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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 30, 2026 has been entered.
Notes
All the objections and rejections in the previous Office action not reiterated herein have been withdrawn.
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: “sealing material” in claim 1.
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 1-5, 7-9, 13 and 15 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 recites the limitation “the sealing material to permanently or semi-permanently seal the second end of the reaction wells semi-permanent” in lines 14-15. However, it is unclear as to the type of sealing that constitutes a semi-permanent sealing. Applicant’s specification discloses in paragraph [0166] that “it may be desirable in some cases to form a permanent or semi-permanent seal that can maintain the integrity of the fluid contents of reaction wells for hours, days, or weeks after a reaction is complete—e.g., after a reaction container is removed from an instrument.” However, the specification does not define as to what constitutes a semi-permanent sealing, and how the semi-permanent sealing is distinguishable from the permanent sealing with respect the claimed sealing between the reaction wells. Claims 2-5, 7-9, 13 and 15 are included in this rejection by virtue of their dependency upon a rejected base claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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.
Claims 1-5, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Ririe et al. (already of record, US 8,895,295; hereinafter “Ririe”) in view of Heinz et al. (US 2009/0021728; hereinafter “Heinz”).
Regarding claims 1, 3-5 and 15, Ririe discloses a method for in-situ sealing of a fluid sample in a plurality of reaction wells, comprising: providing a reaction container comprising an array having a plurality of reaction wells (FIGS. 16-17: high density array 581; see col. 28, line 63 to col. 29, line 3), wherein the array is provided between a first outer layer (FIG. 16: outer layer 587; col. 28, line 63 to col. 29, line 3). 63-66) and a second outer layer (FIG. 16: outer layer 518; col. 28, ll. 63-66), the first outer layer being bonded to a first end of the array to seal a first end of the reaction wells (layer 587 is bonded to bottom openings of wells 582; col. 29, ll. 1-3), wherein open ends of the plurality of reaction wells are defined between the first outer layer and the second outer layer (FIG. 16), a second end of the array being spaced from the second outer layer to permit fluid to flow into the open ends of the reaction wells (layer 518 is spaced from upper openings of wells 582; col. 29, ll. 33-49), wherein the second outer layer is a flexible film layer that can be pressed against the array to seal the open ends of the reaction wells (col. 4, ll. 63-65; col. 29, ll. 43-46; claim 2), and the second end of the array or an inner surface of the second outer layer being provided with a sealing material for in-situ sealing of the open ends of the reaction wells (sealing layer is provided on an inner surface of layer 518; col. 29, ll. 46-49), introducing a fluid sample into the reaction zone such that each of the plurality of reaction wells is filled with a portion of the fluid sample (col. 29, ll. 41-43), exposing the array to a reaction condition including heat and/or pressure to cause the sealing material to seal the second end of the reaction wells in-situ to substantially prevent flow of the fluid sample out of the plurality of reaction wells during and after exposure to the reaction condition (second end of the reaction wells are sealed once fluid is introduced into the reaction wells by applying pressure to the layer 518 to seal the reaction wells; see col. 29, ll. 41-46), wherein the plurality of reaction wells remain sealed by the sealing material such that the fluid sample remains sealed within the reaction wells after the reaction condition is complete, when the heat and/or pressure of the reaction condition is removed, and the reaction container is removed from an instrument in which the reaction condition occurred (Ririe discloses that the reaction well is arranged within an instrument (col. 16, ll. 7-12); the reaction container is arranged within a pouch that is discarded (disposable pouch comprising said reaction container; col. 2, ll. 1-5), the materials within the wells of the reaction container are sealed during and after exposure to the reaction condition to prevent cross-contamination between wells, and to prevent contaminating the instrument; col. 1, ll. 61-62; col. 2, ll. 1-5; col. 8, ll. 55-62; col. 28, ll. 17-62; col. 29, ll. 41-49; col. 29, ll. 17-21). Ririe discloses wherein for sealing the second end of the reaction wells in-situ (see, e.g., col. 29, ll. 41-49), but does not explicitly disclose wherein the sealing is permanent or semipermanent, and assuming arguendo that Ririe fails to disclose the fluid sample remains sealed within the reaction wells after the reaction condition is complete, when the heat and/or pressure of the reaction condition is removed, and the reaction container is removed from an instrument in which the reaction condition occurred. Heinz discloses a reaction container comprising an array having a plurality of reaction wells (FIG. 1A: planar vessel having a plurality of interconnected chambers; [0313], [0320]). Heinz further discloses wherein the plurality of reaction wells can be sealed and isolated from one another by employing various types of seals including temporary seals (e.g., burstable heat seal; [0320]) or permanent seals to prevent communication between the reaction wells ([0013]). In view of Heinz, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the seal between the wells of Ririe to have temporary or permanent seal as disclosed by Heinz ([0313], [0320]). Oner of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known sealing means for another for the predictable result of sealing the connection between wells according to need as suggested by Heinz ([0313], [0320]).
