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 2 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.
Claim 2 recites the limitation "the steering member" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 2 recites the limitation "the estimated position" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
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.
Claims 1, 2, 4-8 and 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stigall et al. (US 20160051323 A1) in view of Ryan et al. (US 20100286531 A1).
Regarding claim 1, Stigall discloses (fig. 1-2, 23-25, and 27) a method comprising:
advancing a medical device 101 through a vessel (see [0127]), wherein the medical device includes a sensing assembly 175 (see [0049]-[0050]); and
sensing tissue properties (different tissue structures) adjacent to the sensing assembly within the vessel (see [0050]).
Stigall is silent regarding the tissue properties include different types of collagen.
However Ryan, in the same filed of endeavor, teaches a sensing assembly (see [0161]), sensing tissue properties adjacent to the sensing assembly within the vessel (see [0161]), wherein the tissue properties include different types of collagen (see [0161], collagen broadly is sensed which can include multiple types of collagen).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Stigall to include collagen as one of the tissue properties sensed as taught by Ryan, for the purpose of measuring different pathiophysiological properties of the tissue (see Ryan [0161]).
Regarding claim 2, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Stigall further discloses (fig. 1-2, 23-25, and 27) steering the medical device with the steering member based on the estimated position (see [0121]).
Regarding claim 4, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Stigall further discloses (fig. 1-2, 23-25, and 27) the sensing assembly 175 includes an ultrasound transducer (see [0048]-[0049]).
Regarding claim 5, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 4. Stigall further discloses (fig. 1-2, 23-25, and 27) emitting ultrasonic energy with the ultrasound transducer to sense the tissue properties (see [0050]).
Regarding claim 6, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Stigall further discloses (fig. 1-2, 23-25, and 27) the sensing assembly includes an optical fiber (see [0049]).
Regarding claim 7, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 6. Stigall further discloses (fig. 1-2, 23-25, and 27) emitting light with the optical fiber to sense the tissue properties (see [0049], “optical coherence tomography” involves emitting light while sensing).
Regarding claim 8, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Stigall is silent regarding sensing the tissue properties with fluorescence spectroscopy.
However Ryan further teaches sensing the tissue properties with fluorescence spectroscopy (see [0019]).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Stigall to include fluorescence spectroscopy foe sensing the tissue properties as taught by Ryan, for the purpose of being able to provide pathophysiologic or morphologic features diagnosis of a plaque during a procedure without any significant additional cost, risk, or work for the physician (see Ryan [0019]).
Regarding claim 11, Stigall discloses (fig. 1-2, 23-25, and 27) a medical device comprising:
a catheter 103 configured to be advanced within a vessel (see [0047]); and
a sensing assembly 175 provided with the catheter (see fig. 2 and [0047]),
the sensing assembly configured to sense tissue properties (different tissue properties) adjacent to the sensing assembly within the vessel (see [0050]).
Stigall is silent regarding the tissue properties include different types of collagen.
However Ryan, in the same filed of endeavor, teaches a sensing assembly (see [0161]), sensing tissue properties adjacent to the sensing assembly within the vessel (see [0161]), wherein the tissue properties include different types of collagen (see [0161], collagen broadly is sensed which can include multiple types of collagen).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Stigall to include collagen as one of the tissue properties sensed as taught by Ryan, for the purpose of measuring different pathiophysiological properties of the tissue (see Ryan [0161]).
Regarding claim 12, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Stigall further discloses (fig. 1-2, 23-25, and 27) the sensing assembly 175 includes an ultrasound transducer (see [0048]-[0049]).
Regarding claim 13, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Stigall further discloses (fig. 1-2, 23-25, and 27) the sensing assembly 175 includes an optical fiber (see [0049]).
Regarding claim 14, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Stigall further discloses (fig. 1-2, 23-25, and 27) a core 161 disposed within the catheter 103 (see fig. 2).
