DETAILED CORRESPONDENCE
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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/16/23 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered. The examiner notes that several NPL references appear to be listed in the specification (non-limiting examples at pages 1, 13, 14, 17) where these documents are not listed in the IDS and have not been considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-16) in the reply filed on 1/13/26 is acknowledged. Claims 17-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim.
Claim Status
Claims 1-18 are pending with claims 1-16 being examined and claims 17-18 deemed withdrawn.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: “fluid resistance element providing a fluid resistance force…” 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.
The instant specification describes the fluid resistance element as a ridge or as a structure that crosses the valve chamber in the width direction (pages 5 and 26 of the instant specification) and also shows the fluid resistance element as reference character #235 in Figure 5. For purposes of examination, the examiner will interpret the fluid resistance element as a ridge or as a structure that crosses the valve chamber.
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 1-16 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 pre-AIA the applicant regards as the invention.
As to claim 1, it is unclear what a “front side” is referring to in line 5. Previously, in line 4 “one side” of the mainframe is described. However, the elastic member in line 5 has not been described as having a front or back and it is unclear what side is the “front” side. How is the front side related to the other components of the device? Is the front side the side that is attached to the “one side” of the mainframe or is it a different side?
Claims 2-16 are rejected based on further claim dependency.
With respect to the elastic member formed in an “elastic pad type” in claim 3, it is unclear what applicants are attempting to define. Specifically, it is unclear what “type” is intending to convey where these limitations are rendered indefinite because it is unclear if an elastic pad is required or if there is some other structure that is not an elastic pad that may be considered a “type” (see MPEP 2173.05(b)).
Appropriate correction and/or clarification is required.
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 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.
Claims 1-4 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Aravanis et al (US 20170189904; hereinafter “Aravanis”).
As to claim 1, Aravanis teaches a cartridge for detecting a target analyte (Aravanis teaches a cartridge 104504; Fig. 1A, 5-8), comprising: a mainframe comprising a chamber, a passage connected to the chamber (Aravanis teaches a mainframe as the top layer 521 in Fig. 5-8. There is a passage 526 in the main frame as a fluid network; [126-128, 130]. The fluid network is connected to chamber 116 which is the sample port; [82]. Similarly, Aravanis teaches that the fluid elements include cavities, modules, reservoirs which store the fluids used in the device and would be considered a chamber; [76].), and a valve connected to the passage (Aravanis teaches a valve that protrudes downward from the mainframe and is a projection between channels 532 and 534; Fig. 5-8, [127-128, 130]); an elastic member located on a one side of the mainframe and covering the valve (Aravanis teaches a flexible membrane 530 which covers the valve; [127, 130], Fig. 5-8); and a subframe located on a front side of the elastic member, wherein the subframe has a pressure supply hole at a portion corresponding to the valve and wherein the elastic member can be supplied with a pressure through the pressure supply hole (Aravanis teaches a subframe as the bottom layer 508; Fig. 5-8. Aravanis teaches that the bottom layer has a through pressure supply hole through which pressure is supplied through the hole; [127-130], Fig. 7-8).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Aravanis teaches the cartridge according to claim 1, wherein the elastic member is elastically deformable and coupled between the mainframe and the subframe (Aravanis; Fig. 5-8, [130]).
As to claim 3, Aravanis teaches the cartridge according to claim 2, wherein the elastic member is formed in an elastic pad type and coupled, in a compressed state, between the mainframe and the subframe (Aravanis teaches a deformable pad; Fig. 5-8, [130]).
As to claim 4, Aravanis teaches the cartridge according to claim 1, wherein the valve is a normally open (NO) valve that is closed when a pressure is supplied to the elastic member through the pressure supply hole (Aravanis teaches the valve is normally open in Figure 7, where pressure is then applied and the valve is closed as shown in Figure 8; [130]).
Claims 1-16 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Wimberger-Friedl et al (US 20120266986; hereinafter “Wimberger”).
