DETAILED ACTION
This office action is responsive to the amendment filed 2/13/2026. Claims 1-4 and 7-29 remain pending and under prosecution.
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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the locking mechanism of Claims 24-25 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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 Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“movable element” in claims 15, 20, and 26 – appears to refer to inner chamber housing 2419 in Figure 24B;
“stopping element” in claim 26 – appears to refer to tangs 2421, best seen in Figure 24C-D.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4 and 7-29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In regard to Claim 1, the recitation of “movable seal” is not adequately supported by the disclosure. As best understood, the instant invention is drawn to the embodiment found in Figure 24A-D, which comprises housing 2416 with inner chamber housing 2419, which moves between a first and second position to direct the blood flow into the chamber and then the blood sampling channel, respectively. While the inner chamber housing is clearly movable, the term “seal” implies to a skilled artisan a specific mechanism, often including a fluid tight closure, such as from gas or liquid. Additionally, a seal is typically formed due to the accompanying structure or material of the adjoining structures. For example see https://www.merriam-webster.com/dictionary/seal. The disclosure does not provide support for the specificity of such fluid tight closure, in function or structure. As such, usage of the term “seal” in the element movable seal, fails the written description requirement.
Similar lack of written description is found in the dependent claims such as Claim 14 off claim 1, as well as Claims 19 and 23, which also recite the “seal” function. It is noted that in the rejection below, the art is applied accordingly, in other words, without requiring a specific seal function or structure.
In regard to Claim 1, the recitation of “the movable seal configured to transition to a second state due to an increase [emphasis added] in a pressure differential across the movable seal” is not adequately supported by the disclosure.
Paragraph 0143 of the filed specification states “As the initial aliquot of blood flows into the blood sequestration chamber, it displaces air therein and eventually the blood contacts the blood barrier 2420, forcing the inner chamber housing to the second position. The inner chamber housing 2419 and/or housing 2416 can include a locking mechanism of one or more small tabs, grooves, detents, bumps, ridges, or the like, to maintain the inner chamber housing 2419 in the first position until the blood sequestration chamber 2418 is filled, providing force to overcome the locking mechanism to enable movement of the inner chamber housing 2419 to the second position.”
While the above paragraph states that a force is used to overcome the locking mechanism to allow the inner chamber housing to move, the disclosure does not state that the movement is specifically “due to an increase in a pressure differential across the movable seal.” Additionally, it is unclear how a pressure differential would structurally cause the movable seal to move from the first position to the second position, as the direction/location of the pressure differential, its increase, and its interactions with the inner chamber housing have not been elaborated.
While the claim states that “the increase in the pressure differential across the movable seal is a result of the volume of blood in the chamber limiting gas flow through the blood barrier,” this has also not been described in regard to Figure 24A-D. As noted in the 112b rejection below, it is unclear where the pressure differential exists, how it increases, and why gas flow is limited. Thus, the recitation appears to fail the written description requirement.
Claim 15 similarly lacks adequate support in the disclosure as reciting “a movable element configured to perform a movement based on a pressure differential across the movable element due to blood filling the chamber” (emphasis added) because the specification does not sufficiently support the movement of the movable element is “due to” the blood filling the chamber.
Claim 20 similarly lacks adequate support in the disclosure as reciting “a movable element configured to perform a movement based on a force applied to the movable element from a pressure differential across the movable element” (emphasis added) because the specification does not provide sufficient support for the force on the movable element is “from” the pressure differential.
Claim 26 similarly lacks adequate support in the disclosure as reciting “a movable element configured to perform a linear movement in response to a pressure differential across the movable element caused by blood filling the chamber” (emphasis added) because the specification does not provide sufficient support for the filling the chamber with blood “causes” the linear movement.
Claim 27 similarly lacks adequate support in the disclosure as reciting “the linear movement is due to a pressure differential between the inlet port and the outlet port” (emphasis added).
In regard to Claim 7, the movable seal is recited as formed from an elastomeric material. However, there is no disclosure of the inner chamber housing 2419 in Figure 24A-D being formed of an elastomeric material. Therefore, the claim fails the written description requirement.
In regard to Claims 18, 22, and 29, the recitation of “the movable element comprises the material and the pressure differential across the material causes the movement” is not supported by the disclosure.
Claims 2-4, 8-13, 16-17, 21, 24-25, and 28 are rejected by dependence on the above claims.
If support does exist for the above limitations, applicant is requested to point out where in the specification said disclosure exists.
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 1-4 and 7-29 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.
