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 .
Election/Restrictions
Newly amended submitted claims 9-11 and 13 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The amended claim 9 is directed to a process of manufacture requiring a layer of the microfluidic dual cartridge to be formed by injection molding and the layer comprising (i) a first portion for forming a part of a first microfluidic analysis device of the microfluidic dual cartridge, (ii) a second portion for forming a part of a second microfluidic analysis device cartridge, and (iii) a connection point connecting the first portion and the second portion, wherein the forming comprises injecting a plastic melt into an injection mold having a first cavity corresponding to the first portion and a second cavity corresponding to the second portion through an injection point of a hot runner, positioning the injection point at a transition between the first cavity and the second cavity, and simultaneously filling the first cavity and the second cavity through the injection point, such that the injection point forms the connection point in the layer; and joining the layer with a further layer to produce the microfluidic dual cartridge.
The device of claim 1 is not required to comprise any layers and first and second portions as provided for in the method claim 9. The device of claim 1 is not required to comprise, be made of any plastic. Therefore, the device of claim 1 is not required to comprise the same structural elements as that manufactured by the method claim 9. The method of claim 9 is not directed to making the specific device of claim 1. The device of claim 1 can be manufactured from different methods than that of claim 9, including but not limited to: mechanically assembling pre-manufactured parts, etching, laser etching/ablation, carving, cutting, plastic/glass blowing, extrusion molding, metallurgy molding, cast molding, thermoforming, compression molding, punching, stamping, dye cutting, etc. and further known manufacturing techniques.
Had the claims as now amended had been presented as the original claims, a restriction requirement would have been made and an election required between the distinct inventions (product and process of manufacture/making).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 9-11 and 13 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Arguments
Applicant's arguments filed July 9, 2026 have been fully considered but they are not persuasive.
The claims remain subjected to 112 issues. See rejections herein.
As to the art rejections based upon GHS, applicant asserts:
As amended, claim 1 recites a microfluidic dual cartridge including a first microfluidic analysis cartridge and a second microfluidic analysis cartridge interconnected at a connection point. The connection point is configured to permit a defined separation of the first microfluidic analysis cartridge from the second microfluidic analysis cartridge. Claim 1 further requires that, after the defined separation, each of the first and second microfluidic analysis cartridges is configured for individual use by being insertable into an analysis unit for processing respective sample material received by that cartridge. GHS does not disclose the claimed dual cartridge configuration.
In the Office Action, it was alleged that the sampling device 1, the supply chip 8, the storage device 6, the chip card 14, and the predetermined breaking point 5 correspond to the microfluidic dual cartridge as previously recited. (Office Action at pages 10 and 11). In particular, the Office Action mapped the sampling device 1 and the supply chip 8, or alternatively the storage device 6 and the chip card 14, to the claimed first and second analysis devices, as were previously recited. (Id.).
The supply chip 8 is not a dual cartridge made up of two separately usable microfluidic analysis cartridges. Rather, GHS describes a single supply chip 8 on which a sampling device 1 and a storage device 6 are formed. The sampling device 1 is a sample-taking structure, e.g., a capillary bundle/needle for receiving blood or another substance, while the storage device 6 includes storage capillaries 4, 7 that receive and store the substance taken in by the sampling device 1. Thus, the sampling device 1 and storage device 6 are cooperating portions of one supply chip 8 for taking and storing a single sample, not first and second cartridges each configured for individual insertion into an analysis unit for processing respective sample material.
The predetermined breaking point 5 is provided so that the storage device 6 can be separated from the sampling device 1 to facilitate standardized flushing of the remaining portion of the supply chip. That separation does not produce two microfluidic analysis cartridges that are each individually insertable into an analysis unit for processing respective first and second sample materials.
The alternative mapping of the storage device 6 and the chip card 14 also does not correspond to the amended microfluidic dual cartridge. The storage device 6 and the chip card 14 are connected for cooperative analysis, not separated from one another at a connection point to form two individually usable microfluidic analysis cartridges. The chip card 14 receives the supply chip 8 to establish fluid communication between the storage device and reactor device; it is not one of two cartridges produced by separating a dual cartridge.
