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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02/15/2023 was considered by the examiner.
Claim Objections
Claims 1, 4, and 7 are objected to because of the following informalities:
Claim 1, line 6: “is” should be deleted;
Claim 4, line 13: “a treatment device” should be replaced with –the treatment device–; and
Claim 7, line 3: “by the control unit” should be deleted.
Appropriate correction is required.
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:
Detection device in claims 1, 8, and 15 because it uses a generic placeholder (i.e., device) that is coupled with functional language (i.e., configured to detect a state of a treatment target) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to an elongated balloon catheter system, as described in ¶¶ [0026], [0055] of the published application, and equivalents thereof.
Control unit in claim 1 because it uses a generic placeholder (i.e., unit) that is coupled with functional language (i.e., configured to selected a treatment device or a treatment method) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to a central processing unit (CPU), as described in ¶ [0037] of the published application, and equivalents thereof.
Inflation portion of claims 2, 10, and 16 because it uses a generic placeholder (i.e., portion) that is coupled with functional language (i.e., configured to inflate and deflate in the blood vessel) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to a balloon, as described in ¶ [0025] of the published application, and equivalents thereof.
Contact detection unit in claims 2 and 10 because it uses a generic placeholder (i.e., unit) that is coupled with functional language (i.e., configured to detect contact of the inflation portion with the treatment target) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to a plurality of electrodes, a plurality of electrode conductive wires, and a contact detection control unit, as described in ¶ [0030] of the published application, and equivalents thereof.
Strain detection unit of claims 2 and 10 because it uses a generic placeholder (i.e., unit) that is coupled with functional language (i.e., configured to detect a strain amount of the treatment target) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond to a plurality of strain sensors, a plurality of strain sensor conductive wires, and a strain detection control unit, as described in ¶ [0031] of the published application, and equivalents thereof.
Imaging apparatus of claims 4, 12, and 18 because it uses a generic placeholder (i.e., apparatus) that is coupled with functional language (i.e., configured to capture the image) without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
The limitation is being interpreted to correspond toa contrast-enhanced computed tomography (CT) apparatus, a magnetic resonance imaging (MRI) apparatus, a magnetic resonance angiography (MRA) apparatus, as described in ¶ [0034] of the published application, and equivalents thereof.
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.
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 § 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 3-6, 11-14, and 15-20 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.
Claim 3 recites “flexibility or elasticity, which is a state of the treatment target” in line 5. Claim 1 recites “a state of a target treatment” in lines 3-4. It is unclear if these recitations are the same as, related to, or different from each other. For the purposes of examination, claim 3 will be interpreted such that flexibility or elasticity is the state of the treatment target. Claims 11 and 17 recite similar limitations, so they are rejected on similar grounds.
Claim 3 recites “select the treatment device or the treatment method on a basis of the calculated flexibility or elasticity” in lines 7-8. Claim 1 recites “select a treatment device or a treatment method” in line 6. It is unclear whether these selections are the same as, related to, or different from each other. For example, are there multiple selections or just one? If they are the same, consistent terminology should be used. If they are different or related, then the relationship should be made clear. For the purposes of examination, the recitation in claim 3 will be interpreted to be “wherein the selection of the treatment device or treatment method is based on the calculated flexibility or elasticity”.
Claims 4-6 are rejected by virtue of their dependence from claim 3.
Claim 4 recites “determine the treatment device or the treatment method calculated from the treatment target specified from the image acquired from the imaging apparatus as a treatment device or the treatment method to be selected”, which is indefinite. The recitation is so grammatically awkward that the meaning is unclear. For example, what is being determined? How is a treatment device or a treatment method “calculated” from the treatment target? How is the recitation of “as a treatment device or the treatment method to be selected” related to the other limitations? Claims 12 and 18 recite similar limitations, so they are rejected on similar grounds.
Claim 4 recites “the treatment device or the treatment method calculated from the treatment target” in lines 11-12. There is insufficient antecedent basis for the recitation in the claim.
Claim 4 recites “is within a preset allowable value” in line 9. It is unclear how a ratio is “within” a value. For the purposes of examination, the recitation will be interpreted to be “is a preset allowable value”. Claims 11 and 18 recite similar limitations, so they are rejected on similar grounds.
Claim 5 recites “the strain amount measured by the strain detection unit” in lines 3-4. Claim 2 recites “a strain amount” in line 6. Claim 4 recites “an actual strain amount detected by the strain detection unit” in line 6. It is unclear whether the recitation in claim 5 refers to the recitation in claim 2 or claim 4. Claims 6, 13-14, and 19-20 recite similar limitations, so they are rejected on similar grounds.
