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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Acknowledgment is made that this application is a continuation of parent application 17498132 (USPN 11534751).
US National Stage of PCT
Acknowledgment is made that this application is the US national phase of international application PCT/GB2021/053376 filed 12/20/2021 which designated the U.S. and claims the benefit of GB2020375.8, filed 12/22/2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
While it is not necessary for the applicant to submit an information disclosure statement that lists the prior art cited by the examiner in the parent application for the continuing application claiming the benefit under 35 U.S.C. 120 to said parent application (other than an international application that designated the U.S.), the information will not be printed on the patent issuing from the continuing application unless cited by the Applicant on an IDS or by the Examiner for the present application. See MPEP § 609.02. While the Examiner has reviewed the references of the parent application(s), the Examiner has not verified that all of the references listed in the parent application(s) appear on the present IDS.
The information disclosure statement(s) (IDS) submitted on 06/20/2023 is/are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “361” has been used to designate both “channel” (appears appropriate) and “upper disc” (Examiner suggests correcting instance in specification). See also PCT Rule 11.13(m).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “402” has been used to designate both “disc” (appears appropriate) and “inlet well” (Examiner suggests correcting instance in specification to 402b). See also PCT Rule 11.13(m).
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5), and correspondingly for PCT 11.13(l), because they include the following reference character(s) not mentioned in the description: “14a” (fig. 91).
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.
Specification
Related to the drawing objection(s) above, the specification is likewise objected to for the inconsistent referencing.
Claim Interpretation
The Examiner acknowledges the definition(s) of “wafer” as a “sample carrier” in/on Field of the Invention of the originally filed specification. MPEP § 2111 states that “the specification must provide a clear and intentional use of a special definition for the claim term to be treated as having a special definition”. Where Applicant’s definitions are optional or non-limiting (e.g., “may or may not”) the definitions (or portions thereof) are not considered special definitions and claim terms referencing such definitions will instead be considered under the broadest reasonable interpretation in view of the specification.
If Applicant wishes to provide further explanation or dispute the Examiner’s interpretation of the definitions or to identify missed definitions, Applicant should clearly identify the special definitions and corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action. Examples should be clearly delineated from required features.
Double Patenting
Instant Claim(s) 1, 15-16, 20, 25, 29, and 32 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over reference patented claim(s) 2 of U.S. Patent No. 11534751.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the reasons put forth in the table below:
One-Way Double Patenting Analysis Table
18/268,524
(instant)
11534751 (reference)
Obviousness Analysis of instant claim over reference claim
1
2
A wafer for carrying a biological sample (1 “A wafer for carrying a biological sample”), the wafer comprising: a pair of plates or circular discs (1 “a pair of circular discs”), wherein at least one of the plates or circular discs is transparent (1 “wherein at least one of the discs is transparent”); and a gap between the plates or circular discs adapted to receive a biological sample (1 “and a gap between the discs adapted to receive a biological sample”), wherein the gap is sized to pull a biological sample into the gap by capillary action (2 “wherein the gap is sized to pull a biological sample into the gap by capillary action”).
Indistinctly recites the claimed limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
15
2
The wafer of claim 1, further comprising an inlet into the gap (1 “an inlet into the gap”).
Indistinctly recites the claimed limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
16
2
The wafer of claim 15, wherein the inlet extends to an edge of the wafer (1 “wherein one of the discs has an opening which provides an inlet into the gap, and the opening comprises a recess, notch or channel in an edge of the one of the discs at an outer circumference of the wafer”).
Indistinctly recites the claimed limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
20
2
The wafer of claim 1, wherein the gap comprises a sample chamber (1 “A wafer for carrying a biological sample” and “a gap between the discs adapted to receive a biological sample”).
Examiner acknowledges that the patented claimed invention does not call the gap which receives and carries the biological sample a sample chamber, however, an ordinary artisan would broadly and reasonably interpret the patented claim invention as a reasonable and definitionally equivalent to sample chamber, and therefore indistinctly recites the claimed limitations, differences being merely nominal nomenclatural differences or grammatical variations not amounting to patentable distinction.
25
2
The wafer of claim 1, further comprising one or more spacers between the discs or plates (1 “one or more spacers between the discs”).
29
2
The wafer of claim 25, wherein the one or more spacers control a size of the gap (1 “one or more spacers between the discs; and a gap between the discs”).
Examiner acknowledges that the reference claim does not explicitly state that the spacers control a size of the gap, however, an ordinary artisan would at once envisaged that the space of the gap is defined by the spacers and/or it would have been obvious to one of ordinary skill in the art before the effective filing date of the patented claimed invention to commonsensically and conventionally space the gap by the size of the spacers. The Examiner notes that the prior art of record provides factual evidence of the ordinary skill thereof.
