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 .
Acknowledgments
In the reply, filed on April 1, 2026, Applicant amended claims 1 and 5-6.
In the non-final rejection of October 17, 2025, Examiner objected to the Abstract. Applicant amended the Abstract and the Specification; however, the amended Abstract was not presented on a separate sheet, apart from any other text. See MPEP § 608.01(b). Objection is maintained.
Examiner objected to the Specification. Applicant amended the Specification; however, Applicant amended the Specification with the filing date of U.S. provisional application no. 63/010,985 being “April 1, 2020”, when the filing date of U.S. provisional application no. 63/010,985 is actually “April 16, 2020”. Objection is maintained.
Examiner objected to claims 1-3, 6, 9-15, 17, and 19-20. Applicant amended claims 1 and 5-6, and argued:
In claim 1, line 1, "comprising" was not changed to "the apparatus comprising" since the current form is clear and more succinct than the proposed amendment. Moreover, the claim as drafted is not indefinite because it is grammatically correct and unambiguous (Arguments and Remarks, page 7). Examiner disagrees. The claim language “a patient fluid sample, comprising:” looks like a patient fluid sample, and not an apparatus, is being claimed.
In claim 1, line 9, "negative" was not changed to "negative pressure" since the current phrase "negative and positive pressure" is grammatical correct, clear and more succinct. (Arguments and Remarks, pages 7-8). Examiner disagrees. Changing "negative" to "negative pressure" would provide clarity as to what “negative” refers to.
In claim 2, line 3, the word "said" was inserted before "mixing valve" for improved grammatical recitation only (Arguments and Remarks, pages 7-8). Examiner disagrees. Examiner was not referring to “said mixing valve” in claim 2, line 2. Examiner was instead referring to “mixing valve” in claim 2, line 3, which should be changed to “the mixing valve” in order to refer back to “a mixing valve” in claim 1, line 6.
In claim 3, line 3, "the outer diameter" was not changed to "an outer diameter" since doing so would make the claim language less articulate. Moreover, the claim is not indefinite because a tube inherently has an inner and outer diameter, and therefore these terms need not be affirmatively recited in the first instance. M.P.E.P. 2173.05(e) "Inherent components of elements recited have antecedent basis in the recitation of the elements themselves. For example, the limitation "the outer surface of said sphere" would not require an antecedent recitation that the sphere has an outer surface." Id. (citations omitted) (Arguments and Remarks, page 8). Examiner disagrees. “the outer diameter” should be changed to “an outer diameter” as the first recitation of the term.
In claim 3, line 3, "it" was not changed to "the capillary tube" since doing so would make the claim language less articulate. Moreover, the claim as drafted is not indefinite because under the rules of English grammar, pronouns refer to the immediately preceding noun, i.e., its antecedent (Arguments and Remarks, page 8). Examiner disagrees. It is unclear which previous claim term “it” refers back to.
In claim 6, line 2, "distal, proximal" were not changed to "a distal wall, a proximal wall" because the since doing so would make the claim less articulate and less succinct. Moreover, the claim as drafted is not indefinite because it is grammatically correct and unambiguous. If the adjectives "distal", "proximal" and "lateral" were compound adjectives, they would be compound hyphenated and written as such as "distal-proximal-lateral" (Arguments and Remarks, page 8). Examiner disagrees. Changing "distal" to "a distal wall" would provide clarity as to what “distal” refers to, and changing "proximal" to "a proximal wall" would provide clarity as to what “proximal” refers to.
In claim 6, line 3, "a distal and proximal bore that extends axially through the distal and proximal wall" has not been changed to "a distal bore and a proximal bore that extend axially through the distal wall and the proximal wall" because doing so would make the claim less articulate and less succinct. Moreover, the claim as drafted is not indefinite because it is grammatically correct and unambiguous (Arguments and Remarks, page 8). Examiner disagrees. Changing "a distal" to "a distal bore" would provide clarity as to what “a distal” refers to, and changing "the distal al" to "the distal wall" would provide clarity as to what “the distal” refers to.
In claim 6, line 10, said distal valve body wall" has not been changed to "said distal wall" since because doing so would make the claim less articulate and less succinct. Moreover, the claim as drafted is not indefinite because it is grammatically correct and unambiguously refers to the distal wall of the valve body (Arguments and Remarks, page 8). Examiner disagrees. The term was originally introduced as “distal… walls” in claim 6, line 2. Thus, changing “said distal valve body wall” to “said distal wall” would refer back to the original recitation of the term.
In claim 9, line 1, "said central cavity" has been changed to "said internal cavity" for improved grammatical recitation only (Arguments and Remarks, page 8). Examiner disagrees. Claim 9 was not amended.
In claim 9, line 1, "dilution solution" has been changed to "the diluting solution" for improved grammatical recitation only. Applicant believes the claim as drafted is not indefinite since the term "dilution solution" clearly refers to the same "diluting solution" recited in claim (Arguments and Remarks, page 9). Examiner disagrees. Claim 9 was not amended.
