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.
Preliminary Amendment
3. The preliminary amendment filed 28 September 2023, in which the Abstract, specification, and claims 1 and 4-8 were amended is acknowledged.
Election/Restrictions
4. Applicant’s election without traverse of Group I in the reply filed on 14 April 2026 is acknowledged.
Claims 8-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 14 April 2026.
5. Claims 1-7 are under prosecution.
Information Disclosure Statement
6. The Information Disclosure Statements filed 28 September 2023, 22 August 2024, 9 October 2024, and 19 May 2025 are acknowledged and have been considered.
Claim Interpretation
7. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
8. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
A. A “density gradient configuration assembly…configured to carry out…” in claim 1;
B. A “capture outlet…configures to be in communication” in claim 1; and
C. A “reagent storage assembly…configured for storing…” in claim 1.
However, none of these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because there is no limiting definition of the claimed limitations that cover the corresponding structure described in the specification as performing the claimed function, of equivalents thereof.
If Applicant does intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, Applicant must indicate where in the specification the limiting definitions are provided.
Claim Rejections - 35 USC § 112
9. 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.
10. Claims 1-7 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.
Claim 1 (upon which claims 2-7 depend) contains the trademark/trade name Ficoll. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a chemical compound and, accordingly, the identification/description is indefinite.
Claim Rejections - 35 USC § 103
11. 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.
12. 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.
13. Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Wo et al. (U.S. Patent Application Publication No. US 2018/0133714 A1, published 17 May 2018) and Husain et al. (U.S. Patent Application Publication No. Us 2017/0320038 A1, published 9 November 2017).
Regarding claim 1, Wo et al. teach a microfluidic chip (paragraph 0006) comprising a density gradient centrifugation assembly, in the form of a separation chamber comprising a density gradient solution of Ficoll-Paque (paragraph 0047); thus, the assembly is configured to obtain the separation of whole blood into the claimed layers. The chip further comprises a reagent storage assembly, in the form of reservoirs in communication with an inlet (paragraphs 0058 and 0061).
It is noted that the courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced (In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). See MPEP 2144.04 VI.B. Thus, the inclusion of multiple storage chambers is obvious.
Wo et al. also teach staining solutions (e.g., fluorescent dye solutions; paragraph 0063) and washing solutions (i.e., buffers; paragraph 0050). Thus, it would have been obvious to have the staining solution and wash solution stored in the reagent reservoirs.
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.
Wo et al. further teach the chip comprises a cell capture assembly (i.e., collection chamber) having an inlet (i.e., intake opening) connected to the density gradient centrifugation assembly (i.e., separation chamber; paragraph 0005) and further connected to an outlet (paragraph 0037). Wo et al also teach the capture assembly comprises a channel (e.g., chamber 206; paragraph 0037 and Figure 4B), and that the chip has the added advantage of allowing automated continuous fluidic input (paragraph 0004). Thus, Wo et al. teach the known techniques discussed above.
While Wo et al. discuss cell capture (paragraph 0080), tumor cells (paragraph 0044), and that the collection chamber also includes a reagent, in the form of labeling of sample preparation materials (paragraph 0050), Wo et al. do not explicitly teach the collection chamber captures cells.
However, Husain et al. teach a cell capture chip (Title and Abstract) comprising a plurality of through-holes having a diameter large enough to receive only a single cell (paragraph 0044). The holes are connected to negative pressure chambers (i.e., channels; paragraphs 0052-0053).
While not actually required by the claim, Husain et al. further teach a negative pressure source, in the form of a pneumatic device (paragraph 0036).
Husain et al. also teach the cell capture chip has the added advantage of allowing capture of single cells (Abstract). thus, Husain et al. teach the known techniques discussed above.
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., separating a while blood sample into layers) fail to define additional structural elements of the claimed chip. Because the cited prior art teaches the structural elements of the claim, the claim is obvious. See MPEP § 2114.
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 sizing of the chambers merely represent an obvious variant and/or routine optimization of the values of the cited prior art.
The courts have further held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device (In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950)). See MPEP §2144.04.
Thus, any claimed arrangement of the structural limitations is an obvious variant of the teachings of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
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 Wo et al. and Husain et al. to arrive at the instantly claimed chip 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 chip having the added advantages of allowing automated continuous fluidic input as explicitly taught by Wo et al (paragraph 0004) and allowing capture of single cells as explicitly taught by Husain et al. (Abstract). 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 structures useful for isolating cells from a sample.
Regarding claim 2, the chip of claim 1 is discussed above. It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, aligning the capture holes and capture chambers along an inner wall along the claimed direction is an obvious variant of he cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 3, the chip of claim 1 is discussed above. Wo et al. each the capture channel (i.e., collection component 206) has a meandering distribution in the vertical direction (paragraphs 0042-0043 and Figures 3A-3C).
Regarding claim 4, the chip of claim 1 is discussed above. It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, aligning the capture holes and capture chambers along a lower part of an inner wall along the claimed direction is an obvious variant of he cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
Regarding claim 5, the chip of claim 1 is discussed above. Husain et al. teach to top opening of the hole has a radial size (i.e., diameter) that is smaller than the interior (i.e., bottom) of the hole (paragraph 0044).
It is also 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 sizing of the holes merely represents 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.
Regarding claim 6, the chip of claim 1 is discussed above. It is reiterated that courts have held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced, and that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device. Thus, the inclusion of multiple staining solution storage chambers and wash solution storage chambers and their arrangements is obvious.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
12. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Wo et al. (U.S. Patent Application Publication No. US 2018/0133714 A1, published 17 May 2018) and Husain et al. (U.S. Patent Application Publication No. Us 2017/0320038 A1, published 9 November 2017) as applied to claim 1 above, and further in view of Ausserer et al. (U.S. Patent Application Publication No. US 2002/0033337 A1, published 21 March 2002).
Regarding claim 7, the chip of claim 1 is discussed above.
While Wo et al. teach waste outlets (paragraph 0037), neither Wo et al. nor Husain et al. teach a waste solution chamber.
However, Ausserer et al. teach microfluidic chips (paragraphs 0083-0084) comprising a waste solution chamber (i.e., reservoir) connected to a negative pressure source (i.e., vacuum) via a hole (i.e., port) which has the added advantage of loading the sample materials into the device (paragraph 0029). Thus, Ausserer et al. teach the known techniques discussed above.
It is reiterated that the courts have held that the rearrangement of parts within a device is obvious when the arrangement does not specifically modify the operation of the device.
Thus, any claimed arrangement of the structural limitations is an obvious variant of the teachings of the cited prior art.
Applicant is again cautioned against merely relying upon counsel’s arguments in place of evidence in the record.
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 Ausserer et al. with Wo et al. and Husain et al. to arrive at the instantly claimed chip 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 chip having the added advantage of aiding in the loading of sample material into the chip as explicitly taught by Ausserer et al. (paragraph 0029). In addition, it would have been obvious to the ordinary artisan that the known techniques of Ausserer et al. could have been combined with the cited prior art with predictable results because the known techniques of Ausserer et al. predictably result in structures useful loading a sample.
Conclusion
13. No claim is allowed.
14. 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Robert T. Crow
Primary Examiner
Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
Prosecution Insights