DETAILED CORRESPONDENCE
Note: This office action is in response to communication filed on 07/24/2025.
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 .
Status of Claims
Claim(s) 1-20 is/are pending in the application.
Claim(s) 17-20 is/are withdrawn from consideration.
Claim(s) 1-16 is/are examined on the merits.
Response to Arguments
Applicant’s arguments/remarks filed on 07/24/2025 have been fully considered.
With respect to the claim rejection(s) 1-16 under 35 U.S.C. § 103, applicant’s arguments are fully considered and persuasive. Therefore, the rejection has been withdrawn. Specifically, the previously cited art did not teach “one or more frits disposed within a distal end of the actuator”. However, upon further consideration, a new ground(s) of rejection is made in view of Bailey (US PGPUB 20180235528). Accordingly, this action is second Non-Final.
With respect to the claim rejection(s) under 35 U.S.C. § 112(b), applicant’s amendment(s) to the claim(s) has/have overcome the claim rejection(s).
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.
In claim 1, line 5, the limitation “a biasing mechanism for retaining the distal end within an inferior of the distal barrel” has been interpreted under 112(f) as a means plus function limitation because of the generic placeholder “mechanism” and associated functional language “for retaining the distal end within an inferior of the distal barrel” without reciting sufficient structure to achieve the function. Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification (the biasing mechanism 140 comprises a coil spring, it is contemplated that, in other embodiments, the biasing mechanism 140 may comprise any of various devices suitable for retaining the collection device 100 in the retracted configuration, without limitation. For example, in some embodiments, the biasing mechanism 140 may comprise a leaf spring made of shape memory metal. Further, in some embodiments, the biasing mechanism 140 may comprise a small piston that compresses air trapped inside a cylinder, such that when the trapped air expands the frits 104 are withdrawn through the distal opening 106 into the distal barrel 108: ¶0025) as performing the claimed function, and equivalents thereof.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim(s) 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “the biasing mechanism is disposed between an interior of the distal barrel and a circumferential lip comprising the actuator” which is indefinite. It is unclear if the claimed “interior of the distal barrel” same or different from the “interior of the distal barrel” introduced in claim 1. The recitation has been examined below as if it reads -- the biasing mechanism is disposed between [[the interior of the distal barrel and a circumferential lip comprising the actuator --.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
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, 3-8, 10-11, and 15-16 is/are rejected under 35 U.S.C 102(a)(1) as being anticipated by Bailey (US PGPUB 20180235528).
Regarding claim 1, Bailey discloses a blood sample collection device (a blood collection device 10/100: ¶0048-0048, 0053, and Figs. 1-4), comprising:
a distal barrel ((112+114): ¶0053 and Fig. 2) coupled with a proximal barrel (a main section 113: ¶0053 and Fig. 2);
an actuator longitudinally disposed throughout the distal barrel and the proximal barrel (a plunger 116 longitudinally disposed throughout (112+114) and 113: Figs. 3A-B and 4);
one or more frits disposed within a distal end of the actuator (a bore 28 or an open-ended liquid take-up element in the form of a glass capillary tube 130 disposed within a distal end of the actuator 116, wherein the distal end of the actuator is at/near the distal barrel portion 114: ¶0049, 0054-0055; Figs. 1, 3A-B and 4);
a biasing mechanism (a retracting spring 19/119: ¶0048, 0058; Figs. 1 and 3A) for retaining the distal end within an interior of the distal barrel (an interior of the distal barrel (112+114): ¶0058-0059 and Figs. 3A-B and 4); and
a push button (a push stem 23 or push clips 123: ¶0048, 0058, and Figs. 1-2) coupled with a proximal end of the actuator (a proximal end of the actuator 116 is at/near the proximal barrel 113: Figs. 1-2) for extending the one or more frits through a distal opening of the distal barrel (a respective opening 15/115: ¶0048, 0059; Figs. 1, 3B, and 4).
Regarding claim 3, Bailey further discloses the biasing mechanism (19/119) is disposed between the interior of the distal barrel (Figs. 1 and 4) and a circumferential lip comprising the actuator (a shoulder 19b or a central plunger guide 125: ¶0048, 0058; Figs. 1 and 4).
Regarding claim 4, Bailey further discloses the push button (23/123) is configured to be pushed is a distal direction to extend the one or more frits through the distal opening (depressing the plush button 23/123 to extend the one or more frits 28/130 in an extended/distal position/direction: ¶0048-0050, 0059; Figs. 1 and 4).
Regarding claim 5, Bailey further discloses the biasing mechanism (23/123) is configured to withdraw the one or more frits through the distal opening when the push button is released (depressing the plush button 23/123 again to release the one or more frits 28/130 in a retracted position: ¶0048-0050, 0059-0060; Figs. 1 and 4).
Regarding claim 6, Bailey further discloses the one or more frits are each configured to intake a blood sample and store the blood sample in a dried state (¶0057).
Regarding claim 7, Bailey further discloses the one or more frits comprise four individual frits (¶0054 and Fig. 3B) that are removably coupled with the distal end of the actuator (frits 130 is removed after the desired number of blood samples are collected: ¶0061).
Regarding claim 8, Bailey further discloses any one or more of the one or more frits includes a desiccant for causing the dried state (hydrophilic silica gel desiccant: ¶0057 and 0070).
Regarding claim 10, Bailey further discloses any one or more of the one or more frits is configured to hold a volume of blood that is greater than 1.0 µL (a single blood sample is in the range from 5 to 30 µL: ¶0047; thus, the taught volume range overlaps the claimed volume range).
Regarding claim 11, Bailey further discloses any one or more of the one or more frits is configured to store a volume of about 60 µL of blood in a dried state (a frit 130 is configured to store a volume of 15 µL; since there are four frits 130, the total volume is 60 µL; thus, the taught volume is within the claimed volume).