The suggested amendments to the following claims have not been amended since doing so would make the claim language less articulate: claim 9, line 2 ("the known volume"); claim 10, line 2 ("the distal end"); claim 10, line 2 ("the proximal end"); claim 11, line 2 ("the inner diameter"); and claim 12, line 2 ("the length"). Moreover, these claims are not indefinite because a tube inherently has each of these properties and structures; therefore these terms need not be affirmatively recited in the first instance. M.P.E.P. 2173.05(e) (Arguments and Remarks, page 9). Examiner disagrees. The terms should be changed as the first recitation of the terms.
In claim 13, line 3, "its distal limit position" has not been changed to "the distal limit position" since doing so would make the claim language less articulate. Moreover, the claim as drafted is not indefinite because under the rules of English grammar, pronouns refer to the immediately preceding noun, i.e., its antecedent (Arguments and Remarks, page 9). Examiner disagrees. It is unclear which previous claim term “its” refers back to.
In claim 14, lines 2-3, "the transitions between the main body, mixing valve and capillary tube" has not been changed to "transitions between the main body, the mixing valve, and the capillary tube" since because doing so would make the claim less articulate and less succinct. Moreover, the claim as drafted is not indefinite because it is grammatically correct and unambiguous (Arguments and Remarks, page 9). Examiner disagrees. “the transitions” should be changed to “transitions” as the first recitation of the term, changing “mixing valve” to “the mixing valve” would allow for referring back to “a mixing valve” in claim 1, line 6, and changing “capillary tube” to “the capillary tube” would allow for referring back to “a capillary tube” in claim 1, line 5.
In claim 15, line 1, "comprising" has not been changed to "the apparatus comprising" since the current form of the claim is clear and more succinct than the proposed amendment. Moreover, the claim as drafted is not indefinite because it is grammatically correct and unambiguous (Arguments and Remarks, page 9). Examiner disagrees. The claim language “a patient fluid sample, comprising:” looks like a patient fluid sample, and not an apparatus, is being claimed.
In claim 15, lines 6-7, "said internal cavity; and," has been changed to "said internal cavity;" for improved grammatical recitation only (Arguments and Remarks, page 9). Examiner disagrees. Claim 15 was not amended.
In claim 15, line 10, "diluting solution" has not been changed to "the diluting solution" since the current form is clear and more succinct than the proposed amendment. Moreover, the claim as drafted is not indefinite because it is grammatically correct and unambiguous (Arguments and Remarks, page 9). Examiner disagrees. Changing “diluting solution” to “the diluting solution” would allow for referring back to “a diluting solution” in claim 15, line 4.
In claim 17, line 2, "it" has not been changed to "the diluted fluid sample" and in claim 19, line 2, "it" has not been changed to "the valve" since doing so would make the claim language less articulate. Moreover, the claim as drafted is not indefinite because under the rules of English grammar, pronouns refer to the immediately preceding noun, i.e., its antecedent (Arguments and Remarks, pages 9-10). Examiner disagrees. In both claims 17 and 19, it is unclear which previous claim term “it” refers back to.
In claim 20, line 1, "said preventing means" has not been changed to "said means for preventing" since doing so would make the claim language less articulate. It is common for practitioners to use means plus function language interchangeably to render the claim more articulate without sacrificing clarity. Claim 20 is not indefinite since the "preventing means" of claim 20 clearly refers to, and is used as an abbreviated form of, the "means for preventing" recited in claim 19. "The mere fact that a term or phrase used in the claim has no antecedent basis in the specification disclosure does not mean, necessarily, that the term or phrase is indefinite. There is no requirement that the words in the claim must match those used in the specification disclosure. Applicants are given a great deal of latitude in how they choose to define their invention so long as the terms and phrases used define the invention with a reasonable degree of clarity and precision." M.P.E.P. 2173.05(e) (Arguments and Remarks, page 10). Examiner disagrees. The term was originally introduced as “means for preventing” in claim 19, line 1. Thus, changing “said preventing means” to “said means for preventing” would refer back to the original recitation of the term.
Examiner rejected claims 5-8 and 15-20 under 35 U.S.C. 112(b). Applicant amended claims 5-6 and persuasively argued the corresponding structures for performing means-plus-function terms (Arguments and Remarks, pages 10-14); however, Applicant did not address all of the rejections. Rejection is maintained.
Currently, claims 1-20 are under examination.
Specification
The abstract of the disclosure is objected to because:
In line 2, “the collection port” should be changed to “a collection port”
In line 3, “a predefined volume of fluid sample” should be changed to “the predetermined volume of the patient fluid sample”
In line 4, “the whole blood” should be changed to “whole blood”
In line 5, “the POC test kit” should be changed to “the point-of-care diagnostic test”
In line 9, “the valve body” should be changed to “the mixing valve”
In line 10, “negative” should be changed to “negative pressure”
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
The disclosure is objected to because of the following informalities:
In the Cross-Reference to Related Applications section, “April 1, 2020” should be changed to “April 16, 2020” as the filing date of U.S. provisional application no. 63/010,985.
Claim Objections
Claims 1-3, 6, 9-15, 17, and 19-20 are objected to because of the following informalities:
In claim 1, line 2, “comprising:” should be changed to “the apparatus comprising:”.
In claim 1, line 10, “negative” should be changed to “negative pressure”.
In claim 2, line 3, “mixing valve” should be changed to “the mixing valve”.
In claim 3, lines 2-3, “the outer diameter” should be changed to “an outer diameter”.
