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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/28/2025 has been entered.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “engagement feature” in claim 14.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding the engagement feature, the specification at [0055] (citing PGPUB US 20200289085 A1 herein and hereafter) iterates that this is “any number of securing mechanisms or methods as known in the art, such as, but not limited to surface roughening, grooves, threads”. Therefore the examiner will interpret the feature as any securing method or mechanism known in the art.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Allowable Subject Matter
Claims 1-14 remain allowed as previously indicated.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 18-19 are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by US5368037A by Eberle et al. (hereafter Eberle2, newly of record).
Regarding claim 18, Eberle2 teaches: 18. An apparatus comprising: an intravascular ultrasound (IVUS) imaging catheter (see Eberle2’s Abstract) comprising:
a flexible elongate member configured to be inserted into a blood vessel of a patient (see Eberle2’s Col.1 lines 12-42 which describes this or see Fig. 1 which is fully capable of this);
an ultrasound scanner assembly configured to obtain ultrasound imaging data while positioned within the blood vessel, wherein the ultrasound scanner assembly comprises a proximal portion, a distal portion, and a plurality of transducer elements (see Eberle2’s Figs. 1-2 noting at least part 14. Specifically, this is an assembly not a means and therefore it is unclear what if any other component should be included but many other such components exist (e.g. electronics body 12) all of which may or may not be part of the assembly but regardless 14 alone is fully capable of being used to obtain US data. That all structures that have physical dimensions have a proximal and distal end is inherent but see also e.g. Fig. 1 noting the proximal and distal ends of at least part 14) in a rolled configuration (the claims are not directed to a process of manufacture or a product by process claim so this is regarded as being inherent/holding no patentable weight. To compact prosecution from a first perspective the examiner notes that part 14 is round when assembled as per the depiction in Figs. 1-2 which teaches the only structural configuration that the claim language could be regarded as attempting to address. To further compact prosecution from a second perspective the examiner notes that the transducer can be mounted on a flexible backing layer and formed by rolling/wrapping as per col. 7 line 67 to col. 8 line 36 which may become relevant if the applicant later claims a method of forming the transducer assembly by way of rolling the assembly components);
a tip member (see either Eberle2’s Fig. 1 noting the balloon part 1 or Fig. 2 (with Fig. 6 showing a cut away view of this same embodiment) noting nose cone part 25) different from the ultrasound scanner assembly (as best understood this is so broad as to be inherent in the foregoing, e.g. having any component be different or even having a different use would qualify as “different” among much more, for example the US scanner performs US scanning which is “different” than the tip member which cannot do as much or one can see that they are comprised of different components as iterated above etc. For compact prosecution see Eberele2’s col. 2 line 61 to col. 3 line 41 which shows that these components are made into discernable different sections that are bonded together) and comprising, a proximal portion, a distal portion, and an intermediate portion disposed between an directly physically continuous with the proximal portion and distal portion, wherein the proximal portion of the tip member comprises an outer diameter that is increasing along a proximal-to-distal direction, wherein the distal portion of the tip member comprises an outer diameter, that is decreasing along the proximal-to-distal direction, and wherein the intermediate portion of the tip member comprises a constant outer diameter (as the claim language refers to arbitrary portions with no further requirements except their ODs, as such the examiner notes that multiple options exist that would read on the claim language including both the balloon and nose cone embodiments; see the annotated excerpts of Eberle2’s Figs. 1 and 6 below which each show a proximal portion A, an intermediate portion B, and a distal portion C each having the OD requirements of the claim), and
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an adhesive disposed between the proximal portion of the tip member and the distal portion of the ultrasound scanner assembly such that: the adhesive couples the tip member and the ultrasound scanner assembly; the tip member is positioned distal of the ultrasound scanner assembly; and the plurality of transducer elements is entirely proximal of the tip member (see Eberle2’s Figs. 1-2 noting that the transducer assembly, exemplified by at least part 14, is entirely proximal to the tip assembly 1/25 and that an epoxy 8 (only shown in Fig. 1, though see the cited description) couples these otherwise different components together as per col. 4 line 48 – col. 5 line 12).
Regarding claim 19, Eberle2 further teaches: 19. The device of claim 18, wherein the proximal portion of the tip member comprises a plurality of wall thicknesses along a length of the proximal portion of the tip member corresponding to the increasing outer diameter, wherein each of the plurality of the wall thicknesses at the proximal portion of the tip member is less than a constant wall thickness of the intermediate portion of the tip member corresponding to the constant outer diameter of the intermediate portion (see Eberele2’s Fig. 6 and/or the annotated copy thereof provided above noting the claimed ODs and thicknesses are clearly depicted).
Claim Rejections - 35 USC § 103
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 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 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over US 20170065793 A1 by Scarpine et al. (hereafter Scarpine, previously of record) further in view of Eberle2.