As to claim 1, Wimberger teaches a cartridge for detecting a target analyte (Wimberger; Fig. 1-4), comprising: a mainframe comprising a chamber, a passage connected to the chamber (Wimberger teaches a chamber as the entrance portion of 112 as the chamber and the passage as the horizontal portion of the channel; Fig. 1, [92]), and a valve connected to the passage (Wimberger teaches valve projection 115; Fig. 1, [96]); an elastic member located on a one side of the mainframe and covering the valve (Wimberger teaches flexible member 105 covering the valve; Fig. 1, [89, 90]); and a subframe located on a front side of the elastic member, wherein the subframe has a pressure supply hole at a portion corresponding to the valve and wherein the elastic member can be supplied with a pressure through the pressure supply hole (Wimberger teaches a subframe 101 that includes a pressure hole; Fig. 1, [90, 91]).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 2, Wimberger teaches the cartridge according to claim 1, wherein the elastic member is elastically deformable and coupled between the mainframe and the subframe (Wimberger; Fig. 1, [89, 90]).
As to claim 3, Wimberger teaches the cartridge according to claim 2, wherein the elastic member is formed in an elastic pad type and coupled, in a compressed state, between the mainframe and the subframe (Wimberger teaches an elastic pad membrane; Fig. 1, [89, 90]).
As to claim 4, Wimberger teaches the cartridge according to claim 1, wherein the valve is a normally open (NO) valve that is closed when a pressure is supplied to the elastic member through the pressure supply hole (This language is functional and related to intended use; MPEP 2114. However, Wimberger teaches that the valve on the right is normally open where the normally open configuration is shown in Fig. 1, and when a positive pressure is supplied to the valve then it is closed).
As to claim 5, Wimberger teaches the cartridge according to claim 1, wherein the valve comprises a valve chamber fluidly connected to the passage and having a width greater than a width of the passage and a fluid resistance element providing a fluid resistance force in the flow direction of a fluid passing through the valve chamber (Wimberger teaches the valve chamber as the region of space from the slanted portion of membrane 109 and upwards, where the area of the slanted space is larger than the area of the passage preceding the valve; Fig. 1. Wimberger teaches the fluid resistance element 115 as a protrusion/ridge extending into the valve chamber; Fig. 1. Alternatively, the valve chamber is the region of space to the right of 115 which has a width larger than the width of the passage; Fig. 1).
As to claim 6, Wimberger teaches the cartridge according to claim 5, wherein the valve chamber has a shape that narrows in the direction of the passage at a portion connected to the passage (In Wimberger, the valve chamber narrows from the middle chamber 103 to the left region of denoted by reference character 104 as it gets closer to the passage. Also, the valve chamber from the region of space 104 to where the slanted elastic membrane meets 115 also narrows; Fig. 1. Further, the chamber at the slanted portion narrows upwards in the direction of the passage; Fig. 1).
As to claim 7, Wimberger teaches the cartridge according to claim 5, wherein the valve chamber has a depth shallower than a depth of the passage (The valve chamber directly below 115 has a depth shallower than the passage as the elastic membrane closes; Fig. 1. Also, the passage depth extends vertically upwards towards the opening 112 where this depth is larger than the valve chamber space directly below and surrounding 115; Fig. 1).
As to claim 8, Wimberger teaches the cartridge according to claim 5, wherein the fluid resistance element is formed by a ridge protruding from the one side of the mainframe and crossing over the valve chamber in the width direction (Wimberger teaches the fluid resistance element 115 as a protrusion/ridge extending into the valve chamber; Fig. 1).
As to claim 9, Wimberger teaches the cartridge according to claim 5, wherein the fluid resistance element is arranged together with a passage wall forming the passage and a valve wall forming the valve chamber in the one side of the mainframe to have the same height to each other (Wimberger teaches the fluid resistance element 115 as a protrusion/ridge extending into the valve chamber; Fig. 1. In Wimberger, element 115 forms walls on the left and right, where the height of the walls on each side of element 115 is the same; Fig. 1).
As to claim 10, Wimberger teaches the cartridge according to claim 9, wherein the passage wall, the valve wall and the fluid resistance element are formed by a ridge protruding from the one side of the mainframe (Wimberger teaches the fluid resistance element 115 as a protrusion/ridge extending into the valve chamber; Fig. 1. In Wimberger, element 115 forms walls on the left and right, where the height of the walls on each side of element 115 is the same; Fig. 1).
