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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/05/2026 has been entered.
Response to Arguments
Applicant's arguments filed 05/05/2026 have been fully considered but they are not persuasive.
The Applicant has argued “The band (20) does not have designated or preset distinct, specific sizing points (the various holes and cut lines in the band are evenly spaced, neither the holes nor the cut lines are labeled, there are more than four or five sizing options, and the band is length-adjusted through trial and error to stay on the head of the patient and then portions of the band are cut away). Even knowing "the potential stages of life of a human and the corresponding sizes of the skull," Bern does not have any designated sizing points to "fit the size of the skull of the user," as alleged by the Examiner. As such, it would not be obvious to modify the headband of Bern to be adjustable among a designated adult male sizing point, a designated adult female sizing point, a designated child sizing point, and a designated infant sizing point as Bern does not teach, suggest, or disclose any designated sizing points”.
However, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
The Applicant has also argued “Further, the band (20) of Bern is merely fitted to stay on the head of the patient. The band (20) is not sized to fit the head of the patient with any specific coupling force (fitting the bands (20) of Bern on various people means the band stays on the head of the patient - it does not mean the band fits the head of the patient with a specific coupling force). For example, an elastic band of Bern can be at the wrong coupling force but still fit the head of the patient. As a result, the band could result in a wide range of coupling forces, which would be unknown until subsequently measured, so the band (20) cannot achieve a coupling force between 500 grams and 602 grams between a bone conduction audiometric vibrator and the head of an adult male patient, the head of an adult female patient, the head of a child patient, or the head of an the infant patient, as required by amended independent claim 1. The benefits of the headband of the present disclosure, which has designated sizing points associated with specific-sized patients and a specific force to allow immediate attachment of the headband to various sized patients at the proper coupling force, is not present in Bern nor made obvious by Bern, alone or in combination with other references. Bern does not show the user where to connect the band (20) to fit various specific-sized patients, let alone where to connect the band to achieve a specific coupling force for various specific-sized patient”. However, although the elastic band of Bern can be set to the wrong coupling force but fit the head of the patient, Bern does not explicitly teach away from the modification made by Ito in the current prior art rejection. Bern does not explicitly disparage using a specific coupling force or specific sizing points, and modifying this primary reference in the manner suggested by the secondary reference (Ito, Jia, Schlottau) would not forego the benefits taught by the primary reference of implementing a bone conduction hearing device.
The applicant has also argued, regarding Jia: “The left elastic band (3) and the right elastic band (4) do not have designated or preset distinct, specific sizing points (the various adjustment holes are evenly spaced along the elastic band, neither the adjustment holes nor the buckle are labeled, there are more than four or five sizing options, and the band is length- adjusted through trial and error to stay on the head of the patient such that the flexible dry electrode contacts the head of the patient). Even knowing "the potential stages of life of a human and the corresponding sizes of the skull," as alleged by the Examiner with respect to Bern, Jia does not have any designated sizing points to "fit the size of the skull of the user," as alleged by the Examiner. As such, neither Bern nor Jia teach, suggest, or disclose any designated sizing points.” However, the examiner is not alleging that Bern or Jia teach predetermined sizing points—rather, the examiner is alleging the combined teachings of the Bern and Jia would have suggested to those of ordinary skill in the art the obvious modification of designated sizing points for each head size.
The applicant has also argued “a designated sizing point on the headband for a specific coupling force is not possible with the headband device of Jia as the movement of the other headband components introduce more variables that would affect both the headband device staying on the head of the patient and fitting the head of the patient with a specific coupling force. As a result, the headband device of Jia could result in a wide range of coupling forces, which would be unknown until subsequently measured, so the headband device (even when combined with Bern and assuming the desired coupling force is known) cannot achieve a known coupling force between 500 grams and 602 grams between a bone conduction audiometric vibrator and the head of an adult male patient, the head of an adult female patient, the head of a child patient, or the head of an the infant patient, as required by amended independent claim 1”. However, the other headband components of Jia are not being imported into the device of Bern—merely the sizing points. Therefore, the other components of the band of Jia are not relevant to the current rejection.
Regarding Ito, the applicant has argued “Ito does not disclose designated or preset distinct, specific sizing points to achieve the correct coupling force, and the steel headband is not adjustable among various designated sizing points to achieve the correct coupling force for various patient head sizes. Thus, combining Ito with Bern and Jia does not resolve the deficiencies of Bern and Jia.” However, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
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.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Bern et al (US 20180077505 A1, hereinafter Bern) in view of Jia et al (CN 109009100 B, hereinafter Jia; an attached machine translation was relied upon in this rejection) and the Non-Patent Literature (NPL) to Ito (“Bone Conduction Thresholds and Skull Vibration Measured on the Teeth during Stimulation at Different Sites on the Human Head”, hereinafter Ito).
