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 as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: Figures 4A and 4B are missing reference numerals “11” (upper bent region) and “12” (lower straight region) as are described in paragraphs [0030] and [0032] of the specification. 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. 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
Claims 1 and 11 are objected to because of the following informalities which require appropriate correction:
In claim 1 lines 3-6, the claim should be amended as follows for improved clarity: “…wherein the strap has a bent region…”.
In claim 11 line 4, the numeral “30” should be removed.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim(s) 1-12 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Specifically, Claims 1-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Claim 1 positively recites part of the human body in combination with the device, as for example: in claim 1, the limitation reciting “…a shoulder portion placed on an affected shoulder” of the claim encompasses a human being. It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the constitution. Accordingly, proper procedure where a claim is directed to an apparatus “attached to” the human body or any part thereof is to reject such claim under 35 U.S.C 101 with an explanation that, because the claim positively recites a part of the human body, it is directed to nonstatutory subject matter. See Animals – Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987). Therefore, for at least this reason, claim 1 has been rejected under 35 USC 101. It is suggested that claim 1 be amended as follows in order to overcome this rejection: “a shoulder portion configured to be placed on an affected shoulder”.
Additionally, claim(s) 2, and 4-9 include the following structural limitations that are defined by areas of the human body and functional limitations which recite method steps defined by movement of the human body: For example, claim 2 recites: “an underarm band connecting…the shoulder portion of the strap through an axilla”; claim 4 recites: “the strap descends from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, passes through a lower surface side of the forearm from the ulnar side to a radial side, traverses a front side of an upper arm from the radial side of the forearm, and connects to a back end of the shoulder portion through an axilla”; claim 5 recites: “the strap descends from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, passes through a lower surface side of the forearm from the ulnar side to a radial side, traverses a front side of an upper arm from the radial side of the forearm, and connects to a back end of the shoulder portion through an axilla”; claim 6 recites: “the strap descends from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, passes through a lower surface side of the forearm from the ulnar side to a radial side, traverses a front side of an upper arm from the radial side of the forearm, and connects to a back end of the shoulder portion through an axilla”; claim 7 recites: “the strap descends from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the first end of the strap is fixed to the elbow pad, and the second end of the strap is fixed to the elbow pad from a back end of the shoulder portion through an axilla, traverses a front side of an upper arm, and connects to a radial side of the forearm”; claim 8 recites: “the strap descends from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the first end of the strap is fixed to the elbow pad, and the second end of the strap is fixed to the elbow pad from a back end of the shoulder portion through an axilla, traverses a front side of an upper arm, and connects to a radial side of the forearm”; and claim 9 recites: “the strap descends from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the first end of the strap is fixed to the elbow pad, and the second end of the strap is fixed to the elbow pad from a back end of the shoulder portion through an axilla, traverses a front side of an upper arm, and connects to a radial side of the forearm”. Thus, claims 2 and 4-9 each define an invention that includes non-statutory subject matter. It is suggested that the claims be amended as follows in order to overcome these rejections: in claim 2: “an underarm band configured for connecting…the shoulder portion of the strap through an axilla”; in claim 4: “the strap is configured to descend from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, is configured to pass through a lower surface side of the forearm from the ulnar side to a radial side, is configured to traverse a front side of an upper arm from the radial side of the forearm, and is configured to connect to a back end of the shoulder portion through an axilla”; in claim 5: “the strap is configured to descend from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, is configured to pass through a lower surface side of the forearm from the ulnar side to a radial side, is configured to traverse a front side of an upper arm from the radial side of the forearm, and is configured to connect to a back end of the shoulder portion through an axilla”; in claim 6: “the strap is configured to descend from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, is configured to pass through a lower surface side of the forearm from the ulnar side to a radial side, is configured to traverse a front side of an upper arm from the radial side of the forearm, and is configured to connect to a back end of the shoulder portion through an axilla”; in claim 7: “the strap is configured to descend from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the first end of the strap is fixed to the elbow pad, and the second end of the strap is fixed to the elbow pad and configured to extend from a back end of the shoulder portion through an axilla, is configured to traverse a front side of an upper arm, and is configured to connect to a radial side of the forearm; in claim 8: “the strap is configured to descend from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the first end of the strap is fixed to the elbow pad, and the second end of the strap is fixed to the elbow pad and configured to extend from a back end of the shoulder portion through an axilla, is configured to traverse a front side of an upper arm, and is configured to connect to a radial side of the forearm; and in claim 9: “the strap is configured to descend from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the first end of the strap is fixed to the elbow pad, and the second end of the strap is fixed to the elbow pad and configured to extend from a back end of the shoulder portion through an axilla, is configured to traverse a front side of an upper arm, and is configured to connect to a radial side of the forearm.
Claims 3 and 10-12 each depend directly or indirectly from a rejected claim and, therefore, contain the same deficiencies as the claims from which they depend.
