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 .
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.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the plurality (minimally 2) pores (claim 4) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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 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]inclusion 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.
The claims are directed to a chip, an apparatus, defined by the positively claimed structural elements listed in the claims. Although the claims mention a specimen (to be dispensed), it is noted that the specimen is not positively claimed as an element of the invention (not required to be present). The specimen is a material or article intended to be, can be used with, worked upon by the chip. What is intended “to be” done does not provide for any further structure of the apparatus. There is no requirement for any dispensing of any specimen to occur, nor any other method steps, actions to occur. There is no requirement for the claimed apparatus to be used in any method at all including with any specimen as may be intended by applicant.
It is noted that the last 3 paragraphs of the claim do not provide for any further structural elements of the chip. Such are directed to intended, conditional use (as indicated by the “when” clauses) relative to the unclaimed, unspecified specimen. There is no requirement for any dispensing, permeation, flowing of any specimen (nor anything else) from, to , in, or through any positively claimed structural element at any velocity during any period (of time) to satisfy V1 greater than V2 to ever be performed. There is no requirement for anything to be done, performed before or after anything. The same is applicable to further intended use, conditional process steps recited throughout the dependent claims, as recited in the “when” clauses.
The recited variables that are intended to “represent” velocities, electrodes, angles, etc. are not structures and are not structural elements of the apparatus. Therefore, any mathematical relationships of such possible values of the variables (resulting from possible, intended uses) of such are also not structures.
The claims in general are replete with language directed to intended use relative to the unclaimed specimen and conditional usage relative to an unclaimed, unspecified specimen that do not provide for any further structure of the claimed apparatus.
It is noted that the terms “reference” and “working” (chose/elected names) do not provide for any further structure of the respective electrodes.
The term “has” such as in the phrase “the first chamber has a reference electrode” is interpreted as “comprising”.
It is noted that the term “plurality” only requires 2.
Claim Objections
Applicant is advised that should claim 4 be found allowable, claim 5 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
There is no structural difference (of the chip being defined) between claims 4 and 5. The difference in the claims is that the claims provide for different results, what is intended to occur based upon conditional process/method steps relative to an unclaimed, unspecified specimen.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-2 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 18/618,542 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application provide for the same structural elements of the instant claims.
For example, claim 1 of the co-pending application provides for:
A microanalysis chip comprising a porous substrate having provided therein a channel wall, the channel wall defining:
a dispensing section to which a specimen is to be dispensed;
a first channel chamber;
a second channel chamber;
a first channel connecting the dispensing section and the first channel chamber to each other; and
a second channel connecting the dispensing section and the second channel chamber to each other,
wherein the first channel chamber has a reference electrode arranged therein, the reference electrode having a surface on which an ion crystal having specimen solubility is arranged,
wherein the second channel chamber has a working electrode arranged therein.
5. The microanalysis chip according to claim 1, wherein the porous substrate has permeation anisotropy, wherein, when the specimen is dispensed to the porous substrate in which the channel wall is not formed, a permeation shape formed on a surface of the porous substrate by the dispensed specimen is an ellipse.
Therefore, the apparatus claims of the patent disclose the same structural elements as provided for in the instant claims. The claims differ in recited conditional use as indicated by the respective “when” clauses.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 5 of copending Application No. 18/920,335 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the copending application provide for the same structural elements of the instant claims.
For example, claim 1 of the co-pending application provides for:
1. A microanalytical chip made up of a first porous substrate and a second porous substrate laminated on each other, wherein
a first channel chamber, a second channel chamber, and a first channel connecting the first channel chamber with the second channel chamber are formed by a channel wall in the first porous substrate,
a reference electrode is disposed in the first channel chamber,
a working electrode is disposed in the second channel chamber, and
the second porous substrate is disposed so as to overlap at least part of a region, where the working electrode is formed, on a surface of the first porous substrate.
5. The microanalytical chip according to claim 1, further comprising an ionic crystal having a sample solubility, the ionic crystal being disposed on a surface of the reference electrode.
It is noted that a portion of the channel wall can be considered as a “dispensing section”. Therefore, the apparatus claims of the patent disclose the same structural elements as provided for in the instant claims. The claims differ in recited conditional use as indicated by the “when” clause of instant claim.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-5 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 apparatus can comprise a channel wall without requiring a channel. While a channel can comprise a channel wall, it is confusing as to how a channel wall (wall of a channel) comprises chambers and channels as provided for in the claim. In view of the drawings, it appears as if it is the substrate 1 that comprises channels (3, 4 , that comprise channel walls.
