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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-10, in the reply filed on 08/10/2026 is acknowledged. Claims 21-30 will also be examined as falling within the scope of elected Group I.
Claims 1-10 and 21-30 are pending in the application. Claims 11-20 are cancelled.
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: “sample measurement device” in claims 1, 2, 9, 21, 22, 23, 24, 29, and 30.
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.
The sample measurement device is defined, in para. [0007, 0067-0068, 0077] of the published specification see (US 20240200080 A1), as a digital microfluidic biochip, a test cassette, point-of-care membrane-based test strip, a free-standing enzyme-modified responsive polymer membrane-based biosensor, rapid antigen test.
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 § 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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-3 and 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 10946139 B2) in view of Hulvershorn (US 9888881 B2), further in view of Mann (US 5406959 A), further in view of Chang (US 20180214878 A1), and further in view of Melanson (US 20200077905 A1).
Regarding claim 1, Hochman discloses a medical device (disposable fluid flow assembly 10, figs. 1 & 10, Abstract), comprising: a tubular body (10, figs. 1 & 10) defining a lumen extending longitudinally therethrough (unlabeled, but as seen in fig. 1, col. 13 lines 33-53), the tubular body (10, figs. 1 & 10) comprising: a needle (needle 24, figs. 1 & 10) comprising the lumen extending longitudinally therethrough (“hollow-bore needle”, col. 21 lines 24-27); a handle (handle 27, fig. 10) proximal to the needle (as seen in fig. 10, col. 16 line 55 – col. 16 line 4); a connecting tube (tubing 22, figs. 1 &10) proximal to the handle (as seen in fig. 110), the connecting tube comprising the lumen (as seen in fig. 1); a pressure transducer (pressure transducer 20, fig.1) proximal to the connecting tube (as seen in fig. 1); and a syringe (syringe 18, fig. 1) proximal to the pressure transducer (as seen in fig. 1); wherein the medical device (disposable fluid flow assembly 10, figs. 1 & 10, Abstract) is configured to provide a measurement of pressure (“aspiration of a fluid-filled tissue space ... “entry pressure” is measured”, col. 7 lines 32-45).
Hochman does not expressly disclose the tubular body defining a longitudinal axis.
However, Hulvershorn directed to methods and structures for detecting a physiologic parameter of a target anatomical environment discloses a tubular body (assembly 1200, fig. 10A), the tubular body defining a longitudinal axis (long axis 1218, fig. 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman such that the tubular body defines a longitudinal axis, in view of the teachings of Hulvershorn, as this would aid in providing an in-line or axially aligned assembly of components.
Hochman, as modified by Hulvershorn, does not expressly disclose a stopcock proximal to the handle, the stopcock configured to close or open the lumen to flow of a sample proximal to the stopcock, and that the that the connecting tube is proximal to the stopcock.
However, Mann directed to medical surgical and diagnostic procedures discloses a handle (inner tube handle 54, figs. 9-10) and a stopcock (stopcock 112, figs. 9-10, col. 9 lines 5-14) proximal to the handle (stopcock 112 connected to tube fitting 76 on the proximal end of handle 54, as seen in figs. 9-10, col. 7 lines 32-52), the stopcock configured to control a flow of a sample proximal to the stopcock (“direct various fluid flows into and out of the inner tube”, col. 9 lines 5-14), and a connecting tube (vacuum tube 120, fig. 10) connected to the proximal end of the stopcock (as seen in fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn hereinabove, such that the medical device comprises a stopcock proximal to the handle, the stopcock configured to control a flow of a sample proximal to the stopcock, and the connecting tube proximal to the stopcock, in view of the teachings of Mann, as this would aid in directing various fluid flows into and out of the connecting tube.
Hochman, as modified by Hulvershorn and Mann hereinabove, does not disclose a sample measurement device attached to the handle or to the needle near a distal tip of the needle; wherein the medical device is configured to provide a measurement of portal pressure in a vein of a mammal and an indication of a measurement of a diagnostic biomarker in a sample from the vein before the needle is removed from the vein.