In regard to Claim 1, the recitation “the increase in the pressure differential across the movable seal is a result of the volume of blood in the chamber limiting gas flow through the blood barrier” is indefinite because it is unclear what or where “the pressure differential across the movable seal” specifically refers to, and how this is “increased.” It is noted that the specification does not elaborate or even mention any change in the pressure differential, as noted in the 112a rejection above. It is further noted that a pressure differential must be defined between two reference points. Since this has not been defined, it is unclear where or how the pressure differential exists, and how it is increased, despite the claim reciting that it is a result of blood in the chamber limiting gas flow through the blood barrier, since this limitation has also not been found in the disclosure (see 112a rejection above).
Similar indefiniteness is found with respect to Claims 18, 22, and 29 because all recite “the pressure differential (force) across the material causes the movement,” which presents the same issue of lack of clarity of how and where the pressure differential exists across the blood barrier material and how it “causes” the movement as recited. Clarification is requested.
In regard to Claim 15, the recitation of “a movable element configured to perform a movement based on a pressure differential across the movable element due to blood filling the chamber” is similarly indefinite because it is unclear how the movable element performs a movement “due to” blood filling the chamber, as this has not been adequately supported by the disclosure. See 112(a) rejection above.
In regard to Claim 20, the recitation of “a force applied to the movable element from a pressure differential across the movable element” is similarly indefinite because it is unclear how a force is applied “from” a pressure differential “across the movable element” as described above. Also see 112(a) rejection above.
In regard to Claim 26, the recitation of “a movable element configured to perform a linear movement in response to a pressure differential across the movable element caused by blood filling the chamber” is similarly indefinite because it is unclear how blood filling the chamber “causes” the linear movement of the movable element as described above. Also see 112(a) rejection above.
Claims 2-4, 7-14, 16-17, 19, 21, 23-25, and 27-28 are rejected by virtue of dependence on the above claims.
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) 15-16, 19-20, and 23-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bullington et al (US Pub No. 20140163419). Bullington et al in view of Andersen (US Pat No. 4519402).
In regard to Claim 15, Bullington et al disclose a device, comprising:
an inlet port 405, best seen in Figure 12 (0081, 0089);
an outlet port 402 (proximal end portion of housing 401), best seen in Figure 13-15 (0085);
a chamber 480 (first fluid reservoir) connected with the inlet port, best seen in Figure 14 (0079, 0091);
a sampling channel 433 (second lumen) connected with the inlet port, best seen in Figure 15 (0095); and
a movable element 430, 431, 435 (flow control mechanism first member 431 controlled by member 435), the movable element also defined by plunger 476 (0084 – Figure 13-15),
configured to perform a movement based on a pressure differential across the movable element, i.e. movement of plunger 476 is based on creating a negative pressure which happens as blood is filling the chamber – “Expanding further, the negative pressure within the first reservoir 480 produced by the movement of the plunger 476 (as indicated by the arrow II) introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480. In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants” (0092),
the movement being from a first position – plunger 476 begins in the position shown in Figure 13 and moves to the position in Figure 14 –
that allows the chamber 480 to receive a first portion of blood – “the proximal motion of the second member 451 moves the plunger 476 of the first member 470 in the proximal direction relative to the shunt tube 471… increases the volume of the portion of the inner volume 411 of the housing 401 that is distal of the plunger 476, thereby defining the first reservoir 480, as shown in FIG. 14. With the plunger 476 forming a fluid tight seal with the inner surface of the walls defining the inner volume 411 and with the shunt tube 471 about which the plunger 476 is disposed, the volume increase of the portion of the inner volume 411 can produce a negative pressure within the first reservoir 480” (0079, 0091); “Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092),
to a second position – plunger 476 in the position of Figures 14-15 – that creates a pathway from the inlet port to the sampling channel that allows blood through the sampling channel 433, best seen in Figure 15 – moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 405 such that “a desired amount of bodily-fluid is drawn through the port 405, the second lumen 433 of the flow control mechanism 430, the second lumen 407 of the diverter 409, and the lumen 475 defined by the shunt tube 471 and into the second reservoir 490. Moreover, the bodily-fluid disposed within the second reservoir 490 is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the first reservoir 480” (0082, 0083, 0095, 0097). Also see 112(a)/(b) rejections above.
16. The device of claim 15, wherein the pressure differential is between the inlet port 405 and the outlet port 402, due to plunger 476 positioned therebetween, best seen in Figure 13-15.
19. The device of claim 15, wherein the movable element 430, 431, 435, 476 seals the sampling channel from receiving blood when the movable element is in the first position – in the first position, moving member 435 rotates first member 431 such that lumen 433 (sampling channel) is fluidically isolated, due to lumen 432 of the flow control mechanism aligned with the inlet port 405, which leads through lumen 406 in diverter 409 and into chamber 480. Plunger 476 also seals by nature of its function, best seen in Figure 13-15. See 112(a) rejection above.