Regarding Claim 1, Bern discloses a headband (See Fig. 4A) for forehead-positioned and mastoid-positioned bone conduction (“A mounting assembly for arranging a bone conducting hearing device to a skin surface over the skull of a user is disclosed”, Abstract) audiometric testing in patients with different head sizes (“The band is provided with length adjusting members 46, 46′ for adjusting the length of the band in order to make it fit to the user”, [0202]), the headband comprising:
an elastic strap (Element 20, Fig. 4A) comprising elastic material (“The band 20 comprises a portion 82 such as a rear portion that may be made in an elastic material”, [0233]);
an anchor (Element 28, Fig. 10H) positioned on a first end of the elastic strap (See Fig. 10H), wherein the anchor is a first type of fastener (“The engagement members 28 (at one end) fit the receiving portion 30 of the engagement member 32 of the other end. The mechanism of the couplable engagement members may be selected from hook-and-loop fasteners, zippers, button-loop arrangement, a male-female configuration such as illustrated in the figure where a male member at one end is slidably positionable in a slot arranged at the second end when the male member is moved along direction of width of the band. Other generally known mechanisms may also be implemented. Hereby, it is possible to attach the two ends of the band 20 to each other by means of a simple geometric engagement”, [0246]);
a first sizing point (Element 24, Figs. 9C and 10F) on a second end of the elastic strap and a first distance from the anchor (“Cutting lines 24 may be indicated at least at one end of the band and preferably at both ends of the band 20. By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]), wherein the first distance is between a center of the anchor and a center of the first sizing point (A first distance exists between a center of the anchor and the center of cutting line 24);
a second sizing point on the elastic strap (A second element 24 closer to the anchor than the first element 24, Figs. 9C and 10F) and a second distance from the anchor (“Cutting lines 24 may be indicated at least at one end of the band and preferably at both ends of the band 20. By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]), wherein the second distance is between the center of the anchor and a center of the second sizing point, and wherein the second distance is less than the first distance (By being closer to the anchor than the first element, a second distance that is less than the first distance exists);
a third sizing point on the elastic strap (A third element 24 closer to the anchor than the second element 24, Figs. 9C and 10F) and a third distance from the anchor, wherein the third distance is between the center of the anchor and a center of the third sizing point, and wherein the third distance is less than the second distance (By being closer to the anchor than the second element, a third distance that is less than the second distance exists); and
a fourth sizing point on the elastic strap (A fourth element 24 closer to the anchor than the third element 24, Figs. 9C and 10F) and a fourth distance from the anchor, wherein the fourth distance is between the center of the anchor and a center of the fourth sizing point, and wherein the fourth distance is less than the third distance (By being closer to the anchor than the third element, a fourth distance that is less than the third distance exists).
Bern discloses the claimed invention except for expressly disclosing wherein the first sizing point is a designated adult male sizing point, the second sizing point is a designated adult female sizing point, the third sizing point is a designated child sizing point, the fourth sizing point is a designated infant sizing point; and
wherein the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, and the designated infant sizing point are each a second type of fastener that mates with the first type of fastener; and
wherein the headband is adjustable among the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, and the designated infant sizing point to fit a head of an adult male patient, a head of an adult female patient, a head of a child patient, or a head of an infant patient with a coupling force between 500 grams and 602 grams between a bone conduction audiometric vibrator and the head of the adult male patient, the head of the adult female patient, the head of the child patient, or the head of the infant patient.
However, Bern clearly teaches the headband to be for a human, and for the sizing points to be for adjusting the headband to fit the size of the skull of the user (“By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]). As the potential stages of life of a human and the corresponding sizes of the skull are well-known prior art conditions within the headband arts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Bern and specifically designate different sizing points for specific users, wherein the first sizing point is a designated adult male sizing point, the second sizing point is a designated adult female sizing point, the third sizing point is a designated child sizing point, and the fourth sizing point is a designated infant sizing point.
Jia, which also discloses a headband (Abstract), teaches wherein the first to fourth sizing points are each a second type of fastener that mates with the first type of fastener (See Fig. 1; each sizing point is a hole that mates with a buckle), wherein the headband is adjustable among the first to fourth points (“by adjusting the buckling position of the headband adjusting buckle 4, realizing adjusting the size of the headband device, so that the headband device can adapt to different head type”, page 8, paragraph 4 of the attached machine translation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the sizing points and adjustment mechanism of Bern (which utilizes cutting the headband, [0244]) with the sizing points and adjustment mechanism of Jia, such that the headband is adjustable between the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, and the designated infant sizing point, because the sizing points and adjustment mechanism of Jia can be enlarged or shrunk multiple times and is reusable.
