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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-11, drawn to a pre-mix device.
Group II, claim(s) 15, 16, 18-20, drawn to a medical test device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a pre-mix device for use with a test unit, the device comprising: a vessel, a sample opening and a discharge port, the discharge port being separate from the sample opening, wherein the vessel is operatively adapted to receive a sample via the sample opening, so that when the pre-mix device is operatively engaged with the test unit, the contents of the vessel are released from the discharge port to the test unit, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Irmscher et al (US 20200030806; hereinafter “Irmscher”) or Katz et al (US 20200140251; hereinafter “Katz”). Irmscher teaches a pre-mix device for use with a test unit (Irmscher; #100, Fig. 1-6), the device comprising: a vessel (Irmscher teaches a vessel formed by 100 and including parts 10 and 30; [196], Fig. 4), a sample opening and a discharge port, the discharge port being separate from the sample opening (Irmscher teaches sample opening 14; [197], Fig. 5. Irmscher teaches discharge port 53; [202, 208, 255], Fig. 6, 13-15. Irmscher also teaches a seal as 61 that is pierced thereby providing a discharge opening; Fig. 6, [195, 207, 220, 257]), wherein the vessel is operatively adapted to receive a sample via the sample opening, so that when the pre-mix device is operatively engaged with the test unit, the contents of the vessel are released from the discharge port to the test unit (What the vessel receives and how it operated is a matter of intended use and function. The examiner notes that the sample and the test unit are not positively recited. Irmscher teaches that a sample is placed in the opening; [197]. Irmscher teaches that the device 100 engages the test unit 200; [168, 195] Fig. 2, 3, 7). Katz teaches a pre-mix device for use with a test unit (Katz; Fig. 1-4), the device comprising: a vessel (Katz; 2, 4), a sample opening and a discharge port, the discharge port being separate from the sample opening (Katz teaches sample opening 3 and discharge opening along 14; [55, 56], Fig. 1-3), wherein the vessel is operatively adapted to receive a sample via the sample opening, so that when the pre-mix device is operatively engaged with the test unit, the contents of the vessel are released from the discharge port to the test unit (What the vessel receives and how it operated is a matter of intended use and function. The examiner notes that the sample and the test unit are not positively recited. Katz teaches that a sample is placed in the opening; [55, 56, 57, 62]. Irmscher teaches that the device engages the assay device 5/7; [58], Fig. 3).
During a telephone conversation with Brian Paul on 6/4/26 a provisional election was made without traverse to prosecute the invention of group I, claims 1-11. Affirmation of this election must be made by applicant in replying to this Office action. Claims 15, 16, 18-20 are hereby withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 1/30/24 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-11, 15, 16, 18-20 are pending with claims 1-11 being examined and clams 15, 16, 18-20 deemed withdrawn.
Drawing Objections
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters “30” and “40” have been used to designate multiple different parts/features as seen in Figure 6, and Figures 4 & 6, respectively. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 2-11 are objected to.
Claims 2-11 recite “A pre-mix device according to claim…” in the preamble where the referenced device in the previous claims has already been recited. Thus, since there is antecedent basis for the terms, the preamble should read as “The pre-mix device…”.
Claim 5 recites “the the” where one of “the” should be deleted.
Appropriate correction is required.
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.
Claim 6 is 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 6, it is unclear what “when the substantially…” is reciting in lines 4-5. The sentence does not actually appear to be finished and it is unclear what occurs once this condition is met. The examiner suggests removing “when the”.
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 1-11 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Irmscher et al (US 20200030806; hereinafter “Irmscher”).
