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 .
Notice of Amendment
In response to the amendment filed on 10/3/2025, amended claims 1, 13, 16-17, 22, and 30, cancelled claims 2-3, 5, 9, 14-15, 18, and 27, and new claims 31-35 are acknowledged. Claims 1, 4, 6-8, 10-13, 16-17, 19-26, and 28-35 are currently pending. The following new and reiterated grounds of rejection are set forth:
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a vertical measurement mechanism” in claim 1
“a horizontal measurement mechanism” in claims 4 and 23
“an arch height measurement mechanism” in claims 9, 16-18, and 27
“a torque member” in claims 10, 19, and 28
“a foot length measurement mechanism” in claim 16
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 22, 24-26, and 28-31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al. (“The Reliability and Validity of a First Ray Measurement Device”, Foot & Ankle International. Vol. 21, No. 3, March 2000) (cited by Applicant), further in view of Ferber et al. (US Publication No. 2016/0073931 A1) (previously cited).
Regarding claim 22, Glasoe et al. discloses a foot structure and function assessment device comprising:
a base having a top surface for supporting a patient's foot (see Figures 1a-b);
a clamp attached to the base for immobilizing a second metatarsal of the patient's foot (see Figures 1a-b and p. 241, col. 1 – “A screw tightened clamp prevents second through fifth metatarsal movement during testing”);
a measurement sensor carried by the base for measuring both a first ray position of the patient's foot and a first ray mobility of the patient's foot (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)”);
an actuation member for displacing the first ray (see p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”); and
a controller operatively in communication with the actuation member and configured to:
apply a first load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “the initial load applied to the first ray was 10N +/- 1N of force”), and determine the first ray position of the patient's foot based on the first load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”), and
apply a second load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “Load increments of 20 N, 35 N, 55 N, 85 N, and unloading increments of 55 N, 35 N, 20 N, 10 N were used”), and determine the first ray mobility of the patient's foot based on the second load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”).
It is noted Glasoe et al. does not specifically teach an arch height measurement mechanism laterally spaced from the actuation member and movable about a length of the patient's foot for measuring an arch height of the patient's foot. However, Ferber et al. teaches an arch height measurement mechanism (6) laterally spaced from the actuation member and movable about a length of the patient's foot for measuring an arch height of the patient's foot (see Figures 6-8 and [0055] and [0063]-[0066]). 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 device of Glasoe et al. to include an arch height measurement mechanism laterally spaced from the actuation member and movable about a length of the patient's foot for measuring an arch height of the patient's foot, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0011]).
Regarding claim 24, Glasoe et al. teaches the clamp is laterally spaced from the actuation member (see Figure 1a).
Regarding claim 25 Glasoe et al. teaches the clamp is spaced from the actuation member such that the clamp spatially corresponds to and is operable to immobilize a second metatarsal of the patient's foot as the actuation member displaces the first ray (see Figure 1a).
Regarding claim 26, Glasoe et al. teaches the actuation member is configured to contact a plantar surface of the first ray (see Figure 1a).
Regarding claim 28, it is noted Glasoe et al. does not specifically teach a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint. However, Ferber et al. teaches a torque member (9) laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint (see Figures 9-10 and 13 and [0056] and [0068]). 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 device of Glasoe et al. to include a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0008] and [0011]).
Regarding claim 29, Glasoe et al. teaches the measurement sensor is a position sensor or a linear variable differential transformer (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)”).
Regarding claim 30, Glasoe et al. teaches the controller is further configured to measure the first ray position of the patient's foot under the applied first load, and to measure the first ray mobility of the patient's foot under the applied second load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”).
Regarding claim 31, Glasoe et al. discloses a foot structure and function assessment device comprising:
a base having a top surface for supporting a patient's foot (see Figures 1a-b);
a clamp attached to the base for immobilizing a second metatarsal of the patient's foot (see Figures 1a-b and p. 241, col. 1 – “A screw tightened clamp prevents second through fifth metatarsal movement during testing”);
a measurement sensor carried by the base for measuring both a first ray position of the patient's foot and a first ray mobility of the patient's foot (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)”);
an actuation member for displacing the first ray (see p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”); and
a controller operatively in communication with the actuation member and configured to:
apply a first load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “the initial load applied to the first ray was 10N +/- 1N of force”), and determine the first ray position of the patient's foot based on the first load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”), and
apply a second load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “Load increments of 20 N, 35 N, 55 N, 85 N, and unloading increments of 55 N, 35 N, 20 N, 10 N were used”), and determine the first ray mobility of the patient's foot based on the second load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”).