Ito teaches wherein a wearable loop holds an audiometric bone conduction vibrator to a head of a patient (“BC thresholds were measured with stimulation at 6 different sites of the head: the forehead, the ipsilateral and contralateral mastoids...”, “Measurement of BC Threshold”, page 14, col. 1) with a coupling force between 500 grams and 602 grams (“The bone vibrator was fixed at the measurement sites with a static force of either 2 N or 5 N provided by steel headbands”, “Measurement of BC Threshold”, page 14, col. 1; the examiner notes 5 N is within the claimed range of 500-602 grams (5.4 N ± 0.5 N)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the coupling force of Ito to the headband of modified Bern, such that the adjustable headband fits a head of an adult male patient, a head of an adult female patient, a head of a child patient, or a head of an infant patient with a coupling force between 500 grams and 602 grams between a bone conduction audiometric vibrator and the head of the adult male patient, the head of the adult female patient, the head of the child patient, or the head of the infant patient because the coupling force to fix the bone vibrator is an important issue for BC hearing thresholds (Ito, “Introduction”, page 13, col. 2) and the applicant’s own specification admits this coupling force range is the recommended standard for bone conduction audiometric testing in patients ([0003]).
Regarding Claim 2, modified Bern discloses the headband of claim 1, and further comprising:
a fifth sizing point on the elastic strap (A fifth element 24 closer to the anchor than the fourth element 24, Figs. 9C and 10F) and a fifth distance from the anchor, wherein the fifth distance is between the center of the anchor and a center of the fifth sizing point, wherein the fifth distance is less than the fourth distance (By being closer to the anchor than the fourth element, a fifth distance that is less than the fourth distance exists).
Modified Bern discloses the claimed invention except for expressly disclosing wherein the fifth sizing point is a designated newborn sizing point, and wherein the designated newborn sizing point is the second type of fastener. However, Bern clearly teaches the headband to be for a human, and for the sizing points to be for adjusting the headband to fit the size of the skull of the user (“By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]). As the potential stages of life of a human and the corresponding sizes of the skull are well-known prior art conditions within the headband arts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bern wherein the fifth sizing point is a designated newborn sizing point as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband more versatile and efficient to use with multiple patients.
Jia teaches wherein fifth sizing point is the second type of fastener (See Fig. 1; each sizing point is a hole). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the sizing points and adjustment mechanism of modified Bern (which utilizes cutting the headband, [0244]) with the sizing points and adjustment mechanism of Jia such that the fifth sizing point is also the second type of fastener, because the sizing points and adjustment mechanism of Jia can be enlarged or shrunk multiple times and is reusable.
Regarding Claim 3, modified Bern discloses the headband of claim 2. Modified Bern discloses the claimed invention except for expressly disclosing wherein the first distance is between 16.375 inches (41.59 cm) and 16.625 inches (42.23 cm); wherein the second distance is between 15.5 inches (39.37 cm) and 15.75 inches (40.00 cm); wherein the third distance is between 14.25 inches (36.20 cm) and 14.5 inches (36.83 cm); wherein the fourth distance is between 12.625 inches (32.07 cm) and 12.875 inches (32.70 cm); and wherein the fifth distance is between 11 inches (27.94 cm) and 11.5 inches (29.21 cm). However, Bern clearly teaches the headband to be for a human, and for the sizing points to be for adjusting the headband to fit the size of the skull of the user (“By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]). As the potential stages of life of a human and the corresponding sizes of the skull are well-known prior art conditions within the headband arts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bern wherein the first distance is between 16.375 inches (41.59 cm) and 16.625 inches (42.23 cm); wherein the second distance is between 15.5 inches (39.37 cm) and 15.75 inches (40.00 cm); wherein the third distance is between 14.25 inches (36.20 cm) and 14.5 inches (36.83 cm); wherein the fourth distance is between 12.625 inches (32.07 cm) and 12.875 inches (32.70 cm); and wherein the fifth distance is between 11 inches (27.94 cm) and 11.5 inches (29.21 cm) as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband more versatile and efficient to use with multiple patients.
Regarding Claim 4, modified Bern discloses the headband of claim 3. Modified Bern discloses the claimed invention except for expressly disclosing wherein the first distance is 16.5 inches (41.91 cm), the second distance is 15.625 inches (39.69 cm), the third distance is 14.375 inches (36.51 cm), the fourth distance is 12.75 inches (32.39 cm), and the fifth distance is 11.125 inches (28.26 cm). However, Bern clearly teaches the headband to be for a human, and for the sizing points to be for adjusting the headband to fit the size of the skull of the user (“By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]). As the potential stages of life of a human and the corresponding sizes of the skull are well-known prior art conditions within the headband arts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bern wherein the first distance is 16.5 inches (41.91 cm), the second distance is 15.625 inches (39.69 cm), the third distance is 14.375 inches (36.51 cm), the fourth distance is 12.75 inches (32.39 cm), and the fifth distance is 11.125 inches (28.26 cm) as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband more versatile and efficient to use with multiple patients.
Regarding Claim 5, modified Bern discloses the headband of claim 2, wherein the anchor is a first piece of hook- and-loop tape and the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, the designated infant sizing point, and the designated newborn sizing point are each a piece of hook-and-loop tape that mates with the first piece of hook-and- loop tape (“The engagement members 28 (at one end) fit the receiving portion 30 of the engagement member 32 of the other end. The mechanism of the couplable engagement members may be selected from hook-and-loop fasteners…”, [0246]; these sizing points were modified to be the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, the designated infant sizing point, and the designated newborn sizing point in parent Claim 1).
