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 .
Response to Arguments
Applicant's arguments filed October 24, 2025 have been fully considered but they are not persuasive.
The claim amendments are not sufficient such that the claims are clear, not subjected to 112 rejections. See rejections herein.
It is noted that applicant has amended the claims, but fails specify, provide for the text of the originally filed specification that supports each individual amendment of claim 1 and the further amended claims. It is hereby requested that applicant provide for the specific text of the specification/support for each and all claim amendments.
It is noted that applicant summarily asserts: “Claim 1 has been amended herein to incorporate features of claim 2, 3, 7-12, 17, 18, and paragraphs [0178]-[0182] and support for this amendment can be found throughout the specification.” It noted that the originally filed specification nor amended specification provides for any paragraph numbers. Furthermore, the statement summarily addresses all of the amendments of claim 1, but does not provide for what text supports each individual amendment of claim 1 nor the amendments of the further dependent claims.
As to the paragraph numbers, it presumed that applicant is referring to the US Publication 2023/0302446. However, even if such, the examiner fails to locate any description of an inlet positioned at an upper portion and outlet positioned at a lower portion as recited relative to the sample receiving well and sample drawing well and a detection well configured to detect whether a target analyte is present and fluid-tight seal as provided for in claim 1 within such paragraphs.
As to the 102 and 103 art rejections, applicant states:
“The cited reference fails to disclose "a cartridge for detecting a target analyte, comprising a sample receiving well, a sample drawing well, a processing well, and a detection well". Moulton only discloses "a filtration apparatus which can be operated to simultaneously filter one or more small fluid samples for extremely small particles (lines 7-9 of column 1)."
Also, Moulton fails to disclose "a sample flowing channel fluidically connecting the outlet of the sample receiving well and the pipette tip seating portion of the sample drawing well".
Moulton only discloses "a plurality of filtration wells 32 and a plurality of extraction wells 20 corresponding to each of the filtration wells 32," and each extraction well 20 is not in fluid communication with one another. Moreover, to achieve the purpose of the filtration device, one would not expect each extraction well 20 to be in fluid communication with one another.
Also, Moulton fails to disclose "the pipette tip seating portion is configured to contact the end of the pipette tip to form a fluid-tight seal such that a negative pressure delivered through the pipette tip is directly delivered to the sample flowing channel". Moulton only discloses ". Moulton only discloses, "A fluid sample 50 is then introduced into the proximal chamber 40 of each filtration well 32 (lines 24-25 of column 4)." In other words, no negative pressure is provided to the filtration well 32 disclosed in Moulton. Moreover, given that the fluid sample 50 introduced by a pipette passes through the filter 48 by gravity, it cannot be envisioned that the pipette would contact the wall. Furthermore, Moulton discloses that "Walls 42 may be sloped towards distal channel 44 to guide the fluid sample 50 towards filter 48 during filtration (lines 37-39 of column 3)." which discloses or suggests that the pipette does not make contact with the wall.
Thus, Moulton fails to disclose all elements of amended Claim 1, and therefore a prima facie case of anticipation cannot be established based on the cited reference.
As described above, Moulton describes extraction wells 20. However, Moulton fails to disclose sample drawing well. While Moulton discloses a feature in which the walls of the filtration well 32 are sloped, this is not the same element as the pipette tip seating portion of Claim 1, because it does not perform the same function.
The pipette tip seating portion may be configured to contact the end of the pipette tip to form a fluid-tight seal such that a negative pressure delivered through the pipette tip is directly delivered to the sample flowing channel.
Furthermore, the invention of Claim 1 may apply a negative pressure delivered through a pipette tip directly to the sample receiving part, allowing a sample to pass through a filter quickly; and may employ a structure in which part of the end of the pipette tip is inserted into a pipette tip support hole in the sample drawing part to suck a sample, thus drawing up a sample while minimizing the residue that is left in the sample drawing part. (paragraphs [0037]-[0038] of the present application).”