32
2
The wafer of claim 1, wherein a size of the gap is less than 20μm (2 “wherein the gap is sized to pull a biological sample into the gap by capillary action”).
Examiner acknowledges that the reference claim does not explicitly state that the gap is less than 20μm, however, an ordinary artisan would at once envisaged that a gap of capillary size would overlap in scope with gaps of less than 20μm, and/or it would have been obvious to one of ordinary skill in the art before the effective filing date of the patented claimed invention to commonsensically include this claimed range for the expected advantages of reducing size, material costs, and/or providing the desired capillary force based on such factors as the type of sample. The Examiner notes that the prior art of record provides factual evidence of the ordinary skill thereof.
The Double Patenting Rejections will not be held in abeyance. See MPEP § 804 & 714.02.
Claim Objections
Claim(s) 19, 21, 25-28, 29, 53, and 55-57 is/are objected to because of the following informalities:
As to claim 21,
the Examiner objects to the use of the possessive pronoun “its” in the claim, noting in particular that while the antecedent basis of the pronoun is present, the use of a pronoun is ambiguous as to which element the pronoun is being substituted for. In all cases, “it” is presumed to be substituted for the immediately preceding noun in the limitation. The Examiner suggests explicit recitations.
As to claims 19, 25, 53, 55, 56, 57,
the Examiner objects to the inconsistency and shorthand in claim element nomenclature, noting that in independent claim 1, Applicant introduces “a pair of plates or circular discs”, whereas in claim 19 Applicant only uses “the discs” (lacks circular) , whereas in claim 25 Applicant references “the discs or plates” (lacks circular; preferably, but not required, the original ordering would be retained as well), whereas in claim 53 Applicant references “the discs or plates” (lacks circular; preferably, but not required, the original ordering would be retained as well) and “the discs” (lacks circular”), whereas in claim 56 Applicant references “the discs or plates” (lacks circular; preferably, but not required, the original ordering would be retained as well), and whereas in claim 57 Applicant references “the discs or plates” (lacks circular; preferably, but not required, the original ordering would be retained as well). Even more preferably, but not required, the Examiner suggests that Applicant reference to the “pair of plates or circular disks”. See related indefinite rejections pertaining to aggravated inconsistency in nomenclature leading to multiple possible interpretations.
Dependent claim(s) of objected to claim(s) is/are likewise objected to.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
MPEP § 2173.02(I) states in part: “if the language of a claim, given its broadest reasonable interpretation, is such that a person of ordinary skill in the relevant art would read it with more than one reasonable interpretation, then a rejection under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph is appropriate”.
Claim(s) 19, 53, and 55-57 is/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 19,
Applicant claimed in preceding independent claim 1, from which claim 19 ultimately depends, “a pair of plates or circular discs”, whereas in claim 19, Applicant claims “wherein an inner face of a lower one of the discs provides a ledge adjacent to the inlet”, leaving it unclear if the claim should be interpreted as requiring the plates or circular discs be narrowed to only circular discs, or if the wherein limitation only applies to the alternative situation of discs (i.e., that the wherein limitation doesn’t apply for plates). For the purpose of compact examination, the Examiner has examined the narrower claim interpretation. Applicant clarification of intended claim interpretation and appropriate correction is respectfully requested.
Regarding claim 53,
Applicant claimed “the discs or plates” and then references “the gap between the discs”. Similar to the preceding analysis of multiple interpretations, it is unclear if only the alternative of the discs requires the gap or the gap is between the discs or plates. For the purpose of examination, the Examiner assumes based on disclosure that the gap would be present regardless of whether discs or plates were brought together.
Regarding claim 55,
Applicant claimed in claim 53, from which claim 55 depends, “the discs or plates”, whereas Applicant claims in claim 55 “the wafer comprising an upper disc or plate, and a lower disc or plates”. Similar to the preceding analysis of multiple interpretations, it is unclear if these discs/plates are distinct elements from or are comprised by the discs or plates of claim 53, and it is further unclear if subsequent “the discs or plates” references back to the original “discs or plates” or to the newly introduced upper/lower discs/plates. For the purpose of examination, the Examiner assumes based on the disclosure “wherein the discs or plates comprise an upper disc or plate, and a lower disc or plate”.
Dependent claim(s) of rejected claim(s) is/are likewise rejected.
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, 15-16, 20-21, and 53 is/are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by newly cited Gunnerson et al (US 20140275866 A1; hereafter “Gunnerson”).
