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 .
Status of Claims
This Office Action is in response to the amendment filed 7/15/25. As directed by the amendment, claim 1 has been amended, claims 2 and 8 are cancelled. Claims 1, 3-7 and 15 are pending in this application.
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.
Use of the word “means” (or “step for”) in a claim with functional language creates a rebuttable presumption that the claim element is to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is invoked is rebutted when the function is recited with sufficient structure, material, or acts within the claim itself to entirely perform the recited function.
Absence of the word “means” (or “step for”) in a claim creates a rebuttable presumption that the claim element is not to be treated in accordance with 35 U.S.C. § 112(f) (pre-AIA 35 U.S.C. 112, sixth paragraph). The presumption that § 112(f) (pre-AIA § 112, sixth paragraph) is not invoked is rebutted when the claim element recites function but fails to recite sufficiently definite structure, material or acts to perform that function.
Claim elements in this application that use the word “means” (or “step for”) are presumed to invoke § 112(f) except as otherwise indicated in an Office action. Similarly, claim elements that do not use the word “means” (or “step for”) are presumed not to invoke § 112(f) except as otherwise indicated in an Office action.
In the instant case there does not appear to be any means for language in the claims and/or language to be considered under 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 103 AIA
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Talarico US 4642911 (herein after Talarico) in view of WERT US 7913429 B1 (herein after Wert) and Omarsson US 20160220375 A1 (herein after Omarsson).
Regarding claim 1, Talarico discloses an orthosis for alleviating knee osteoarthritis (Abstract), comprising: an insole (Col 1, lines 5-16, Col 20, lines 47-51, as seen in annotated Figure 14 – Talarico teaches a sole, a midsole and an innersole also commonly known in the art, and as defined by Merriam Webser as an insole) having a lateral side portion (as seen in annotated Figure 14) and a medial side portion (as seen in annotated Figure 14), the medial side portion formed from a first material having a first density (Col. 1, lines 6-18, as seen in annotated Figure 14) and the lateral side portion formed from a second material having a second density (Col. 10, lines 32-40, as seen in annotated Figure 14), the second density greater than the first density (as seen in annotated Figure 14, Col. 10, lines 32-40), wherein the medial side portion and the lateral side portion join at an oblique angle (Col. 11, lines 29-55, as seen in annotated Figure 14).
[AltContent: textbox (Wherein the medial side portion and the lateral side portion join at an oblique angle.)][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (An insole.)][AltContent: textbox (A lateral side portion.)][AltContent: textbox (A medial side portion. )]
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Figure 14
However, Talarico does not specifically disclose the medial side portion of the insole having a contoured arch support portion, and the contoured arch support portion configured to accommodate a particular arched foot posture of a user to provide foot and ankle stabilization.
Wert teaches the medial side portion of the insole having a contoured arch support portion (as seen in annotated Figures 1 and 12), and the contoured arch support portion (as seen in annotated Figure 1, 7 and 10) configured to accommodate a particular arched foot posture of a user to provide foot and ankle stabilization (Col. 4, lines 18-52).
[AltContent: textbox (The medial side portion of the insole having a contoured arch support portion.)]
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Lateral side)][AltContent: textbox (Lateral side)][AltContent: arrow]
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Talarico and Wert are analogous art to the claimed invention as they relate to orthotic inserts contoured to the shape of the foot.
It would have been obvious to one having ordinary skill in the art before the effective filing date
of the invention to have modified the orthosis of Talarico, by constructing the medial side portion of the insole having a contoured arch support portion, and the contoured arch support portion configured to accommodate a particular arched foot posture of a user to provide foot and ankle stabilization, as taught by Wert in order to provide better support of the foot. The modification of the orthotic would create an orthotic with a contoured surface that will hold the foot comfortably in place while correcting any pronation issues.
However, Talarico and Wert are silent to the orthosis insertable for insertion into footwear, the insole extending from a posterior end to a predefined location, the predefined location defined by one or more of a 1st metatarsal head and a 5th metatarsal head, the orthosis further comprising a lateral wedge coupled to a bottom of the insole the lateral wedge being thicker on a lateral side of the orthosis and tapering down to a medial side of the orthosis.
Omarsson teaches the orthosis for alleviating knee osteoarthritis (paragraph 0040 and 0062) insertable for insertion into footwear, the insole (0062, 0075 and 0076) extending from a posterior end to a predefined location (as seen in annotated Figure 13A-13D), the predefined location defined by one or more of a 1st metatarsal head and a 5th metatarsal head (as seen in annotated Figure 13A-13D, paragraph 0086, 521), the orthosis further comprising a lateral wedge (as seen in annotated Figure 11) coupled to a bottom of the insole (as seen in annotated Figures 13A-13D), the lateral wedge being thicker on a lateral side of the orthosis and tapering down to a medial side of the orthosis (as seen in annotated Figure 11 and paragraph 0079).