However, Chang directed to a testing device discloses a medical device (“Lab-in-a-Needle” liver assessment device 400, fig. 4) comprising a handle (Handlegrip 182/482 & Mainbody 180/480, fig. 4, para. [0077]) and a sample measurement device (testing device 101 including a microfluidic chip 120/420, para. [0041, 0045, 0086-0087]) attached to the handle or to the needle near a distal tip of the needle (as seen in fig. 4, “480 ... housing for the entire LOC microfluidic platform for the device”, para. [0086]), wherein the medical device is (“Lab-in-a-Needle” liver assessment device 400, fig. 4) configured to provide a measurement of a diagnostic biomarker in a sample from the vein before the needle is removed from the vein (“capture fluorescence emissions ... determine up- or down-regulation of target gene sequences ... comparative analysis of mRNA concentration via fluorescence emissions”; “clinical analysis to body liquid sample such as blood”; “initial nucleic acid concentrations of target mRNA biomarkers”, para. [0081, 0088, 0101-0102, 0106-0107, 0124]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn and Mann hereinabove, such that the medical device comprises a sample measurement device attached to the handle or to the needle near a distal tip of the needle; and the medical device is configured to provide an indication of a measurement of a diagnostic biomarker in a sample from the vein before the needle is removed from the vein, in view of the teachings of Chang, as this would aid in providing a lab-on-chip (LOC) platform for performing diagnostics of the sample captured by the capturing tool completely in vivo (Chang, para. [0041, 0127]).
Hochman, as modified by Hulvershorn, Mann, and Chang hereinabove, does not expressly disclose the medical device is configured to provide a measurement of portal pressure in a vein of a mammal.
However, Melanson directed to system for measuring a pressure in a vein discloses a medical device comprising a needle (“needle”, para. [0046-0047]) and a pressure sensing device (“pressure sensing device”, para. [0046-0047]), wherein the medical device is configured to provide a measurement of portal pressure in a vein of a mammal (“measure the portal pressure”, para. [0046-0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, and Chang hereinabove, such that the medical device is configured to provide a measurement of portal pressure in a vein of a mammal, in view of the teachings of Melanson, as this would aid in monitoring portal pressure.
Regarding claim 2, upon the modification of Hochman to incorporate the testing device of Chang, as describe with respect to claim 1 above, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1, wherein the sample measurement device (Chang, testing device 101 including a microfluidic chip 120/420, para. [0041, 0045, 0086-0087]) is configured to detect a bilirubin concentration (Chang, para. [0124], “bilirubin”).
Regarding claim 3, upon the modification of Hochman to incorporate the testing device of Chang, as describe with respect to claim 1 above, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1, wherein the sample measurement device is a digital microfluidic biochip (Chang, (testing device 101 including a microfluidic chip 120/420 and LCD display 172/472, para. [0041, 0045, 0070, 0086-0088]).
Regarding claim 8, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1. Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, does not expressly disclose wherein the vein is a hepatic vein, a portal vein, or both.
However, Melanson directed to a system for measuring a pressure in a vein discloses that the vein is a hepatic vein, a portal vein, or both. (“needle that is guided to the portal vein”, para. [0046-0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, such that the vein is a hepatic vein, a portal vein, or both, in view of the teachings of Melanson, as this would aid in accessing the portal vein for measuring portal pressure.
Regarding claim 9, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1. Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, does not expressly disclose wherein the sample measurement device is configured to communicate an indication of a measurement to an external receiver.
However, Hulvershorn discloses wherein the sample measurement device (AECD 102, fig. 1C, “biochip”, col. 10 line 54 – col. 11 line 14) is configured to (Examiner’s Note: functional language, i.e., capable of) communicate an indication of a measurement to an external receiver (fig. 1C, “communicate with a remote or external device such as a computer system 90 ... sensing unit 140 ... physiologic correlate parameter values”, col. 15 line 39 – col. 16 line 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, such that the sample measurement device is configured to communicate an indication of a measurement to an external receiver, in view of the teachings of Hulvershorn, as this would aid in monitoring physiologic parameter values.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Hulvershorn, Mann, Chang, and Melanson, as applied to claim 1 above, and further in view of Ahn (US 20050130292 A1).