Regarding independent claim 1,
Gunnerson teaches (best shown in figs. 1) a wafer (figs. 1, sample collection device 10) for carrying a biological sample (Title “ROTATABLE DISK-SHAPED FLUID SAMPLE COLLECTION DEVICE”; Abstract; [0002] “biological samples”), the wafer (figs. 1, sample collection device 10) comprising:
a pair of plates or circular discs (figs. 1 top piece 15A and bottom piece 15B) ([0032] “substantially disk-shaped"), wherein at least one of the plates or circular discs (figs. 1 top piece 15A and bottom piece 15B) is transparent ([0032] “sample collection device can be made from any suitable material, such as a plastics material, such as polymethyl methacrylate (other plastic materials can include polystyrene, polyethylene, cyclic olefins, acrylics, or moldable polyesters), and is preferably formed by molding such as injection molding. Other possible materials include glass, metal, ceramic, etc. In a preferred embodiment, the device is at least partially transparent for the flow of the fluid in the capillary channel can be observed”; Examiner exemplary notes materials such as glass as the transparent material to form the plates/discs of sample collection device); and
a gap (figs. 1, capillary channel 11 with sample collection well 14) between the plates or circular discs (figs. 1 top piece 15A and bottom piece 15B) adapted to receive a biological sample ([0002] “biological sample”),
wherein the gap (figs. 1, capillary channel 11 with sample collection well 14) is sized to pull a biological sample ([0002] “biological sample”) into the gap (figs. 1, capillary channel 11 with sample collection well 14) by capillary action (Abstract “adapted to draw the fluid into the channel by capillary action”).
Regarding claim 15, which depends on claim 1,
Gunnerson teaches further comprising an inlet (figs. 1, end 12) into the gap (figs. 1, capillary channel 11 with sample collection well 14) ([0034] “The first end 12 of the channel is adapted to draw fluid into the capillary channel. Preferably, the first end opens on the side surface of the disk-shaped body in order to simplify sample collection from a live subject as describe in more detail below. However, in some embodiments, it may be preferable to have the first end opening onto the top or bottom surface of the disk-shaped collection device”).
Regarding claim 16, which depends on claim 15,
Gunnerson teaches wherein the inlet (figs. 1, end 12) extends to an edge (edge of sample collection device 10) of the wafer (figs. 1, sample collection device 10) ([0034 “Preferably, the first end opens on the side surface of the disk-shaped body in order to simplify sample collection from a live subject as describe in more detail below”).
Regarding claim 20, which depends on claim 1,
Gunnerson teaches wherein the gap (figs. 1, capillary channel 11 with sample collection well 14) comprises a sample chamber (figs. 1 sample collection well 14).
Regarding claim 21, which depends on claim 20,
Gunnerson teaches wherein the sample chamber (figs. 1 sample collection well 14) comprises an edge wall (edge wall of well 14) which provides a boundary of the sample chamber (figs. 1 sample collection well 14) at its outer edge (edge of well 14).
Regarding Method claim 53, which depends on Apparatus claim 1, as best understood,
Gunnerson teaches a method of manufacturing a wafer (figs. 1, sample collection device 10) according to claim 1 (see analysis of claim 1), the method comprising:
bringing the discs or plates (figs. 1 top piece 15A and bottom piece 15B) ([0032]) together to provide the gap (figs. 1, capillary channel 11 with sample collection well 14) between the discs (figs. 1 top piece 15A and bottom piece 15B); and
fixing the discs or plates (figs. 1 top piece 15A and bottom piece 15B) together ([0033] “top piece 15A is joined to the bottom piece 15B, such as by an adhesive”).
Claim Rejections - 35 USC § 103
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) 42-44 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant cited Chou et al (US 20180246089 A1; hereafter “Chou089”).