Regarding Claim 6, modified Bern discloses the headband of claim 5. Modified Bern discloses the claimed invention except for expressly disclosing wherein the anchor is on a first side of the elastic strap and the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, the designated infant sizing point, and the designated newborn sizing point are located on a second side of the elastic strap, so each sizing point creates a continuous loop when that sizing point connects to the anchor. However, Jia teaches wherein the anchor is on a first side of the strap and the first to fifth sizing points are located on a second side of the strap, so each sizing point creates a continuous loop when that sizing point connects to the anchor (See Fig. 4; “The purpose of this design is when the positive forehead shell 11, left forehead shell 12, right forehead shell 26; the left elastic belt 3 and the right elastic belt through the headband adjusting buckle 4 to form an annular headband device”, page 8 of the attached machine translation).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the headband of Bern wherein the anchor is on a first side of the elastic strap and the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, the designated infant sizing point, and the designated newborn sizing point are located on a second side of the elastic strap, so each sizing point creates a continuous loop when that sizing point connects to the anchor, as taught by Jia, for the advantage of adapting the headband to different head types as taught by Jia (page 8).
Claims 7-13 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Bern in view of Jia and Ito, and further in view of Albert (US 20220054917 A1, hereinafter Albert).
Regarding Claim 7, modified Bern discloses the headband of claim 1. Modified Bern discloses the claimed invention except for expressly disclosing wherein the elastic strap comprises elastic material selected from the group consisting of nylon, spandex, polyester, rubber, and combinations thereof. However, Albert, which also discloses an elastic headband (Element 112/212, Figs. 1-5; “The head band 112 may be made of any suitable material or materials, such as plastic, nylon, an elastic material...”, [0013]), teaches wherein the strap is comprised of elastic material selected from the group consisting of nylon, spandex, polyester, rubber, and combinations thereof (“The head band 112 may be made of any suitable material or materials, such as plastic, nylon, an elastic material, such as rubber, spandex, elastane, or fold-over elastic stretch”, [0013]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the headband of Bern with the elastic material of Albert, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Regarding Claim 8, Bern discloses a headband (See Fig. 4A) for forehead-positioned and mastoid-positioned bone conduction (“A mounting assembly for arranging a bone conducting hearing device to a skin surface over the skull of a user is disclosed”, Abstract) audiometric testing in patients with different head sizes (“The band is provided with length adjusting members 46, 46′ for adjusting the length of the band in order to make it fit to the user”, [0202]), the headband comprising:
an anchor (Element 28, Fig. 10H) positioned on a first side and a first end of the strap (See Fig. 10H), wherein the anchor is a first type of fastener (See [0246]);
a first sizing point (Element 24, Figs. 9C and 10F) positioned on a second side and a second end of the strap (See Figs. 10G-10H; “Cutting lines 24 may be indicated at least at one end of the band and preferably at both ends of the band 20. By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]),
a second sizing point (A second element 24 closer to the anchor than the first element 24, Figs. 9C and 10F) positioned on the second side of the strap (“Cutting lines 24 may be indicated at least at one end of the band and preferably at both ends of the band 20. By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]) between the first end and the first sizing point (By being closer to the anchor than the first element, the second sizing point is between the first end and the first sizing point);
a third sizing point (A third element 24 closer to the anchor than the second element 24, Figs. 9C and 10F) positioned on the second side of the strap (“Cutting lines 24 may be indicated at least at one end of the band and preferably at both ends of the band 20. By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]) between the first end and the second sizing point (By being closer to the anchor than the first element, the third sizing point is between the first end and the second sizing point); and
a fourth sizing point (A fourth element 24 closer to the anchor than the third element 24, Figs. 9C and 10F) positioned on the second side of the strap between the first end and the third sizing point (By being closer to the anchor than the first element, the fourth sizing point is between the first end and the third sizing point).
Bern discloses the claimed invention except for expressly disclosing the headband comprising:
a strap made of one-inch wide double-fold elastic with a stretch factor between 110% and 120%;
the first sizing point being a designated adult male sizing point, wherein the designated adult male sizing point is a second type of fastener for mating with the first type of fastener;
the second sizing point being a designated adult female sizing point, wherein the designated adult female sizing point is the second type of fastener;
the third sizing point being a designated child sizing point, wherein the designated child sizing point is the second type of fastener; and
the fourth sizing point being a designated infant sizing point, wherein the designated infant sizing point is the second type of fastener;
wherein the headband is adjustable among the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, and the designated infant sizing point to fit a head of an adult male patient, a head of an adult female patient, a head of a child patient, or a head of an infant patient with a coupling force between 500 grams and 602 grams between a bone conduction audiometric vibrator and the head of the adult male patient, the head of the adult female patient, the head of the child patient, or the head of the infant patient.
