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 sling 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 patient’s joint (“the treated joint”)” should be “a patient’s joint . Appropriate correction is required.
Claim 1 objected to because of the following informalities: “the anchor and cradle bear which” should be “the anchor and the cradle [[bear]] [[which]]” in line 13. Appropriate correction is required.
Claim 5 objected to because of the following informalities: “the patient’s CMC joint” should be “the patient’s carpometacarpal [[CMC]] joint” in line 3. Appropriate correction is required.
Claim 5 objected to because of the following informalities: “the CMC joint” should be “the carpometacarpal [[CMC]] joint” in line 4. Appropriate correction is required.
Claim 6 objected to because of the following informalities: “a surface of the patient’s thumb” should be “[[a]] the surface of the patient’s thumb” in lines 1-2. Appropriate correction is required.
Claim 6 objected to because of the following informalities: “the CMC joint” should be “the carpometacarpal [[CMC]] joint” in line 2. Appropriate correction is required.
Claim 7 objected to because of the following informalities: “a surface of the patient’s thumb” should be “[[a]] the surface of the patient’s thumb” in lines 1-2. Appropriate correction is required.
Claim 10 objected to because of the following informalities: “wherein the first arm has a curved shape which allows it to confirm to the inner surface of the patient’s hand in the region adjacent to the CMC joint, and further wherein the second arm has a curved shape which allows it to conform to the outer surface of the patient’s hand in a region adjacent the CMC joint” should be “wherein the first arm has a curved shape which allows it to conform to the inner surface of the patient’s hand in the region adjacent to the carpometacarpal [[CMC]] joint, and further wherein the second arm has a curved shape which allows it to conform to the outer surface of the patient’s hand in a region adjacent the carpometacarpal [[CMC]] joint” in lines 2-5. Appropriate correction is required.
Claim 12 objected to because of the following informalities: “wherein the amount of flex in the bridge is relatively minimal” should be “wherein an amount of the flex in the bridge is relatively minimal” in lines 1-2. 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 1-2, 5, 7, and 11 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 3-4, 6, 8-10, and 12-17 are also rejected due to their dependency on independent claim 1.
Claim 1 recites the limitation "the treated joint" in lines 1, 4, 9, and 14. There is insufficient antecedent basis for this limitation in the claim. Examiner suggest “the patient’s joint” rather than “the treated joint” for clarity purposes.
Claim 1 recites the limitation “the points of the patient’s body" in lines 12-13. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 1, the limitation “the anchor and cradle bear which provides a traction force to the treated joint on contraction of muscles in the patient’s body” is unclear. Examiner is unsure how the traction force relates to the contraction of muscles in the patient’s body. Examiner examined this claim as best understood.
Claim 2 recites the limitation "the treated joint" in line 2. There is insufficient antecedent basis for this limitation in the claim. Examiner suggest “the patient’s joint” rather than “the treated joint” for clarity purposes.
Claim 5 recites the limitation "the treated joint" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner suggest “the patient’s joint” rather than “the treated joint” for clarity purposes.
The term “substantially” in claim 7 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Therefore, the limitation “wherein the cradle is configured to bear against a surface of the patient’s thumb that is at least one of substantially adjacent to or distal to, a joint between the metacarpal and the proximal phalange of the patient’s thumb” has been rendered indefinite.
Regarding claim 7, the limitation “further wherein contraction of muscles in the patient’s thumb to cause flexion in the joint between the metacarpal and the proximal phalange causes the traction force” is unclear. Examiner is unsure how the flexion in the joint cause traction force and the relationship between flexion and traction force. Examiner examined this claim as best understood.
Claim 11 recites the limitation "the bearing portion" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-2 and 5-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Anglada et al (US 20120179081 A1), with extrinsic evidence provided by “Physiopedia” for the rejection of claim 1, “healthiack” for annotated figure 1, and “Anatomy System” for annotated figure 2.