As to claim 1, it is unclear what is structurally required to be, define “a dispensing section” of a channel wall because such is not clearly defined in the claims as being any specific structure nor by and definitive structural dimensions, boundaries so as to distinguish such section of the channel wall from any other section, area, region, portion, location, etc. of the wall. One can choose to dispense a broad, unspecified “specimen” to any location of the channel wall that one desires. The chip is not claimed as comprising any structure capable of dispensing any specimen to “a dispensing section” of the channel wall and the “dispensing section” (of the channel wall) is not defined in the claim as comprising any structure that provide for any “dispensing”.
As to claim 1, it is unclear what the pronoun “therein” references. It is suggested that the claim/term be amended to provide the specific structure that such is intended to reference.
As to claim 1, it is unclear what is required, meant by the phrase “ion crystal having specimen solubility” because the phrase does not provide for any value of solubility of the ion crystal. Nor any reference as to what the solubility is based upon, in reference to the ion crystal being able to be dissolved in what liquid. Furthermore, it is unclear what specimen is being referenced in the claim and what is the solubility of such specimen because the claim does not provide for such. One can assert that the ion crystal is a specimen and as such it has specimen solubility.
As to claim 1, it is unclear what is further structurally required by the last 3 paragraphs of the claim because the phrase “wherein the micro-analysis chip is configured so that…” clause is directed to the entire invention/apparatus being defined in the claim, “a micro-analysis chip” (not any prior positively claimed structural element that structurally define the chip) can possibly, is intended to do relative to an unclaimed, unspecified specimen. See Claim Interpretations above. Not only is a specimen not claimed, but the chip is also not claimed as comprising any structure that can provide for any motive force to provide for any flowing, moving of any specimen (nor anything else) at any specific velocity to and/or from and further structural element of the chip.
Furthermore, it is unclear how a channel wall of a porous substrate is considered as “forming” chambers and channels as recited in the claim is considered as being “micro-analysis chip” because the substrate is not currently performing a process of “forming” anything. Furthermore, the chip is claimed as comprising any structural element that can provide for any “analysis” of anything.
As to claim 1, although the “when” clause does not provide for any further structural elements of the apparatus, it is unclear what is structurally meant by the phrase “when an average areal velocity which is an area of a region that the specimen has permeated per unit time in a surface of the porous substrate during a period until the dispensed specimen reaches the reference electrode is represented by V1” because of reasons stated above.
Furthermore, “an average areal velocity” (of what?) is not structure nor defined as being any velocity of anything, produced, generated, by any positively claimed structural element. It is unclear how “an average areal velocity” can be defined as being structure (velocity is known to be defined as a measurement of speed in a certain direction of motion…change in position/distance travel per unit of time), what is structurally required for “an average areal velocity” to be considered as being “an area of a region” (of what? Structure?). The phrase “an average areal velocity” appears to contradict the know meaning of the term “velocity”. It is further noted that the terms “area” and “region” are considered as being the same as “section”. All of such are synonyms and are relatively broad and are not clearly structurally defined in the claims. See prior rejection directed to the term “section” above.
Claim 1 recites the limitation "the dispensed specimen" in the paragraph beginning with “wherein the micro-analysis chip is…”. There is insufficient antecedent basis for this limitation in the claim. No such specimen has been required to be dispensed. Nor is there any requirement for any specimen to reach any electrode. See Claim Interpretations.
Dependent claims 2-5 are rejected via dependency upon a rejected claim.
As to claims 2 and 4, it is unclear what is structurally meant, required by “the porous substrate has permeation anisotropy” because the claims do not clearly recite such. There is no requirement for any permeation of anything to occur to relative to the substrate nor any element of the substrate. See also prior rejections/remarks above.
As to claim 2, although no specimen is required to be dispensing anywhere (to any location, structure of the chip, channel wall), it is unclear what structurally constitutes, is considered as “the porous substrate in which the channel wall is not formed” because the chip as claimed is only defined by a channel wall. Therefore, it is unclear what is “the porous substrate in which the channel wall is not formed”. The claim is unclear and confusing.
Furthermore, it is noted that “a permeation shape” presumptively of the porous substate is not a structural element (a shape is not structure, nor is such a recognized geometrical shape) nor is a shape (ellipse, which is a 2 dimensional shape, no specified cross section) of the specimen; and directions (regardless of names of such….”major axis direction” of the ellipse; “fiber direction of the porous substrate…”; moving direction of the specimen; and other such directions) are not structural elements of the apparatus. As noted above, no specimen is claimed as an element of the apparatus nor required to be moved in any direction. Furthermore, the porous substrate is not claimed as comprising any fibers.