Regarding claim 2, modified Ririe discloses wherein exposing the array to the reaction condition includes applying heat or pressure to the array, and wherein the reaction condition comprises substantially applying only heat or pressure to the array and no additional heat or pressure need be added in-situ to seal the reaction wells with the sealing material (second end of the reaction wells are sealed once fluid is introduced into the reaction wells by applying pressure to the layer 518 to seal the reaction wells; see col. 29, ll. 41-46).
Regarding claim 13, modified Ririe further discloses wherein the reaction container is a closed reaction container (reaction wells of reaction container of Ririe are sealed and thus the reaction container of Ririe meets the limitation “closed container”).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ririe in view of Heinz as applied to claim 1 above, and further in view of Brown (already of record, US 2008/0287585).
Regarding claim 7, modified Ririe discloses the method according to claim 1 as set forth above. Modified Ririe further discloses wherein the sealing material comprises a film layer bonded to the inner surface of the second outer layer adjacent to the second end of the reaction wells (see claim 1 above), and the method further comprising bonding the sealing material under the reaction condition to seal each of the plurality of wells (see claim 1 above). Modified Ririe does not explicitly disclose wherein the sealing material is selected from the group consisting of a heat and pressure-activated adhesive, a swelling material that swells in an aqueous environment, a wax, and combinations thereof. Brown discloses a system comprising an array of reaction wells (FIG. 2) and a sealing film having a sealing material (heat and pressure activated adhesive layer) for sealing the film to the array of reaction wells ([0065]). Brown discloses that various types of sealing material can be used to seal the film to the reaction wells ([0065]). In view of Brown, it would have been prima facie obvious to one of ordinary skill in the art to have substituted the sealing material of modified Ririe with the sealing material of Brown to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known sealing material for another for the predictable result of sealing components to one another as disclosed by Brown ([0065]).
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ririe in view of Heinz as applied to claim 1 above, and further in view of Brown (already of record, US 2008/0287585) and Gravel et al. (already of record, US 2012/0045604; hereinafter “Gravel”).
Regarding claim 8, modified Ririe discloses the method according to claim 1 as set forth above. Modified Ririe does not explicitly disclose wherein the sealing material for in-situ sealing of the open ends of the reaction wells is a heat and pressure- activated adhesive. selected from the group consisting of ethylene-vinyl acetate (EV A), ethylene-ethyl acetate (EEA), ethylene-methyl acetate (EMA), ethylene n-butyl acrylate (EnBA), ethylene-acrylic acid (EAA), thermoplastic polyurethane (TPU), polycaprolactone, silicone rubbers, thermoplastic elastomers, waxes, polyethylene, polypropylene, low-density polypropylene, co-polymers thereof, and combinations thereof. Brown discloses a system comprising an array of reaction wells (FIG. 2) and a sealing film having a sealing material (heat and pressure activated adhesive layer) for sealing the film to the array of reaction wells ([0065]). Brown discloses that various types of sealing material can be used to seal the film to the reaction wells ([0065]). In view of Brown, it would have been prima facie obvious to one of ordinary skill in the art to have substituted the sealing material of modified Ririe with the sealing material of Brown to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known sealing material for another for the predictable result of sealing components to one another as disclosed by Brown ([0065]). Modified Ririe does not explicitly disclose wherein the heat and pressure-activated adhesive selected from the group consisting of ethylene-vinyl acetate (EV A), ethylene-ethyl acetate (EEA), ethylene-methyl acetate (EMA), ethylene n-butyl acrylate (EnBA), ethylene-acrylic acid (EAA), thermoplastic polyurethane (TPU), polycaprolactone, silicone rubbers, thermoplastic elastomers, waxes, polyethylene, polypropylene, low-density polypropylene, co-polymers thereof, and combinations thereof. Gravel discloses a pressure-sensitive adhesive can be formed from various materials including polycaprolactones ([0021]). In view of Gravel, it would have been prima facie obvious to one of ordinary skill in the art to have substituted the material of the sealing material of modified Ririe with the material of Gravel to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known material for another. Further, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. See In re Leshin, 125 USPQ 416 (CCPA 1960) (see MPEP § 2144.07).
Regarding claim 9, modified Ririe further discloses wherein the heat and pressure-activated adhesive has a melting point in the range of about 60°C to about 100°C (polycaprolactones; Gravel at [0021]), and the in-situ sealing includes softening or at least partially melting the heat- and pressure-activated adhesive in- situ under thermocycling conditions to deform the heat- and pressure-activated adhesive into an opening of the plurality of wells (the sealing material intrinsically at least partially melts after applying heat to the sealing material).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-5, 7-9, 13 and 15 have been considered but are moot in view of the new ground of rejection.
Conclusion
No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799