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 Objections
Claims 1 and 46 are objected to because of the following informalities:
Regarding claim 1, the semicolon following “the method being executed by a processor, the method comprising;” in the preamble should be replaced with a colon.
Regarding claim 46, the semicolons following “applied through the vessel to the encased portion of the skin” and “between about 1 cm and about 30 cm” should be replaced with commas.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 14-18, 21, 26, 35, 36, 39, 46, 48, 53, and 54 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
More specifically, the system of claim 14, as written, is not clearly setting forth the structure (the processor) configured to execute the instructions of the method. Examiner suggests amending claim language to reflect the following: “A system for determining a pressure within an anatomical cavity of a patient, the system comprising: a processor, wherein the process is configured to: obtain a pressure value; obtain a skin displacement value; determine a pressure…”.
In addition, it is unclear how claim 14 is drawn to a "system" as set forth in the preamble, as a "system" requires plural components to define it, but the claim only indicates "a processor" as part of the system.
Regarding claims 35 and 46, both independent claims state in their respective preambles that the devices are for determining a pressure. However, no sensor elements are disclosed in the independent claims and only pressure chambers are disclosed. In addition, claim 35 only discusses components for applying pressure.
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, 14, and their respective dependent claims are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of claims 1-4, 12-18, 21, and 26 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 2A, Prong 1
Each of claims 1-4, 12-18, 21, and 26 recite at least one step or instruction for collecting and determining information, which is grouped as a mental process under the 2019 PEG. The claimed limitation involves a generic computer collecting, comparing, and determining data without demonstrating the computer into a practical application. Accordingly, claims 1 and 14 recite an abstract idea.
Specifically, claim 1, and substantially similar limitations in claim 14, recites:
A processor
obtaining, by the processor, a pressure value (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
obtaining, by the processor, a skin displacement value (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG);
determining, by the processor, a pressure of the anatomical cavity (observation, judgment or evaluation, which is grouped as a mental process under the 2019 PEG).
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Further, dependent Claims 2-4, 12, 13, 15-18, 21, and 26 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the process steps are performed.
Step 2A, Prong 2
The above-identified abstract idea in independent claims 1 and 14 (and its respective dependent Claims 2-4, 12, 13, 15-18, 21, and 26) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent claim 1), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional element of a processor as recited in independent claims 1 and 14 is a generically recited computer element which does not improve the functioning of a computer, or any other technology or technical field. Nor does this above-identified additional element serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional element does not add a meaningful limitation to the abstract idea because it amounts to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent claims 1 and 14 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed method and system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., the processor as claimed). In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent claims 1 and 14 (and its respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 1 and 14 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of claims 1-4, 12-18, 21, and 26 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
Examiner notes that aspects of the vessel disclosed in claims 1 and 14 are not disclosed to impact how data is received by a processor and therefore is considered pre-solution activity. In addition, the limitation of the pressure being determined “based on a static force balance of the vessel and the encased portion of the skin while the pressure is being applied” points more to how measurement conditions are matched during data collection rather than to how the processor carries out the determining operation.
These claims require the additional element of a processor as recited in independent claims 1 and 14.
The above-identified additional element is a generically claimed computer component which enables the above-identified abstract idea to be conducted by performing the basic functions of automating mental tasks. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Per Applicant’s specification in paragraph 0132, the Applicant discloses that those “skilled in the art will appreciate that processor 110 is generally representative of a processing capability. In some embodiments, in place of or in addition to one or more conventional Central Processing Units (CPUs), one or more specialized processing cores may be provided. For example, one or more Graphic Processing Units (GPUs), Tensor Processing Units (TPUs), and/or other so-called accelerated processors (or processing accelerators) may be provided in addition to or in place of one or more CPUs.” Such computer elements are well-understood, routine, and conventional.
Accordingly, in light of Applicant’s specification, the claimed term processor is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the processor. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in claims 1-4, 12-18, 21, and 26 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general-purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the method and system of claims 1-4, 12-18, 21, and 26 are directed to applying an abstract idea (e.g., mental process or certain method of organizing human activity) on a general-purpose computer without (i) improving the performance of the computer itself (as in McRO, Bascom and Enfish), or (ii) providing a technical solution to a problem in a technical field (as in DDR). In other words, none of claims 1-4, 12-18, 21, and 26 provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional element in independent claims 1 and 14 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply instruct the practitioner to implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. As such, the above-identified additional elements, when viewed as whole, do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, claims 1-20 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 1-4, 12-18, 21, and 26 amounts to significantly more than the abstract idea itself.
Accordingly, claims 1-4, 12-18, 21, and 26 are not patent eligible and rejected under 35 U.S.C. 101 as being directed to abstract ideas implemented on a generic computer in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. and 2019 PEG.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 13-17, and 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tang et al. (CN105249979A), hereinafter Tang.