The term “permeation shape” in claims 2 and 4-5 is a relative term which renders the claim indefinite. The term “permeation shape” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As noted above, a permeation shape is not structure, and such is not a definitive recognized/known geometrical shape. It is unclear what is intended to have such a shape. It is noted that the claims are contingent upon conditions as indicted by the “when” clauses. However, what be considered as “a permeation shape” to one person my not be considered as such to another and vice versa.
Furthermore, what applicant choses to “regard” (label, name, rename, etc.) anything as does not provide for any further structure of the apparatus. One can choose to “regard” anything as one so desires. (See also claim 3). Referring to, regarding as the broad structurally undefined “dispensing section as an upstream and downstream region” does not further structurally define such section. Furthermore, there is no requirement for any stream of anything to flow relative to any of the positively claimed elements to clearly indicate what is structurally considered as “upstream” and “downstream”. It is noted that because each of such downstream and upstream regions are not clearly structurally defined in the claims that is unclear what each of such regions begins and ends. (claim 3).
As to claim 3, it is unclear what is further structurally required by the claim because the claim recites “a channel in the first channel chamber”. The examiner fails to locate in the specification any description of the first channel chamber 1 comprising a channel. Furthermore, it is unclear what is the structural nexus, connectivity of the “a channel in the first channel” to the prior first and second channels (3, 4) of claim 1 because the claim does provide for such. It is hereby requested that applicant provide for the specific text that describes the first channel chamber as comprising a channel.
Furthermore, it is unclear what is structurally required to be considered as two regions of the of the dispensing section because as previously stated above such dispensing section is not clearly structurally defined and neither are such “two regions” of the dispensing section and further downstream and upstream “regions”.
Furthermore, it is unclear what/which regions are being reference by the phrase “the regions” because the claim does not clearly provide for such. It is noted that the claim previously recites a number “regions” and claim 1 also mentions a region. Therefore, it is unclear which what regions are being referenced by the phrase “the regions”.
Furthermore, it is unclear what is structurally considered as “a sectional area” and what “sectional area” of what is being referenced because the claim does not clearly state such. Any location, region, area, of anything can be subjectively named/referenced as a sectional area of a region and have dimensions (not specified in the claim) that would meet that as recited in the claim.
It is noted that the claim attempts to define such relative to “a moving direction of the specimen”. However, no specimen is positively claimed as an element of the chip, and the specimen is not required to be moved in any direction relative to any of the positively claimed structural elements of the chip. It is presumed that the phrase is intended to refer to a specific cross-sectional area of something. However, the claim does not clearly recite such. Therefore, it is unclear what is further structurally meant, required by the phrase and the claim as a whole. See also prior remarks/rejections directed to “when” clauses recited throughout the claims.
As to claim 4, see prior applicable rejections above. Furthermore, it is unclear what is structurally meant, required by the phrase
It is further unclear what is the structural nexus/connectivity of the plurality of the pores to the prior positively claimed structural elements of claim 1 because the claim does not clearly recite such.
Furthermore, it is unclear what is structurally required by the phrase “when the specimen is dispensed exhibits a non-isotropic ellipse shape for which a major axis and a minor axis are definable” because no specimen is claimed, required to be dispensed from anywhere to anywhere. As well as the term “exhibits” is unclear as such appears to be directed to what is/can be done “when” the specimen is dispensed, which is a conditional process step that is never required to occur.
Furthermore, it is noted that no “major axis” and “minor axis” are not structures. However, the phrase “are definable” does not provide for any further structures. Any “axes” can be “defined” relative to anything one chooses. Also applicable to claim 5.
Furthermore, it is unclear what is required, meant by the phrase “the porous substrate in a channel….” Because it is unclear if such “a channel” is an element of the invention and what is the structural nexus/connectivity of “a channel” to prior recited channels and other channel.
It is noted that claim 5 employs the same or similar language as claim 4. There is no structural difference in the claims. The difference in the claims is that of the conditional “when” clauses which do not provide for any structural elements of the claims. What is intended to occur, be exhibited relative “when” if an unclaimed specimen is used with the chip is/are not structural elements of the chip. See Claim Interpretations and prior applicable rejections above. No unclaimed, unspecified specimen is every required to be used with the chip and furthermore, there is no guarantee that each and every “specimen” that one may elect to use with the chip will provide for the results recited in the claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. MAEDA; HARUNOBU et al.; IKAMI; YASUKAZU et al.; MAEDA; HARUNOBU et al.; Berduque; Alfonso et al.; ABE; KATSUICHI et al.; ENOKIDO; FUKA et al.; MASTERS; Liam et al.; Wu; Dan et al.; KOJIMA; Junko et al.; SHIN; Se-Hyun et al.; deSa; Johann et al.; Harper; Jason C. et al.; Reymond; Frederic et al.; and Wohlstadter; Jacob N. et al. disclose devices comprising electrodes.
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..
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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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