DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. Please note that the examiner for this application has changed. Please address future correspondence to Robert T. Crow (Art Unit 1683) whose telephone number is (571) 272-1113.
Amendments and Election/Restrictions
3. This action is in response to papers filed 12 December 2025 in which claims 1 and 4 were amended. Claims 21-66 were previously cancelled.
4. Applicant’s election without traverse of Group I in the reply filed on 12 December 2025 is acknowledged.
Claims 18-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 12 December 2025.
Claims 1-17 are under prosecution.
Information Disclosure Statement
5. The Information Disclosure Statements filed 9 January 2023 and 5 August 2024 are acknowledged and have been considered.
Claim Interpretation
6. The claims are subject to the following interpretation:
A. It is noted that the courts have held that “while features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). In addition, “[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). Therefore, the various uses recited in the claims (e.g., treating cells with particles, separating cells, etc.) fail to define additional structural elements of the claimed devices and systems. Prior art that teaches the structural elements of the claims therefore either anticipates, or renders obvious, said claims. See MPEP § 2114.
B. A review of the specification yields no limiting definition of a “semi-permeable membrane.” The claimed “semi-permeable membrane” is therefore interpreted as any membrane that allows some members of a solution to pass while prohibiting the passage of other members of a solution, and the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a “semi-permeable membrane” (In re Hyatt, 211 F.3d1367, 1372, 54 USPQ2d 1664, 1667 (Fed. Cir. 2000) (see MPEP 2111).
C. A review of the specification yields no limiting definition of a “plate.” The claimed “plate” is therefore interpreted as flat material, and the claim has been given the broadest reasonable interpretation consistent with the teachings of the specification regarding a “plate.”
D. Claims 15-17 are drawn to a “system.” The specification recites a “system” wherein the “system” is defined in terms of structural limitations. In addition, the claims recite structural limitations of the “system.” Thus, the “system” is interpreted to encompass any collection of reagents and parts used together that are not necessarily part of a completely integrated single unitary device. Any further interpretation of the word is considered an “intended use” and does not impart any further structural limitation on the claimed subject matter.
E. Applicant is advised that MPEP 716.01(c) makes clear that “[t]he arguments of counsel cannot take the place of evidence in the record” (In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965)). Thus, Applicant should not merely rely upon counsel’s arguments in place of evidence in the record.
Claim Rejections - 35 USC § 112
7. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
8. Claims 3, 11-13, and 15-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
A. Claim 3 is indefinite in the recitations “the port of the first plate” and “the port of the second plate,” each of which lacks antecedent basis because claim 1 does not recite any ports.
B. The term “low” in claim 11 (upon which claims 12-13 depend) is a relative term which renders the claim indefinite. The term “low” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
C. Claim 12 (upon which claim 13 depends) is indefinite in the recitation “about 10 mm Hg/min or less.” The phrase “or less” typically indicates a maximum point; however, the phrase “or less” is controverted by the term “about,” which implies that values above and below the indicated amount are permitted. Therefore, the juxtaposition of these two terms makes it unclear what maximum dimensions are encompassed by the claim.
In Amgen, Inc. v. Chugai Pharmaceutical co., 927 F.2d 1200 (CAFC 1991), the CAFC stated, “[t]he district court held claims 4 and 6 of the patent invalid because their specific activity of “at least about 160,000” was indefinite.” After review, the CAFC states “[w]e therefore affirm the district court’s determination on this issue.” Thus, the CAFC found the phrase “at least about” indefinite where the metes and bounds of the term were not defined in the specification. The phrase “about…or less” is therefore also deemed indefinite. See MPEP 2173.05(b) III.
D. Claim 15 (upon which claims 16-17 depend) is indefinite in the rection “the transverse port,” which lacks antecedent basis because there is no previous recitation of a “transverse port.”
Claim Rejections - 35 USC § 103
9. 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.
10. 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.
11. Claims 1-2 and 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al. (U.S. Patent Application Publication No. US 2004/0245102 A1, published 9 December 2004).
Regarding claim 1, Gilbert et al. teach devices comprising a semi-permeable membrane, in the form of a filter membrane layer (paragraph 0203), which is semi-permeable because it filters substances by size exclusion or other measures (paragraph 0084). The devices further comprise a first plate, in the form of capping module 15 bonded to impermeable layer 790, which forms chamber 73 having channels 71 and 72 (i.e., holes; paragraph 0132 and Fig. 14) transversely laid across membrane 79 (Figure 10 and paragraph 0119). Figure 16 illustrates the device of Figure 10 atop a second plate, in the form of microfluidic device 11 (compare figure 10 and 16); Gilbert et al. explicitly teach assembling in top of chip substrate 11 (paragraph 0137), and that 11 has channels etched therein (paragraphs 0098, 0109 and 119, and Figures 10 and 16).
Any additional layers or elements are encompassed by the open claim language “comprising” found in the instant claims.
With respect to the clamed plates, the cited Figures clearly show each of the elements as being flat on at least one side, and thus are reasonably interpreted as the claimed “plates.”
