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 Objections
The Claims are objected to because of the following informalities:
In Claim 3, the term “wherein the slide has a shape is selected from the group consisting of a concave slide, a rectangular slide, a rounded rectangular slide, or a V-shaped slide” should be replaced with -- wherein the slide has a shape [[is]] selected from the group consisting of a concave slide, a rectangular slide, a rounded rectangular slide, or a V-shaped slide. -- for grammatical clarity.
In Claim 17, the term “wherein the plunger and lancet elements are structured and arranged to translate through the collection cup subassembly to the blood sampling location” should be replaced with -- wherein the plunger and at least one lancet element are structured and arranged to translate through the collection cup subassembly to the blood sampling location--
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
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 13-15 and claims dependent thereon 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 pre-AIA the applicant regards as the invention.
Regarding Claims 13-15, the term “a housing" renders the claim indefinite because it this terms has been previously introduced for the collection cup subassembly. Thus subsequent uses of the phrases “the housing” in claims 13-15 could be in reference to “the housing” of the collection cup subassembly or “the housing” of the mid-body subassembly. Appropriate changes would include –a second housing-- and Examiner will be interpreting the claim as such.
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) 1-5, 7-10, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berthier et al (US 2016/0174888) (“Berthier 888”) in view of Krasnow et (US 2016/0256095) (“Krasnow 095”).
Regarding Claim 1, while Berthier 888 teaches a device for collecting blood from a mammalian subject without using spontaneous capillary blood flow (Abstract, device for collecting blood from a mammalian subject [0096]-[0097] motivates the use of gravity as a directing force for blood, [0108]-[0110] where modifying the width of the fluidic channels change its reliance on either capillary blood flow or gravitational force, [0102] the system can be configured to rely solely on gravity, and thus collects without using spontaneous capillary blood flow as confirmed in [0142], Fig. 5A, [0136]-[0138]), the device comprising:
a collection cup subassembly (Figs. 1A-1F, 2A-2F, [0102], Figs. 5A-5E, [0136]-[0137] device 400 acts as collection subassembly) comprising:
a housing (Figs. 5A-5E, device 400 shown with a housing); and
a slide structured and arranged in the housing for transporting blood down and away from a blood sampling location (Figs. 5A-5E, first microfluidic channel is a ramp 424 / slide); and
a plunger subassembly couplable to the collection cup for creating a negative pressure in the housing of the collection cup subassembly (Figs. 1A-1F, 2A-2F, [0102], Figs. 5A-5E, [0137] actuator 404 acts as plunger subassembly, coupled to device 400, where a decreased pressure from actuation of the actuator 404 within device 400 enhances fluid flow, by creation of negative pressure), thereby causing the blood to flow into a blood sample container ([0102], [0136] reservoir),
Berthier 888 fails to teach the collection cup subassembly comprising a cantilevered slide.
However Krasnow teaches an automated blood sampling device (Abstract) comprising the use of negative pressure ([0042]) and teaches a cantilevered structure that guides fluid away from the skin opening (Fig. 4, [0059] stores blood in blood storage element 440, shown in the figure as a cantilevered structure).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the ramp of Berthier 888 be a cantilevered structure with a free end as taught by Krasnow as a simple substitution of one form of configuring a blood flow directing component adjacent the skin (Berthier 888: a diagonal structure integrated into the wall of the housing) for another (Krasnow: a diagonal structure extending from the wall of the housing) to obtain predictable results of directing blood a preset distance and angle away from the skin opening.
Regarding Claim 2, Berthier 888 and Krasnow teach the device of claim 1, wherein the slide is cantilevered (See Claim 1 Rejection) at an obtuse angle from an opening in the housing of the collection cup subassembly (See Claim 1 Rejection, the ramp of Berthier 888, shown in Figs. 3B. 3C. 5D, 5E, 6A, shown at an obtuse angle relative to the opening of the housing).
Regarding Claim 3, Berthier 888 and Krasnow teach the device of claim 1, wherein a channel connected to the slide has a shape selected from the group consisting of a concave slide, a rectangular slide, a rounded rectangular slide, or a V-shaped slide (Fig. 6A-6B, [0141]-[0142] the channel continuous from ramp 424 shown to be a rectangular slide), their combined efforts fail to explicitly teach the slide has slide a shape selected from the group consisting of a concave slide, a rectangular slide, a rounded rectangular slide, or a V-shaped slide
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the cantilevered slide of Berthier 888 and Krasnow to utilize a rectangular shape as Berthier 888 has noted this as a shape that facilitates blood collection.
Regarding Claim 4, Berthier 888 and Krasnow teach the device of claim 1, and Krasnow teaches wherein a hydrophobic agent is applied to the fluid directing components ([0047]) and a fluid directing component is the slide (See Claim 1 Rejection).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the cantilevered slide of Berthier 888 and Krasnow to utilize a hydrophobic agent as Krasnow teaches that such a coating can enhance desired blood flow guidance ([0047]).