It is noted Glasoe et al. does not specifically teach a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint. However, Ferber et al. teaches a torque member (9) laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint (see Figures 9-10 and 13 and [0056] and [0068]). 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 device of Glasoe et al. and Jones et al. to include a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0008] and [0011]).
Claim(s) 1, 6-8, 10-12, and 32 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al., further in view of Ferber et al. and Jones et al. (“The Validity and Reliability of the Klaue Device”, Foot & Ankle International. Vol. 26, No. 11, November 2005).
Regarding claim 1, Glasoe et al. discloses a foot structure and function assessment device comprising:
a base having a top surface for supporting a patient's foot (see Figures 1a-b);
a clamp attached to the base for immobilizing a second metatarsal of the patient's foot (see Figures 1a-b and p. 241, col. 1 – “A screw tightened clamp prevents second through fifth metatarsal movement during testing”);
a vertical measurement mechanism carried by the base for measuring displacement of a first ray of the patient's foot (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)”);
an actuation member for vertically displacing the first ray (see p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”); and
a controller operatively in communication with the actuation member and configured to:
apply a first vertical load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “the initial load applied to the first ray was 10N +/- 1N of force”), and determine the first ray position of the patient's foot based on the first vertical load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”), and
apply a second vertical load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “Load increments of 20 N, 35 N, 55 N, 85 N, and unloading increments of 55 N, 35 N, 20 N, 10 N were used”), and determine the first ray mobility of the patient's foot based on the second vertical load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”).
It is noted Glasoe et al. does not specifically teach the actuation member including a first movable pointer adjacent the vertical measurement mechanism for measuring a first ray position of the patient's foot, and a second movable pointer adjacent the vertical measurement mechanism for measuring a first ray mobility of the patient's foot or an arch height measurement mechanism laterally spaced from the actuation member and movable about a length of the patient's foot for measuring an arch height of the patient's foot. However, Jones et al. teaches a first movable pointer adjacent the vertical measurement mechanism for measuring a first ray position or a first ray mobility of the patient's foot (see Figure 3 and Abstract – “a modified ankle-foot orthosis with an attached micrometer to objectively measure first ray mobility”). Ferber et al. teaches an arch height measurement mechanism (6) laterally spaced from the actuation member and movable about a length of the patient's foot for measuring an arch height of the patient's foot (see Figures 6-8 and [0055] and [0063]-[0066]).
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 device of Glasoe et al. to include a first movable pointer adjacent the vertical measurement mechanism for measuring a first ray position or a first ray mobility of the patient's foot, as disclosed in Jones et al., because objective measurement of first ray dorsal mobility is critical to understanding the association between abnormal motion and forefoot abnormalities (see Jones et al.: p. 955, col. 2). 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 device of Glasoe et al. to include an arch height measurement mechanism laterally spaced from the actuation member and movable about a length of the patient's foot for measuring an arch height of the patient's foot, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0011]).
Moreover, 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 device of Glasoe et al. in combination with Jones et al. to include separate movable pointers, one to measure a first ray position of the patient's foot and the other to measure a first ray mobility of the patient’s foot, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Regarding claim 6, Glasoe et al. teaches the clamp is laterally spaced from the actuation member (see Figure 1a).
Regarding claim 7, Glasoe et al. teaches the clamp is spaced from the actuation member such that the clamp spatially corresponds to and is operable to immobilize a second metatarsal of the patient's foot as the actuation member displaces the first ray (see Figure 1a).
Regarding claim 8, Glasoe et al. teaches the actuation member is configured to contact a plantar surface of the first ray (see Figure 1a).
Regarding claim 10, it is noted neither Glasoe et al. nor Jones et al. specifically teach a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint. However, Ferber et al. teaches a torque member (9) laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint (see Figures 9-10 and 13 and [0056] and [0068]). 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 device of Glasoe et al. and Jones et al. to include a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0008] and [0011]).
Regarding claim 11, Glasoe et al. teaches the vertical measurement mechanism includes a vertical graticule, a position sensor, or a linear variable differential transformer (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)”).
Regarding claim 12, Glasoe et al. teaches the controller is further configured to measure the first ray position of the patient's foot under the applied first vertical load, and to measure the first ray mobility of the patient's foot under the applied second vertical load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”).
