FINAL OFFICE ACTION
This application has been assigned or remains assigned to Technology Center 1700, Art Unit 1774 and the following will apply for this application:
Please direct all written correspondence with the correct application serial number for this application to Art Unit 1774.
Telephone inquiries regarding this application should be directed to the Electronic Business Center (EBC) at http://www.uspto.gov/ebc/index.html or 1-866-217-9197 or to the Examiner at (571) 272-1139. All official facsimiles should be transmitted to the centralized fax receiving number (571)-273-8300.
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 .
Priority
Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d). All of the CERTIFIED copies of the priority documents have been received in this national stage application from the International Bureau (PCT Rule 17.2(a)).
Claim Rejections - 35 USC § 103
The terms used in this respect are given their broadest reasonable interpretation in their ordinary usage in context as they would be understood by one of ordinary skill in the art, in light of the written description in the specification, including the drawings, without reading into the claim any disclosed limitation or particular embodiment. See, e.g., In re Am. Acad. of Sci. Tech. Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004); In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000); In re Morris, 127 F.3d 1048, 1054-55 (Fed. Cir. 1997); In re Zletz, 893 F.2d 319, 321-22 (Fed. Cir. 1989). The Examiner interprets claims as broadly as reasonable in view of the specification, but does not read limitations from the specification into a claim. Elekta Instr. S.A.v.O.U.R. Sci. Int'l, Inc., 214 F.3d 1302, 1307 (Fed. Cir. 2000).
To determine whether subject matter would have been obvious, "the scope and content of the prior art are to be determined; differences between the prior art and the claims at issue are to be ascertained; and the level of ordinary skill in the pertinent art resolved .... Such secondary considerations as commercial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the circumstances surrounding the origin of the subject matter sought to be patented." Graham v. John Deere Co. of Kansas City, 383 U.S. 1, 17-18 (1966).
The Supreme Court has noted:
Often, it will be necessary for a court to look to interrelated teachings of multiple patents; the effects of demands known to the design community or present in the marketplace; and the background knowledge possessed by a person having ordinary skill in the art, all in order to determine whether there was an apparent reason to combine the known elements in the fashion claimed by the patent at issue.
KSR Int'l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1740-41 (2007). "Under the correct analysis, any need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed." (Id. at 1742).
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.
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.
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.
The instant office action conforms to the policies articulated in the Federal Register notice titled “Updated Guidance for Making a Proper Determination of Obviousness” at 89 Fed. Reg. 14449, February 27, 2024, wherein the Supreme Court’s directive to employ a flexible approach to understanding the scope of prior art is reflected in the frequently quoted sentence, ‘‘A person of ordinary skill is also a person of ordinary creativity, not an automaton.’’ Id. at 421, 127 S. Ct. at 1742. In this section of the KSR decision, the Supreme Court instructed the Federal Circuit that persons having ordinary skill in the art (PHOSITAs) also have common sense, which may be used to glean suggestions from the prior art that go beyond the primary purpose for which that prior art was produced. Id. at 421–22, 127 S. Ct. at 1742. Thus, the Supreme Court taught that a proper understanding of the prior art extends to all that the art reasonably suggests, and is not limited to its articulated teachings regarding how to solve the particular technological problem with which the art was primarily concerned. Id. at 418, 127 S. Ct. at 1741 (‘‘As our precedents make clear, however, the analysis need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.’’). ‘‘The obviousness analysis cannot be confined . . . by overemphasis on the importance of published articles and the explicit content of issued patents.’’ Id. at 419, 127 S. Ct. at 1741. Federal Circuit case law since KSR follows the mandate of the Supreme Court to understand the prior art— including combinations of the prior art—in a flexible manner that credits the common sense and common knowledge of a PHOSITA. The Federal Circuit has made it clear that a narrow or rigid reading of prior art that does not recognize reasonable inferences that a PHOSITA would have drawn is inappropriate. An argument that the prior art lacks a specific teaching will not be sufficient to overcome an obviousness rejection when the allegedly missing teaching would have been understood by a PHOSITA—by way of common sense, common knowledge generally, or common knowledge in the relevant art. For example, in Randall Mfg. v. Rea, 733 F.3d 1355 (Fed. Cir. 2013), the Federal Circuit vacated a determination of nonobviousness by the Patent Trial and Appeal Board (PTAB or Board) because it had not properly considered a PHOSITA’s perspective on the prior art. Id. at 1364. The Randall court recalled KSR’s criticism of an overly rigid approach to obviousness that has ‘‘little recourse to the knowledge, creativity, and common sense that an ordinarily skilled artisan would have brought to bear when considering combinations or modifications.’’ Id. at 1362, citing KSR, 550 U.S. at 415–22, 127 S. Ct. at 1727. In reaching its decision to vacate, the Federal Circuit stated that by ignoring evidence showing ‘‘the knowledge and perspective of one of ordinary skill in the art, the Board failed to account for critical background information that could easily explain why an ordinarily skilled artisan would have been motivated to combine or modify the cited references to arrive at the claimed inventions.’’ Id.
From Norgren Inc. v. Int’l Trade Comm’n, 699 F.3d 1317, 1322 (Fed. Cir. 2012) (‘‘A flexible teaching, suggestion, or motivation test can be useful to prevent hindsight when determining whether a combination of elements known in the art would have been obvious.’’); Outdry Techs. Corp. v. Geox S.p.A., 859 F.3d 1364, 1370–71 (Fed. Cir. 2017) (‘‘Any motivation to combine references, whether articulated in the references themselves or supported by evidence of the knowledge of a skilled artisan, is sufficient to combine those references to arrive at the claimed process.’’). In keeping with this flexible approach to providing a rationale for obviousness, the Federal Circuit has echoed KSR in identifying numerous possible sources that may, either implicitly or explicitly, provide reasons to combine or modify the prior art to determine that a claimed invention would have been obvious. These include ‘‘market forces; design incentives; the ‘interrelated teachings of multiple patents’; ‘any need or problem known in the field of endeavor at the time of invention and addressed by the patent’; and the background knowledge, creativity, and common sense of the person of ordinary skill.’’ Plantronics, Inc. v. Aliph, Inc., 724 F.3d 1343, 1354 (Fed. Cir. 2013), quoting KSR, 550 U.S. at 418–21, 127 S. Ct. at 1741–42.
The Federal Circuit has also clarified that a proposed reason to combine the teachings of prior art disclosures may be proper, even when the problem addressed by the combination might have been more advantageously addressed in another way. PAR Pharm., Inc. v. TWI Pharms., Inc., 773 F.3d 1186, 1197–98 (Fed. Cir. 2014) (‘‘Our precedent, however, does not require that the motivation be the best option, only that it be a suitable option from which the prior art did not teach away.’’) (emphasis in original). One aspect of the flexible approach to explaining a reason to modify the prior art is demonstrated in the Federal Circuit’s decision in Intel Corp. v. Qualcomm Inc., 21 F.4th 784, 796 (Fed. Cir. 2021), which confirms that a proposed reason is not insufficient simply because it has broad applicability. Patent challenger Intel had argued in an inter partes review before the Board that some of Qualcomm’s claims were unpatentable because a PHOSITA would have been able to modify the prior art, with a reasonable expectation of success, for the purpose of increasing energy efficiency. Id. at 796–97. The Federal Circuit explained that ‘‘[s]uch a rationale is not inherently suspect merely because it’s generic in the sense of having broad applicability or appeal.’’ Id. The Federal Circuit further pointed out its pre-KSR holding ‘‘that because such improvements are ‘technology independent,’ ‘universal,’ and ‘even common-sensical,’ ‘there exists in these situations a motivation to combine prior art references even absent any hint of suggestion in the references themselves.’ ’’ Id., quoting DyStar Textilfarben GmbH v. C.H. Patrick Co., 464 F.3d 1356, 1368 (Fed. Cir. 2006) (emphasis added by the Federal Circuit in Intel). When formulating an obviousness rejection, the PTO may use any clearly articulated line of reasoning that would have allowed a PHOSITA to draw the conclusion that a claimed invention would have been obvious in view of the facts. MPEP 2143, subsection I, and MPEP 2144. Acknowledging that, in view of KSR, there are ‘‘many potential rationales that could make a modification or combination of prior art references obvious to a skilled artisan,’’ the Federal Circuit has also pointed to MPEP 2143, which provides several examples of rationales gleaned from KSR. Unwired Planet, 841 F.3d at 1003.
