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 .
Status of Claims
Claims 1-6 are presently pending in this application.
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 1-6 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.
Regarding Claim 1, the claim recites “the therapeutic or surgical fiber”. There is lack of antecedent basis for this limitation in the claims. It appears this limitation is referring to the previously recited “optical fiber”, and therefore will be interpreted as such by the Examiner. Appropriate correction or clarification is required. Claims 2-6 are rejected for depending on Claim 1.
Regarding Claim 1, the claim recites “the handpiece”. There is lack of antecedent basis for this limitation in the claims. For purposes of examination, the Examiner will interpret this limitation as “a handpiece”. Appropriate correction or clarification is required. Claims 2-6 are rejected for depending on Claim 1.
Regarding Claim 5, the claim recites “the temporary protective sleeve has a color that is different than a color of the buffer of the optical fiber”. However, “the buffer” lacks antecedent basis in the claims, because Claim 4 (from which Claim 5 depends) only recites “a section of a buffer of the optical fiber that has been stripped from the optical fiber”. Therefore, it is unclear as to whether “the temporary protective sleeve” is referring to the same or a different ‘buffer’ than the section of buffer that has been removed. Therefore, this limitation is indefinite. For purposes of examination, the Examiner will interpret this limitation as “the temporary protective sleeve has a color that is different than a color of a buffer on the optical fiber which has not been removed”. Appropriate correction or clarification is required. Claims 2-6 are rejected for depending on Claim 1.
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, 4, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bierbaum et al. (US Publication No. 2010/0216088).
Regarding Claims 1 and 6, Bierbaum et al. discloses a method of preparing for a therapeutic or surgical procedure (Abstract; Paragraph 0002, 0007), comprising steps of:
providing an optical fiber (fiber-optic insert 10, Figs. 1, 2, 5, 8; Abstract, Paragraph 0051, 0055, 0056) having a pre-formed tip (see tip of fiber-optic insert 10, Figs. 1, 2, 5, 8);
placing a temporary protective sleeve (sleeve 80, Fig. 8; and base member 21, Fig. 2) over the pre-formed tip (Paragraph 0020, 0076-0077, 0055-0057, 0059, 0080, 0036, 0064; Abstract);
inserting the optical fiber (fiber-optic insert 10, Figs. 1, 2, 5, 8) with the protective sleeve through the handpiece (grip/handpiece, 3, 4, 5, Figs. 1, 2, 4; Paragraph 0020, 0076-0077, 0055-0057, 0059, 0080, 0036, 0064; Abstract);
and before beginning the therapeutic or surgical procedure, removing the
protective sleeve from the optical fiber (Paragraph 0020, 0076-0077, 0055-0057, 0059, 0080, 0036, 0064; Abstract),
wherein the temporary protective sleeve is reusable (reusable elements, Paragraph 0008, 0020, 0076-0077, 0055-0057, 0059, 0080, 0036, 0064).
Regarding Claim 2, Bierbaum et al. discloses the method further wherein the temporary protective sleeve (sleeve 80, Fig. 8; and base member 21, Fig. 2) is configured to grip the therapeutic or surgical fiber during insertion through the handpiece (Paragraph 0020, 0076-0077, 0055-0057, 0059, 0080, 0036, 0064; Abstract), while enabling removal of the temporary protective sleeve from the optical fiber by a technician after completion of insertion through the handpiece (Paragraph 0020, 0076-0077, 0055-0057, 0059, 0080, 0036, 0064; Abstract).
Regarding Claim 4, Bierbaum et al. discloses the method further wherein the temporary protective sleeve (sleeve 80, Fig. 8; and base member 21, Fig. 2) is a section of a buffer of the optical fiber that has been stripped from the optical fiber (section of material that is removable from optical fiber, see Paragraphs 0076-0077, 0055-0057, 0059, 0080, 0036, 0064; e.g. see tube 8 and/or hose 2, Fig. 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.
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 3 is rejected under 35 U.S.C. 103 as being unpatentable over Bierbaum et al. (US Publication No. 2010/0216088).
Regarding Claim 3, Bierbaum et al. discloses the method further wherein the temporary protective sleeve (sleeve 80, Fig. 8; and base member 21, Fig. 2) is placed over the optical fiber, (fiber-optic insert 10, Figs. 1, 2, 5, 8; Abstract, Paragraph 0051, 0055, 0056), but does not explicitly disclose wherein the temporary protective sleeve is made of PTFE or ETFE.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the temporary protective sleeve to be made of PTFE or ETFE, since these are known biocompatible materials used in medical devices, and since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Bierbaum et al. (US Publication No. 2010/0216088) in view of Leeflang et al. (US Publication No. 20100087789).
Regarding Claim 5, Bierbaum et al. discloses the method further wherein the temporary protective sleeve (sleeve 80, Fig. 8; and base member 21, Fig. 2) is a section of a buffer of the optical fiber that has been stripped from the optical fiber (section of material that is removable from optical fiber, see Paragraphs 0076-0077, 0055-0057, 0059, 0080, 0036, 0064; e.g. see tube 8 and/or hose 2, Fig. 1). However, Bierbaum et al. does not explicitly disclose wherein the temporary protective sleeve has a color that is different than a color of the buffer of the optical fiber.
Leeflang et al. teaches a method including a medical device for a therapeutic or surgical procedure (Abstract) wherein different tubular sections of the medical device are different colors, in order to facilitate identification of the different/distinct sections (Paragraph 0010, 0011, 0101, 0151). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to configure the temporary protective sleeve to have a color that is different than a color of the buffer of the optical fiber, in the method disclosed by Bierbaum et al., in order to facilitate identification of the different/distinct sections, as taught by Leeflang et al., since such a modification would have involved a mere change in the form of a component. A change in form is generally recognized as being within the level of ordinary skill in the art. In re Dailey, 149 USPQ 47 (CCPA 1976).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAMELA M BAYS whose telephone number is (571)270-7852. The examiner can normally be reached 9:00am - 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer McDonald can be reached at 571-270-3061. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAMELA M. BAYS/Primary Examiner, Art Unit 3796