Accordingly, GHS fails to disclose the first microfluidic analysis cartridge and the second microfluidic analysis cartridge that are each configured for individual use by being insertable into an analysis unit for processing respective sample material received by the respective cartridge. Anticipation under 35 U.S.C. § 102 is proper only if the prior art reference discloses each and every element of the claim. Since GHS does not disclose each and every element of Applicant's claim 1, GHS does not anticipate claim 1.”
The examiner respectfully disagrees. The apparatus, “microfluidic dual cartridge”, of claim 1 is defined by the positively claimed structural elements listed on separate indented lines in the body of the claim after the transitional phrase “comprising”. Here, such structural elements are: (1) a first (broad, structurally undefined …, not defined by any specific structures) microfluidic analysis cartridge; (2) a second (broad, structurally undefined …, not defined by any specific structures) microfluidic analysis cartridge; and (3) a (broad, structurally undefined …, not defined by any specific structures) connection point that is connected to and between the first microfluidic analysis cartridge and the second microfluidic analysis cartridge. The connection point provides for a location where the first and second cartridges can be separated from each other (by any desired means…See “Claim Interpretations” and further rejections and remarks herein). Although the connection point allows for the first and second cartridges to possibly be separated from each other, the claims are directed to an apparatus (as noted above) and there is no requirement for any separation of such cartridges to ever be performed. Furthermore, what is intended to be/can be done after such separating is performed is directed to process steps (not structural elements of the apparatus). What can be and/or is intended to be done to the separated cartridges relative to any unclaimed, unspecified “sample materials” and “analysis unit”.
It is noted that the invention as defined by the claim (language) structural elements positively claimed in the claims must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art.
Here, applicant’s arguments do not provide for any structural distinctions in the apparatus as defined in claim 1 and that indicated in the rejection as being same or structural equivalents to the positively claimed structural elements in the claim. Instead, applicant states: for example:
“The supply chip 8 is not a dual cartridge made up of two separately usable microfluidic analysis cartridges. Rather, GHS describes a single supply chip 8 on which a sampling device 1 and a storage device 6 are formed. The sampling device 1 is a sample-taking structure, e.g., a capillary bundle/needle for receiving blood or another substance, while the storage device 6 includes storage capillaries 4, 7 that receive and store the substance taken in by the sampling device 1. Thus, the sampling device 1 and storage device 6 are cooperating portions of one supply chip 8 for taking and storing a single sample, not first and second cartridges each configured for individual insertion into an analysis unit for processing respective sample material.
The predetermined breaking point 5 is provided so that the storage device 6 can be separated from the sampling device 1 to facilitate standardized flushing of the remaining portion of the supply chip. That separation does not produce two microfluidic analysis cartridges that are each individually insertable into an analysis unit for processing respective first and second sample materials.”
The name of the structures (“microfluidic analysis cartridges”) do not provide for any structural elements of the structures nor structural distinctions from the structural elements of the names of the structures of GHS. Applicant opined classification, labeling of the sampling device and storage device as being “cooperation portions” does not provide for any structural distinctions from the claim language, apparatus as structurally defined in claim 1. The broad, structurally undefined first and second cartridges of claim 1 are and can be considered as “cooperating portions”. Applicant clearly acknowledges that the sampling device and storage device can be separated via breaking point 5 (connection point). However, applicant further states that purpose of such breaking is not for the same intended use as that recited in the claim. Whether or not the intended use/purpose (what can be done after such separating, breaking is performed) is the same or not as that as recited in the claim does not provide for any further structure of the claimed invention. There is nothing precluding one from choosing to refer to the sampling device and storage device (nor any other connected structural elements of GHS capable of being separated by any desired structural means and processes from each other) as “microfluidic analysis cartridges” and subsequently after separating such, placing the separated devices/structures in anything, location including a broad “analysis unit” as one desires. The same is applicable to applicants arguments directed to the alternative mapping of GHS. The intended purpose of such connection “for cooperative analysis” does not provide for any structural distinction between the apparatus as claimed (established by the claim language, positively claimed structure elements) and the structure provided for, disclosed in GHS.