As to claim 1, Irmscher teaches a pre-mix device for use with a test unit (Irmscher; #100, Fig. 1-6), the device comprising: a vessel (Irmscher teaches a vessel formed by 100 and including parts 10 and 30; [196], Fig. 4), a sample opening and a discharge port, the discharge port being separate from the sample opening (Irmscher teaches sample opening 14; [197], Fig. 5. Irmscher teaches discharge port 53; [202, 208, 255], Fig. 6, 13-15. Irmscher also teaches a seal as 61 that is pierced thereby providing a discharge opening; Fig. 6, [195, 207, 220, 257]), wherein the vessel is operatively adapted to receive a sample via the sample opening, so that when the pre-mix device is operatively engaged with the test unit, the contents of the vessel are released from the discharge port to the test unit (What the vessel receives and how it operated is a matter of intended use and function. The examiner notes that the sample and the test unit are not positively recited. Irmscher teaches that a sample is placed in the opening; [197]. Irmscher teaches that the device 100 engages the test unit 200; [168, 195] Fig. 2, 3, 7).
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, Irmscher teaches the pre-mix device according to claim 1, wherein the pre-mix device further includes an integrated reservoir of test fluid, and the reservoir is adapted to discharge test fluid from the reservoir into the vessel, so that the vessel operatively discharges a mixture of test fluid and sample to the test unit (Irmscher teaches reservoir 24/25; Fig. 4, [196, 198, 208, 252]).
As to claim 3, Irmscher teaches the pre-mix device according to claim 1, wherein the discharge port is sealed and selectively openable by engagement of the pre-mix device with the test unit (This limitation is functional as the test unit is not positively recited. Irmscher teaches discharge port 53; [202, 208, 255], Fig. 6, 13-15. Irmscher also teaches a seal as 61 that is pierced thereby providing a discharge opening; Fig. 6, [195, 207, 220, 257]).
As to claim 4, Irmscher teaches the pre-mix device according to claim 2, wherein the opening is closed until a movement of a section of the body of the pre-mix device (Irmscher teaches that the device being opened; Fig. 5, [197]. Irmscher would be capable of reversing the movement to close the opening).
As to claim 5, Irmscher teaches the pre-mix device according to claim 4, wherein the test fluid is released by the same movement as causes the sample opening to be operable (Irmscher teaches the movement of the device to release the fluid thereby making the device operable; see claim 4 above).
As to claim 6, Irmscher teaches the pre-mix device according to claim 2, wherein the volume of test fluid is selected to deliver substantially the test volume required for the test unit, so that operatively, when the substantially all the mixed sample and test fluid is adapted to be discharged to the test unit via the discharge port (What the volume of fluid is intended to do is a matter of intended use. Irmscher teaches discharge port 53; [202, 208, 255], Fig. 6, 13-15. Irmscher also teaches a seal as 61 that is pierced thereby providing a discharge opening; Fig. 6, [195, 207, 220, 257]. Irmscher teaches releasing the fluid reservoir 24/25; Fig. 4, [196, 198, 208, 252])
As to claim 7, Irmscher teaches the pre-mix device according to sample opening is at the top of the vessel, and the discharge port is at the base of the vessel (Irmscher teaches the opening in the top and the discharge port in the base; Fig. 1-6).
As to claim 8, Irmscher teaches the pre-mix device according to claim 1, wherein the sample opening is adapted to allow a swab carrying a sample to be inserted, the shape and dimensions of the vessel being such that swab is closely engaged with internal walls of the vessel, so as to assist in removal of the sample from the swab (The limitations recited with respect to the sample opening are related to intended use since the swab has not been positively recited. Irmscher teaches sample opening 14; [197], Fig. 5).
As to claim 9, Irmscher teaches the pre-mix device according to claim 2, wherein the pre-mix device further includes an interlock, so that unless a test unit is engaged with the base of the device, the mixture of the sample and the test fluid cannot be discharged through the discharge port (What the vessel receives and how it operated is a matter of intended use and function. The examiner notes that the sample and the test unit are not positively recited. Irmscher teaches that a sample is placed in the opening; [197]. Irmscher teaches that the device 100 engages the test unit 200; [168, 195] Fig. 2, 3, 7).
As to claim 10, Irmscher teaches the pre-mix device according to claim 1, wherein the vessel further includes a dry reagent (Irmscher teaches that the first reagent can be a lysis buffer, and that it may be dry; [37, 44, 45, 105, 198, 214, 230]. Irmscher teaches that the buffer assists in removing sample from swab; [156]).