In claim 3, line 4, “it” should be changed to “the capillary tube”.
In claim 6, line 2, “distal, proximal” should be changed to “a distal wall, a proximal wall,”.
In claim 6, line 3, “a distal and proximal bore that extends axially through the distal and proximal wall” should be changed to “a distal bore and a proximal bore that extend axially through the distal wall and the proximal wall”.
In claim 6, line 6, “shape” should be changed to “a shape”.
In claim 6, line 9, “said distal and proximal bores” should be changed to “said distal bore and said proximal bore”.
In claim 6, lines 11-12, “said distal valve body wall” should be changed to “said distal wall”.
In claim 9, line 1, “said central cavity” should be changed to “said internal cavity”.
In claim 9, line 2, “dilution solution” should be changed to “the diluting solution”.
In claim 9, line 3, “the known volume” should be changed to “a known volume”.
In claim 10, line 2, “the distal end” should be changed to “a distal end”.
In claim 10, line 2, “the proximal end” should be changed to “a proximal end”.
In claim 11, line 3, “the inner diameter” should be changed to “an inner diameter”.
In claim 12, line 2, “the length” should be changed to “a length”.
In claim 13, line 4, “its distal limit position” should be changed to “the distal limit position”.
In claim 14, lines 2-3, “the transitions between the main body, mixing valve and capillary tube” should be changed to “transitions between the main body, the mixing valve, and the capillary tube”.
In claim 15, line 2, “comprising:” should be changed to “the apparatus comprising:”.
In claim 15, line 8, “said internal cavity; and,” should be changed to “said internal cavity;”.
In claim 15, line 11, “diluting solution” should be changed to “the diluting solution”.
In claim 17, line 2, “it” should be changed to “the diluted fluid sample”.
In claim 19, line 2, “it” should be changed to “the valve”.
In claim 20, line 1, “said preventing means” should be changed to “said means for preventing”.
Appropriate correction is required.
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 6-8 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 regards to claim 6, lines 8-10 recite: a fluid-flow channel extending axially therethrough that can align with said distal and proximal bores in the valve body “when said valve is in the first position”; however, such is new matter not described in the Specification. Claims 7-8 are rejected by virtue of being dependent upon claim 6.
In regards to claim 6, lines 11-13 recite: a vent channel extending down a face of said distal valve body wall that can align with said capillary tube “when said valve is in the second position”; however, such is new matter not described in the Specification. Claims 7-8 are rejected by virtue of being dependent upon claim 6.
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 6-8 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 claim 6, line 8 recites “a fluid-flow channel”. Claim 6 depends upon claim 5, which depends upon claim 1. Claim 1, line 7 recites “a fluid-flow channel”. It is unclear whether the two recitations are the same component or different components. Claims 7-8 are rejected by virtue of being dependent upon claim 6.
In regards to claim 6, lines 8-10 recite: a fluid-flow channel extending axially therethrough that can align with said distal and proximal bores in the valve body “when said valve is in the first position”. Claim 6 depends upon claim 5. Claim 5, lines 1-3 recite: wherein said mixing valve… “isolates said capillary tube from the internal cavity in a first position”. As claim 5 establishes that the capillary tube is isolated from the internal cavity in the first position, then it is unclear how the fluid-flow channel would also align with the distal and proximal bores in the valve body in the first position. Claims 7-8 are rejected by virtue of being dependent upon claim 6.
In regards to claim 6, lines 11-13 recite: a vent channel extending down a face of said distal valve body wall that can align with said capillary tube “when said valve is in the second position”. Claim 6 depends upon claim 5. Claim 5, lines 1-5 recite: wherein said mixing valve… enables the fluid sample to flow from said capillary tube into said internal cavity in a second position. As claim 5 establishes that the fluid sample can flow from the capillary tube into the internal cavity in the second position, then it is unclear how the vent channel would also align with the capillary tube in the second position. Claims 7-8 are rejected by virtue of being dependent upon claim 6.
In claim 7, line 1 recites “the open position”. There is insufficient antecedent basis for this limitation in the claim. Claim 8 is rejected by virtue of being dependent upon claim 7.
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.
Claims 1-2, 4-10, 15-16, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Oh et al (KR 20130049037).
In regards to claim 1, Oh et al teaches an apparatus (Figures 2-5) for collecting, diluting and dispensing a patient fluid sample, comprising:
an elongate, main body (11) having a longitudinally-extending central axis, a distal end, a proximal end, and an internal cavity containing a diluting solution
a capillary tube (21) at said distal end of said main body
a mixing valve (100) intermediate said capillary tube and said internal cavity for selectively connecting and disconnecting a fluid-flow channel (33) between said capillary tube and said internal cavity
a plunger (12/13) that can reciprocate within said main body between a retracted limit position and a distal limit position for creating negative and positive pressure within said internal cavity
In regards to claim 2, Oh et al teaches a nosepiece (41) on a distal face of said mixing valve, which is constructed and arranged to releasably connect the capillary tube in fluid connection with mixing valve.
In regards to claim 4, Oh et al teaches said mixing valve having an open position (Figure 4)) and a closed position (Figure 3), and a vent channel (34) in fluid connection with said capillary tube when said mixing valve is in the closed position.
