Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Information Disclosure Statement
Applicant should note that the large number of references in the attached information disclosure statement have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b).
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
laser transmitting element in independent claim(s) 1, 9 and their dependents; structure found in e.g. instant Fig. 2C;
rotatable optical element in independent claim(s) 1, 9 and their dependents; structure found in e.g. instant Fig. Fig. 2A-2C;
imaging element in independent claim(s) 1, 9 and their dependents; structure found in e.g. instant Fig. 6-7;
pressure-inducing element in dependent claim 11; structure found in e.g. instant Fig. 5B; Fig. 8.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 1, 2, 6-13 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tearney (US 20070282403 A1; 12/6/2007; cited in IDS) in view of Fischer (US 20140017635 A1; 1/16/2014; cited in IDS), and further in view of Kittrell (US 5693043 A; 12/2/1997; cited in IDS).
Regarding claim 1, Tearney teaches a method for treating a disorder associated with a gastro-intestinal tract ([0008]-[0009]; [0065]), the method comprising:
transmitting, using a catheter comprising a laser transmitting element, a focused laser beam in a first direction parallel to a longitudinal axis of the catheter body (Fig. 21-23; [0016]);
impinging the laser beam on a target area in a spiral-like or helical-like pattern ([0018] “helical; claim 9; claim 19; Fig. 29C) by directing the beam in a direction essentially perpendicular to the transmitted beam using a rotatable optical element, concomitantly with moving of the catheter along its longitudinal axis (Fig. 18-20; Fig. 22-23).
Tearney does not teach wherein the focused laser beam has a beam diameter of less than 1 mm at focal length in a range of 2-25 mm. Note that Tearney teaches to "vary the depth of laser damage ... while not significantly altering the transverse extent of injury" ([0110]). However, Fischer teaches in the same field of endeavor (Abstract) teach wherein the focused laser beam has a beam diameter of less than 1 mm ([0018] "may have a diameter of about 0.1 microns to about 50 microns"; [0050]) at focal length in a range of 2-25 mm at focal length in a range of 2-25 mm ([0019]). Thus it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the teaching of Tearney to include this feature as taught by Fischer because this is a suitable dimension for laser treatment ([0016]; [0018]). It has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.
The combination of Tearney and Fischer does not teach imaging, using an imaging element, at least a portion of laser radiation back-reflected from the target area. Note that Tearney teaches imaging (Fig. 23) but not at least a portion of laser radiation back-reflected from the target area. However, Kittrell teaches in the same field of endeavor (Abstract) imaging, using an imaging element, at least a portion of laser radiation back-reflected from the target area (Fig. 21-23; Fig. 24, 64; Fig. 27). Thus it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the teaching of Tearney and Fischer to include this feature as taught by Kittrell because this enables diagnosis of the tissue (Fig. 24; Col. 18 lines 20-30; Col. 19 lines 27-35; Col. 19 lines 50-55).
Claim 9 is rejected under substantially the same basis as claim 1 above.
Regarding claim 2, in the combination of Tearney, Fischer, and Kittrell, Tearney teaches wherein said laser radiation is configured to heat the area to a temperature above 45° C ([0059] "temperatures in excess of 60-70° C"; [0063] "laser heating...beginning as low as 45° C").
Claim 10 is rejected under substantially the same basis as claim 2 above.
Regarding claim 6, the combination of Tearney, Fischer, and Kittrell teaches wherein the laser beam has a wavelength of 808 nm, 980 nm, or 1500 nm (Tearney [0112] "1340 nm-1570 nm"; Fischer [0051]; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.).
Claim 12 is rejected under substantially the same basis as claim 6 above.
Regarding claim 7, the combination of Tearney, Fischer, and Kittrell teaches wherein the laser beam transmitted by the laser transmitting element has a beam diameter in a range of 1-20 mm (Tearney Fig. 27; [0093]; [0129]; Fischer [0025]; In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); MPEP 2144.05.).
Claim 13 is rejected under substantially the same basis as claim 7 above.
Regarding claim 8, in the combination of Tearney, Fischer, and Kittrell, Tearney teaches wherein the impingement of the laser beam on the target area heats the area to a temperature above 45° C ([0059] "temperatures in excess of 60-70° C"; [0063] "laser heating...beginning as low as 45° C").
Regarding claim 11, in the combination of Tearney, Fischer, and Kittrell, Tearney teaches at least one pressure-inducing element coupled with the catheter body (Fig. 23, balloon).
Claim(s) 3-5 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Tearney, Fischer, and Kittrell as applied to claim(s) 1 above, and further in view of Lane (US 20140074077 A1; 3/13/2014; cited in IDS).
Regarding claim 3, the combination of Tearney, Fischer, and Kittrell does not teach wherein the disorder is obesity. However, Lane teaches in the same field of endeavor (Fig. 5D; [0002]) wherein the disorder is obesity ([0002]; [0052]). Thus it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the teaching of Tearney, Fischer, and Kittrell to include this feature as taught by Lane because this enables laser treatment for overweight or obese individuals ([0002]; [0007]; [0052]).
Regarding claim 4, the combination of Tearney, Fischer, and Kittrell does not teach wherein the target area is a duodenal wall. However, Lane teaches in the same field of endeavor (Fig. 5D; [0002]) wherein the target area is a duodenal wall ([0024]; [0055]; [0064]; [0066]). Thus it would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the teaching of Tearney, Fischer, and Kittrell to include this feature as taught by Lane because this enables laser treatment for overweight or obese individuals ([0002]; [0007]; [0052]).
Regarding claim 5, the combination of Tearney, Fischer, Kittrell, and Lane teaches further comprising exerting pressure on at least part of the duodenal wall so as to obtain a fixed diameter thereof (Tearney Fig. 23, balloon; Lane Fig. 2, 28; Fig. 5B, 28, 28'; [0008] "tissue expander"; [0068]; [0055]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan T Kuo whose telephone number is (408)918-7534. The examiner can normally be reached M-F 10 a.m. - 6 p.m. PT.
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/JONATHAN T KUO/Primary Examiner, Art Unit 3792
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