In regard to Claim 20, Bullington et al disclose a device, comprising:
an inlet port 405, best seen in Figure 12 (0081, 0089);
an outlet port 402 (proximal end portion of housing 401), best seen in Figure 13-15 (0085);
a chamber 480 (first fluid reservoir) connected with the inlet port, best seen in Figure 14 (0079, 0091);
a sampling channel 433 (second lumen) connected with the inlet port, best seen in Figure 15 (0095); and
a movable element 430, 431, 435 (flow control mechanism first member 431 controlled by member 435), the movable element also defined by plunger 476 (0084 – Figure 13-15),
configured to perform a movement based on a force applied to the movable element from a pressure differential across the movable element – i.e. movement of plunger 476 is based on creating a negative pressure – “Expanding further, the negative pressure within the first reservoir 480 produced by the movement of the plunger 476 (as indicated by the arrow II) introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480. In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants” (0092),
due at least in part to a first portion of blood contacting the movable element – movement of plunger 476 occurs when the user applies force to proximally move the plunger and is due at least in part to blood contacting the plunger, which occurs at least at some point of the filling of the chamber 480 with the first portion of blood – “Therefore, the first reservoir 480 is placed in fluid communication with the portion of the patient (e.g., the vein). Expanding further, the negative pressure within the first reservoir 480 produced by the movement of the plunger 476 (as indicated by the arrow II) introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092), additionally –
“the flow control mechanism 430 can be configured to automatically move from the first configuration to the second configuration to divert fluid flow without user intervention” (0094) – movement of flow control mechanism 430 occurs based on a force applied by the user to the flow control mechanism 430, which occurs after and is thus due at least in part to a first portion of blood contacting the plunger 476 portion of the movable element to change the flow mechanism to the configuration in Figure 15 from Figure 14,
the movement being from a first position – plunger 476 begins in the position shown in Figure 13 and moves to the position in Figure 14; additionally – moving member 435 rotates first member 431 such that lumen 433 (sampling channel) is fluidically isolated, due to lumen 432 of the flow control mechanism aligned with the inlet port 405, which leads through lumen 406 in diverter 409 and into chamber 480 –
that allows the chamber 480 to receive a first portion of blood – “the proximal motion of the second member 451 moves the plunger 476 of the first member 470 in the proximal direction relative to the shunt tube 471… increases the volume of the portion of the inner volume 411 of the housing 401 that is distal of the plunger 476, thereby defining the first reservoir 480, as shown in FIG. 14. With the plunger 476 forming a fluid tight seal with the inner surface of the walls defining the inner volume 411 and with the shunt tube 471 about which the plunger 476 is disposed, the volume increase of the portion of the inner volume 411 can produce a negative pressure within the first reservoir 480” (0079, 0091); “Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092),
to a second position – plunger 476 in the position of Figures 14-15, moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 40 –
that allows blood through the sampling channel 433, best seen in Figure 15 – moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 405 such that “a desired amount of bodily-fluid is drawn through the port 405, the second lumen 433 of the flow control mechanism 430, the second lumen 407 of the diverter 409, and the lumen 475 defined by the shunt tube 471 and into the second reservoir 490. Moreover, the bodily-fluid disposed within the second reservoir 490 is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the first reservoir 480” (0082, 0083, 0095, 0097). Also see 112(a)/(b) rejections above.
23. The device of claim 20, wherein the movable element 430, 431, 435, 476 seals the sampling channel from receiving blood when the movable element is in the first position – in the first position, moving member 435 rotates first member 431 such that lumen 433 (sampling channel) is fluidically isolated, due to lumen 432 of the flow control mechanism aligned with the inlet port 405, which leads through lumen 406 in diverter 409 and into chamber 480. Plunger 476 also seals by nature of its function, best seen in Figure 13-15. Also see previous 112(a) rejection.
24. The device of claim 20, the device further comprising a locking mechanism 474 configured to maintain the movable element 476 in the first position – “a protrusion 474 that is configured to engage the plunger 476 to substantially limit a proximal movement of the plunger 476 relative to the shunt tube 471,” best seen in Figure 13-14 (0085, 0091, 0096).
25. The device of claim 24, wherein the locking mechanism 474 comprises one or more small tabs, grooves, detents, bumps, or ridges, best seen in Figure 13-14 (0085).
