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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the Achilles tendon bandage or orthosis must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 objected to because of the following informalities: “A pad for an Achilles tendon bandage or orthosis, wherein the pad comprises a front surface, a rear surface and two lower pad arms, wherein each of the lower pad arms has at least one pressure element on the front surface which is a plateau-like protrusion with rounded edges, characterised in that that the lower pad arms run below the malleoli in an applied state of the pad and pressure is exerted on the tissue below the malleoli by the at least one pressure element arranged on each of the two lower pad arms” should be “A pad for an Achilles tendon bandage or orthosis, wherein the pad comprises a front surface, a rear surface and two lower pad arms, wherein each of the lower pad arms of the two lower pad arms has at least one pressure element on the front surface which is a plateau-like protrusion with rounded edges, characterized two lower pad arms are configured to run below the malleoli in an applied state of the pad and is configured to exert pressure lower pad arm of the two lower pad arms” in lines 1-7. Appropriate correction is required.
Claim 2 objected to because of the following informalities: “characterised in that each of the lower pad arms has a single pressure element on the front surface” should be “wherein each of the lower pad arms of the two lower pad arms has a single pressure element on the front surface” in lines 1-2. Appropriate correction is required.
Claim 3 objected to because of the following informalities: “characterised in that each of the lower pad arms has a single pressure element on the front surface, wherein the lower pad arms run below the malleoli in the applied state of the pad and pressure is exerted on the tissue below the malleoli by the one pressure element arranged on each of the two lower pad arms, wherein the one pressure element is a plateau-like protrusion with rounded edges” should be “wherein each of the lower pad arms of the two lower pad arms has a single pressure element on the front surface, wherein the two lower pad arms are configured to run below the malleoli in the applied state of the pad and is configured to exert pressure [[is]] of the lower pad arms of the two lower pad arms, wherein the one pressure element is a plateau-like protrusion with rounded edges” in lines 1-6. Appropriate correction is required.
Claim 4 objected to because of the following informalities: “characterised in that the front surface of the pad is nubbed” should be “wherein the front surface of the pad is nubbed” in lines 1-2. Appropriate correction is required.
Claim 5 objected to because of the following informalities: “characterised in that the pad has a perforation” should be “wherein the pad has a perforation” in lines 1-2. Appropriate correction is required.
Claim 6 objected to because of the following informalities: “characterised in that the pad is mirror symmetrical” should be “wherein the pad is mirror symmetrical” in lines 1-2. Appropriate correction is required.
Claim 7 objected to because of the following informalities: “characterised in that the pad has a material taper in an area of a mirror plane” should be “wherein the pad has a material taper in an area of a mirror plane” in lines 1-2. Appropriate correction is required.
Claim 8 objected to because of the following informalities: “characterised in that the pad is formed from at least one elastic material” should be “wherein the pad is formed from at least one elastic material” in lines 1-2. Appropriate correction is required.
Claim 9 objected to because of the following informalities: “characterised in that the pad has two upper pad arms and two lower pad arms” should be “wherein the pad has two upper pad arms and two lower pad arms” in lines 1-2. Appropriate correction is required.
Claim 10 objected to because of the following informalities: “wherein the lower arms (5a, 5b) are longer than the upper pad arms” should be “wherein the two lower pad arms two upper pad arms” in lines 1-2. Appropriate correction is required.
Claim 11 objected to because of the following informalities: “a pad” should be “[[a]] the pad” in line 1. Appropriate correction is required.
Claim 12 objected to because of the following informalities: “a pad” should be “[[a]] the pad” in line 1. Appropriate correction is required.
Claim 13 objected to because of the following informalities: “A pad for an Achilles tendon bandage comprising: a front surface, a rear surface and two lower pad arms, wherein each of the two lower pad arms comprises a pressure element on the front surface which is a plateau-like protrusion with rounded edges, wherein, when the pad is in an applied state, the two lower pad arms run below a malleoli of a user and exert pressure on the tissue below the malleoli by the pressure element on each of the two lower pad arms” should be “A pad for an Achilles tendon bandage comprising: a front surface, a rear surface and two lower pad arms, wherein each lower pad arm of the two lower pad arms comprises a pressure element on the front surface which is a plateau-like protrusion with rounded edges, wherein, when the pad is in an applied state, the two lower pad arms are configured to run below a malleoli of a user and is configured to exert pressure on the tissue below the malleoli by the pressure element on each lower pad arm of the two lower pad arms” in lines 1-7. Appropriate correction is required.