[AltContent: textbox (Lateral side.)]
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Medial side.)]
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[AltContent: textbox (The predefined location defined by one or more of a 1st metatarsal head and a 5th metatarsal head.)]
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow]
[AltContent: arrow][AltContent: textbox (Lateral side)][AltContent: arrow][AltContent: textbox (Medial side)][AltContent: arrow][AltContent: textbox (Posterior end)]
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Omarsson is analogous art to the claimed invention in that it relates to orthotic insoles.
It would have been obvious to one having ordinary skill in the art before the effective filing date
of the invention to have modified the orthotic insole of Talarico and Wert, by constructing the insole to extend from a posterior end to a predefined location, where the predefined location is defined by one or more of a 1st metatarsals head and a 5th metatarsal head, as taught by Omarsson in order to form an orthotic that better stabilizes the foot and corrects the angulation of the foot. The modification of configuration of the insole would create an orthotic that better stabilizes the foot and protects injury.
The applicant has written the claim to include functional language recitations and terminology. A recitation of the function of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The applicant has used functional terminology to define structural elements, for example for alleviating knee osteoarthritis. These terms can be interpreted as functional language. If the prior art structure is capable of performing the function, then it meets the claim. Functional language recitations such as "... for alleviating knee osteoarthritis..." carry little patentable weight as the application is examined as an apparatus with its structural limitations, not its function or intended use.
Regarding claim 15, the modified orthosis of the combined references discloses wherein the particular arched foot posture includes a high arched foot posture (paragraphs 0078 and 0106, as seen in annotated Figures 13B, 13C, 13D of Omarsson), a medium arched foot posture (as seen in annotated Figures 13B, 13C, 13D of Omarsson) and a low arched foot posture (as seen in annotated Figures 13B, 13C, 13D of Omarsson).
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (A high arched foot posture.)][AltContent: textbox (A low arched foot posture.)][AltContent: textbox (A medium arched foot posture.)]
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Claims 3, 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Talarico US 4642911 (herein after Talarico) in view of WERT US 7913429 B1 (herein after Wert) and Omarsson US 20160220375 A1 (herein after Omarsson) as applied to claim 1 and further in view of
Park US 20110061268 (herein after Park).
Regarding claim 3, the modified orthosis of the combined references discloses all the limitations of claim 3 however they do not disclose an arch support material infilling an arch volume formed by the contoured arch support portion.
Park discloses an arch support material infilling an arch volume formed by the contoured arch support portion (as seen in annotated Figures 10 and 12 of Park).
Park is analogous art to the claimed invention in that it relates to orthotic inserts that are contoured to the shape of the foot.
It would have been obvious to one having ordinary skill in the art before the effective filing date
of the invention to have modified the orthosis of Talarico, Wert, Omarsson by constructing the orthotic having an arch support, as taught by Park in order to provide better support of the foot. The modification of the orthotic would create an orthotic with a contoured surface that will hold the foot comfortably in place while correcting any pronation issues.
Regarding claim 4, the modified orthosis of the combined references discloses a contoured lateral portion and a contoured posterior portion (as seen annotated Figures 9 and 13 of Park).
[AltContent: arrow][AltContent: arrow][AltContent: textbox (A contoured posterior portion.)]
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[AltContent: textbox (A contoured lateral portion.)][AltContent: arrow]
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Regarding claim 5, the modified orthosis of the combined references discloses a contoured shell (as seen in annotated Figure 9 of Park), wherein the contoured shell extends distally to a location past a fifth metatarsal head (as seen in annotated Figure 9 of Park).
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (A contoured shell.)][AltContent: textbox (The contoured shell extends distally to a location past a fifth metatarsal head.)]
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Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Talarico US 4642911 (herein after Talarico) in view of WERT US 7913429 B1 (herein after Wert) and Omarsson US 20160220375 A1 (herein after Omarsson) as applied to claim 1 and further in view of Olk GB 2508204 (herein after Olk).
Regarding claim 6, the orthosis of the combined references discloses all the limitations of claim 6 except they do not disclose a textured surface over one or more regions of the orthosis.
Olk teaches a textured surface (38b – the rib structure) over one or more regions of the orthosis (as seen in annotated Figure 5 and at least pages 12-13).
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (A textured surface over one or more regions of the orthosis.)]
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Olk is analogous art to the claimed invention in that it provides a surface detail on the top of the orthotic.
It would have been obvious to one having ordinary skill in the art before the effective filing date
of the invention to have modified the orthosis of Talarico, Wert and Omarsson by constructing the orthotic having a surface detail, as taught by Olk in order to stimulate the bottom of the foot. The modification of the orthosis would create an orthotic that relieves foot pain, mediates pressured regions and stimulates the foot during wear.