In regard to Claim 26, Bullington et al disclose a device, comprising:
an inlet port 405, best seen in Figure 12 (0081, 0089);
an outlet port 402 (proximal end portion of housing 401), best seen in Figure 13-15 (0085);
a chamber 480 (first fluid reservoir) connected with the inlet port, best seen in Figure 14 (0079, 0091);
a sampling channel 433 (second lumen) connected with the inlet port, best seen in Figure 15 (0095); and
a movable element 430, 431, 435 (flow control mechanism first member 431 controlled by member 435), the movable element also defined by plunger 476 (0084 – Figure 13-15),
configured to perform a linear movement (proximal motion of plunger 476) in response to a pressure differential across the movable element caused by blood filling the chamber – i.e. linear movement of plunger 476 creates a negative pressure across the plunger caused by blood filling the chamber – “Expanding further, the negative pressure within the first reservoir 480 produced by the movement of the plunger 476 (as indicated by the arrow II) introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480. In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants” (0092), best seen in Figure 13-15,
the linear movement being from a first position – plunger 476 begins in the position shown in Figure 13 and moves to the position in Figure 14 –
that allows the chamber 480 to receive a first portion of blood – “the proximal motion of the second member 451 moves the plunger 476 of the first member 470 in the proximal direction relative to the shunt tube 471… increases the volume of the portion of the inner volume 411 of the housing 401 that is distal of the plunger 476, thereby defining the first reservoir 480, as shown in FIG. 14. With the plunger 476 forming a fluid tight seal with the inner surface of the walls defining the inner volume 411 and with the shunt tube 471 about which the plunger 476 is disposed, the volume increase of the portion of the inner volume 411 can produce a negative pressure within the first reservoir 480” (0079, 0091); “Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092),
to a second position – plunger 476 in the position of Figures 14-15 – that allows blood through the sampling channel 433, best seen in Figure 15 – moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 405 such that “a desired amount of bodily-fluid is drawn through the port 405, the second lumen 433 of the flow control mechanism 430, the second lumen 407 of the diverter 409, and the lumen 475 defined by the shunt tube 471 and into the second reservoir 490. Moreover, the bodily-fluid disposed within the second reservoir 490 is fluidically isolated from the first, predetermined amount of bodily-fluid contained within the first reservoir 480” (0082, 0083, 0095, 0097),
the movable element 476 comprising a stopping element 474 configured to engage a surface to stop the movable element to at least temporarily maintain the movable element in the second position, best seen in Figure 14-15 – “a protrusion 474 that is configured to engage the plunger 476 to substantially limit a proximal movement of the plunger 476 relative to the shunt tube 471” (0085). Also see 112(a)/(b) rejections above.
27. The device of claim 26, wherein the linear movement is due to a pressure differential between the inlet port 405 and the outlet port 402 – plunger 476 performs linear movement and a pressure differential exists between the inlet port and the out let port – “Expanding further, the negative pressure within the first reservoir 480 produced by the movement of the plunger 476 (as indicated by the arrow II) introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092). Also see 112a rejection 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.
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) 1-4, 8-14, 17-18, 21-22, and 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Bullington et al in view of Andersen (US Pat No. 4519402).
In regard to Claim 1, 17, 21, and 28, Bullington et al disclose a device, comprising:
a housing 401 having an inlet 405 and an outlet 402 (proximal end portion of housing 401 – 0085), best seen in Figure 12-15 – “distal end portion 403 of the housing 401 includes a port 405 and a diverter 409” (0081);
a chamber 480 (first fluid reservoir) connected with the inlet, best seen in Figure 14 (0079, 0091);
a sampling channel 433 (second lumen) connected with the inlet, best seen in Figure 15 (0095); and
a movable seal 430, 431, 435 (flow control mechanism first member 431 controlled by member 435), the movable element also defined by plunger 476 (0084 – Figure 13-15), disposed between the inlet and a portion of the sampling channel – portions 430, 431 of movable seal is between the inlet and a portion of the sampling channel, best seen in Figure 13-15,
in a first state, to separate the inlet 405 from the portion of the sampling channel 433 – moving member 435 rotates first member 431 such that lumen 433 (sampling channel) is fluidically isolated, due to lumen 432 of the flow control mechanism aligned with the inlet 405, which leads through lumen 406 in diverter 409 and into chamber 480, best seen in Figure 14 (0081, 0092),
such that a pressure differential between the inlet and the outlet – caused by moving plunger 476 proximally as seen in Figure 13-14 – causes a volume of blood to flow into the chamber 408 – “Therefore, the first reservoir 480 is placed in fluid communication with the portion of the patient (e.g., the vein). Expanding further, the negative pressure within the first reservoir 480 produced by the movement of the plunger 476 (as indicated by the arrow II) introduces a suction force within the portion of the patient. Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480” (0092),
the movable seal configured to transition to a second state due to an increase in a pressure differential across the movable seal to form a pathway from the inlet port to the sampling channel – plunger 476 in the position of Figures 14-15, moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 40 such that “a desired amount of bodily-fluid is drawn through the port 405, the second lumen 433 of the flow control mechanism 430, the second lumen 407 of the diverter 409, and the lumen 475 defined by the shunt tube 471 and into the second reservoir 490” (0082, 0083, 0095, 0097). Also see 112a, b rejections above.