As to Grolla, applicant’s arguments are similar or the same as those addressed above relative to GHS. Applicant does not provide for any structural distinctions (that the reference lacks any teaching of the same or structural equivalents) between positively claimed structural elements of claim 1 and the structures of the apparatus(es) of Grolla. Instead, applicant’s arguments are directed to the intended/possible usage and/or intended purpose of the structures. However, as Grolla applicant acknowledges that the structures of Grolla can be separated via “the weakened breaking point 3C”. However, applicant continues to assert that separable structures of Grolla are filtration devices and after separation (process step that is not required to be performed) are not, does not yield two separately usable microfluidic analysis cartridges. The examiner disagrees. One can name, refer to, label, etc. … the separated devices of Grolla as one desires and insert such devices in any location in which such are capable of being located within including any structure that one chooses to name, refer to as “an analysis unit” (that is not structurally defined in the claim and not claimed as a structural element of the claimed invention).
As to Flemming and Bard, applicant’s arguments are essentially the same as those addressed above relative to GHS and Grolla. The arguments are directed to intended/possible uses rather than providing for any structural distinctions between the apparatus of claim 1 defined by the positively claimed structural elements and structural elements taught by the references.
Therefore, the claims remain rejected as given herein.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
Content of Specification
(k) CLAIM OR CLAIMS: See 37 CFR 1.75 and MPEP § 608.01(m). The claim or claims must commence on a separate sheet or electronic page (37 CFR 1.52(b)(3)). Where a claim sets forth a plurality of elements or steps, each element or step of the claim should be separated by a line indentation. There may be plural indentations to further segregate subcombinations or related steps. See 37 CFR 1.75 and MPEP 608.01(i)-(p).
The claimed invention is defined by the positively claimed elements, the structural elements listed on separate indented lines listed in the body of the claim after the transitional phrase, “comprising”.
A claim is only limited by positively claimed elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims”. MPEP 2115 Material or Article Worked Upon by Apparatus.
It is noted that the apparatus claims (1-8 and 16) mention a structurally undefined analysis unit, a first (unspecified) sample material, a second (unspecified) sample material, reagent, and liquid reagent. However, none of the prior are positively claimed as structural elements of the apparatus. It is noted is noted that “a defined separation” is also not structure. It is noted that the structurally undefined analysis unit and sample materials (not specified as being any specific material, substance, chemical, etc.) are materials and/or articles that is intended be, can be worked upon, used with the apparatus. It is noted that there is no requirement for any “defined” separation of the first and second microanalysis cartridges to ever be performed. The claimed apparatus is defined by the positively claimed structural elements listed in the body of the claim on separate indented lines not by any possible method steps, uses that can possibly be performed relative to any further unclaimed materials/articles (including those noted above). There is no requirement for first and second microfluidic analysis cartridges to ever receive any unclaimed, unspecified sample materials; be separated and either to be inserted in any unclaimed, structurally undefined analysis; nor be employed to perform unspecified processing of the unclaimed, unspecified sample materials. An owner, operator, possessor, etc. of the claimed invention is not required to do anything to nor use the claimed invention in any process at all, including that as may be intended by applicant. Even if one were to choose to separate/break the first and second cartridges a part at the connection point, one is not required to do anything further with the cartridges. One can do/use the separated cartridges as one so desires, if anything further at all. Therefore, the portions of the claims (including, but not limited to the “wherein” clauses of claim 1 and claim 3 as a whole) directed to what can be done (process steps) with/to the apparatus do not provide for any further structure of the claimed apparatus.
Furthermore, while no processing of any sample material is not required to ever be performed (such is not a structural element), there is no indication as to what is required to be done that is considered as “process”. Anything act that can be done to a sample material can be considered as “processing” the sample material.
Furthermore, it is noted that “a connection point” is not defined as being any specific structure. Any point (location) at which two structures are or can be connected is a connection point. It is noted that the connection point is not claimed as any device that can perform any separation (break, unplug, detach, disconnect, etc.; separate itself). While the devices can possibly be separated at the connection point, the connection point does not and cannot perform the separation. While no separation of the devices is required to be performed, it is noted that such separation whether intentional or not can be done by any suitable structural and process means (sufficient force, i.e. cutting, breaking, etc.) that would provide such separation. It is commonly, inherently known that a “force” would be necessary to disconnect, separate (break, cut, split, etc.) connected structures from each other. The ability to separate connected structures and use the separated structures as desired including inserting (locating) such separated structures within further structures for further use (“processing”) is not a new and non-obvious concept.
