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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because of the inclusion of legal phraseology such as “comprising” and “said”. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities: On page 5, line 18 of the specification, the phrase “Figures 5A-5B correspond to…” should be changed to –Figure 5 corresponds to…-- since the drawings only depict a Figure 5. On page 5, line 31 of the specification, the phrase “Figure 8 illustrates…” should be changed to –Figures 8(a) and 8(b) illustrate…-- since the drawings depict Figures 8(a) and 8(b).
Appropriate correction is required.
Drawings
Figure 1 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated, as described on lines 20-24 on page 1 of the specification. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim 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 15-28 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.
On lines 12-13 of claim 15, the phrase “the pushing direction and the support surface form a relative angle substantially different from 90o” is indefinite since it is not clear what the pushing direction is, and what physical features of the impelling surface of the header and the blister body allow for a relative angle substantially different from 90o to form between the pushing direction and the support surface. According to the specification and the drawings of the instant application, it appears that the impelling surface 2’ of the header 2 in the instant invention has a sloped surface that when pushed against the blister body in a pushing direction that is vertical relative to the horizontal support surface, causes one end of the blister body to be compressed first relative to the opposite end of the blister body and a relative angle substantially different from 90o to form between the pushing direction and the support surface. See Figures 3(a)-3(d) in the instant application. Claim 15 should be amended to recite this physical feature of the impelling surface of the header.
Claim 16 is indefinite since it depends from now canceled claim 1. See this same problem in each of claims 17-27. Claims 16-27 should be amended to depend from independent claim 15 or another pending claim. On line 2 of claim 16, the phrase “the 80% of the liquid volume” lacks antecedent basis. Claim 16 is also indefinite since it implies that a liquid volume is actually present in the blister body to be dispensed when the impelling surface is pressed against the blister body. However, independent claim 15 does not positively recite that a liquid volume is actually present in the blister body, but rather, only recites that the blister body is “adapted for storing a liquid volume”. Therefore, it is not clear that there is a liquid volume inside of the blister body from which at least 80% can be dispensed when the impelling surface pressed against the blister body.
On line 2 of claim 17, the phrase “the complementary angle” lacks antecedent basis. It is suggested to change the phrase “at the complementary angle of the relative angle” on lines 2-3 of claim 17 to –at an angle that is complementary to the relative angle--.
On line 3 of claim 19, the phrase “the complementary angle” lacks antecedent basis. It is suggested to change the phrase “at the complementary angle of the relative angle” on line 3 of claim 19 to –at an angle that is complementary to the relative angle--.
Claim 23 is indefinite since it is not clear when the notch, the protrusion or the indentation on the header is placed adjacent to the fluidic outlet channel. Does this occur only when the header applies pressure to the blister body so as to compress the blister body?
On line 4 of claim 24, the phrase “the gas volume” lacks antecedent basis and should be changed to –a gas volume--.
On lines 1-2 of claim 26, the phrase “a holder adapted with at least a blister seat for placing a blister body” is indefinite since it is not clear whether the holder positively contains or comprises a blister seat from this phrase. It is not clear what “adapted with” means in this phrase. In addition, the phrase “a blister body” on line 2 of claim 26 should be changed to –the blister body—so as to positively refer to the blister body recited in claim 15. Claim 26 is indefinite since it is not clear whether the piston is connected to the snail cam.
Claim 27 should be amended to depend from claim 26 so that the recited rotation of the mechanical arrangement and the piston in claim 27 have proper antecedent basis. On line 4 of claim 27, the phrase “if the header contact with the blister body” should be changed to –and if the header contacts the blister body—so as to make proper sense.
Claim 28 is indefinite since it depends from canceled claim 12. Claim 28 should be amended to depend from a pending claim. On line 2 of claim 28, the phrase “the fluid outlet channel” should be changed to –the fluidic outlet channel—so as to recite the same terminology as recited in claim 15. On line 3 of claim 28, the phrase “the liquid volume” and “the gas volume” lack antecedent basis.
Inventorship
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 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) 15, 17-21 and 25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Crivelli et al (US 2017/0152018, submitted in the IDS filed on February 5, 2024).