However, Albert, which also discloses a headband (Element 112/212, Figs. 1-5), teaches a strap (Element 112, Fig. 1) made of double-fold elastic (“The head band 112 may be made of any suitable material or materials, such as plastic, nylon, an elastic material, such as rubber, spandex, elastane, or fold-over elastic stretch”, [0013]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Bern with the modifications of Albert, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further make the headband one-inch wide with a stretch factor between 110% and 120%, as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband aesthetically pleasing and comfortable.
Bern clearly teaches the headband to be for a human, and for the sizing points to be for adjusting the headband to fit the size of the skull of the user (“By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]). As the potential stages of life of a human and the corresponding sizes of the skull are well-known prior art conditions within the headband arts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Bern such that the first sizing point is a designated adult male sizing point, the second sizing point is a designated adult female sizing point, the third sizing point is a designated child sizing point, and the fourth sizing point is a designated infant sizing point, as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband more versatile and efficient to use with multiple patients.
Jia, which also discloses a headband (Abstract), teaches wherein the first to fourth sizing points are each a second type of fastener for mating with the first type of fastener (See Fig. 1; each sizing point is a hole that mates with a buckle), wherein the headband is adjustable among the first to fourth sizing points (“by adjusting the buckling position of the headband adjusting buckle 4, realizing adjusting the size of the headband device, so that the headband device can adapt to different head type”, page 8, paragraph 4 of the attached machine translation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the sizing points and adjustment mechanism of Bern (which utilizes cutting the headband, [0244]) with the sizing points and adjustment mechanism of Jia, such that the headband is adjustable among the adult male sizing point, the adult female sizing point, the child sizing point, and the infant sizing point to fit a head of an adult male patient, a head of an adult female patient, a head of a child patient, or a head of an infant patient, because the sizing points and adjustment mechanism of Jia can be enlarged or shrunk multiple times and is reusable.
Ito teaches wherein a wearable loop holds an audiometric bone conduction vibrator to a head of a patient (“BC thresholds were measured with stimulation at 6 different sites of the head: the forehead, the ipsilateral and contralateral mastoids...”, “Measurement of BC Threshold”, page 14, col. 1) with a coupling force between 500 grams and 602 grams (“The bone vibrator was fixed at the measurement sites with a static force of either 2 N or 5 N provided by steel headbands”, “Measurement of BC Threshold”, page 14, col. 1; the examiner notes 5 N is within the claimed range of 500-602 grams (5.4 N ± 0.5 N)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add the coupling force of Ito to the headband of modified Bern, such that the adjustable headband fits a head of an adult male patient, a head of an adult female patient, a head of a child patient, or a head of an infant patient with a coupling force between 500 grams and 602 grams between a bone conduction audiometric vibrator and the head of the adult male patient, the head of the adult female patient, the head of the child patient, or the head of the infant patient because the coupling force to fix the bone vibrator is an important issue for BC hearing thresholds (Ito, “Introduction”, page 13, col. 2) and the applicant’s own specification admits this coupling force range is the recommended standard for bone conduction audiometric testing in patients ([0003]).
Regarding Claim 9, modified Bern discloses the headband of claim 8, and further comprising:
a fifth sizing point (A fifth element 24, closer to the anchor than the fourth element 24, Figs. 9C and 10F) positioned on the second side of the strap between the first end and the infant sizing point (By being closer to the anchor than the first element, the fifth sizing point is between the first end and the fourth/infant sizing point).
Modified Bern discloses the claimed invention except for expressly disclosing wherein the fifth sizing point is a designated newborn sizing point, wherein the designated newborn sizing point is the second type of fastener.
However, Bern clearly teaches the headband to be for a human, and for the sizing points to be for adjusting the headband to fit the size of the skull of the user (“By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]). As the potential stages of life of a human and the corresponding sizes of the skull are well-known prior art conditions within the headband arts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Bern wherein the fifth sizing point is a designated newborn sizing point as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband more versatile and efficient to use with multiple patients.
Jia teaches wherein fifth sizing point is the second type of fastener (See Fig. 1; each sizing point is a hole). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the sizing points and adjustment mechanism of modified Bern (which utilizes cutting the headband, [0244]) with the sizing points and adjustment mechanism of Jia such that the fifth sizing point is also the second type of fastener, because the sizing points and adjustment mechanism of Jia can be enlarged or shrunk multiple times and is reusable.
Regarding Claim 10, modified Bern discloses the headband of claim 9. Modified Bern discloses the claimed invention except for expressly disclosing wherein the elastic has a stretch factor between 110% and 120%, and wherein the elastic has a stretch factor of 114%. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Bern wherein the elastic has a stretch factor of 114% as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband aesthetically pleasing and comfortable.