As to claim 11, Wimberger teaches the cartridge according to claim 5, wherein the pressure supply hole of the subframe is located in correspondence with the fluid resistance element, and wherein the elastic member is interposed between the pressure supply hole and the fluid resistance element (Wimberger teaches the pressure supply hole located in correspondence with resistance element 115; Fig. 1).
As to claim 12, Wimberger teaches the cartridge according to claim 5, wherein the subframe comprises an inlet of the pressure supply hole is disposed in a front side of the subframe, and an outlet of the pressure supply hole is disposed in a back side of the subframe facing the elastic member and has an area greater than an area of the inlet of the pressure supply hole (Wimberger teaches the subframe has an inlet at the bottom and then an outlet at the top where the outlet opens and has a larger area than the bottom inlet; Fig. 1).
As to claim 13, Wimberger teaches the cartridge according to claim 12, wherein the outlet of the pressure supply hole has a shape corresponding to the edge of the valve chamber or is disposed inside the edge of the valve chamber (Wimberger teaches the subframe has an inlet at the bottom and then an outlet at the top where the outlet opens and has a larger area than the bottom inlet; Fig. 1. In Wimberger, the outlet has a shape that corresponds to the edge of the valve chamber which is the region of space above the outlet; Fig. 1. The examiner notes that the valve chamber has not been constrained).
As to claim 14, Wimberger teaches the cartridge according to claim 5, wherein the passage comprises a front passage formed in a front side of the mainframe, a back passage formed in a back side of the mainframe and a through passage formed through the mainframe to connect the front passage and the back passage (Wimberger teaches the passage as the portion that extends in the back from near the opening and then a through passage and then to the front side of the mainframe to the left of 115 and below the upper layer structure 100; Fig. 1).
As to claim 15, Wimberger teaches the cartridge according to claim 14, wherein one end of the through passage is provided in the valve chamber, and the other end of the through passage is connected to the back passage (Wimberger teaches that the passage of 103 extends to the valve chamber, where the various interpretations of the valve chamber are provided in claim 5).
As to claim 16, Wimberger teaches the cartridge according to claim 14, wherein the valve comprises a first valve chamber positioned on one side of the fluid resistance element and connected to the front passage or the back passage, and a second valve chamber positioned on the other side of the fluid resistance element and connected to the through passage (Wimberger teaches distinct valve chambers as the region of space on either side of 115, and also teaches the valve chambers formed by the slanted portions of the membrane; Fig. 1).
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 4 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Wimberger-Friedl et al (US 20120266986; hereinafter “Wimberger”) in view of Jovanovich et al (US 20130203634; hereinafter “Jovanovich”).
As to claim 4, Wimberger teaches the cartridge according to claim 1, with the pressure valve that controls pressure to an elastic member through a pressure hole to control the valve and fluid flow, and where the valve is a diaphragm valve (see above).
If it is deemed that Wimberger is not capable of wherein the valve is a normally open (NO) valve that is closed when a pressure is supplied, then Jovanovich teaches the analogous art of flexible diaphragm valve that controls fluid flow using fluid pressure where the valve is a normally open (NO) valve that is closed when a pressure is supplied (Jovanovich teaches that diaphragm valves can be configured to be normally open or normally closed, and in the normally open configuration then the flexible member is open and then closed when pressure is applied; [115]). It would have been obvious to one of ordinary skill in the art to have modified the elastic member that controls fluid flow with the valve of Wimberger to have been configured as a normally open valve as in Jovanovich because Jovanovich teaches that there are only two configurations of elastic diaphragm valves and that they are obvious variants of each other (Jovanovich; [115]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Samsoondar et al (US 20190224667; hereinafter “Samsoondar”) and Chao et al (US 20130142709; hereinafter “Chao”) teaches a rounded valve; Fig. 27 of Samsoondar and Fig. 34 of Chao, respectively.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/Benjamin R Whatley/Primary Examiner, Art Unit 1798