Regarding independent claim 42,
Chou089 reasonably teaches a wafer (wafer comprising first plate, second plate, spacer) for carrying a biological sample (Title; Abstract “bio/chemical sensing”; [0002] “bio/chemical sampling”), the wafer (wafer comprising first plate, second plate, spacer) comprising:
a pair of circular discs (first and second plate), wherein at least one of the discs (first and second plate) is transparent ([0416] “The shape of the plate can be rectangle, square, round”; [0122] “The term “optical transparent” refers to a material that allows a transmission of an optical signal, wherein the term “optical signal” refers to, unless specified otherwise, the optical signal that is used to probe a property of the sample, the plate, the spacers, the scale-marks, any structures used, or any combinations of thereof”’; [0490] “at least one of the plates is transparent”); and
a gap (gap formed between first and second plates via spacer) between the discs (first and second plate) adapted to receive a biological sample,
wherein a size of the gap (gap formed between first and second plates via spacer) varies in a radial direction away from a centre of the wafer (wafer comprising first plate, second plate, spacer) ([0428] “The spacer(s) is a single spacer or a plurality of spacers. (e.g. an array). Some embodiments of a plurality of spacers is an array of spacers (e.g. pillars), where the inter-spacer distance is periodic or aperiodic, or is periodic or aperiodic in certain areas of the plates, or has different distances in different areas of the plates”; [0429] “There are two kinds of the spacers: open-spacers and enclosed-spacers”; [0440] “The material for the spacers is rigid, flexible or any flexibility between the two”; [0441]; [0207] “one or both plates are flexible”; [0410] “a selection of rigid or flexible plate are determined from the requirements of controlling a uniformity of the sample thickness”; [0051] “using a proper flexible plate and a proper inter-spacer distance, the effect of a dust is isolated to a small area around dust, while in other areas, the plate spacing (hence the sample thickness) is regulated by the spacers not the dust”; the Examiner notes in particular the teachings of the flexible plate and the spacer being an enclosure results in a radial varying of size gap since there is sagging between the spacers, see cross section views in fig. 5, noting the cheaper situation of 5a which has more sagging, and the less sagging if additional centered spacer is added in 5b, and see figs. 8 & 9 for understanding of how these cross sections would correspond to enclosure spacer layout; while it is the Examiner’s position that this is at once envisaged from the teachings of the disclosure, which is written in sections on different features instead of single embodiments shown in single figures; additional obviousness analysis is provided for the particular combination).
The Examiner notes with respect to the above teachings being shown in different figures, that while the reference does not expressly show all of the above claimed features clearly in a single depicted embodiment as a single figure, either one of ordinary skill in the art would at once envisaged the
combination from the generic teachings thereof and/or specific possible choices of the structural components
thereof, or, in the alternative, it at least would have been obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to nevertheless so combine the above features for the
purpose and combinations as proposed by said reference and as analyzed by the Examiner
including the citations and/or Examiner comments provided above in reference to the claimed features.
Pertinently, the Examiner further notes that "Combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness", see Boston Scientific Scimed, Inc. v. Cordis Corp., 554 F.3d 982, 991 (Fed. Cir. 2009). More particularly, it is Examiner’s position that either the combination of features is at once envisaged without a leap of inventiveness, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before
the effective filing date of the claimed invention to combine Chou089’s flexible plate design with Chou089’s spacer ring design for the expected advantages of both as explained by Chou089 the Examiner further adding that the flexible plate design is robust against dust or other particles interfering with the wafer manufacturing/usability and/or saving material costs and the enclosing ring shape design being useful for conveniently providing an enclosing volume wherein the perimeter thereof is used to prevent samples from going outside said perimeter. With respect to Chou’s taught round shape, legal precedent has condoned the use of particular examples of what may be considered common sense or ordinary routine practice including changes in shape, see MPEP § 2141(I) & 2144.04(IV)(B), and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966), and in the present case Chou089 explicitly teaches the round shape, and it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize Chou089’s round shape with Chou’s circular enclosure for the commonsense advantages of saving material costs (as opposed to unneeded space on corners), centering of the spacer ring providing increased symmetry/weight distribution.
Regarding claim 43, which depends on claim 42,
Chou084 reasonably teaches/suggests (see analysis of independent claim) wherein the size of the gap (gap formed between first and second plates via spacer) increases in the radial direction away from the centre of the wafer (wafer comprising first plate, second plate, spacer) (Examiner emphasizes that for circular spacer having flexible plate thereon, the flexible plate will sag in the center away from the support by the circular spacer).
Regarding claim 44, which depends on claim 42,
Chou084 reasonably teaches/suggests (see analysis of independent claim) wherein the pair of circular discs (first and second plate) ([0416] “The shape of the plate can be rectangle, square, round”) comprise an upper disc (second plate) and a lower disc (first plate), and the upper disc (second plate) is sagged at the centre (Examiner emphasizes that for circular spacer having flexible plate thereon, the flexible plate will sag in the center away from the support by the circular spacer) of the wafer (wafer comprising first plate, second plate, spacer) ([0428]; [0429]; [0440]; [0441]; [0207]; [0410]; [0051]) or drooped at an edge of the upper disc.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over newly cited Gunnerson in view of newly cited Handique (US 20090047713 A1; hereafter “Handique”).