Claim 5 recites “the compliance value” in lines 4-5. Claim 5 recites “an actual compliance value” in line 3, and claim 4 recites “a reference compliance value” in line 10. It is unclear whether the recitation of “the compliance value” refers to “an actual compliance value” or “a reference compliance value”. For the purposes of examination, the recitation of “the compliance value” will be interpreted to be “the actual compliance value”. Claims 6, 13-14, and 19-20 recite similar limitations, so they are rejected on similar grounds.
Claim 5 recites “calculate an actual compliance value… to determine whether the compliance value is greater than or less than the reference compliance value” in lines 3-5. It is unclear how the recitation of “to determine whether the compliance value is greater than or less than the reference compliance value” should be interpreted. The claim language suggests that either (A) the calculation of the actual compliance value results in the determination of whether the compliance value is greater than or less than the reference value or (B) the calculation of the actual compliance value may be used in the determination of whether the compliance value is greater than or less than the reference value. However, the specification suggests that they are separate steps (Fig. 4 depicts separate steps S10, S11). The Examiner suggests amending the limitation to be a separate step for determining whether the compliance value is greater than or less than the reference compliance value. Claims 6, 13-14, and 19-20 recite similar limitations, so they are rejected on similar grounds.
Claim 5 recites “in a case where a predetermined inflation force is applied to the inflation portion after the contact detection unit detects the contact of the inflation portion with the treatment in a case where the strain ratio exceeds the allowable value” in lines 5-8. The recitation is so grammatically awkward that the meaning is unclear. For example, how is “in a case where the strain ratio exceeds the allowable value” related to the other limitations in the claim? Do both “in a case” conditions need to occur to calculate the actual compliance? Clarification is required. Claims 6, 13-14, and 19-20 recite similar limitations, so they are rejected on similar grounds.
Claim 15 recites “detecting a state of a treatment target which is the blood vessel or an object attached to the blood vessel to detect flexibility of the treatment target” in lines 4-5, which is unclear in light of the specification. The recitation suggests that the state of a treatment target is detected to detect flexibility of the treatment target, which suggests that the state and the flexibility are different. However, the specification indicates that the flexibility or elasticity is a state of the treatment target (¶ [0055] of the published application), which suggests that they are the same. Therefore, it is unclear whether the state and the flexibility are the same as or different from each other.
Claims 16-20 are rejected by virtue of their dependence from claim 15.
Claim 18 recites “determining a treatment device or treatment method calculated from a size of the treatment target specified from an image acquired from an imaging apparatus configured to be capable of capturing the image of the treatment target as a treatment device or treatment method to be selected” in lines 9-12. The recitation is so grammatically awkward that the meaning is unclear. How is “a treatment device or treatment method to be selected” related to the previously recited limitations, and how is it related to “a treatment device or a treatment method” of claim 8, line 6. Additionally, “determining a treatment device or treatment method calculated” creates confusion as to whether the treatment device is or treatment method is calculated or determined.
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 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. Claims 1-20 do not include additional elements that integrate the exception into a practical application of the exception or that are sufficient to amount to significantly more than the judicial exception for the reasons provided below which are in line with the 2014 Interim Guidance on Patent Subject Matter Eligibility (Federal Register, Vol. 79, No. 241, p 74618, December 16, 2014), the July 2015 Update on Subject Matter Eligibility (Federal Register, Vol. 80, No. 146, p. 45429, July 30, 2015), the May 2016 Subject Matter Eligibility Update (Federal Register, Vol. 81, No. 88, p. 27381, May 6, 2016), the 2019 Revised Patent Subject Matter Eligibility Guidance (Federal Register, Vol. 84, No. 4, p. 50, January 7, 2019), and the 2024 Guidance Update on Patent Subject Matter Eligibility (Federal Register, Vol. 89, No. 137 p. 58128, July 17, 2024).
The analysis of claim 1 is as follows:
Step 1: Claim 1 is directed to a machine, which is a statutory category.
Step 2A - Prong 1: Claim 1 is directed to an abstract idea in the form of a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components.
In particular, claim 1 recites the following limitations:
[A1]: select a treatment device or a treatment method, is the treatment device or the treatment method being suitable for the state of the treatment target detected by the detection device
These elements [A1]-[E1] of claim 1 are directed to an abstract idea because they are processes that, under their broadest reasonable interpretation, are mere steps that are capable of being mentally performed with the aid of pen and paper. For example, a skilled artisan is capable of selecting an appropriate treatment method or device based on sensor measurements.
