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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/8/2026 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites “tubular member … having a length … wherein the optical fiber has a pressure equalization channel defined therein that extends the length of the tubular member”. The examiner notes that the broadest reasonable interpretation of a length of a tubular member includes both the entire length of the tubular member and a partial length of the tubular member. However, the original disclosure does not disclose a pressure equalization channel that extends the entire length of the tubular member. Therefore, the original disclosure does not support that the inventors possessed the full scope of the invention.
Claims 2-12 depend on claim 1 and are rejected for inheriting the same problem.
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 1-3, 8, 12, 14, 19 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent 4,787,396 issued to Pidorenko (“Pidorenko”).
As for claim 1, Pidorenko discloses a pressure sensing guidewire, comprising:
a tubular member (53) having a lumen formed therein (see Fig. 2) and having a length (the broadest reasonable interpretation of “a length” includes a partial length of 53; in this case the length is the length of 53 along 44);
an optical fiber (20, 44) disposed within the lumen, the optical fiber having a distal end region (left end in Fig. 2);
a pressure sensor (22, 24 and space between 22, 24) disposed at the distal end region of the optical fiber (see Fig. 2), the pressure sensor including a sensor cavity (space between 22, 24) and a deflectable membrane (24) disposed across the sensor cavity;
wherein the optical fiber (20, 44) has a pressure equalization channel (52) defined therein (see Fig. 2) that extends the length (i.e. of 44) of the tubular member; and
wherein the pressure equalization channel (52) is in fluid communication with the sensor cavity (see Fig. 2).
As for claim 2, Pidorenko discloses that the pressure sensor includes a sensor head (42) coupled to the optical fiber (20, 44).
As for claim 3, Pidorenko discloses that the pressure equalization channel (52) extends through the sensor head (see Fig. 2).
As for claim 8, Pidorenko discloses that the pressure sensor (22, 24 and space between 22, 24) is defined in the distal end region (left end in Fig. 2) of the optical fiber (see Fig. 2).
As for claim 12, Pidorenko discloses that the optical fiber (20, 44) has a longitudinal axis (54 in Fig. 3) and wherein the pressure equalization channel (52) is radially offset from the longitudinal axis (see Fig. 3).
As for claim 14, Pidorenko discloses a pressure sensing medical device, comprising:
a tubular member (53) having a proximal region (portion of 53 at the middle portion of 44 in Fig. 2), a proximal end (portion of 53 at the right end of 44 and extending further to the right) and a housing region (left end of 53);
an optical fiber (20, 44) extending at least partially through the tubular member (see Fig. 2), the optical fiber having a distal end region (left end in Fig. 2);
a pressure sensor (22, 24 and space between 22 and 24) disposed at the distal end region of the optical fiber and within the housing region (see Fig. 2);
wherein the pressure sensor includes a cavity (space between 22 and 24) and a deflectable membrane (24) extending across the cavity; and
a pressure equalization channel (52) defined in the optical fiber (20, 44) and in fluid communication with the deflectable membrane (see Fig. 2), the pressure equalization channel (52) extending within the optical fiber (i.e. within 44) to a position (at the right end of 44) adjacent to the proximal end of the tubular member.
As for claim 19, Pidorenko discloses a pressure sensing guidewire, comprising:
an elongate shaft (53) having a proximal end (portion of 53 at the right end of 44 and extending further to the right);
an optical fiber (20, 44) disposed within the elongate shaft (see Fig. 2), the optical fiber having a distal end region (left end in Fig. 2) and a proximal end region (right end of 44) adjacent to the proximal end of the elongate shaft;
a pressure equalization channel (52) defined in the optical fiber (see Fig. 2), the pressure equalization channel (52) extending within the optical fiber (i.e. within 44) from the distal end region (left end of 44) of the optical fiber to the proximal end region (right end of 44) of the optical fiber; and
a pressure sensor (22, 24 and space between 22 and 24) disposed at the distal end region of the optical fiber (see Fig. 2), the pressure sensor being in fluid communication with the pressure equalization channel (see Fig. 2).
As for claim 20, Pidorenko discloses that the pressure sensor (22, 24 and space between 22 and 24) includes a cavity (space between 22 and 24) and wherein the pressure equalization channel is in fluid communication with the cavity (see Fig. 2).
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.
Claims 4-7, 9-11, 13 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 4,787,396 issued to Pidorenko (“Pidorenko”) in view of U.S. Patent Application Publication 2012/0210797 by Yu et al. (“Yu”).
As for claim 4, Pidorenko discloses the pressure sensing guidewire of claim 1 (see the rejection of claim 1 above).
Pidorenko does not disclose that the deflectable membrane includes a polymer.
However, Yu discloses a deflectable membrane that includes a polymer and a metal (paragraph [0023]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the deflectable membrane of Pidorenko to include a polymer and a metal as disclosed by Yu in order to enhance mechanical stability, provide biological compatibility and to fine tune the sensitivity of the sensing head and to increase reflectivity (Yu: paragraph [0023]).
