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 .
Response to Arguments
This case is no longer assigned to Examiner Davis and has been inherited by Examiner Melendez.
Applicant's arguments filed 11/10/25 have been fully considered but they are not persuasive to the extent that they apply to current rejection. Applicant argues piezoelectric and echogenic are not synonymous, but the examiner notes that Massengale teaches that the echogenic property is brought about by the use of piezoelectric transducers and therefore they are reasonably considered piezoelectric bands [0077]. Applicant argues Massengale does not teach placement of the echogenic bands in the sidewall but Massengale notes use of an echogenic coating on the sidewall [0018-0020]. Applicant argues that melting in place (ie embedding) the bands of Melsheimer would also no disclose the wall formed of the band, but the instant invention only discloses 2 methods of incorporating the echogenic bands into the sidewall coating or embedding [0060-0063]. Hence, the embedded bands of Melsheimer would disclose a smooth/continuous sidewall partially formed of the bands at least to the same extent as that of applicant. Applicant argues that Packard does not teach echogenic effects, but as Massengale and Melsheimer already noted piezoelectric materials, and Packard utilizes piezoelectric and pyroelectric materials as art recognized equivalents in catheter applications. One of ordinary skill in the art would have a reasonable expectation of success utilizing pyroelectric materials as these materials were already known for use within catheters and used with piezoelectric materials.
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.
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 15, 29-32 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. The examiner is unable to locate within the specification a disclosure describing the “graphene bands contact at least a portion of the form a smooth and continuous inner surface of the catheter.” In fact, the specification appears to emphasize their lack of smoothness [0017].
Claims 15, 29-32 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.
The term “smooth” in claims 15 and 29, are a relative term which renders the claim indefinite. The term “smooth” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Specification does not provide any guidance as to how one of ordinary skill in the art would determine what degree of smoothness would meet the claim.
Dependent claims inherit the indefiniteness of their parent.
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 14-21, 29-32 are rejected under 35 U.S.C. 103 as being unpatentable over Massengale et al (2012/0095404 A1: figures 4-20 and paragraphs 12, 16-20, 30, 57, 59, 60, 67, 68, 70, 71, 73, 75-77, 79, 81, 82 and 84) taken together with Melsheimer et al (2012/0265055 A1: figures 1-6 and paragraphs 40 and 41), Packard (US 3294988) and Ong et al (“Engineered Piezoelectricity in Graphene” from ACS Nano of 2012).
Massengale et al teach a method of making an echogenic catheter for controlled delivery of a fluid across an anatomical region, the method comprising: providing a tubular catheter (102) that is coaxially around a conductive needle [Abstract, Fig 4, 0012-0015] and securing an echogenic catheter tip (108) to the tubular catheter by either adhesive bonding, force fit or other mechanical means, paragraph 71. The reference also teaches inserting an echogenic plug (150) into the elongated tubular member (102) of the catheter as illustrated in figure 13A and detailed in paragraph 73. Wireless echogenic bands (182) in paragraph 76 and a pair of echogenic metal bands (250 and 252) are provided in the tip of the catheter, see paragraph 79. The catheter is rendered echogenic by the insertion of an echogenic internal component that includes an energy source and a piezoelectric transducer that converts the energy into acoustic waves ie a stimulator assembly capable of activating the bands, see paragraphs 20 and 84. The echogenic bands may also be integral with a sidewall that extends from a proximal end to a distal end with the bands (250, 252) positioned circumferentially around the lumen [Fig 4, 19, 0079]. Massengale explicitly states “bands may include grooves, indentations, cross-hatching or the like to enhance visualization by sonic imaging techniques” [0079] and notes that the echogenic portions may be coatings/bands applied to the interior of the side wall and therefore would contact the surface of the inner sidewall [0018-0020].
Massengale et al discloses all claimed features securing the echogenic insert to the elongate tube of the catheter body with the exception of embedding the component into the side wall or heating the sidewall until a portion of the distal end melts over the piezoelectric component.
Melsheimer et al discloses a method of making an echogenic catheter comprising placing tubular bands (20A, 20B) into the tubular member (12) of the catheter and melting the tubular member to lock the bands in place. This step of assembly reads on embedding the insert in the tubular member and heating the tubular member to melt the tubular to cure over the insert.
It would have been obvious at the time of the effective filing date of the application to one of ordinary skill in the art to modify the process of Massengale et al by melting the tubular member of the catheter to embed the insert within the wall of the tubular member as disclosed by Melsheimer et al for the purpose of attaching the echogenic insert to the catheter body. One of ordinary skill in the art would expect melting to lock the insert in place to work at least as well as the adhesive bonding or force fitting of the Massengale et al reference.
As the embedding within the side wall taught by the combination of Massengal and Melsheimer would place the bands internally to the side wall, the thickness of the sidewall would necessarily be increased by the thickness of the bands, hence the shielded area (which would just be the area where the bands are embedded) would have a greater wall thickness than the other portions of the catheter. Furthermore, the instant invention only discloses 2 methods of incorporating the echogenic bands into the sidewall coating or embedding [0060-0063]. Hence, the embedded bands of Melsheimer would disclose a smooth/continuous sidewall partially formed of the bands at least to the same extent as that of applicant.
As the Massengale explicitly states “bands may include grooves, indentations, cross-hatching or the like to enhance visualization by sonic imaging techniques” [0079]. When the bands are embedded within the sidewall as suggested by Melsheimer the discontinuities on the band would be sealed by being embedded in the melted material.
Massengale does not explicitly state the piezoelectric bands are heat activated.
Packard teaches transducers wherein pyroelectric (aka heat activated)/piezoelectric materials are used in the end of a catheter in order to measure biophysical temperatures and pressures [col 1 line 9-16, col 1 line 30-70]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have altered the invention of Massengale and included a pyroelectric/piezoelectric material, as suggested by Packard, in order to measure biophysical temperatures and such material had demonstrated success for use in catheters to relay internal information about the body.
Massengale et al disclose all claimed features except for the use of graphene as the piezoelectric material.
Ong et al disclose manipulating graphene by doping such that the material has piezoelectric properties, page 1388, first column. The material is stated to have utility in high frequency acoustics.
It would have been obvious at the time of the effective filing date of the application to one of ordinary skill in the art to modify the process of Massengale et al by using a graphene material to form the inserts as Ong et al disclose that doped graphene has suitable piezoelectric properties. One of ordinary skill in the art would expect a band of graphene to function at least as well as the materials disclosed by Massengale et al.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARMAND MELENDEZ whose telephone number is (571)270-0342. The examiner can normally be reached 9 AM- 6 PM Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at 571-272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ARMAND MELENDEZ/ Primary Examiner, Art Unit 1759