DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the 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.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
The following claim limitations
Movement mechanism (claim 1)
Restriction member (claim 9)
Lock mechanism (claim 10)
has/have been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses/they use a generic placeholder
Mechanism (Movement mechanism - claim 1)
Member (Restriction member - claim 9)
mechanism (Lock mechanism - claim 10)
coupled with functional language
interlocking the hub fixation part with the skin fixation part… (Movement mechanism - claim 1)
that restricts a movable region of the hub fixation part (Restriction member - claim 9)
configured to fix a position of the hub fixation part with respect to the skin fixation part (Lock mechanism - claim 10)
without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier.
Since the claim limitation(s) invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, claim(s) 1 has/have been interpreted to cover the corresponding structure described in the specification that achieves the claimed function, and equivalents thereof.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
guide rails (¶0019), linear guide (¶0027), wheel (¶0034), flexible member (¶0052) or stoppers (¶0053)(Movement mechanism - claim 1)
stoppers (¶0053) (Restriction member - claim 9)
lock pin (¶0014) (Lock mechanism - claim 10)
If applicant wishes to provide further explanation or dispute the examiner’s interpretation of the corresponding structure, applicant must identify the corresponding structure with reference to the specification by page and line number, and to the drawing, if any, by reference characters in response to this Office action.
If applicant does not intend to have the claim limitation(s) treated under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112 , sixth paragraph, applicant may amend the claim(s) so that it/they will clearly not invoke 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, or present a sufficient showing that the claim recites/recite sufficient structure, material, or acts for performing the claimed function to preclude application of 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
For more information, see MPEP § 2173 et seq. and Supplementary Examination Guidelines for Determining Compliance With 35 U.S.C. 112 and for Treatment of Related Issues in Patent Applications, 76 FR 7162, 7167 (Feb. 9, 2011).
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.
Claim 11 is 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.
Regarding claim 11:
The claim limitation “a fixing surface” in line 2 is unclear. The limitation is unclear because of the earlier recitation of the limitation “a fixing surface” in line 8 of claim 1 (on which this claim depends) which raises a question of if two of fixing surfaces are required by the claim 11 or only one. For the sake of examination, the office has assumed that only one fixing surface is required by the claim. This rejection is made due to the amendments to claim 1.
Claim Rejections - 35 USC § 103
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(s) 1 and 9-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20120041378 A1 to Bierman in view of WO 2010002393 A1 to Ciccone et al. (Ciccone).
Regarding claim 1:
Bierman discloses:
A catheter fixing device (figures 3-8) comprising:
a skin fixation part (16) configured to come into contact with skin (¶0055);
a hub fixation part (20) configured to retain a catheter hub (25/28); and
a movement mechanism (rails 100 or latch 94/114/112/110/116 which is consistent with the 35 USC 112(f) interpretation above) provided between the skin fixation part (16) and the hub fixation part (20) (as shown in figure 8) and interlocking the hub fixation part (20) with the skin fixation part (16) such that the hub fixation part (20) and the skin fixation part (16) are movable relative to each other (the rails 100 and latch 94 allows hub fixation part 20 to move relative to the skin fixation part 16; ¶0105, ¶0131) in a length direction of the skin fixation part (the rails 100 and latch 94 allows hub fixation part 20 to move in the length wise direction relative skin fixation part 16).
Bierman fails to disclose:
The hub fixation part and the skin fixation part are movable relative to each other in both a length direction of the skin fixation part and a width direction of the skin fixation part, the length direction and the width direction being parallel to a fixing surface of the skin fixation part, and the width direction being perpendicular to the length direction.
Ciccone teaches:
A catheter fixation device (figure 4) that includes a skin fixation part (22) and hub fixation part (24). The reference further teaches that there should be play or leeway between the skin fixation part and the hub fixation part (¶0073) to allow for the parts to mate together despite manufacturing tolerances of the parts.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bierman to allow for a gap/play/leeway between the movement mechanism between the skin and hub fixation parts as taught by Ciccone to allow for the movement mechanism to better fit the skin and hub fixation parts despite the manufacturing tolerances of the movement mechanism (Ciccone, ¶0073). The gap/play/leeway added to the movement mechanism would allow for movement in the width direction perpendicular to the length direction so that the mating parts of the movement mechanism would fit together despite manufacturing tolerances.
Regarding claim 9:
Bierman discloses:
The catheter fixing device according to claim 1, wherein:
the movement mechanism (rails 100 or latch 94/114/112/110/116) comprises a restriction member (see the wall/stopper B in figure 1 below of the rails 100 that limits the motion of the 120 and by extension hub fixation part 20) that restricts a movable region of the hub fixation part (20).