However, Bullington et al do not expressly disclose a blood barrier disposed in the housing between the chamber and the outlet, the blood barrier being gas permeable and blood impermeable.
Andersen teach that it is well-known in the art to provide an analogous device (syringe) comprising a blood barrier disposed in the housing between the chamber and the outlet, the blood barrier being gas permeable (pervious to gas) and blood impermeable (impervious to liquid) to enable venting of gas as well as automatic stopping of the flow of blood into the chamber because “the flow of blood into the syringe is automatically stopped when the sample collecting chamber of the syringe has been filled, because blood cannot pass the liquid impervious material arranged in the recesses” (abst).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing such that Bullington et al includes a blood barrier disposed in the housing between the chamber and the outlet, the blood barrier being gas permeable and blood impermeable, as taught by Andersen, to effectively enable venting of gas as well as automatic stopping of the flow of blood into the chamber due to the pressure differential between the inlet and outlet that causes a gas to flow from the chamber through the blood barrier of Andersen and a volume of blood to flow into the chamber, wherein the increase in the pressure differential across the movable seal is a result of the volume of blood in the chamber limiting gas flow through the blood barrier, as suggested by Andersen. Also see 112a, b rejections above.
2. Bullington et al disclose the device of claim 1, wherein the inlet 405 is configured to be fluidically coupled to a patient (0089, 0092).
3. Bullington et al disclose the device of claim 1, wherein the outlet 402 is configured to be fluidically coupled to a fluid collection device 451, best seen in Figure 14 (0079).
4. Bullington et al disclose the device of claim 3, wherein fluidically coupling the outlet 402 to the fluid collection device 451 generates the pressure differential between the inlet and the outlet – “The arrangement of the actuator mechanism 440 is such that the proximal motion of the second member 451 moves the plunger 476 of the first member 470 in the proximal direction… Moreover, the proximal movement of the plunger 476 increases the volume of the portion of the inner volume 411 of the housing 401 that is distal of the plunger 476, thereby defining the first reservoir 480, as shown in FIG. 14. With the plunger 476 forming a fluid tight seal with the inner surface of the walls defining the inner volume 411 and with the shunt tube 471 about which the plunger 476 is disposed, the volume increase of the portion of the inner volume 411 can produce a negative pressure within the first reservoir 480” (0091).
8. Bullington et al disclose the device of claim 1, further comprising: a lock 474 configured to engage the movable seal 476 to at least temporarily maintain the movable seal in the second state – “a protrusion 474 that is configured to engage the plunger 476 to substantially limit a proximal movement of the plunger 476 relative to the shunt tube 471,” best seen in Figure 13-14 (0085, 0091, 0096).
9. Bullington et al disclose the device of claim 1, wherein the movable seal 430, 431, 435 is configured, in the second state, such that the sampling channel 433 defines a portion of a flow path between the inlet 405 and the outlet 402 that receives a subsequent volume of blood, i.e. into second reservoir 490, best seen in Figure 15 (0097).
10. Bullington et al disclose the device of claim 9, wherein the housing 401 is configured such that the chamber 480 contains the volume of blood to limit contamination of the subsequent volume of blood that flows through the flow path, which reduces false results in culture testing of the subsequent volume of blood – “Thus, a bodily-fluid is drawn through the port 405, the first lumen 432 defined by the flow control mechanism 430, and the first lumen 406 defined by the diverter 409 and into the fluid reservoir 480. In some embodiments, the bodily-fluid can contain undesirable microbes such as, for example, dermally-residing microbes and/or other external contaminants” (0092).
11. Bullington et al disclose the device of claim 1, wherein the transition of the movable seal 430, 431, 435, 476 from the first state to the second state includes the movable seal being moved from a first position – plunger 476 begins in the position shown in Figure 13 and moves to the position in Figure 14; additionally – moving member 435 rotates first member 431 such that lumen 433 (sampling channel) is fluidically isolated, due to lumen 432 of the flow control mechanism aligned with the inlet port 405, which leads through lumen 406 in diverter 409 and into chamber 480 (0082, 0083, 0092),
to a second position – plunger 476 in the position of Figures 14-15, moving member 435 rotates first member 431 such that lumen 433 is aligned with inlet port 40, best seen in Figure 15 (0082, 0083, 0095, 0097).