Regarding claim 32, Glasoe et al. discloses a foot structure and function assessment device comprising:
a base having a top surface for supporting a patient's foot (see Figures 1a-b);
a clamp attached to the base for immobilizing a second metatarsal of the patient's foot (see Figures 1a-b and p. 241, col. 1 – “A screw tightened clamp prevents second through fifth metatarsal movement during testing”);
a vertical measurement mechanism carried by the base for measuring displacement of a first ray of the patient's foot (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)”);
an actuation member for vertically displacing the first ray (see p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”); and
a controller operatively in communication with the actuation member and configured to:
apply a first vertical load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “the initial load applied to the first ray was 10N +/- 1N of force”), and determine the first ray position of the patient's foot based on the first vertical load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”), and
apply a second vertical load to the first ray using the actuation member for displacing the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “Load increments of 20 N, 35 N, 55 N, 85 N, and unloading increments of 55 N, 35 N, 20 N, 10 N were used”), and determine the first ray mobility of the patient's foot based on the second vertical load (see p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”).
It is noted Glasoe et al. does not specifically teach the actuation member including a first movable pointer adjacent the vertical measurement mechanism for measuring a first ray position of the patient's foot, and a second movable pointer adjacent the vertical measurement mechanism for measuring a first ray mobility of the patient's foot or a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint. However, Jones et al. teaches a first movable pointer adjacent the vertical measurement mechanism for measuring a first ray position or a first ray mobility of the patient's foot (see Figure 3 and Abstract – “a modified ankle-foot orthosis with an attached micrometer to objectively measure first ray mobility”). Ferber et al. teaches a torque member (9) laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint (see Figures 9-10 and 13 and [0056] and [0068]).
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 device of Glasoe et al. to include a first movable pointer adjacent the vertical measurement mechanism for measuring a first ray position or a first ray mobility of the patient's foot, as disclosed in Jones et al., because objective measurement of first ray dorsal mobility is critical to understanding the association between abnormal motion and forefoot abnormalities (see Jones et al.: p. 955, col. 2). 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 device of Glasoe et al. and Jones et al. to include a torque member laterally spaced from the actuation member for applying a moment to the patient's foot about an axis of rotation of a first metatarsophalangeal joint, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0008] and [0011]).
Moreover, 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 device of Glasoe et al. in combination with Jones et al. to include separate movable pointers, one to measure a first ray position of the patient's foot and the other to measure a first ray mobility of the patient’s foot, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al., Jones et al., and Ferber et al., further in view of Amos et al. (US Publication No. 2017/0086751 A1) (previously cited).
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al. and Ferber et al., further in view of Amos et al. (US Publication No. 2017/0086751 A1) (previously cited).
Regarding claims 4 and 23, it is noted none of Glasoe et al., Jones et al., or Ferber et al. specifically teach a heel cup movably attached to the base for contacting a patient's rearfoot; and a horizontal measurement mechanism carried by the base for measuring a foot length of the patient's foot. However, Amos et al. teaches a heel cup (140) movably attached to the base for contacting a patient's rearfoot (see [0039] – “the heel plate 140 is slidably attached to a guide channel 160 formed through an interior portion of the base plate 12 that extends substantially parallel to the longitudinal axis L of the base plate 12”); and a horizontal measurement mechanism (138) carried by the base for measuring a foot length of the patient's foot (see Figure 3 and [0039] – “In some examples, the upper surface 130 of the base plate 12 includes a foot length gauge 138 that may be used to determine a position of the heel plate 140 relative to the base plate 12. Namely, the gauge 138 may include a series of graduations 139 that may be aligned with one or both edges 142, 144 of the heel plate 140 to determine the position of the heel plate 140 relative to the base plate 12”). 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 device of Glasoe et al., Jones et al., and Ferber et al. to include a heel cup movably attached to the base for contacting a patient's rearfoot; and a horizontal measurement mechanism carried by the base for measuring a foot length of the patient's foot, as disclosed in Amos et al., so as to align the axis of rotation of the MTP joint with the base plate regardless of the length of the particular foot (see Amos et al.: [0039]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al., further in view of Zifchock et al. (“The Effect of Gender, Age, and Lateral Dominance on Arch Height and Arch Stiffness”, Foot & Ankle International, Vol. 27, No. 5, May 2006).