The examiner disagrees. The claims are directed to an apparatus not a process of use. The claim language, positively claimed elements must provide for a structural distinction from the prior art in order to patentably distinguish the claimed invention from the prior art. Here, applicant has not provided for any such structural distinction. There is no requirement for the claimed invention to be used in any process at all including for detecting an analyte. The invention is defined by the positively claimed structural elements listed in the body of the claim not by any and all possible uses of the apparatus. An owner, operator, purchaser, owner of the instant apparatus would not be required to use the apparatus in any process at all, including that as may be intended by applicant. If one elects to use the claimed invention, such use does not have to be the same as that intended by applicant. It is noted that the chosen names of the various wells do not structurally define the respective wells. There is no requirement for any sample to be received any well, no well is required to be subjected to any drawing, no processing, reacting, and detecting is required to be done in any well. There is nothing precluding all of such actions from done to any of the wells. However, it is noted that none of the wells as claimed are structurally capable of performing any of the previously recited actions.
As to the sample flowing channel, the examiner has clearly identified a flow channel that is fluidically connected to each of the wells in Moulton. However, it is noted that no sample is required to flow nor be flowing in the claimed channel. Furthermore, it is noted that the sample flowing channel is not capable of providing for any motive force, pressure to provide for any flow of any unclaimed, unspecified sample nor reagent. In order for any flow to occur within the channel or any sample to be moved from any well, there must be adequate structure that can do such. In this case, applicant refers to a pipette tip that is not positively claimed as a structural element of the apparatus (as previously noted in the prior Office Action). However, it is noted that a pipette tip alone is not capable of providing for any pressure to move any sample.
As to applicant arguments directed to a recited purpose of the apparatus of Moulton, there is no requirement for a structurally equivalent apparatus to be disclosed as being used for the same purpose of the claimed apparatus. As noted above, one is not required to use an apparatus in any particular manner nor for any specific purpose. The intended use and purpose of an apparatus does not structurally define, provide for any structural elements of the apparatus. There is no requirement for any negative pressure to be applied to any well of the instant apparatus. However, it is noted that there is nothing structurally precluding one from choosing to apply a negative pressure to a first well of Moulton such that contents (sample) of a second well are drawn into the first well.
As to applicant’s arguments directed to the intended use of the sloped walls of the wells, there is nothing structurally precluding one from providing for a pipette tip of suitable dimensions such that a seal is formed between the pipette tip and the sloped walls. However, as noted above, no pipette tip is positively claimed as an element of the invention, required be present sealed with any walls of any well, nor required to ever be used with the claimed apparatus. Furthermore, it is noted that the invention, no positively claimed structural element is capable of applying any negative pressure, the pipette tip nor any other such structure is positively claimed as an element of the invention.
Moulton discloses the same or structural equivalents of the positively claimed structural elements recited as defining the instant apparatus. Therefore, the claims are rejected as given herein.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: because the amended specification now employs different terminology to refer to the same structures. For example, the amended specification recites “sample receiving well 102” and “sample receiving part 102”; and “sample drawing well 103” and “sample drawing part 103”. It is presumed that the respective structures (wells and parts) are the same If so, consistent terminology should be employed to reference the same structures. If not the same, then different structures are referenced by the same respective reference numerals. Applicant should review the specification for any further inconsistencies and/or errors.
Appropriate correction is required.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the claims mention a target analyte, sample (as admitted by applicant on page 9 of the remarks), pipette tip, reagent, and fluids. However, none of such are positively claimed as structural elements of the inventions and none of such (excluding the pipette tip) are specifically defined as being any specific substance, material, etc. All of such are considered are considered as materials and/or articles intended to be or can be worked upon, used with the inventions. However, the claims are directed to an apparatus not a process of use. There is no requirement for the apparatus to be used in any method with any further unclaimed structures or materials including performing any reacting, detecting, receiving, flowing, drawing, inserting, processing, mixing, extracting, filtering, applying negative pressure, nor delivering of anything.
It is noted that the various names of the respective wells do not provide for any structure of the respective wells, channel, and portion. For example, the phrases, “sample receiving”, “sample drawing”, “sample flowing”, “processing”, “detection”, “pipette tip seating” do not provide for any further structure, but are directed to intended use of the respective wells. As noted above no sample, reagent, nor pipette tip are positively claimed as elements of the invention and are not required to be present nor ever required to be present. The apparatus is defined by the positively claimed structural elements, not by the possibles of the elements with unclaimed materials or articles. The drawing well is not defined as comprising any structure that would be capable for providing for any motive forces to draw any sample; the sample flowing channel is not claimed as comprising any structure that can provide any motive force to create any flow; the processing well is not claimed as comprising any structure that perform and processing, drawing, and the detection well is not claimed as comprising any structure that can perform any detecting.