Regarding claim 4, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1. Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove wherein the diagnostic biomarker comprises: a white blood cell count, a red blood cell count, a platelet count, a hematocrit, one or more of red blood cell indices, or combinations thereof.
However, Ahn directed to a fully-integrated, disposable biochip for point-of-care testing of clinically relevant parameters discloses a diagnostic biomarker (“clinically relevant parameters”, Abstract, para. [0074]), wherein the diagnostic biomarker comprises: a white blood cell count, a red blood cell count, a platelet count, a hematocrit, one or more of red blood cell indices, or combinations thereof (“hematocrit”, para. [0074, 0081]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, such that the diagnostic biomarker comprises: a white blood cell count, a red blood cell count, a platelet count, a hematocrit, one or more of red blood cell indices, or combinations thereof, in view of the teachings of Ahn, as this would aid in monitoring clinically relevant parameters.
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Hulvershorn, Mann, Chang, and Melanson, as applied to claim 1 above, and further in view of Holmes (US 20130079599 A1).
Regarding claim 5, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1. Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, does not expressly disclose wherein the diagnostic biomarker comprises: apolipoprotein F, lipopolysaccharide-binding protein, ficolin-2, apolipoprotein D, kininogen-1, apolipoprotein M, thrombospondin-1, IgG F C-binding protein, cystatin-C, alpha 1-acid glycoprotein 2, leucine-rich alpha-2-glycoprotein, or combinations thereof.
However, Holmes directed to systems and methods for sample processing discloses wherein the diagnostic biomarker comprises: apolipoprotein F, lipopolysaccharide-binding protein, ficolin-2, apolipoprotein D, kininogen-1, apolipoprotein M, thrombospondin-1, IgG F C-binding protein, cystatin-C, alpha 1-acid glycoprotein 2, leucine-rich alpha-2-glycoprotein, or combinations thereof (“Biochip microarray”; “Analyte receptors ... protein analytes ... Cystatin-C”, para. [01555, 01559]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, such that the diagnostic biomarker comprises: apolipoprotein F, lipopolysaccharide-binding protein, ficolin-2, apolipoprotein D, kininogen-1, apolipoprotein M, thrombospondin-1, IgG F C-binding protein, cystatin-C, alpha 1-acid glycoprotein 2, leucine-rich alpha-2-glycoprotein, or combinations thereof, in view of the teachings of Holmes, as this would aid in monitoring protein analytes.
Regarding claim 7, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1. Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, does not expressly disclose wherein the diagnostic biomarker comprises Alpha FetoProtein.
However, Holmes directed to systems and methods for sample processing discloses wherein the diagnostic biomarker comprises Alpha FetoProtein (“Biochip microarray”; “Analyte receptors ... protein analytes ... Alpha-fetoprotein (AFP)”, para. [01555, 01559]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, such that the diagnostic biomarker comprises Alpha FetoProtein, in view of the teachings of Holmes, as this would aid in monitoring protein analytes.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Hulvershorn, Mann, Chang, and Melanson, as applied to claim 1 above, and further in view of Hyde (US 20090093807 A1).
Regarding claim 6, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1. Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, does not expressly disclose wherein the diagnostic biomarker comprises circulating tumor cells, exosomes, or combinations thereof.
However, Hyde directed to devices, methods, and systems related to imaging and ablation discloses a diagnostic biomarker, wherein the diagnostic biomarker comprises circulating tumor cells, exosomes, or combinations thereof (“infrared spectroscopy imaging ... infrared absorbance properties ... circulating tumor cells”, para. [0021, 0236, 0251]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, such that the diagnostic biomarker comprises circulating tumor cells, exosomes, or combinations thereof, in view of the teachings of Hyde, as this would aid in sensing of one or more targets associated with one or more diseases or disorders for which the subject is considered at risk (Hyde, para. [0097]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Hulvershorn, Mann, Chang, and Melanson, as applied to claim 1 above, and further in view of Gupta (US 20140187892 A1).