Regarding claim 13, Glasoe et al. discloses a method for assessing foot structure and function, comprising:
immobilizing, using a clamp, a second metatarsal of a patient's foot (see Figures 1a-b and p. 241, col. 1 – “A screw tightened clamp prevents second through fifth metatarsal movement during testing”);
applying, using an actuation member laterally spaced from the clamp, a first vertical load to a first ray of a patient's foot while the second metatarsal is immobilized (see p. 241, col. 2 – “the initial load applied to the first ray was 10N +/- 1N of force”), for displacing the first ray (see p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”);
measuring, using a sensor, a first ray position of the patient's foot under the applied first vertical load (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)” and p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”);
applying, using the actuation member, a second vertical load to the first ray while the second metatarsal is immobilized (see p. 241, col. 2 – “Load increments of 20 N, 35 N, 55 N, 85 N, and unloading increments of 55 N, 35 N, 20 N, 10 N were used”), for displacing the first ray (see p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”); and
measuring, using the sensor, a first ray mobility of the patient's foot under the applied second vertical load (see p. 241, col. 2 – “Displacement of the first ray was measured from the dorsal surface of the first metatarsal by a Linear Variable Differential Transformer (LVDT)” and p. 242, col. 1 – “The value of device-measured displacement recorded at each targeted test increment was expressed relative to the displacement value recorded at the 10 N preload”).
It is noted Glasoe et al does not specifically teach determining, using an arch height measurement mechanism, an arch height index of the patient's foot while the patient is seated; determining, using the arch height measurement mechanism, an arch height index of the patient's foot while the patient is standing; measuring, using a scale, a body weight of the patient; and determining an arch stiffness of the patient's foot based on the body weight, the seated arch height index, and the standing arch height index. However, Zifchock et al. teaches determining, using an arch height measurement mechanism, an arch height index of the patient's foot while the patient is seated (see Figure 1 and p. 368, col. 2 – “AHIMS”); determining, using the arch height measurement mechanism, an arch height index of the patient's foot while the patient is standing (see Figure 1 and p. 369, col. 1); measuring, using a scale, a body weight of the patient (see Table 1 and p. 360, col. 1); and determining an arch stiffness of the patient's foot based on the body weight, the seated arch height index, and the standing arch height index (see equation on p. 369, col. 2).
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 method of Glasoe et al. to include determining, using an arch height measurement mechanism, an arch height index of the patient's foot while the patient is seated; determining, using the arch height measurement mechanism, an arch height index of the patient's foot while the patient is standing; measuring, using a scale, a body weight of the patient; and determining an arch stiffness of the patient's foot based on the body weight, the seated arch height index, and the standing arch height index, as disclosed in Zifchock et al., so as to lend insight into the predilection for injury between genders, with increasing age, and between sides of a given subject (see Zifchock et al.: Abstract).
Claim(s) 16, 19, and 33-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al., further in view of Zifchock et al. and Ferber et al.
Regarding claim 16, it is noted Glasoe et al. does not specifically teach measuring, using a foot length measurement mechanism or a position sensor coupled to the actuation member, a foot length of the patient's foot; measuring, using the arch height measurement mechanism laterally spaced from the actuation member, an arch height of the patient's foot; and determining the arch height index of the patient's foot based on normalizing the arch height using the foot length. However, Ferber et al. teaches measuring, using a foot length measurement mechanism (3c) or a position sensor coupled to the actuation member, a foot length of the patient's foot (see [0061]); measuring, using an arch height measurement mechanism (6) laterally spaced from the actuation member, an arch height of the patient's foot (see Figures 6-8 and [0055] and [0063]-[0066]); and determining an arch height index of the patient's foot based on normalizing the arch height using the foot length (see [0006]). 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 method of Glasoe et al. to include measuring, using a foot length measurement mechanism or a position sensor coupled to the actuation member, a foot length of the patient's foot; measuring, using an arch height measurement mechanism laterally spaced from the actuation member, an arch height of the patient's foot; and determining an arch height index of the patient's foot based on normalizing the arch height using the foot length, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0008] and [0011]).
Regarding claim 19, it is noted Glasoe et al. does not specifically teach applying, using a torque member laterally spaced from the actuation member, a joint moment to a first metatarsophalangeal joint of the patient's foot; and determining a first metatarsophalangeal joint flexibility of the patient's foot under the applied joint moment. However, Ferber et al. teaches applying, using a torque member (9) laterally spaced from the actuation member, a joint moment to a first metatarsophalangeal joint of the patient's foot; and determining a first metatarsophalangeal joint flexibility of the patient's foot under the applied joint moment (see Figures 9-10 and 13 and [0056] and [0068]). 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 method of Glasoe et al. to include applying, using a torque member laterally spaced from the actuation member, a joint moment to a first metatarsophalangeal joint of the patient's foot; and determining a first metatarsophalangeal joint flexibility of the patient's foot under the applied joint moment, as disclosed in Ferber et al., so as to provide better fitting shoes for the general population and for patients with specialized needs such as diabetic patients (see Ferber et al.: [0008] and [0011]).