Regarding claim 1, Anglada et al. discloses a splint (1 – figure 9, an orthosis: paragraph 0061) to treat a patient’s joint (“the treated joint”) (see annotated figure 1, the orthosis [1] is placed on the user’s hand to treat rhizarthrosis [arthritis of the carpometacarpal {CMC} joint, as evidenced by “Physiopedia”]: paragraph 0001-0002), wherein the treated joint has an axis of rotation (see annotated figure 1, the treated joint is the CMC joint of the thumb, which has an axis of rotation: paragraph 0001-0002), wherein the splint (1) includes a cradle (2 – figure 4/figure 5, a supporting member that is engaged between the thumb and index finger: paragraph 0053) and an anchor (18 – figure 6, a third branch that is orthogonal to the other branches [16/17 – figure 6]: paragraph 0056), and wherein the splint (1) is, in use, positioned with respect to the treated joint so that: the cradle (2) is adjacent to and bears against a surface of a patient’s body that is distal to the axis of rotation (see annotated figure 1/figure 4/figure 5, the cradle [2] is adjacent to and bears against a surface of a patient’s body [hand] that is distal to the axis of rotation of the treated joint [CMC]; the term “distal” is defined as “situated away from the point of origin or attachment, as of a limb or bone” by Distal - definition of distal by The Free Dictionary. The cradle [2] is situated away from the CMC joint of the thumb; it is situated between the thumb and index finger: paragraph 0053), and the anchor (18) is adjacent to and bears against a portion of the patient’s body that is proximal to the axis of rotation (see annotated figure 1, the anchor [18] is adjacent to and bears against a surface of the patient’s body [hand] that is proximal to the axis of rotation of the treated joint [CMC]; the term “proximal” is defined as “Nearest; proximate” by Proximal - definition of proximal by The Free Dictionary. The anchor [18] is proximate to the CMC joint); and the splint (1) is configured to position bones forming the treated joint in a desired orientation and at least partially restrict movement at the bones away from the desired orientation (see annotated figure 1, the splint comprises a cradle [2] and strap [3 – figure 9]; the cradle [2] ensures a spacing [desired orientation] between the thumb and the index finger that procures an antalgic effect and preserves the range of motion and the strap [3] creates, combined with the cradle [2], bearing on both sides of the hand that immobilizes the osteoarticular column of the thumb and prevents the luxation of the joint: paragraph 0014/0060); and further wherein the cradle (2) and the anchor (18) together define a lever arm based on the points of the patient’s body with which the anchor (18) and cradle (2) bear which provides a traction force to the treated joint on contraction of muscles in the patient’s body (the strap [3] comprising the anchor [18] helps immobilizes the wrist, which makes it possible to create a significant lever arm that improves the effect of the orthosis [1] comprising the cradle [2] on rhizarthrosis; the cradle [2] and anchor [18] provides a bearing [traction force] that immobilizes the osteoarticular column of the thumb and prevents the luxation of the joint [see examiner further notes below]: paragraph 0016/0032).
Examiner further notes: While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
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Annotated figure 1: image of hand anatomy (left, provided by “Healthiack”) and apparatus of Anglada et al. (right)
Regarding claim 2, Anglada et al. discloses the invention as discussed in claim 1. Anglada et al. further discloses wherein the splint (1) further comprises a fastener (19 – figure 6, a catching zone made of Velcro.RTM: paragraph 0056/0060) configured to attach the splint (1) to the patient’s body relative to the treated joint (see annotated figure 1/figure 6/figure 8, the fastener [19] attaches the splint [1] to the patient’s body; the fastener [19] makes it possible to wrap the strap [3] around the patient’s body relative to the treated joint and the cradle [2]: paragraph 0060).
Regarding claim 5, Anglada et al. discloses the invention as discussed in claim 1. Anglada et al. further discloses wherein treated joint is the patient’s CMC joint (see annotated figure 1, the orthosis [1] is placed on the user’s hand to treat rhizarthrosis [arthritis of the carpometacarpal {CMC} joint, as evidenced by “Physiopedia”]: paragraph 0001-0002), and further wherein the cradle (2) is configured to be positioned and bear against a surface of the patient’s thumb (see annotated figure 1, the cradle [2] is positioned and bear against a surface of the patient’s thumb: paragraph 0053), and wherein the anchor (18) is configured to bear against a surface of the patient’s body which is proximal to the CMC joint (see annotated figure 1, the anchor [18] bear against the surface of the patient’s body which is proximal to the CMC joint; the term “proximal” is defined as “Nearest; proximate” by Proximal - definition of proximal by The Free Dictionary).
Regarding claim 6, Anglada et al. discloses the invention as discussed in claim 5. Anglada et al. further discloses wherein the cradle (2) is configured to bear against a surface of the patient’s thumb on the distal side of the CMC joint (see annotated figure 1, the cradle [2] bear against a surface of the patient’s thumb on the distal side of the CMC joint; the term “distal” is defined as “situated away from the point of origin or attachment, as of a limb or bone” by Distal - definition of distal by The Free Dictionary. The cradle [2] is situated away from the CMC joint of the thumb; it is situated between the thumb and index finger: paragraph 0053).
Regarding claim 7, Anglada et al. discloses the invention as discussed in claim 6. Anglada et al. further discloses wherein the cradle (2) is configured to bear against a surface of the patient’s thumb that is at least one of substantially adjacent to or distal to, a joint between the metacarpal and the proximal phalange of the patient’s thumb (see annotated figure 1/annotated figure 2, the cradle [2] bears against a surface of the patient’s thumb that is adjacent to a joint between the metacarpal and the proximal phalange of the patient’s thumb; the term “adjacent” is defined as “Close to; lying near” by Adjacent - definition of adjacent by The Free Dictionary. The cradle [2] is lying near a joint [thumb-index commissure] between the metacarpal and proximal phalange of the thumb: paragraph 0053), and further wherein contraction of muscles in the patient’s thumb to cause flexion in the joint between the metacarpal and the proximal phalange causes the traction force (the cradle [2] is capable of contracting muscles in the patient’s thumb to cause flexion in the joint between the metacarpal and the proximal phalange which causes the traction force [see examiner further notes below]).