Claim 14 objected to because of the following informalities: “A method of draining lymphatic fluid and relieving the Achilles tendon, the method comprising: selecting a pad comprising a front surface, a rear surface and two lower pad arms, wherein each of the two lower pad arms comprises a pressure element on the front surface which is a plateau-like protrusion with rounded edges; applying the pad to a user such that the two lower pad arms run below a malleoli of the user and the pressure element on each of the two lower pad arms exert pressure on the tissue below the malleoli” should be “A method of draining lymphatic fluid and relieving the Achilles tendon, the method comprising: selecting a pad comprising a front surface, a rear surface and two lower pad arms, wherein each lower pad arm of the two lower pad arms comprises a pressure element on the front surface which is a plateau-like protrusion with rounded edges; applying the pad to a user such that the two lower pad arms is configured to run below a malleoli of the user and the pressure element on each lower pad arm of the two lower pad arms are configured to exert pressure on the tissue below the malleoli” in lines 1-8. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-3, 9, and 13-14 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 4-8 and 10-12 are also rejected due to their dependency on claim 1.
Regarding claim 1, the use of the term “plateau-like" does not positively recite the "plateau" and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting "plateau-shaped" in order to overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph.
Regarding claim 2, the limitation “a single pressure element” is unclear. Examiner is unsure whether the single pressure element is referring back to the at least one pressure element in independent claim 1 or if it is introducing another pressure element. Examiner examined this claim as best understood.
Regarding claim 3, the limitation “a single pressure element” is unclear. Examiner is unsure whether the single pressure element is referring back to the at least one pressure element in independent claim 1 or if it is introducing another pressure element. Examiner examined this claim as best understood.
Claim 3 recites the limitation "the one pressure element" in lines 4 and 5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 3, the use of the term “plateau-like" does not positively recite the "plateau" and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting "plateau-shaped" in order to overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph.
Regarding claim 9, the limitation “two lower pad arms” is unclear. Examiner is unsure whether the two lower pad arms are referring back to the two lower pad arms in independent claim 1 or if it is introducing two lower pad arms. Examiner examined this claim as best understood.
Regarding claim 13, the use of the term “plateau-like" does not positively recite the "plateau" and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting "plateau-shaped" in order to overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph.
Regarding claim 14, the use of the term “plateau-like" does not positively recite the "plateau" and renders the claim indefinite because the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. The Office suggests reciting "plateau-shaped" in order to overcome the 35 U.S.C. 112 (pre-AIA ), second paragraph.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sandhof (EP 2103287 B1).
Regarding claim 1, Sandhof discloses a pad (1 – see annotated figure 1, a pad: paragraph 0031) for an Achilles tendon bandage or orthosis (the pad [1] is used with an Achilles tendon bandage: paragraph 0033-0037), wherein the pad (1) comprises a front surface (A – see annotated figure 1, a front surface of the pad), a rear surface (B – see annotated figure 1, a rear surface of the pad that is opposite of the front surface of the pad) and two lower pad arms (C/D – see annotated figure 1, two lower pad arms), wherein each of the lower pad arms (C/D) has at least one pressure element (2 – see annotated figure 1, wavy lines that protrude out of the front surface [A] and is on each of the lower pad arms [C/D]: paragraph 0013/0017/0031) on the front surface (A) which is a plateau-like protrusion with rounded edges (see annotated figure 1, the at least one pressure element [2] protrudes on the front surface [A] and has rounded edges due to the at least one pressure element [2] having a shape of a sinusoidal function [as seen in figure 2]: paragraph 0032), characterised in that that the lower pad arms (C/D) run below the malleoli in an applied state of the pad (1) and pressure is exerted on the tissue below the malleoli by the at least one pressure element (2) arranged on each of the two lower pad arms (C/D) (see annotated figure 1, the lower pad arms [C/D] comprising the at least one pressure element [2] and the shape of the pad [1] fits medially and laterally onto the heel [below the malleoli] and extends dorsally over the Achilles tendon; the pad [1] encloses the Achilles tendon about 4cm on both sides and provides a compression/massage on the tissue below the malleoli [see examiner further notes below]: paragraph 0022-0023/0034-0037).