In regards to claim 5, Oh et al teaches wherein said mixing valve enables admission of the fluid sample into said capillary tube and isolates said capillary tube from the internal cavity in a first position (Figure 3 – it is understood that 100 partially isolates 21 from the internal cavity of 11 as foreign substances 51, such as glass fragments of glass ampules or rubber fragments of vials, are prevented from traveling from 21 to the internal cavity of 11), and enables the fluid sample to flow from said capillary tube into said internal cavity in a second position (Figure 4 – it is understood that flow can also occur from 21 to the internal cavity of 11 with retraction of 12/13).
In regards to claim 6, Oh et al teaches said mixing valve including:
a valve body (40) having distal, proximal and lateral side walls, a central channel, and a distal and proximal bore that extends axially through the distal and proximal wall, respectively, of the valve body and are positioned coaxially with said central axis (Figures 2-4)
a valve gate (30) having:
a size and shape that are complimentary to said central channel of said valve body and slidable within said central channel (Figures 3-4)
a fluid-flow channel (33) extending axially therethrough that can align with said distal and proximal bores in the valve body when said valve is in the first position (Figure 3)
a vent channel (34) extending down a face of said distal valve body wall that can align with said capillary tube when said valve is in the second position (Figure 4)
an actuator button (32) fixed to one end of said valve gate for moving said valve gate from the first position to the second position (Figures 3-4)
In regards to claim 7, Oh et al teaches wherein said mixing valve is in the open position when said actuator button is depressed to an open limit position abutting said valve body (Figure 4).
In regards to claim 8, Oh et al teaches wherein said actuator button sits flush with said valve body in the open limit position (Figure 4).
In regards to claim 9, Oh et al teaches wherein said central cavity of said main body is pre-loaded with a precise, predetermined amount of dilution solution based on the known volume of the capillary tube (Figure 3 – it is understood that the central cavity of 11 is capable of being pre-loaded with a precise, predetermined amount of dilution solution according to the volume of 21, as the volume of 21 is smaller than the volume of the central cavity of 11, as shown in Figure 2).
In regards to claim 10, Oh et al teaches said plunger comprising an actuator stem (13), a seal (12) seated at the distal end of said stem, and a handle fixed to the proximal end of said stem (Figure 2).
In regards to claim 15, Oh et al teaches an apparatus (Figures 2-5) for collecting, diluting and dispensing a patient fluid sample, comprising:
a body (11) having a longitudinally-extending central axis, a distal end, a proximal end, and an internal cavity containing a diluting solution
a capillary tube (21) at said distal end of said body
a valve (100) intermediate said capillary tube and said internal cavity for selectively connecting and disconnecting a fluid-flow connection (33) between said capillary tube and said internal cavity
means (12/13) for transferring the fluid sample in the capillary tube into said internal cavity
first means (12/13) for mixing the fluid sample and diluting solution within said cavity to form a diluted fluid sample
means (12/13) for expelling the diluted fluid sample from said internal cavity and into said capillary tube (Figure 4)
In regards to claim 16, Oh et al teaches means (12/13) for expelling the diluted fluid sample from said capillary tube.
In regards to claim 19, Oh et al teaches means (71/73) for preventing the apparatus from being re-used by preventing the valve from being closed once it is opened (Figure 4).
In regards to claim 20, Oh et al teaches wherein said preventing means comprises a detent (71/73) that retards actuation of the valve and a valve shape that retards manual actuation of the valve (Figure 4).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Oh et al, as applied to claim 2 above, and further in view of Gupta et al (US 9,925,343).
In regards to claim 3, Oh et al is silent about wherein said nosepiece is made of an elastomeric material. And Oh et al teaches said nosepiece has a socket (47); however, Oh et al does not teach the socket with an inner diameter slightly smaller than the outer diameter of said capillary tube so that a compressive force connects the capillary tube when it is forced into said socket, as Oh et al instead teaches the capillary tube connected to the outer surface of the nosepiece (Figure 2). Gupta et al teaches an apparatus (Figures 2A-2B) wherein a nosepiece (50/40) is made of an elastomeric material (column 7, lines 14-16), and has a socket (44) with an inner diameter slightly smaller than the outer diameter of a capillary tube (73/78) so that a compressive force connects the capillary tube when it is forced into said socket (Figures 2A-2B). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said nosepiece, of the apparatus of Oh et al, to be made of an elastomeric material and have a socket with an inner diameter slightly smaller than the outer diameter of said capillary tube so that a compressive force connects the capillary tube when it is forced into said socket, as taught by Gupta et al, as such is particularly resilient to degradation or interaction with chemicals, pharmaceuticals or liquids in general, and is more desirable for contact with the contents of a syringe, particularly in prefillable syringes storage conditions, than are typical plastics used for syringes or molded syringe parts (column 7, lines 26-34).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al, as applied to claim 10 above, and further in view of Hopkins (US 2018/0221577).
