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 .
DETAILED ACTION
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-15, drawn to a device for storing or delivering an aqueous solution.
Group II, claim(s) 16-18, drawn to a method of manufacturing.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because the groups do not share the same or corresponding technical feature.
The technical feature of Group I is drawn to a non-porous hydrophobic substrate and a plurality of hydrophilic porous protrusions discretely distributed on and integrally formed with the non-porous hydrophobic substrate, wherein such technical feature is not found in Group II. The technical feature of Group II is drawn to the process steps recited therein that are not found in Group I.
During a telephone conversation with Mike Bertelson on June 1st, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-18 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claim Objections
Claim 8 is objected to because of the following informalities: Use of the word “shapes” at the end of the recitation appears to be incorrect and inadvertently included. 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.
Claims 4 and 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.
The metes and bounds of the sought hydrophilic porous protrusions are indefinitely defined herein.
Initially, it is set forth that the recitation of claim 4 is drawn to an incomplete sentence by way of “…protrusions are made [from?] polymeric powders…”.
Further, the recitation in and of itself is not clearly understood as it pertains to the device as it appears to read on a precursor form that is to be processed in order to arrive at a protrusion. Herein, the claims are drawn to a device in which the structure of a plurality of protrusions are established positively claimed elements of the device.
Does Applicant intend to recite something on the order of “wherein the plurality of hydrophilic porous protrusions is made of a polymeric material having a second melting temperature, the second melting temperature being higher than the first melting temperature of the non-porous hydrophobic substrate”?
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of the claimed different heights (i.e. elevation) from the substrate are indefinitely provided for herein.
The claim appears to intend to provide that there are multiple different elevations of protrusions relative to the substrate (i.e. protrusion #1 protrudes 1mm above the substrate, and protrusion #2 protrudes 3mm above the substrate), however, the recitation to “one or more protrusions of different heights from the non-porous hydrophobic substrate” indefinitely provides for any such different heights from the substrate. Given the choice of one protrusion, it is indefinitely provided that different heights from the substrate may be achieved.
Claims 9 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of what a subset of the plurality of hydrophilic porous protrusions form are indefinitely defined herein by way of “a picture” and “a geographic shape.”
Applicant’s disclosure is absent particular discussion and definition as to what constitutes a “picture” and “a geographic shape” as claimed herein.
These terms are overly broad and vague. A picture is both subjective with respect to the creator and observer, and also completely open-ended. The term “geographic shape” is not particularly grounded and would read on shapes to that of nature that are practically limitless as well as depictions thereof such as outlines or forms of objects as seen on a 2-D/3-D representation or map.
Clarification is required.
Further, the recitation of “pattern, picture, or geographic shape” presents a recitation of a broad range together with a narrow range thereof.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 9 recites the broad recitation of picture, and the claim also recites pattern which is the narrower statement of the range/limitation (i.e. patterns may be a picture, as in a species of the genus picture). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
It is also seen that “picture” and “geographic shape” may be related as genus and species, however, the indeterminate nature of the terms renders this categorical classification uncertain.
Further, as in cl. 10, the recited pattern is indefinitely defined as it relates to the plurality of hydrophilic porous protrusions, whereas preceding claim 9 defines such pattern with respect to a subset thereof. Clarification is required.
Claims 11 and 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds to the sought sizing/shaping of the protrusions are indefinitely defined herein.
In both instances, the claim provides a qualifier of one or more have same size/shape (and likewise with different size/shape), in which a provision to a singular protrusion indefinitely provides for such a relative (‘difference’) assessment.
Does Applicant intend to provide that two or more provide these qualifications, or does Applicant intend to provide a comparative qualifier to the end of these recitations such as in “…as compared to another one of the plurality of protrusions”? *[noting this is for discussion purposes and not for literal claim amendments as such language does not appear to slot in the present framework]*
Claim 14 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The metes and bounds of the recitation of claim 14 are indefinitely understood herein. It is not clear, nor made by the specification, what constitutes an “environment solution,” in which such term is not a recognized term of art and appears to be drawn Applicant’s own, contrived language and is not supported by particular definition thereto.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, claim 14 recites the broad recitation biological solution or sample, and the claim also recites beverage (i.e. beverages such as water, kombucha, probiotics, and the like are biological) which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 provides further discussion to the pattern, however, a pattern is not necessitated by claim 9, wherein claim 9 provides alternative choice of pattern, picture, and geographic shape.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Herein, it may also be that Applicant intends to recite something on the order of “….wherein a subset of the…forms a pattern, and wherein the pattern comprises…”, however, Examiner further notes that the “subset” aspect is not particularly addressed (see also above in rejection under 35 USC 112 b/2nd).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 6, 8-11, and 13-15 is/are rejected under 35 U.S.C. 102a1 as being anticipated by Williams et al. (EP 0973863A1), hereafter Williams.
Williams discloses a device for partitioning biological sample liquids into microvolumes (abstract). With regard to claim 1, Williams discloses a device for storing or delivering an aqueous solution comprising a non-porous hydrophobic substrate (item ‘32’, fig. 4 [silicon film], item ‘40’, fig. 5a to the hydrophobic polypropylene film, abstract, pars.[0050]), and a plurality of hydrophilic porous protrusions discretely distributed on the non-porous hydrophobic substrate and integrated thereon wherein each of the hydrophilic porous protrusions is configured to absorb and hold an aqueous solution (item ‘34’, fig. 4, item ‘42’, fig. 5a to the hydrophilic liquid-retaining zones; par.[0045,0050], for example).
