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 .
Election/Restrictions
Applicant’s election without traverse of Invention II in the reply filed on July 24, 2026is acknowledged.
Claim Objections
Claims 16 and 17 are objected to because of the following informalities: The claim recites: “the malleable guide member” however the limitation should read “the malleable guide rail” as this is the term previously set forth. 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 1-19 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 1 and 16 recites: “the guide rail being configured to fit in an anatomical passageway in a head of a patient” -it is unclear what is required by this limitation since it is trying to further an element i.e. “guide rail” that is not positively recited.
Claim 18 recites: “wherein the apparatus is configured to allow an operator to form a bend in the malleable guide rail at any selected position along the length of the malleable guide rail within a range from approximately 20 mm from the distal tip of the guide rail to approximately 7 mm from the distal tip of the guide rail” -it is unclear what is required by this limitation since it is trying to further an element i.e. “guide rail” that is not positively recited.
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 1-7 and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Beck et al. (hereafter “Beck”)(US 3,236,082).
With regards to claim 1, Beck discloses an apparatus, comprising:
a base (11);
an actuator (52), the actuator being pivotably coupled with the base; and
a clamp member (43), the clamp member being operable i.e. that is to be capable of selectively clamping a malleable guide rail relative to the base, , the actuator being operable to pivot relative to the base to thereby bend the guide rail while the guide rail is clamped by the clamp member.
The following is considered intended use: “the guide rail being configured to fit in an anatomical passageway in a head of a patient.” 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. See In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967) and In re Otto, 312 F.2d 937, 939, 136 USPQ 458, 459 (CCPA 1963).
With regards to claim 2, Beck discloses wherein: the base includes a block (28), and
the clamp member is operable to clamp the guide rail against the block.
With regards to claim 3, Beck discloses wherein: the block includes a recess (39), and the recess is configured to receive a portion of the guide rail.
With regards to claim 4, Beck discloses wherein the recess has a radiused profile, as seen in at least Figure 1.
With regards to claim 5, Beck discloses wherein: the block further includes indicia (roll 28 includes scale 46 on bar 42 extending from roll 2846), and the indicia is configured to indicate a depth of insertion of the guide rail into a space between the clamp member and the block [Column 2, lines 49-52].
With regards to claim 6, Beck discloses wherein: the base defines an upper surface, and the block (28) extends upwardly from the upper surface, as seen in Figure 1.
With regards to claim 7, Beck discloses wherein: the actuator (52) includes a lever arm (58) and a hub (frame 52 defines a hub), and the actuator is pivotably coupled with the base via the hub, as seen in Figure 1 and 6.
With regards to claim 10, Beck discloses wherein: the hub (frame 52 defines a hub) defines an annular recess (roller 53 of frame 52 defines a recess), and the annular recess is configured to receive a portion of the guide rail, as seen in Figures 2 and 6.
With regards to claim 11, Beck discloses wherein the annular recess has a curved profile with a radius configured to complement a radius of the guide rail, as seen in Figures 2 and 6.
With regards to claim 12, Beck discloses wherein the base further includes a set of indicia (32), the indicia being configured to visually indicate a plurality of bend angles, as seen in Figure 2.
Claims 16-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cao (CN 102756024).
With regards to claim 16, Cao discloses an apparatus, comprising:
a base (1), the base comprising a block (2);
an actuator (4), the actuator comprising a lever arm (7) pivotably coupled with the base; and
a clamp member (14), the clamp member being slidably coupled with the base, the clamp member being operable to slide relative to the base between an open position and a closed position,
wherein (i) the clamp member in the open position being configured to define a gap with the block, the gap being configured to allow positioning of a malleable guide rail between the clamp member and the block, as seen in Figure 1,
(ii) the clamp member in the closed position being configured to clamp the malleable guide member against the block, as seen in Figure 1, and (iii) the lever arm being configured to bend the malleable guide rail when the lever arm is pivoted relative to the base while the malleable guide member is clamped against the block, as seen in Figure 1.
The following is considered intended use: “the guide rail being configured to fit in an anatomical passageway in a head of a patient.” 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. See In re Casey, 370 F.2d 576, 152 USPQ 235 (CCPA 1967) and In re Otto, 312 F.2d 937, 939, 136 USPQ 458, 459 (CCPA 1963).
With regards to claim 17, Cao discloses wherein the clamp member (14) and the block (2) are configured to: allow the malleable guide rail to be positioned at a plurality of different longitudinal positions within the gap when the clamp member is in the open position, and clamp the malleable guide rail at any longitudinal position of the plurality of different longitudinal positions when the clamp member is in the closed position [paragraph 0054 and Figure 1].
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of Clouse (US Patent 2,466,381).
Beck discloses the invention substantially as claimed except for wherein: the base further includes an integral post, and the hub is pivotably coupled with the post. Clouse is relied upon to teach a tube bending device comprising a base (5) including an integral post (7) and a hub (8) that is pivotably coupled with the post, as seen in Figure 1. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Beck’s device with a post as taught by Clouse because combining prior art elements according to known methods to yield predictable results require only routine skill in the art. [KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)].
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Cao in view of Beck.
Cao discloses the invention substantially as claimed except for wherein the base includes indicia configured to enable an operator to visually confirm formation of a bend in the malleable guide rail at any selected bend angle within a range from approximately 45 degrees to approximately 135 degrees. Beck is relied upon to teach a tube bending device comprising a base includes indicia (32) configured to enable an operator to visually confirm formation of a bend in the malleable guide rail at any selected bend angle within a range from approximately 45 degrees to approximately 135 degrees [Column 2, lines 15-25]. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide Cao’s device with indicia as taught by Beck because combining prior art elements according to known methods to yield predictable results require only routine skill in the art. [KSR Int’l Co. v. Teleflex Inc., 127 S.Ct. 1727, 1742, 82 USPQ2d 1385, 1396 (2007)].
Allowable Subject Matter
Claims 9 and 13-15 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure and further shows the state of the art: US Patent 3,621,697.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA M EKIERT whose telephone number is (571)272-1901. The examiner can normally be reached Monday-Friday 8AM-4:30PM EST.
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/TERESA M EKIERT/Primary Examiner, Art Unit 3725
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