When considering the prior art in its entirety, note Allied Erecting v. Genesis Attachments, 825 F.3d 1373, 1381, 119 USPQ2d 1132, 1138 (Fed. Cir. 2016) ("Although modification of the movable blades may impede the quick-change functionality disclosed by Caterpillar, ‘[a] given course of action often has simultaneous advantages and disadvantages, and this does not necessarily obviate motivation to combine.’" (quoting Medichem, S.A. v. Rolabo, S.L., 437 F.3d 1157, 1165, 77 USPQ2d 1865, 1870 (Fed Cir. 2006) (citation omitted))). However, "the prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
Accordingly, claims 1, 3-6, and 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over POST et al. (US 9724658 B2) in view of EP 1712285 A1.
The publication to POST et al. discloses an apparatus and method comprising: a fluid storing container 3; a syringe 13 including a gasket (i.e., piston) configured to be slid on an inner peripheral wall of the syringe by a plunger 14 ¶ [0034]; a tube 11, 17, or 21 having one end inserted in the container 3 and another end connected to the syringe 13; and a control section 9 that performs control of the plunger to move forward and backward, wherein under the control by the control section 9, an atomization process is performed at least once in which the plunger is moved backward to allow the process-target fluid in the process-target fluid storing container to flow into the syringe via the tube so as to be stored in the syringe and the plunger is moved forward to return the process-target fluid stored in the syringe into the process-target fluid storing container via the tube [0019]; the tube having a diameter and length as seen in the drawing Figures; the control section 9 controls a speed of the fluid extruded through the tube by the plunger in such a way that a flow of the fluid in the tube can become turbulent, and controls the number of times the atomization process is performed by a reciprocating operation of the plunger to a predetermined number of times;
and furthermore POST et al. further discloses a method including inserting one end of a tube 11, 17, or 21 into a fluid storing container 3 for storing a process-target fluid; connecting another end of the tube to a syringe 13 including a gasket (piston) configured to be slid on an inner peripheral wall of the syringe 13 by a plunger 14; and performing an atomization process at least once in which the plunger is moved backward to allow the process-target fluid in the process-target fluid storing container to flow into the syringe via the tube so as to be stored in the syringe and the plunger is moved forward to return the process-target fluid stored in the syringe into the process-target fluid storing container via the tube, per [0011], [0013], [0015], [0017], [0018], [0019], [0035], [0036], [0038], [0039]; the tube formed to have a diameter and length as seen in the drawing Figures; and wherein a speed of the process-target fluid extruded via the tube by the plunger is controlled in such a way that a flow of the process-target fluid in the tube becomes turbulent, and the number of times the atomization process is performed by a reciprocating operation of the plunger is controlled to a predetermined number of times, per [0011], [0013], [0015], [0017], [0018], [0019], [0035], [0036], [0038], [0039].
More specifically, POST et al. discloses an apparatus and method of homogenizing a liquid in a container, comprising the steps of withdrawing liquid from the container at a first flow speed (S1) and then returning the liquid to the container at a second flow speed (S2), higher than the first flow speed (S1). The invention relates to a method of homogenizing a liquid in a container. The invention further relates to an assembly for dispensing a liquid comprising a container and a syringe pump and to an apparatus comprising a plurality of such assemblies.