As to claim 11, Irmscher teaches the pre-mix device according to claim 10, wherein the dry reagent is a lyophilized buffer (Irmscher teaches that the first reagent can be a lysis buffer, and that it may be dry; [37, 44, 45, 105, 198, 214, 230]. Irmscher teaches that the buffer assists in removing sample from swab; [156]. Irmscher teaches that the reagent can be lyophilized; [294]).
Claims 1-2, 4-11 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Katz et al (US 20200140251; hereinafter “Katz”).
As to claim 1, Katz teaches a pre-mix device for use with a test unit (Katz; Fig. 1-4), the device comprising: a vessel (Katz; 2, 4), a sample opening and a discharge port, the discharge port being separate from the sample opening (Katz teaches sample opening 3 and discharge opening along 14; [55, 56], Fig. 1-3), wherein the vessel is operatively adapted to receive a sample via the sample opening, so that when the pre-mix device is operatively engaged with the test unit, the contents of the vessel are released from the discharge port to the test unit (What the vessel receives and how it operated is a matter of intended use and function. The examiner notes that the sample and the test unit are not positively recited. Katz teaches that a sample is placed in the opening; [55, 56, 57, 62]. Irmscher teaches that the device engages the assay device 5/7; [58], Fig. 3).
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, Katz teaches the pre-mix device according to claim 1, wherein the pre-mix device further includes an integrated reservoir of test fluid, and the reservoir is adapted to discharge test fluid from the reservoir into the vessel, so that the vessel operatively discharges a mixture of test fluid and sample to the test unit (Katz teaches reservoirs 11/12; [52, 53, 62, 63]).
As to claim 4, Katz teaches the pre-mix device according to claim 2, wherein the opening is closed until a movement of a section of the body of the pre-mix device (Katz teaches that the opening for receiving the test swab can be closed and blocked initially until the body is actuated at which time fluid is released where the swab is then inserted through the opening after actuation; [27, 56, 62]).
As to claim 5, Katz teaches the pre-mix device according to claim 4, wherein the test fluid is released by the same movement as causes the sample opening to be operable (Katz teaches that the opening for receiving the test swab can be closed and blocked initially until the body is actuated at which time fluid is released where the swab is then inserted through the opening after actuation; [27, 56, 62]).
As to claim 6, Katz teaches the pre-mix device according to claim 2, wherein the volume of test fluid is selected to deliver substantially the test volume required for the test unit, so that operatively, when the substantially all the mixed sample and test fluid is adapted to be discharged to the test unit via the discharge port (What the volume of fluid is intended to do is a matter of intended use. Katz teaches reservoirs 11/12 through which fluid is discharged; [52, 53, 62, 63]).
As to claim 7, Katz teaches the pre-mix device according to sample opening is at the top of the vessel, and the discharge port is at the base of the vessel (Katz teaches the opening at the top and the discharge port at the base; Fig. 1-4).
As to claim 8, Katz teaches the pre-mix device according to claim 1, wherein the sample opening is adapted to allow a swab carrying a sample to be inserted, the shape and dimensions of the vessel being such that swab is closely engaged with internal walls of the vessel, so as to assist in removal of the sample from the swab (The limitations recited with respect to the sample opening are related to intended use since the swab has not been positively recited. Katz teaches sample opening; [55, 56, 57, 62]).
As to claim 9, Katz teaches the pre-mix device according to claim 2, wherein the pre-mix device further includes an interlock, so that unless a test unit is engaged with the base of the device, the mixture of the sample and the test fluid cannot be discharged through the discharge port (What the vessel receives and how it operated is a matter of intended use and function. The examiner notes that the sample and the test unit are not positively recited. The sample and test fluid cannot be discharged unless fully connected because Katz teaches the connection between 2/4 as an interlock where if 2 is not connected to 4 then the sample and test fluid cannot be discharged).
As to claim 10, Katz teaches the pre-mix device according to claim 1, wherein the vessel further includes a dry reagent (Katz; [48]).
