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 .
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.
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 housing that encloses a chamber configured to hold dry chemicals and having a first opening and a second opening smaller than the first opening; wherein the housing is configured to be inserted into an opening of the microfluidic device, such that the container is independently secured within the opening, and such that a microfluidic channel of the microfluidic device is fluidically coupled with the chamber via the second opening in claim 1; and one or more structures that protrude outward from the first cylindrical portion and are configured to hold the housing within the microfluidic device when the housing is inserted into the opening of the microfluidic device in claim 5.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-12 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.
Claims 1, 5, 7, 8, 9, 10-11 are not clear with respect to what applicant is claiming. The claims do not clearly set forth the metes and bounds of the patent protection desired.
Claim 1 is unclear reciting “wherein the housing is configured to be inserted into an opening of the microfluidic device, such that the container is independently secured within the opening, and such that a microfluidic channel of the microfluidic device is fluidically coupled with the chamber via the second opening” because it is unclear whether the limitation(s) following the phrase “configured to” are part of the claimed invention. It is further unclear the recitation includes elements that have not been positively claimed (i.e., microfluidic device, microfluidic channel, etc.). For this reason, claim 5 is similarly unclear.
Claims 1, 10, and 11 are unclear. Claim 1 is unclear reciting “a housing that encloses a chamber configured to hold dry chemicals and having a first opening and a second opening smaller than the first opening” because it is unclear whether the limitation(s) following the phrase “configured to” are part of the claimed invention (i.e., is the applicant is claiming dry chemicals in the chamber?). It is further unclear what structural configuration is being claimed. Claim 10 is similarly unclear. Claim 11 is indefinite reciting “wherein the dry chemicals include freeze-dried reagents” because the recitation includes elements that have not been positively claimed.
Claims 1, 5, 7, 8, 9, and 10 are indefinite, as they fail to clearly define structural configurations.
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 § 103
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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Engel et al. (US 2017/0014826 A1) in view of Curry et al. (US 2011/0212002 A1).
Regarding claim 1, Engel et al. teach:
1. A container (e.g., 104) capable of connecting with a microfluidic device (see ¶ 0026-0032 & Figs. 1A-1C for example), the container comprising:
a housing (e.g., 202) that encloses a chamber (e.g., 105) capable of holding dry chemicals (see ¶ 0040 for example) and having a first opening (e.g., 212) and a second opening (e.g., 214) smaller than the first opening (see ¶ 0037 & Fig. 2B for example);
a first lid (e.g., 208) configured to cover the first opening (see ¶ 0037 for example); and
a second removable lid (e.g., 210) configured to cover the second opening (see ¶ 0037 for example),
wherein the housing is capable of being inserted into an opening of the microfluidic device (see Fig. 1A for example), such that the container is independently secured within the opening, and such that a microfluidic channel of the microfluidic device is fluidically coupled with the chamber via the second opening (see ¶ 0026-0032 & Figs. 1A-1C for example).
Regarding claims 1, 10-12, Engel et al. do not explicitly teach: the first lid having a column that extends from the first lid into the chamber. 10. The container of claim 1, wherein the column is configured to secure the dry chemicals within the chamber. 11. The container of claim 10, wherein the dry chemicals include freeze-dried reagents. 12. The container of claim 1, wherein the column includes a tip at a distal end of the column, the tip having a round shape or a conical shape.
Curry et al. teach: a first lid (e.g., 100) having a column (e.g., 108) that extends from the first lid into a chamber (see Figs. 1-3 for example); wherein the column is capable of securing dry chemicals within the chamber (¶ 0155); wherein the dry chemicals include freeze-dried reagents (¶ 0155); wherein the column includes a tip at a distal end of the column, the tip having a round shape or a conical shape (Fig., 3B).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to modify the first lid of Engel et al. with the column of Curry et al. for the purpose of securing one or more reagents in a dried or lyophilized form (dry chemicals/freeze-dried reagents) (Curry et al. ¶ 0155).
Regarding claim 1, modified Engel et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “to connect with a microfluidic device”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
With regard to limitations in claim 1, 5, 7-11, (e.g., [...] to hold [...], [...] to be inserted into an opening of the microfluidic device, such that the container is independently secured within the opening, and such that a microfluidic channel of the microfluidic device is fluidically coupled with the chamber via the second opening, 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 2-9, modified Engel et al. teach:
2. The container of claim 1, wherein the first lid includes a protruding structure (e.g., 302) that is capable of preventing moisture from entering into the chamber through the first opening when the first opening is covered by the first lid (see ¶ 0039 for example).
3. The container of claim 1, wherein the housing has a first cylindrical portion (e.g., 204) and a second cylindrical portion (e.g., 206) smaller than the first cylindrical portion (see ¶ 0036 for example).
4. The container of claim 3, wherein a diameter of the first cylindrical portion is substantially equal to a diameter of the first opening and a diameter of the second cylindrical portion is substantially equal to a diameter of the second opening (see Claim 3 for example).
5. The container of claim 3, further comprising one or more structures (e.g., 502) that protrude outward from the first cylindrical portion and are capable of holding the housing within the microfluidic device when the housing is inserted into the opening of the microfluidic device (see ¶ 0042 for example).
6. The container of claim 1, wherein the first lid includes one or more protruding structures (e.g., 302, 306) that is capable of allowing the first lid to sit overtop the first opening by resting on the one or more protruding structures without sealing the first opening (see ¶ 0039 for example).
7. The container of claim 6, wherein the first lid includes one or more slotted openings (e.g., 306) capable of allowing air to pass through the first opening when the first lid is resting on the one or more protruding structures (see ¶ 0040 for example).
8. The container of claim 1, wherein the housing includes a necking region (e.g., 702) located closer to the second opening than the first opening, the necking region being capable of holding the dry chemicals around the necking region (see ¶ 0045 for example).
9. The container of claim 1, wherein the housing includes one or more interior structures (e.g., 704) located closer to the second opening than the first opening, the one or more interior structures being capable of holding the dry chemicals around the one or more interior structures (see ¶ 0045 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