It is noted that the “configured to…” and “configured for…” clauses recited throughout the claims do not provide for any further structural elements.
It is noted that the term “plurality” only requires two.
It is noted that the phrase “at least one” only requires one, but can be, is not precluded from being more than one.
It is noted that claim 2 is not directed to any specific shape of any structural element of the first and second cartridges. “Cartridges” can have numerous structures that have numerous shapes (circle, square, triangle, rectangle, etc.). If any element of a first cartridge as any structure that can be said to have any shape, it is only required that the second cartridge have a structure that is also that same shape as the that of the first cartridge. It is noted that a shape is not the same as any specific dimensional value (length, width, height, area, etc.).
As to claim 5, it is noted that “a connection element” is not defined as being any specific structure in the claim.
As to claim 6, it is noted that “a microfluidic network” is not structurally defined in the claim as comprising and specific structures. Furthermore, it is noted that the claim does not provide for any structural connectivity of the plurality of layers of each of the first and second microfluidic analysis cartridges (note: although a plurality allows for more than two layers, the specification and drawings appears to only provide for two layers, a first layer having a bottom surface on top of and in contact with a top surface of a bottom layer, but such is not provided for in the claim).
As to claim 8, it is noted that the phrase, “at least one portion” of the structurally unspecified, undefined connection point and first and second microfluidic analysis cartridges is not defined as any specific structure nor by any definitive structural dimensions (boundaries) so as to structurally distinguish the “at least one portion” from any other “portion” of the first and second analysis cartridges. Any “location” of such cartridges including at any point or part of the cartridges that are directly or indirectly connected can be subjectively considered as a “portion” of the connection point.
As to claim 16, it is noted that the bars are not claimed as comprising a reagent and the receptacles are not required to contain any liquid reagent.
Claim Rejections - 35 USC § 112
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-8 and 16 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 what is structurally required to define each of the first and second microfluidic analysis cartridges because the claim does not clearly recite such. Renaming the prior first and second “devices” as “cartridges” does not provide for any actual structural elements of the devices/cartridges. Each of the microfluidic analysis cartridges are not structurally defined in the claims by any specific structural elements, including any structural element that is capable for performing any “microfluidic analysis” of anything. Therefore, it is unclear what is structurally required to define each of the “microfluidic analysis cartridges”. The term “microfluidic analysis” appears to be directed to intended use of the cartridges. Numerous structures can be named as desired. Two connected structures such as containers, vials, wells, cavities, chambers, compartments, channels, conduits, chips, substrates, plates, and many other conventional, known structures in the art that can possibly be separated at some connection point can be subjectively considered, named, labeled, and/or characterized as “microfluidic analysis cartridges”.
Claims 2-8 and 16 are rejected via dependency upon a rejected claim.
As to claim 3, it is unclear what is further structurally meant, required by the claim because the claim does not provide for any further structure of the connection point. The claim only renames that the connection as “predetermined breaking point”. There is no recitation in the claim as to what is structurally required by the term “predetermined”. No determination of anything relative to such point is required to be made by anything nor anyone “pre” (prior) to any future time or event. Any point can be subjectively considered as being “predetermined” relative to a future time or future event and any determination is “predetermined” relative to any future time period or event relative to any determination being made. Furthermore, the phrase “breaking point” is not structurally defined as being any specific structure different from the connection point of claim 1. The phrase is moreso directed to what is intended to be, can possibly be done as such connection point. It has already been established in claim 1 that it is possible for the cartridges to be “separated” at the connection point. Choosing to perform such separation if all, by “breaking” is a choice, not a requirement. See prior remarks/rejections above. Therefore, it is unclear what is further structurally required by the claim that is different from that structurally required by claim 1.
It is unclear what is further structurally required by claim 4 because the claim is directed to the process (injection molding) that the connection point was made. Referring to/renaming the connection point as “an injection point” does not provide for any further structure of the connection point. The connection point and injection point appear to be structurally one in the same. There is no requirement for any injection molding process to be performed nor anything to be injected at any structurally undefined injection point. Process of manufacture steps (process of how the connection point is made) and a broad, structurally undefined injection point of such process are not structural elements. A process by which the apparatus (or any element of such apparatus) can be made is not a structural element of the apparatus. An apparatus comprising the same structural elements or structural equivalents made by any process will suffice to read on the instant apparatus. "[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production.” MPEP 2113 Product-by-Process Claims I.