Regarding claim 15, Scarpine teaches: 15. An intraluminal imaging device (regarding being an intraluminal device see Scarpine’s [0001]-[0002], as for imaging, see Scarpine’s [0101] which, in discussing the method of use/intended use notes that the invention may use IVUS or other US imaging to locate and navigate to the ROI), comprising:
a flexible elongate member configured to be inserted into a lumen of a patient (See Scarpine’s Fig. 1 noting the proximal 17A and distal 17B portions and the bottom and top of the page respectively, or see [0053] for a textual explanation. While there is no limitation on the flexibility per se, note that Fig. 9 sets forth that this is introduced into the vasculature (i.e. is flexible enough to navigate blood vessels) and also textually addressed in [0075] noting that while the proximal material is rigid it is thin walled to allow for flexibility);
…; and
a tip member … (see Fig. 1 part 12B and/or see expanded view of Figs. 2-3) comprising:
a first region comprising a first material and disposed at a distal portion of the tip member, wherein an outer diameter of the first material changes along a length of the first region (see the region indicated by numeral 20 in Scarpine’s Fig. 3. Noting that this is both depicted as and called a taper section such that it is clear that the OD changes and it, like all things, is made of a material);
a second region comprising a second material and disposed at a proximal portion of the tip member wherein an outer diameter of the second material is the same along a length of the second region (see Scarpine’s Fig. 3 noting the portion of wall 12 which is on the left of/proximal to the transition region which starts in the area indicated by 17B and it, like all things, is made of a material); and
a transition region comprising the first material and the second material, wherein the transition region is disposed between and directly physically continuous with the first region and the second region, wherein an outer diameter of the first material and the second material is the same along a length of the transition region (see Scarpine’s Fig. 3 noting that between the start of 17B and before 20 there is a region containing both materials from 12 and 20 which is a transition region between the taper and the main body and wherein the OD (from material1’s OD+material2’s OD) is constant over this area which is continuous),
wherein the first material is relatively less rigid than the second material such that the distal portion of the tip member is more flexible than the proximal portion of the tip member (Scarpine may intend the flexible elongated member to be flexible, but the proximal (in the vernacular of the claims, second) portion is made of a rigid material as per [0054]; whereas, the distal (in the vernacular of the claims, first) portion is made of a semi-flexible (i.e. more flexible) material as per [0080]); and …
In the foregoing the examiner omitted the limitation that the device included “an ultrasound imaging assembly disposed at the distal portion and configured to obtain ultrasound imaging data while positioned within the lumen of the patient, wherein the ultrasound scanner assembly comprises a proximal portion, a distal portion, and an ultrasound transducer element” and that the tip member is “different from the ultrasound scanner assembly”, and that the bonding between these is formed by “an adhesive disposed between the proximal portion of the tip member and the distal portion of the ultrasound scanner assembly such that the adhesive couples the tip member and the ultrasound scanner assembly” as indicated by ellipsis as while Scarpine teaches that the invention is for use in the vasculature and can take IVUS images as iterated above, Scarpine does not iterate details about the IVUS transducer and therefore does not expressly/directly teach the details of this assembly nor how it would be coupled to or different from the other claimed elements.
However Eberle2 in the same or eminently related field of intravascular/intracardiac imaging catheters (see Eberle2’s Abstract and col. 1 line 19 to col. 2 line 27) teaches IVUS is a suitable and even advantageous modality for cardiac/intravascular applications of the sort taught by Scarpine and teaches an ultrasound imaging assembly coupled by epoxy to the tip at the claimed area of the distal portion to accomplish this imaging (see Eberle2’s col. 1 line 19 to col. 2 line 27 which describes that, in addressing the same problem of vascular plaques as identified in Scarpine, there is a need for IVUS/US imaging; then see col. 2 lines 29 to col. 3 line 3 which describe that the instant invention of Eberle2 is suitable for providing this already advantageous imaging in an advantageous manner (i.e. at high resolution while maintaining a small size by utilizing a form where the transducer assembly can be separate/different from the other components and bonded thereto using adhesive/epoxy which also advantageously allows this design to be used in combination with a variety of tips (see col. 4 line 57 to col. 5 line 3 noting the use of epoxy as an adhesive to bond in this way, and/or see Figs. 1-2 and 6 which both show this and showcase how the modularity of the components allows different tip attachments (e.g. such as the one of Scarpine) to be used with this transducer assembly) by way of creating an assembly that can be formed into a catheter, see in particular Figs. 1-2 and 6 showing the assembly coupled to and mounted at the distal portion of the catheter but proximal to the tip which is prima facie “different” from the tip member in its construction, function, location, etc.).
Therefore it would have been obvious to one of ordinary skill in the art prior to the date of invention to modify the imaging catheter with particular tip but vaguely disclosed imaging assembly of Scarpine to use an ultrasonic imaging assembly of the sort taught by Eberle2 because it was known to be a suitable imaging means for the same procedures the primary reference of Scarpine was purposes for, i.e. as per MPEP 2144.07, and/or because Eberle taught multiple advantages to this sort of arrangement as set forth above.
Response to Arguments
Applicant’s arguments, see page 8, filed 04/28/2025, with respect to the claim rejections under 112(b) have been fully considered and are persuasive. The associated rejections of the previous office action have been withdrawn.
Applicant’s arguments with respect to claim(s) 18-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant’s arguments, see pages 9-11, filed 04/28/2025, with respect to the rejection(s) of claim(s) 15 under Scarpine and Eberle have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the new art of Eberle2 and in view of the new claim limitations relating to the adhesive which require such new grounds of rejection.
The applicant opines that claim 21, newly added, is also patentable. This argument is prima facie not convincing because no such claim is presented, as previously in the response to the after final mailed 05/20/2025.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael S Kellogg whose telephone number is (571)270-7278. The examiner can normally be reached M-F 9am-1pm.
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, Keith Raymond can be reached at (571)270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL S KELLOGG/Examiner, Art Unit 3798
/KEITH M RAYMOND/Supervisory Patent Examiner, Art Unit 3798