In regards to claim 11, Oh et al does not teach an expulsion rod fixed to the distal end of said actuator stem, said rod having a diameter slightly smaller than the inner diameter of the capillary tube. Hopkins teaches an apparatus (Figures 17-20) including an expulsion rod (343) fixed to a distal end of an actuator stem (344), said rod having a diameter slightly smaller than an inner diameter of a capillary tube (337) (Figures 19-20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus, of Oh et al, with an expulsion rod fixed to the distal end of said actuator stem, said rod having a diameter slightly smaller than the inner diameter of the capillary tube, as taught by Hopkins, as such will assist the seal in pushing out a first amount of fluid from the internal cavity and through and out the capillary tube (paragraph [0100])(Figures 19-20).
In regards to claim 12, in the modified apparatus of Oh et al and Hopkins, Oh et al does not teach wherein said expulsion rod has a chamfered distal nose and a flat surface that extends along the length of said expulsion rod. Hopkins does not teach wherein said expulsion rod has a chamfered distal nose and a flat surface that extends along the length of said expulsion rod, as Hopkins instead teaches wherein said expulsion rod has a flat distal nose and a cylindrical surface that extends along the length of said expulsion rod (Figures 17-20). But before the effective filing date of the claimed invention, it would have been an obvious matter of design choice to a person having ordinary skill in the art to modify said expulsion rod, of the modified apparatus of Oh et al and Hopkins, to have a chamfered distal nose, as Applicant has not disclosed that such a configuration of the distal nose provides an advantage, is used for a particular purpose, or solves a stated problem. One of ordinary skill in the art, furthermore, would have expected Applicant’s invention to perform equally well with said expulsion rod having a flat distal nose, as taught by Hopkins, as a person having ordinary skill in the art would have known how to configure the distal nose in order to allow for efficiently pushing out a first amount of fluid from the internal cavity and through and out the capillary tube. Further, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said expulsion rod, of the modified apparatus of Oh et al and Hopkins, to have a flat surface that extends along the length of said expulsion rod, as either a cylindrical surface that extends along the length of said expulsion rod, of Hopkins, or a flat surface that extends along the length of said expulsion rod, of Applicant, will arrive at the same end result of allowing for fluid flow by pushing out a first amount of fluid from the internal cavity and through and out the capillary tube.
In regards to claim 13, in the modified apparatus of Oh et al and Hopkins, Oh et al does not teach wherein said expulsion rod is arranged co-axially with said central axis so that said expulsion rod extends through the fluid-flow channel in the mixing valve and the capillary tube when said plunger is moved to its distal limit position. Hopkins teaches wherein said expulsion rod is arranged co-axially with a central axis so that said expulsion rod extends through the capillary tube when a plunger (344/354/368) is moved to its distal limit position (Figures 19-20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said expulsion rod, of the modified apparatus of Oh et al and Hopkins, to be arranged co-axially with said central axis so that said expulsion rod extends through the capillary tube when said plunger is moved to its distal limit position, as taught by Hopkins, as such will assist the seal in pushing out a first amount of fluid from the internal cavity and through and out the capillary tube (paragraph [0100])(Figures 19-20). However, Hopkins does not teach a fluid-flow channel in a mixing valve. But as the mixing valve having the fluid-flow channel is between the internal cavity and the capillary tube, in Oh et al, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said expulsion rod, of the modified apparatus of Oh et al and Hopkins, to extend through the fluid-flow channel in the mixing valve, of Oh et al, in order to access the capillary tube for pushing fluid from the internal cavity to the capillary tube and through and out the capillary tube.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Oh et al and Hopkins, as applied to claim 11 above, and further in view of Chen et al (CN 210290723).
In regards to claim 14, in the modified apparatus of Oh et al and Hopkins, Oh et al does not teach wherein said expulsion rod is made from Teflon and can slide smoothly through the transitions between the main body, mixing valve and capillary tube. Hopkins teaches wherein said expulsion rod can slide smoothly through transitions between a main body (338) and capillary tube (Figures 19-20). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said expulsion rod, of the modified apparatus of Oh et al and Hopkins, to slide smoothly through the transitions between the main body and capillary tube, as taught by Hopkins, as such will assist the seal in pushing out a first amount of fluid from the internal cavity and through and out the capillary tube (paragraph [0100])(Figures 19-20). However, Hopkins does not teach a mixing valve. But as the mixing valve is between the main body and the capillary tube, in Oh et al, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said expulsion rod, of the modified apparatus of Oh et al and Hopkins, to slide smoothly through the transitions between the main body, mixing valve and capillary tube, of Oh et al, in order to access the capillary tube for pushing fluid from the internal cavity to the capillary tube and through and out the capillary tube. However, Hopkins is silent about wherein said expulsion rod is made from Teflon. Chen et al teaches an apparatus (Figures 1-3) wherein an expulsion rod (3) is made from Teflon (the top end of the piston push rod 7 of dead volume discharge cone 3 is made of PEEK material or PTFE material). It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify said expulsion rod, of the modified apparatus of Oh et al and Hopkins, to be made from Teflon, as taught by Chen et al, as such will improve the existing injector low temperature resistance performance difference (Abstract)
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Oh et al, as applied to claim 16 above, and further in view of Sogaro (US 2002/0087122).
In regards to claim 17, Oh et al does not teach second means for mixing the diluted fluid sample within said capillary tube as it is being expelled. Sogaro teaches an apparatus (Figures 1-3) including second means (188) for mixing a diluted fluid sample within a capillary tube (180) as it is being expelled. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify the apparatus, of Oh et al, with second means for mixing the diluted fluid sample within said capillary tube as it is being expelled, as taught by Sogaro, as such will enhance the intermixing of two components (paragraph [0042]).
