DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. The information disclosure statement (IDS) submitted on 1/29/2025, 7/1/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Amendment
3. Acknowledgement is made of the preliminary amendment(s) filed 3/14/2024.
Claim Interpretation
4. 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.
5. This application includes one or more claim limitations that use the word “means” or “step” but are nonetheless not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph because the claim limitation(s) recite(s) sufficient structure, materials, or acts to entirely perform the recited function. Such claim limitation(s) is/are:
Regarding claims 1 & 3-6 the recitation, “a sample dispensing mechanism for insertion into the cartridge body” contains the term “mechanism” which is deemed a generic placeholder for “means”. Although the recitation contains a generic place holder, a corresponding structure is clearly defined (‘i.e. sample dispensing”) and therefore the limitation is deemed to be NOT invoking 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph
Because this/these claim limitation(s) is/are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are not being interpreted to cover only the corresponding structure, material, or acts described in the specification as performing the claimed function, and equivalents thereof.
If applicant intends 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 remove the structure, materials, or acts that performs the claimed function; or (2) present a sufficient showing that the claim limitation(s) does/do not recite sufficient structure, materials, or acts to perform the claimed function.
Claim Rejections - 35 USC § 112
6. 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 and 3 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.
Regarding claim 1 the recitation Regarding claim 12 the recitation “at least one seal capable of being punctured by a piercing tip” is ambiguous and overly broad. With emphasis on the phrase “capable of”, this is an indefinite and / or relative phrase and raises the question as to whether the claimed seal becomes punctured or not?
The following limitation is hereby suggested. “at least one seal that during operation is punctured by a piercing tip to thereby enable fluid movement….”
Claims 3-6, 16, 20-23, 25-26, 33-38, 40-43 & 45-49 are rejected based on their dependency of rejected claims 1 and / or 33.
Regarding claim 33 the recitation Regarding claim 12 the recitation “at least one piercing tip disrupting the at least one seal is capable of generating one or more flaps” is ambiguous and overly broad. With emphasis on the phrase “capable of”, this is an indefinite and / or relative
phrase and raises the question as to whether the piercing tip generates one or more flaps or not?
The following limitation is hereby suggested. “at least one piercing tip disrupting the at least one seal that generates one or more flaps….”
Claim Rejections - 35 USC § 102
7. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 3-6, 16, 20-23, 25, 36-38, 40, 48 & 49 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hopper (WO 2019060950 A1.)
Regarding claims 1, 5, 25 Hopper et al teaches a cartridge body 1 101 to receive a biological or environmental sample (Abstract) into a sample preparation fluid 11 contained in the cartridge 101 body for (intended use recitation) preparation of a sample fluid (Abstract) [Claims 1, 3, 8-10, 13-15] therefrom; at least one reaction chamber 1 3 107 108 coupled to the cartridge body 1 101; at least one seal 2 5 (Abstract)[Claim 1, 3 & 4](Entire Specification) to prevent fluid movement between the cartridge body 1 11 and the at least one reaction chamber 1 3 107 108, the at least one seal (Abstract)[Claim 1, 3 & 4](Entire Specification) is situated between the cartridge body 1 101 and the at least one reaction chamber 1 3 107 108, the at least one seal (Abstract)[Claim 1, 3 & 4] capable of being punctured by a piercing tip 26 to thereby enable fluid movement between the cartridge body 1 101 and the at least one reaction chamber 1 3 107 108; and a sample dispensing mechanism (Abstract) 120 121 122 for insertion into the cartridge body, wherein the sample dispensing mechanism (Abstract) 120 121 122 is operable to disrupt (Abstract)(Summary)[Claim 1] the at least one seal (Abstract)[Claim 1, 3 & 4](Entire Specification) to allow sample fluid (Abstract) [Claims 1, 3, 8-10, 13-15] to enter the at least one reaction chamber 1 3 107 108 from the cartridge body 1 11, and to dispense a predetermined sub-volume [Claims 1, 8 & 9] of the sample fluid from the cartridge body into the at least one reaction chamber for testing therein while preventing further fluid movement between the cartridge body and the at least one reaction chamber (Summary)[Claim 1], wherein the sample dispensing mechanism (Abstract) 120 121 122 comprises a dispense rod 121 comprising at least one piercing tip 26 that disrupts the at least one seal (Abstract)[Claim 1, 3 & 4] by forming at least one opening therein, and wherein the at least one piercing tip comprises a geometry configured to generate a large opening in the at least one sea (Abstract) (Interpreted as piercing the seal large enough to allow a fluid movement).
Regarding claim 3 Hopper teaches a closure 2 20 to seal the cartridge body 1 11 after receipt of the biological or environmental sample and the sample dispensing mechanism (Abstract) 120 121 122 therein, wherein at least one of the closure 2 20 and the cartridge body 1 11 is configured to prevent or at least inhibit removal of the closure from the cartridge body 1 11 so that the fluids remain sealed within the sample testing system (Figs. 1, 7, 18 21.
Regarding claim 4 Hopper teaches the sample dispensing mechanism (Abstract) 120 121 122 is attached to the closure so that an act of applying the closure to the cartridge body 1 11 also effects the insertion of the sample dispensing mechanism (Abstract) 120 121 122 into the cartridge body 1 11.