The invention relates to a method of homogenizing a liquid in a container, comprising the steps of withdrawing liquid from the container at a first flow speed (S1) and then returning the liquid to the container at a second flow speed (S2), higher than the first flow speed (S1). These measures were found to result in effective mixing, even without the use a stirrer. In an embodiment, part, preferably most of the liquid is returned in a direction having an axial component, preferably returned along the central axis of the container.
The liquid is preferably returned at a pressure in a range from 2 to 10 bar, more specifically 3 to 8 bar, more specifically 4 to 6 bar. By adjusting the flow speed to the viscosity of the liquid in such a way that a pulse flow is created at the exit of the conduit connecting the container to a pump, the liquid will flow upwards trough the center of the container and reach the top portion of the liquid in the container. To avoid that the returned liquid will break through the liquid surface in the container, the pump stroke and pump speed can be adjusted to the actual liquid level and liquid specification (density, viscosity, rheologic structure, etc.).
To efficiently homogenize the whole contents of the container, it is preferred to withdraw liquid from the lower half, preferably the bottom portion of the liquid in the container and return it to the upper half, preferably the top portion of the liquid in the container.
Another embodiment comprises consecutively repeating the steps of withdrawing liquid from the container and then returning the liquid to the container until a volume corresponding to at least 50%, preferably at least 70% of the liquid in the container has been withdrawn and returned. This procedure can be carried out e.g. between dispensing recipes or when the dispenser has been idle for a pre-selected period, e.g. six hours.
To compensate for variations in viscosity resulting from, e.g., variations in temperature, in an embodiment, the method comprises establishing, e.g. measuring, calculating or retrieving from a database, the viscosity of the liquid in the container and adjusting the first and/or second flow speeds depending on the viscosity.
The invention further relates to an assembly for dispensing a liquid comprising a container for holding a liquid, a pump connected to the container via at least one conduit and a controller [control section] for operating the pump, wherein the controller is arranged to operate the pump to withdraw liquid from the container at a first flow speed (S1) and then return the liquid to the container at a second flow speed (S2), higher than the first flow speed (S1). In an embodiment, the conduit is oriented in a direction having a component extending along the central axis of the container, i.e. an axial component, and preferably extends coaxial with the central axis of the container. In another embodiment no stirrer is present in the container.
Within the framework of the present invention the term "liquid" is defined as any flowable material that comprises a liquid phase and thus includes suspensions and emulsions. Liquids often contain high density pigments or particles suspended in (instable) liquid binder/solvent solutions.
FIG. 1 shows an example of an apparatus 1 for dispensing a plurality of liquids, such as liquids for paints, but also hair dyes, shampoos, foundations, and the like. It can be used for dispensing numerous recipes and formulas of the said products and it can be located e.g. at a retailer of decorative paints.
This particular dispensing apparatus 1 is an automated version and includes a horizontal turntable 2, with a plurality of containers 3 mounted along its circumference. Each container 3 is provided with a pump 4 and a valve 5 (FIGS. 2A to 5).
The turntable 2 can be rotated between discrete positions, e.g. twelve or sixteen positions including a dispensing position, i.e. a position where the pumps and valves are operated by means of a central actuator. Liquids are dispensed in a receptacle, in this example a bucket 6 on an adjustable shelf 7. The apparatus 1 includes a base 8 made e.g. by injection molding a polymer. A computer 9 for entering and storing information, such as customer data and recipes, and generating instructions for driving the turntable 2, pumps and valves, is positioned on a separate stand 10.
