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 June 30, 2026 have been fully considered but they are not persuasive.
` As to the terms/phrases “positioned above”, “positioned below”, and “facing”, such do not provide for any structural connectivity of the hydrophobic layer, top layer, and bottom layer. The phrases/terms only provide for general relative locations. According to the claim, although the structures are not capable of floating in air relative to each other. The terms/phrases allow for the top layer to be “positioned above” at any unspecified distance from the hydrophobic layer and the same is applicable to the bottom layer “positioned below” the hydrophobic layer. There is no requirement for a lower surface of top layer to be on a top surface of the hodographic layer, and a bottom surface of the hydrophobic layer to be on a top surface of the bottom layer. Three layers not required to be structural connected to define a single apparatus. This is clearly evidenced by claim 3. However, even claim 3 does not require all of the 3 layers to be “adhered” to each other (bottom surface of the top layer adhered to top surface of the hydrophobic layer, and bottom surface of the hydrophobic layer adhered to the top surface of the bottom layer. A list of structures (parts) not claimed as being structurally connected is just a list of parts. If applicant intends to define a single apparatus, then the structural connectivity of such structural elements that define such single apparatus should be clearly provided for in the claim.
As to the term “facing” see remarks above. Applicant states:
“Applicant further submits that the term "facing" is clear. The Examiner asserts that
'facing' does not specify which surfaces of the respective layers are meant (Office Action (OA)7). Applicant respectfully disagrees. In a layered laminate device of the type disclosed herein, each layer has two primary planar faces - an outer face and an inner face directed toward the adjacent layer. The surface 'facing the hydrophobic layer' is unambiguously the inner face of the top layer that is in direct contact with or immediately adjacent to the hydrophobic layer. This meaning is confirmed by the specification, which states: 'the surface of the top layer that faces the hydrophobic layer comprises a material or is coated with a hydrophilic material' (Specification, [0065]), and: 'the surface of the bottom layer that faces the hydrophobic layer comprises a material or is coated with a hydrophilic material' (Specification, [0068]).
One of ordinary skill in the art reading the claims in light of Figs 1-3 would understand with reasonable certainty which surface is meant. Applicant therefore respectfully requests withdrawal of this objection.”
The examiner disagrees. The arguments are not commensurate in scope with the claims. Claim is not directed to a “laminated” device (no requirement for any layer to be “laminated”. Furthermore, there is no requirement for each layer to comprise “two primary planar faces” as asserted by applicant. There is no mention of “inner face” of the top layer nor any other layer that is in “direct contact with” or “immediately adjacent to” (such phrase also does not require any structural connectivity of any layers) the hydrophobic layer. Furthermore, there is no mention of any coating in claim 1. No hydrophilic coating is listed, claimed as being on any surface of the hydrophobic layer comprising or being coated with a hydrophilic material as stated by applicant. The examiner maintains that previously stated above….reciting that objects are facing each other does not require any structural connectivity. For example, a wall of building, house, etc. that faces and or is labeled as being “immediately adjacent to” (that phrase does not provide for any structural connectivity, nor definitive structural nexus the phrase is subjective/relative) a wall of another building, house does not require the two buildings, houses to be structurally connected. The buildings, houses (or any other structures) described as such could be any unspecified distances apart and still be subjectively considered as “facing” and “immediately adjacent to one another”. If applicant intends for the layers to be connected, adhered, a bottom surface of a layer in direct contact with a top surface of another layer as argued, then the claim should clearly recite such. Otherwise as presently drafted, there is no structurally connectivity claimed/required to exist in claim 1.
The amended claims provide for additional 112 issues and applicant has not addressed each of the prior 112 rejections. See rejections herein.
Applicant asserts that the amendments of claim 1 are supported within paragraph [0039] (presumptively of the original filed specification) . The examiner disagrees. Paragraph [0039] states:
[0039] In one embodiment, the present disclosure relates to an apparatus for processing fluid samples such as blood samples or blood products. In some aspects, the apparatus comprises: (1) a hydrophobic layer comprising at least one microchannel having a first and a second end which defines a path for capillary fluid flow; and (2) a top layer that flanks or is positioned above the hydrophobic layer. In some aspects, the surface of the top layer facing the hydrophobic layer comprises a hydrophilic material. In other aspects, the apparatus can optionally further comprise a bottom layer that flanks or is positioned below the hydrophobic layer. When the bottom layer is present, the surface of the bottom layer facing the hydrophobic layer comprises a hydrophilic material. In yet further aspects, the top layer comprises a sample inlet. In still further aspects, the sample inlet comprises a separation membrane. In some aspects, the hydrophobic layer and optionally, the bottom layer, comprise an opening below the sample inlet. In yet further aspects, the opening in the hydrophobic layer is connected to the first end of the microchannel.
There is no description of the bottom surface comprising 2 surfaces, a first surface on a second surface as now claimed... “wherein the bottom layer further comprises a hydrophilic surface on the surface facing the hydrophobic layer”. And there is no prior basis for the bottom surface comprising “the surface facing the hydrophobic layer (note: not required to face any specific surface of the hydrophobic layer). Just because the bottom layer is described as comprising a hydrophilic material does mean that such is a further surface of the bottom layer on a surface of the bottom layer and does not preclude such hydrophilic material from being mixed with other materials (composition), contained within (interior), a location of the bottom layer other that any surface of the bottom layer.