Regarding Claim 11, modified Bern discloses the headband of claim 10. Modified Bern discloses the claimed invention except for expressly disclosing wherein the elastic is comprised of a material selected from the group consisting of nylon, spandex, polyester, rubber, and combinations thereof. However, Albert, which also discloses a headband (Element 112/212, Figs. 1-5), teaches wherein the strap is comprised of elastic material selected from the group consisting of nylon, spandex, polyester, rubber, and combinations thereof (“The head band 112 may be made of any suitable material or materials, such as plastic, nylon, an elastic material, such as rubber, spandex, elastane, or fold-over elastic stretch”, [0013]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the headband of Bern with the elastic material of Albert, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art.
Regarding Claim 12, modified Bern discloses the headband of claim 10, wherein the anchor connects to:
the designated adult male sizing point creating a wearable loop (“the band 20 with main portion comprising the engagement members 28 at two ends of the bands are adapted to engage with one another to form a closed loop”, [0245]) that holds the bone conduction audiometric vibrator to the head of the adult male patient (“FIG. 4A illustrates a schematic, side view of a hearing device 2 comprising a vibrator 4 attached to a band 20 fixed to the skull 14 of a user by means of one embodiment according to the disclosure”, [0201]; “The vibrator assembly of the hearing device 2 attached to the abutment enables the vibrator assembly to transmit vibrations to the skin and through the bone to the inner ear of the user via the abutment and the mounting assembly of the embodiment of the disclosure”, [0203]);
the designated adult female sizing point creating a wearable loop (“the band 20 with main portion comprising the engagement members 28 at two ends of the bands are adapted to engage with one another to form a closed loop”, [0245]) that holds the bone conduction audiometric vibrator to the head of the adult female patient (“FIG. 4A illustrates a schematic, side view of a hearing device 2 comprising a vibrator 4 attached to a band 20 fixed to the skull 14 of a user by means of one embodiment according to the disclosure”, [0201]; “The vibrator assembly of the hearing device 2 attached to the abutment enables the vibrator assembly to transmit vibrations to the skin and through the bone to the inner ear of the user via the abutment and the mounting assembly of the embodiment of the disclosure”, [0203]);
the designated child sizing point creating a wearable loop (“the band 20 with main portion comprising the engagement members 28 at two ends of the bands are adapted to engage with one another to form a closed loop”, [0245]) that holds the bone conduction audiometric vibrator to the head of the child patient (“FIG. 4A illustrates a schematic, side view of a hearing device 2 comprising a vibrator 4 attached to a band 20 fixed to the skull 14 of a user by means of one embodiment according to the disclosure”, [0201]; “The vibrator assembly of the hearing device 2 attached to the abutment enables the vibrator assembly to transmit vibrations to the skin and through the bone to the inner ear of the user via the abutment and the mounting assembly of the embodiment of the disclosure”, [0203]);
the designated infant sizing point creating a wearable loop (“the band 20 with main portion comprising the engagement members 28 at two ends of the bands are adapted to engage with one another to form a closed loop”, [0245]) that holds the bone conduction audiometric vibrator to the head of the infant patient (“FIG. 4A illustrates a schematic, side view of a hearing device 2 comprising a vibrator 4 attached to a band 20 fixed to the skull 14 of a user by means of one embodiment according to the disclosure”, [0201]; “The vibrator assembly of the hearing device 2 attached to the abutment enables the vibrator assembly to transmit vibrations to the skin and through the bone to the inner ear of the user via the abutment and the mounting assembly of the embodiment of the disclosure”, [0203]); or
the designated newborn sizing point creating a wearable loop (“the band 20 with main portion comprising the engagement members 28 at two ends of the bands are adapted to engage with one another to form a closed loop”, [0245]) that holds the bone conduction audiometric vibrator to the head of the infant patient (“FIG. 4A illustrates a schematic, side view of a hearing device 2 comprising a vibrator 4 attached to a band 20 fixed to the skull 14 of a user by means of one embodiment according to the disclosure”, [0201]; “The vibrator assembly of the hearing device 2 attached to the abutment enables the vibrator assembly to transmit vibrations to the skin and through the bone to the inner ear of the user via the abutment and the mounting assembly of the embodiment of the disclosure”, [0203]).
Modified Bern discloses the claimed invention except for expressly disclosing wherein each wearable loop holds the audiometric bone conduction vibrator to the head of each patient with a coupling force between 500 grams and 602 grams. However, Ito teaches wherein a wearable loop holds the audiometric bone conduction vibrator to a head of each patient (“BC thresholds were measured with stimulation at 6 different sites of the head: the forehead, the ipsilateral and contralateral mastoids...”, “Measurement of BC Threshold”, page 14, col. 1) with a coupling force between 500 grams and 602 grams (“The bone vibrator was fixed at the measurement sites with a static force of either 2 N or 5 N provided by steel headbands”, “Measurement of BC Threshold”, page 14, col. 1; the examiner notes 5 N is within the claimed range of 500-602 grams (5.4 N ± 0.5 N)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the headband of Bern, with the coupling force of Ito, because the coupling force to fix the bone vibrator is an important issue for BC hearing thresholds (Ito, “Introduction”, page 13, col. 2).
