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 .
Response to Arguments
Applicant’s arguments, see page 12, filed 09/09/2025, with respect to the objections to Claims 2 and 9 have been fully considered and are persuasive. The objections to Claims 2 and 9 has been withdrawn.
Applicant’s arguments, see pages 12-13, filed 09/09/2025, with respect to the rejection of Claim 12 under 35 U.S.C. § 112(b) have been fully considered and are persuasive. The applicant is correct that the previous rejection was intended to refer to Claim 12. The rejection of Claim 12 under 35 U.S.C. § 112(b) has been withdrawn.
Applicant's arguments filed 09/09/2025 have been fully considered but they are not persuasive.
Regarding the rejection of Claims 1-6 under 35 U.S.C. § 103, the applicant argues “Bern does not teach, suggest, or disclose 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 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” (page 19). However, in the rejection of Claim 1 of the previously issued office action, Bern was modified to disclose an adjustable headband (“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, because the sizing points and adjustment mechanism of Jia can be enlarged or shrunk multiple times and is reusable”, page 6, emphasis added). Furthermore, the applicant’s own specification admits that the coupling force between 500 and 602 grams was known and recommended in the existing prior art by the American National Standards Institute ([0003], [0022]). Finally, Ito teaches a coupling force between 500 and 602 grams.
The applicant has also argued “Ito does not teach, suggest, or disclose a headband that 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 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. As is clearly disclosed in Ito, the coupling forces of the steel headbands were checked with spring gauges. Ito does not disclose preset distinct or designated 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. A combination of Bern and Ito would not be capable of functioning the same way as the headband of the present application, where coupling force is consistent regardless of who is using the headband. An adult male, an adult female, a child, or an infant can use the same headband by selecting the designated sizing point that corresponds to them and immediately having the correct coupling force. The advantages of having a headband that is adjustable among the designated sizing points to fit the heads of different-sized patients with a coupling force between 500 grams and 602 grams, described in the specification of the present application, would not be achieved by Bern and Ito, where there are no preset designated sizing points and no sizing points that correspond to a specific coupling force” (page 23). 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). Given that modified Bern discloses an adjustable headband for different-sized patients, a coupling force between 500 and 602 grams was known and recommended in the existing prior art by the American National Standards Institute, and Ito teaches a headband with a coupling force in this range, one of ordinary skill in the art could have easily foreseen the advantage of ensuring a headband for forehead-positioned and mastoid-positioned bone conduction audiometric testing conformed to already known audiometric testing coupling force standards for all patients of any size.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
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:
a strap (Element 20, Fig. 4A);
an anchor (Element 28, Fig. 10H) positioned on a first end of the 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 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 adult male 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 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 adult female 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 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 child 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 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 infant 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 an adult male sizing point, the second sizing point is an adult female sizing point, the third sizing point is a child sizing point, the fourth sizing point is an infant sizing point; and
wherein the adult male sizing point, the adult female sizing point, the child sizing point, and the 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 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 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 wherein the first sizing point is an adult male sizing point, the second sizing point is an adult female sizing point, the third sizing point is a child sizing point, the fourth sizing point is an 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 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 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 2, modified Bern discloses the headband of claim 1, and further comprising:
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 the fifth distance is between the center of the anchor and a center of the newborn 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; the Examiner notes this clause is interpreted in light of the claim objection applied above).
Modified Bern discloses the claimed invention except for expressly disclosing wherein the fifth sizing point is a newborn sizing point, and wherein the 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 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 adult male sizing point, the adult female sizing point, the child sizing point, the infant sizing point, and the 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]).
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 strap and the adult male sizing point, the adult female sizing point, the child sizing point, the infant sizing point, and the newborn sizing point 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. However, Jia teaches wherein the anchor is on a first side of the strap and the adult male sizing point, the adult female sizing point, the child sizing point, the infant sizing point, and the newborn sizing point 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 strap and the adult male sizing point, the adult female sizing point, the child sizing point, the infant sizing point, and the newborn sizing point 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, 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 strap is comprised of elastic 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 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 end of the strap (See Fig. 10H), wherein the anchor is a first type of fastener ([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 a strap made of one-inch wide double-fold elastic with a stretch factor between 110% and 120%;
the first sizing point being an adult male sizing point, wherein the adult male sizing point is a second type of fastener for mating with the first type of fastener;
the first sizing point being an adult female sizing point, wherein the adult female sizing point is the second type of fastener;
the first sizing point being a child sizing point, wherein the child sizing point is the second type of fastener; and
the first sizing point being an infant sizing point, wherein the infant sizing point is the second type of fastener;
wherein 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 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 wherein the first sizing point is an adult male sizing point, the second sizing point is an adult female sizing point, the third sizing point is a child sizing point, the fourth sizing point is an 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 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 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 newborn sizing point, wherein the 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 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 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 12, modified Bern discloses the headband of claim 10, wherein the anchor connects to:
the 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 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 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 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 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]).
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 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, wherein a center of the first sizing point is a first distance from a center of 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]);
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 second 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 third 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 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 fourth 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); and
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 fifth 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); and
a bone conduction audiometric vibrator (Element 4, Fig. 4A) held adjacent to a head of a patient by the headband (See Fig. 4A; “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]).
Modified Bern discloses 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 an adult male sizing point, wherein the adult male sizing point is a second type of fastener for mating with the first type of fastener, and wherein the first sizing point connects to the anchor to form a first 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 an adult female sizing point, wherein the adult female sizing point is the second type of fastener, and wherein the 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 child sizing point, wherein the child sizing point is the second type of fastener, and wherein the 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 an infant sizing point, wherein the infant sizing point is the second type of fastener, and wherein the 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 newborn sizing point, wherein the newborn sizing point is the second type of fastener, and wherein the 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);
wherein the headband is adjustable among the adult male sizing point, the adult female sizing point, the child sizing point, the infant sizing point, and the 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 a 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 a 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 a 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 a 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 a 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 th