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 .
Specification
The disclosure is objected to because of the following informalities:
The Applicant’s Specification recites “Fig. 7a-d several views of a plug of the trigger mechanism according to the embodiment of Fig. 2” [p. 7], which should be on a new/separate line from the description of Fig. 6.
Appropriate correction is required.
Claim Objections
Claim(s) 1, 4-5, 10, 14-15, and 17 is/are objected to because of the following informalities:
Claim 1 should read “[line 3].
Claims 4-5, 10, 15, and 17 interchangeably recite “deformable and/or elastic element” and “deformable and/or partially elastic element”. The noted claims should be amended to recite only one or the other of “deformable and/or elastic element” and “deformable and/or partially elastic element”.
Claim 10 should read “for control purposes” [line 4].
Claim 14 should read “wherein between the cap and the plug a spring is arranged, wherein the spring is configured and arranged to” [lines 2-3].
Appropriate correction is required.
Claim Interpretation
Examiner Notes: currently, NO limitation invokes interpretation under § 112(f).
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.
Claim(s) 5-6, 10, 19-20, and those dependent therefrom is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitations “the end portion” [line 3] and “the first end” [line 4], which lack antecedent basis, as claims 1-5 fail to previously define either of “the end portion” and “the first end”. The recited limitations are further considered indefinite, as it is unclear whether either recited limitation is meant to refer to either of the previously defined “connecting end” of claim 4 [line 2] or “free end” of claim 4 [line 3], or define new ends/portions of the deformable and/or elastic element. For examination purposes, the Examiner has interpreted “the end portion” to refer to the “free end” and “the first end” to refer to the “connecting end” in claim 5 and claims dependent therefrom, based on p. 8 of the Applicant’s Specification.
Claim 6 recites the limitation “wherein the trigger element has a main body” [line 2], which is considered indefinite, as claim 4 [from which claim 6 depends from] previously defined “a main body of the trigger element” [lines 2-3], such that it is unclear whether the main body as defined by claim 6 is meant to define a new or separate main body of the trigger element, or refer to the previously defined main body of the trigger element. For examination purposes, the Examiner has interpreted the indefinite limitation to refer to the main body of the trigger element as previously defined in claim 4.
Claim 10 recites the limitation “an end portion of the deformable and/or elastic element” [lines 2-3], which is considered indefinite, as claim 5 previously recites “the end portion of the deformable and/or partially elastic element”, which is considered indefinite under § 112(b) and interpreted to refer to the “free end” of claim 4 [see rejection above], such that it is unclear whether the indefinite recitation of claim 10 is meant to also refer to the “free end” of claim 4 or define any new end portion of the deformable and/or elastic element. For examination purposes, the Examiner has interpreted “an end portion of the deformable and/or elastic element” to refer to the “free end” based on the interpretation of claim 5 above.
Claim 19 recites the limitation “for allowing releasing of the vacuum in a second chamber” [lines 10-11], wherein “the vacuum in a second chamber” is considered to lack antecedent basis, as claims 1 and 19 fail to previously define a vacuum in a second chamber. The recited limitation is further considered indefinite, as it is not clear whether the recited limitation is meant to refer to the pre-packaged vacuum sealed in the first chamber as being released into the second chamber or define respective vacuums for each of the first chamber and the second chamber. For examination purposes, the Examiner has interpreted the indefinite limitation to read “for allowing pre-packaged vacuum sealed in the first chamber into a second chamber” based on p. 2 of the Applicant’s Specification [The second suction pack comprises a button, formed on one of its outer surfaces, and a piercing protrusion which is located below the button such that, once the user activates the button, the piercing protrusion pierces a membrane (e.g., an Aluminum membrane) provided in the first suction pack, thereby transferring the vacuum from the first vacuum chamber to a second chamber (i.e., a collection chamber). Once the vacuum is released in the second chamber, the skin of the user is deformed and sucked inside the device].
Claim 20 recites the limitation “the trigger element features” [line 2], which lacks antecedent basis, as claims 1 and 20 fail to previously define any particular trigger element “features”. The recited limitation is further considered indefinite, as it is not clear what is being referred to by “features” of the trigger element, as the Examiner notes that claim 1 defines the trigger element based on structural relationships to other structures and functionality of the trigger element. For examination purposes, the Examiner has interpreted any structural relationship of the trigger element relative to any other structure or any functionality of the trigger element to read on a “trigger element feature”.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-9, 12-15, and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barone (US-20190159709-A1).