Regarding claim 10, Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, discloses the medical device of claim 1. Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, does not disclose the medical device further including a test cassette connected to the needle.
However, Gupta directed to medical testing device discloses a sample measurement device (“independent test module ... test strip”; “cassette”, Abstract, para. [0054]) wherein the sample measurement device is a test cassette (independent testing module 10, fig. 1, “cassette”, para. [0054], figs. 1-3) attached to the needle (needle 18, figs. 1-3) (as seen in figs. 1-3, para. [0055]) and includes a point-of-care membrane-based test strip (“point of care”; “immunochromatographic membrane 2 ... test strip 28”, para. [0039, 0046, 0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Mann, Chang, and Melanson hereinabove, such that the sample measurement device is a test cassette attached to the needle and includes a point-of-care membrane-based test strip, in view of the teachings of Gupta, as this would aid in providing a qualitative/semi-quantitative measure of a biomarker and dividing or classifying the different intensities of signal as negative or as positive.
Claims 21-22 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Mann, and further in view of Hulvershorn.
Regarding claim 21, Hochman a medical device (disposable fluid flow assembly, figs. 1 & 10, Abstract), comprising: a handle (handle 27, fig. 10); a needle (needle 24, figs. 1 &10) connected to a distal end of the handle (as seen in fig. 10); a connecting tube (tubing 22, figs. 1 & 10) connected to the proximal end of the handle (as seen in figs. 1 & 10); a lumen included in the handle, needle, and connecting tube (unlabeled, but as seen in figs. 1 & 10); a pressure transducer (pressure transducer 20, fig. 1) connected to a proximal end of the connecting tube (as seen in fig. 1); and a syringe (syringe 18, fig. 1) connected to a proximal end of the pressure transducer (as seen in fig. 1).
Hochman does not expressly disclose a stopcock connected to a proximal end of the handle, the connecting tube connected to the proximal end of the stopcock, wherein the connecting tube is connected to the stopcock at a distal end of the connecting tube.
However, Mann directed to medical surgical and diagnostic procedures discloses a handle (inner tube handle 54, figs. 9-10) and a stopcock (stopcock 112, figs. 9-10, col. 9 lines 5-14) connected to a proximal end of the handle (stopcock 112 connected to tube fitting 76 on the proximal end of handle 54, as seen in figs. 9-10, col. 7 lines 32-52), a connecting tube (vacuum tube 120, fig. 10) connected to the proximal end of the stopcock (as seen in fig. 10), wherein the connecting tube is connected to the stopcock at a distal end of the connecting tube (as seen in fig. 10, “stopcock ... distal end of vacuum tubing 120”, col. 11 lines 1-4).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman such that the medical device comprises a stopcock connected to a proximal end of the handle, the connecting tube connected to the proximal end of the stopcock, and that the connecting tube is connected to the stopcock at a distal end of the connecting tube, in view of the teachings of Mann, as this would aid in directing various fluid flows into and out of the connecting tube.
Hochman, as modified by Mann hereinabove, does not disclose a sample measurement device, wherein the sample measurement device is one of 1) included in the pressure transducer, 2) attached to the handle, or 3) attached to the needle near a distal tip of the needle.
