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
Regarding the previous 112a written description and 112b indefiniteness rejections, applicant’s amendments have overcome these rejections and they are hereby withdrawn. However, applicant’s amendments have created new issues; see below.
Regarding the 102 rejection to Miyagawa, applicant’s amendments and related arguments have been fully considered, but are not persuasive. Specifically, applicant argues “Miyagawa does not expressly or inherently teach a manifold body including a manifold proximal end that is secured to, much less fixedly secured to, the guide distal end of the energy guide”, but provides no specifics, details or evidence to support this general allegation/opinion.
First and foremost, the BRI of “fixedly secured” needs to be established, as the examiner believes that applicant is taking an improperly narrow interpretation of what is meant by “fixedly attached”, specifically it seems as if applicant’s position is that “fixedly secured” somehow means that the two elements are permanently or always attached, e.g. bonded. The examiner disagrees. While the specification supports the interpretation that “bonding” (e.g. see page 38 of applicant’s specification) it is a single example of a fixed attachment, and it’s clear that a fixed attachment is much broader than just bonding. Furthermore, it is emphasized that applicant elected the manifold body embodiment shown in Figs. 2-3, which provides no details or explanation related to this embodiment of the manifold body being “fixedly” secured or bonded to the optical fiber. In fact, the specification makes it clear that “as illustrated in Figure 2, the energy guide 222A can be located at or near a manifold proximal end 260P of the manifold body 260, i.e. with the guide distal end 222D of the energy guide 222A inserted into the manifold proximal end 260P of the elongated manifold body 260”. Therefore, in the same way that Miyagawa discloses that the optical fiber is inserted into the manifold body, but then once inserted these two elements move, i.e. rotate and slide, integrally together (Par 0139) seems to meet the BRI of fixedly secured, as this is seemingly the same attachment disclosed by applicant for the elected embodiment. The examiner interprets this connection taught by Miyagawa in Par 0139 as a friction or interference fit, which is interpreted as a form of “fixed” attachment, as once the elements are together they move integrally together as one element. Similarly, the previously cited disclosure of the outer diameter of the light guide being the same as the inner diameter of the manifold body (light guide tube 134) is interpreted as an interference or friction fit, which reads on the BRI of “fixedly secured”. As an analogy to clarify/elaborate the examiner’s position, a silicone protective tip/cover that slides over a straw tip is considered fixedly secured once in place, as moving the straw causes the cover/tip to move together with the straw as one integral entity. It’s clear that applicant is trying to distinguish between something that is “secured” versus something that is “fixedly secured”, but seemingly this a relative term or term of degree, and the specification provides no clarification/details as to what the exact distinction is between something that is just secured versus something that is fixedly secured. If it’s applicant’s intention to require “bonding”, the examiner takes the position that 1. Fixedly secured is broader than bonding and 2. The elected embodiment seemingly does not support such bonding; see new 112a written description and 112b indefiniteness rejections below.
Therefore, as discussed above, the examiner contends that what is taught by Miyagawa in Pars 0137-139, specifically that once inserted the optical fiber (129) and manifold body (light guide tube 134) move integrally together as one entity, as well as the inner/outer diameters being the same, reads on “fixedly secured”. Applicant’s arguments fail to point out or apprise the examiner of any supposed errors in this interpretation, therefore it is being maintained. Specifically, the examiner is substantially maintaining the previous 102 with updated claim mapping to address the amendments.
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 1-20 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] The limitation “fixedly secured” fails the written description requirement, as it appears that applicant is claiming a genus while the specification only supports a species of bonding. Stated differently, “fixedly secured” encompasses numerous types of attachments, e.g. friction fit, Velcro, fasteners, etc., but only discloses bonding, which does not satisfy a “representative number of species” requirement as detailed in MPEP 2163. It is emphasized that the word “fixedly” appears nowhere in applicant’s disclosure. Specifically MPEP 2163.03 states that a “claim may lack written description support when… a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated.
Furthermore, it is emphasized that the elected embodiment does not encompass bonding. Therefore, if applicant wanted to clarify/amend the claims to require the disclosed bonding (which would solve the 112a written description issue), this would seemingly be a non-compliant amendment, as it does not read on the elected embodiment.
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.
Claims 1-20 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.