With regards to claim 15, Crivelli et al teach of a blister opening system. In a first embodiment, the blister opening system comprises a blister body 132 arranged over a support surface 150 (see Figures 1A and 1B in Crivelli et al), wherein the blister body 132 is collapsible under pressure and is adapted for storing a liquid volume, a header 186 comprising an impelling surface, wherein the header 186 is adapted for being movable relative to the blister body 132 and to transmit a pressure against the blister body 132 through the impelling surface in a pushing direction (see Figures 6, 7 and 9 in Crivelli et al), and a fluidic outlet channel 156 fluidly connected to the blister body 132 and adapted such that a liquid volume in the blister body 132 can flow from the blister body towards the fluidic outlet channel 156 when pressure is exerted against the blister body 132 by the header 186 (see Figures 2-3, 7 and 9 in Crivelli et al), wherein the impelling surface of the header 186 is arranged such that, in at least a relative position between the header 186 and the blister body 132, the pushing direction and the support surface 150 form a relative angle substantially different from 90o (see Figure 9 in Crivelli et al where the tip or impelling surface of the header 186 is rounded in shape at the end and flanked by a configuration that presses the blister body 132 obliquely from the outside and therefore, can be considered to disclose a relative angle different from 90o), and the pressure of the impelling surface against the blister body 132 configures a gas entrapment volume in the blister body 132 that is located at an opposite end of the blister body 132 from the fluidic outlet channel 156 (see Figure 6 in Crivelli et al where the impelling surface of the header 186 is pressed into the end of the blister body 132 closest to the fluidic outlet channel 156 which would naturally cause a gas entrapment volume to form at the opposite end of the blister body 132 with respect to the fluidic outlet channel 156). See Figures 1A, 1B, 2-3, 6-7 and 9, and paragraphs 0095-0101, 0107-0112 and 0151 in Crivelli et al.
With regards to claim 15, Crivelli et al also teach of a second embodiment of a blister opening system. In the second embodiment, the blister opening system comprises multiple blister bodies 1742 arranged over a support surface 1730 (see Figures 17A, 18 and 19 in Crivelli et al), wherein the blister bodies 1742 are collapsible under pressure and are adapted for storing a liquid volume, a header 1710 comprising multiple impelling surfaces1714, wherein the header 1710 is adapted for being movable relative to the blister bodies 1742 and to transmit a pressure against the blister bodies 1742 through the impelling surfaces 1714 in a pushing direction (see Figures 17A, 18 and 19 in Crivelli et al), and fluidic outlet channels 1734 fluidly connected to each of the blister bodies 1742 and adapted such that a liquid volume in the blister bodies 1742 can flow from the blister bodies towards the fluidic outlet channels 1734 when pressure is exerted against the blister bodies 1742 by the header 1710 (see Figures 17A, 18 and 19 in Crivelli et al), wherein the impelling surfaces 1714 of the header 1710 are arranged such that, in at least a relative position between the header 1710 and the blister bodies 1742, the pushing direction and the support surface 1730 form a relative angle substantially different from 90o (see Figures 17A, 18 and 19 in Crivelli et al which show that as the header 1710 of the system moves to close over the top surface of the blister bodies 1742, a relative angle of less than 90o between the pushing direction of the header 1710 and the support surface 1730 forms), and the pressure of the impelling surfaces 1714 against the blister bodies 1742 configures a gas entrapment volume in the blister bodies 1742 that is located at an opposite end of the blister bodies 1742 from the fluidic outlet channels 1734 (see Figures 18 and 19 in Crivelli et al which depict that the impelling surfaces 1714 of the header 1710 first compress the ends of the blister bodies 1742 closest to the fluidic outlet channels 1734, which would naturally cause a gas entrapment volume to form at the opposite ends of the blister bodies 1742 with respect to the fluidic outlet channels 1734). See Figures 17A, 18 and 19, and paragraphs 0136-0143 and 0151 in Crivelli et al.
With regards to claim 17, Crivelli et al teach that in the second embodiment of the blister opening system, the impelling surfaces 1714 of the header 1710 are substantially tilted to the support surface 1730 at an angle complementary to the relative angle. See Figures 17A, 18 and 19 in Crivelli et al.
With regards to claim 18, Crivelli et al teach that in the first embodiment of the blister opening system, the impelling surface of the header 186 is substantially parallel to the support surface 150. See Figures 7 and 9 in Crivelli et al.
With regards to claim 19, Crivelli et al teach that in the first embodiment of the blister opening system, the blister body 132 comprises a surface adapted to contact the impelling surface of the header 186, and this surface is substantially tilted relative to the support surface 150 at an angle complementary to the relative angle. See Figure 9 in Crivelli et al which depicts the top sides of the blister body 132 after being pushed by the impelling surface of the header 186, and these top sides are substantially tilted relative to the support surface 150 at an angle complementary to the relative angle
With regards to claim 20, Crivelli et al teach that the header 186 comprises a plunger or a pusher. See Figures 7 and 9 in Crivelli et al.
With regards to claim 21, Crivelli et al teach that the impelling surface of the header 186 is substantially flat. See Figures 7 and 9 in Crivelli et al. With regards to claim 25, Crivelli et al teach that the impelling surface of the header 186 switches between a first position in which the impelling surface occludes the fluidic outlet channel 156 (see Figure 7 in Crivelli et al where the impelling surface of the header 186 is in a first position and the fluidic outlet channel 156 is blocked from flowing liquid therethrough), and a second position in which the impelling surface of the header 186 leaves open the fluidic outlet channel 156 (see Figure 9 in Crivelli et al where the impelling surface of the header 186 is in a second position where the header 186 presses the blister body 132 and the impelling surface leaves open the fluidic outlet channel 156 for liquid to flow therethrough).
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.
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crivelli et al (US 2017/0152018, submitted in the IDS filed on February 5, 2024). For a teaching of Crivelli et al, see previous paragraphs in this Office action.
