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 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: “search apparatus” in claim 4, “focusing apparatus” in claim 5, and “dosing apparatus” in claim 9.
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.
“search apparatus” is interpreted as a controller as mentioned in [0022] and Fig. 1 of the PGPUB
“focusing apparatus” is interpreted as an objective lens, as mentioned in [0017] of the PGPUB
“dosing apparatus” is interpreted as drug injection apparatus, as mentioned in [0014] and Fig. 1 of the PGPUB
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 1, 2, 8, and 10 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. Claims 3-7 and 11-14 are further rejected due to their dependency to claim 1, 8, or 10.
The term “close” in claims 1, 8, and 10 is a relative term which renders the claim indefinite. The term “close” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear what it means for the inspection port being “close to an outside of the organism” as the disclosure fails to provide a clear description for “close.” It is noted that Fig. 1 shows that the implant can be above the epidermis. For examination purposes, “close to an outside of the organism” is interpreted as “above the epidermis.”
The term “high transmissivity” in claim 2 is a relative term which renders the claim indefinite. The term “high transmissivity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure fails to provide a standard for “high transmissivity of light.” It is unclear what kind of light is considered to have “high transmissivity.” Clarification is requested.
Claim 8 is “a monitoring system...comprising…the analyzer apparatus according to claim 3.” However, claim 3 is “an analyzer apparatus…comprising…an irradiation apparatus that irradiates the inspection port of the implant according to claim 1…” Claim 1 and claim 8 recite similar subject matter (implant, connection ends, inspection port). It is unclear if claim 8 should read as “a monitoring system...comprising…a detector that detects a scattered light from the inspection port” (one implant with connection ends and inspection port and a detector) or if the system of claim 8 includes two implants with connection ends and an inspection port and a detector. Clarification is requested.
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, 3, 8, and 10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaoka et al. ‘719 (US Pub No. 2015/0272719 – cited by Applicant).
Regarding claim 1, Yamaoka et al. ‘719 teaches an implant that is configured so that it is able to be embedded under a skin of an organism (Fig. 5 artificial blood vessel and [0203]), the implant comprising an artificial blood vessel that is molded or able to deform into an arch shape, a U shape, or a V shape (Fig. 5 shows that the artificial blood vessel is in an arch shape.) and the implant includes:
connection ends configured to be connected to a blood vessel of the organism under the skin ([0205]; “…from a femoral artery of a left leg side (LFA) to the femoral artery of the right leg side…”); and
an inspection port arranged between the connection ends ([0205]; “bypass pathway”), and which is configured to be provided on an epidermis of the organism, in the epidermis of the organism, or just below the epidermis of the organism, close to an outside of the organism (Because the artificial blood vessel connects the RFA to the LFA, one of ordinary skill would understand that this is under the epidermis.), and in which a blood flow is permitted to flow via the connection ends ([0205]; “The bypass pathway thus formed restored the blood flow from the sutured part toward the toe side.”).
Regarding claim 3, Yamaoka et al. ‘719 teaches an analyzer apparatus that is configured to be attached to a skin of an organism, comprising:
an irradiation apparatus that irradiates the inspection port of the implant according to claim 1 that has been embedded under the skin of the organism (see art rejection for claim 1) with at least one laser ([0211]; “laser Doppler”); and
a detector that detects scattered light from the inspection port (One of ordinary skill would understand that using a laser Doppler would require a detector that detects light in order to create the image as seen in Fig. 6.).