Regarding claim 7, the modified orthosis of the combined references discloses wherein the one or more regions are determined at least in part on one or more of increasing pressure on a selected region of a plantar side of a foot (as seen in annotated Figure 3 of Olk), decreasing pressure on a selected region of a plantar side of a foot and stimulating sensation in a selected region of a plantar side of a foot (as seen in annotated Figure 3 of Olk).
[AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: arrow][AltContent: textbox (Decreasing pressure on a selected region of a plantar side of a foot and stimulating sensation in a selected region of a plantar side of a foot.)][AltContent: arrow][AltContent: textbox (Wherein the one or more regions are determined at least in part on one or more of increasing pressure on a selected region of a plantar side of a foot.)]
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The applicant has written the claim to include functional language recitations and terminology. A recitation of the function of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The applicant has used functional terminology to define structural elements, for example wherein the one or more regions are determined at least in part on one or more of increasing pressure on a selected region of a plantar side of a foot, decreasing pressure on a selected region of a plantar side of a foot and stimulating sensation in a selected region of a plantar side of a foot. These terms can be interpreted as functional language. If the prior art structure is capable of performing the function, then it meets the claim. Functional language recitations such as "... wherein the one or more regions are determined at least in part on one or more of increasing pressure on a selected region of a plantar side of a foot, decreasing pressure on a selected region of a plantar side of a foot and stimulating sensation in a selected region of a plantar side of a foot..." carry little patentable weight as the application is examined as an apparatus with its structural limitations, not its function or intended use.
ARGUMENTS
Applicant’s arguments have been fully considered but are not convincing. Applicant’s arguments are directed towards structural elements included in the amended claims and thus do not apply to the manner in which prior art has been applied in the current rejection. In view of Applicant's amendments, the search has been updated, and a rejection on the amended claims is applied above.
In response to applicant’s arguments that Talarico, Wert and Omarrsson do not teach an orthosis for alleviating knee osteoarthritis as defined in amended claim 1. While the amended claim includes limitations that provide further definition to the claimed invention the amendment is part of the preamble. That said, Omarrsson (Abstract, paragraphs 0040, 0062 and 0079, as seen in annotated Figures 10, 11, 13A-D) teaches an orthosis for alleviating knee osteoarthritis (paragraphs 0005 and 0006 and 0039 – the orthotic being capable of alleviating knee osteoarthritis – “..a lateral wedge providing a construction and design that facilitates more comfortable and effective support of a user's foot during the treatment of joint disease (e.g., osteoarthritis) of the knee and/or structural biomechanical abnormalities of the user's foot and/or ankle…).
In response to applicant’s arguments that Talarico does not disclose an "insole" anywhere in the detailed description, the examiner respectfully disagrees. Talarico teaches an insole (Col 1, lines 5-16, Col 20, lines 47-51, as seen in annotated Figure 14 – Talarico teaches a sole, a midsole and an “innersole” also commonly known in the art, and defined by Merriam Webser as an insole).
In response to applicant’s arguments that Talarico does not disclose an insole, or an orthosis for insertion into footwear. Omarrsson (Abstract, paragraphs 0040, 0062 and 0079) teaches an insole, and an orthosis for insertion into footwear.
In response to applicant’s arguments that the invention of Talarico is for forefoot compensations only, the examiner respectfully disagrees. Talarico (Figures 5, 12, 13, 14 and 15, and Col 20, lines 47-51, Col 11, lines 29-55) clearly shows the compensations are for other regions of the foot to include the arches of the foot.
[AltContent: textbox (Arch region.)][AltContent: ]
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In response to applicant’s arguments that Talarico is not directed towards an "orthosis for alleviating knee osteoarthritis, the orthosis insertable into footwear". Applicant is reminded that the rejection is based on multiple references and it is the combined references that teach the limitation. Omarrsson (Abstract, paragraphs 0040, 0062 and 0079, as seen in annotated Figures 10, 11, 13A-D) teaches an orthosis for alleviating knee osteoarthritis, the orthosis insertable into footwear.
In response to applicant’s arguments that Talarico does not teach, a "lateral wedge coupled to a bottom of the insole, the lateral wedge being thicker on a lateral side of the orthosis and tapering down to a medial side of the orthosis", the examiner respectfully disagrees. Omarrsson (paragraph 0079, and Figure 11) teach a lateral wedge coupled to a bottom of the insole, the lateral wedge being thicker on a lateral side of the orthosis and tapering down to a medial side of the orthosis.
[AltContent: arrow][AltContent: arrow][AltContent: textbox (Medial side.)][AltContent: textbox (Lateral side.)]