Regarding claim 6 Hopper teaches the single action by the user is a sustained screwing action 28 29 (Fig. 4applied to the closure 2 20 relative to the cartridge body 1 11, and wherein the screwing action causes operation of the sample dispensing mechanism and seals the cartridge body, and wherein the closure comprises a screw thread 28 29.
Regarding claim 16 Hopper teaches the at least one piercing tip 26 comprises a ball point tip, an arrow head tip, or a frustoconical tip (figs. 6 & 9).
Regarding claim 20 Hopper teaches the at least one piercing tip 26 comprises a flat surface, and wherein the flat surface is at an angle of less than about 200, about 15°, about 10°, about 50, or about 1°, relative to the surface of the at least one seal (figs. 6 & 9).
Regarding claim 21 Hopper teaches the at least one piercing tip 26 is fluted (figs. 6 & 9).
Regarding claims 22 & 23 Hopper teaches the at least one piercing tip 26 (via amplification tube 3) comprises one or more flow channels (“Multiple Tube Cartridge Embodiment” section), and wherein the one or more flow channels (“Multiple Tube Cartridge Embodiment” section)are positioned at (i) the proximal end of the at least one piercing tip 26, (ii) the distal end of the at least one piercing tip 26 (via amplification tube 3), or (iii) across the length of the at least one piercing tip 26 (via amplification tube 3).
Regarding claim 36 Hopper inherently teaches a puncture (via puncturing tip 26) of at least about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, about 98%, or about 99%, of the surface area of at least one seal (Abstract)[Claim 1, 3 & 4](Entire Specification).
Regarding claim 37 Hopper inherently teaches a puncture of at least about 50%, about 55%, about 60%, about 65%, about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, about 98%, or about 99%, of the surface area of the at least one seal (Abstract)[Claim 1, 3 & 4].
Regarding claim 38 Hopper inherently teaches at least about 70%, about 75%, about 80%, about 85%, about 90%, about 95%, about 98%, or about 99%, of the predetermined sub-volume [Claims 1, 8 & 9] of the sample fluid (Abstract) enters the at least one reaction chamber 1 3 107 108.
Regarding claim 40 Hopper inherently teaches the predetermined sub-volume [Claims 1, 8 & 9] of the sample fluid (Abstract) comprises at least about 10 µL, about 15 µL, about 20 µL, about 25 µL, about 30 µL, about 35 µL, about 40 µL, about 45 µL, about 50 µL, about 60 µL, about 70 µL, about 80 µL, about 90 µL, about 100 µL, about 110 µL, about 120 µL, about 128 µL, about 130 µL, about 140 µL, about 150 µL, about 160 µL, about 170 µL, about 180 µL, about 190 µL, or about 200 µL, of the sample fluid [Claims 1, 8 & 9] (Figs. 1-32 & 39)
Regarding claim 48 Hopper teaches the cartridge body 1 11 comprises sample preparation reagents 111, and wherein at least one of the reaction chambers 1 3 107 108 comprises one or more reagents for (Intended use recitation) a reverse transcription reaction and/or an amplification reaction.
Regarding claim 49 Hopper teaches the cartridge body 1 11 comprises one or more alignment features 10 configured to align and engage with one or more mating slots of a testing apparatus, wherein the one or more alignment features prevent rotation of the cartridge body when it is in place in the testing apparatus, and wherein the one or more alignment features 10 enable a user to.
Claim Rejections - 35 USC § 103
8. 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.
Claim(s) 46 & 47 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hopper (WO 2019060950 A1).
Regarding claims 46 & 47 Hopper teaches all of the basic features. However, Hopper does not teach the at least one reaction chamber is two reaction chambers (having different reagents), wherein the at least one piercing tip is two piercing tips. Since Hopper at the very least discloses at least one reaction chamber 1 3 107 108 and at least one piercing tip 26, it would have been obvious to a person having ordinary skill in the art of sample testing devices before the effective filing date of the claimed invention to provide more than one piercing tip and / or a plurality of reaction chambers within a sample testing system for the purpose of minimizing errors, optimizing testing results and / or providing backup test components. Furthermore, it has been held that duplicating the components of a prior art device is a consideration within the skill of the art (MPEP 2144.04 VI B.) .In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960). In this particular case, it would be well within the skill set of a person having ordinary skill in the art experiment and stress test multiple variations of a sample testing device for the purposes of manufacturing a test kit that can provide effective and efficient results.
Allowable Subject Matter
9. Claims 26, & 41 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 26 the cited prior / pertinent art does not anticipate nor render obvious at least one opening that grows larger in size as at least one piercing tip moves into at least a portion of at least one reaction chamber.
Regarding claim 41 the cited prior / pertinent art does not anticipate nor render obvious a sample dispensing mechanism comprising an overmolded layer disposed on the surface of at least a portion of the dispense rod 131
Claims 42-43 are objected too based on their dependency of claim 41
10. Claim 33 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 33 the cited prior / pertinent art does not anticipate nor render obvious at least one piercing tip that disrupts at least one seal generates one or more flaps, wherein the one or more flaps comprise portion(s) of the at least one seal disrupted by the at least one piercing tip.
Claims 34-35 would be allowable based on their dependency of rejected claim 33
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDRE J ALLEN whose telephone number is (571)272-2174. The examiner can normally be reached Mon-Fri. 9am-5PM.
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/ANDRE J ALLEN/Primary Examiner, Art Unit 2855