Regarding Claim 13, modified Bern discloses the headband of claim 9, wherein the first type of fastener is hook tape and the second type of fastener is loop tape (“The mechanism of the couplable engagement members may be selected from hook-and-loop fasteners”, [0246]; hook tape and loop tape are a type of hook-and-loop fastener).
Regarding Claim 21, Bern discloses an audiometric testing system comprising:
a headband (See Fig. 4A) for bone conduction audiometric testing (“A mounting assembly for arranging a bone conducting hearing device to a skin surface over the skull of a user is disclosed”, Abstract) in patients with different head sizes (“The band is provided with length adjusting members 46, 46′ for adjusting the length of the band in order to make it fit to the user”, [0202]), the headband comprising:
an anchor (Element 28, Fig. 10H) positioned on a first end of a strap (See Fig. 10H), wherein the anchor is a first type of fastener ([0246]);
a first sizing point (Element 24, Figs. 9C and 10F) on a second end of the strap (See Figs. 10G-10H; “Cutting lines 24 may be indicated at least at one end of the band and preferably at both ends of the band 20. By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]), wherein a center of the designated adult male sizing point is a first distance from a center of the anchor (A first distance exists between a center of the anchor and the center of cutting line 24),
a second sizing point on the strap (A second element 24 closer to the anchor than the first element 24, Figs. 9C and 10F), wherein a center of the designated adult female sizing point is a second distance from the center of the anchor, wherein the second distance is less than the first distance (By being closer to the anchor than the first element, a second distance that is less than the first distance exists),
a third sizing point on the strap (A third element 24 closer to the anchor than the second element 24, Figs. 9C and 10F), wherein a center of the designated child sizing point is a third distance from the center of the anchor, wherein the third distance is less than the second distance (By being closer to the anchor than the second element, a third distance that is less than the second distance exists),
a fourth infant sizing point on the strap (A fourth element 24 closer to the anchor than the third element 24, Figs. 9C and 10F), wherein a center of the designated infant sizing point is a fourth distance from the center of the anchor, wherein the fourth distance is less than the third distance (By being closer to the anchor than the third element, a fourth distance that is less than the third distance exists),
a fifth sizing point on the strap (A fifth element 24 closer to the anchor than the fourth element 24, Figs. 9C and 10F) and a fifth distance from the anchor, wherein a center of the designated newborn sizing point is a fifth distance from the center of the anchor, wherein the fifth distance is less than the fourth distance (By being closer to the anchor than the fourth element, a fifth distance that is less than the fourth distance exists).
Modified Bern discloses the claimed invention except for expressly disclosing the headband comprising: a strap made of one-inch wide double-fold elastic with a stretch factor between 110% and 120%;
wherein the first sizing point is a designated adult male sizing point, wherein the designated adult male sizing point is a second type of fastener for mating with the first type of fastener, and wherein the designated adult male sizing point connects to the anchor to form an adult male wearable loop with a circumference between 16.375 inches (41.59 cm) and 16.625 inches (42.23 cm);
wherein the second sizing point is a designated adult female sizing point, wherein the designated adult female sizing point is the second type of fastener, and wherein the designated adult female sizing point connects to the anchor to form an adult female wearable loop with a circumference between 15.5 inches (39.37 cm) and 15.75 inches (40.00 cm);
wherein the third sizing point is a designated child sizing point, wherein the designated child sizing point is the second type of fastener, and wherein the designated child sizing point connects to the anchor to form a child wearable loop with a circumference between 14.25 inches (36.20 cm) and 14.5 inches (36.83 cm);
wherein the fourth sizing point is a designated infant sizing point, wherein the designated infant sizing point is the second type of fastener, and wherein the designated infant sizing point connects to the anchor to form an infant wearable loop with a circumference between 12.625 inches (32.07 cm) and 12.875 inches (32.70 cm); and
wherein the fifth sizing point is a designated newborn sizing point, wherein the designated newborn sizing point is the second type of fastener, and wherein the designated newborn sizing point connects to the anchor to form a newborn wearable loop with a circumference 11 inches (27.94 cm) and 11.5 inches (29.21 cm); and
a bone conduction audiometric vibrator held adjacent to a head of a patient by the headband; wherein the headband is adjustable among the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, the designated infant sizing point, and the designated newborn sizing point to fit a head of an adult male patient, a head of an adult female patient, a head of a child patient, a head of an infant patient, or a head of a newborn patient with a coupling force between 500 grams and 602 grams between the bone conduction audiometric vibrator and the head of the adult male patient, the head of the adult female patient, the head of the child patient, the head of the infant patient, or the head of the newborn patient;
wherein the adult male wearable loop holds the bone conduction audiometric vibrator to the head of the adult male patient with the coupling force between 500 grams and 602 grams;
wherein the adult female wearable loop holds the bone conduction audiometric vibrator to the head of the adult female patient with the coupling force between 500 grams and 602 grams;
wherein the child wearable loop holds the bone conduction audiometric vibrator to the head of the child patient with the coupling force between 500 grams and 602 grams;
wherein the infant wearable loop holds the bone conduction audiometric vibrator to the head of the infant patient with the coupling force between 500 grams and 602 grams; and
wherein the newborn wearable loop holds the bone conduction audiometric vibrator to the head of the newborn patient with the coupling force between 500 grams and 602 grams.