As to claim 5, it is unclear if the connection point is defined by a location at which the first connection element and second connection element are releasably, form-fit connected (not specifically defined in the claim as to what structurally defines “form-fit”) to each other because the claim does not specifically recite such. The “configured for…” and “in order to…” clauses are directed to what is possible and/or intended, but do not actually require for such elements to actually be releasably form-fit connected. If such a “form fit” connection is intended to be required to be present, the claim should clearly recite, require the elements to be connected as such.
As to claim 7, it is unclear what is the structural nexus, connectivity of the film to prior first and second plurality of the layers because the claim does not provide for such. The claim does not require the film to be “applied to” (on) any specific structural elements of either of first and second microfluidic analysis cartridge nor precludes the film from being a layer of the respective plurality of layers. Furthermore, it is unclear if such film is required to be applied to (on) the connection point because the claim does not clearly recite such. The “connection point” is not previously claimed as being any structure of either of the first and second microfluidic analysis cartridges. Furthermore, it is noted that the phrase “separating line” is directed to intended/possible use. A line is not necessarily required to be any tangible structure. It appears that such line refers to an “intangible” line where such separating is intended be, can possibly be performed. Furthermore, it is unclear what is structurally required by the term “along” because the term does not provide for any definitive relative structural nexus/location. The term “along” does not necessarily mean “on”. A location (distance from a line) that may be considered as “along” a “line” to one person may not be considered as such to another and vice versa.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-6, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by EP 0 992 287 A2 (GHS GESUNDHEITS SERVICE AG).
GHS discloses a microfluidic dual cartridge (see figures 2 and 3), wherein the dual cartridge comprises a first microfluidic analysis cartridge for processing sample material (reference numeral 1) and a second microfluidic analysis cartridge for processing sample material (reference numeral 8) which are interconnected via a connection point (reference numeral 5), wherein the connection point (see predetermined breaking point 5) is designed to bring about defined separation of the first analysis device and the second analysis device under the action of a force (paragraph [0052]).
Alternatively, the storage device 6 can be considered to be the first analysis device and the chipcard 14 can be considered to be the second analysis device because the storage device 6 is inserted in chip 14 and a connection is produced (see paragraph [0038]).
GHS also discloses that the two analysis devices are identical in form (see the fact that this relates to chips), that the connection point is in the form of an integrally bonded predetermined breaking point or cutting edge (see paragraph [0052], relating to the storage device 6 and the sample receiving device 1) or that the connection point is formed at least in part by complementary interlocking connection elements for interlockingly connecting the first analysis device (reference numeral 6) to the second analysis device (reference numeral 14) (see paragraph [0053] relating to the chips 6 and 14, the chip 6 being inserted into a recess 8a) (form-fit connection; bar and receptacle) and that the analysis devices consist of layers (see paragraph [012]) which comprise further elements (see e.g. the waste reservoir 18 in figure 1 and paragraph [0062]).
As to claim 2, as shown in the figures the cartridges have a same shape.
Claim(s) 1-4 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Grolla et al., US 2013/0341265 A1.
Grolla discloses a microfluidic dual cartridge (see figures 1A and 2), wherein the dual cartridge comprises: a first microfluidic analysis device for processing sample material (see fluidic system 4) and a second microfluidic analysis device for processing sample material (see separating device 6) which are interconnected via a connection point (see indention 3C and paragraphs [0057], [0059]), wherein the connection point (see predetermined breaking point 3C, indention/perforation) is designed to bring about defined separation of the first analysis device and the second analysis device under the action of a force (see paragraphs [0056]-[0059]).
As to claim 2, each device can have a same shape.
As to claim 4, Grolla also discloses that the duo cartridge is produced in one piece by an injection-moulding process (see paragraph [0080]), which implies that the connection point is also produced by this method (the predetermined breaking point represents the injection point).
As to claims 6-7, the dual cartridge comprises a plurality of layers (see substrate 4 and film 5 in figure 1A and the plurality of layers of the analysis device 6 in figure 1B), and both analysis devices can be fitted or are fitted with microfluidic elements.