Regarding claim 15, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 14. Stigall further discloses (fig. 1-2, 23-25, and 27) the core 161 is fixed to the catheter (fixed via handle 121; see fig. 2 and [0047]).
Regarding claim 16, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 14. Stigall further discloses (fig. 1-2, 23-25, and 27) the core 161 is moveable relative to the catheter 103 (see [0047]).
Regarding claim 17, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 16. Stigall further discloses (fig. 1-2, 23-25, and 27) the core 161 is removable from the catheter 103 (the core is moveable relative to the catheter and can be removed is disassembled).
Regarding claim 18, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 14. Stigall further discloses (fig. 1-2, 23-25, and 27) the sensing assembly 175 is coupled to the core 161 (via the handle 121, see fig. 1-2).
Regarding claim 19, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 14. Stigall further discloses (fig. 1-2, 23-25, and 27) the core 161 includes a penetrating tip 169 at a distal end thereof (see fig. 2 and [0047]).
Regarding claim 20, Stigall as modified discloses the claimed invention substantially as claimed, as set forth above for claim 11. Stigall further discloses (fig. 1-2, 23-25, and 27) a steering member configured to steer the catheter within the vessel (“steering wire”, see [0121]; [0127] discloses that “any device shown herein or any device with any combination of features shown herein may be used in the method 2701 for crossing a CTO according to the invention”).
Claims 1, 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Selmon et al. (US 6,010,449) in view of Ryan.
Regarding claim 1, Selmon discloses (fig. 1-3) a method comprising:
advancing a medical device 40 through a vessel (see fig. 1 and col. 8 ln. 66 – col. 9 ln. 20), wherein the medical device includes a sensing assembly 208 (see col. 8 ln. 15-31); and
sensing tissue properties (environment) adjacent to the sensing assembly within the vessel (see col. 8 ln. 32-53).
Selmon is silent regarding the tissue properties include different types of collagen.
However Ryan, in the same filed of endeavor, teaches a sensing assembly (see [0161]), sensing tissue properties adjacent to the sensing assembly within the vessel (see [0161]), wherein the tissue properties include different types of collagen (see [0161], collagen broadly is sensed which can include multiple types of collagen).
Therefore it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify Selmon to include collagen as one of the tissue properties sensed as taught by Ryan, for the purpose of measuring different pathiophysiological properties of the tissue (see Ryan [0161]).
Regarding claim 9, Selmon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Selmon further discloses (fig. 1-3) the medical device includes a catheter 50, and wherein the sensing assembly 208 is moveable relative to the catheter 50 (see col. 8 ln. 15-31).
Regarding claim 10, Selmon as modified discloses the claimed invention substantially as claimed, as set forth above for claim 9. Selmon further discloses (fig. 1-3) the sensing assembly 208 is coupled to a core 200 (see fig. 3 and col. 8 ln. 15-31), wherein the core 200 is moveable within a lumen of the catheter 50 (see col. 8 ln. 15-31).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,408,934 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant claims is claimed in the claims of 12,408,934 as outlined below:
Claims of instant application
Claims of 12,408,934
1
1
2
1
3
1
4
2
5
2
6
3
7
3
8
4
Claims 1-5, 11, 12, 14-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 8-10 of U.S. Patent No. 12,016,579 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the scope of the instant claims is claimed in the claims of 12,016,579 as outlined below:
Claims of instant application
Claims of 12,016,579
1
10
2
10
3
10
4
10
5
10
11
1
12
1
14
1
15
8
16
9
17
9
18
1
19
10
20
2
Allowable Subject Matter
Claim 3 would be allowable if a terminal disclaimer is filed or the claims rewritten to overcome the double patenting rejection(s) and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: the prior art, alone or in combination, fails to teach or render obvious estimating the position of the medical device within the vessel passed on tissue properties where the tissue properties are different types of collagen.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H MENDEZ whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 8 am-4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHERINE H MENDEZ/Primary Examiner, Art Unit 3771
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