12. Bullington et al disclose the device of claim 1, the housing 401 defining each of the chamber 480 and the sampling channel 433, best seen in Figure 12 and 14.
13. Bullington et al disclose the device of claim 12, wherein the housing 401 has an inner surface that defines each of the chamber 480 and the sampling channel 433, best seen in Figure 12 and 14.
14. Bullington et al disclose the device of claim 13, wherein the movable seal 430, 431, 435, 476 in the first state forms a seal with a portion of the inner surface to prevent the volume of blood from flowing through the sampling channel – in the first state, moving member 435 rotates first member 431 such that lumen 433 (sampling channel) is fluidically isolated, due to lumen 432 of the flow control mechanism aligned with the inlet port 405, which leads through lumen 406 in diverter 409 and into chamber 480. Plunger 476 also seals by nature of its function, best seen in Figure 13-15.
18. Bullington et al in combination with Andersen disclose the device of claim 17, wherein the movable element 430, 431, 435, 476 comprises the material of Andersen and the pressure differential across the material causes the movement as best understood. Also see 112(a)/(b) rejection above.
22. Bullington et al in combination with Andersen disclose the device of claim 21, wherein the movable element 430, 431, 435, 476 comprises the material of Andersen and the force applied to the material causes the movement as best understood. Also see 112b rejection above.
29. Bullington et al in combination with Andersen disclose the device of claim 28, wherein the movable element 430, 431, 435, 476 comprises the material of Andersen such that a pressure differential across the material causes the linear movement as best understood. Also see 112b rejection above.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Bullington et al and Andersen, further in view of Martel (US Pat No. 4732162).
Bullington et al in combination with Andersen disclose the invention but do not expressly disclose the movable seal is formed from an elastomeric material.
Martel teach that it is well-known in the art to provide an analogous device, i.e. syringe, with a plunger like the plunger 476 of Bullington et al made from an elastomeric material as an effective material for its use (Col.2: 64-67). Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to modify the movable seal of Bullington et al as modified by Andersen such that it is formed from an elastomeric material as taught by Martel as an effective material for its use. Also see 112a rejection above.
Response to Arguments
Applicant's arguments filed have been fully considered but they are not persuasive. In regard to the Drawing Objection and applicant’s submission of amended drawings, it is noted that drawing amendment is Not Entered because they are not properly supported. The submitted drawings show the location of the locking mechanism added at the location near tangs 2421; however, there is no support in the specification for said specific location of said recited locking mechanism. It is further noted that while applicant has alleged that drawings are not necessary for “proper understanding” of said feature, it is submitted that knowing the location and/or structure of said locking mechanism is necessary for proper understanding of the instant invention. Therefore, the submitted drawings dated 2/13/2026 are not accepted as not being adequately supported by the disclosure, and the Drawing Objection is maintained.
In regard to the 112(f) interpretation, it is noted that the interpretation as presented has only been applied to Claims 15, 20, and 26 and any dependents; not all of the claims. While applicant states that 112(f) was not intended/disagreed with, applicant has not amended the functional language to provide sufficient structure to overcome the 112(f) interpretation. For example, the terms “movable element” and “stopping element” only recite the functions of “moving” and “stopping” without including any (inferred) structure. Therefore, the 112(f) interpretation is maintained.
In regard to the 112(a) rejections:
In regard to the rejection to Claim 1 involving the “seal” function, applicant contends that paragraph 0142 recites opening and closing of apertures in the embodiment of Figure 24 as evidence of “a seal” (Remarks pg. 11). However, this is not persuasive; as previously elaborated, the term “seal” implies a specific mechanism as recognized by one of ordinary skill in the art, often including a fluid tight closure, such as from gas or liquid. Additionally, a seal is typically formed due to the accompanying structure or material of the adjoining structures. For example see https://www.merriam-webster.com/dictionary/seal. The disclosure does not provide support for the specificity of such fluid tight closure, in function or structure. In other words, the scope of “opening” and “closing” as indicated in the disclosure of Figure 24 is more general/broad and does not rise to the level of “seal” as understood by a skilled artisan.
Additionally, applicant cites paragraph 0137, which refers to Figure 23, and includes valve 2308 as support for the seal (Remarks pg. 11). However, this is not persuasive because all of the instant claims are drawn to the embodiment in Figure 24, not Figure 23. For example, Claim 1 recites “the movable seal configured to transition to a second state due to an increase in a pressure differential across the movable seal, to form a pathway from the inlet port to the sampling channel.” However, the valve 2308 appears to be operated by the user and does not “move” to transition to a second state due to an increase in a pressure differential, in the manner that is disclosed with inner chamber housing 2419 of Figure 24. Therefore, it is submitted that the disclosure does not provide adequate support for usage of the specific term “seal” in the movable seal of Claim 1 and thus the rejection is maintained. It is noted that the term is not found in the description of the embodiment of Figure 24 recited in the instant claims. The rejection also applies to claims 14, 19, and 23 as previously noted.