In regards to claim 18, in the modified apparatus of Oh et al and Sogaro, Oh et al teaches means (34) for venting said capillary tube as the diluted fluid sample is being expelled from said capillary tube.
Response to Arguments
Applicant's arguments filed April 1, 2026, have been fully considered but they are not persuasive:
In regards to claim 1, Applicant argued: In connection with claim 1, the Office Action alleges that Oh teaches an apparatus for "collecting, diluting and dispensing a patient fluid sample." Applicant believes this is incorrect because the device disclosed by Oh is not intended for "collecting" a patient sample, does not disclose "diluting" a patient sample, and does not disclose several of the structural limitations recited in claim 1 (Arguments and Remarks, page 14). Examiner disagrees. First, the recitation “for collecting, diluting and dispensing a patient fluid sample” is an intended use of the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The apparatus (Figures 2-5) of Oh et al is structurally capable of collecting a patient sample and diluting the patient sample, thus meeting the claim. Second, Oh et al teaches the claimed apparatus (Figures 2-5) as in the rejection of claim 1 above.
In regards to claim 1, Applicant argued: Claim 1 is not anticipated because Oh does not teach, disclose or suggest "an apparatus for collecting, diluting and dispensing a patient fluid sample" as recited in the preamble. Oh teaches a conventional apparatus for collecting (aspirating) a liquid drug from a vial and dispensing (administering) the drug to a patient through a hypodermic needle. Oh does not teach, disclose or suggest collecting and dispensing a "patient fluid sample" since there would be no need to provide a filter for foreign substances 50 if the needle was used to take a blood sample from the patient. Moreover, Oh does not teach, disclose or suggest "diluting" the liquid drug once aspirated into the tube 11 of the syringe body 10. In fact, Oh teaches away from "diluting" the liquid drug since the syringe body 10 is never sealed. In both the first and second positions, fluid can flow in either direction through the filter via the suction path 34 or expulsion path 33. Therefore, if the syringe body 10 was pre-loaded with a dilution solution, it would leak out through the switching device 100. Therefore, Oh teaches away from an apparatus that dilutes a patient sample (Arguments and Remarks, pages 14-15). Examiner disagrees. First, the recitation “for collecting, diluting and dispensing a patient fluid sample” is an intended use of the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The apparatus (Figures 2-5) of Oh et al is structurally capable of collecting a patient sample, diluting the patient sample, and dispensing the patient fluid sample, thus meeting the claim. Second, “a diluting solution” is not a positively recited structure of the claimed apparatus. Thus, Oh et al needs to only teach an elongate, main body (11) having an internal cavity capable of being loaded or filled with a diluting solution for diluting a patient sample.
In regards to claim 1, Applicant argued: Oh also fails to teach, disclose or suggest several other structural elements recited in claim 1. For example, Oh does not disclose "an elongate, main body ... containing a diluting solution." The Office Action does not identify any diluting solution in the main body 10. And, as described above, Oh teaches away from a diluting solution in the tube 11 of the syringe body 10 because the switching device 100 never seals the syringe body 10. Therefore, any pre- loaded diluting solution would leak out. Oh deals exclusively with filtration of foreign substances, not sample dilution (Arguments and Remarks, page 15). Examiner disagrees. “a diluting solution” is not a positively recited structure of the claimed apparatus. Thus, Oh et al needs to only teach an elongate, main body (11) having an internal cavity capable of being loaded or filled with a diluting solution for diluting a patient sample.
In regards to claim 1, Applicant argued: Oh also fails to teach, disclose or suggest "a capillary tube at said distal end of said main body." The Office Action incorrectly equates the needle 21 with the claimed capillary tube. A capillary tube is a small, narrow tube used in medical practice to collect and analyze liquid samples. Fluid is admitted to the capillary tube by capillary action (adhesion, cohesion and surface tension) when one open end is immersed in the liquid sample. Capillary tubes need no vacuum pressure source to admit fluid into the tube. In contrast, a hypodermic needle is a hollow, slender, and sharp metal tube used with a syringe to inject substances into a body or extract fluids from the body. A needle has a hollow shaft with a sharp, beveled tip to minimize tissue damage during puncture. Needles are used in conjunction with a syringe, such as shown in Oh, for admitting and dispensing fluid through the needle. While capillary tubes and needles share some functionality, a POSA would understand that they are not the same and function differently. If the Examiner is relying on personal knowledge that contradicts this understanding, Applicant respectfully requests she issue an affidavit or declaration under 37 C.F.R. 1.104(d)(2). M.P.E.P. 2144.03(C) (Arguments and Remarks, pages 15-16). Examiner disagrees. Oh et al teaches a capillary tube (21) at said distal end of said main body (11). As argued above, Applicant structurally defines a capillary tube as a small, narrow tube. Needle pin 21 of Oh et al is a small, narrow tube (Figure 2) thus structurally teaching a capillary tube, as claimed.