Regarding claim 8, Yamaoka et al. ‘719 teaches a monitoring system for an organism comprising:
an implant that is configured so that it is able to be embedded under a skin of an organism (Fig. 5 artificial blood vessel and [0203]), the implant comprising an artificial blood vessel that is molded or able to deform into an arch shape, a U shape, or a V shape (Fig. 5 shows that the artificial blood vessel is in an arch shape.) and the implant includes:
connection ends configured to be connected to a blood vessel of the organism under the skin ([0205]; “…from a femoral artery of a left leg side (LFA) to the femoral artery of the right leg side…”); and
an inspection port arranged between the connection ends ([0205]; “bypass pathway”), and which is configured to be provided on an epidermis of the organism, in the epidermis of the organism, or just below the epidermis of the organism, close to an outside of the organism (Because the artificial blood vessel connects the RFA to the LFA, one of ordinary skill would understand that this is under the epidermis.), and in which a blood flow is permitted to flow via the connection ends ([0205]; “The bypass pathway thus formed restored the blood flow from the sutured part toward the toe side.”); and
the analyzer apparatus according to claim 3 (see art rejection for claim 3).
Regarding claim 10, Yamaoka et al. ‘719 teaches a method of monitoring the condition of an organism comprising the claimed steps, as the subject matter of claim 10 is analogous to the subject matter of claims 1, 3, and 8.
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, 4, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaoka et al. ‘719 in view of Segawa ‘917 (US Pub No. 2020/0311917, foreign priority date 25 March 2019).
Regarding claim 2, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for wherein the inspection port is formed of a member with a high transmissivity of light with a wavelength from red to near infrared.
Segawa ‘917 teaches an infrared blood flow image after surgical restoration in Figs. 14-16. The figures show that the infrared blood flow image includes the artificial blood vessel O3 ([0109]). Because the artificial blood vessel can be seen in the infrared blood flow image, one of ordinary skill would understand that the inspection port includes a material that has “high transmissivity of light.”
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the inspection port of Yamaoka et al. ‘719 to include being formed of a member with a high transmissivity of light with a wavelength from red to near infrared as Segawa ‘917 teaches that this will aid in analyzing blood flow after surgical restoration ([0109]).
Regarding claim 4, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for a search apparatus that searches for the inspection port provided on the epidermis, within the epidermis, or directly below the epidermis and controls an irradiation location of the at least one laser.
Segawa ‘917 teaches a control device 9 that comprehensively controls an operation of a medical observation system 1 (Fig. 1 and [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyzer apparatus of Yamaoka et al. ‘719 to include a search apparatus as Segawa ‘917 teaches that this will aid in comprehensively controller an operation of the medical device.
Regarding claim 11, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for searching for the inspection port provided on the epidermis, within the epidermis, or just below the epidermis and controlling an irradiation location of the at least one laser by a search apparatus of the analyzer apparatus.
Segawa ‘917 teaches a control device 9 that comprehensively controls an operation of a medical observation system 1 (Fig. 1 and [0040]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yamaoka et al. ‘719 to include searching for the inspection port provided on the epidermis, within the epidermis, or just below the epidermis and controlling an irradiation location of the at least one laser by a search apparatus of the analyzer apparatus as Segawa ‘917 teaches that this will aid in comprehensively controller an operation of the medical device.
Claims 5, 6, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaoka et al. ‘719 in view of Chabok ‘238 (US Pub No. 2021/0128238, provisional date 04 November 2019).
Regarding claim 5, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for wherein the irradiation apparatus includes a focusing apparatus that focuses at least two laser beams to form a common spot in the inspection port.
Chabok ‘238 teaches an optical tweezer that uses highly focused laser bens to hold and move microscopic objects in a manner similar to tweezers ([0440]). This can be used for cell manipulation (Fig. 60 and [0439].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irridation apparatus of Yamaoka et al. ‘719 to include a focusing apparatus that focuses at least two laser beams to form a common spot in the inspection port as Chabok ‘238 teaches that this will aid in hold and move microscopic objects in a manner similar to tweezers.
Regarding claim 6, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for an optical tweezers apparatus that forms an optical trap inside the inspection port.
Chabok ‘238 teaches an optical tweezer that uses highly focused laser bens to hold and move microscopic objects in a manner similar to tweezers ([0440]). This can be used for cell manipulation (Fig. 60 and [0439].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyzer apparatus of Yamaoka et al. ‘719 to include an optical tweezers apparatus that forms an optical trap inside the inspection port as Chabok ‘238 teaches that this will aid in hold and move microscopic objects in a manner similar to tweezers.