With regard to claim 2, Williams discloses the non-porous hydrophobic substrate is made of a solid non-porous polymeric material sheet having a first melting temperature (pars.[0045,0050]). With regard to claim 3, Williams discloses the non-porous hydrophobic substrate is made of a material or combination thereof as recited (pars.[0045,0050]).
With regard to claim 6, Williams discloses each of the plurality of hydrophilic porous protrusions comprise a height (H) and wherein the height of each hydrophilic porous protrusions is the same, such that tops of each hydrophilic porous protrusions define an upper plane raised a distance H from the non-porous hydrophobic substrate (figs. 4&5).
With regard to claim 8, Williams discloses a shape of each of the plurality of hydrophilic porous protrusions comprises at least one of a cylinder, a polygonal prism, a cone, a torus, a star, a half-sphere, a rectangle, a square, or a pyramid shapes (figs. 4&5; i.e. cylinder or polygonal prism). With regard to claim 9, as best understood, Williams discloses a subset of the plurality of hydrophilic porous protrusions forms a pattern, a picture, or a geographic shape on the non-porous hydrophobic substrate (figs. 4&5; a pattern is shown by the common retaining areas, as well as a picture given by a subset thereof, and a geographic shape). With regard to claim 10, as best understood, Williams discloses a pattern comprises the plurality of protrusions are evenly distributed in n rows and n columns (see figs. 4&5). With regard to claim 11, as best understood, Williams discloses the plurality of hydrophilic porous protrusions comprises one or more protrusions having same size and/or shape (figs. 4&5).
With regard to claim 13, Williams discloses each of the plurality of hydrophilic porous protrusions is configured to uptake aqueous solution from a range as recited therein (par.[0032]). With regard to claim 14, Examiner asserts that the aqueous solution is not a positively claimed element of the device and is drawn to a prospective workpiece that is not attributed patentable weight; further, the commensurately structured hydrophilic porous protrusions of Williams are fully capable of absorbing thereof in as much as claimed and recited herein, and further noting pars.[0034,0035] to such aqueous solutions. With regard to claim 15, Williams discloses the non-porous hydrophobic substrate is transparent to allow visibility of colors or changes in color of the aqueous solution (pars.[0066,0072]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 4 and 5, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Mao et al. (USPN 9,101,311), hereafter Mao.
Williams has been discussed above.
Williams does not specifically disclose the hydrophilic porous protrusions having a second melting temperature being higher than the first melting temperature of the non-porous hydrophobic substrate (no patentable weight is being attributed to the process of making the protrusions from powder given that the claims are drawn to a device, and as seen above with respect to the rejection under 35 USC 112 b/2nd), and wherein such hydrophilic porous protrusions having a second melting temperature higher than the first of the substrate are made of HDPE or UHMWPE.
Mao discloses cards for sample storage and delivery (abstract). Mao discloses that the sintered porous matrix in the sample receiving spots may be made from a variety of plastics such as in polyethylene, HDPE, UHMWPE, polystyrenes, polyesters, and others (lines 7-25, col. 4, for example).
It would have been obvious to one of ordinary skill in the art to modify Williams to provide the hydrophilic porous protrusions having a second melting temperature being higher than the first melting temperature of the non-porous hydrophobic substrate wherein such hydrophilic porous protrusions having a second melting temperature higher than the first of the substrate are made of HDPE or UHMWPE such as disclosed by the analogous art of Mao to sample receiving and/or delivery cards in order to provide an obvious, alternative material of construction to the hydrophilic porous protrusions for liquid retention as in Williams in which Williams discloses likewise polymers as in Mao and utilization of HDPE or UHMWPE would have a reasonable expectation of success in Williams for a likewise desired purpose of retaining sample/liquid, and wherein a provision of differing material melting temperatures from that of the substrate to that of the HDPE/UHMWPE hydrophilic protrusions is seen as an obvious engineering design choice that suitably provides a hydrophobic substrate and hydrophilic substrate for their intended functionalities, absent a showing of a criticality or unexpected results arising otherwise.
Claim(s) 7 and 12, as best understood, is/are rejected under 35 U.S.C. 103 as being unpatentable over Williams in view of Kinoshita et al. (EP 0656420A1), hereafter Kinoshita.
Williams has been discussed above.
Williams does not specifically disclose the plurality of hydrophilic porous protrusions comprise one or more protrusions of different heights from the non-porous hydrophobic substrate, and does not specifically disclose the plurality of hydrophilic porous protrusions comprise one or more protrusions having different sizes and/or shapes.
Kinoshita discloses a chemical and microbial test device comprising sample retaining portions on a substrate. Kinoshita discloses that the size and shape of the sample-receiving parts and the arrangement of them on the support is not particularly limited and can be suitably selected dependent on desired reaction system or culture system to be retained for a given intended test (lines 19-33, col. 5).
It would have been obvious to one of ordinary skill in the art to modify Williams to provide the plurality of hydrophilic porous protrusions comprise one or more protrusions of different heights from the non-porous hydrophobic substrate, and does not specifically disclose the plurality of hydrophilic porous protrusions comprise one or more protrusions having different sizes and/or shapes as being drawn to an obvious alternative form to the one or more protrusions of Williams and an obvious engineering design choice in providing an arrangement of retaining zones for holding particular quantities of liquid for a given intended test, wherein such variable arrangement of heights/sizes/shapes affords the ability to retain different quantities of fluid for more dynamic assays or for carrying out a second different assay (i.e. in parallel) that has different liquid retention requirements from a first at the other section, and would have a reasonable expectation of success in Williams for a likewise desired purpose of retaining amounts of liquid for the assay at-hand.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEIL N TURK whose telephone number is (571)272-8914. The examiner can normally be reached M-F 930-630.
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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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/NEIL N TURK/Primary Examiner, Art Unit 1798
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