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.
Claim(s) 1, 3-4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nakamitsu (US 10434004).
With respect to claim 1, Nakamitsu discloses a therapeutic shoulder brace (shoulder brace shown in figs 1-4; see col 7 lines 43-63) comprising a shoulder portion placed on an affected shoulder (upper portion of device which includes upper portion 1a and pad 3 which is placed on the shoulder during use as shown in figs 1-4) and a strap (strap 1) hung so as to hold an upper limb in a physiological basic position (shown in figs 1-3), wherein in a developed plan view of the therapeutic shoulder brace developed in a length direction with the shoulder portion at a center (view in fig 4), the strap (1) has a bent region that includes the shoulder portion and extends inwardly in a convex shape (portion of strap at upper portion 1a which is placed on the shoulder during use is curved and extends slightly inwardly in a direction towards the user’s head in a convex shape as shown in fig 4), and a straight region that is connected to a front end and a back end of the bent region and extends linearly in a front-back direction (section of strap in figures 1-2 which includes a portion at T1 that extends linearly in a straight line in the vertical direction and connects to the front of portion 1a near adjustment portion 5 as shown in figs 1-3 and wraps about the arm as shown in fig 1 to then connect to the back end of portion 1a at the back of the shoulder as shown in fig 3).
With respect to claim 3, Nakamitsu discloses the brace as claimed (see rejection of claim 1) and Nakamitsu also discloses that when the shoulder portion is placed on a shoulder (as shown in figs 1-4), the shoulder portion is inclined in a same direction as an inclination of the shoulder (as shown in figures 2-4; especially figure 3 which shows the shoulder portion of the brace following the same contour as the shoulder and being inclined in the same direction as the shoulder).
With respect to claim 4, Nakamitsu discloses the brace as claimed (see rejection of claim 1) and Nakamitsu also discloses that the strap (1) is ring-shaped (shown in fig 5), and in an applied state (shown in figs 1-4), the strap (1) descends from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, passes through a lower surface side of the forearm from the ulnar side to a radial side, traverses a front side of an upper arm from the radial side of the forearm, and connects to a back end of the shoulder portion through an axilla (as shown in figure 1; see also col 7 lines 43-63).
With respect to claim 6, Nakamitsu discloses the brace as claimed (see rejection of claim 3) and Nakamitsu also discloses that the strap (1) is ring-shaped (shown in fig 5), and in an applied state (shown in figs 1-4), the strap (1) descends from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, passes through a lower surface side of the forearm from the ulnar side to a radial side, traverses a front side of an upper arm from the radial side of the forearm, and connects to a back end of the shoulder portion through an axilla (as shown in figure 1; see also col 7 lines 43-63).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamitsu (US 10434004) in view of Rozell (US 6106493).
With respect to claim 2, Nakamitsu discloses the brace as claimed (see rejection of claim 1) but Nakamitsu does not disclose that the brace comprises an underarm band connecting a vicinity of a front end and a vicinity of a back end of the shoulder portion of the strap through an axilla.
Rozell, however, teaches a brace which includes a shoulder portion configured to be placed on a shoulder (portion of strap 11 at reference numeral 31 in fig 1-2) and an underarm band (lower stabilizing 13; fig 1-2) connecting a vicinity of a front end and a vicinity of a back end of the shoulder portion of the strap (shown in fig 2) through an axilla (as shown in fig 1 where the device is in position on a user). Rozell further teaches that the strap 13 restrains the strap 11 from sliding upward off the shoulder when the arm is raised (col 4 lines 61-66). Thus, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have added an underarm band connecting a vicinity of a front end and a vicinity of a back end of the shoulder portion of the strap through an axilla, like the strap 13 in Rozell, in order to prevent the shoulder strap from sliding off the shoulder when the arm is raised.
With respect to claim 5, Nakamitsu in view of Rozell discloses the brace substantially as claimed (see rejection of claim 2) and Nakamitsu also discloses that the strap (1) is ring-shaped (shown in fig 5), and in an applied state (shown in figs 1-4), the strap (1) descends from a front end of the shoulder portion to an elbow proximal part of a forearm on an ulnar side, passes through a lower surface side of the forearm from the ulnar side to a radial side, traverses a front side of an upper arm from the radial side of the forearm, and connects to a back end of the shoulder portion through an axilla (as shown in figure 1; see also col 7 lines 43-63).
Claim(s) 7, 9-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamitsu (US 10434004) in view of Coleman (US 4617923).
With respect to claims 7 and 9, Nakamitsu discloses the brace as claimed (see rejection of claims 1 and 3) and Nakamitsu also discloses that the brace comprises an elbow pad for supporting a forearm (forearm trough which cups the elbow and supports the forearm as shown in figs 1-4), wherein in an applied state (shown in figs 1-4), the strap (1) descends from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the strap is positioned on the elbow pad and extends from a back end of the shoulder portion through an axilla, traverses a front side of an upper arm, and connects to a radial side of the forearm (as shown in figure 1; see also col 7 lines 43-63).