Step 2A - Prong Two: Claim 1 does not recite additional elements that integrate the judicial exception into a practical application. Claim 1 recites the following additional elements:
[A2]: a detection device inserted into a blood vessel and configured to detect a state of a treatment target, the treatment target being the blood vessel or an object attached to the blood vessel; and
[B2]: control unit.
The elements [A2]-[B2] do not integrate the exception into a practical application of the exception.
The element [A2] does not integrate the exception into a practical application of the exception because the element amounts to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.04(d); MPEP 2106.05(g).
The element [B2] does not integrate the exception into a practical application of the exception because the element amount to mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - See MPEP 2106.04(d) and MPEP 2106.05(f).
Accordingly, each of the additional elements do not integrate the abstract into a practical application because they do not impose any meaningful limitations on practicing the abstract idea.
Step 2B: Claim 1 does not recite additional elements that amount to significantly more than the judicial exception itself. Claim 1 recites the following additional elements:
[A2]: a detection device inserted into a blood vessel and configured to detect a state of a treatment target, the treatment target being the blood vessel or an object attached to the blood vessel; and
[B2]: control unit.
The elements [A2]-[B2] do not amount to significantly more than the judicial exception itself.
The element [A2] does not amount to significantly more than the judicial exception itself because the element amounts to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional. The element is disclosed in ¶ [0001] of US 2006/0149166 A1 (Zvuloni); ¶¶ [0288]-[0289] of US 2016/0310077 A1 (Hunter); and ¶ [0011] of US 2021/0401375 A1 (Quint), wherein the plurality of disclosures demonstrate the well-understood, routine, and conventional nature of the element.
Simply reciting the element [B2] does not qualify as significantly more because the element is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (See MPEP 2106.05(d)(II); Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (See MPEP 2106.05(d)(II); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
In view of the above, the additional elements individually do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Independent claim 8 recites mirrored method limitations and is not patent eligible for substantially similar reasons.
Claim 15 recites similar limitations with the addition of the following elements:
[A3]: inserting, into a blood vessel, a detection device configured to be capable of detecting a state of a treatment target which is a blood vessel or an object attached to the blood vessel to detect flexibility of the treatment target.
[B3]: displaying information regarding the selected treatment device or the treatment method on a display unit.
The elements [A3]-[B3] do not integrate the exception into a practical application of the exception and do not amount to significantly more than the judicial exception itself because the elements amount to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.05(g). Specifically, the detection device and the display unit are recited at a high level of generality and are conventional, routine, and well known elements. The detection device of element [A3] is disclosed in ¶ [0001] of US 2006/0149166 A1 (Zvuloni); ¶¶ [0287]-[0289] of US 2016/0310077 A1 (Hunter); and ¶ [0024] of US 2021/0401375 A1 (Quint), wherein the plurality of disclosures demonstrate the well-understood, routine, and conventional nature of the detection device. The display unit of element [B3] is well-understood, routine, and conventional as evidenced by ¶ [0041] of US 2016/0228180 A1 (Sliwa).
Claims 2-6 depend from claim 1, and they recite the same abstract idea as claim 1. Claims 9-14 depend from claim 8, and they recite the same abstract idea as claim 8. Claims 16-20 depend from claim 15, and they recite the same abstract idea as claim 15. Furthermore, these claims only contain recitations that further limit the abstract idea (that is, the claims only recite limitations that further limit the mental process or mathematical algorithm) and/or append abstract ideas (that is, the claims only recite limitations that add further mental processes or mathematical algorithms) except for the following limitations.
Claim 2 recites “the detection device comprises: an inflation portion configured inflate and deflate in the blood vessel; a contact detection unit configured to detect contact of the inflation portion with the treatment target; and a strain detection unit configured to detect a strain amount of the treatment target”. The element does not integrate the exception into a practical application of the exception and does not amount to significantly more than the judicial exception itself because the element amounts to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.05(g). Additionally, the element is well-understood, routine, and conventional. The element is disclosed in ¶ [0009] of US 2021/0401375 A1 (Quint); ¶¶ [0014], [0016] of US 2017/0196478 A1 (Hunter); and ¶¶ [0081], [0084] and Fig.8 of US 2023/0047610 A1 (Balmforth) wherein the plurality of disclosures demonstrate the well-understood, routine, and conventional nature of the element.