In addition, the courts have found that changes in shape are obvious (In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966)). Thus, the any “plate” shape or “substantially transverse” flow channels are obvious variants of the cited prior art. See MPEP 2144.04 IV B.
Regarding claim 2, the device of claim 1 is discussed above. The instant limitations are drawn to the types of particles, which are not part of the claimed device, and there for do not further limit the structure of the device.
Regarding claim 7, the device of claim 1 is discussed above. Gilbert et al. teach the chamber (i.e., channel) having a 1 mm dimension (paragraph 0203), as well as chamber (i.e., channel) dimensions of 500 microns (paragraph 0003), and that the capping module has a dimension from about 1 mm to 5 cm (paragraph 0100). Thus, it would have been obvious to have a height in the claimed range.
In addition, with respect to claims 7 and 8, it is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01).
The courts have also found that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05 II.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
12. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al. (U.S. Patent Application Publication No. US 2004/0245102 A1, published 9 December 2004) as applied to claim 1 above, and further combination with Antwiler (U.S. Patent Application Publication No. US 2008/0227190 A1, published 18 September 2008).
Regarding claim 3, the device of claim 1 is discussed above in Section 11.
Gilbert et al. teach the device comprises two ports, including one of the second plate (e.g., Figure 6a), as well as one port on the first plate (i.e., capping module; paragraph 0137). Thus, it would have been obvious to have one port on each plate.
Gilbert et al. also teach the devices are used to retain portions of a sample for reactions (paragraph 0115) and have the added advantage of allowing selective capture of molecules for later release (paragraph 0018). Thus, Gilbert et al. teach the known techniques discussed above.
Gilbert et al. do not teach a recycle loop.
However, Antwiler teaches bioreactor devices having a top plate and a bottom plate with a membrane in between (Abstract), wherein the top plate comprises a recycle (i.e., recirculation loop that connects outlet port 44 in bottom plate 106 to inlet port 42 of top plate 104 (Figure 2 and paragraphs 0037 and 0021). Antwiler also teaches the loop has the added advantage of recirculating supply media to the cells (paragraph 0037). Thus, Antwiler teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Antwiler and Gilbert et al. to arrive at the instantly claimed device with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in a device having the added advantages of allowing selective capture of molecules for later release as explicitly taught by Gilbert et al. (paragraph 0018) and recirculating supply media to the cells as explicitly taught by Antwiler (paragraph 0037). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in devices useful for cell-based assays.
13. Claims 7-17 are rejected under 35 U.S.C. 103 as being unpatentable over Gilbert et al. (U.S. Patent Application Publication No. US 2004/0245102 A1, published 9 December 2004) as applied to claim 1 above, and further combination with Hacker et al. (U.S. Patent Application Publication No. US 2013/0157277 A1, published 20 June 2013) and, as applied to claim 11, as evidenced by sigmaaldrich.com ([retrieved on 2026-03-13]. Retrieved from the Internet: <URL:www.sigmaaldrich.com/US/en/product/aldrich/wha10417012?msockid=1b670dd579d162a210ba1ace784c63c9>) and, as applied to claim 16 below, as evidenced by biologyinsights.com ([retrieved on 2026-03-14]. Retrieved from the Internet:
<URL:biologyinsights.com/bacillus-cereus-morphology-structure-and-characteristics/>).
It is noted that while claims 7-8 have been rejected as described above, the claims are also obvious using the interpretation outlined below.
Regarding claims 7-14, the device of claim 1 is discussed above in Section 11.
Gilbert et al. also teach the devices are used to retain portions of a sample for reactions (paragraph 0115) and have the added advantage of allowing selective capture of molecules for later release (paragraph 0018). Thus, Gilbert et al. teach the known techniques discussed above.
While Gilbert et al. teach Nucleopore filter membranes (paragraph 0203), which are hydrophilic (i.e., claim 11) and made of polycarbonate (i.e., claim 14) as evidenced by sigmaaldrich.com, Gilbert et al. do not teach the claimed pore diameters or low protein binding (i.e., claim 11).
However, Hacker et al. teach devices for filtering cells (i.e., microorganisms) from fluid (Abstract), wherein the filters have pore diameters of 20 nm and are hydrophilic and have low protein binding (i.e., claims 10-11) and are made of polyethersulfone (i.e., claims 13-14; paragraph 0052).
Hacker et al. further teach cellular (i.e., bacterial) sample comprising beads having a diameter of about 1 micron (paragraph 0045), and that the filter pore diameters are 0.45 microns, which is about 45% or the particle diameter (i.e., claim 9; paragraph 0052).
With respect to claim 12, Example 17 and Figures 42A-B of the instant specification clearly show that polyethersulfone membranes having 30 nm pores meet the instantly claimed limitations. Paragraph 0052 of Hacker et al. teach polyethersulfone membranes and pore diameters of 20-300 nm, which include 30 nm.