Regarding claim 1, Barone teaches
A trigger mechanism for a sample collection device, the trigger mechanism comprising a trigger element [rotary latch 30 (Barone Figs. 18-23)] and a preloaded plug with a blade [post 94 coupled to flow activator 90 (Barone Figs. 18-23); the bi-stable element is coupled to the microneedles via an intermediate post 94 (Barone ¶0085); the flow activator may include one or more needles (Barone ¶0107), wherein needles are considered to read on a blade], whereas the trigger element is relatively movable to the plug [wherein as depicted in Barone Figs. 18-23, the rotary latch 30 is movable relative to the post 94], the trigger mechanism being configured to release the preloaded plug with the blade for perforating a user's skin for blood collection [As the rotary latch 30 presses on the deployment actuator 60, the deployment actuator 60 is actuated (e.g., the force exerted on the deployment actuator 60 is greater than the “trip” force of the deployment actuator, causing the deployment actuator to move from a first un-deployed state to a second deployed state. In some embodiments, the deployment actuator is a bi-stable element that inverts from a first stable state to a second stable state when the “trip” force is exceeded). The result is shown in FIG. 21, which depicts the flow activator 90 in the fully deployed state for insertion into a subject's skin (Barone ¶0115)], the trigger element further being arranged to be activated and moved relatively to the plug by an activation force created by a skin part being vacuum-sucked into the sample collection device and pressing directly or indirectly against the trigger element [vacuum may be generated during actuation of the device (Barone ¶0098); Next, as seen in FIG. 20, with the device actuator 10 fully depressed, the rotary latch pusher 32 has moved downward. Downward movement of the rotary latch pusher 32 causes the pusher 32 to push against the rotary latch 30, which causes the rotary latch 30 to rotate and move downward (Barone ¶0115), wherein the Examiner notes that the force acting to push the device actuator 10 is counteracted by the reaction force from the device of Barone being applied to skin, which is considered to read on the claimed activation force].
Regarding claim 2, Barone teaches
The trigger mechanism according to claim 1, wherein the trigger mechanism comprises at least one deformable and/or partially elastic element [a first arm of arms 232 (Barone Figs. 29A-C); the rotary latch 30 also has a plurality of arms 232, each having ends 233. The arms are cantilevered from the main body 239 of the rotary latch 30. The arms are shaped and made of a material such that the ends 233 deflect when the arm is subjected to a sufficient amount of force. As a result, the arms 232 behave like springs, each having a stiffness, also referred to as its k-value, or spring constant (Barone ¶0126)], which is configured and arranged to create at least partially a counterforce against the activation force [Once the rotary latch 30 has cleared the ledge surfaces of the protrusions, the arm ends 233 come into contact with the top surface of the carrier 50. The bottom surface 242 of the main body 239 of the rotary latch 30 is the surface that contacts the deployment actuator to “trip” and actuate the deployment actuator. Actuation of the deployment actuator is delayed until after the carrier 50 bottoms out against the base 100 due to contact between the arms 232 and the top surface of the carrier 50 (Barone ¶0128)].
Regarding claim 3, Barone teaches
The trigger mechanism according to claim 2, wherein the deformable and/or partially elastic element is a beam [Barone ¶0126, Figs. 29A-C].
Regarding claim 4, Barone teaches
The trigger mechanism according to claim 3, wherein the beam has a connecting end, which is connected to a main body of the trigger element, and a free end, wherein the free end has a smaller cross-section than the connecting end [see Annotated Fig. 1].
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Annotated Fig. 1. The Examiner notes that the arms 232 of Barone are considered to define a connecting end, which is connected to a main body of the trigger element [main body 239 of rotary latch 30 (Barone ¶0128, Fig. 29B)], and a free end, wherein the connecting end has a larger cross-section than the free end [wherein as annotated above, the connecting end is depicted as having a cross-section that gradually increases radially inwards towards the main body 239], such that a first arm of the arms 232 is considered to comprise the claimed features.
Regarding claim 5, Barone teaches
The trigger mechanism according to claim 4, wherein the deformable and/or elastic element has a cross section which is set to be minimum in the proximity of the end portion of the deformable and/or partially elastic element, and gradually increases towards the first end [see Annotated Fig. 1].
Regarding claim 6, Barone teaches
The trigger mechanism according to claim 4, wherein the trigger element has a main body and the beam is formed integrally on the main body [see arms 232 as formed on main body 239 (Barone Figs. 29A-C)].
Regarding claim 7, Barone teaches
The trigger mechanism according to claim 1, wherein the trigger element is arranged eccentrically and/or is asymmetrically formed [wherein as depicted in Barone Figs. 29A-C, the arms 232 are considered to be asymmetrically formed].
Regarding claim 8, Barone teaches
The trigger mechanism according to claim 5, wherein the trigger element has a slot formed between the main body of the trigger element and the beam [wherein as depicted in Barone Figs. 29A-C, a slot (space) is formed between a first arm of arms 232 and main body 239].