However, Hulvershorn discloses a pressure transducer (anatomical environment characterization device (AECD) 100/102 comprising sensing unit including a piezoelectric pressure transducer 144, figs. 1B-1C, col. 9 lines 15-55 & col. 10 line 24 – col. 11 line 14) and a sample measurement device (“biological microchip (e.g., a biochip) or a microfluidic lab-on-a-chip ... blood oxygenation characteristics”, col. 10 line 54 – col. 11 line 34), wherein the sample measurement device is one of 1) included in the pressure transducer (as seen in figs. 1B-1C, AECD 100/102 “includes ... sensing unit 140”; “sensing unit 140 includes ... pressure transducer ... biochip”, col. 9 lines 15-55 & col. 10 line 24 – col. 11 line 14, figs. 1B-1C), 2) attached to the handle, or 3) attached to the needle near a distal tip of the needle.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann hereinabove, such that the medical device comprises a sample measurement device, wherein the sample measurement device is one of 1) included in the pressure transducer, 2) attached to the handle, or 3) attached to the needle near a distal tip of the needle, in view of the teachings of Hulvershorn, as such a modification would have been merely a substitution of the pressure transducer of Hochman for the AECD of Hulvershorn to monitor pressure and blood oxygenation/signal and/or a type of physiologic measurement that can be generated or obtained using the sensing signal.
Regarding claim 22, upon the modification of Hochman to incorporate the AECD of Hulvershorn, as describe with respect to claim 21 above, Hochman, as modified by Mann and Hulvershorn hereinabove, discloses the medical device of claim 21, wherein the sample measurement device is included in the pressure transducer (Hulvershorn, col. 9 lines 15-55 & col. 10 line 24 – col. 11 line 14, fig. 1C), wherein a sample flows upward through the lumen from the needle (Hochman, col. 19 line 64 – col. 20 line 14 “move the plunger 70 ... to the left to aspirate fluid back to the syringe body”) and is directed into the sample measurement device (Hulvershorn, col. 9 lines 15-55 & col. 10 line 24 – col. 11 line 14).
Regarding claim 29, Hochman, as modified by Mann and Hulvershorn hereinabove, discloses the medical device of claim 21. Hochman, as modified by Mann and Hulvershorn hereinabove, does not expressly disclose wherein the sample measurement device is configured to communicate an indication of a measurement to an external receiver.
However, Hulvershorn discloses wherein the sample measurement device (AECD 102, fig. 1C) is configured to (Examiner’s Note: functional language, i.e., capable of) communicate an indication of a measurement to an external receiver (fig. 1C, “communicate with a remote or external device such as a computer system 90 ... sensing unit 140 ... physiologic correlate parameter values”, col. 15 line 39 – col. 16 line 39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann and Hulvershorn hereinabove, such that the sample measurement device is configured to communicate an indication of a measurement to an external receiver, in view of the teachings of Hulvershorn, as this would aid in monitoring physiologic parameter values.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Mann and Hulvershorn, as applied to claim 21 above, and further in view of Bigelow (US 20170020422 A1).
Regarding claim 23, Hochman, as modified by Mann and Hulvershorn hereinabove, discloses the medical device of claim 21. Hochman, as modified by Mann and Hulvershorn hereinabove, does not expressly disclose wherein the sample measurement device is embedded in the needle close to the distal tip of the needle.
However, Bigelow directed to a device for biosensing with an indwelling venous catheter discloses a needle (needle 10, para. [0016], fig. 1) and a sample measurement device (sensors 130, para. [0016, 0034], fig. 1), wherein the sample measurement device is embedded in the needle close to the distal tip of the needle (“imbedded ... needle 10 ... located at or near the distal end of the ... needle”, para. [0016], fig. 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann and Hulvershorn hereinabove, such that the sample measurement device is embedded in the needle close to the distal tip of the needle, in view of the teachings of Bigelow, as this would aid in continuously monitoring the concentrations of various biomarkers in the blood using the needle bearing at least one sensor (Bigelow, para. [0013]).
Claims 24 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Mann and Hulvershorn, as applied to claim 21 above, and further in view of Chang (US 20180214878 A1).
Regarding claim 24, Hochman, as modified by Mann and Hulvershorn hereinabove, discloses the medical device of claim 21. Hochman, as modified by Mann and Hulvershorn hereinabove, does not expressly disclose wherein the sample measurement device is attached to the handle.