Claim 4 recites “receive an image from an imaging apparatus configured to capture the image with which a size of the treatment target can be specified”. However, the element does not integrate the exception into a practical application of the exception and does not amount to significantly more than the judicial exception itself because the element amounts to merely adding insignificant extra-solution activity to the judicial exception, e.g., mere data gathering at a higher level of generality in conjunction with the abstract idea that uses conventional, routine, and well known elements - see MPEP 2106.05(g). Additionally or alternatively, the element is simply appending well-understood, routine and conventional activities previously known in the industry, specified at a high level of generality, to the judicial exception, e.g., a claim to an abstract idea requiring no more than a generic computer to perform generic computer functions that are well-understood, routine and conventional activities previously known in the industry (See MPEP 2106.05(d)(II); Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network)) and/or a claim to an abstract idea requiring no more than being stored on a computer readable medium which is a well-understood, routine and conventional activity previously known in the industry (See MPEP 2106.05(d)(II); Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93).
Claim 7 recites “a display unit configured to display the selected treatment device or the selected treatment method”. However, the element does not integrate the exception into a practical application of the exception and does not amount to significantly more than the judicial exception itself because the element amounts to merely adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g). Specifically, the display unit is recited at a high level of generality, and the display unit is conventional, routine, and well known as evidenced by ¶ [0041] of US 2016/0228180 A1 (Sliwa).
In view of the above, the additional elements do not integrate the abstract idea into a practical application and do not amount to significantly more than the above-judicial exception (the abstract idea). Looking at the limitations as an ordered combination (that is, as a whole) adds nothing that is not already present when looking at the elements taking individually. There is no indication that the combination of elements improves the functioning of a computer, for example, or improves any other technology. There is no indication that the combination of elements permits automation of specific tasks that previously could not be automated. There is no indication that the combination of elements includes a particular solution to a computer-based problem or a particular way to achieve a desired computer-based outcome. Rather, the collective functions of the claimed invention merely provide conventional computer implementation, i.e., the computer is simply a tool to perform the process.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-7 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites “a detection device inserted into a blood vessel” in line 3, which requires the blood vessel. Therefore, claim 1 encompasses a human organism. The Examiner suggests amending the recitation to be “a detection device configured to be inserted into a blood vessel”.
Claims 2-7 are rejected by virtue of their dependence from claim 1.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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, 7-9, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2010/0234840 A1 (Jackson)
With regards to claims 1, 8, and 15, Jackson teaches a medical support system that supports intravascular treatment, and a method for controlling a medical support system that supports intravascular system (¶ [0014] disclose methods and systems for sizing a body lumen and treating the body lumen once the proper measurements have been made; also see Fig. 16 and ¶ [0109] regarding an exemplary mechanism for performing balloon sizing), the medical support system comprising: a detection device inserted into a blood vessel and configured to detect a state of a treatment target (Fig. 4 and ¶¶ [0025]-[0026] depict an expansion member being a balloon coupled to a catheter; ¶ [0039] depict determining the expansion of the balloon via a pressure sensor coupled to the balloon, wherein the pressure sensor may be a strain gauge; ¶¶ [0106]-[0108] depict estimating diameters of the balloon and effectively the lumen diameter), the treatment target being the blood vessel or an object attached to the blood vessel (¶ [0018] discloses treating tissue in the body lumen); and a control unit configured to select a treatment device or a treatment method, is the treatment device or the treatment method being suitable for the state of the treatment target detected by the detection device (¶¶ [0106]-[0108] depict the generator 230 automatically recommends an ablation balloon catheter diameter to be subsequently used, which necessarily requires the use of a control unit), transmitting information regarding the selected treatment or the selected treatment method to a display unit configured to display the information and displaying the information on the display unit (¶ [0107] discloses displaying the recommended balloon diameter on display 250, which indicates that the information regarding the diameter is transmitted and displayed on the display 250).
With regards to claim 7, Jackson further teaches a display unit configured to display the treatment device or the selected treatment method by the control unit (¶ [0107] discloses displaying the recommended balloon diameter on display 250)
With regards to claim 9, Jackson further teaches displaying the treatment device or the selected treatment method on the display unit (¶ [0107] discloses displaying the recommended balloon diameter on display 250)
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.
Claims 2, 10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson, as applied to the respective rejection of claims 1, 8, and 15 under 35 U.S.C. §102 above, and in view of US 2017/0196478 A1 (Hunter)
With regards to claims 2, 10, and 16, Jackson further teaches the detection device comprises an inflation portion configured to inflate and deflate in the blood vessel (¶ [0023] of Jackson teaches inflating and deflating a balloon inside the body lumen).
Jackson is silent regarding whether the detection device comprises a contact detection unit configured to detect contact of the inflation portion with the treatment target; and a strain detection unit configured to detect a strain amount of the treatment target.
