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 applicant's claim for domestic priority under 35 U.S.C. § 119(e).
Information Disclosure Statement
Note the attached PTO-1449 forms submitted with the Information Disclosure Statements.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant's cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The abstract is acceptable.
The title is acceptable.
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 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 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). "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Verdegaal Bros. Inc. v. Union Oil Co. of California, 814 F.2d 628, 631 (Fed. Cir. 1987).
The express, implicit, and inherent disclosures of a prior art reference may be relied upon in the rejection of claims under 35 U.S.C. 102 or 103. "The inherent teaching of a prior art reference, a question of fact, arises both in the context of anticipation and obviousness." In re Napier, 55 F.3d 610, 613, 34 USPQ2d 1782, 1784 (Fed. Cir. 1995) (affirmed a 35 U.S.C. 103 rejection based in part on inherent disclosure in one of the references). See also In re Grasselli, 713 F.2d 731, 739, 218 USPQ 769, 775 (Fed. Cir. 1983). See MPEP 2112.
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.
Claims 1-3, 5, 11, 12, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by GIESLER et al. (US 5746708).
The patent to GIESLER et al. discloses a blood processing system in at least Figures 1-3 and 10-12 comprising: a blood processing device having device components 236A-236C arranged on a component surface 238 and a holder proximate 14 configured to support one or more fluid containers 20; a packaging tray 26 with a peripheral edge configured to be selectively arranged on and removable from the component surface 238, the packaging tray 26 comprising: a first surface and a second surface opposite to the first surface and spaced apart by a thickness (Figures 10-12); first, second, and third component sections 150A-150C arranged at spaced positions corresponding to positions of respective device components, the component sections respectively formed, at least partially, as openings 150A-150C extending through the thickness, and a plurality of recessed pathways 146, 148, 156, 158 formed on the first surface of the tray, the recessed pathways extending between the component sections; and a fluid flow circuit 14, 18 having circuit components configured to interact with corresponding device components, wherein the one or more fluid containers 20 are arrangeable in fluid communication with the circuit components, wherein the component sections are configured to accommodate corresponding circuit components such that the circuit components are interfaced with corresponding device components with the packaging tray 26 arranged on the component surface 238 as seen in the Figures;
the component sections comprising the first through the third component sections each formed at least partially as first through third openings extending through the thickness; the first through the third component sections being spaced from each other; wherein the recessed pathways extend between the first component section, the second component section and the third component section.
a support surface (the vertical support part at 14) extending upward from and angled relative to the component surface 238, wherein the support surface is non-planar relative to the component surface 238;
a controller 246 operably connected to and configured to control the pump system, the cassette nesting module, the centrifuge mounting station and drive unit and the plurality of tubing clamps; a user interface 248 operably connected to the controller, wherein the user interface is configured to receive an instruction from an operator and the controller is configured to selectively control one or more of the pump system, the cassette nesting module, the centrifuge mounting station and drive unit and the plurality of tubing clamps according to the instruction;
the device components include a nesting module 236A-236C and pump system 254, 292, a centrifuge mounting station 16 and drive unit 364, and a plurality of clamps 240, the circuit components include a flow control cassette 22A-22C and external tubing loops 14, 18, a separation chamber 230 and/or 470, and tubing segment 14, 18; and the flow control cassette and external tubing loops are configured to interact with the nesting module and pump system, the separation chamber is configured to interact with the centrifuge mounting station and drive unit, and at least a portion of the tubing segments are configured to interact with the plurality of clamps.
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).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over GIESLER et al. (US 5746708) in view of SMITH et al. (US 2002/0131891 A1).
GIESLER et al. does not disclose the weight scale. SMITH et al. discloses an analogous blood processor including a case 36 that contains components compactly arranged to aid in blood processing such as a centrifuge station 20 and pump and valve station 30; the case 36 includes a weight scale station 238 and one or more trays 212 or hangers 248 for containers; the weight scale station 238 comprises a series of container hangers/weigh sensors 246 arranged along the top of the lid 40. In use, the containers 304, 308, 312 are suspended on the hangers/weigh sensors 246; the tray 212 holding the container 276 and the hanger 248 also include weigh sensors 246. As blood or liquids are received into and/or dispensed from the containers during processing, the weigh sensors 246 provide output reflecting weight changes over time. This output is conveyed to the controller 16. The controller 16 processes the incremental weight changes to derive fluid processing volumes. The controller generates signals to control processing events based, in part, upon the derived processing volumes.
Accordingly, it would have been obvious to one skilled in the art before the effective filing date of the invention to have provided the blood processor of GIESLER et al. with a weight scale as taught by SMITH et al. for the purposes of providing output reflecting weight changes over time wherein the output is conveyed to the controller whereby the controller 16 processes the incremental weight changes to determine fluid processing volumes thus enabling the controller to generate signals to control processing events based, in part, upon the determined processing volumes, per ¶ [0078] - [0082].
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over GIESLER et al. (US 5746708) in view of COBDEN et al. (US 5765689).
GIESLER et al. does not disclose the folding line. COBDEN et al. discloses a tray 1 that includes first and second portions 2 and 3, each of which can be formed of a suitable plastic material such as polypropylene joined by a flexible plastic hinge at a folding line 4. The tray has openings therein at 8 to permit articles to placed in the openings 8 The portions 2 and 3 are preferably molded as an integral unit with the connecting hinge at the folding line 4 formed by a continuation of the upper surface 5 of the two portions 2 and 3 so that the two portions can be unfolded into a flat open position for use as shown on FIG. 1 or folded up towards each other into a closed position. Thus, in this folded condition the tray can be easily carried personally either in a pocket, handbag or other bag of the user. By the top surface 5 joining the two portions 2 and 3, when the tray is unfolded into the position shown in the drawings, the adjacent end portions 6 and 7 abut each other to prevent the tray over folding or over hinging past the 180 degree position of the portions. Thus, the tray may be in the folded position with the portions 2 and 3 abutting each other, or spread into the carrying position with the portions planar to each other as shown in the drawings, the end portions of each portion preventing the portions passing over the 180 degree position. The portable foldable tray includes at least two portions hinged together so that said portions can be folded into a closed position when not in use, and unfolded into a flat open position for use.
It would have been obvious to one skilled in the art before the effective filing date of the invention to have provided the tray of GIESLER et al. with a folding line as taught by COBDEN et al. for the purposes of enabling the tray to be folded into a more compact configuration for storage, transport, or the like (col. 2, lines 27-48).
Allowable Subject Matter
Claims 4, 6-8, 10, and 13-17 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited prior art discloses blood processing systems, some with trays.
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.
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/CHARLES COOLEY/
Examiner, Art Unit 1774
DATED: 6 AUG 2026
Prosecution Insights