Regarding claim 33, Zifchock et al. teaches the foot length is a total foot length (see p. 368, col. 2). Ferber et al. also teaches the foot length is a total foot length (see [0006]).
Regarding claim 34, Zifchock et al. teaches the foot length is a truncated foot length (see p. 368, col. 2). Ferber et al. also teaches the foot length is a truncated foot length (see [0006]).
Regarding claim 35, Zifchock et al. teaches the arch height index of the patient's foot is determined by dividing the arch height by the foot length (see p. 369, col. 1). Ferber et al. also teaches the arch height index of the patient's foot is determined by dividing the arch height by the foot length (see [0006]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al., Zifchock et al., and Ferber et al., further in view of Zifchock et al. (“The Relationship Between Arch Height and Arch Flexibility”, Journal of the American Podiatric Medical Association, Vol. 107, No. 2, March/April 2017) (previously cited; hereinafter Zifchock #2).
Regarding claim 17, it is noted Glasoe et al. does not specifically teach determining, using an arch height measurement mechanism laterally spaced from the actuation member, an arch height of the patient's foot while the patient is seated; determining, using the arch height measurement mechanism, an arch height of the patient's foot while the patient is standing; measuring, using a scale laterally spaced from the actuation member, a body weight of the patient; and determining an arch height flexibility of the patient's foot based on the seated arch height, the standing arch height, and the body weight. However, Zifchock #2. teaches determining, using an arch height measurement mechanism laterally spaced from the actuation member, an arch height of the patient's foot while the patient is seated; determining, using the arch height measurement mechanism, an arch height of the patient's foot while the patient is standing; measuring, using a scale laterally spaced from the actuation member, a body weight of the patient; and determining an arch height flexibility of the patient's foot based on the seated arch height, the standing arch height, and the body weight (see p. 121, col. 1). 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 method of Glasoe et al. to include determining, using an arch height measurement mechanism laterally spaced from the actuation member, an arch height of the patient's foot while the patient is seated; determining, using the arch height measurement mechanism, an arch height of the patient's foot while the patient is standing; measuring, using a scale laterally spaced from the actuation member, a body weight of the patient; and determining an arch height flexibility of the patient's foot based on the seated arch height, the standing arch height, and the body weight, as disclosed in Zifchock #2, so as to provide a meaningful descriptor of the relationship between foot structure and foot function (see Zifchock #2: p. 120, col. 1).
Claim(s) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Glasoe et al., Zifchock et al., and Ferber et al., further in view of Cody et al. (“Measuring Joint Flexibility in Hallux Rigidus Using a Novel Flexibility Jig”, Foot & Ankle International, Vol. 38, No. 8, 2017) (previously cited).
Regarding claim 20, it is noted none of Glasoe et al., Zifchock et al., or Ferber et al. specifically teach the determining the first metatarsophalangeal joint flexibility comprises determining the first metatarsophalangeal joint flexibility based on determining a slope of a first metatarsophalangeal joint flexibility curve. However, Cody et al. teaches the determining the first metatarsophalangeal joint flexibility comprises determining the first metatarsophalangeal joint flexibility based on determining a slope of a first metatarsophalangeal joint flexibility curve (see Figure 2 and p. 887, col. 1 and p. 890, col. 2). 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 method of Glasoe et al., Zifchock et al., and Ferber et al. to include the determining the first metatarsophalangeal joint flexibility comprises determining the first metatarsophalangeal joint flexibility based on determining a slope of a first metatarsophalangeal joint flexibility curve, as disclosed in Cody et al., so as to provide an indication of the pathology of hallux rigidus based on decreased early flexibility (see Cody et al.: p. 888, col. 2).