In the same field of endeavor of monitoring lumen properties using a catheter, Hunter teaches a balloon catheter (¶ [0009]-[0010] depict the medical tubes being directed to a balloon catheter; also see ¶ [0071]) comprising a contact detection unit configured to detect contact of the inflation portion with the treatment target (¶ [0016] discloses contact sensors provided between the medical device and the surrounding tissue; also see ¶ [0071]); and a strain detection unit configured to detect a strain amount of the treatment target (¶ [0016] discloses strain gauges are provided to detect the strain between a catheter and the surrounding tissue; also see ¶ [0071]) and receiving contact detection result from the contact detection unit and a strain amount detection result from the strain detection unit (¶ [0072] discloses continuously monitoring the above sensors to provide a ‘real-time’ data, imaging, and changes in function over the course of the procedure, and to better understand the conditions which balloon catheters are exposed to in the real world). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the balloon catheter of Jackson to incorporate a contact detection unit configured to detect contact of the inflation portion with the treatment target; and a strain detection unit configured to detect a strain amount of the treatment target; and receiving contact detection result from the contact detection unit and a strain amount detection result from the strain detection unit as taught by Hunter. The motivation would have been to improve the detection of proper placement, anatomy, effective dilation (and elimination of the obstruction), forces exerted on surrounding tissues, balloon inflation and deflation, and to detect the strain encountered in an balloon procedure (¶ [0071] of Hunter).
Claims 3, 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Jackson in view of Hunter, as applied to the rejections of claims 2, 10, and 16 above, and further in view of US 2008/0009746 A1 (Forster).
With regards to claims 3, 11, and 17, the above combination teaches or suggests the control unit is configured to receive a contact detection result from the contact detection unit and a strain amount detection result from the strain detection unit (see the above combination in view of Hunter; ¶ [0072] of Hunter discloses continuously monitoring the above sensors to provide a ‘real-time’ data, imaging, and changes in function over the course of the procedure).
The above combination is silent regarding whether the control unit is configured to calculate flexibility or elasticity, which is a state of the treatment target, from the contact detection result and the strain amount detection result; and select the treatment device or the treatment method on a basis of the calculated flexibility or elasticity.
In a system relevant to the problem of properly selecting and sizing devices (¶ [0020] of Forster), Forster teaches calculating flexibility or elasticity, which is a state of the treatment target, from a contact detection result and the strain amount detection result (¶¶ [0038], [0081] depict a resistance strip for measuring strain to identify a correlation between pressure of the diagnostic balloon and circumferential length, wherein compliance is proportional to the pressure encountered by the balloon upon engagement with the internal walls of the lumen or hollow portion of the organ); and select the treatment device or the treatment method on a basis of the calculated flexibility or elasticity (¶ [0004] discloses using the information to select the size and/or shape of the prosthetic device (i.e., a treatment device) to closely match the size, shape, and topography of the treatment location). It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control unit of the above combination to incorporate that it is configured to calculate flexibility or elasticity, which is a state of the treatment target, from the contact detection result and the strain amount detection result; and select the treatment device or the treatment method on a basis of the calculated flexibility or elasticity. The motivation would have been to provide a treatment device that more closely matches the size, shape, and topography of the treatment location (¶ [0004] of Forster).
No Prior Art Rejections of Claims 4-6, 12-14, and 18-20
With regards to claims 4, 12, and 18, the prior art does not teach or suggest determining whether or not a strain ratio, which is a ratio of an absolute value of a deviation amount of an actual strain amount detected by the strain detection unit, with respect to an assumed strain amount which is a strain amount assumed to be generated in the treatment target in a case where a predetermined inflation force is applied to the inflation portion, is within a preset allowable value on an assumption that the treatment target includes a reference compliance value set in advance, along with the other features of claims 4, 12, and 18..
There are no prior art rejections of claims 5-6, 13-14, and 19-20 by virtue of their dependence from respective claims 4, 12, and 18.
US 2025/0099724 A1 (Schoenle) teaches a plot that established artery compliance, wherein the information from the actual compliance encountered would then pull up an incremental inflation routine that uses a predetermined or user selected pulse count with strain rate based on the artery compliance observed (¶ [0073]). However, Schoenle does not teach or suggest the above limitations.
US 2008/0009746 A1 (Forster) teaches using the information to select the size and/or shape of the prosthetic device (i.e., a treatment device) to closely match the size, shape, and topography of the treatment location (¶ [0004]), but Forster does not teach or suggest the above limitations
Conclusion
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/S.C.K./Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791