As shown in FIGS. 2A to 5, each valve 5 is connected by means of a conduit 11 to the bottom of a container 3, to a positive displacement pump 4, and to a dispense opening or dispense conduit 12. In this example, the pump 4 comprises a cylinder/syringe 13 and a piston and piston rod 14 slidably accommodated inside the cylinder/syringe 13. Further, the valve 5 comprises an operating element, e.g. a handle, lever, or, in this example, a rotary knob 15. The valve 5 and rotary knob 15 provide three positions, a first or closed position wherein both the outlet opening and the connection between the container and the pump are closed, a second or intake position wherein the connection between the container and the pump is open and the outlet is closed, and a third or dispense position wherein the connection between the container and the pump is closed and the outlet is open.
An example of the method of the present invention is illustrated in FIGS. 2A and 2C. In a first step (FIG. 2A), the valve is in its second or intake position and the piston is pulled out, thus withdrawing liquid from the container at a first speed, S1. If the liquid is to be dispensed (FIG. 2B), the valve is rotated to its dispense position and the piston is pushed in. If (part of) the liquid is to used for homogenizing the contents of the container, the valve remains at (or is returned to) the second position and the piston is pushed in at a higher speed thus injecting the liquid back into the container at a second speed, S2, higher than the first speed.
In FIG. 2C, the second speed is selected such that the major part of the returned liquid reached the middle part of the container. However, to homogenize the whole contents of the container, it is preferred to withdraw the liquid from the bottom of the container and return it to the upper half, preferably the top portion of the liquid in the container.
Homogenization can be further enhanced in various ways. FIG. 3 shows an embodiment of an assembly of a container and pump in accordance with the present invention, comprising an additional (internal or external) conduit 16 connecting the valve 5 and pump 4 to the top part of the container 3 to deliver the returned liquid directly to the top portion of the container 3.
FIG. 4 shows an embodiment comprising a central riser or pipe 17, with one or more openings 18 in its wall near the bottom of the container 3. Further, the bottom portion 19 of the container 3 is frustoconical, has a smaller diameter than the rest of the container and/or comprises other means to increase flow resistance for liquid flowing out of the openings. The flow resistance generated by these means and the flow resistance in the pipe are balanced to ensure that during the withdrawing of the liquid from the container at a first, relatively low speed S1, most liquid will be withdrawn from the bottom portion of the liquid in the container and that during the returning of the liquid from the container at a second, relatively high speed S2, most liquid will be expelled from the top opening in the pipe, i.e. at the top portion of the liquid in the container.
The assembly shown in FIG. 4 further comprises a cover 20 for the top opening of the pipe. This cover will prevent a fountain inside the container if the liquid is returned at too high a speed. Also, if the container is provided with a flexible bag (not shown) holding the liquid--e.g. to prevent interaction between the liquid and any air in the container--, the cover prevents blocking of the top opening in the pipe by the flexible bag.
FIG. 5 shows an embodiment comprising another example of a structure 21 for increasing mixing efficiency. The structure 21, shown in more detail in FIGS. 6A and 6B, comprises a top surface 22 provided with a central opening 23 and a plurality of radial openings 24. The area and length of the central opening on the one hand and the area and length of the radial opening, the diameter, D1, of the top surface, and the inner diameter, D2, of the container at the axial position of the structure, on the other hand, have been selected to increase the amount of liquid that is directed in axial direction during the returning of the liquid at the second speed.
With regard to new claims 11 and 12, the tube at portions 11 and 17 extend in a linear fashion and is of uniform diameter as seen in Figures 2a-2c and 4; and when viewing Figures 2a-2c and 4 with the syringe 13 located at the 12 o’clock location, the tube 11 is disposed to extend vertically such that the other end that is connected to the syringe 13 is a upper end of the tube 11 and the one end at 17 inserted in the container 3 is a lower end of the tube.
