DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
The claims will be read under the broadest reasonable interpretation standard outlined in
MPEP § 2111.01.
Claim Objections
Claims 3 and 13 are objected to for the following informalities:
“with different medical device” reads as a grammatical error.
“from the t least one” reads as a typographical error for “from the at least one”
Claims 5 and 15 are objected to for the following informalities:
“fluid plow path” reads as a typographical error for “fluid flow path”.
Appropriate correction is required.
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.
Claims 3, 9, 13 and 19 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
With respect to claims 3 and 13, the following issues of antecedent basis are present:
“including the disconnection of the medical device” as recited by limitations (ii) and (iii). The limitation is recited without respect to the prior introduced first and second medical devices. The examiner further notes that the open-ended transition phrase “comprising” was used in claims 1 and 11 upon which claims 3 and 13 depend respectively. The examiner will presume any medical device as reading upon the claim.
“the patient” as recited by limitations (ii) and (iii). The examiner will interpret any patient as reading upon the claim.
“a replacement of the medical device with different medical device” as recited by limitation (iii), potentially lacks antecedent basis depending on the resolution of the claim objection recited above. The examiner will presume any “different” medical device as reading upon the prior art.
“the another medical device” as recited by limitation (iii). The examiner will interpret any “other” medical device as reading upon the claim.
“the spatial relationships between the plurality of medical devices”, as “spatial relationships” cannot be presumed as synonymous with the locations, distances, connections, and disconnections of claims 1 and 3/13, since “spatial relationship[s]” may include a broader class of information than what was recited. The examiner will interpret any spatial relationship as reading upon the claim.
With respect to claims 9 and 19, the following issue of antecedent basis is present:
“including the medical device”, as it is unclear whether this refers to the first medical device, the second medical device, or a different medical device under the open-ended transitional phrase “comprising”. The examiner will presume any medical device as reading upon the prior art.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 U.S.C. 101 because they are directed to ineligible patent subject matter. The claims are directed to the Abstract Idea grouping of mental processes under MPEP § 2106.04(a)(2)(III). This is a judicial exception under Step 2A, Prong One of the framework established by the cases of Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 216, 110 USPQ2d 1976, 1980 (2014) and Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66, 71, 101 USPQ2d 1961, 1965 (2012). See MPEP § 2106.04(II).
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Step 1: The claims in question are directed to a method, device (system) for “vascular access management”. Machines and processes are statutory categories. See MPEP 2106.03(I), “A machine is a "concrete thing, consisting of parts, or of certain devices and combination of devices." Digitech, 758 F.3d at 1348-49, 111 USPQ2d at 1719 (quoting Burr v. Duryee, 68 U.S. 531, 570, 17 L. Ed. 650, 657 (1863)). This category "includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result." Nuijten, 500 F.3d at 1355, 84 USPQ2d at 1501 (quoting Corning v. Burden, 56 U.S. 252, 267, 14 L. Ed. 683, 690 (1854))”; See MPEP 2106.03(I), “NTP, Inc. v. Research in Motion, Ltd., 418 F.3d 1282, 1316, 75 USPQ2d 1763, 1791 (Fed. Cir. 2005) ("[A] process is a series of acts.") (quoting Minton v. Natl. Ass’n. of Securities Dealers, 336 F.3d 1373, 1378, 67 USPQ2d 1614, 1681 (Fed. Cir. 2003)). As defined in 35 U.S.C. 100(b), the term "process" is synonymous with "method."”. (Step 1: Yes).
Step 2A, Prong One: As explained in MPEP 2106.04(II), a claim “recites” a judicial
exception when the judicial exception is “set forth” or “described” in the claim. Here, each
claim recites or depends upon the mental processes of capturing, determining various classes of information through observation, and updating a database. (Claim 1, “capturing…a plurality of images…determining…a plurality of locations…determining…a plurality of distances…determining…at least one event of the following…updating…a database”; Claim 3, “determining…one of the following further events…”; Claim 4, “determining…a plurality of orientations…”; Claim 5, “determining…based on an orientation…a direction of fluid flow…”; Claim 7, “determining…further determines a probability…”; Claim 8, “delaying…determining the plurality of distances…until a location…changes”; Claim 9, “providing…an alert… automatically controlling (noting that under the broadest reasonable interpretation standard, a human can perform tasks “automatically”)…at least one medical device to stop a flow of fluid…”)
The claims are recited at a high level of generality and lack any specifics precluding such
an analysis from being interpreted under the mental processes grouping of “practically performed
in the mind” (see also MPEP § 2106.04(a)(2) identifying how e.g. a use of pen and paper, a ruler,
or a computer as a tool (to assist in visually/mentally analyzing/observing acquired
images/video) fails to preclude such an interpretation under the mental processes judicial
exception). Activities such as “with the one or more processors” therefore may be performed mentally, even if they may require the additional computer tool. Similarly, basic image capturing and database components do not elevate these claims past a mental process.
