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 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 1-8 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 1 recites “a plurality of bag-like structures layered with longitudinal directions aligned windably around a living body” in lines 2-3. It is unclear as to how the structures can be layered with longitudinal directions. A direction, no matter if it is longitudinal or not, does not constitute a physical element; therefore, it is unclear as to how a structure can be layered with longitudinal directions. Furthermore, it is unclear as to whether “aligned windably around a living body” should be modifying the “longitudinal directions” or modifying the “plurality of bag-like structures”.
Claim 1 recites “windably” in line 3. The term “windably” is not defined by the dictionary. Although the applicant may act as his or her own lexicographer, the written description must then clearly define the claim term and set forth the definition. Although the term “windably” is used once in [0012] of the Applicant’s Specification, there is no definition provided. Therefore, the term is indefinite because the specification does not clearly define the term.
Claim 1 recites the limitation "the same position" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “the longitudinal direction” in line 7. It is unclear as to whether this element is referring to one of the “longitudinal directions” previously introduced in line 2 of Claim 1, or a separate element.
Claim 1 recites the limitation "the other end" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites “a fixing portion provided in a frame shape inside the outer circumferential edges of a sheet member of the two sheet members and a sheet member of the two sheet members facing each other of the corresponding two adjacent bag-like structures of the plurality of bag-like structures” in lines 9-12. It is unclear as to what exactly this limitation entails as there appear to be idiomatic and/or grammar errors.
Specifically, it is unclear as to whether “a sheet member of the two sheet members and a sheet member of the two sheet members” recited in lines 10-11 was meant to be repeated twice. Furthermore, it is unclear as to whether the fixing portion is provided into each of the sheet members of the two sheet members, or if the fixing portion is provided into only one sheet member of the two sheet members. Additionally, it is unclear as to what limitations are meant to be “facing each other”, as it could be referring to each of the sheet members of the two sheet members facing each other, or it could be interpreted as one of the sheet members facing the fixing portion. Clarification is requested.
Claim 1 recites the limitation "the corresponding two adjacent bag-like structures" in line 8. There is insufficient antecedent basis for this limitation in the claim.
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.
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 1-8 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 “windably around a living body” in line 3. Claim 2 recites “wound around the living body” in line 2. Claim 5 recites “attached to the living body” in line 3. Claims 1-2 and 5 reference a “living body”, which may be construed as being positively recited as part of the claimed invention. To overcome the rejection, it is suggested that the Applicant make clear that some element of the system is “adapted to” or “configured to” be attached to or wound around the living body. For examination purposes, the claim is construed as being intended for use in the manner claimed, rather than the living body being construed as part of the invention itself.
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Karo et al (U.S. Publication No. 2006/0135873).
Regarding Claim 1, Karo discloses a cuff (Cuff for blood pressure monitor, and blood pressure monitor having the same; Abstract) comprising:
a plurality of bag-like structures (air bag 150C…first and second bag members; [0124]) layered with longitudinal directions aligned windably around a living body (cuff 130 is mounted on the wrist; [0125]), each of the plurality of bag-like structures being configured by two sheet members (resin sheets 151, 152, 153, 154; [0124]) long in one direction being fixed to each other at outer circumferential edges (two resin sheets 151, 152 of an approximately rectangular shape in two dimensions are laid one on the other and their rims are melted and bonded to form a first bag member having a first inflated/deflated space 166 a therein, two resin sheets 153, 154 of an approximately rectangular shape in two dimensions are laid one on the other and their rims are melted and bonded to form a second bag member having a second inflated/deflated space 166 b therein; [0124]);
a cutout portion provided at the same position of each of the plurality of bag-like structures in the longitudinal direction, the cutout portion being cut out from one end toward the other end in a width direction of the bag-like structure (Of the four resin sheets, two resin sheets 152, 153 located in the region where the first and second bag members are connected have holes bored in advance at prescribed positions corresponding to each other, which constitute a communication hole 165 through which first inflated/deflated space 166 a and second inflated/deflated space 166 b communicate with each other after formation of air bag 150C; [0124]); and
a fixing portion provided in a frame shape inside the outer circumferential edges of a sheet member of the two sheet members and a sheet member of the two sheet members facing each other of the corresponding two adjacent bag-like structures of the plurality of bag-like structures, the fixing portion being configured to fix the two adjacent bag-like structures to each other (resin sheets 152, 153 constitute a connecting portion 164 located between outer wall portion 161 and inner wall portion 162 inside air bag 150C and connecting a pair of side wall portions 163 located at the respective side end portions of air bag 150C. Connecting portion 164 is for guiding side wall portions 163 serving as the gussets to be surely folded inwards when air bag 150C changes from the inflated state to the deflated state; [0126]).
Regarding Claim 2, Karo discloses wherein the cutout portion is formed avoiding a position facing an artery in a state of the cuff being wound around the living body (Of the four resin sheets, two resin sheets 152, 153 located in the region where the first and second bag members are connected have holes bored in advance at prescribed positions corresponding to each other, which constitute a communication hole 165 through which first inflated/deflated space 166 a and second inflated/deflated space 166 b communicate with each other after formation of air bag 150C; [0124]; Examiner’s Note: As shown in Figures 9A-9C, the cutout portion is formed in the middle of the two bag-like structures. Therefore, the cutout portion is formed avoiding a position facing an artery, as the middle would never be facing an artery in a state of the cuff being wound around the living body).
