DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election of Group I, claims 1-14 in the reply filed on 07/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 112
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.
Claims 1-14 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 is unclear because “(of the plurality of sets (531)”.
Regarding claims 1, 3, 6-10, 12, 14, the phrase “configured to [...]” renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 6 is unclear reciting “a medium valve chamber” because it is unclear whether the applicant is claiming a size, a content, a valve, and/or a chamber.
Claim 8 recites the limitation "the plurality of sets of cell channels" in L2. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim limitation “configured to [...]” has been evaluated under the three-prong test set forth in MPEP § 2181, subsection I, but the result is inconclusive. Thus, it is unclear whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because: the term “means” or generic placeholder is modified by a word, which is ambiguous regarding whether it conveys structure or function; and/or the claim limitation uses the word “means” or a generic placeholder coupled with functional language, but it is modified by some structure or material that is ambiguous regarding whether that structure or material is sufficient for performing the claimed function. The boundaries of this claim limitation are ambiguous; therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
In response to this rejection, applicant must clarify whether this limitation should be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Mere assertion regarding applicant’s intent to invoke or not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph is insufficient. Applicant may:
(a) Amend the claim to clearly invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by reciting “means” or a generic placeholder for means, or by reciting “step.” The “means,” generic placeholder, or “step” must be modified by functional language, and must not be modified by sufficient structure, material, or acts for performing the claimed function;
(b) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, should apply because the claim limitation recites a function to be performed and does not recite sufficient structure, material, or acts to perform that function;
(c) Amend the claim to clearly avoid invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, by deleting the function or by reciting sufficient structure, material or acts to perform the recited function; or
(d) Present a sufficient showing that 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, does not apply because the limitation does not recite a function or does recite a function along with sufficient structure, material or acts to perform that function.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Di Tullio (Di Tullio et al. US 2019/0033331 A1).
Regarding claim 1, Di Tullio teaches:
1. A cartridge comprising:
a chip chamber configured to house a microfluidic chip (see Fig. 24; see also the incorporated reference U.S. patent application Ser. No. 13/724,348 to Emeric et al., teaching a microfluidic chip housed in a cartridge (see C7/L30-37 & Fig. 1A); Emeric ‘348 further incorporates U.S. Patent Application Publication No. 2011/0150705 to Doyle et al., provides a discussion of the structural features of the cartridge including a microfluidic chip formed in a cartridge housing (entire reference)) comprising a plurality of sets of cell channels (e.g., conduits) configured to capture cells from a biological sample (see ¶ 0050-0053 for example);
a sample chamber (e.g., 20) configured to receive the biological sample and be in fluid connection with the plurality of sets of cell channels (see ¶ 0071 for example);
a plurality of medium reservoirs (i.e., reservoirs formed by the one or more substrates 45/90 and the cover 65 for one or more reagents 40 ¶ 0071, 0076-0077+; see also fluid-containing foil pack ¶ 0130; fluid-containing package ¶ 0135), wherein each medium reservoir of the plurality of medium reservoirs is configured to be in fluid connection with a respective set of cell channels (of the plurality of sets (531) of cell channels (see ¶ 0071-0072, 0130, 0135 for example); and
a culture medium source in fluid connection with the plurality of medium reservoirs and configured to supply a culture medium to the plurality of medium reservoirs (see e.g., a sugar, gelatin, agarose, a polysaccharide, a saccharide, sucrose, polyethylene glycol, etc. ¶ 0072+).
With regard to limitations in claims 1, 3, 6-10, 12, 14 (e.g., [...] to house a microfluidic chip [...] to capture cells [...] to receive [...] to be [...] to supply [...], etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115).
Regarding claims 2-14, Di Tullio teaches:
2. The cartridge of claim 1, wherein the plurality of medium reservoirs has a substantially same shape and/or internal volume (see ¶ 0096 & Fig. 1 for example).
3. The cartridge of claim 1, wherein at least some of the plurality of medium reservoirs are preloaded with different amounts of an agent or different agents (see ¶ 0015, 0072-0073 for example).