In regards to claim 1, Applicant argued: Oh also fails to teach, disclose or suggest "a mixing valve . . .for selectively connecting and disconnecting a fluid-flow channel between said capillary tube and said internal cavity. As described above, the switching device 100 of Oh does in fact provide a fluid-flow channel between the needle 21 and the syringe body 10. However, the switching device 100 does not selectively connect and disconnect that fluid-flow channel. It is always connected. Instead, the switching device provides a filter 50 that is movable between a first position shown in Fig. 3, and a second position shown in Fig. 4. In the first position, the filter 50 is positioned in the fluid-flow path between the needle 21 and the syringe body 10 so that any foreign substances 51 within the liquid drug are trapped on the filter 50 during aspiration. In the second position, the filter 50 is moved out of the fluid-flow path from the syringe body 10 to the needle so the foreign substances 51 trapped on the filter 50 are not delivered to the patient. In both positions of the switching device 100, fluid can flow between the syringe body 10 and the needle 21. Therefore, the switching device does not selectively disconnect the fluid-flow channel between the syringe body and the needle as recited in claim 1 (Arguments and Remarks, page 16). Examiner disagrees. Oh et al teaches a mixing valve (100) for selectively connecting and disconnecting a fluid-flow channel (33) between said capillary tube (21) and said internal cavity (of 11). In the state of Figure 3, the fluid-flow channel (33) is connected between the capillary tube (21) and the internal cavity (of 11). And in the state of Figure 4, the fluid-flow channel (33) is disconnected between the capillary tube (21) and the internal cavity (of 11).
In regards to claim 4, Applicant argued: Claim 4 depends from claim 1 and is not anticipated for at least the same reasons as discussed above with respect to claim 1. Claim 4 is also not anticipated by Oh since it Oh fails to teach, disclose or suggest "a vent channel in fluid connection with said capillary tube when said mixing valve is in the closed position." The Office Action identifies element 34 as the vent channel; however, element 34 is not a vent channel as that term is commonly understood to those skilled in the relevant art. Element 34 of Oh is the "suction passage" that connects the needle 21 to the tube 11 of the syringe body 10 during aspiration of liquid drug from the vial. The tube 11 of the syringe body 10 is a closed container that allows a vacuum to be created when the piston 12 is retracted. In contrast, a "vent" is a passageway that connects a fluid-flow channel to the atmosphere to prevent the buildup of pressure within fluid-flow channel. As best seen in Fig. 9, Applicant's vent 38 extends down along the distal face 34a of the valve gate 34 and vents the capillary tube 18 and the distal axial bore 36a to the atmosphere when the valve is in the closed position. Spec. [0043]. Without the vent 38 to atmosphere, backpressure would build up and not allow the fluid sample to completely enter the capillary tube 18. Since the suction passage 34 of Oh does not vent to atmosphere, if the apparatus of Oh was used with a capillary tube instead of a needle, back pressure would build up in the tube 11 of the syringe body 10 and hinder the capillary action of the capillary tube. Therefore, Oh does not teach, disclose or suggest the vent channel recited in claim 4 (Arguments and Remarks, pages 16-17). Examiner disagrees. First, Oh et al teaches a vent channel (34) in fluid connection with said capillary tube (21) when said mixing valve (100) is in the closed position (Figure 3). Second, the claim does not require a vent channel to be “a passageway that connects a fluid-flow channel to the atmosphere to prevent the buildup of pressure within fluid-flow channel” and “extends down along the distal face of the valve gate and vents the capillary tube and the distal axial bore to the atmosphere” when the valve is in the closed position, as argued by Applicant. The term “vent” also means “an opening for the escape of a gas or liquid” (https://www.merriam-webster.com/dictionary/vent). Oh et al teaches suction passage 34 to allow for the escape of drug from a vial and into the tubular body 11 (Figure 3), thus the suction passage 34 is a vent channel meeting the claim.
In regards to claim 5, Applicant argued: Claim 5 depends from claim 1 and is not anticipated by Oh for at least the same reasons as discussed above with respect to claim 1. Claim 5 as amended is also not anticipated by Oh since it fails to teach, disclose or suggest "wherein said mixing valve enables admission of the fluid sample into said capillary tube and isolates said capillary tube from the internal cavity in a first position . . .." In support of the rejection of claim 5, the Office Action states: "(Figure 3 - it is understood that 100 partially isolates 21 from the internal cavity as foreign substances 51, such as glass fragments of glass ampules or rubber fragments of vials, are prevented from traveling from 21 to the internal cavity of 11)". Office Action, p. 10 (emphasis added). This statement contradicts the plain and ordinary meaning of the word "isolates" which means: 1. To place apart; cause to be alone." https://www.dictionary.com/browse/isolate last accessed March 31, 2026. In an electrical context, "isolate" means: 5. Electronics to prevent interaction between (circuits, components, etc.); insulate. Id. The Office Action improperly equated this plain and ordinary meaning with the phrase "partially isolates." Since the filter 50 of the switching device 100 allows fluid flow to and from the tube 11 of the syringe body 10, it clearly does not "isolate" the tube 11 from the needle 21 as the term "isolates" is commonly understood and as used in Applicant's specification (Arguments and Remarks, page 17). Examiner disagrees. Oh et al teaches wherein said mixing valve (100) enables admission of the fluid sample into said capillary tube (21) and isolates said capillary tube from the internal cavity (of 11) in a first position (Figure 3 – it is understood that 100 partially isolates 21 from the internal cavity of 11 as foreign substances 51, such as glass fragments of glass ampules or rubber fragments of vials, are prevented from traveling from 21 to the internal cavity of 11). As foreign substances such as glass fragments of glass ampules or rubber fragments of vials are prevented from traveling from the capillary tube (21) to the internal cavity (of 11), it is understood that said foreign substances/fragments in the capillary tube are isolated or placed apart from the internal cavity.