POST et al. does not necessarily disclose the subject matter added to the end portions of claims 1 and 6. POST et al. does disclose an assembly for dispensing a liquid comprising a container for holding a liquid, a pump connected to the container via at least one conduit and a controller [control section] for operating the pump, wherein the controller is arranged to operate the pump to withdraw liquid from the container at a first flow speed (S1) and then return the liquid to the container at a second flow speed (S2), higher than the first flow speed (S1). POST et al. does not necessarily achieve turbulent flow of the fluid in the tube as argued by Applicant in conjunction with the revised claims.
EP 1712285 A1 discloses an apparatus in Figure 4 and a method including a fluid container 12, 17; a syringe having a cylinder and a plunger including a piston/gasket movably disposed within a linear tube 52, 61, 62, 19 having sections of uniform diameter (¶ [0084] and Figure 4); wherein the linear tube is disposed to extend vertically such that the other end connected to the syringe is an upper end of the tube at 52 and/or 61 and the one end 19 inserted in the fluid storing container 12, 17 is a lower end of the tube at 19 (Figures 1A, 1B, 4); and a control section 55 that controls the syringe and thus the flow speed of the fluid in the apparatus and method thereof such that turbulent flow of the fluid in the tube is achieved per ¶ [0017], [0037], [0056], [0093], [0098].
It would have been obvious to one skilled in the art before the effective filing date of the invention to have provided the apparatus and method of POST et al. with a control section to control the operation of the syringe such that turbulent flow of the fluid in the tube is achieved as taught by EP ‘285 for the purposes of blending/binding and ensuring fluidity of the substances being processed in the apparatus and via the method as a result of creating turbulent flow by the control section:
The controller [control section] 55 monitors outputs of the pressure sensor 65 while the multiple pipette assembly 19 is driven for aspiration and dispensation, and drives the pumps 52 according to feedback of drive signals so as to set the aspiration and dispensation at a target pressure. The pipette tubes 19a and 19b can operate for aspiration and dispensation at the target pressure. A flow rate of the fluid and time of its dispensation can be managed precisely. Also, the controller 55 checks whether the detected inner pressure level is within an acceptable range according to the output from the pressure sensor 65. If the detected inner pressure level is not in the acceptable range, the controller 55 determines occurrence of failure such as leakage of fluid.
Preferably, while the sample fluid is in the flow channel, the pump controller causes a first one of the pipette devices to aspirate and a second one of the pipette devices to dispense in an alternate manner repeatedly, to create a flow in turbulence of the sample fluid in the flow channel.
Preferably, while the sample fluid is in the flow channel, a first one of the pipette devices is caused to aspirate and a second one of the pipette devices is caused to dispense in an alternate manner repeatedly, to create a flow in turbulence of the sample fluid in the flow channel.
However, the ligand fluid 21 can be preferably stirred or turbulently flowed for ensured fluidity in the flow channel 16. The stirring or turbulent flow can promote binding of the ligand 21a with the linker film 22, to raise an immobilized amount of the ligand 21a.
The ligand fluid 21 can be preferably stirred or turbulently flowed for ensured fluidity in the flow channel 16 by alternate repetition of aspiration and dispensation of the multiple pipette assembly 19. The stirring or turbulent flow can promote binding of the ligand 21a with the linker film 22, to raise an immobilized amount of the ligand 21a.
per ¶ [0017], [0037], [0056], [0093], [0098].
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over POST et al. in view EP 1712285 A1.
Modified POST et al. does not specify the recited diameter of the tube in new claim 13. With respect to the limitation of the parameter regarding the diameter of the tube which is present in the claim at issue, the examiner has found that the specification contains absolutely no disclosure of any unexpected results arising therefrom, and that as such the parameter is arbitrary and therefore obvious. Such unsupported limitations cannot be a basis for patentability, since where patentability is said to be based upon particular chosen parameters or upon another variable recited in a claim, the applicant must show that the chosen dimensions are critical. In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990) and MPEP 2144.05(III).
With respect to the limitation of the recited tube diameter, it would have been obvious to one of ordinary skill in the art to have provided the apparatus defined by the disclosure of POST et al. with the diameter recited in the claim which is considered at most an optimum choice, lacking any disclosed criticality.