Examiner further notes: While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
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Annotated figure 2: apparatus of Anglada et al. (left) and anatomy of human (right, provided by “Anatomy System”)
Regarding claim 8, Anglada et al. discloses the invention as discussed in claim 7. Anglada et al. further discloses wherein the cradle (2) is defined by a first wing (A – see annotated figure 3, a first wing of the cradle) and a second wing (B – see annotated figure 3, a second wing of the cradle), and further wherein the first wing (A) and the second wing (B) are configured to at least partially wrap around the patient’s thumb (see annotated figure 3, the first wing [A] and second wing [B] are extending in opposite directions and partially wraps around the patient’s thumb).
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Annotated figure 3: the cradle’s first wing and second wing
Regarding claim 9, Anglada et al. discloses the invention as discussed in claim 8. Anglada et al. further discloses wherein the cradle (2) is structured to allow at least partial movement of the bones from the desired orientation further towards one or more of extension, and abduction (the cradle [2] can be made from a flexible material that can be elastically deformed, such as silicone; due to its material, it is capable of allowing partial movement of the bones from the desired orientation further towards extension and/or abduction [see examiner further notes below]: paragraph 0026/0054).
Examiner further notes: While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function.” In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997) (The absence of a disclosure in a prior art reference relating to function did not defeat the Board’s finding of anticipation of claimed apparatus because the limitations at issue were found to be inherent in the prior art reference); see also In re Swinehart, 439 F.2d 210, 212-13, 169 USPQ 226, 228-29 (CCPA 1971); In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA 1959). Thus, if a prior art structure is capable of performing the intended use as recited in the preamble, or elsewhere in a claim, then it meets the claim.
Regarding claim 10, Anglada et al. discloses the invention as discussed in claim 9. Anglada et al. further discloses wherein the splint (1) includes a first arm (16 – figure 6/figure 9, a first branch: paragraph 0060) and a second arm (17 – figure 6/figure 9, a second branch: paragraph 0060), wherein the first arm (16) has a curved shape which allows it to conform to the inner surface of the patient’s hand in the region adjacent to the CMC joint (see annotated figure 1, the first arm [16] has a curved shape that allows it to conform to the inner surface [palm] of the patient’s hand in the region adjacent to the CMC joint; the term “adjacent” is defined as “Close to; lying near” by Adjacent - definition of adjacent by The Free Dictionary. The first arm [16] lies near the CMC joint), and further wherein the second arm (17) has a curved shape which allows it to conform to the outer surface of the patient’s hand in a region adjacent the CMC joint (see annotated figure 1, the second arm [16] has a curved shape that allows it to conform to the outer surface [back of the palm] of the patient’s hand in the region adjacent to the CMC joint; the term “adjacent” is defined as “Close to; lying near” by Adjacent - definition of adjacent by The Free Dictionary. The second arm [17] lies near the CMC joint).
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.
Claims 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Anglada et al (US 20120179081 A1) in view of Darcey (US 6261252 B1).
Regarding claim 3, Anglada et al. discloses the invention as discussed in claim 2.
However, Anglada et al. fails to disclose wherein the splint includes a liner.
Darcey teaches wherein analogous splint (15 – figure 7, a thumb spica splint: column 4, lines 27-28) includes a liner (40 – figure 5, an inner cushion layer made of EVA micro-perf closed cell foam: column 5, lines 13-20).
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 splint of Anglada et al. with a liner as taught by Darcey in order to provide an improved splint with a liner that provides a comfortable surface next to the user’s skin and can bend easily with the components of the splint (column 5, lines 13-20, Darcey).
Regarding claim 4, Anglada et al. in view of Darcey discloses the invention as discussed in claim 3. Darcey further teaches wherein the liner (40) is formed from a material which is at least one of soft, flexible, water resistant, and breathable (the liner [40] is made of EVA micro-perf closed cell foam that is flexible: column 5, lines 13-20).
Allowable Subject Matter
Claim 11 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Furthermore, claim 11 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter:
Claim 11 contains allowable subject matter because the prior art fails to disclose, either singly or
in combination, the limitations of the claim. The closest prior art made of record was Anglada et al (US 20120179081 A1).
Anglada et al. discloses the splint (1 – figure 9, an orthosis: paragraph 0061), the cradle (2 – figure 4/figure 5, a supporting member that is engaged between the thumb and index finger: paragraph 0053), and the first arm (16 – figure 6/figure 9, a first branch: paragraph 0060), and the second arm (17 – figure 6/figure 9, a second branch: paragraph 0060).
However, none of the relevant prior art discloses wherein the splint includes a bridge which connects the cradle to one or more of the first arm, the second arm, and the bearing portion. Therefore, claim 11 would be allowable once the 35 U.S.C. 112(b) issues have been resolved.
Claims 12-17 are also allowable due to their dependency on claim 11 once the 35 U.S.C. 112(b) issues have been resolved.
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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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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