Regarding the “due to an increase” language in Claim 1 and “pressure differential” in Claim 27, applicant contends: “Air initially in the chamber (on the inlet-facing side of the air-permeable barrier) has one pressure and the other side of the barrier (outlet-facing) is at a lower pressure. The device is designed so that this initial pressure does not result in movement of the inner chamber housing - so that the chamber can collect the first portion of contaminated blood. Once blood contacts the barrier, air flow out through the barrier is restricted and over time pressure across the barrier increases. This is because as air on the outlet side of the blood barrier is drawn away, the pressure on that side drops, causing an increase in the pressure across the barrier” (Remarks pg. 12).
Firstly, it is noted that the above explanation does not make sense and has not been cited in the specification. Thus, this explanation has not been fully supported in the disclosure and appears to be an allegation. Applicant asserts that initially, “the other side of the barrier (outlet-facing) is at a lower pressure.” As best understood, applicant is stating that there is a pressure differential that exists between the chamber and “the other side of the barrier (outlet-facing).” While it is unclear if “the other side of the barrier” is “outside” of the device 2408 entirely, or within the inner chamber housing 2419, or some other interpretation, it is best understood that when no blood/fluid is present within the chamber, the pressure between the chamber and “the other side of the barrier” (since the air permeable barrier is positioned within the chamber – paragraph 0142 filed spec), would be equal because air can flow between. Thus, stating that there exists a pressure differential initially “across the barrier” does not make sense.
Applicant also states “once blood contacts the barrier, air flow out through the barrier is restricted and over time pressure across the barrier increases. This is because as air on the outlet side of the blood barrier is drawn away, the pressure on that side drops, causing an increase in the pressure across the barrier.” However, there is no evidence that “pressure drops” as air is drawn away. If anything, it is believed, as evidenced by other portions of the disclosure, that filling of the chamber/inner chamber housing 2419 increases the pressure in said chamber to be equal to that of the patient’s vein. For example see paragraph 0092, which states that “Once the sequestration chamber 1318 is filled and the air in the sequestration chamber 1318 displaced, the blood pressure of the patient will be insufficient to drive or provide further blood into the blood sequestration device 1302, and in particular the outlet port 1312, until a force such as a vacuum or other pressure, such as provided by the blood sample collection device like Vacutainer is provided to draw out a next aliquot or amount of blood or bodily fluid.” This mechanism appears to be how all of the embodiments in the disclosure operate.
Thus, applicant’s statement that “pressure drops” is unclear and doesn’t make sense. However, it does appear that the pressure in the chamber increases to match that of the vein. Furthermore, applicant’s assertion that “pressure across the barrier increases” (and also recited) is vague and unclear as it does not clearly explain what “across the barrier” means, as the permeable blood barrier 2420 appears disposed within the inner chamber housing 2419, but not within chamber 2418 of Figure 24. As noted above, it is unclear if “the other side of the barrier” is “outside” of the device 2408 entirely, or within the inner chamber housing 2419, or some other interpretation. Thus, applicant’s assertion that “over time pressure across the barrier increases. This is because as air on the outlet side of the blood barrier is drawn away, the pressure on that side drops, causing an increase in the pressure across the barrier” does not make sense and more importantly, does not clarify the mechanism by which the claim recites its function.
In other words, applicant’s explanation merely uses the same claim language to describe itself. There is no explanation of how “the movable seal configured to transition to a second state due to an increase in a pressure differential across the movable seal” because applicant’s assertion does not provide a structural nexus between the movable seal and the pressure differential that exists/is build up. It is noted that a general explanation is not sufficient when the claims recite specific terms and mechanisms. Thus, the rejection is maintained. Claim 27 is addressed similarly.
Similar rejections regarding Claims 15, 20, and 26 are added.
In regard to Claim 7, applicant contends that paragraph 0061 recites sequestration chamber 55 can be make of an elastomeric material (Remarks pg. 13). However, this is not persuasive because given the large number of different embodiments in the specification, the cited paragraph referring to a different embodiment that is not Figure 24 does not provide adequate support for the specific structure and function of the movable seal of Claim 1. Also, as mentioned above, reference to Figure 23 is also not relevant to the cited claims of Figure 24 (Remarks pg. 13). Therefore, the rejection is maintained.
