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 .
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 14 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 14, the claim recites “a pattern analogous to the lines seen on a pumpkin”, this limitation is unclear. Pumpkins have various shapes and layouts, and it is unclear what limitations are present on the geometry. Furthermore, the perspective is not claimed. Accordingly, the limitation is unclear. The examiner will interpret this as requiring only a generally cylindrical pattern.
Claim Rejections - 35 USC § 102
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) 1-7, 10, 13-17 and 19-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 5,100,429 to Sinofsky et al. (Sinofsky hereinafter).
Regarding claim 1, Sinofsky teaches collagen cross-linking system (col. 8, ln. 6-15) comprising a system for treating a tissue of a patient, the system comprising: a catheter (20) comprising a flexible shaft (20) and a conforming member (50), the flexible shaft having a distal end (left side of Fig. 7), a proximal end (right side of Fig. 7), a shaft body (20) extending between the distal end and the proximal end, the shaft body defining a lumen (ending at 55, see col. 6, ln. 37-40), the conforming member being fixed to the catheter shaft near the distal end, the conforming member comprising a membrane (54) defining a cavity (56) in fluid communication with the lumen (via 55); a fluid source (not shown, but providing the cross-linking material operatively coupled to the proximal end of the catheter, the flexible shaft of the catheter being adapted and configured so that a flow of photosensitizing fluid (collagen-based material, col. 6, ln. 64-66) provided by the fluid source flows through the membrane of the conforming member; and a light source (see col. 6, ln. 54, “laser energy is then supplied”) operatively coupled to the proximal end of the catheter, the catheter being adapted and configured so that photo-activating light generated by the light source passes through the membrane of the conforming member.
Regarding claim 2, Sinofsky teaches that the conforming member (50) is configured to apply forces to the tissue, at least by application of collagens.
Regarding claims 3 and 10, Sinofsky teaches inflation (col. 6, ln. 26-43).
Regarding claim 4, Sinofsky teaches a reservoir of photosensitizing fluid (from which balloon 54 is filled).
Regarding claims 5-6 and 19-20, Sinofsky teaches the use of riboflavin (col. 9, ln. 66-68), which comprises oxygen.
Regarding claims 7 and 17, Sinofsky teaches UV light (col. 9, ln. 66-68).
Regarding claim 9, Sinofsky teaches a method for treating a target tissue comprising positioning a conforming member (50) near the target tissue, the conforming member having a membrane (54), directing a flow of photosensitizing fluid to impinge on the target tissue (col. 6) through the membrane, and irradiating the target tissue with UV light (col. 9, ln. 66-68).
Regarding claim 13, Sinofsky teaches shielding a pattern of the tissue (with the membrane 54, col. 7, ln. 4-25, “spacing between lines”).
Regarding claim 14, viewed end on, and as best understood by the examiner, the unshielded portions are arranged in a circular pattern analogous to a pumpkin shape.
Regarding claim 15, Sinofsky teaches that the lines may be arranged in a criss-cross pattern (Fig. 5, noting that the lines of holes and the spaces between are both arranged in such a pattern).
Regarding claim 16, Sinofsky teaches a circular pattern of photo-activating light.
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) 8, 11-12 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sinofsky.
Regarding claims 8 and 18, Sinofsky teaches the use of UV light, which includes light with a wavelength of 370 nm. The particular wavelength is a known result effective variable for molecular resonance in effects such as the collagen linking of Sinofsky. Accordingly, it would have been obvious to arrive at the claimed wavelength as a matter of routine optimization within the range specified by the prior art.
Regarding claims 11 and 12, Sinofsky teaches expanding by inflation the membrane (54). Those of ordinary skill in the art would appreciate that such expansion will provide at least some compression of the targeted tissue into the surrounding tissue, and that such compression would cause stretching. Accordingly, it would have been obvious to one of ordinary skill in the art to use the apparatus of Sinofsky in treating target tissue of sufficient narrowness that the tissue would be compressed and stretched outward. Additionally, the examiner notes that the embodiment of Fig. 7 expands to fill its surroundings and will function in the same manner with less sensitivity to the size of the target tissue.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILIP E STIMPERT whose telephone number is (571)270-1890. The examiner can normally be reached Monday-Friday, 8a-4p.
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/PHILIP E STIMPERT/Primary Examiner, Art Unit 3783 25 September 2025