Regarding claim 12, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for forming an optical trap inside the inspection port by an optical tweezers apparatus of the analyzer apparatus.
Chabok ‘238 teaches an optical tweezer that uses highly focused laser bens to hold and move microscopic objects in a manner similar to tweezers ([0440]). This can be used for cell manipulation (Fig. 60 and [0439].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yamaoka et al. ‘719 to include forming an optical trap inside the inspection port by an optical tweezers apparatus of the analyzer apparatus as Chabok ‘238 teaches that this will aid in hold and move microscopic objects in a manner similar to tweezers.
Claims 7 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaoka et al. ‘719 in view of Nagata et al. ‘560 (US Pub No. 2013/0231560).
Regarding claim 7, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for an electromagnetic field generator that performs microfluidic control of a fluid inside the inspection port.
Nagata et al. ‘560 teaches a Doppler sensor causes a microwave (electromagnetic wave) to be radiated from an antenna to a blood vessel to be measured, through the skin of the subject, and reflects from the object to be measured (blood flow) ([0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the analyzer apparatus of Yamaoka et al. ‘719 to include an electromagnetic field generator that performs microfluidic control of a fluid inside the inspection port as Nagata et al. ‘560 teaches that this would aid in measuring blood flow. This would be combining prior art elements (Doppler) according to known methods to yield predictable results (measuring blood flow).
Regarding claim 13, Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for performing microfluidic control of a fluid inside the inspection port by an electromagnetic field generator of the analyzer apparatus.
Nagata et al. ‘560 teaches a Doppler sensor causes a microwave (electromagnetic wave) to be radiated from an antenna to a blood vessel to be measured, through the skin of the subject, and reflects from the object to be measured (blood flow) ([0030]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yamaoka et al. ‘719 to include performing microfluidic control of a fluid inside the inspection port by an electromagnetic field generator of the analyzer apparatus as Nagata et al. ‘560 teaches that this would aid in measuring blood flow. This would be combining prior art elements (Doppler) according to known methods to yield predictable results (measuring blood flow).
Claims 9 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Yamaoka et al. ‘719 in view of Ferren et al. ‘109 (US Pub No. 2009/0287109).
Regarding claim 9, Yamaoka et al. ‘719 teaches a management system for an organism comprising: the monitoring system according to claim 8 (see 35 U.S.C. 102(a)(1) rejection for claim 8 above).
Yamaoka et al. ‘719 teaches all of the elements of the current invention as mentioned above except for a dosing apparatus that injects a drug into the organism through the skin based on a condition of the organism obtained by the analyzer apparatus.
Ferren et al. ’109 teaches a command sequence of a control logic signally an injection of a bolus of an antiplatelet drug or other antiaggregant transluminally responsive to one or more imaging and/or pressure sensors indicating an apparent blockage ([0405]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the management system of Yamaoka et al. ‘719 to include a dosing apparatus that injects a drug into the organism through the skin based on a condition of the organism obtained by the analyzer apparatus as Ferren et al. ‘109 teaches that this will aid in treating a vessel blockage or other pathology ([0405]).
Regarding claim 14, Yamaoka et al.’ 719 teaches all of the elements of the current invention as mentioned above except for injecting a drug into the organism through the skin based on a condition of the organism obtained by the analyzer apparatus by a dosing apparatus attached to a surface of the organism.
Ferren et al. ’109 teaches a command sequence of a control logic signally an injection of a bolus of an antiplatelet drug or other antiaggregant transluminally responsive to one or more imaging and/or pressure sensors indicating an apparent blockage ([0405]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Yamaoka et al. ‘719 to include injecting a drug into the organism through the skin based on a condition of the organism obtained by the analyzer apparatus by a dosing apparatus attached to a surface of the organism as Ferren et al. ‘109 teaches that this will aid in treating a vessel blockage or other pathology ([0405]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791