With respect to claim 7-8, Hacker et al. teach the device comprises a flow chamber (i.e., cavity) above the filter membrane (Figures 2-), and that the depth (i.e., height) of the cavity is 10 to 100 times the diameter of the beads (paragraph 0010). Thus, for a 150 micron (i.e., 0.15 mm) diameter bead (paragraph 0045) of Hacker et al. the flow chamber height is 1.5 mm, which is in the instantly claimed range.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Hacker et al. also teach the devices have the added advantage of avoiding retention of unwanted species the can block the filter (paragraph 0052). Thus, Hacker et al. teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Hacker et al. with Gilbert et al. to arrive at the instantly claimed devices with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in devices having the added advantages of allowing selective capture of molecules for later release as explicitly taught by Gilbert et al. (paragraph 0018) and preventing blockage of the filter by avoiding retention of unwanted species as explicitly taught by Hacker et al. (paragraph 0037). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in devices useful for filtering of cells.
Regarding claim 15, the device of claim 1 is discussed above.
Gilbert et al. teach systems (Abstract) comprising a plurality of the molecular fractionation devices and that each device produces its own fraction (paragraphs 0022-0024 and 0184-0185).
Gilbert et al. teach the devices comprise two ports, including one of the second plate (e.g., Figure 6a and paragraph 0137).
Thus, it would have been obvious to have a plurality of different devices each comprising ports and a different semi-permeable membranes having pores.
Gilbert et al. do not teach the removal of particles from the cells.
However, Hacker et al. teach filters that remove particles (i.e., particulates) from the cells (i.e., microorganisms) using a suitable filter (paragraph 0055). Thus it would have been obvious to have a device having pore dimensions that allow the passage of particles but not cells.
It is reiterated that the courts have held that apparatus claims cover what a device is, not what a device does. Therefore, the various uses recited in claim 15 (e.g., using one device to retain cells and particles and another device to retain cells but not particles) fail to define additional structural elements of the claimed devices and systems. Prior art that teaches the structural elements of the claims therefore renders obvious said claims.
Hacker et al. also teach the devices have the added advantage of avoiding retention of unwanted species the can block the filter (paragraph 0052). Thus, Hacker et al. teaches the known techniques discussed above.
It would therefore have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Hacker et al. with Gilbert et al. to arrive at the instantly claimed devices with a reasonable expectation of success. The ordinary artisan would have been motivated to make the combination because said combination would have resulted in devices having the added advantages of allowing selective capture of molecules for later release as explicitly taught by Gilbert et al. (paragraph 0018) and preventing blockage of the filter by avoiding retention of unwanted species as explicitly taught by Hacker et al. (paragraph 0037). In addition, it would have been obvious to the ordinary artisan that the known techniques of the cited prior art could have been combined with predictable results because the known techniques of the cited prior art predictably result in devices useful for filtering of cells.
Regarding claims 16-17, the system of claim 15 is discussed above. Hacker et al. teach the use of Bacillus cereus cells, which have a smallest dimension of 1 micron, as evidenced by biologyinsights.com. Thus, the 0.45 micron pore diameters are 45% the average dimension of the cells (i.e., claim 16) and are in the range of claim 17.
It is reiterated that the courts have stated where the claimed ranges overlap or lie inside the ranges disclosed by the prior art and even when the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have similar properties, a prima facie case of obviousness exists, and that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.
Therefore, the claimed ranges merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
In addition, with respect to claims 9 and 15-17, it is noted that the claimed structural parameters are defined by the cells and the particles, which are actually not part of the claimed devices or systems.
Double Patenting
14. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
15. Claims 1, 4, and 7-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-57 of U.S. Patent No. 11,584,908 B1 in view of Gilbert et al. (U.S. Patent Application Publication No. US 2004/0245102 A1, published 9 December 2004).
Both sets of claims are drawn to devices, cells and particles, semi-permeable membranes, pore and particle diameters, monolayers, etc. Any additional limitations of the ‘908 claims are encompassed by the open claim language “comprising” found in the instant claims.
The ‘908 claims do not require the claimed plates, channels, or flow chamber dimensions.
However, these limitations, as well as the rationale for combining, are taught by Gilbert et al. as discussed above.
16. Claim 3 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-57 of U.S. Patent No. 11,584,908 B1 in view of Gilbert et al. (U.S. Patent Application Publication No. US 2004/0245102 A1, published 9 December 2004) as applied to claim 1 above, and further combination with Antwiler (U.S. Patent Application Publication No. US 2008/0227190 A1, published 18 September 2008) based on the citations and rational provided above.
17. Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,39,697 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are drawn to devices comprising the same limitations. Any additional limitations of the ‘908 claims are encompassed by the open claim language “comprising” found in the instant claims.
Prior Art
18. The following prior art is hereby made of record, but not presently relied upon for any rejection, as it is considered pertinent to Applicant's disclosure.
Chiang et al. (U.S. Patent No. 6,056,796) note that hydraulic resistance is generally determined by the thickness of certain polymer coatings (column 8, lines 30-55). The coatings described by Chaing et al. are the same as the membrane materials of instant clams 11-14 which are taught by Hacker et al. and Gilbert et al. as discussed above. However, there is no guidance in the cited prior art as to the specific selection of materials and thicknesses that would result in the claimed relative hydraulic resistance as claimed in claim 4.
Conclusion
19. No claim is allowed.
20. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert T. Crow whose telephone number is (571)272-1113. The examiner can normally be reached M-F 8:00-4:30.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683