However, Chang directed to a testing device discloses a handle (Handlegrip 182/482 & Mainbody 180/480, fig. 4, para. [0077]) and a sample measurement device (testing device 101 including a microfluidic chip 120/420, para. [0041, 0045, 0086-0087]), wherein the sample measurement device is attached to the handle (as seen in fig. 4, “480 ... housing for the entire LOC microfluidic platform for the device”, para. [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman such that the sample measurement device is attached to the handle, in view of the teachings of Chang, as this would aid in providing lab-on-chip (LOC) platform for performing diagnostic of the sample captured by the capturing tool completely in vivo (Chang, para. [0041, 0127]).
Regarding claim 28, Hochman, as modified by Mann and Hulvershorn hereinabove, discloses the medical device of claim 21. Hochman further discloses that aspiration may be used either to withdraw a sample off tissue or extracellular fluid (col. 7 lines 32-45). Hochman, as modified by Mann and Hulvershorn hereinabove, does not expressly disclose wherein the needle includes a biopsy needle.
However, Chang directed to a testing device comprising a needle 410 (fig. 4) discloses wherein the needle (needle 410, fig. 4) includes a biopsy needle (“industrial-standard core biopsy needle”, para. [0081, 0085]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann and Hulvershorn hereinabove, such that the needle includes a biopsy needle, in view of the teachings of Chang, as this would aid in performing liver biopsy.
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Mann and Hulvershorn, as applied to claim 21 above, further in view of Shkolnikov (US 11278887 B2), and further in view of Pelssers (US 20240099647 A1).
Regarding claim 25, Hochman, as modified by Mann and Hulvershorn hereinabove, discloses the medical device of claim 21. Hochman, as modified by Mann and Hulvershorn hereinabove, does not expressly disclose wherein the sample measurement device is a digital microfluidic biochip including a top plate and a bottom plate parallel to the top plate, a patterned array of controllable electrodes attached to a top surface of the bottom plate, a first hydrophobic insulation coated over the patterned array of controllable electrodes, a continuous ground electrode coated on a bottom surface of the top plate, a second hydrophobic insulation coated over the continuous ground electrode, and a filler medium between the top plate and the bottom plate.
However, Shkolnikov discloses wherein the sample measurement device (microfluidic device (chip) 100, fig. 2B) is a digital microfluidic biochip (microfluidic device (chip) 100; “digital”, Abstract, col. 1 lines 5-12, fig. 2B) including a top plate (220, fig. 2B) and a bottom plate parallel to the top plate (substrate 120, fig. 2B), a patterned array of controllable electrodes attached to a top surface of the bottom plate (transfer electrode 144 and multiple transport electrodes 146, fig. 2B), a first hydrophobic insulation coated over the patterned array of controllable electrodes (hydrophobic layer 200, fig. 2b), a continuous ground electrode coated on a bottom surface of the top plate (“electrically ground conducting cover”; “ground conductor”, col. 3 line 64 – col. 4 line 27 & col. 6 line 65 – col. 7 line 6, fig. 2B), and a filler medium between the top plate and the bottom plate (“air (or another fluid that may fill the device 100”, col. 4 lines 11-14).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann and Hulvershorn hereinabove, such that the sample measurement device is a digital microfluidic biochip including a top plate and a bottom plate parallel to the top plate, a patterned array of controllable electrodes attached to a top surface of the bottom plate, a first hydrophobic insulation coated over the patterned array of controllable electrodes, a continuous ground electrode coated on a bottom surface of the top plate, and a filler medium between the top plate and the bottom plate, in view of the teachings of Shkolnikov, as this would aid in controlling and timing the motion of droplets (Shkolnikov, col. 7 lines 7-15).
Hochman, as modified by Mann, Hulvershorn, and Shkolnikov hereinabove, does not disclose a second hydrophobic insulation coated over the continuous ground electrode.