As such, the usage of a computer to capture images, actuate devices, or update a database does not elevate these claims beyond a mental process. (Step 2A, Prong One: Yes).
Step 2A, Prong Two: If Prong One of Step 2A is met, the examiner must consider (1)
whether there are any ‘additional elements’ recited in the claim beyond the judicial exception,
and (2) evaluate those additional elements individually and in combination to determine whether
the claim as a whole integrates the exception into a practical application. See MPEP §
2106.04(d).
Limitations the courts have found indicative of integration include: an improvement in
the functioning of a computer, or an improvement to other technology or technical field, as
discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a); applying or using a judicial exception to
effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in
MPEP § 2106.04(d)(2); implementing a judicial exception with, or using a judicial exception in
conjunction with, a particular machine or manufacture that is integral to the claim, as discussed
in MPEP § 2106.05(b); effecting a transformation or reduction of a particular article to a
different state or thing, as discussed in MPEP § 2106.05(c); and applying or using the judicial
exception in some other meaningful way beyond generally linking the use of the judicial
exception to a particular technological environment, such that the claim as a whole is more than
a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Limitations that the courts have found non-indicative of integration include: merely
reciting the words "apply it" (or an equivalent) with the judicial exception, or merely including
instructions to implement an abstract idea on a computer, or merely using a computer as a tool to
perform an abstract idea, as discussed in MPEP § 2106.05(f); adding insignificant extra-solution
activity to the judicial exception, as discussed in MPEP § 2106.05(g); and generally linking the
use of a judicial exception to a particular technological environment or field of use, as discussed
in MPEP § 2106.05(h).
As an additional note, ‘additional elements’ are generally limitations excluded from
interpretation under the Abstract Idea groupings, and may comprise portions of limitations
otherwise identified as falling under those Abstract Idea groupings of the 2019 PEG (e.g. any
‘determination’ that may be made mentally by a user, neural network and/or generic computer hardware is considered under the ‘apply it’ considerations of 2106.05(f)). Any ‘providing’/outputting broadly, and ‘collection/input’ of data (i.e updating a database, and basic gathering of image input), also fail(s) to integrate at least in view of MPEP 2106.05(g) (extra-solution data gathering/output) and/or 2106.05(h) as ‘generally linking’ the exception to a field of use involving machine learning and/or imagery so acquired (e.g. the use of a image capture device to acquire said image broadly, the use of a database, the use of medical devices). The same determination holds for dependent claims that serve to limit the collection/output of data/images (by means of what is collected based on recited conditions) and/or introduce limitations generally linking to a field of use.
None of the instant claims appear to explicitly/clearly capture/recite any disclosed
improvement in technology (see MPEP 2106.05(a), with note that ‘functioning of a computer’
concerns functions integral to the way a computer operates and not ‘functions’ that a generic
computer can be programmed/adapted to perform (see also 2106.05(f))) and any ‘additional
elements’, even when considered in combination, fail to integrate at Prong Two of Step 2A
accordingly. Integration in view of subsection (a) requires an identification of the manner in
which the improvement is achieved, to be explicitly and specifically recited in the claims, as
‘additional elements’ precluded from interpretation under any of the Abstract Idea groupings
(since the improvement cannot be to the exception itself). With reference to MPEP 2106.05(a):
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981))
As applicable here, additional limitations not directed to a judicial exception fail to
integrate at Prong Two of Step 2A. Claim 1 recites a “image capture devices…processors…medical devices…a database”; Claim 2 recites a “wherein the first medical device includes…”; Claim 6 recites “wherein the first medical device includes…”; Claim 10 recites “wherein the one or more image capture devices includes…”. The incorporation of conventional computer, medical device, and imaging systems does little more than generally link the judicial exceptions of mental processes to a field-of-use and technological environment. See MPEP §§ 2106.05(h); 2106.05(f).