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Annotated figure 1: pad of Sandhof
Examiner further notes: A recitation of the intended use 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. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 2, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses characterised in that each of the lower pad arms (C/D) has a single pressure element on the front surface (A) (each lower pad arm [C/D] on the front surface [A] can have a single or plurality of pressure elements [2]; there can be 1 to 10 pressure elements [2]: paragraph 0010/0014).
Regarding claim 3, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses characterised in that each of the lower pad arms (C/D) has a single pressure element on the front surface (A) (each lower pad arm [C/D] on the front surface [A] can have a single or plurality of pressure elements [2]; there can be 1 to 10 pressure elements [2]: paragraph 0010/0014), wherein the lower pad arms (C/D) run below the malleoli in the applied state of the pad (1) and pressure is exerted on the tissue below the malleoli by the one pressure element (2) arranged on each of the two lower pad arms (C/D) (see annotated figure 1, the lower pad arms [C/D] comprising the pressure element [2] and the shape of the pad [1] fits medially and laterally onto the heel [below the malleoli] and extends over the Achilles tendon; the pad [1] encloses the Achilles tendon about 4cm on both sides and provides a compression/massage on the tissue below the malleoli [see examiner further notes below]: paragraph 0022-0023/0034-0037), wherein the one pressure element (2) is a plateau-like protrusion with rounded edges (see annotated figure 1, the at least one pressure element [2] protrudes on the front surface [A] and has rounded edges due to the at least one pressure element [2] having a shape of a sinusoidal function [as seen in figure 2]: paragraph 0016-0017/0032).
Examiner further notes: A recitation of the intended use 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. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 5, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses characterised in that the pad (1) has a perforation (4 – see annotated figure 1, the pad [1] has holes to suppress perspiration: paragraph 0036).
Regarding claim 6, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses characterised in that the pad (1) is mirror symmetrical (see annotated figure 1, when the mirror plane [F – see annotated figure 1] is in the center of the pad [1], both sides of the mirror plane [F] are symmetrical to each other).
Regarding claim 7, Sandhof discloses the invention as discussed in claim 6. Sandhof further discloses characterised in that the pad (1) has a material taper (G – see annotated figure 1, there is a material taper around the perforations [4 – see annotated figure 1] in an area of a mirror plane (F – see annotated figure 1, mirror plane) (see annotated figure 1, the material taper [G] is in the area of the mirror plane [F]).
Regarding claim 8, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses characterised in that the pad (1) is formed from at least one elastic material (the pad [1] can be made from soft-elastically non-compressible materials, soft-elastically compressible materials or combinations of the aforementioned materials: paragraph 0024).
Regarding claim 9, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses characterised in that the pad (1) has two upper pad arms (H/I – see annotated figure 1, the pad has two upper pad arms) and two lower pad arms (C/D).
Regarding claim 10, Sandhof discloses the invention as discussed in claim 9. Sandhof further discloses wherein the lower pad arms (C/D) are longer than the upper pad arms (H/I) (see annotated figure 1, the lower pad arms [C/D] are longer than the upper pad arms [H/I]).
Regarding claim 11, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses an Achilles tendon bandage or orthosis comprising a pad according to claim 1 (the pad [1] is used with an Achilles tendon bandage: paragraph 0033-0037).
Regarding claim 12, Sandhof discloses the invention as discussed in claim 1. Sandhof further discloses a use of a pad (1) according to claim 1 for draining lymphatic fluid and relieving the Achilles tendon (the pad [1] is used for draining lymphatic fluid and relieving the Achilles tendon: paragraph 0022-0023/0033-0037).