Regarding Claim 5, Berthier 888 and Krasnow teach the device of claim 1, wherein the collection cup subassembly further comprises a plurality of sidewall elements that are formed within and about at least one opening in the housing and that are structured and arranged to funnel blood from the blood sampling location to the slide (Figs. 1D and 2A, [0103], [0128] collection sites connect to microfluidic channels that funnel blood to the fluid reservoir 104, where the slide is an intermediate component in that guidance).
Regarding Claim 7, Berthier 888 and Krasnow teach the device of claim 1, wherein the housing of the collection cup subassembly comprises a connection opening structured and arranged for releasably connecting the blood sample container to the housing of the collection cup subassembly ([0102] device 400 / collection cup subassembly comprising a connection opening / coupling portion skirt 410 structured and arranged for releasably connecting the blood sample container / reservoir 402 to the housing of the collection cup subassembly).
Regarding Claim 8, Berthier 888 and Krasnow teach the device of claim 1, wherein the housing of the collection cup subassembly comprises at least one opening formed therethrough for placement against the epidermis of the subject (Figs. 1D and 2A, [0103], [0128] collection sites).
Regarding Claim 9, Berthier 888 and Krasnow teach the device of claim 8, wherein the at least one opening comprises a plurality of openings (See Claim 8 Rejection).
Regarding Claim 10, Berthier 888 and Krasnow teach the device of claim 9, further comprising a blood diverter configured to divert blood flow originating from a first opening of the plurality of openings around a second opening of the plurality of openings (See Claim 8 Rejection, [0128] branched channels divert blood flow from a first opening in a controlled manner around other openings).
Regarding Claim 16, Berthier 888 and Krasnow teach the device of claim 1, wherein the plunger subassembly comprises:
a first end and a second end;
a plunger formed at the second end; and
at least one lancet element attached to the plunger (Fig. 1D, [0104]-[0105] unseen top of actuator 110 acts as first end, shown bottom of actuator 110 acts as second end, where the whole assembly is noted as a plunger 18, thus indicating that the plunger is formed at the second end. Further, the lancet elements 30 attach to the plunger at the second end as shown in the Figure).
Regarding Claim 17, Berthier 888 and Krasnow teach the device of claim 16, wherein the plunger and lancet elements are structured and arranged to translate through the collection cup subassembly to the blood sampling location ([0105]-[0106]).
Regarding Claim 18, Berthier 888 and Krasnow teach the device of claim 16, wherein the plunger subassembly further comprises a base portion formed at the first end (See Claim 16 Rejection, [0104]-[0106] the first end of actuator 110 corresponds to a base portion).
Claim(s) 6 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berthier 888 in view of Krasnow and further in view of Berthier et al (US 2020/0085414) (“Berthier 414”) as noted in Applicant IDS dated 5/28/2025.
Regarding Claim 6, while Berthier 888 and Krasnow teach the device of claim 1, their combined efforts fail to teach wherein the collection cup subassembly further comprises a one-way valve disposed in the housing for creating the negative pressure within a plenum space within the housing.
However Berthier 414 teaches a blood collection device (Abstract) comprising a collection cup subassembly and a plunger subassembly ([0043] housing 102 / collection cup subassembly and actuator 104 / plunger subassembly), wherein the collection cup subassembly further comprises a one-way valve disposed in the housing for creating the negative pressure within a plenum space within the housing ([0051] one-way valve 128 that facilitates vacuum generation through plunger 122 actuation).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have the device of Berthier 888 and Krasnow include a one-way valve as taught by Berthier 414 as the one-way valve supports the creation of a pressure differential in Berthier 888.
Regarding Claim 11, while Berthier 888 and Krasnow teach the device of claim 10, their combined efforts fail to teach wherein blood flow is diverted along a path that exceeds 2 mm.
However Berthier 414 teaches a blood collection device (Abstract) comprising a collection cup subassembly and a plunger subassembly ([0043] housing 102 / collection cup subassembly and actuator 104 / plunger subassembly), wherein the openings of the collection cup subassembly can be between 3 and 30 mm ([0131]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to note that the device of Berthier 888 and Krasnow could set the opening sizes to exceed 2 mm as taught by Berthier 414 as a size to provide sufficient surface area to draw blood through (Berthier 414: [0131]). And utilizing fluidic channels around openings of 3-30 mm to divert blood flow as taught by Berthier 888 would indicate that the diversion path exceeds 2 mm.
Claim(s) 12-15 and 19-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berthier 888 in view of Krasnow and further in view of Berthier et al (US 2017/0172481) (“Berthier 481”).
Regarding Claim 12, while Berthier 888 and Krasnow teach the device of claim 1, their combined efforts fail to teach the device further comprising:a mid-body subassembly couplable to the collection cup subassembly and comprising a housing having a proximal end and a distal end and defining a plenum space.