Claim 1 recites “capturing, with one or more image capture devices…”, and “updating, with the one or more processors…a database…”. These limitations constitute insignificant extra-solution activity under MPEP § 2106.05(g). Specifically, the limitations amount to no more than necessary data inputting and outputting, under rationale 3 of MPEP § 2106.05(g).
Even when viewed in combination, any additional elements present do not integrate the
recited judicial exception into a practical application (Step 2A, Prong Two: No), and the claims
are directed to the judicial exception. (Revised Step 2A: Yes → Step 2B).
Step 2B: If Prong Two of Step 2A is not met, the examiner must consider whether the
claim as a whole amounts to ‘significantly more’ than the recited exception, i.e., whether any
‘additional element’, or combination of additional elements, adds an inventive concept to the
claim. The considerations of Step 2A Prong 2 and Step 2B overlap, but differ in that 2B also
requires considering whether the claims feature any “specific limitation(s) other than what is
well-understood, routine, conventional activity in the field” (WURC) (MPEP § 2106.05(d)).
Such a limitation if specifically recited however, must still be excluded from interpretation under
any of the Abstract Idea groupings. Step 2B further requires a re-evaluation of any additional
elements drawn to extra-solution activity in Step 2A (e.g. image capture, database updating) – however no limitations appear directed to any novel collection or output generation per se. Limitations not indicative of an inventive concept/‘significantly more’ include those that are not specifically recited (instead recited at a high level of generality), those that are established as WURC (a plurality of cited references serve to evidence the WURC nature of ‘analysis’ based at least in part on corroborating/additional ground data), and/or those that are not ‘additional elements’ by nature of their analysis at Prong One of Step 2A (i.e. directed to the exception). The July 2024 PEG describes that an improvement/inventive concept (for ‘significantly more’ determination(s)) cannot be to the judicial exception itself.
The claims in question recite little beyond those limitations recited at a high level
of generality and falling under e.g. the mental processes Abstract Idea grouping, and would
monopolize the exception accordingly. The additional limitations of imaging, medical devices, and databases as recited are WURC, as evidenced by the body of prior art cited by the examiner in this office action. (Step 2B: No).
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-4, 8-9, 11, 13-14, and 18-19 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Blau (US 20210248779 A1) (Hereinafter, “Blau”).
With respect to claim 1, Blau discloses:
A method ([0002]) comprising:
capturing, with one or more image capture devices, over a period of time, a plurality of images of an environment surrounding the one or more image capture devices ([0022] “According to an embodiment, a 3D reconstruction (i.e., a determination of a 3D representation) and localization of an object is provided whose shape and appearance have some variability. This can be done based on a single X-ray image or, for increased accuracy, a plurality of X-ray images. A 3D representation and localization of related objects like anatomical structures, implants, surgical tools, and/or parts of implant systems, even if not or only partially visible in the X-ray image, may also be provided.”; [0024] “It is noted that the image data of the processed X-ray image may be received directly from an imaging device, for example from a C-arm based 2D X-ray device, or alternatively from a database. Aspects of the invention may also be used to process medical images acquired using other imaging modalities, such as ultrasound or magnetic resonance imaging”; [0057])
determining, with one or more processors, based on a plurality of images, a plurality of locations of a plurality of medical devices within the environment over the period of time and a plurality of types of the plurality of medical devices (Fig. 9; [0025]; [0027] “In the context of the invention, it will be differentiated between an “object” and a “model”. The term “object” will be used for a real object, e.g., for a bone or part of a bone or another anatomical structure, or for an implant like an intramedullary nail, a bone plate or a bone screw, or for a surgical tool like a sleeve, k-wire, scalpel, drill, or aiming device, which may be connected to an implant. An “object” may also describe only part of a real object (e.g., a part of a bone), or it may be an assembly of real objects and thus consist of sub-objects. In order to emphasize that an object is a sub-object of another object, it may also be called a “structure”. For instance, a “locking hole” of a nail may be considered a structure (or sub-object) of the object “nail”. As another example, a “pedicle” of a vertebra may be considered a structure of the object “vertebra”. Nevertheless, a structure itself (like the pedicle) may also be referred to simply as “object”.”; [0045]; [0055])
determining, with the one or more processors, based on the plurality of locations of the plurality of medical devices within the environment over the period of time, a plurality of distances between the plurality of medical devices over the period of time (Fig. 9; Fig. 17; [0032]-[0033] “Further, a spatial relation between the first object and the second object is determined based on the 3D model of the first object…”; [0043]; [0051] “According to an embodiment, the system may compute geometrical aspects of an object (e.g., an axis, a plane, a trajectory, an outline, a curvature, a center point, or a one- or two-dimensional manifold), and dimensions of an object (e.g., a length, a radius or a diameter, a distance). This may be accomplished due to the correspondence between the model and the virtual projection that has been matched to the projection seen in the X-ray image.”; [0214] “Furthermore, the system may also calculate the penetration depth, in this case, e.g., the distance between drill tip and nail, and thus inform the user”; [0222] “Any potential inaccuracies in distal-proximal direction may not matter because an incorrect positioning of the tool's tip in distal-proximal direction may be detected and computed after (approximately) aligning the tool with the target trajectory, rotating the C-arm around the C-axis, and acquiring another X-ray image. If necessary, instructions for correcting the tool's tip position in distal-proximal direction may then be given. As discussed above in Step 5, it may be sufficient that the tool's tip lies in a plane spanned by target trajectory and nail axis. The remainder of the procedure follows the steps for the first hole.”)