However, Pelssers directed to an apparatus for transporting fluid to a sensor for monitoring biomarkers (Abstract, para. [0110]) discloses a first hydrophobic insulation (hydrophobic layer 124A, fig. 33) and a second hydrophobic insulation (hydrophobic layer 404, fig. 33) coated over a continuous ground electrode (conductive layer 402, fig. 33) (as seen in fig. 33, para. [0470-0471]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann, Hulvershorn, and Shkolnikov hereinabove, such that the digital microfluidic biochip includes a second hydrophobic insulation coated over the continuous ground electrode, in view of the teachings of Pelssers, as this would aid in transporting fluid to a sensor for monitoring biomarkers.
Claim 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Mann and Hulvershorn, as applied to claim 21 above, and further in view of Gupta (US 20140187892 A1).
Regarding claim 26, Hochman, as modified by Mann and Hulvershorn hereinabove, discloses the medical device of claim 21. Hochman, as modified by Mann and Hulvershorn hereinabove, does not disclose wherein the sample measurement device is a test cassette attached to the needle and includes a point-of-care membrane-based test strip.
However, Gupta directed to medical testing device discloses a sample measurement device (“independent test module ... test strip”; “cassette”, Abstract, para. [0054]) wherein the sample measurement device is a test cassette (independent testing module 10, fig. 1, “cassette”, para. [0054], figs. 1-3) attached to the needle (needle 18, figs. 1-3) (as seen in figs. 1-3, para. [0055]) and includes a point-of-care membrane-based test strip (“point of care”; “immunochromatographic membrane 2 ... test strip 28”, para. [0039, 0046, 0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann and Hulvershorn hereinabove, such that the sample measurement device is a test cassette attached to the needle and includes a point-of-care membrane-based test strip, in view of the teachings of Gupta, as this would aid in providing a qualitative/semi-quantitative measure of a biomarker and dividing or classifying the different intensities of signal as negative or as positive.
Regarding claim 27, Hochman, as modified by Mann, Hulvershorn, and Gupta hereinabove, discloses the medical device of claim 26. Hochman, as modified by Mann, Hulvershorn, and Gupta hereinabove, does not expressly disclose wherein the test cassette is configured to provide at least one of a control indication, a first indication, and a second indication, wherein a control indication indicates a test was performed accurately.
However, Gupta directed to medical testing device discloses wherein the test cassette (“test strip”, para. [0044-0045]) is configured to provide at least one of a control indication, a first indication, and a second indication (“control line ... dark-colored line ... lacks a line in the reactive field”, para. [0044-0046]), wherein a control indication indicates a test was performed accurately (“control line appears in the control field and determines when enough of the biological fluid has been collected”, para. [0044-0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Mann, Hulvershorn, and Gupta hereinabove, such that the test cassette is configured to provide at least one of a control indication, a first indication, and a second indication, wherein a control indication indicates a test was performed accurately, in view of the teachings of Gupta, as this would aid in providing a qualitative/semi-quantitative measure of a biomarker and dividing or classifying the different intensities of signal as negative or as positive.
Claim 30 is rejected under 35 U.S.C. 103 as being unpatentable over Hochman in view of Hulvershorn, further in view of Melanson (US 20200077905 A1), further in view of Mann, and further in view of Chang.
Regarding claim 30, Hochman discloses a medical device (disposable fluid flow assembly, figs. 1 & 10, Abstract), comprising: a tubular body (10, figs. 1 & 10) defining a lumen extending longitudinally therethrough (unlabeled, but as seen in fig. 1, col. 13 lines 33-53), , the tubular body (10, figs. 1 & 10) comprising: a needle (needle 24, figs. 1 & 10), wherein the needle comprises the lumen extending longitudinally therethrough (“hollow-bore needle”, col. 21 lines 24-27); a handle (handle 27, fig. 10) proximal to the needle (as seen in fig. 10, col. 16 line 55 – col. 16 line 4);; a connecting tube (tubing 22, figs. 1 &10) proximal to the handle (as seen in fig. 110), the connecting tube comprising the lumen; a pressure transducer proximal to the connecting tube; and a syringe proximal to the pressure transducer; and
Hochman does not expressly disclose the tubular body defining a longitudinal axis.