Regarding claim 19, which depends on claim 15, as best understood,
Gunnerson (broadly) reasonably teaches wherein an inner face (inner face3 of bottom piece 15B) of a lower one (figs. 1, bottom piece 15B) of the discs (figs. 1 top piece 15A and bottom piece 15B) provides a ledge (portion of 15B adjacent end 12 which opens onto the top) adjacent to the inlet (figs. 1, end 12) ([0034] “it may be preferable to have the first end opening onto the top or bottom surface of the disk-shaped collection device”).
For compact prosecution and narrower claim interpretation:
Gunnerson does not explicitly call the aforementioned portion a “ledge”.
Handique explicitly teaches wherein an inner face of a lower microfluidic substrate provides a ledge adjacent to an inlet ([0192] “The inlet holes are moved a few millimeters away from the edge of the cartridge to allow room for a 2 mm alignment ledge in the cartridge” and “The alignment ledge permits the cartridges to be stacked during storage”; Title “Microfluidic Cartridge And Method Of Making Same”; Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Handique’s explicit ledge adjacent to an inlet with Gunnerson’s inlet for the expected purposes of providing a ledge for more stable stacking and storage of Gunnerson’s wafers.
Claim(s) 32, 25-27, and 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over newly cited Gunnerson in view of newly cited Wang (US 20090211344 A1; hereafter “Wang”).
Regarding claim 32, which depends on claim 1,
Gunnerson is generally suggestive (at once so envisaged; additional obviousness analysis provided) wherein a size of the gap (figs. 1, capillary channel 11 with sample collection well 14) is less than 20 μm ([0067]; [0068] “height in the interval of about 15 to about 150 .mu.m” and “such, that lateral capillary flow of the fluid, such as plasma, preferably human plasma, in the zone is achieved”; Examiner notes that and ordinary artisan would at once so envisage a gap height of about 15 μm from the aforementioned teachings).
The Examiner acknowledges that Gunnerson does not explicitly state wherein a size of the gap is less than 20 μm.
However:
It has been held that a mere change in size is generally recognized as being within the level of ordinary skill in the art, see MPEP § 2144.04(IV)(A), In re Rose, 105 USPQ 237 (CCP A 1955), In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976), and Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to adjust the size of the capillary gap.
It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, see MPEP § 2144.05 and In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to optimize the workable capillary gap range, based on such factors as the type of biological sample, flow optimization, and/or ability to hold onto collection (or conversely ability to re-dispense/clean).
Furthermore, Wang teaches wherein a size of a gap (spacer 15 defines size of sample chamber 20 having inlet 21 between substrate plates 12 and 14) is less than 20 μm ([0039] “the thickness of the spacer may be constant throughout, and may be at least about 0.01 mm (10 .mu.m) and no greater than about 1 mm or about 0.5 mm. For example, the thickness may be between about 0.02 mm (20 .mu.m)”) (Examiner notes the overlapping range of about 10 μm to 20 μm, and that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists, see MPEP § 2144.05(I), In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976), and In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Gunnerson reasonably suggests wherein the size of the gap is less than 20 μm, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to optimize Gunnerson’s capillary gap to be less than 20 μm—as factually supported by Wang—for the expected purpose of capillary action that is optimized for biological liquids while still being a practically large enough size for engineering ease as well as still resistive to gravitational drainage and/or bubble entrapment.
Regarding claim 25 and claim 26 and claim 29, where claim 25 depends on claim 1 and where claim 26 depends on claim 25 and where claim 29 depends on claim 25,
Gunnerson teaches wherein the pair of plates or circular discs (figs. 1 top piece 15A and bottom piece 15B) are joined by an adhesive ([0033] “the top piece 15A is joined to the bottom piece 15B, such as by an adhesive”), wherein at least one of the plates or circular discs (figs. 1 top piece 15A and bottom piece 15B) has an integral one or more spacers (spacer negatively created via grooving) ([0033] “grooved”) that control a size of the gap (figs. 1, capillary channel 11 with sample collection well 14).
Gunnerson does not teach (claim 25 limitation follows) further comprising (distinct element) one or more spacers between the discs or plates, (claim 26 limitation follows) wherein the one or more spacers comprise an adhesive tape, (claim 29 limitation follows) wherein the one or more spacers control a size of the gap.