Regarding claim 9, Barone teaches
The trigger mechanism according to claim 8, wherein the slot has a first end and a second end, wherein a hook-shaped positioning portion is formed in the proximity of the second end of the slot [see Annotated Fig. 2].
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Annotated Fig. 2. The Examiner notes that a first arm 232 may be considered to define the beam, wherein as annotated above a slot is formed having a first end and a second end between the beam and the main body of the trigger element; and wherein a second arm 232 may define a “hook-shaped positioning portion”.
Regarding claim 12, Barone teaches
The trigger mechanism according to claim 1, wherein the trigger mechanism has a cap [carrier 50 (Barone Figs. 18-23); The deployment actuator 60, post 94, and flow activator 90, which are coupled to the carrier, are also moved downward as the carrier 50 moves downward (Barone ¶0115)].
Regarding claim 13, Barone teaches
The trigger mechanism according to claim 12, wherein the cap is arranged between trigger element and plug [wherein as depicted in Figs 18-23, the carrier 50 (cap) is disposed between the rotary latch 30 (trigger element) and plug (post 94)].
Regarding claim 14, Barone teaches
The trigger mechanism according to claim 12, wherein between cap and plug a spring is arranged, whereas the spring is configured and arranged to pre-load the plug [deployment actuator 60 (Barone Figs. 18-23); a deployment actuator 60 such as a snap dome or other bi-stable element (Barone ¶0085), wherein as depicted in Figs. 18-23, the deployment actuator 60 (spring) is positioned between the carrier 50 (cap) and the post 94 (plug); wherein a snap dome is considered to define a particular type of pre-loaded spring].
Regarding claim 15, Barone teaches
The trigger mechanism according to claim 9, wherein an opening is defined between the end portion of the deformable and/or partially elastic element and the hook-shaped positioning portion [see Annotated Figs. 1-2, wherein a space (opening) is considered to be depicted between the identified end portion of the deformable and/or partially elastic element and the hook-shaped positioning portion].
Regarding claim 19, Barone teaches
A sample collection device for extracting and collecting a sample of a fluid of a user, the sample collection device comprising:
- the trigger mechanism according to claim 1 [see § 102 rejection of claim 1 above];
- an outer shell [device cover 20 (Barone Fig. 4)];
- an inner shell having a pierceable membrane, wherein a pre-packaged vacuum is sealed in a first chamber defined between the outer shell and the inner shell [what is referred to as the “vacuum chamber” is this sealed space defined by the device cover, base and cap body. Vacuum is pre-packaged into this space such that the air pressure in the vacuum chamber is lower than the ambient pressure outside the device (Barone ¶0090); the flow controller is opened, e.g. by piercing a seal, opening fluid communication from the vacuum chamber 156 to the storage chamber 140, the channel 110, and the device opening 130 (Barone ¶0092)], and
- a partially elastically deformable push button section, including a center portion having a sharp piercing element for piercing the pierceable membrane of the inner shell when a pushing force is applied on the push button section, for allowing releasing of the vacuum in a second chamber, defined by the inner shell [a flow controller such as seal 76 prevents fluid communication between the vacuum chamber 156 and the section of the device open to ambient pressure (Barone ¶0091); the flow controller is opened, e.g. by piercing a seal, opening fluid communication from the vacuum chamber 156 to the storage chamber 140, the channel 110, and the device opening 130 (Barone ¶0092); vacuum may be generated during actuation of the device (Barone ¶0098); the piercing element 510 has pierced through the vacuum seal 76 that previously closed fluid communication between the device opening and the vacuum chamber. With the seal 76 pierced open, the vacuum chamber 156 is in fluid communication with the storage chamber 140 and the device opening 130 (Barone ¶0117), wherein the storage chamber 140 is considered to define the “second chamber”, wherein the Examiner notes that the naming “partially elastically deformable push button section” is not considered to impart any structural limitations on the section itself],
wherein, when the vacuum is released in the second chamber and the user's skin is deformed and at least partially sucked into the sample collection device, the trigger element is configured to be activated to release the preloaded plug for perforating the user's skin for fluid collection [Barone ¶¶0098, 0115].
Regarding claim 20, Barone teaches
A trigger element for a trigger mechanism according claim 1, comprising the trigger element features [see § 102 rejection of claim 1 above].
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) 10-11 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barone, as applied to claim 5 above, in view of Schwartz (US-20150374272-A1).
Regarding claim 10, Barone teaches
The trigger mechanism according to claim 5, wherein a pin is formed at an end portion of the deformable and/or elastic element and is configured to be applied onto a counterstructure for positioning and/or force control purpose [ends 233 (Barone Figs. 29A-C); The arms are shaped and made of a material such that the ends 233 deflect when the arm is subjected to a sufficient amount of force (Barone ¶0126); During actuation, the rotary latch 30 rotates off of these protrusions 51. Once the rotary latch 30 has cleared the ledge surfaces of the protrusions, the arm ends 233 come into contact with the top surface of the carrier 50 (Barone ¶0128), wherein the ends 233 (pin) is considered to be applied onto carrier 50].