It is noted that the claims are replete with language directed to intended use. For example, the “for detecting” clause, various other “for” clause, “configured to…” and similar clauses recited throughout the claims are directed to intended use. It is noted that no detector is positively claimed as an element of the invention.
It is noted that the term “portion” as employed in claim 1 and throughout the claims is not defined as being any specific structure nor defined by any definitive structural boundaries.
It is noted that the term “or” provides for alternatives.
It is noted that the terms “inlet” and “outlet” are not limited to any specific structure and both are not mutually exclusive. A structure named “an inlet” is moreso directed to intended use. An inlet is no necessarily precluded from being used as an outlet and vice versa.
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, 4, 6, 13, 19, and 23-24 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.
The claims are generally narrative and indefinite, failing to conform with current U.S. practice. They appear to be a literal translation into English from a foreign document and are replete with grammatical and idiomatic errors.
As to claims 1, it is unclear how the respective wells, channel, and pipette seating portion can be present/exist without claiming the body part 11 that comprises all of such elements. The claim as drafted is not consistent with the specification and drawings.
As to claim 1, in the first and second paragraphs, it unclear what “upper portion” and “lower portion” of what is being referenced because the claim does not state such. Furthermore, it is noted such respective “portions” are not structurally defined by, as comprising any specific structures nor structural boundaries so as to determine where each portion begins and ends to provide for a distinction of what is considered as each of the respective portions. Furthermore there is no relative basis provided in the claim to indicate what is considered “upper” and “lower” (relative to what; higher than what, lower than what). This is also applicable to the same terms recited in claim 19 and 23 respectively.
As noted above, no pipette tip and no structure capable of providing for any negative pressure is positively claimed as elements of the invention. Therefore, references to the pipette tip do not further structurally define the claimed invention. See also remarks above.
As to claim 1, it is unclear if applicant intends for “a pipette tip” be a structural element of the invention. It is presumed that such is not an element of the invention because such is not listed on a separate intended line so as clearly indicate that the invention comprises a pipette tip having an end seated on the pipette tip seating portion. If applicant intends, for the claim to comprise such pipette tip, then the claim should clearly recite such.
Although such pipette tip is mentioned in terms of intended use, it is noted that a pipette tip alone is not capable of providing for any force, negative pressure to draw any sample nor reagent.
Claim 1 recites the limitation " the sample drawn from the sample drawing well" in the paragraph beginning with “a processing well”. There is insufficient antecedent basis for this limitation in the claim. No sample is positively claimed as noted above. No sample is previously mentioned as being located in the sample drawing well nor previously mentioned as drawn from the sample drawing well. Furthermore, it is presumed that the “and to provide a space” clause is applicable to the “configured to…” clause. It is noted that space is not structure. However, it is unclear what is structurally required by such clause because the processing well either comprises a space or it does not. The “configured to provide a space” implies that the processing well does not necessarily comprises such a space, but could possibly somehow at any instance produce, provide for such a space. If applicant intends for the processing well to comprise an interior space/chamber, then the claim should clearly recite such.
Furthermore, it is noted that the “configured to receive” clause does not provide for nor require any structural fluidic connection between the processing well and sample drawing well. There is nothing precluding one from drawing a sample from the drawing well by/into any device one desires (syringe, dropper, pipette, pump, etc.) and then directly transferring/dispensing from such device the drawn sample into the processing well as one desires. However, as previously noted the claims are directed to an apparatus not a process of use.
As to claim 1, it is unclear if the “a target analyte” recited in the paragraph beginning with “a detection well” is the same or different from the “a target analyte” recited in the preamble because the claim does not indicate such. Furthermore, it is noted that the “after reacting with the reagent” clause is directed to intended use, process steps because there is no requirement for any reacting of any unclaimed sample and reagent nor detecting to ever be performed. When applicant intends for detection to be performed does not further structurally limit the claimed apparatus. Furthermore, the detection well is not claimed as comprising any detector that is capable of providing for detection. This is not consistent with the specification because such well itself is not disclosed as being a detector, comprising a detector or any structure that can provide for detecting.