Wang teaches a wafer (fig. 1, sensor 10) for carrying a biological sample (Title “ANALYTE SENSORS AND METHODS OF USE”; Abstract “sample chamber having an inlet with a projection extending from an edge”; [0004] “The sensors have an inlet to the sample chamber that facilitates drawing of sample (e.g., blood) into the chamber”), the wafer (fig. 1, sensor 10) comprising: a pair of plates or circular discs (fig. 1, substrates 12 & 14); and a gap (fig. 1, inlet 21 with sample chamber 20) between the plates or circular discs (fig. 1, substrates 12 & 14) adapted to receive a biological sample ([0042] “The sample chamber has a volume sufficient to receive a sample of biological fluid therein”), wherein the gap (fig. 1, inlet 21 with sample chamber 20) is sized to pull a biological sample into the gap (fig. 1, inlet 21 with sample chamber 20) by capillary action ([0026] “facilitate the drawing of fluid sample (e.g., blood) into sensor strip 10 by capillary fluid flow mechanism”), (claim 25 limitation follows) further comprising one or more spacers (fig. 1, spacer(s) 15) between the discs or plates (fig. 1, substrates 12 & 14) ([0076] “Sensor strips 10, 110, 210, 210' discussed above, are sandwiched or layered constructions having substrates 12, 14, 112, 114 spaced apart, such as by spacer 15, 115”), (claim 26 limitation follows) wherein the one or more spacers (fig. 1, spacer(s) 15) comprise an adhesive tape ([0038] “the spacer is an adhesive layer or double-sided adhesive tape”), (claim 29 limitation follows) wherein the one or more spacers (fig. 1, spacer(s) 15) control a size of the gap (fig. 1, inlet 21 with sample chamber 20) ([0039] “the thickness of the spacer may be constant throughout, and may be at least about 0.01 mm (10 .mu.m) and no greater than about 1 mm or about 0.5 mm. For example, the thickness may be between about 0.02 mm (20 .mu.m)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s design having adhesive tape spacers to form a capillary channel & chamber with Gunnerson’s capillary channel & chamber, thereby eliminating the need to groove any components and therefore reducing complexity and/or leaving the plate/disc components more robust. The Examiner additionally notes with respect to distinct element spacers that it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art, see MPEP § 2144(V)(C), Nerwin v. Erlichman, 168 USPQ 177, 179 (BPAI. 1969), and In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Regarding claim 25 and claim 27 and claim 29, where claim 25 depends on claim 1 and where claim 27 depends on claim 25 and where claim 29 depends on claim 25,
Gunnerson teaches wherein at least one of the plates or circular discs (figs. 1 top piece 15A and bottom piece 15B) has an integral one or more spacers (spacer negatively created via grooving) ([0033] “grooved”) that comprise an opening which provides an inlet to and further control a size of the gap (figs. 1, capillary channel 11 with sample collection well 14).
Gunnerson does not teach (claim 25 limitation follows) further comprising one or more (distinct element) spacers between the discs or plates, (claim 27 limitation follows) wherein the one or more spacers comprise a spacer with an opening which provides an inlet into the gap, (claim 29 limitation follows) wherein the one or more spacers control a size of the gap.
Wang teaches a wafer (fig. 2, sensor 110) for carrying a biological sample (Title “ANALYTE SENSORS AND METHODS OF USE”; Abstract “sample chamber having an inlet with a projection extending from an edge”; [0004] “The sensors have an inlet to the sample chamber that facilitates drawing of sample (e.g., blood) into the chamber”), the wafer (fig. 2, sensor 110) comprising: a pair of plates or circular discs (fig. 2, substrates 112 & 114); and a gap (fig. 2, inlet 121 with sample chamber 120) between the plates or circular discs (fig. 2, substrates 112 & 114) adapted to receive a biological sample ([0042] “The sample chamber has a volume sufficient to receive a sample of biological fluid therein”), wherein the gap (fig. 2, inlet 121 with sample chamber 120) is sized to pull a biological sample into the gap (fig. 2, inlet 121 with sample chamber 120) by capillary action ([0026] “capillary fluid flow mechanism”), (claim 25 limitation follows) further comprising one or more spacers (fig. 2, spacer 115) between the discs or plates (fig. 2, substrates 112 & 114) ([0076] “Sensor strips 10, 110, 210, 210' discussed above, are sandwiched or layered constructions having substrates 12, 14, 112, 114 spaced apart, such as by spacer 15, 115”), (claim 27 limitation follows) wherein the one or more spacers comprise a spacer (fig. 2, spacer 115) with an opening (opening shown on right side), (claim 29 limitation follows) wherein the one or more spacers (fig. 2, spacer 115) control a size of the gap (fig. 2, inlet 121 with sample chamber 120) ([0039] “the thickness of the spacer may be constant throughout, and may be at least about 0.01 mm (10 .mu.m) and no greater than about 1 mm or about 0.5 mm. For example, the thickness may be between about 0.02 mm (20 .mu.m)”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s design having spacers to form a capillary channel & chamber with Gunnerson’s capillary channel & chamber, thereby eliminating the need to groove any components and therefore reducing complexity and/or leaving the plate/disc components more robust. The Examiner additionally notes with respect to distinct element spacers that it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art, see MPEP § 2144(V)(C), Nerwin v. Erlichman, 168 USPQ 177, 179 (BPAI. 1969), and In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961).