With regards to claim 16, Crivelli et al fail to teach that the impelling surface of the header 186/1710 is adapted to press the blister body 132/1742 to dispense at least 80% of a liquid volume stored within the blister body through the fluidic outlet channel 156/1734. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to adapt the impelling surface of the header 186/1710 taught by Crivelli et al to press the blister body 132/1742 to dispense at least 80% of a liquid volume stored within the blister body through the fluidic outlet channel 156/1734 because doing so would allow a majority of the liquid volume held within the blister body to be dispensed therefrom for use in a chemical or biological assay without wasting any of the liquid volume.
Claim(s) 26-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Crivelli et al (US 2017/0152018, submitted in the IDS filed on February 5, 2024) in view of Matear et al (US 2016/0296930). For a teaching of Crivelli et al, see previous paragraphs in this Office action.
With regards to claims 26-27, Crivelli et al fail to teach that the blister opening system further comprises a holder having a blister seat for placing the blister body 132/1742, and actuation means comprising a piston, a snail cam connected to a rotating camshaft, and a stepper motor for actuating the rotating camshaft to induce displacement of the piston towards the blister body 132/1742 to exert pressure on the blister body.
Matear et al teach of an assay fluid delivery system comprising an array of blister bodies 62 containing fluids therein on a holder 64, and a fluid delivery control system 50. The fluid delivery control system 50 comprises a plurality of reciprocally mounted actuators or pistons 10, each associated with a respective blister body 62 and being movable between a retracted position and an actuating position at which it causes fluid to be delivered from a corresponding blister body 62, a plurality of snail cams 11-20 mounted on a common rotatable cam shaft 6, and a stepper motor 27. Each snail cam 11-20 is engaged with a respective one of the actuators 10, and rotation of the cam shaft 6 by the motor 27 causes rotation of the snail cams 11-20 and movement of the corresponding actuators 10 between a retracted position and an actuating position where the actuators 10 press on the blister bodies 62 to cause fluid to be dispensed from the bodies 62. See Figures 1, 2 and 4, the abstract, and paragraphs 0043-0055 in Matear et al.
Based upon a combination of Crivelli et al and Matear et al, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include in the blister opening system taught by Crivelli et al a holder having a blister seat for placing the blister body 132/1742, and actuation means comprising a piston, a snail cam connected to a rotating camshaft, and a stepper motor for actuating the rotating camshaft to induce displacement of the piston towards the blister body 132/1742 to exert pressure on the blister body because Matear et al teach that these components in a fluid delivery system can be used in conjunction with blister bodies holding fluids therein so as to deliver the fluids from the blister bodies in a controlled manner to an assay device without being bulky, costly or inefficient (see paragraphs 0001-0003 and 0014-0016 in Matear et al).
With regards to claim 27, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further include a switch in the blister opening system taught by the combination of Crivelli et al and Matear et al that is configured to stop rotation of the rotating camshaft and the snail cams if the piston or header reaches a predetermined maximum position or if the header contacts the blister body because this type of switch would ensure that the header or piston does not unnecessarily damage the blister body and only applies a controlled pressing force on the blister body.
Allowable Subject Matter
Claims 22-24 and 28 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims since the closet prior art reference to Crivelli et al (described above) fails to teach or fairly suggest that either the header 186 or the impelling surface on the header 186 comprises one or more indentations, recesses, notches or protrusions, that when the impelling surface of the header 186 exerts pressure on the blister body 132, the impelling surface occludes the fluidic outlet channel 156 while at least a portion of the blister body stores a gas volume in the gas entrapment volume, and that the blister opening system further comprises a blister metering device fluidically coupled to the fluid outlet channel 156 that is adapted to measure a liquid volume and a gas volume dispensed through the fluidic outlet channel 156.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Please make note of: Kurowski et al (US 2013/0327672) who teach of a blister package for holding a liquid and a use thereof; Haines et al (US 2024/0100530) who teach of sample preparation blister packs; Arlett et al (US 2018/0015474) who teach of a cartridge reader to carry out a diagnostic test on a fluid sample comprising blister actuators for depressing collapsible blisters in a cartridge; Oppenheimer et al (US 9,610,579) who teach of a system for fluid delivery from a deformable reservoir or blister into a microfluidic device; Wright (US 2022/0258165) who teach of a fluid delivery blister actuator for dispensing fluid from a blister assembly to a cartridge; and Amorese et al (US 2019/0120868) who teach of a reagent delivery system for delivering reagents contained in deformable blisters.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAUREEN M WALLENHORST whose telephone number is (571)272-1266. The examiner can normally be reached on Monday-Thursday from 6:30 AM to 4:30 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander, can be reached at telephone number 571-272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Examiner interviews are available via a variety of formats. See MPEP § 713.01. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) Form at https://www.uspto.gov/InterviewPractice.
/MAUREEN WALLENHORST/Primary Examiner, Art Unit 1797 July 30, 2026
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