In regard to Claims 18, 22, and 29, the recitation of “the movable element comprises the material and the pressure differential across the material causes the movement” is not supported by the disclosure for similar reasons elaborated above. It is noted that said claims were previously rejected under 112(a).
Overall, it is noted that while the disclosure provides support for the elements claimed and the movement of the movable element from a first position to a second, the disclosure does not provide adequate support for how the movable element is moved by a force/how the force is generated. Discussion about pressure differentials, while generally present in the invention (though perhaps not as specifically as has been recited), are not adequately supported in the disclosure as being the cause of said movement. Applicant has not provided any evidence of why such pressure differential would cause said movement of the movable element, especially when all the other embodiments in the disclosure require subject input, such as providing a vacuum at the outlet, to direct the flow into the sampling channel. Therefore, the 112(a) rejections are maintained.
In regard to the 112(b) rejection, applicant’s explanation as elaborated above does not clarify the nature of the pressure differential in Claim 1 as well as the specific language referring to the pressure differential “causing” the movement of the movable element, as additionally set forth above. Therefore, the rejection is maintained.
It is noted that applicant’s explanation in terms of the volume of blood in the chamber limits the gas flow in Claim 1 is accepted.
In regard to Bullington et al, applicant contends that because the user must manually engage member 435, the invention is not taught. Firstly, it is noted that the claims do not preclude a user providing manual input to facilitate the fluid flow, as the claims use “comprising” language. Furthermore, the 112(a) and (b) rejections do not clarify how the movable element must move and therefore, interpretation of Bullington et al has been maintained for the reasons above. It is noted that the force of Bullington et al on the movable element as defined above occurs when the plunger is retracted, which occurs at the same time as blood contacts the plunger as the chamber is progressively filled, and a pressure differential is created by the process of filling.
Additionally, it is noted that separate components may be defined as the movable element as the claims do not specify any specific structure for said movable element and the “comprising” nature of the claims allows for broad interpretation. At least one component of the movable element of Bullington et al as defined performs the functions above, as recited. Since the flow mechanism 430, 431, 435 and plunger 476 of Bullington et al clearly operate together to perform the functions of the device as taught by Bullington et al, they are reasonably interpreted as such, especially given the “comprising” language in the apparatus claims.
In regard to Claim 1, applicant contends that Bullington et al would not be modified to have a blood barrier disposed in the housing between the chamber and the outlet which would prevent the suction force from happening. However, it is noted that Andersen teach exactly that – an analogous syringe with a blood barrier between the chamber and an outlet, seen in the figures, and previously cited in the rejection above in the (abst).
Specifically, Andersen teach “When a blood sample is to be collected from an artery, the piston 106 is positioned in such an axial position that the volume of the blood collecting chamber 108 substantially corresponds to the desired volume of the blood sample, and in that position the piston sealing ring 107 must be in engagement with the gas pervious material arranged in the recesses 102. The pointed free end of the hollow needle 110 is now inserted into an artery so that arterial blood may flow through the needle 110 and into the chamber 108 under the arterial blood pressure. Gas or air may then escape from the blood collecting chamber 108 through a venting passage formed by a space 103 defined between the peripheral outer wall of the piston 106 and the inner wall of the syringe cylinder 101 and by the gas pervious material arranged within the recess or recesses 102. When all of the air has been expelled from the chamber 108 and blood has penetrated into the space 103 up to the sealing ring 107, further progress of the blood is stopped, because gas, but not blood, can pass through the hydrophobic material in the recesses, and the hollow needle may now be removed from the artery” (Col.4: 1-19).
Thus, Andersen make possible the combination to provide advantages such as venting of gas as well as automatic stopping of the flow of blood into the chamber (see abst, including “The axial innermost portion of the inner cylinder wall, which is not recessed, may cooperate with the piston in a conventional manner so as to provide a suction effect within the blood collecting chamber, if desired”). It is noted that the Andersen reference previously cited an incorrect reference number in the office action, but was corrected cited in the PTO-892. This has been corrected, as the citation in the abstract cited in the office action was from the corrected reference number, as well as in light of the claim amendments. The change in reference number does not affect the rejection nor applicant’s remarks.
Furthermore, it is noted that skilled artisan may place the blood barrier of claim 1 closer to the outlet (proximal end of housing 401), which would still be between the chamber and the outlet of Bullington et al as recited, and thus the blood barrier would not interfere with the vacuum formed by the plunger of Bullington et al. It is noted that while applicant has illustrated the blood barrier disposed distally, near the flow mechanism 430 of Bullington et al, this is not presently required by the claim. Therefore, the rejection is maintained.
Conclusion
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 Huong NGUYEN whose telephone number is (571)272-8340. The examiner can normally be reached 10 am - 6 pm.
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/H.Q.N/Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791