4. The cartridge of claim 3, wherein a first set of the plurality of medium reservoirs is preloaded with the different amounts of an agent or the different agents, and a second set of the plurality of medium reservoirs is not preloaded with any agent (see ¶ 0071-0073 for example).
5. The cartridge of claim 3, wherein the agent is an antimicrobial agent or the different agents are different antimicrobial agents (see ¶ 0072-0073 for example).
6. The cartridge of claim 1, further comprising: an entrance hole in fluid communication with the culture medium source (see i.e., the inlet chamber connected to the reagent regions in Figs. 27-29, 32-33, 35, 37-38); and a plurality of medium reservoir holes, wherein each medium reservoir hole of the plurality of medium reservoir holes is in fluid communication with a respective medium reservoir of the plurality of medium reservoirs (see i.e., channels connected to the reagent regions in Figs. 27-29, 32-33, 35, 37-38); and a culture medium valve (see i.e., fluidic valves in Figs. 27-29).
7. The cartridge of claim 6, wherein the culture medium source comprises: a culture medium container (e.g., fluid-containing foil pack ¶ 0130; fluid-containing package ¶ 0135) prepackaged with the culture medium (see ¶ 0130, 0135 for example); and a chamber (e.g., cavity 620) configured to house the culture medium container (¶ 0130, 0135) and comprising: a drainage hole (e.g., conduit 625) in fluid communication with the plurality of medium reservoirs (see ¶ 0130, 0135 for example); and a cutter (e.g., spike) configured to cut a surface of the culture medium container (see ¶ 0135; see also the incorporated reference U.S. Pat. No. 5,821,399 to Zelin discloses a first cavity 18, a pin 40, and a sealed pouch 60 in C7/L17-32 & Figs. 2-4).
8. The cartridge of claim 1, further comprising a pump configured to move biological sample from the sample chamber into the plurality of sets of cell channels (see ¶ 0053+ for example).
9. The cartridge of claim 1, further comprising a surfactant chamber (e.g., 40) configured to be in fluid communication with the plurality of sets of cell channels and the culture medium source (see ¶ 0130, 0135 for example), wherein the surfactant chamber is preloaded with a surfactant (see ¶ 0072-0073 for example).
10. The cartridge of claim 1, further comprising: a chip carrier (e.g., base 565) attached to the microfluidic chip and comprising: a first set of holes configured to provide fluidic connection between the plurality of sets of cell channels and the sample chamber (see i.e., channels connected to the inlet chamber in Figs. 27-29, 32-33, 35, 37-38); and a second set of holes, wherein each hole of the second set of holes is configured to provide fluidic connection between a respective set of cell channels of the plurality of sets of cell channels and a respective medium reservoir of the plurality of medium reservoirs (see i.e., channels connected to the reagent regions in Figs. 27-29, 32-33, 35, 37-38).
11. The cartridge of claim 10, wherein each set of cell channels of the plurality of sets of cell channels comprises: a first port in fluid communication with a hole of the first set of holes; and a second port in fluid communication with a hole of the second set of holes (see i.e., fluidic channels, valves, vents in Figs. 27-29, 32-33, 35, 37-38).
12. The cartridge of claim 1, further comprising: a substrate (e.g., base 565) comprising the chip chamber, the sample chamber, the plurality of medium reservoirs and the culture medium source (see claim 1 rejection above); and a lid (e.g., rigid cover 560) attached to the substrate and comprising a window configured to enable imaging the plurality of sets of cell channels (see e.g., transparent optical cover 415 C16/L3 in the incorporated reference Emeric ‘348; and an optically transparent plastic to permit light generated by an assay reaction to reach a detector ¶ 0046 in the incorporated reference Doyle ‘705).
13. The cartridge of claim 1, wherein each set of cell channels of the plurality of sets of cell channels is formed as a compartment in the microfluidic chip, which is separate from other sets of cell channels of the plurality of sets of cell channels (i.e., conduits, cavity, fluid-containing pack).
14. The cartridge of claim 1, wherein the chip chamber comprises the microfluidic chip comprising the plurality of sets of cell channels configured to capture cells from the biological sample (see ¶ 0050-0053 for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, CHARLES CAPOZZI can be reached at (571)270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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