Regarding claim 1, and substantially similar limitations in claim 14, Tang discloses a method for determining a pressure within an anatomical cavity of a patient, the method being executed by a processor, the method comprising;
obtaining, by the processor [device of the present invention may also include a conventional data collector and a computer, see in ¶ 0018], a pressure value [pressure sensor 5, see Figs. 2,3 and ¶ 0049], the pressure value comprising a pressure applied to skin associated with the anatomical cavity by a vessel [suction cup 2 and sleeve 4, see Figs.1-5 and ¶ 0048-¶ 0049], the vessel having a first end and a second end [see in Figs. 1-5], the first end being open and arranged to contact the skin to encase a portion of the skin, and the vessel being arranged such that a pressure can be applied through the vessel to the encased portion of the skin [see in ¶ 0048 – ¶ 0049];
obtaining, by the processor, a skin displacement value associated with the obtained pressure value, the skin displacement value comprising a distance of the encased portion of the skin from a baseline while the pressure is being applied [micro-displacement sensor 1, see Fig.1 and ¶ 0015];
determining, by the processor, a pressure of the anatomical cavity using the obtained pressure value and the obtained skin displacement value, and based on a static force balance of the vessel and the encased portion of the skin while the pressure is being applied [The changing relationship between F and F; the corresponding changes in the reference point can be used to infer the tension of the entire abdominal cavity, see in ¶ 0049; see also in ¶ 0048].
Regarding claim 13, Tang discloses the method of claim 1, wherein the applied pressure is a positive pressure [Pressure is applied to the abdomen through the lead weight … when pressure is applied, the input resistance decreases, see in ¶ 0049; see also in ¶ 0052].
Regarding claim 15, Tang discloses the system of claim 14, further comprising the vessel [suction cup 2 and sleeve 4, see Figs. 1-5, ¶ 0043 – ¶ 0044].
Regarding claim 16, Tang discloses the system of claim 15, further comprising a pressure unit fluidly connectable to the vessel for applying the pressure to the encased portion of the skin [pressure applicator 3 in connection with suction cup and sleeve and is movable with spring and pressure part, see in ¶ 0015 – ¶ 0017; Examiner notes that fluidly connectable is interpreted as connected in a way that flows or moves easily].
Regarding claim 17, Tang discloses the system of claim 16, wherein the pressure unit comprises a pump [pressure applicator 3, see in Fig. 5, ¶ 0015].
Regarding claim 26, Tang discloses the system of claim 14, further comprising a pressure sensor [pressure sensor 5, see in ¶ 0051] for measuring the applied pressure in the vessel, the pressure sensor communicatively connected to the processor [see in ¶ 0018 and ¶ 0051].
Claims 35, 36, 46, and 53 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Weston (US 7998125 B2).
Regarding claim 35, Weston discloses a device for determining a pressure within an anatomical cavity of a patient, the device comprising: a vessel, the vessel having a first end and a second end, the first end being open and arranged to contact the skin to encase a portion of the skin, wherein the vessel is arranged such that a pressure can be applied through the vessel to the encased portion of the skin; a pressure unit fluidly connectable to the vessel for applying the pressure to the encased portion of the skin [see in Fig. 3; see also in Col. 28, lines 3-6 and 24-38]. Examiner reiterates that no pressure sensor aspects were disclosed in independent claim 35 (see in above in section Claim Rejections - 35 USC § 112), such that the positively claimed elements pertaining to a device for determining a pressure do not define over the device disclosed by Weston.
Regarding claim 36, Weston discloses the device of claim 35, wherein the pressure is a negative pressure and the pressure unit is fluidly connected to the second end of the vessel through which fluid can be drawn out of the vessel to apply the negative pressure to the encased portion of the skin [see in Col. 4, lines 38-45; see in Col. 5, lines 23-28; see in Col. 28, lines 24-33].
Regarding claim 46, Weston discloses a device for determining a pressure within an anatomical cavity of a patient, the device comprising: a vessel having a cylindrical form, the vessel having a first end and a second end, the first end being open and arranged to contact the skin to encase a portion of the skin, wherein the vessel is arranged such that a pressure can be applied through the vessel to the encased portion of the skin [see in Fig. 3; see also in Col. 28, lines 3-6 and 24-38]; wherein an internal diameter of the vessel at the first end is between about 1 cm and about 30 cm [The rigid or semi-rigid chamber is generally sized to enclose the distal extremital portion of the body and adapted to maintain reduced pressure within the volume of the rigid or semi-rigid chamber, Col. 6, lines 39-42; Examiner notes that although the exact diameter is not disclosed, a generally sized chamber exemplified in Fig. 3 to enclose a distal extremital portion of the body can be expected to have an internal diameter between 1 cm and 30 cm]; and a length of the vessel is at least equal to, or more than, an internal radius of the vessel [see in Fig. 3].