However, Albert, which also discloses a headband (Element 112/212, Figs. 1-5), teaches a strap (Element 112, Fig. 1) made of double-fold elastic (“The head band 112 may be made of any suitable material or materials, such as plastic, nylon, an elastic material, such as rubber, spandex, elastane, or fold-over elastic stretch”, [0013]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Bern with the modifications of Albert, because all of the claimed elements were known in the prior art before the effective filing date of the claimed invention, and one with ordinary skill in the art could have combined all the claimed elements by known methods, and the result would have been obvious to one of ordinary skill in the art. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further make the headband one-inch wide with a stretch factor between 110% and 120%, as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband aesthetically pleasing and comfortable.
Bern clearly teaches the headband to be for a human, and for the sizing points to be for adjusting the headband to fit the size of the skull of the user (“By cutting the band 20 it is possible to adjust the length of the band 20 in order to make it fit the size of a skull”, [0244]). As the potential stages of life of a human and the corresponding sizes of the skull are well-known prior art conditions within the headband arts, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Bern wherein the first sizing point is a designated adult male sizing point, the second sizing point is a designated adult female sizing point, the third sizing point is a designated child sizing point, the fourth sizing point is a designated infant sizing point, and the fifth sizing point is a designated newborn sizing point as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband more versatile and efficient to use with multiple patients.
It also would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the headband of Bern wherein the designated adult male sizing point connects to the anchor to form an adult male wearable loop with a circumference between 16.375 inches (41.59 cm) and 16.625 inches (42.23 cm), wherein the designated adult female sizing point connects to the anchor to form an adult female wearable loop with a circumference between 15.5 inches (39.37 cm) and 15.75 inches (40.00 cm), wherein the designated child sizing point connects to the anchor to form a child wearable loop with a circumference between 14.25 inches (36.20 cm) and 14.5 inches (36.83 cm), wherein the designated infant sizing point connects to the anchor to form an infant wearable loop with a circumference between 12.625 inches (32.07 cm) and 12.875 inches (32.70 cm), and wherein the designated newborn sizing point connects to the anchor to form a newborn wearable loop with a circumference 11 inches (27.94 cm) and 11.5 inches (29.21 cm) as a matter of routine optimization within prior art conditions or through routine experimentation for the advantage of making the headband more versatile and efficient to use with multiple patients.
Jia, which also discloses a headband (Abstract), teaches wherein the first to fifth sizing points are each a second type of fastener that mates with the first type of fastener (See Fig. 1; each sizing point is a hole that mates with a buckle), wherein the headband is adjustable among the first to fifth sizing points (“by adjusting the buckling position of the headband adjusting buckle 4, realizing adjusting the size of the headband device, so that the headband device can adapt to different head type”, page 8, paragraph 4 of the attached machine translation). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the sizing points and adjustment mechanism of Bern (which utilizes cutting the headband, [0244]) with the sizing points and adjustment mechanism of Jia, such that the headband is adjustable among the designated adult male sizing point, the designated adult female sizing point, the designated child sizing point, the designated infant sizing point, and the designated newborn sizing point to fit a head of an adult male patient, a head of an adult female patient, a head of a child patient, a head of an infant patient, or a head of a newborn patient, because the sizing points and adjustment mechanism of Jia can be enlarged or shrunk multiple times and is reusable.
Ito teaches wherein a wearable loop holds the audiometric bone conduction vibrator to a head of each patient (“BC thresholds were measured with stimulation at 6 different sites of the head: the forehead, the ipsilateral and contralateral mastoids...”, “Measurement of BC Threshold”, page 14, col. 1) with a coupling force between 500 grams and 602 grams (“The bone vibrator was fixed at the measurement sites with a static force of either 2 N or 5 N provided by steel headbands”, “Measurement of BC Threshold”, page 14, col. 1; the examiner notes 5 N is within the claimed range of 500-602 grams (5.4 N ± 0.5 N)). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to further modify the headband of Bern wherein each of the designated adult male, adult female, child, infant, and newborn wearable loops hold the audiometric vibrator to a head of the patient with a coupling force between 500 grams and 602 grams, suggested by Ito, because the coupling force to fix the bone vibrator is an important issue for BC hearing thresholds (Ito, “Introduction”, page 13, col. 2).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
See Isberg et al (US 20150160090 A1; [0051]).
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/JONATHAN E. COOPER/Examiner, Art Unit 3791
/JACQUELINE CHENG/Supervisory Patent Examiner, Art Unit 3791
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