinsky teaches a method of making biomedical devices [0010] wherein produced structures are rapidly frozen [0013, 0019, 0023] which allows for complex structures [0032]. The freezing step is accomplished by a cooling system utilizing liquid nitrogen (which would have a temperature of approximately -200 C) [0019, 0023-0025, 0044, 0045, 0047, 0070, 0072] which eliminates “thermal stresses” that are a key element in maintaining the integrity and stability of the formed product. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have altered the invention of Hart and included a cooling system coupled to the collection surface for cooling the collection surface to a temperature of -200 C (ie that of liquid nitrogen), as suggested by Rubinsky, in order to produce complex structures with good integrity and stability.
Claim(s) 40 is rejected under 35 U.S.C. 103 as being unpatentable over Maggiore (US 2017/0335268) in view of Souza (US 2016/0137974).
As to claim 40, Maggiore notes the collection surface is a multi-well plate within a sterile room [0154, 0155] as explained above but does not explicitly state comprise a sterile vial.
Souza notes vessels for bioprinting [0004, 0013] and notes that both vials phrased as test tubes and multiwell plates are commonly used [0019]. Thus, test tubes and multi well plates are art recognized equivalents. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have altered the method of Maggiore and simply substituted the multiwell plates for test tubes, as suggested by Souza, as both had demonstrated success and were commonly used in bioprinting. Moreover, substituting an art recognized equivalent for another, in this case a well plate for a vial, is generally recognized to be obvious, see MPEP 2144.06 II.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARMAND MELENDEZ whose telephone number is (571)270-0342. The examiner can normally be reached 9 AM- 6 PM Monday-Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ARMAND MELENDEZ/Primary Examiner, Art Unit 1759
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