Regarding claim 13, Sandhof discloses a pad (1 – see annotated figure 1, a pad: paragraph 0031) for an Achilles tendon bandage (the pad [1] is used with an Achilles tendon bandage: paragraph 0033-0037) comprising: a front surface (A – see annotated figure 1, a front surface of the pad), a rear surface (B – see annotated figure 1, a rear surface of the pad that is opposite of the front surface of the pad) and two lower pad arms (C/D – see annotated figure 1, two lower pad arms), wherein each of the two lower pad arms (C/D) comprises a pressure element (2 – see annotated figure 1, wavy lines that protrude out of the front surface [A]: paragraph 0013/0017/0031) on the front surface (A) which is a plateau-like protrusion with rounded edges (see annotated figure 1, the at least one pressure element [2] protrudes on the front surface [A] and has rounded edges due to the at least one pressure element [2] having a shape of a sinusoidal function [as seen in figure 2]: paragraph 0032), wherein, when the pad (1) is in an applied state, the two lower pad arms (C/D) run below a malleoli of a user and exert pressure on the tissue below the malleoli by the pressure element (2) on each of the two lower pad arms (C/D) (see annotated figure 1, the lower pad arms [C/D] comprising the pressure element [2] and the shape of the pad [1] fits medially and laterally onto the heel [below the malleoli] and extends dorsally over the Achilles tendon; the pad [1] encloses the Achilles tendon about 4cm on both sides and provides a compression/massage on the tissue below the malleoli [see examiner further notes below]: paragraph 0022-0023/0034-0037).
Examiner further notes: A recitation of the intended use 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. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 14, Sandhof discloses a method of draining lymphatic fluid and relieving the Achilles tendon (when the pad [1 – see annotated figure 1] used with a Achilles tendon bandage, lymphatic fluid is supplied from the interstituium via the paths of the dorso-lateral lymphatic bundle and thus from the periphery via the vena saphena parva to the venous system by compression and massage and is finally excreted: paragraph 0037), the method comprising: selecting a pad (1 – see annotated figure 1, a pad: paragraph 0031) comprising a front surface (A – see annotated figure 1, a front surface of the pad), a rear surface (B – see annotated figure 1, a rear surface of the pad that is opposite of the front surface of the pad) and two lower pad arms (C/D – see annotated figure 1, two lower pad arms), wherein each of the two lower pad arms (C/D) comprises a pressure element (2 – see annotated figure 1, wavy lines that protrude out of the front surface [A]: paragraph 0013/0017/0031) on the front surface (A) which is a plateau-like protrusion with rounded edges (see annotated figure 1, the at least one pressure element [2] protrudes on the front surface [A] and has rounded edges due to the at least one pressure element [2] having a shape of a sinusoidal function [as seen in figure 2]: paragraph 0032); applying the pad (1) to a user such that the two lower pad arms (C/D) run below a malleoli of the user and the pressure element (2) on each of the two lower pad arms (C/D) exert pressure on the tissue below the malleoli (see annotated figure 1, the lower pad arms [C/D] comprising the pressure element [2] and the shape of the pad [1] fits medially and laterally onto the heel [below the malleoli] and extends dorsally over the Achilles tendon; the pad [1] encloses the Achilles tendon about 4cm on both sides and provides a compression/massage on the tissue below the malleoli: paragraph 0022-0023/0034-0037).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Sandhof (EP 2103287 B1) in view of Scheuermann et al. (US 10751210 B2)
Regarding claim 4, Sandhof discloses the invention as discussed in claim 1.
However, Sandhof fails to disclose characterised in that the front surface of the pad is nubbed.
Scheuermann et al. teaches characterised in that an analogous front surface of the pad (E – see annotated figure 2, a front surface of the pad) is nubbed (23 – see annotated figure 2, the nubs: column 6, lines 66-67 & column 7, lines 1-3) (see annotated figure 2, the front surface of the pad [E] is nubbed).
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Annotated figure 2: apparatus of Scheuermann et al.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the front surface of Sandhof with nubs as taught by Scheuermann et al. in order to provide a pad that has an improved front surface to provide additional advantageous massaging effect (column 7, lines 1-3, Scheuermann et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at (571) 270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