As to claim 8, the connection point 3C can be considered as at least a portion of device 4 or 6.
Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fleming , WO 2006/065705.
Fleming discloses a microfluidic dual cartridge (see e.g. figures 4a and 4b), wherein the dual cartridge comprises a first microfluidic analysis device for processing sample material (12) and a second microfluidic analysis device for processing sample material (14) which are interconnected via a connection point ( see claim 1), wherein the connection point is in the form of a predetermined breaking point in order to bring about defined separation of the first analysis device and the second analysis device under the action of a force (see claim 1).
Fleming also discloses that the connection point is formed at least in part by complementary interlocking connection elements for interlockingly connecting the first analysis device to the second analysis device (see paragraphs [00073]-[00074]), that the analysis device comprises at least one part of the connection point (see figures 13a and 13b and paragraphs [00073]-[00074]) and that a further layer or film is provided (see reference number 52 in figures 4a and 4b and paragraphs [00057] and [00058]). The analysis device is inserted into an analysis unit (see figure 3 and paragraph [00055]).
Claim(s) 1-4 and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bard, WO 95/26796.
Bard discloses a microfluidic duo cartridge (see figures 2 and 3), wherein the dual cartridge comprises a first microfluidic analysis device for processing sample material (see reference numeral 20 in figure 2 or 80 in figure 3) and a second microfluidic analysis device for processing sample material (reference numeral 100, 60 and 70) which are interconnected via a connection point (see reference numeral 40 and 41 or 30-37, or fluidic connection points via channels 82 and 83), wherein the connection point is designed to bring about defined separation of the first analysis device and the second analysis device under the action of a force (see page 5, line 25 - page 6, line 16; page 9, lines 14-20; or claims 4 and 6).
The analysis devices can be identical shape (see page 9, lines 14-20) and have individual uses, each analysis device consists of a plurality of layers which contain the microfluidic elements (see figures 1 a-1d), the analysis devices comprise at least one part of the connection point (see figures 2 and 3) and the step of providing the fittings can be repeated (i.e. when assembling a complete system) and the modules can be replaced, i.e. the analysis devices are separated.
Claim(s) 1-8 and 16 is/are rejected under 35 U.S.C. 102(a)(1),(a)(2) as being anticipated by Angros et al., .
As to claims 1-4, Angros discloses as shown in FIGS. 1-4, in one embodiment, the preassembled tiles 16 having reagent containers 14 positioned thereon on the reagent strip 10 can be perforated or easily separated via tile score lines 34 (connection point, breaking point, injection point) to produce reagent modules 50 (first and second cartridges) thereby enabling the reconfiguration of the reagent modules 50 as described elsewhere herein. The reagent tiles 16 can be any size but preferably those in the same reagent strip 10-10b are all the same size (cartridges have a same shape). (paragraph 0157). The cartridges are manufactured via molding. (paragraphs 0146, 149, 152).
As to claims 5, 8, and 16, the cartridges are form fit together via connecting elements/portions extending from the cartridges, jigsaw-like male interlocking portion 98 (bars) and jigsaw-like female interlocking portion 100 (receptacle), each of which is connectable to an adjacent female interlocking portion 100 individual interlocking tiles 96. (paragraphs 0152-153; Figures 18-22).
As to claims 6-8, each of the cartridges comprises a plurality of layers 12 (film), 14 that define networks including apertures, openings, and chambers (28, 32, 42, 46; paragraph 0146).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Babcock; Brian David; Spero; Richard et al.; Babcock; Brian David; King; William P. et al.; KVIST; Thomas et al.; Keatch; Steven Alexander et al.; Berganzo Ruiz; Javier et al.; Thuo; Martin Mwangi et al.; Hansen; Carl Lars Genoble et al.; Lowe; Phillip et al.; Zucchelli; Piero et al.; Angros; Lee et al. discloses cartridge devices and methods of use.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN R GORDON whose telephone number is (571)272-1258. The examiner can normally be reached M-F, 8-5:30pm; off every other Friday..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at 571-270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN
/BRIAN R GORDON/Primary Examiner, Art Unit 1798
Prosecution Insights