Nakamitsu does not, however, explicitly disclose that the strap has a band shape including a first end and a second end wherein the first end of the strap is fixed to the elbow pad and the second end of the strap is fixed to the elbow pad.
Coleman, however, teaches an arm sling which includes an elbow pad for supporting a forearm (pocket portion 12 which cups the elbow and also supports the forearm as shown in figs 1-2) and a strap (14a) that has a band shape (shown in figs 1-2) including a first end and a second end wherein the first end of the strap is fixed to the elbow pad and the second end of the strap is fixed to the elbow pad (the opposing ends of the strap 14a are each attached to the pocket portion 12 as shown in figures 1-2). 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 strap on the brace of Nakamitsu so that it has a band shape including a first end and a second end wherein each of the first and second ends of the strap are fixed to the elbow pad, like the strap on the device of Coleman, in order to firmly secure the strap in a given position/configuration on the elbow pad to thereby prevent inadvertent sliding or movement of the strap which could lead to improper positioning of the arm.
With respect to claims 10 and 12, Nakamitsu in view of Coleman discloses the brace substantially as claimed (see rejection of claims 7 and 9) and Coleman further teaches that the second end of the strap is fixed to the elbow pad at a position closer to a front side than a longitudinal midpoint (M) of the elbow pad (as shown in figures 1 and 2, one end of strap 14a is attached to pocket 12 closer to the front end where wrap 22 is provided than the longitudinal midpoint [which is interpreted as being approximately at the location of the reference numeral “12” in fig 2]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the brace of Nakamitsu in view of Coleman such that the second end of the strap is fixed to the elbow pad at a position closer to a front side than a longitudinal midpoint (M) of the elbow pad, like the strap in Coleman, in order to provide support for the weight of the user’s hand and, furthermore, since rearranging parts of an invention involves only routine skill in the art.
Claims 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamitsu (US 10434004) in view of Rozell (US 6106493) and further in view of Coleman (US 4617923).
With respect to claim 8, Nakamitsu in view of Rozell discloses the brace substantially as claimed (see rejection of claim 2) and Nakamitsu also discloses that the brace comprises an elbow pad for supporting a forearm (forearm trough which cups the elbow and supports the forearm as shown in figs 1-4), wherein in an applied state (shown in figs 1-4), the strap (1) descends from a front end of the shoulder portion to an elbow proximal part of the forearm on an ulnar side, the strap is positioned on the elbow pad and extends from a back end of the shoulder portion through an axilla, traverses a front side of an upper arm, and connects to a radial side of the forearm (as shown in figure 1; see also col 7 lines 43-63).
Nakamitsu does not, however, explicitly disclose that the strap has a band shape including a first end and a second end wherein the first end of the strap is fixed to the elbow pad and the second end of the strap is fixed to the elbow pad.
Coleman, however, teaches an arm sling which includes an elbow pad for supporting a forearm (pocket portion 12 which cups the elbow and also supports the forearm as shown in figs 1-2) and a strap (14a) that has a band shape (shown in figs 1-2) including a first end and a second end wherein the first end of the strap is fixed to the elbow pad and the second end of the strap is fixed to the elbow pad (the opposing ends of the strap 14a are each attached to the pocket portion 12 as shown in figures 1-2). 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 strap on the brace of Nakamitsu so that it has a band shape including a first end and a second end wherein each of the first and second ends of the strap are fixed to the elbow pad, like the strap on the device of Coleman, in order to firmly secure the strap in a given position/configuration on the elbow pad to thereby prevent inadvertent sliding or movement of the strap which could lead to improper positioning of the arm.
With respect to claim 11, Nakamitsu in view of Rozell and further in view of Coleman discloses the brace substantially as claimed (see rejection of claim 8) and Coleman further teaches that the second end of the strap is fixed to the elbow pad at a position closer to a front side than a longitudinal midpoint (M) of the elbow pad (as shown in figures 1 and 2, one end of strap 14a is attached to pocket 12 closer to the front end where wrap 22 is provided than the longitudinal midpoint [which is interpreted as being approximately at the location of the reference numeral “12” in fig 2]). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to have configured the brace of Nakamitsu in view of Coleman such that the second end of the strap is fixed to the elbow pad at a position closer to a front side than a longitudinal midpoint (M) of the elbow pad, like the strap in Coleman, in order to provide support for the weight of the user’s hand and, furthermore, since rearranging parts of an invention involves only routine skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLIN CARREIRO whose telephone number is (571)270-7234. The examiner can normally be reached M-F 7:30am-4pm.
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/CAITLIN A CARREIRO/Primary Examiner, Art Unit 3786