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 .
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 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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 & 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cauley (CAULEY, III et al. US 2021/0008559 A1) in view of Bort (BORT et al. US 2014/0161686 A1).
Regarding claim 1, Cauley teaches:
1. A fluid input module (Abstract & Fig. 1+) for microfluidic cartridges (¶ 0092), the module comprising:
a container (e.g., 210, Fig. 2; ¶ 0107) for holding a fluid (¶ 0096, the capsule 100 to seal the opening of each flow-through port at the second surface, thereby providing a bottom to the capsule to allow the capsule to hold a liquid or dried reagent), the container comprising an interior (e.g., 211, Fig. 2) and at least one inlet (Fig. 2 - the top inlet of container 210) thereto;
a cap (e.g., 250, Fig. 2; ¶ 0111) comprising a tubular body (Fig. 2 - the hollow body of layer 250) with an axial passage (Fig. 2 - the passage extending between top surface 251 and the bottom surface 252; ¶ 0108) wherein a first end (e.g., 252, Fig. 2) of the axial passage sealingly connects to an inlet (Fig. 2 - the top inlet of container 210) of the container (see Fig. 2 for example), a pierceable film (e.g., 140, Fig. 1; 540, Fig. 5; ¶ 0095; ¶ 0115, This film can bond to the top layer of the planar layer of the reagent storage component so that the layer encloses the capsule by covering the opening, ¶ 0143, ¶ 0154, "a seal can be removed or punctured to open the capsule to fluidic flow) sealingly covers a second end of the axial passage (see Fig. 2 for example), and the second end (251) of the axial passage comprises a cap fitting (Fig. 2 - the outer edges of 250 and 251); and
an inlet (Fig. 6 - the top inlet of 670) operationally associated with a microfluidic device (e.g., 670, Fig. 6; ¶ 0153) comprising an inlet fitting (Fig. 6 - the square recess of 670 for interference fitting with the square cap of the capsule 610) capable of forming an air tight seal (¶ 0036, 0153) with the cap fitting (Fig. 2 - the outer edges of 250), the inlet (Fig. 6 - the top inlet of 670) having a planar region (e.g., 675, Fig. 6) comprising at least one inlet port (e.g., 672, Fig. 6; ¶ 0153) capable for accepting fluid from the container (210) and at least one outlet port (e.g., 671, Fig. 6) capable for inserting a driving fluid (¶ 0153 - rehydration fluid entering capsule) into the container (210) to force fluid to exit the container (210) through a predetermined inlet port (e.g., 672, Fig. 6), wherein the inlet (672) and outlet ports (671) are spaced apart within the planar region (675) and a piercing element (¶ 0152, a piercing feature in the assay device can directly create a flow path through the capsule membrane; ¶ 0154, For example, the capsule may be attached to a device that comprises a blunt tip, a needle, or other mechanical apparatus to pierce an impermeable seal), thereby allowing driving fluid to enter the interior of the container and to force fluid from the container (210) to enter the inlet port of the inlet (672).
However, Cauley does not explicitly teach: each inlet port and outlet port comprises a piercing element, wherein each piercing element has a pointed shape protruding from the planar region such that whenever the cap fitting and the inlet fitting are engaged the piercing elements of the planar region are forced into contact with and pierce the pierceable film.
Bort teaches: a fluid input module (Fig. 8-11) comprising a piercing element (850, 852, Fig. 8-10), wherein the piercing element (850, 852, Fig. 8-10) has a pointed shape (Fig. 8-10 - the conical shape of 852) protruding from a planar region (810, Fig. 8-10) such that the piercing element (850, 852, Fig. 8-10) of the planar region is forced into contact with and pierces a pierceable film (824, Fig. 8-10), thereby allowing driving fluid to enter an interior of a container (812, 820, Fig. 8-10) and to force fluid (822, Fig. 8-10) from the container (812, 820, Fig. 8-10).
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have added the piercing element of Bort to the inlet port and outlet port of Cauley to effectively pierce the pierceable film and allow the fluid to enter the inlet of the microfluidic device.
Regarding claims 2-9, modified Cauley teaches:
2. The fluid input module of claim 1 wherein said fluid is a biological sample (¶ 0169, 0244).
3. The fluid input module of claim 2 wherein said biological sample is selected from the group consisting of blood, saliva, urine, and plasma (¶ 0169, 0244).
4. The fluid input module of claim 1 wherein there is one inlet port (e.g., 672, Fig. 6) and one outlet port (e.g., 671, Fig. 6).
5. The fluid input module of claim 1 wherein said pointed shape of said piercing elements is conical or pyramidal (¶ 0056, pointed tip 152 is cone shaped).
8. The fluid input module of claim 1 wherein said container further includes disposed therein a dried reagent (¶ 0096, the capsule 100 to seal the opening of each flow-through port at the second surface, thereby providing a bottom to the capsule to allow the capsule to hold a liquid or dried reagent).
9. The fluid input module of claim 1 wherein said container further includes a filter (e.g., 145, Fig. 1; ¶ 0095).
12. The fluid input module of claim 1 wherein said cap fitting and said inlet fitting are snap-on fittings, interference fittings, or threaded fittings (see ¶ 0123-0124, 0164 for example).
Regarding claim 6, modified Cauley does not explicitly teach: 6. The fluid input module of claim 1 wherein there is one outlet port and a plurality of inlet ports. It is known that duplication of parts is an ordinary skill in the art and it is well known in the art that routine experimentation and various design engineering choices could have been used to have arrived at duplicating the inlet port. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have duplicated the inlet port to improve fluid flow through the system, as desired or necessary to meet the requirements of a particular implementation.
Regarding claim 7, modified Cauley does not explicitly teach: 7. The fluid input module of claim 1 wherein said container comprises a plurality of compartments each associated with a separate inlet port. It is known that duplication of parts is an ordinary skill in the art and it is well known in the art that routine experimentation and various design engineering choices could have been used to have arrived at duplicating the inlet port and have each inlet port be associated with a single compartment. Accordingly, it would have been obvious to one of ordinary skill in the art at the time the invention was made to have duplicated the inlet port and have each inlet port be associated with a single compartment to improve fluid flow through the system, as desired or necessary to meet the requirements of a particular implementation.
Allowable Subject Matter
Claims 10-11 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 10-11, the prior art does not teach individually nor fairly suggest in combination: 10. The fluid input module of claim 1 further comprising a rigidity plate contacting said pierceable film on a side opposite said planar region of said inlet whenever said cap fitting and said inlet fitting are engaged, the rigidity plate comprising a hole in each position where said piercing element contacts said pierceable film. 11. The fluid input module of claim 10 wherein each of said holes comprises an area and shape that permits said piercing elements to pierce said pierceable film whenever said cap fitting and said inlet fitting are engaged.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Shi (SHI et al. US 2020/0094255 A1) teaches a fluid input module (Fig. 1A-18B; Abstract) comprising a pierceable film (Fig. 4D - the Barrier Layer 1: film 1; ¶ 0103).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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