However Berthier 481 teaches a blood collection device (Abstract) comprising a collection cup subassembly and a plunger subassembly (Figs. 10A-10C, [0066], [0074]-[0075] base 110 / collection cup subassembly and a plunger 90 and membrane 80 / plunger subassembly), and further including a mid-body subassembly couplable to the collection cup subassembly and comprising a housing having a proximal end and a distal end and defining a plenum space (Fig. 2A, actuator 40 that couples to the base 110 / collection cup subassembly through housing 12, with a proximal end / top button surface 42 and a distal end opposite, the actuator 40 surrounding the plunger subassembly and thus defining a plenum space).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to configure the plunger subassembly of Berthier 888 to further include a separate actuator 40 as taught by Berthier 481 as it provides a locking mechanism to prevent undesired actuation of the plunger ([0082]-[0084]).
Regarding Claim 13, Berthier 888, Krasnow, and Berthier 481 teach the device of claim 12, wherein the mid-body subassembly further comprises a pair of opposing tabs formed at the distal end of the housing, wherein the opposing tabs are configured to retain at least one biasing element (Fig. 3A-3D, [0083] actuator arms 50 comprise at least a pair of opposing tabs formed at the distal of the housing of actuator 40, wherein the opposing tabs are configured to retain at least one biasing element by surrounding the biasing element within the plunger subassembly and by performing the locking of the actuation mechanism).
Regarding Claim 14, Berthier 888, Krasnow, and Berthier 481 teach the device of claim 12, and Krasnow teaches wherein the biasing element comprises a pair of springs specific to each lancet ([0051]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to substitute the plunger subassembly with a single spring of Berthier 888 with biasing elements specific to each lancet as taught by Krasnow as a simple substitution of form of biasing multiple lancets (Berthier 888: a singular spring surrounding all of the lancets) for another form of biasing multiple lancets (Krasnow: multiple springs surrounding each specific lancet) to obtain the predictable results of appropriate guided lancets.
Regarding Claim 15, Berthier 888, Krasnow, and Berthier 481 teach the device of claim 12, wherein the mid-body subassembly further comprises a tab formed at the proximal end of the housing for retaining a plunger within the plenum space ([0065], [0079] tabs / threshold stops 45 formed at a proximal end of the housing of mid-body subassembly to maintain the plunger in the ready position, where the actuator surrounds the plunger subassembly and thus retains the plunger within the plenum space).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to include the threshold stops of Berthier 481 with the device of Berthier 888, Krasnow, and Berthier 481 to enable a locking of a ready position taught in Berthier 481 as a preliminary step to ready the device, reducing the potential for accidental activations.
Regarding Claim 19, while Berthier 888 and Krasnow teach the device of claim 18, teaches the system comprising a biasing element ([0107] spring 24) and implies the base portion comprises a pair of protrusions that are structured and arranged to retain a biasing element (Fig. 1D, between the exterior walls of 110 and a raised structure behind face 28, there appears to be a gap that could interface with spring 24), their combined efforts fail to explicitly teach the base portion comprises a pair of protrusions that are structured and arranged to retain a biasing element.
However Berthier 481 teaches a blood collection device (Abstract) comprising a collection cup subassembly and a plunger subassembly (Figs. 10A-10C, [0066], [0074]-[0075] base 110 / collection cup subassembly and a plunger 90 and membrane 80 / plunger subassembly), with a base top portion of the plunger subassembly (Figs. 10A-10C), where the base portion comprises a pair of protrusions that are structured and arranged to retain a biasing element (Figs. 10A-10C, an inner wall of membrane 80 and outer wall of plunger 90 extend from the base portion to act as a pair of protrusions that are structured and arranged to retain a biasing element / spring 100).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to apply the retaining structure by a pair of protrusions taught by Berthier 481 to the system of Berthier 888 as a confirmed way to retain a plunger device with the blood collection structure provided in the base portion of Berthier 888.
Regarding Claim 20, Berthier 888, Krasnow, and Berthier 481 teach the device of claim 16, wherein the plunger is structured and arranged to create the negative pressure in the housing of the collection cup subassembly ([0137]).
Regarding Claim 21, Berthier 888, Krasnow, and Berthier 481 teach the device of claim 16, and Bernier 481 wherein the plunger subassembly further comprises at least one sealing device disposed about the plunger ([0066], [0097] membrane 80 / sealing device disposed about the plunger 90 facilitates the creation of the vacuum).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to set a sealing membrane about the plunger as taught by Berthier 481 for the plunger subassembly of 888 as a way to facilitate the creation of the vacuum in Berthier 481.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 16 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 20 of U.S. Patent No. 11,478,175. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are only clearly differentiated by the allowed claims including a tab for retaining the plunger subassembly – a limitation that is impertinent to the negative pressure generation of the plunger assembly.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791