[Claim 1] The limitation “fixedly secured” is indefinite, as it is a relative term. The term “fixedly” 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. Specifically, there appears to be a distinction (at least to applicant) between something that is just “secured” versus something that is “fixedly secured”, however it is unclear what this degree of securement entails. It is noted that the word “fixed” or “fixedly” is never mentioned in applicant’s specification. While the specification discloses “bonding” as an example of two elements being “secured”, but seemingly this is a single example and not a definition, making it clear that other types of attachment are included. Furthermore, the elected embodiment of Figs. 2-3 make no mention of bonding or other types of secured attachment. It’s unclear if “fixedly secured” requires permanent attachment, i.e. two elements that are always attached, or if it encompasses a removable attachment, e.g. friction fit. Additionally, the lack of details or discussion in the specification, as pointed out above in relation to the written description rejection, fails to provide any guidance on what “fixedly secured” encompasses and how it differs from just “secured”. For examination purposes, the examiner takes the position that as long as the attached elements move together, i.e. integrally as one, then this reads on “fixedly secured”.
[Claims 2, 3, 11 and 12] The limitation “the first manifold aperture” is indefinite as it lacks proper antecedent basis. The independent claims (1 and 10) provide antecedent basis for “a manifold aperture”, but it’s not clear if this manifold aperture is the same as the “first manifold aperture”. For examination purposes, the examiner interprets “the first manifold aperture” to be the same as the previously recited “a manifold aperture”. If applicant agrees with this interpretation, the claims should be amended to make this clear.
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.
Claims 1, 4-10, 13-16, 18 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO 2015/056662 to Miyagawa*
*It is noted that while the WIPO is being used for the actual rejection, the application US 2020/0289202 is being used for translation/citations purposes in the explanation of the rejection, below.
[Claims 1 and 10] A catheter system (ablation system 110 in Figs. 6-8) for treating a vascular lesion within or adjacent to a blood vessel (intended use in preamble; see MPEP 2111.02. See also artery 40, Fig. 8) within a body of a patient, the catheter system being configured to use a catheter fluid (balloon fluid; at least Abstract), the catheter system comprising:
an energy source (laser light generating unit 112, Fig. 6) that is configured to generate energy, the energy source including one of a light source and an electrical source;
a catheter shaft (shaft 122, Figs. 6-8);
a balloon (balloon 121, Figs. 6-8) that is coupled to the catheter 32shaft, the balloon including a balloon wall that defines a balloon interior (best seen in Figs. 7-8), the balloon being selectively inflatable with the catheter fluid so that the balloon expands to an inflated state (At least Pars 0011-12), the balloon wall being configured to be positionable adjacent to the vascular lesion (see Fig. 8 which shows the balloon wall being positioned adjacent to a renal artery 40. Whether or not a vascular lesion exists at this location of the renal artery does not impart patentability to the claims; see MPEP 2115 and 2114);
an energy guide (optical fiber 129, Figs. 6-8) including a guide distal end (distal end surface 132 in Fig. 7) that is configured to be selectively positioned near the vascular lesion (see arrows 152 and 153 in Fig. 8; Pars 0095-96 and 0151 which shows/discusses the ability of the fiber to slide and rotate, i.e. be positionable wherever desired), the energy guide being configured to receive energy from the energy source so that a plasma bubble is generated within the catheter fluid in the balloon interior (intended effect; the optical fiber is structurally capable of providing this effect depending on the type of fluid and laser parameters chosen. Specifically, the optical fiber disclosed by Miyagawa is the same exact structure/optical fiber disclosed by applicant that provides this function, therefore the optical fiber taught by Miyagawa has all the necessary structure to be inherently capable of providing this effect; MPEP 2114); and
an energy manifold (light guide tube 134, Figs. 7-8) including (i) a manifold body that defines a body chamber (“tubular body” Par 0136 and “internal space of light guide tube 134” Par 0138; Fig. 7. Furthermore, tube 134 inherently defines a body chamber, per the definition of a tube; see Figs. 7-8.), the manifold body being spaced apart from the balloon and the catheter shaft (tube 134 are shown inside, i.e. spaced apart from/not-touching the catheter shaft wall 122 and balloon wall 121; see Figs.7-8. This is the same configuration as disclosed by applicant; see Fig. 2 of applicant’s specification), the manifold body including a manifold proximal end that is fixedly secured to the guide distal end of the energy guide (as seen in the zoomed-in view of Fig. 7, the proximal end of 134 is secured to fiber 129, as they are in direct contact with each other. Furthermore, Par 0137 states “the inner diameter of the internal space of the light guide tube 134 is equal to the outer diameter of the optical fiber 129” which is interpreted as a friction/interference fit, i.e. fixedly secured. Additionally, Par 0139 makes it clear that once inserted the fiber 129 and manifold body 134 move integrally together; see 112b indefiniteness rejection for more details. This appears to be the exact same attachment as disclosed by applicant in relation to the elected embodiment of the manifold body shown in Figs. 2-3), the body chamber being configured to retain at least some of the catheter fluid (the tubular body of 134 is clearly in fluid communication with the balloon cavity 121 and openings 130 and 131; Pars 0130 and 0134), and (ii) at least one manifold aperture (opening 135) that extends through the manifold body, the energy manifold being configured to direct energy from the plasma bubble out of the body chamber through the at least one manifold aperture toward the balloon wall (the energy manifold, i.e. light guide tube 134 and opening 135, disclosed by Miyagawa is the same exact structure disclosed by applicant that provides this function, therefore the energy manifold taught by Miyagawa has all the necessary structure to be inherently capable of providing this effect; MPEP 2114. See laser light 42 and reflector 133 which directs light out of the manifold aperture 135 into the balloon; at least Pars 0138 and 0153).