determining, with the one or more processors, based on the plurality of distances between the plurality of medical devices over the period of time and the plurality of types of the plurality of medical devices, at least one event of the following events: (i) a connection of a first medical device of the plurality of medical devices to a second medical device of the plurality of medical devices (Fig. 23; [0032]-[0033] “Further, a spatial relation between the first object and the second object is determined based on the 3D model of the first object, the 3D model of the second object and the information that the second geometrical aspect, e.g. a point of the second object, is located on the geometrical aspect of the first object”, i.e., recognition of distance = 0; i.e., connection; [0037] “According to an embodiment, the selected point of the second object may be a tip of the object, e.g. of a drill, and the information about the 3D location of said tip is a point of contact of the tip with a surface of the first object, e.g. an outer surface of a vertebra or of a long bone like the femur”, wherein “object” as defined by the disclosure also includes other medical devices, [0027]; [0063] “the tip of the drill is positioned on or at least in the vicinity of the hole axis…”; [0067]) and (ii) a disconnection of the first medical device of the plurality of medical devices from the second medical device of the plurality of medical devices ([0211] “Third, the system may now highlight the center of the locking hole in the X-ray image, which the tool should aim for. This highlighted (target) point lies on the target trajectory and, in the described scenario, is the center of the circle. The system may then detect in 2D the tool's tip and compute the required movement of the tip to reach the target point. The system may support the user in an iterative process (each iteration consisting of acquiring a new X-ray image and repositioning the tool) to reach the target point. FIG. 22 shows an X-ray of a nail (22.N) and a drill (22.D) with a displaced drill tip. FIG. 23 shows an X-ray of a nail (23.N) and a drill (23.D) with the drill tip placed on an axis through the hole”, wherein a “disconnection” may simply be a state where the devices are not touching, with distance between them; [0237]-[0247] “Eighth, once an X-ray has been acquired and above conditions are satisfied, the system may then compute the deviation between the tool's axis and the reference trajectory, which it may provide to the user (e.g., by displaying two angle values). The user may then withdraw the tool to the original reference point and realign it with the reference trajectory. The system may help the user find the original reference point... Furthermore, the system may also calculate the penetration depth, in this case, e.g., the distance between tool's tip and target end point, and thus inform the user. During tool insertion, further X-rays may be acquired and above steps may be repeated” ([0214] further establishing that the “target end point” may also be another medical device such as a nail within algorithmic logic), in combination with [0293] “If opening tool is still fixated in first position (S41 e), user withdraws opening tool until its tip is on target trajectory, then aligns opening tool based on system output, acquires X-ray image. (Alternatively, a second opening tool is used to aim for the target trajectory. In this case go to S44.)”, corresponding to a stricter reading wherein the devices must have already connected by showing that the system continuously tracks objects even as they are retracted; [0248] (describing two interlocking but distinct devices disconnecting during the procedure), in combination with [0294] “S453 e: System compares images (e.g., by image difference analysis). If images are locally (for the target object) close enough, go to S44”, wherein the device is configured to compare images over time”, wherein the system may recognize that a device has been disconnected)