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In response to applicant’s arguments that one skilled in the art would not modify Talarico to incorporate the heel wedges of Wert because that would change the basic principle under which Talarico's forefoot compensated sole operates, the examiner respectfully disagrees. The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the combined references all teach footwear construction to address the positioning of the foot within the shoe to alleviate orthopedic maladies. Further, the disclosed examples such as those referenced in Talarico, Wert, Omarrsson, Park and Olk and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments.” In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989).
In response to applicant’s arguments that the combination of Wert with Talarico would not satisfy the requirement of a lateral wedge coupled to a bottom of the insole. Omarrsson (Abstract, paragraphs 0040, 0062 and 0079, as seen in annotated Figures 10, 11, 13A-D), teaches a lateral wedge coupled to a bottom of the insole.
In response to applicant’s arguments that a heel wedge is placed under the heel of the foot and it is designed to elevate the heel, in contrast to a lateral wedge. While the examiner may agree to this statement it’s unclear what is being argued here. Omarrsson, (paragraph 0079, as seen in Figure 11) teaches a lateral wedge can help to correct or compensate for overpronation (foot rolling inward) or valgus (knock-knee) alignment. Wert is only used to teach the contoured arch support portion.
In response to applicant’s arguments that the combined references fail to teach a lateral wedge can help to correct or compensate for overpronation (foot rolling inward) or valgus (knock-knee) alignment. Omarrsson, paragraph 0079 as seen in Figure 11 teach a lateral wedge can help to correct or compensate for overpronation (foot rolling inward) or valgus (knock-knee) alignment.
In response to applicant’s arguments that “Wert clearly does not teach a lateral wedge not orthosis for alleviating knee osteoarthritis" to which the amended claims are now directed. Omarrsson (Abstract, paragraphs 0040, 0062 and 0079, as seen in annotated Figures 10, 11, 13A-D) is used to teach a lateral wedge (as seen in annotated Figure 11, ref. 308, paragraph 0079 of Omarrsson) and is an orthotic device as well (Abstract, paragraph 0040 and 0062).
In response to applicant’s arguments that a worker skilled in the art, would know an 'arch-supported' lateral wedge minimizes unloading effects at the knee. As such, a worker skilled in the art would not even consider using an arch-supported lateral wedge when the unloading of the medial compartment of the knee is desired to alleviate the effects of knee osteoarthritis. This is supported in the literature, for example in the British Journal of Sports Medicine, February 2018, pages 238-252, titled "The effects of shoe- worn insoles on gait biomechanics in people with knee osteoarthritis: a systematic review and meta-analysis". It is unclear if the applicant is providing an affidavit with the arguments. If so, applicant is reminded that a proper 1.132 Affidavit Declaration submission must meet one of the three above conditions and provide a nexus, a correlative comparison, between the exhibits and the claims in question to clearly show novelty. In the instant application the combination of references teach an arch-supported lateral wedge when the unloading of the medial compartment of the knee is desired to alleviate the effects of knee osteoarthritis (Abstract, paragraphs 0040 and 0062, as seen in annotated Figures 10 and 11 of Omarsson).
In response to applicant’s arguments that Talarico relates to configurations of a sole of a shoe and Wert relates to an orthotic, and as such Talarico and Wert area not even analogous art, the examiner respectfully disagrees. The prior art references are relevant to devices inside a shoe to help correct medical malidies and orthopedic issues. As stated in the MPEP 2141.01a, a reference is analogous art if the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). See Bigio, 381 F.3d at 1325. The prior art references disclose the devices and methods of alleviating orthopedic issues.
In response to applicant’s arguments that Omarrsson does not cure the fundamental deficiencies identified with respect to the combination of Talarico and Wert and that Omarrsson does not teach "an orthosis for alleviating knee osteoarthritis, the orthosis insertable into footwear, the examiner respectfully disagrees. Applicant is reminded that the rejection is a combination of references. Omarrsson is used to teach an orthosis for alleviating knee osteoarthritis (Abstract, 0040 and 0062)
In response to applicant’s arguments that Park does not cure the fundamental deficiencies identified with respect to the combination of Talarico, Wert and Omarrsson to teach "an orthosis for alleviating knee osteoarthritis. Omarrsson is used to teach an orthosis for alleviating knee osteoarthritis (Abstract, 0040 and 0062)
In response to applicant’s arguments that Olk does not teach "an orthosis for alleviating knee osteoarthritis. Omarrsson is used to teach an orthosis for alleviating knee osteoarthritis (Abstract, 0040 and 0062).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CATHERINE M FERREIRA whose telephone number is (571)270-5916, fax number (571) 270-6916. The examiner can normally be reached on Monday - Thursday 9:00 am- 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, ALISSA J. TOMPKINS, at (571) 272-3425. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Catherine M. Ferreira/
Examiner, Art Unit 3732
/ALISSA J TOMPKINS/Supervisory Patent Examiner, Art Unit 3732