As for claim 5, Pidorenko as modified by Yu discloses that the deflectable membrane includes a first coating layer and a second coating layer (Yu: paragraph [0023]).
As for claim 6, Pidorenko as modified by Yu discloses that the first coating layer, the second coating layer (Yu: paragraph [0023]), or both include a metal.
As for claim 7, Pidorenko as modified by Yu discloses that the first coating layer (Yu: paragraph [0023]), the second coating layer, or both include a polymer.
As for claim 9, Pidorenko discloses the pressure sensing guidewire of claim 8 (see the rejection of claim 8 above).
Pidorenko does not disclose that the deflectable membrane includes a first coating layer and a second coating layer.
However, Yu discloses a deflectable membrane that includes a first coating layer and a second coating layer (paragraph [0023]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the deflectable membrane of Pidorenko to include a first coating layer and a second coating layer as disclosed by Yu in order to enhance mechanical stability, provide biological compatibility and to fine tune the sensitivity of the sensing head and to increase reflectivity (Yu: paragraph [0023]).
As for claim 10, Pidorenko as modified by Yu discloses that the first coating layer, the second coating layer (Yu: paragraph [0023]), or both include a metal.
As for claim 11, Pidorenko as modified by Yu discloses that the first coating layer (Yu: paragraph [0023]), the second coating layer, or both include a polymer.
As for claim 13, Pidorenko discloses the pressure sensing guidewire of claim 1 (see the rejection of claim 1 above).
Pidorenko does not disclose that the deflectable membrane is encased in a fluid-impermeable coating.
However, Yu discloses a deflectable membrane (60) that is encased in a fluid-impermeable coating (58, 80).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the deflectable membrane of Pidorenko by encasing it disclosed by Yu in order to enhance mechanical stability, provide biological compatibility and to fine tune the sensitivity of the sensing head and to increase reflectivity (Yu: paragraph [0023]).
As for claim 16, Pidorenko discloses the pressure sensing guidewire of claim 14 (see the rejection of claim 14 above).
Pidorenko does not disclose that the deflectable membrane includes a first coating disposed along a first side of the deflectable membrane, a second coating disposed along a second side of the deflectable membrane, or both.
However, Yu discloses a deflectable membrane that includes a first coating disposed along a first side of the deflectable membrane (paragraph [0023]), a second coating disposed along a second side of the deflectable membrane, or both.
It would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to modify the deflectable membrane of Pidorenko to include a first coating layer as disclosed by Yu in order to enhance mechanical stability, provide biological compatibility and to fine tune the sensitivity of the sensing head and to increase reflectivity (Yu: paragraph [0023]).
As for claim 17, Pidorenko as modified by Yu discloses that the first coating includes a metal (Yu: paragraph [0023]).
As for claim 18, Pidorenko as modified by Yu discloses that the first coating includes a fluid-impermeable material (Yu: paragraph [0023]).
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent 4,787,396 issued to Pidorenko (“Pidorenko”) in view of U.S. Patent 4,210,029 issued to Porter (“Porter”).
As for claim 15, Pidorenko discloses the pressure sensing guidewire of claim 14 (see the rejection of claim 14 above).
Pidorenko does not disclose that the proximal region of the tubular member has a first inner diameter, wherein the housing region of the tubular member has a second inner diameter, and wherein the first inner diameter is different from the second inner diameter.
However, Porter discloses a tubular member (312) that has a proximal region (right side of 312 in Fig. 2) with a first inner diameter, wherein a housing region (middle portion of 312 in Fig. 2) of the tubular member (312) has a second inner diameter, and wherein the first inner diameter is different from the second inner diameter (see Fig. 2).
Because Pidorenko and Porter both disclose tubular members that house an optical fiber, it would have been obvious for one having ordinary skill in the art before the effective filing date of the present application to substitute the tubular member of Porter for the tubular member of Pidorenko to achieve the predictable result of providing a housing for an optical fiber.
Response to Arguments
Applicant's arguments filed 5/8/2026 have been fully considered but they are not persuasive.
On page 1 of the Remarks, Applicant argues that Pidorenko does not disclose a length. The examiner respectfully disagrees. Pidorenko discloses that the tubular member has at least a partial length and a passageway that extends for that partial length as explained in the rejection of claim 1 above.
On pages 1-2 of the Remarks, Applicant argues that Pidorenko does not disclose a channel adjacent to a proximal end region of a tubular member. The examiner respectfully disagrees. Pidorenko discloses a channel adjacent to a proximal end region of a tubular member as explained in the rejections of claims 14 and 19 above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN N OLAMIT whose telephone number is (571)270-1969. The examiner can normally be reached M-F, 8 am - 5 pm (Pacific).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Stephen Meier can be reached at (571) 272-2149. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JUSTIN N OLAMIT/Primary Examiner, Art Unit 2853
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