Claim(s) 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over newly cited Gunnerson in view of newly cited Wang and in further view of newly cited Chou et al (US 20180156775 A1; hereafter “Chou775”).
Regarding claim 28, which depends on claim 27,
Gunnerson teaches wherein the sample chamber (figs. 1, sample chamber 14) is a circular shape which is broken by an opening (see opening connection between chamber 20 and channel 11) ([0036] “[0036] The shape of the capillary channel can be straight”).
Gunnerson does not teach items: 1) further comprising one or more (distinct element) spacers between the discs or plates; and 2) wherein the spacer comprises a ring which is broken by the opening.
Regarding item 1), Wang teaches one or more spacers (fig. 2, spacer 115) between the discs or plates (fig. 2, substrates 112 & 114) ([0076] “Sensor strips 10, 110, 210, 210' discussed above, are sandwiched or layered constructions having substrates 12, 14, 112, 114 spaced apart, such as by spacer 15, 115”), (claim 27 limitation follows) wherein the one or more spacers comprise a spacer (fig. 2, spacer 115) with an opening (opening shown on right side). The Examiner acknowledges that Wang’s spacer is not a ring shape.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Wang’s design having spacers to form a capillary channel & chamber with Gunnerson’s capillary channel & chamber for the same combination and motivation provided for the preceding claim(s) (see at least claim 27).
Regarding item 2):
Gunnerson as modified by Wang is suggestive of retaining Gunnerson’s circular shaped sampled chamber having broken opening as a ring-shaped spacer which is broken by an opening.
Additionally, legal precedent has condoned the use of particular examples of what may be considered common sense or ordinary routine practice including changes in shape, see MPEP § 2141(I) & 2144.04(IV)(B), and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to modify the shape of a spacer into a circular/ring shape.
Furthermore, and as supporting factual evidence of the aforementioned assertion of ordinary skill in modifying a spacer into a ring shape, Chou775 teaches a wafer (wafer comprising first plate, second plate, spacer) for carrying a biological sample (Title; Abstract “bio/chemical sensing”; [0002] “bio/chemical sampling”, the wafer comprising: a pair of plates or circular discs (first and second plate), wherein at least one of the plates or circular discs (first and second plate) is transparent ([0058] “The term “optical transparent” refers to a material that allows a transmission of an optical signal, wherein the term “optical signal” refers to, unless specified otherwise, the optical signal that is used to probe a property of the sample, the plate, the spacers, the scale-marks, any structures used, or any combinations of thereof”’; [0110] “at least one of the plates is transparent”); and a gap (gap formed between first and second plates via spacer) between the plates or circular discs (first and second plate) adapted to receive a biological sample, wherein the gap (gap formed between first and second plates via spacer) is sized for a biological sample in the gap (gap formed between first and second plates via spacer) ([0242] “the enclosed spacer is a ring”; [1044] “capillary force, which is due to a liquid between the first plate and the second plate”), wherein the gap (gap formed between first and second plates via spacer (enclosed ring spacer) comprises a sample chamber (enclosed space with enclosed ring spacer), wherein the spacer (enclosed ring spacer) comprises a ring, wherein the one or more spacers (enclosed ring spacer) control a size of the gap (gap formed between first and second plates via spacer (enclosed ring spacer).
In view of the above, either Gunnerson as already modified by Wang already suggests retaining Gunnerson’s circular shape as a ring spacer, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify with routine and ordinary common sense the shape of the spacer to be explicitly a ring shape—as factually supported by Chou775’s explicit ring shaped spacer—for the expected advantage of retaining Gunnerson’s circular shape and thereby providing a sufficient and useful volume to chamber the sample as is already known in the art.
Claim(s) 55 is/are rejected under 35 U.S.C. 103 as being unpatentable over newly cited Gunnerson in view of Applicant cited Chou089 and in further view of Applicant cited Park et al (US 20090252651 A1; hereafter “Park”).