As to the last “wherein” clause of claim 1, it is presumed it is intended that a fluid-tight seal can be formed between the pipette tip seating portion and the pipette tip. If so, the claim should clearly recite such. However, as previously noted no pipette tip is positively claimed as an element of the invention, not required to ever be present nor used with the claimed invention.
Dependent claims 4, 6, 13, 19, and 23-24 are rejected via dependency upon a rejected claim.
As to claim 19, it is unclear what “upper surface” and “lower surface” of what is being referenced in the claim because the claim does not clearly recite such.
As to claim 23, it is unclear what is the structural nexus, connectivity of the body part to prior positively claimed sample flowing channel, processing well, and detection well because the claim does not provide for such.
Furthermore, It is unclear if it is intended for the bottom surface of the sample receiving well to comprise an opening because the claim does not provide for such. Instead, the claim recites “a lower surface of the body part is structured to open a portion of the bottom surface of the sample receiving well”. This is directed to what is possible, what can possible be done not what is actually required to be present. The phrase does not require the bottom surface of the sample receiving well to be open, comprise an opening.
Claim 23 recites the limitation "the opened portion of the lower surface of the body part" in the last 2 lines. There is insufficient antecedent basis for this limitation in the claim. The lower surface of the body part is not previously claimed as comprising an open portion. However, it is noted that there is no structural distinction between “the opened portion of the lower surface of the body part” and “the outlet positioned at positioned at a lower portion” because such outlet is also “an open portion of the lower surface of the body part” because the sample receiving well is an element of the body part a lower portion of the sample receiving well is also a lower portion of the body part. Therefore, it is unclear which/what open lower portion of the body part is being referenced in the last paragraph of the claim.
Furthermore, it is unclear what is the structurally meant, required by the phrase “to fluid-tight seal” because it is unclear what the phrase is intended to be directed to, what is required to be fluid-tightly sealed with what because the claim does not clearly recite such.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4, 6, 13, 19, and 23-24 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The examiner fails to locate any description of a defection well configured to detect whether a target analyte is present as provided for in claim 1. It is noted that while the specification discloses structures that capable of sensing/detecting an analyte in a well, the specification does not disclose that a detection well, itself is capable of detecting an analyte as now recited in claim 1. The examiner also fails to locate any description of “a fluid tight seal” as recited in claims 1 and 23, respectively and a lower surface of the body part is structured to open a portion of the bottom surface of the sample receiving well and a portion of and the sample flowing channel as now recited in claim 23. Therefore, the claims are directed to new matter. If applicant disagrees, it is hereby requested that applicant provide for the specific text of the originally filed specification that describes each of the recitations.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1, 4, 6, and 13 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Moulton, US 6,063,282.
Moulton discloses a device well plate 14 (body) comprising a plurality of (384)3 wells 32 (parts) and number of which can be a pretreatment area and detection area. (Figures 1-2). Any well can be considered as sample containing part/well, a sample drawing part/well having a filter member 48, furthermore any of the further wells can be considered as buffer wells, a reagent well, processing well, and detection well. The device further includes a flow channel (under the wells 32) that fluidically connects the wells to each other. (Figure 1). The wells includes a pipette tip support part, downward sloping surface (conical shape) towards a pipette tip support hole (that is an outlet of the channel) (Figure 1).
The flow channel is connected to a lower part, to holes of all of the wells (parts) 32.
As to claim 13, the filter is spaced away from surfaces such as surfaces of bottom 12 and form bottom parts of wall 46 by a distance.
The wells are separated by walls 30, 42.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Moulton, US 6,063,282 as applied above, and further in view of Root; David et al., US 4,948,564 A.
Moulton does not disclose that the sample receiving well comprises a spacer; the filter membrane supported on the spacer.
Root discloses a well device including a filer in a well provided on a spacer (Figures 4 and 6-8; and descriptions).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device Moulton by including a spacer on which the filter is located so as to provide support/reinforce the filter as taught by Root.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
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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/BRIAN R GORDON/Primary Examiner, Art Unit 1798