However, Hulvershorn directed to methods and structures for detecting a physiologic parameter of a target anatomical environment discloses a tubular body (assembly 1200, fig. 10A), the tubular body defining a longitudinal axis (long axis 1218, fig. 18).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman such that the tubular body defines a longitudinal axis, in view of the teachings of Hulvershorn, as this would aid in providing an in-line or axially aligned assembly of components.
Hochman, as modified by Hulvershorn hereinabove, does not expressly disclose that the needle is configured to access one or both of a portal vein and a hepatic vein.
However, Melanson directed to system for measuring a pressure in a vein discloses a needle (“needle”, para. [0046]) configured to access one or both of a portal vein and a hepatic vein (“needle that is guided to the portal vein”, para. [0046-0047]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn hereinabove, such that the needle is configured to access one or both of a portal vein and a hepatic vein, in view of the teachings of Melanson, as this would aid in accessing the portal vein for measuring portal pressure.
Hochman, as modified by Hulvershorn and Melanson hereinabove, does not disclose a stopcock proximal to the handle, the stopcock configured to control a flow of a sample proximal to the stopcock, and that the connecting tube is proximal to the stopcock.
However, Mann directed to medical surgical and diagnostic procedures discloses a handle (inner tube handle 54, figs. 9-10) and a stopcock (stopcock 112, figs. 9-10, col. 9 lines 5-14) proximal to the handle (stopcock 112 connected to tube fitting 76 on the proximal end of handle 54, as seen in figs. 9-10, col. 7 lines 32-52), the stopcock configured to control a flow of a sample proximal to the stopcock (“direct various fluid flows into and out of the inner tube”, col. 9 lines 5-14), a connecting tube (vacuum tube 120, fig. 10) connected to the proximal end of the stopcock (as seen in fig. 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn and Melanson hereinabove, such that the medical device comprises a stopcock proximal to the handle, the stopcock configured to control a flow of a sample proximal to the stopcock, and the connecting tube proximal to the stopcock, in view of the teachings of Mann, as this would aid in directing various fluid flows into and out of the connecting tube.
Hochman, as modified by Hulvershorn and Melanson hereinabove, does not disclose a sample measurement device wherein the sample measurement device includes one of a digital microfluidic biochip and a test cassette, wherein the sample measurement device attached to the handle or to the needle near a distal tip of the needle.
However, Chang directed to a testing device discloses a handle (Handlegrip 182/482 & Mainbody 180/480, fig. 4, para. [0077]) and a sample measurement device (testing device 101 including a microfluidic chip 120/420, para. [0041, 0045, 0086-0087]), wherein the sample measurement device includes one of a digital microfluidic biochip and a test cassette (testing device 101 including a microfluidic chip 120/420 and LCD display 172/472, para. [0041, 0045, 0070, 0086-0088]), wherein the sample measurement device attached to the handle or to the needle near a distal tip of the needle (as seen in fig. 4, “480 ... housing for the entire LOC microfluidic platform for the device”, para. [0086]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Hochman, as modified by Hulvershorn, Melanson, and Mann hereinabove, such that the medical device comprises a sample measurement device wherein the sample measurement device includes one of a digital microfluidic biochip and a test cassette, wherein the sample measurement device attached to the handle or to the needle near a distal tip of the needle, in view of the teachings of Chang, as this would aid in providing a lab-on-chip (LOC) platform for performing diagnostics of the sample captured by the capturing tool completely in vivo (Chang, para. [0041, 0127]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kimmel (US 9533120 B1) directed to a transseptal needle assembly; Robinson (US 20120065482 A1) directed to methods and apparatuses related to measurement of analytes; Belluci (US 20050197596 A1) directed to a needle assembly, a base and at least one sampling needle operatively linked to a removable cassette.
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
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