updating, with the one or more processors, based on the at least one determined event, a database including current connections between the plurality of medical devices ([0016]; [0056]; [0061] “A computer program product may preferably be loaded into the random-access memory of a data processor. The data processor or processing unit of a system according to an embodiment may thus be equipped to carry out at least a part of the described process. Further, the invention relates to a computer-readable medium such as a CD-ROM on which the disclosed computer program may be stored. However, the computer program may also be presented over a network like the World Wide Web and can be downloaded into the random-access memory of the data processor from such a network. Furthermore, the computer program may also be executed on a cloud-based processor, with results presented over the network”, wherein under BRI a RAM corresponds to a database)
With respect to claim 3, Blau discloses:
The method of claim 1, further comprising: determining, with the one or more processors, based on the plurality of distances between the plurality of medical devices over the period of time and the plurality of types of the plurality of medical devices, one of the following further events: (i) a reuse of the first medical device including a disconnection of the first medical device from the second medical device in the environment and a reconnection of the first medical device to the second medical device in the environment (As stated above, the system is configured to recognize both a connection and a disconnection in real-time, and thus could necessarily recognize a “reconnection” where after retraction, the device reaches distance = 0 once again; [0032]-[0033] “Further, a spatial relation between the first object and the second object is determined based on the 3D model of the first object, the 3D model of the second object and the information that the second geometrical aspect, e.g. a point of the second object, is located on the geometrical aspect of the first object”; [0237]-[0247] “Eighth, once an X-ray has been acquired and above conditions are satisfied, the system may then compute the deviation between the tool's axis and the reference trajectory, which it may provide to the user (e.g., by displaying two angle values). The user may then withdraw the tool to the original reference point and realign it with the reference trajectory. The system may help the user find the original reference point... Furthermore, the system may also calculate the penetration depth, in this case, e.g., the distance between tool's tip and target end point, and thus inform the user. During tool insertion, further X-rays may be acquired and above steps may be repeated” ([0214] further establishing that the “target end point” may also be another medical device such as a nail within algorithmic logic), in combination with [0293] “If opening tool is still fixated in first position (S41 e), user withdraws opening tool until its tip is on target trajectory, then aligns opening tool based on system output, acquires X-ray image. (Alternatively, a second opening tool is used to aim for the target trajectory. In this case go to S44.)”)
updating, with the one or more processors, based on the further determined event, the database including the spatial relationships between the plurality of medical devices ([0016]; [0056]; [0061])
With respect to claim 4, Blau discloses:
The method of claim 1, further comprising: determining, with the one or more processors, based on the plurality of images, a plurality of orientations of the plurality of medical devices within the environment over the period of time, wherein determining the at least one event is further based on the plurality of orientations of the plurality of medical devices within the environment over the period of time ([0065] “The system may then determine an actual angle between the drill axis and the hole axis based on the knowledge of the contact point, based on a 3D model of the drill and based on a 3D model of the bone nail”; [0246]-[0247] “Eighth, once an X-ray has been acquired and above conditions are satisfied, the system may then compute the deviation between the tool's axis and the reference trajectory, which it may provide to the user (e.g., by displaying two angle values). The user may then withdraw the tool to the original reference point and realign it with the reference trajectory. The system may help the user find the original reference point…After a new X-ray is acquired, the system may then check (e.g., through an image difference analysis) whether the anatomy is still shown in the X-ray in the same orientation and position. If this is the case, the relative 3D position and 3D orientation between tool and anatomy may again be computed because of the a priori information that the tool's tip lies on the reference trajectory”).