The claim is not consistent with the referenced paragraph [0039]. Therefore, this is considered as new matter.
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.
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 apparatus device/apparatus claims mention a broad, unspecified “fluid sample”, “blood”, and “blood products” (not defined in the claim). However, none of the prior are positively claimed as an elements of the device/apparatus. Such are materials or articles intended to be used with, worked upon by the device/apparatus. However, there is no requirement for any fluid sample, blood, and blood product “processing” (not defined in the claims) nor any fluid flow to ever be performed.
Claim 1 is directed to an apparatus not a process of use. Process steps are not structures nor structural limitations. The apparatus is defined by three layers, a hydrophobic layer, a top layer “positioned above” the hydrophobic layer, and a bottom layer positioned “below” hydrophobic layer. There is no requirement for the apparatus be used with to perform and fluid sample processing. The fluid sample is not a structural element of the apparatus. An owner, purchaser, possessor, etc. of the apparatus is not required to used that device for anything to perform any fluid processing nor anything else that may be as intended by applicant. One can use the apparatus, if at all as desired.
It is noted that the phrase at least one, only requires one.
It is noted that the term “end” has not been structurally defined in the claim by any specific structure, nor structural boundaries, dimensions. Over a hallway point, or prior to halfway point (relative to a direction) of a structure can be considered as an “end”.
It is noted that the term “or” and “optionally” (as for example in claim 13) are directed to alternative options not requirements.
It is noted that the term “inlet” is not required to be any specific structure. The term is more so directed to intended use. A hole, orifice, opening, etc. can be an “inlet” and is not precluded from being used as an outlet.
In claim 16, it is noted that the mesh and film are not required to be elements of the sample inlet nor any other previously positively claimed structural element. (see also remarks directed to “above” and “below”.
Claim Rejections - 35 USC § 112
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 and 3-26 are 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 amendment of claim 1 is directed to new matter as noted above. See Response to Arguments.
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 3-26 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.
As to claim 1, it is unclear how the “top” layer is considered as a top layer because such layer is not required to be on top of anything nor a top of nor in contact with any other layer. (also applicable to further dependent claims 3, 7-9, 11-12, and 20). The phrases “positioned above” and “positioned below” as employed throughout the claims does not provide for nor require any structural connection, but is directe0d to a relative, broad general location. Therefore, it is unclear what is the structural connectivity of the hydrophobic layer, top layer, and bottom layer. See Response to Arguments.
Furthermore, it is noted that the term “facing” as employed throughout the claims does not provide for nor require any structural connection, but is also directed to general, relative location. See Response to Arguments.
Although, not positively claimed as elements of the invention, it is noted that the claim does not provide for what is considered as blood “products”.
Claim 1 recites the limitation " the bottom layer further comprises a hydrophilic surface on the surface facing the hydrophobic layer" in the last paragraph. There is insufficient antecedent basis for this limitation in the claim. There is no prior recitation that bottom layer comprises a surface facing the hydrophobic layer. Only the top layer has been previously recited as comprising a surface “facing” (see above remarks) the hydrophobic layer (not a specified surface of the hydrophobic layer).
Dependent claims 3-26 are rejected via dependency upon a rejected claim.
As to claims 3, 7-9, 13, and 20, it is unclear how the “bottom” layer is considered as a bottom layer because such layer is not required to be on bottom of anything nor be a bottom of anything.
As to claim 3, it is unclear what the phrase “each other” references because the claim does not specify such. It is presumed that all of the top, hydrophobic, and bottom layers (all layers are adhered to each other). If so, the claim should clearly recite such. Although the claim appears to be directed to alternatives as indicated by the term “or”, there is no description of an apparatus comprising only two of the layers being structurally connecting while one of the layers is not required to be structurally connected to any of the other two layers. As noted above, structures that are not required to be structurally connected do not define a single apparatus. There is no requirement for all of the layers to be adhered to each other in a specific arrangement (for example, a bottom surface of the top layer is adhered to a top surface of the hydrophobic layer and a bottom surface of the hydrophobic layer is adhered to a top surface of the bottom layer).
As to claim 18, it is unclear what is the structural nexus/connectivity of the agglutinating agent to prior positively claimed elements of claim 1 because the claim does not provide for such.
Claim 20 recites the limitation “the separation membrane”. There is insufficient antecedent basis for this limitation in the claim.
As to claims 21 and 22, it is unclear what is structurally required to be considered as “a sample application area” because such is not defined in the claims as being any specific structure nor by any definitive structural boundaries, dimensions so as to determine where such “area” begins and ends to distinguish such from any other structures/”areas”. The “configured to” clause is directed to intended use relative to an unclaimed sample. It is noted that any location where one can chose to place “a sample” is a sample application area. There is no requirement for any sample to be “received” anywhere nor for any unspecified, undefined processing to be performed to/on the unclaimed sample.
The further clause “for downstream analyte detection” does not provide for any further structure nor structural connections. The phrase “in fluid communication” also does not require any connectivity. Fluid can be communicated between structures without the structures being structurally connected.
Claim 25 recites the limitation "the sample inlet in the top layer". There is insufficient antecedent basis for this limitation in the claim. There is no prior mention of a first layer comprising a sample inlet.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Zanzucchi; Peter John et al. and Oberhardt; Bruce disclose multilayered devices.
THIS ACTION IS MADE FINAL. 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
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