As to claim 11, Irmscher teaches the pre-mix device according to claim 10, wherein the dry reagent is a lyophilized buffer (Katz teaches that the reagent can be a buffer, and that it may be dry; [48]. Because the reagent is dried, then the examiner believes that the dried reagent would behave the same as a lyophilized reagent that was dehydrated and then reconstituted upon contact with liquid. Product-by-process claims are not limited to the manipulations of the recited steps, only to the resulting structure or structure implied by the steps. MPEP 2113: “Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
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.
Claims 4-5 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Irmscher et al (US 20200030806; hereinafter “Irmscher”) in view of Katz et al (US 20200140251; hereinafter “Katz”).
As to claims 4 and 5, Irmscher teaches the pre-mix device of claim 2 (see above), where the test fluid is released by movement of the housing (Irmscher; Fig. 5, [197]). If it is deemed that Irmscher does not specifically teach wherein the opening is closed until a movement of a section of the body of the pre-mix device, and wherein the test fluid is released by the same movement as causes the sample opening to be operable, then Katz teaches the analogous art of housing for a test device that accepts a swab and releases fluid (Katz; Fig. 1-4), wherein the opening is closed until a movement of a section of the body of the pre-mix device, and wherein the test fluid is released by the same movement as causes the sample opening to be operable (Katz teaches that the opening for receiving the test swab can be closed and blocked initially until the body is actuated at which time fluid is released where the swab is then inserted through the opening after actuation; [27, 56, 62]). It would have been obvious to one of ordinary skill in the art to have modified the body which moves with respect to the swab opening in order to actuate fluid release of Irmscher to have been closed initially and then actuated to release and unblock the opening for swab insertion as in Katz because Katz teaches that sometimes it is advantageous to block the opening prior to mixture of the liquids (Katz; [56]) and also because Katz teaches mixing the fluids before and after swab insertion are obvious variants (Katz; [62]).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Katz et al (US 20200140251; hereinafter “Katz”) in view of Irmscher et al (US 20200030806; hereinafter “Irmscher”).
As to claim 3, Katz teaches the pre-mix device according to claim 1, with the discharge port that engages the pre-mix device with the test unit (see above).
Katz does not teach that the discharge port is sealed and selectively openable by engagement of the pre-mix device with the test unit. However, Irmscher teaches the analogous art of a pre-mix device (Irmscher; #100, Fig. 1-6), wherein the discharge port is sealed and selectively openable by engagement of the pre-mix device with the test unit (Irmscher teaches discharge port 53; [202, 208, 255], Fig. 6, 13-15. Irmscher also teaches a seal as 61 that is pierced thereby providing a discharge opening; Fig. 6, [195, 207, 220, 257]. Irmscher teaches that the sample swab is solved in the liquid to remove the sample from the swab before being further processed; [36, 43, 198]). It would have been obvious to one of ordinary skill in the art to have modified the pre-mix device which delivers a sample and reagent to a test device of Katz to have been sealed prior to engagement as in Irmscher because Irmscher teaches that it is advantageous to allow the sample and reagent to mix prior to further processing (Irmscher; [36, 43, 198]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Katz et al (US 20200140251; hereinafter “Katz”) alone or alternatively in view of Kirkpatrick et al (US 20220032295; hereinafter “Kirkpatrick”).
As to claim 11, Katz teaches the pre-mix device according to claim 10, wherein the dry reagent is a buffer (Katz teaches that the reagent can be a buffer, and that it may be dry; [48]).
Although Katz teaches that reagent is a dried buffer, Katz does not specifically teach that the dry reagent is lyophilized. However, it would have been obvious to one of ordinary skill in the art to have modified the dried reagent buffer of Katz to be formed via lyophilization because this is a well-known technique in the laboratory to accomplish drying reagents. Nonetheless, Kirkpatrick teaches the analogous art of a device for delivering samples to a test unit (Kirkpatrick; Fig 1-16) with lyophilized reagents in the device (Kirkpatrick; [240, 254, 267, 269]). It would have been obvious to one of ordinary skill in the art to have modified the dried reagent buffer of Katz to have been lyophilized as in Kirkpatrick because Kirkpatrick teaches that lyophilizing is a known technique to produce dried reagents (Kirkpatrick; [240]).
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
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