With respect to claim 8, Blau discloses:
The method of claim 1, further comprising:
delaying, with the one or more processors, determining the plurality of distances between the plurality of medical devices over a period of time and determining the at least one event until a location of at least one of the first medical device and the second medical device changes in the plurality of images over the period of time ([0213]-[0214] “Fifth, the C-arm is rotated, e.g., around the C-axis by, e.g., 25 degrees, and a new X-ray image is acquired. The system may again localize the target object (or possibly only the target structure). Based on the a priori knowledge that the tool's tip lies on the target trajectory (which remains in a known 3D position and 3D orientation relative to the target object/structure), the relative 3D position and 3D orientation between drill and target object/structure may be determined. Even if the drill's tip in distal-proximal direction no longer lies exactly on the target trajectory, the system may calculate the corresponding deviation”; [0247] “Reaching the correct reference trajectory may require an iterative process acquiring further X-rays. After a new X-ray is acquired, the system may then check (e.g., through an image difference analysis) whether the anatomy is still shown in the X-ray in the same orientation and position. If this is the case, the relative 3D position and 3D orientation between tool and anatomy may again be computed because of the a priori information that the tool's tip lies on the reference trajectory. Furthermore, the system may also calculate the penetration depth, in this case, e.g., the distance between tool's tip and target end point, and thus inform the user. During tool insertion, further X-rays may be acquired and above steps may be repeated”; [0292]- [0293] “S452 e: If opening tool is still fixated in first position (S41 e), user withdraws opening tool until its tip is on target trajectory, then aligns opening tool based on system output, acquires X-ray image. (Alternatively, a second opening tool is used to aim for the target trajectory. In this case go to S44.) S453 e: System compares images (e.g., by image difference analysis). If images are locally (for the target object) close enough, go to S44”; [0299])
With respect to claim 9, Blau discloses:
The method of claim 1, further comprising:
in response to determining the at least one event, at least one of:
providing, with the one or more processors, to a user device, an alert associated with the at least one event ([0017]; [0038]; [0214]-[0215] “Informing the user may be done on a display and/or acoustically. An advantage of an acoustic information may be that the surgeon need not look away from the drill and may thus achieve the right direction for drilling with fewer iterations”; [0247] “Furthermore, the system may also calculate the penetration depth, in this case, e.g., the distance between tool's tip and target end point, and thus inform the user”)
With respect to claim 11, it recites a processor configured to execute the method of claim 1. Blau discloses such a processor ([0055]). Accordingly, the claim is rejected in line with the analysis above.
With respect to claims 13, 14, and 18-19, they are functionally parallel to claims 3, 4, and 8-9 respectively. For the reasons outlined in the rejection of claims 11, 3, 4, and 8-9 above, claims 13, 14, and 18-19 are accordingly rejected.
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.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Blau in view of Strommer et. al (US 20080091171 A1) (Hereinafter, “Strommer”).
With respect to claim 2, Blau teaches the method of claim 1.
Blau does not explicitly teach the further limitations of claim 2.
However, Strommer, in the same field of endeavor of imaging and medical safety, teaches:
wherein the first medical device includes at least one of the following types of medical devices: [0033])
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention, to modify Blau to include the limitation of ultrasound devices, as taught by Strommer. Doing so would have the advantage of including a greater variety of devices within its technique. The systems readily integrate, as Blau is already configured to recognize a wide variety of medical devices and requisite distances associated with such.
With respect to claim 12, it is functionally parallel to claim 2. For the reasons outlined in the rejection of claims 11 and 2 above, claim 12 is accordingly rejected.
Claims 5 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Blau in view of Burkholz et. al (US 20190117888 A1) and Loo (US 20010013370 A1) (Hereinafter, “Loo”)
With respect to claim 5, Blau teaches the method of claim 4.
Blau further teaches:
[0032]-[0033]), and wherein the method further comprises:
updating, with the one or more processors, [0016]; [0056]; [0061])
Blau does not explicitly teach:
wherein the database further includes directions of fluid flows in fluid flow paths through the current connections
determining, with the one or more processors, based on an orientation of the first medical device and an orientation of the second medical device, a direction of a fluid flow in a fluid plow path through the first medical device and the second medical device
updating, with the one or more processors, based on the direction of the fluid flow in the fluid flow path through the first medical device and the second medical device
However, Burkholz, in the same field of endeavor of medical monitoring, teaches:
wherein the database further includes [0021] “The system further includes an infusion set for delivering one or more therapeutic agents from a fluid container to a patient via a vascular access device. The program determines a fluid flow rate for fluid being expelled from the fluid container by processing a series of images captured by the at least one imaging sensor to determine fluid flow from the fluid container”)
determining, with the one or more processors, based on an orientation of the first medical device and an orientation of the second medical device ([0051] “With continued reference to FIG. 1, the system 10 a includes a fluid delivery apparatus 28, such as a pre-filled syringe, pen injector, auto-injector, infusion set, catheter, or any combination thereof”, such that a fluid delivery apparatus may comprise both a “first” and “second” medical device”), Fig. 7; [0022] “The program may verify that the infusion set is correctly connected by identifying connection points between portions of the infusion set on an image of the infusion set captured by the at least one imaging sensor and processes a portion of the image including the connection points to determine whether a sufficient connection exists. The data reporting accessory may also alert the user when the program determines that a connection is not sufficient”; [0058] “In certain embodiments, additional electronic or mechanical sensors could be associated with the fluid delivery apparatus 28 to provide further evidence or confirmation of fluid delivery. For example, sensors could be placed near an injection needle 36 of the fluid delivery apparatus 28. The sensors may record when the needle 36 is correctly inserted in a patient and ensure that fluid passes through the needle 36 and is expelled to the patient”)
updating, with the one or more processors, based on [0058])
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention, to modify Blau to include the limitations of fluid delivery tracking, as taught by Burkholz. Doing so would have the advantage of providing additional information and functionality within the system. The systems readily integrate, as Blau is already configured to track motion and connection amongst medical devices.