Regarding Claim 3, Karo discloses wherein a plurality of the cutout portions are provided (Of the four resin sheets, two resin sheets 152, 153 located in the region where the first and second bag members are connected have holes bored in advance at prescribed positions corresponding to each other, which constitute a communication hole 165 through which first inflated/deflated space 166 a and second inflated/deflated space 166 b communicate with each other after formation of air bag 150C; [0124]; Examiner’s Note: There are a plurality of cutout portions provided, as a communication hole would have had to been cut out from both resin sheet 152 and resin sheet 153).
Regarding Claim 4, Karo discloses a blood pressure measurement device (Cuff for blood pressure monitor, and blood pressure monitor having the same; Abstract) comprising:
the cuff according to claim 1 ([0124-0126]);
a sensing cuff (cuff 130) pressed by the cuff (air bag 150 and curled elastic member 170 extend with their longitudinal direction corresponding to the winding direction of cuff 130; [0091]);
a pump configured to supply fluid to the cuff and the sensing cuff (pump 123 for supplying the air to air bag 150; [0098]);
a pressure sensor configured to detect a pressure in the cuff and the sensing cuff (Air system 121 for blood pressure measurement has a pressure sensor 122 having an output value changed in accordance with the pressure within air bag 150…Pressure sensor 122 serves as a pressure detecting portion for detecting the cuff pressure; [0098]); and
a body (main body 110) attached to the cuff and the sensing cuff and including a control board being built into the body (Main body 110 further includes a CPU (Central Processing Unit) 113 for controlling and monitoring the respective portions in a centralized manner, a memory portion 114 for storing a program for causing CPU 113 to conduct a prescribed operation and various information including blood pressure values measured…CPU 113 serves as a blood pressure value calculating portion for calculating a blood pressure value; [0097]).
Regarding Claim 5, Karo discloses wherein the cutout portion is formed avoiding a position facing an artery in a state of the blood pressure measurement device being attached to the living body (Of the four resin sheets, two resin sheets 152, 153 located in the region where the first and second bag members are connected have holes bored in advance at prescribed positions corresponding to each other, which constitute a communication hole 165 through which first inflated/deflated space 166 a and second inflated/deflated space 166 b communicate with each other after formation of air bag 150C; [0124]; Examiner’s Note: As shown in Figures 9A-9C, the cutout portion is formed in the middle of the two bag-like structures. Therefore, the cutout portion is formed avoiding a position facing an artery, as the middle would never be facing an artery in a state of the cuff being wound around the living body).
Regarding Claim 6, Karo discloses wherein a plurality of the cutout portions are provided (Of the four resin sheets, two resin sheets 152, 153 located in the region where the first and second bag members are connected have holes bored in advance at prescribed positions corresponding to each other, which constitute a communication hole 165 through which first inflated/deflated space 166 a and second inflated/deflated space 166 b communicate with each other after formation of air bag 150C; [0124]; Examiner’s Note: There are a plurality of cutout portions provided, as a communication hole would have had to been cut out from both resin sheet 152 and resin sheet 153).
Regarding Claim 7, Karo discloses a flow path fluidly communicating with the sensing cuff (cuff 130 for the blood pressure monitor of the present embodiment primarily includes a cover member 140 of a bag shape that is made of highly elastic cloth or the like, an air bag 150 identified as a fluid bag that is arranged inside cover member 140…over member 140, air bag 150 and curled elastic member 170 extend with their longitudinal direction corresponding to the winding direction of cuff 130; [0091]), wherein the flow path passes through the cutout portion (Air bag 150 is made of a member of a bag shape that is formed using resin sheets. For example, in an air bag 150A contained in a cuff 130 for a blood pressure monitor according to Example 1 based on the present embodiment as will be described later, a resin sheet 152 constituting an inner wall portion located on the wrist side in the state where cuff 130 is wound around the wrist and a resin sheet 151 constituting an outer wall portion located on the outer side than the inner wall portion are laid one on the other and their rims are melted and bonded to form a bag shape, which has an inflated/deflated space 166 therein (for details, see Example 1 below). Inflated/deflated space 166 is connected via a tube 120 to an air system 121 for blood pressure measurement of main body 110; [0093]; Of the four resin sheets, two resin sheets 152, 153 located in the region where the first and second bag members are connected have holes bored in advance at prescribed positions corresponding to each other, which constitute a communication hole 165 through which first inflated/deflated space 166 a and second inflated/deflated space 166 b communicate with each other after formation of air bag 150C; [0124]).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Karo in view of Kami (U.S. Patent No. 4,549,550).
Regarding Claim 8, Karo fails to disclose electric wiring electrically connected to the control board, wherein the electric wiring passes through the cutout portion.
In a similar technical field, Kami teaches a sphygmomanometer (Abstract), comprising electric wiring (wires 19) electrically connected to the control board, wherein the electric wiring passes through the cutout portion (Said sound sensor 3 in the inflatable bag 2 abuts intimately to a skin engaging lining 6 of the inflatable bag 2 and is connected to said electric circuit 12 in the housing 10 by means of shielded wires 19 extending through the opposite lining of the bag 2 and through an aperture 23 in the retainer 20 in such a way as to provide an airtight seal between the shielded wires 19 and the inflatable bag 2; Column 4 Lines 56-63; numeral 23 designates an aperture through which the shielded wires 19 from the sensor 3 extends and numeral 24 designates an aperture through which the tubing leading to said pressure transducer 14 extends; Column 6 Lines 57-61; Figures 2-3; Examiner’s Note: the aperture of Kami is equivalent to the cutout portion of Karo. Therefore, the limitations are taught as the shielded wires pass through the aperture 23 of the airbag).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have incorporated the electrical wiring teachings of Kami into the invention of Karo in order to provide an airtight seal between the electrical wiring and the airbag (Column 4 Lines 56-63).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J JHIN whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHANEL J JHIN/Examiner, Art Unit 3791
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