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Figure 1 – figure 8 of Bierman, annotated by the examiner
Regarding claim 10:
Bierman discloses:
The catheter fixing device according to claim 1, further comprising:
a lock mechanism (pawl/latch/lock 114 which is consistent with the 35 USC 112(f) interpretation above) configured to fix a position of the hub fixation part (20) with respect to the skin fixation part (16/20) at a predetermined position in a releasable manner (¶0105; ¶0131).
Regarding claim 11:
Bierman discloses:
The catheter fixing device according to claim 1, wherein:
the skin fixation part (16/20) comprises an adhesive material layer (adhesive bottom side 18) on a fixing surface that faces the skin (¶0055).
Regarding claim 12:
Bierman discloses:
The catheter fixing device according to claim 1, wherein:
the hub fixation part (20) comprises a protrusion portion (54/58 as shown in figures 3-4b) that fits and retains (as shown in figure 2) the catheter hub (25/28).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 20120041378 A1 to Bierman in view of US 7666166 B1 to Emmert.
Regarding claim 13:
Bierman discloses:
A catheter fixing device (figures 3-8) comprising:
a skin fixation part (16/20) configured to come into contact with skin (¶0055), the skin fixation part (16/20) comprising:
an adhesive material layer (adhesive bottom side 18) on a fixing surface that faces the skin (¶0055),
a pair of guide rails (rails 100) that extend in a length direction of the skin fixation part (16/20) (as shown in figure 7b where 100/108 extends in the length direction), the pair of guide rails (rails 100) defining a guide groove (see the guide groove 118 as shown in figure 8), and
a locking mechanism (112/110) located at a bottom portion of the guide groove (118) (as shown in figure 8)
a hub fixation part (20) comprising:
a slider part (120/20a) on a lower surface side (as shown in figure 8) of the hub fixation part (20) and located in the guide groove (118) so as to be slidably supported by the locking mechanism (112/110), and
a retaining protrusion (54/58 as shown in figures 3-4b) on a top surface side (as shown in figure 5) of the hub fixation part (20), the retaining protrusion (54/58) being configured to retain (as shown in figure 2) a catheter hub (25/28).
Bierman fails to disclose:
A free ball bearing located at a bottom portion of the guide groove.
Emmert teaches:
An integrated catheter that includes an inner sliding member (248) and an outer housing (246). Further, the catheter includes a free ball bearing (260) that engages with grooves/tabs (216) to restrain the inner sliding member (248) relative to the outer housing (246)(column 10, lines 42-53).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Bierman to replace the locking mechanism in Bierman with the ball bearing/locking mechanism as taught by Emmert. This would replace locking mechanism (112/110) of Bierman with the free ball bearing to engage with the grooves/tabs (112/110) of Bierman. This is a simple substitution of one known element (locking mechanism 114 of Bierman) for another (free ball bearing/locking mechanism of Emmet) to obtain predictable results (to hold the skin fixation part and the hub fixation part in place).
Response to Arguments
Applicant’s arguments, see remarks, filed 8/12/26, with respect to the rejection(s) of claim(s) 1 and 9-12 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Bierman and Ciccone.
Regarding the 35 USC 103 rejection of claim 13:
The applicant has provided arguments for why this rejection is improper however the office is not persuaded. The applicant argues that the ball bearing 260 of Emmert incorporated into Bierman does not enable relative movement between its components and therefore its combination with Bierman would not result in this function (see page 10 of the remarks). However, this overlooks the fact that the structure 260 is referred to as a ball bearing indicating that it does aid in the function of movement of the 248 relative to the body 246. In short, the ball bearings have a dual function of allowing for sliding and for locking the 248 and 246 structures relative to each other. Further, the ball bearing allows the 248 and 246 components to be locked relative to each other at multiple positions as shown by the multiple locking grooves 272 in figure 8a. This further addresses the applicant’s argument that the positioning mechanism 90 of Bierman needs to be able to lock in multiple positions or for fine adjustment (see page 10 of the remarks). Therefore, the ball bearing locking mechanism of Emmert would be able to perform the function of the locking mechanism in Bierman and further read on the structure of the ball bearing required by the claim. For this reason, the applicant’s arguments are not persuasive and the above rejection is maintained.
Regarding the 35 USC 112(b) rejection of claim 13:
The applicant’s amendments to the claims have addressed the previous claim rejections and for this reason they have been withdrawn. However, a new set of rejections have been made due to the amendments to the claims.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WESLEY HARRIS whose telephone number is (571)272-3665. The examiner can normally be reached M to F, 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/WESLEY G HARRIS/Examiner, Art Unit 3783