Blau and Burkholz do not explicitly teach:
direction(s) of fluid flows
However, Loo, in the same field of endeavor of fluid delivery, teaches:
direction(s) of fluid flows (Fig. 6; Fig. 7A; [0007]; [0041] “As the lever 86 is rotated, thereby rotating the core 74, the second flow channel 90 opens in a new direction equal to the direction into which the protruding lever 86 extends. Flow is enabled between the axial port 96 and either the main entry port 76, main exit port 78 or secondary entry port 80 via the axial flow channel 94 when the lever 86 is pointing towards one of these respective ports”; [0044] “Referring to FIG. 7C, the lever 86 has an arrow 98 on its upper surface pointing in a direction in which the lever 86 protrudes. The lever 86 further has the word “ON” 99 written on its upper surface to indicate to the user which way the fluid will flow from or to the axial port 96 into or out of the second flow channel 90. The lever 86 will always point to the specific port that fluid or medication to/from a syringe or secondary IV line attached to the axial port 96 will flow. A clinician can thus immediately know where fluid to or from the axial port 96 will flow”)
As the tertiary reference, Loo teaches the setting of a fluid direction based on an orientation of another device (the stopcock valve).
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention, to modify Blau and Burkholz to include the limitations of fluid direction control based on orientation as taught by Loo. Doing would have the advantage of providing greater control within the system for targeted delivery. The systems readily integrate as the stopcock of Loo could be combined with the fluid delivery apparatus of Blau/Burkholz to a reasonable expectation of success. The fluid delivery apparatus of Blau/Burkholz is already configured to house additional components within a broader “infusion set” ([0016]; [0051]). And with respect to Loo, the reference explicitly teaches the device’s inclusion within a broader IV system ([0011] “Referring to FIG. 2, the body 4 of the three-port, four-way stopcock 2 is molded as one piece. The entry port 6, exit port 8 and injection port 10 are located in a single horizontal plane and are confluent at a central chamber 28, which is filled with the axial portion 14 of the core 12 when the stopcock 2 is assembled. The entry port 6 has a female luer lock connector 30 and is the main fluid entry end of the stopcock 2. It usually is connected to a male luer-lock connector 32 from an IV set connected to a bag of IV fluid. The exit port 8 has a male luer lock or luer slip connector 32 and is the fluid exit end of the stopcock 2 and is usually connected to a female luer lock connector 30 of an IV extension set which ultimately connects to the IV catheter in the patient. The injection port 10 protruding perpendicularly from the middle of the straight line flow path formed by the entry port 6 and exit port 8 has a female luer lock connector 30 and is used for adding medication or fluids to the IV system.”)
With respect to claim 15, it is functionally parallel to claim 5. For the reasons outlined in the rejection of claims 11 and 5 above, claim 15 is accordingly rejected.
Claims 6 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Blau in view of Burkholz, Fitzgerald et. al (US 20170319770 A1) (Hereinafter, “Fitzgerald”) and Abdullah (US 20160193733 A1) (Hereinafter, “Abudllah”)
With respect to claim 6, Blau teaches the method of claim 1.
Blau further teaches:
disclosing various medical devices which do not feature fluid flow between them, [0066])
Blau does not explicitly teach:
[devices configured to form fluid paths generally]
However, Burkholz, in the same field of endeavor of medical monitoring, teaches:
[devices configured to form fluid paths generally] ([0051], fluid delivery apparatus)
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention, to modify Blau to include the limitations of fluid delivery devices, as taught by Burkholz. Doing so would have the advantage of providing additional functionality within the system. The systems readily integrate, as Blau is already configured to track motion and connection amongst various medical devices.