Regarding claim 21, it is noted none of Glasoe et al., Zifchock et al., or Ferber et al. specifically teach the determining the first metatarsophalangeal joint flexibility comprises determining an early first metatarsophalangeal joint flexibility or a late first metatarsophalangeal joint flexibility. However, Cody et al. teaches the determining the first metatarsophalangeal joint flexibility comprises determining an early first metatarsophalangeal joint flexibility or a late first metatarsophalangeal joint flexibility (see Figure 2 and p. 887, col. 1 and p. 890, col. 2). 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 method of Glasoe et al. and Ferber et al. to include the determining the first metatarsophalangeal joint flexibility comprises determining an early first metatarsophalangeal joint flexibility or a late first metatarsophalangeal joint flexibility, as disclosed in Cody et al., so as to provide an indication of the pathology of hallux rigidus based on decreased early flexibility (see Cody et al.: p. 888, col. 2).
Response to Arguments
Applicant's arguments filed 10/3/2025 have been fully considered but they are not persuasive.
Applicant argues that the terms “vertical measurement mechanism” in claim 1, “horizontal measurement mechanism” in claims 4 and 23, “arch height measurement mechanism” in claims 9, 16-18, and 27, “torque member” in claims 10, 19, and 28, and “foot length measurement mechanism” in claim 16 should not be interpreted under 35 U.S.C. 112(f) because one of ordinary skill in the art would understand the terms to have sufficiently definite meanings as the names for the described structure and those terms recite sufficient structure to perform the claimed functions. The Examiner respectfully disagrees and notes the MPEP clearly lists both “mechanism” and “member” in the list of non-structural generic placeholders that may invoke 35 U.S.C. 112(f). Moreover, there is nothing remotely structural connoted by the terms “vertical measurement”, “horizontal” measurement”, “arch height measurement”, “torque” or “foot length measurement” – they are all purely functional descriptors, unlike “detent mechanism”, which is instead a structural modifier (detent) with a generic placeholder (mechanism). A limitation will not invoke 35 U.S.C. 112(f) if there is a structural modifier that further describes the term "means" or the generic placeholder. For example, although a generic placeholder like "mechanism" standing alone may invoke 35 U.S.C. 112(f) when coupled with a function, it will not invoke 35 U.S.C. 112(f) when it is preceded by a structural modifier (e.g., "detent mechanism"). Greenberg, 91 F.3d at 1583, 39 USPQ2d at 1786 (holding that the term "detent mechanism" did not invoke 35 U.S.C. 112, sixth paragraph because the structural modifier "detent" denotes a type of structural device with a generally understood meaning in the mechanical arts). By contrast, a generic placeholder (e.g., "mechanism," "element," "member") coupled with a function may invoke 35 U.S.C. 112(f) when it is preceded by a non-structural modifier that does not have any generally understood structural meaning in the art (e.g., "colorant selection mechanism," "lever moving element," or "movable link member"). See Massachusetts Inst. of Tech., 462 F.3d at 1354, 80 USPQ2d at 1231.
Applicant’s arguments with respect to claim(s) 13 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Instead, Applicant’s arguments are directed to the newly added subject matter of the amended claims, which is addressed in the new grounds of rejection as outlined above.
Applicant argues that the combination of Glasoe, Jones, and Ferber does not teach an arch height measurement mechanism laterally spaced from the actuation member and movable about a length of the patient’s foot for measuring an arch height of the patient’s foot because there is no actuation member in Ferber. The Examiner respectfully disagrees and notes that the rejection relies on Glasoe to teach the actuation member (see Figure 1 and p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”), which is positioned under the first ray of the patient’s foot, whereas the arch heigh measurement mechanism (6) described in Ferber is a) laterally spaced from the first ray of the foot (see Figures 6-8), and therefore also laterally spaced from the actuation member when combined with Glasoe and b) movable about a length of the patient’s foot for measuring an arch height of the patient’s foot (see Figures 6 and 7 and [0055] – “free movement along the length of the inclined rail”). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Similarly, Applicant argues the combination of Glasoe, Jones, and Ferber does not teach a torque member laterally spaced from the actuation member for applying a moment to the patient’s foot about an axis of rotation of a first metatarsophalangeal joint because there is no actuation member in Ferber. The Examiner respectfully disagrees and notes that the rejection relies on Glasoe to teach the actuation member (see Figure 1 and p. 241, col. 2 – “A dorsiflexing force is applied by tightening a screw mechanism that elevates the first ray”), which is positioned under the first ray of the patient’s foot, whereas the torque member (9) described in Ferber is positioned under the big toe (see Figures 9-10 and [0068]) such that it is laterally spaced from the first ray of the foot, and therefore also laterally spaced from the actuation member when combined with Glasoe. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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