Applicant has the burden of proving such criticality. In re Swenson et al., 56 USPQ 372; In re Scherl, 70 USPQ 204. However, even though applicant's modification may result in great improvement and utility over the prior art, it may still not be patentable if the modification was within the capabilities of one skilled in the art. In re Sola, 25 USPQ 433; In re Normannet et al., 66 USPQ 308; In re Irmscher, 66 USPQ 314. More particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955); In re Swain et al., 70 USPQ 412; Minnesota Mining and Mfg. Co. v. Coe, 38 USPQ 213; Allen et al. v. Coe, 57 USPQ 136; MPEP 2144.05(II)(A).
No probative evidence is of record to demonstrate that the dimensions and/or other variables of the invention are significant or are anything more than one of numerous dimensions a person of ordinary skill in the art would find obvious for purposes of merely changing the configurations and/or dimensions to obtain different results. Graham v. John Deere Co., 148 USPQ 459.
Accordingly, the examiner argues that these parameters are rather arbitrary and thus obvious over the prior art per MPEP 2144.05(II)(III).
There is no specific and discrete cause and effect disclosed between the particular parameter recited in new claim 13 and the alleged advantages of the invention.
Furthermore, the Federal Circuit has explained that a reason to optimize prior art parameters may be found in a PHOSITA’s desire to improve on the prior art. In re Ethicon, Inc., 844 F.3d 1344, 1351 (Fed. Cir. 2017) (‘‘The normal desire of artisans to improve upon what is already generally known can provide the motivation to optimize variables such as the percentage of a known polymer for use in a known device.’’).
Claims 2 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over POST et al. in view EP 1712285 A1 that do not necessarily disclose that the tube is detachably connected to the syringe. However, it has been held that to make elements separable/detachable from each other is quite obvious per In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961) (The claimed structure, a lipstick holder with a removable cap, was fully met by the prior art except that in the prior art the cap is "press fitted" and therefore not manually removable. The court held that "if it were considered desirable for any reason to obtain access to the end of [the prior art’s] holder to which the cap is applied, it would be obvious to make the cap removable for that purpose.").
Thus, to make the tube detachable from the syringe in the POST et al. apparatus and method for the purpose of cleaning the tube, replacing the tube, or the like would have been well within the realm of obviousness.
Allowable Subject Matter
No claims stand allowed.
Conclusion
Applicant argues that POST et al. does not involve turbulent flow however the new reference to EP 1712285 clearly teaches implementing turbulent flow in an analogous syringe, tube, and container arrangement that includes a control section that operates the syringe to invoke turbulent flow of fluid within the tube, which turbulent flow induces atomization as admitted by Applicant in the remarks on page 9: “in the present invention particle atomization is caused by generation of turbulence in the tube between the syringe and the container”. To combine these references for the reasons expressed in the rejection is well within the realm of obviousness.
Moreover, turbulent flow in a tube inherently creates a velocity profile wherein there exists a flow speed differential between the central and peripheral parts of the tube as exemplified by:
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Note that the velocity curve of the fluid is greatest at the central axis of the tube or conduit and the velocity decreases significantly as the fluid flow profile approaches the inner diameter/inner periphery of the tube or conduit. Thus, the turbulent flow taught by EP ‘285 in the tube of the syringe generated via control of the syringe operation by a control section would certainly generate the claimed flow speed differential between central and peripheral parts of the tube as established by fluid flow dynamics.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art discloses syringe/piston type mixers and methods that employ the formation of turbulent flow in the tubes thereof.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
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 CHARLES COOLEY whose telephone number is (571)272-1139. The examiner can normally be reached M-F 9:30 AM - 6:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CLAIRE X. WANG can be reached at 571-272-1700. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES COOLEY/
Examiner, Art Unit 1774
DATED: 31 MARCH 2026