Blau and Burkholz do not explicitly teach:
However, Fitzgerald, in the same field of endeavor of medical devices, teaches:
wherein the first medical device includes at least one of a disinfectant cap ([0058])
It would have been obvious to one of ordinary skill in the art as of the effective filing of the claimed invention, to modify Blau and Burkholz to include the limitations of disinfectant caps, as taught by Fitzgerald. Doing so would have the advantage of maintaining cleanliness of the medical devices. The systems readily integrate, as Blau/Burkholz is already configured to accommodate fluid delivery devices which could reasonably benefit from the inclusion of disinfectant caps.
Blau, Burkholz, and Fitzgerald do not explicitly teach:
and a disinfectant swab
However, Abdullah, in the same field of endeavor of medical devices, teaches:
and a disinfectant swab ([0010])
It would have been obvious to one of ordinary skill in the art as of the effective filing of the claimed invention, to modify Blau, Burkholz, and Fitzgerald to include the limitations of disinfectant swabs, as taught by Abdullah. Doing so would have the advantage of maintaining cleanliness of the medical devices. The systems readily integrate, as Blau/Burkholz/Fitzgerald is already configured to accommodate fluid delivery devices which could reasonably benefit from the inclusion of disinfectant swabs.
With respect to claim 16, it is functionally parallel to claim 6. For the reasons outlined in the rejection of claims 11 and 6 above, claim 16 is accordingly rejected.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Blau in view of Shelton et. al (US 20200405405 A1) (Hereinafter, “Shelton”)
With respect to claim 7, Blau teaches the method of claim 1.
Blau does not explicitly teach the further limitations of claim 7.
However, Shelton, in the same field of endeavor of medical device monitoring, teaches:
wherein the determining the at least one event further determines a probability associated with the at least one event ([0438]-[0440] “A probability assessment may be employed by the robotic surgical system to determine the level of risk in process of operating with the variance detected. This risk probability may take into account aspects such as the magnitude of the variance, whether it is increasing or decreasing, proximity to critical anatomic structures or steps, risk of this particular sub-system resulting in a jammed or can not remove situation, among others”)
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention, to modify Blau to include the limitations of probability assessment, as taught by Shelton. Doing would have the advantage of providing additional information within the system. The systems readily integrate, as an objective of Blau is ensuring further safety during operation ([0016] “Beyond distal locking, in order to increase the safety and accuracy of minimally invasive procedures in general, it is necessary for the surgeon to have access to the necessary intraoperative 3D information, i.e., the relative 3D position and 3D orientation between an instrument and a target object/structure or between a plurality of anatomical objects.”)
With respect to claim 17, it is functionally parallel to claim 7. For the reasons outlined in the rejection of claims 11 and 7 above, claim 17 is accordingly rejected.
Claims 10 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Blau in view of Burkholz.
With respect to claim 10, Blau teaches the method of claim 1.
Blau does not explicitly teach the further limitations of claim 10.
However, Burkholz teaches:
The method of claim 1, wherein the one or more image capture devices includes at least one of the following: a plurality of image capture devices ([0009] “at least one imaging sensor”; [0045] “…such as digital cameras…”)
It would have been obvious to one of ordinary skill in the art as of the effective filing date of the claimed invention, to modify Blau to include the limitations of multiple imaging sensors, as taught by Burkholz. Doing so would have the advantage of providing more viewing angles. The systems readily integrate. Under MPEP § 2144.04(VI)(B), the duplication of parts is obvious, and Blau is already configured to include an imaging sensor ([0024]).
With respect to claim 20, it is functionally parallel to claim 10. For the reasons outlined in the rejection of claims 11 and 10 above, claim 20 is accordingly rejected.
Additional References
Additionally cited references (see attached PTO-892) otherwise not relied upon above have been made of record in view of the manner in which they evidence the general state of the art.
Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOAH WILLIAM BOYAR whose telephone number is 571-272-8392. The examiner can normally be reached 10:00 – 6:00 EST, Monday – Friday.
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/NOAH W BOYAR/Examiner, Art Unit 2669
/IAN L LEMIEUX/Primary Examiner, Art Unit 2669
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