Regarding claim 55, which depends on claim 53, as best understood,
Gunnerson teaches the wafer (figs. 1, sample collection device 10) ([0032] “substantially disk-shaped") comprising an upper disc or plate (figs. 1, top piece 15A), and a lower disc or plate (figs. 1, bottom piece 15B) with an integrated one or more spacers portion (spacer negatively created via grooving) which control the size of the gap (figs. 1, capillary channel 11 with sample collection well 14) ([0033] “grooved”), the discs (figs. 1 top piece 15A and bottom piece 15B) or plates being held together by an adhesive ([0033] “top piece 15A is joined to the bottom piece 15B, such as by an adhesive”);
wherein when the discs (figs. 1 top piece 15A and bottom piece 15B) or plates are brought together, the adhesive spreads out (at once so envisaged; additional obviousness analysis provided) until the integrated one or more spacers (spacer negatively created via grooving) contact an underside (underside of top piece 15A) of the upper disc or plate (figs. 1, top piece 15A); and
the adhesive ([0033] “adhesive”) then secures the discs or plates (figs. 1 top piece 15A and bottom piece 15B) together.
Gunnerson does not teach item: 1) further comprising one or more (distinct element) spacers with the lower disc or plate. Gunnerson does not explicitly state item 2) that the adhesive is spread out until the spacers contact the underside of the upper disc or plate. Gunnerson is silent to item 3) that the adhesive is cured.
Regarding item 1):
It has been held that constructing a formerly integral structure in various elements involves only routine skill in the art, see MPEP § 2144(V)(C), Nerwin v. Erlichman, 168 USPQ 177, 179 (BPAI. 1969), and In reDulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961). In the present case, it is the Examiner’s position that only ordinary skill in the art is required to form the spacer(s) as distinctly formed element(s).
Furthermore, and as factually supporting evidence of the aforementioned assertion, Chou089 teaches a wafer (wafer comprising first plate, second plate, spacer) for carrying a biological sample (Title; Abstract “bio/chemical sensing”; [0002] “bio/chemical sampling”, the wafer comprising: a pair of plates or circular discs (first and second plate), wherein at least one of the plates or circular discs (first and second plate) is transparent ([0122] “The term “optical transparent” refers to a material that allows a transmission of an optical signal, wherein the term “optical signal” refers to, unless specified otherwise, the optical signal that is used to probe a property of the sample, the plate, the spacers, the scale-marks, any structures used, or any combinations of thereof”’; [0490] “at least one of the plates is transparent”); and a gap (gap formed between first and second plates via spacer) between the plates or circular discs (first and second plate) adapted to receive a biological sample, wherein the gap (gap formed between first and second plates via spacer) is sized for a biological sample in the gap (gap formed between first and second plates via spacer) ([1122] “capillary force, which is due to a liquid between the first plate and the second plate”), the wafer (wafer comprising first plate, second plate, spacer) comprising an upper disc or plate (second plate), and a lower disc or plate (first plate) with one or more spacers (spacers) which control the size of the gap (gap formed between first and second plates via spacer) (see Section 2.3 Spacers [0426]-[0488]).
In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Chou089’s distinct spacer element design for a wafer with Gunnerson’s wafer and associated manufacturing for the expected advantage of thereby eliminating the need to groove any components and therefore reducing complexity and/or leaving the plate/disc components more robust.
Regarding item 2), the Examiner takes Official Notice that bringing together two components such that the adhesive spreads out and the first component contacts the surface of the second component is conventional in the art.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional knowledge of bringing together components in contact such that the adhesive spreads out with Gunnerson’s manufacturing method of holding together disc/plate components with adhesive, thereby providing the expected advantages of robust securing of said components with the adhesive properly distributed.
Regarding item 3):
The Examiner takes Official Notice that curing adhesives is conventional in the art.
Furthermore, and as supporting factual evidence of the aforementioned assertion, Park teaches a method of manufacturing a wafer, the wafer (Title “MICROFLUIDIC DEVICE AND METHOD OF FABRICATING THE SAME”) for carrying a biological sample ([0005] “biological”; [0006] “bio chip”), the wafer comprising: a pair of plates or circular discs (fig. 2, lower substrate 12 and upper substrate 14) ([0016] “disk shape”), wherein at least one of the plates or circular discs (fig. 2, lower substrate 12 and upper substrate 14) is transparent ([0047] “transparent”); and a gap (gap formed by protrusion pattern 30) between the plates or circular discs (fig. 2, lower substrate 12 and upper substrate 14) adapted to receive a biological sample, wherein the gap (gap formed by protrusion pattern 30) is sized to transport a biological sample into the gap (gap formed by protrusion pattern 30) ([0007] “capillary”; [0061] “capillary force”), the method comprising bringing the discs or plates (fig. 2, lower substrate 12 and upper substrate 14) together to provide the gap (gap formed by protrusion pattern 30) between the discs (fig. 2, lower substrate 12 and upper substrate 14); and fixing the discs or plates