However, while Barone discloses that the pin is configured to be applied onto a counterstructure for positioning and/or force control purpose, Barone fails to explicitly disclose wherein the pin is configured to be inserted into the counterstructure for positioning and/or force control purpose.
Schwartz discloses sample collection devices, wherein Schwartz discloses interfacing between a pin and a groove to control a position of the pin [a user slides on the front cap 20, with the inward protruding oppositely arranged projections 27, aligned with receiving portions or alignment grooves AL of the respective grooves G of the body 10. Thereafter, the user then partially rotates the front cap 20 so that the projections 27 engage with the helical portions of the grooves G (Schwartz ¶0105, Figs. 5-6)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanism of Barone to employ wherein the pin is configured to be inserted into the counterstructure for positioning and/or force control purpose, so as to facilitate the positioning of the pin.
Regarding claim 11, Barone in view of Schwartz teaches
The trigger mechanism according to claim 10, wherein the counterstructure is groove, especially groove in a cap [wherein based on the § 103 modification of claim 10 above, the ends 233 (pin) are configured to be inserted into the interfacing structure of the carrier 50, which may be considered to read on the claimed cap].
Regarding claim 17, Barone in view of Schwartz teaches
The trigger mechanism according to claim 10, wherein the pin is integrally formed with the deformable and/or partially elastic element [see ends 233 as formed on arms 232 (Barone Figs. 29A-C)].
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barone, as applied to claim 1, in view of Schiff (US-20120226123-A1).
Regarding claim 16, Barone teaches
The trigger mechanism according to claim 1.
However, while Barone discloses that the trigger element is activated with a force above a minimum force threshold [The device actuator 10 is compressed as a user presses down on the device actuator 10. The rotary latch pusher 32, which is in contact with the device actuator 10, starts to move downward in reaction to the device actuator 10 being pressed (Barone ¶0114); Downward movement of the rotary latch pusher 32 causes the pusher 32 to push against the rotary latch 30, which causes the rotary latch 30 to rotate and move downward (Barone ¶0115), wherein the force applied by the user pressing down on the device actuator 10 is considered to define a minimum force threshold], Barone fails to explicitly disclose wherein the trigger element is configured to be activated with a force between 2N and 5N.
Schiff discloses sample collection devices, wherein Schiff discloses an activation force defined by a pressing a skin part onto the sample collection device and pressing directly or indirectly against a trigger element for triggering a trigger element as being a result effective variable [For example, a spring may be used that compresses completely at a force of two pounds (8.9 newtons). Accordingly, the minimum force a user must apply prior to lancing is two pounds (8.9 newtons)… Requiring a user to apply a minimum force prior to lancing ensures that the skin conforms with the tip's inner angle, thereby raising the capillary bed. The pressure also causes the skin to stretch, thereby resulting in a larger wound than is created through conventional lancing, as well as facilitating expressing blood from the lanced site (Schiff ¶0045)] in that changing the activation force changes the conformity of skin as applied to the sample collection device and facilitates the expression of blood from a perforated site. Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success to in modifying the Barone trigger mechanism to have an activation force within the claimed range, as it only involves adjusting the minimum force threshold required to depress the device actuator 10 when the device is applied to skin. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the mechanism of Barone to employ wherein the trigger element is configured to be activated with a force between 2N and 5N as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentations.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barone in view of Schwartz, as applied to claim 11 above, in further view of Brancazio (US-20120123297-A1).
Regarding claim 18, Barone in view of Schwartz teaches
The trigger mechanism according to claim 11.
However, Barone in view of Schwartz fails to explicitly disclose wherein the cap and the plug are made of polypropylene and/or the trigger element is made of HDPE and/or polycarbonate.
Brancazio discloses sample collection devices comprising trigger mechanisms, wherein Brancazio discloses known materials for forming elements of the sample collection devices, including polypropylene and polycarbonate [In one set of embodiments, various components of the systems and devices of the invention can be formed of a polymer (Brancazio ¶0220); Other examples of potentially suitable polymers include, but are not limited to,… polycarbonate,… polypropylene (Brancazio ¶0221)].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the trigger mechanism of Barone in view of Schwartz to employ wherein the cap and the plug are made of polypropylene and/or the trigger element is made of HDPE and/or polycarbonate, as polypropylene and polycarbonate are known materials for forming elements of sample collections devices.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEVERO ANTONIO P LOPEZ whose telephone number is (571)272-7378. The examiner can normally be reached M-F 9-6 EST.
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/SEVERO ANTONIO P LOPEZ/Examiner, Art Unit 3791