Regarding claim 15, Bailey further discloses each of the one or more frits is accompanied by a window disposed in the distal end (a nozzle cap 114 is at least partly transparent to allow clear sighting of frits 130: ¶0060; thus, Bailey discloses a window disposed in the distal end).
Regarding claim 16, Bailey further discloses the window facilitates blood being drawn into an adjacent frit without leaking or spreading into neighboring frits (¶0060: the window of Bailey is capable of facilitating blood being drawn into an adjacent frit without leaking or spreading into neighboring frits).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 12 is/are rejected under 35 U.S.C 103 as being unpatentable over Bailey (US PGPUB 20180235528).
Regarding claim 12, Bailey does not disclose the actuator is configured to be removed from the blood sample collection device to enable retrieving filled frits from the distal end of the actuator; however, Bailey further suggests that the collection device can be opened onsite by an authorized person or forwarded to another site for opening after the desired number of blood samples have been collected and extraction or punching out of frits 130 by known means (¶0061).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the blood sample collection device of Bailey by having the actuator removed from the blood sample collection device, motivated by the desire to remove the blood samples from the distal end of the actuator. Thus, the actuator of Bailey is capable of being removed from the blood sample collection device to enable retrieving filled frits from the distal end of the actuator.
Claim(s) 2 is/are rejected under 35 U.S.C 103 as being unpatentable over Bailey (US PGPUB 20180235528) in view of Terbrueggen (US PGPUB 20160045187).
Regarding claim 2, Bailey does not disclose the distal barrel is coupled to the proximal barrel by way of a plurality of threads.
In the same field of endeavor, fluid sample collection system/device, Terbrueggen discloses a device 100 for collecting and stabilizing biological samples comprising a proximal body 106 and a distal body 102 (¶0196 and Figs. 1A-B). Terbrueggen further discloses the proximal body 106 is coupled the distal body 102 by a plurality of threads (¶0197, 0227, and Figs. 1C-D) for the benefit of facilitating releasable engagement between the proximal body and the distal body of the sample collection device (¶0197).
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the blood sample collection device of Bailey in view of Terbrueggen by coupling the distal barrel and the proximal barrel by way of a plurality of threads, in order to facilitate releasable engagement between the proximal body and the distal body of the sample collection device, as suggested in ¶0197 of Terbrueggen.
Claim(s) 9 is/are rejected under 35 U.S.C 103 as being unpatentable over Bailey (US PGPUB 20180235528) in view of Jung (US PGPUB 20040116826).
Regarding claim 9, Bailey does not disclose the collection device is coated with a desiccant to cause the dried state.
In the same field of endeavor, device for sample collection and storage, Jung discloses a device comprising a plurality of areas for collecting and storing biological samples: a chamber for liquid specimen storage 20, a chamber for depositing solid specimen 18, a chamber for depositing biological sample obtained by use of a sample collection protrusion 16, and caps 10 and 19 cover the chambers 16 and 20 (¶0039; Figs. 1A-B and 2). Jung further discloses the caps are coated with a desiccant (¶0042) for the benefit of allowing long-term sample storage by preventing growth of microorganisms and damage or degradation of the sample (¶0042). From these teachings, a person having ordinary skill in the art would have recognized/deduced that coating the collection device with a desiccant to cause dried state yields the predictable result of allowing long-term sample storage by preventing growth of microorganisms and damage or degradation of the sample.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have modified the blood sample collection device of Bailey in view of Jung by coating the collection device with a desiccant, in order to allow long-term sample storage by preventing growth of microorganisms and damage or degradation of the sample, as suggested in ¶0042 of Jung.
Claim(s) 13-14 is/are rejected under 35 U.S.C 103 as being unpatentable over Bailey (US PGPUB 20180235528) in view of Marteau (US PAT 3991617).
Regarding claims 13-14, Bailey does not disclose the actuator includes a tubular casing that houses an extractor and a distal end of the extractor is configured to eject the filled frits from the actuator when a proximal end of the extractor is pressed in a distal direction.
In an analogous art for being directed to solve the same problem, removing tip/frit from a sample collection device, Marteau discloses a device comprising a body 12, a push button 10, a detachable tip 14 (Col. 2, lines 33-50 and Fig. 1) and a tip ejecting device (Abstract and Fig. 1). Marteau further discloses the tip ejecting device comprising a push button 24 connected to an extractor (a rod 20: Col. 2, lines 49-55 and Fig. 1) that is housed in a tubular casing (a passage 22: Col. 2, lines 49-55 and Fig. 1) for the benefit of ejecting the tip (Col. 2, lines 49-55). From these teachings, a person of ordinary skill in the art would have recognized that both push button 10 and push button 24 are used as actuators in the device. Furthermore, a person of ordinary skill in the art would have recognized that incorporating an ejecting device yields the predictable result of assisting in ejecting one or more frits.
It would have been obvious to one of ordinary skill in the art before the effective filling date of the claimed invention to have further modified the sample collection device of Bailey in view of Marteau by incorporating an ejecting device with an actuator and a tubular casing that houses an extractor, in order to assist in ejecting one or more frits, as suggested in Col. 2, lines 49-55 of Marteau. Thus, a distal end of the extractor of Bailey in view of Marteau is capable of ejecting the filled frits from the actuator when a proximal end of the extractor is pressed in a distal direction.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NHU Q TRAN whose telephone number is (571)272-2032. The examiner can normally be reached Monday-Thursday 8:00-5:00 (PST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SARAH AL-HASHIMI can be reached at (571) 272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NHU Q. TRAN/Examiner, Art Unit 3781
/JACQUELINE F STEPHENS/Primary Examiner, Art Unit 3781