In regards to claim 6, Applicant argued: Claim 6 depends from claims 5 and 1 and is not anticipated for at least the same reasons as discussed above with respect to claims 1 and 5. Claim 6 is also not anticipated by Oh since it fails to teach, disclose or suggest "a vent channel extending down the face of said distal valve body wall that can align with said capillary tube when said valve is in the closed position." In support of this rejection, the Office Action alleges that element 34 satisfies the vent channel limitation. As described above with respect to claim 4, the "suction passage" 34 of Oh is not a vent. Moreover, even if the suction passage 34 was a vent, it does not "extend down the face of said distal valve body wall" such as shown in Applicant's Fig. 9 and recited in claim 6 (Arguments and Remarks, pages 17-18). Examiner disagrees. First, Oh et al teaches a vent channel (34) extending down a face of said distal valve body wall (Figure 5) that can align with said capillary tube (21) when said valve (100) is in the second position (Figure 4). Second, the term “vent” also means “an opening for the escape of a gas or liquid” (https://www.merriam-webster.com/dictionary/vent). Oh et al teaches suction passage 34 to allow for the escape of drug from a vial and into the tubular body 11 (Figure 3), thus the suction passage 34 is a vent channel meeting the claim.
In regards to claim 9, Applicant argued: Claim 9 depends from claim 1 and is not anticipated for at least the same reasons as discussed above with respect to claim 1. Claim 9 is also not anticipated by Oh since it fails to teach, disclose or suggest "wherein said central cavity of said main body is pre-loaded with a precise, predetermined amount of dilution solution based on the known volume of the capillary tube." In support of this rejection, the Office Action alleges that "it is understood that the central cavity of 11 is capable of being pre-loaded with a precise, predetermined amount of dilution solution according to the volume of 21, as the volume 21 is smaller than the volume of the central cavity of 11, as shown in Figure 2)." Office Action, p. 11 (emphasis added). This statement comprises an erroneous application of Section 102.
To reject a claim as anticipated under Section 102 by a reference, the disclosure must teach every element required by the claim under its broadest reasonable interpretation. M.P.E.P. 2131. "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference." Id. (citation omitted).
Clearly, Oh does not teach or disclose that the central cavity 11 is pre-loaded with dilution solution. No citation to such teaching is stated in the Office Action. However, assuming arguendo that the central cavity of 11 is capable of being pre-loaded with a precise, predetermined amount of dilution solution, Oh does not anticipate claim 9 under Section 102 unless doing so is inherently described, which it is not. As described above with respect to claim 1, Oh teaches away from "diluting" the liquid drug since the syringe body 10 is never sealed. In both the first and second positions of the switching device 100, fluid can flow in either direction through the filter 50. Therefore, if there was a pre-loaded, dilution solution in the syringe body 10, it would leak out through the switching device 100 and out of the needle 21. Moreover, the apparatus of Oh is not designed to aspirate a precise, predetermined volume of fluid sample in the way a calibrated capillary tube can do. Oh never mentions withdrawing precalculated or precise volumes of medicine from a vial. It focuses solely on the foreign substance issue. In practice, the operator aspirates liquid drug from the vial by withdrawing the piston 12 of the syringe 10. Since the needle 21 is metal, the operator cannot see when the need contains a precise, predetermined amount of fluid sample such as would be admitted by Applicant's capillary tube. Therefore, Oh does not inherently teach an apparatus pre-loaded with a precise, predetermined amount of dilution solution based on the known volume of the capillary tube. Instead, Oh teaches away from a pre-loaded dilution solution (Arguments and Remarks, pages 18-19). Examiner disagrees. First, “a dilution solution” is not a positively recited structure of the claimed apparatus. Thus, Oh et al needs to only teach an elongate, main body (11) having an internal cavity capable of being loaded or filled with a precise, predetermined amount of dilution solution according to the volume of capillary tube (21), wherein the volume of capillary tube (21) is smaller than the volume of the internal cavity (of 11), as shown in Figure 2, thus being able to accommodate the volume of capillary tube (21). Second, the recitation “for collecting, diluting… a patient fluid sample” is an intended use of the claimed apparatus. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The apparatus (Figures 2-5) of Oh et al is structurally capable of collecting a patient sample and diluting the patient sample, thus meeting the claims.
In regards to claim 15, Applicant argued: Claim 15 is not anticipated by Oh since it fails to teach, disclose or suggest the limitations discussed above with respect to claim 1. Claims 16, 19 and 20 depend from claim 15 and are not anticipated by Oh for at least the same reasons as discussed above with respect to claim 15 (Arguments and Remarks, page 19). Examiner disagrees and maintains the rejection of claim 1 for the same reasons as provided above with respect to claim 1.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/SHEFALI D PATEL/Primary Examiner, Art Unit 3783
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