[Claims 4, 5, 13 and 14] Miyagawa discloses an optical fiber (129) as the energy guide that guides the light from the source to the balloon interior (Figs. 6-8; at least Pars 0137. See laser light 42). The examiner contends that any/all optical fibers are inherently capable of guiding laser light having the necessary parameters to provide the claimed effect of “to generate one or more pressure waves within the catheter fluid, the one or more pressure waves imparting a force upon the vascular lesion”. The effect the laser energy has in the fluid is an intended effect; it is emphasized that applicant has not recited a laser source with specific laser parameters or a specific type of fluid, which all effect whether or not a pressure wave is created. See MPEP 2114.
[Claims 6, 8, 15 and 18] Miyagawa discloses wherein the manifold body is substantially cylindrical tube-shaped and defines a substantially cylindrical-shaped body chamber (134 light guide tube with tubular body; Par 0136; Fig. 7. A tube, by definition, meets the claimed shaped) with the proximal end of the manifold body encircles the guide distal end (Everything to the left of opening 135 can be considered the proximal end of the manifold body, therefor as seen in Fig. 7 the proximal end of manifold body 134 encircles the guide distal end 132. Furthermore, Par 0137 discloses “the optical fiber 129 is inserted into and passed through the inside of the light guide tube 134 from the hub 123 to be extended to the opening 135” which makes it clear that the distal end of the optical fiber is capable of being positioned/located at any portion of manifold body, including the proximal end).
[Claims 7 and 16] Miyagawa discloses a guide distal (132; Fig. 7) that is flat (“A distal end surface 132 of the optical fiber 129 is orthogonal to the axis line” Par 0137). The reference is silent to “cleaved”, but this is considered a product by process. MPEP 2113 states “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” The examiner contends the flat distal end of Miyagawa is the exact same structure as applicant’s flat guide distal end (322D, Fig. 3 of applicant’s specification). The examiner takes the position that the manufacturing process of “cleaving” provides no additional or different structural characteristics to the optical fiber; however, if applicant disagrees; see alternative 103 below.
[Claims 9 and 19] As shown in Fig. 7, the distal end of the manifold body (133, i.e. left-most portion of 134) is sealed and planar (in the same manner that applicant’s distal end of manifold body 260D/360D is sealed and planar).
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 2, 3, 7, 11, 12, 16 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Miyagawa.
[Claims 2, 3, 11 and 12] Miyagawa is discussed above, but only teaches a single aperture in the manifold body and therefore fails to teach a plurality of apertures in a radial pattern along the length of the manifold body. The examiner contends that this is merely a duplication of parts (to include multiple apertures) and engineering/design choice (to position them in any desired location/pattern); MPEP 2144.04. Therefore, it would have been obvious to one of ordinary skill in the art to modify the manifold taught by Miyagawa to include multiple apertures in any desired position/pattern, as this is merely routine design/engineering choice and applicant has no criticality to the number of apertures or their specific positions/pattern.
[Claims 7 and 16] Regarding the product-by-process limitation of “cleaved”, MPEP 2113 states "the lack of physical description in a product-by-process claim makes determination of the patentability of the claim more difficult, since in spite of the fact that the claim may recite only process limitations, it is the patentability of the product claimed and not of the recited process steps which must be established. We are therefore of the opinion that when the prior art discloses a product which reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim, a rejection based alternatively on either section 102 or section 103 of the statute is eminently fair and acceptable. As a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith." Therefore, it would have been obvious to try/choose any known manufacturing process that achieves a flat distal-end of an optical fiber, including cleaving, as is known in the art.
[Claim 20] This independent claim recites the exact same subject matter as claims 1, 2, 5 and 7-9 (combined); see explanation/details above, for each of these respective claims.
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 Lynsey C Eiseman whose telephone number is (571)270-7035. The examiner can normally be reached Monday-Thursday and alternating Fridays 7 to 4 EST.
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, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LYNSEY C Eiseman/Primary Examiner, Art Unit 3796