Regarding claim 53, Weston discloses the device of claim 46, further comprising a pressure sensor for measuring the applied pressure in the vessel, the pressure sensor communicatively connected to the processor [control device 44 may also be operably connected to a pressure sensor, see in Col. 18, lines 28-29].
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 12 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Tang (CN 105249979 A) in view of Weston (US 7998125 B2).
Regarding claim 12, Tang discloses the method of claim 1.
Tang fails to disclose that the applied pressure is a negative pressure applied through an opening at the second end of the vessel, and the skin displacement comprises a distance of the encased portion of the skin from the baseline towards the second end of the vessel.
However, Weston discloses that that the applied pressure is a negative pressure applied through an opening at the second end of the vessel, and the skin displacement comprises a distance of the encased portion of the skin from the baseline towards the second end of the vessel [see in Col. 4, lines 38-45; see in Col. 28, lines 24-33].
Tang and Weston are both analogous to the claimed invention because they are in the same field of pressure application devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify Tang and incorporate the teachings of Weston to include negative pressure being applied through the second opening of the vessel and skin displacement comprises a distance of the encased portion of the skin from the baseline towards the second end of the vessel in order to increase blood flow and reduce swelling and inflammation that may interfere with pressure value calculations.
Regarding claim 18, Tang discloses the system of claim 16.
Tang fails to disclose that the pressure is a negative pressure and the pressure unit is fluidly connected to the second end of the vessel through which fluid can be drawn out of the vessel to apply the negative pressure to the encased portion of the skin.
However, Weston discloses that the pressure is a negative pressure and the pressure unit is fluidly connected to the second end of the vessel through which fluid can be drawn out of the vessel to apply the negative pressure to the encased portion of the skin [see in Col. 4, lines 38-45; see in Col. 5, lines 23-28; see in Col. 28, lines 24-33].
Tang and Weston are both analogous to the claimed invention because they are in the same field of pressure application devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify Tang and incorporate the teachings of Weston to include that the pressure is a negative pressure and the pressure unit is fluidly connected to the second end of the vessel through which fluid can be drawn out of the vessel to apply the negative pressure to the encased portion of the skin, in order to rid the tissue area of components that may interfere with pressure value calculations.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Tang (CN 105249979 A) in view of Schorr et al. (US 20210023316 A1), hereinafter Schorr.
Regarding claim 21, Tang discloses the system of claim 14.
Tang fails to disclose that the vessel has an internal diameter at the first end which can be modulated by a shutter-like mechanism.
However, Schorr discloses a vessel that has an internal diameter at the first end which can be modulated by a shutter-like mechanism [controller 130 may control the diameter of the passageway (e.g., by closing and/or opening a shutter), see in ¶ 0206].
Tang and Schorr are both analogous to the claimed invention because they are in the same field of devices with cylindrical vessels. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Tang and incorporated the teachings of Schorr to include an internal diameter that can be modulated by a shutter-like system in order to control the amount of tissue area that will be in contact with the applied pressure.
Claims 39 and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Weston (US 7998125 B2) in view of Schorr (US 20210023316 A1).
Regarding claim 39, and substantially similar limitations in claim 48, Weston discloses the device of claim 35.
Weston fails to disclose that the vessel has an internal diameter at the first end which can be modulated by a shutter-like mechanism.
However, Schorr discloses a vessel that has an internal diameter at the first end which can be modulated by a shutter-like mechanism [controller 130 may control the diameter of the passageway (e.g., by closing and/or opening a shutter), see in ¶ 0206].
Weston and Schorr are both analogous to the claimed invention because they are in the same field of devices with cylindrical vessels. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Weston and incorporated the teachings of Schorr to include an internal diameter that can be modulated by a shutter-like system in order to control the amount of tissue area that will be in contact with the applied pressure.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Weston (US 7998125 B2) in view of Tang (CN 105249979 A).
Regarding claim 54, Weston discloses the device of claim 46.
Weston fails to disclose that the device comprises a distance sensor for measuring the displacement of the skin while the pressure is being applied, the distance sensor being communicatively connected to the processor.
However, Tang discloses a distance sensor for measuring the displacement of the skin while the pressure is being applied, the distance sensor being communicatively connected to the processor [micro-displacement sensor 1, see Fig.1 and ¶ 0015; The micro-displacement sensor 1 and the thin film pressure sensor 5 are respectively connected to the data collector, see in ¶ 0018].
Weston and Tang are both analogous to the claimed invention because they are in the same field of pressure application devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to modify Weston and incorporate the teachings of Tang to include a distance sensor, communicatively connected to the processor, to measure the displacement of the skin while pressure is being applied in order to monitor and control the pressure being applied by the device and the response of the tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HY KHANH DOAN whose telephone number is (703)756-5434. The examiner can normally be reached Monday - Friday 8:00 a.m. - 5 p.m..
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/ERIC F WINAKUR/Primary Examiner, Art Unit 3791
/HY KHANH DOAN/Examiner, Art Unit 3791