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 .
Priority
This application is a CON of 17/981,892 11/07/2022 PAT 12144516
17/981,892 is a CON of 16/831,721 03/26/2020 PAT 11517337
16/831,721 is a CON of 15/725,161 10/04/2017 PAT 10646240
15/725,161 has PRO 62/405,002 10/06/2016 is acknowledged.
Election/Restriction
This application contains claims directed to the following patentably distinct species:
Species I: Fig. 1A-1C
Species II: Fig. 11A
Species III: Fig. 11B
The species are independent or distinct because they disclose different structural embodiment that that finding one limitation for one embodiment might not read on limitations of another embodiment and that is a burden on examination. In addition, these species are not obvious variants of each other based on the current record.
Applicant is required under 35 U.S.C. 121 to elect a single disclosed species, or a single grouping of patentably indistinct species, for prosecution on the merits to which the claims shall be restricted if no generic claim is finally held to be allowable. Currently, there is no generic claim.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
The species require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search queries); and/or the prior art applicable to one species would not likely be applicable to another species.
Applicant is advised that the reply to this requirement to be complete must include (i) an election of a species to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected species or grouping of patentably indistinct species, including any claims subsequently added. An argument that a claim is allowable or that all claims are generic is considered nonresponsive unless accompanied by an election.
The election may be made with or without traverse. To preserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the election of species requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable on the elected species or grouping of patentably indistinct species.
Should applicant traverse on the ground that the species, or groupings of patentably indistinct species from which election is required, are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing them to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the species unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other species.
Upon the allowance of a generic claim, applicant will be entitled to consideration of claims to additional species which depend from or otherwise require all the limitations of an allowable generic claim as provided by 37 CFR 1.141.
During a telephone conversation with Jeffrey Young on 12/31/2025 a provisional election was made without traverse to prosecute the invention of Species II, Fig. 11A, claims 2-15. Affirmation of this election must be made by applicant in replying to this Office action. Claims 16-21 withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
However, claims 13-15 also withdrawn from examination for directing toward non-elected species III, Fig. 11B.
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: “support member” in claim 2.
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.
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.
Claim Objections
Claim 2 objected to because of the following informalities: “a shock wave device” in line 4 should be “the shock wave device”. Appropriate correction is required.
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.
Claim(s) 2-4, 6, 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 6210400 to Hebert et al. (Hebert).
Hebert teaches:
Claim 2: A method for generating shock waves to treat calcified lesions in the body of a patient comprising:
introducing a shock wave device of a shock wave system (Fig. 10) into vasculature of a patient, where the shock wave system comprises the shock wave device and a laser generator (Col. 4, ll. 7-9), the shock wave device further comprising:
an elongate member (438, Fig. 10);
a tubular member (448,Fig. 11B) connected to the elongate member (connect via 440, Fig. 11A) and configured to be filled with a fluid (Col. 10, ll. 50-65, Col. 11, ll. 1-14);
a support member (442, Fig. 10) positioned at least partially within the tubular member; and
a plurality of shock wave generators (431, 433, 435, Fig. 11B) that extend along the elongate member and into the tubular member, where each shock wave generator includes an optical fiber (431, 433, 435, Fig. 11B) for propagating laser pulses, wherein at least one of the optical fibers has a different length than at least one other of the optical fibers (Fig. 11B);
advancing the shock wave device to a region within the vasculature having calcified deposits;
filling the tubular member with a fluid; and
activating the laser generator such that each optical fiber emits laser pulses to generate shock waves in response to the laser pulses being generated by the laser generator. (Abstract) (Col. 10, ll. 50-65, Col. 11, ll. 1-14)
Claim 3: Each optical fiber (431, 433, 435, Fig. 11B) is configured to emit laser pulses for absorption by tissue (Functional limitation) (Col. 2, ll. 5-12).
Claim 4: Each optical fiber (431, 433, 435, Fig. 11B) is configured to emit laser pulses for microablation of tissue subsequent to absorption (Functional limitation, the laser in Hebert is also creating laser pulse and is capable of doing such).
Claim 6: The optical fibers (431, 433, 435, Fig. 11B) are configured to propagate laser pulses into the fluid within the tubular member to form vapor bubbles (functional limitation, the laser in Hebert is creating expansion and collapsing of the bubbles, abstract, would create vapor bubbles).
Claim 10: The optical fibers (431, 433, 435, Fig. 11B) are configured to propagate laser energy into pigmented tissue to generate a shock wave (functional limitation).
Claim 11: Each optical fiber of the plurality of shock wave generators (431, 433, 435, Fig. 11B) is coupled to the laser generator.
Claim 12: The optical fibers (431, 433, 435, Fig. 11B) are configured to propagate laser energy into the fluid within the tubular member to generate a shock wave (Fig. 11B) (Col. 10, ll. 50-65, Col. 11, ll. 1-14).
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 (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 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.
Claim(s) 5, 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hebert in view of US 2016/0184022 to Grace et al. (Grace).
Hebert teaches:
The method of claim 2 (see rejection of claim 2 above).
Hebert fails to teach:
Claim 5: The laser generator is an excimer laser.
Claim 7: The fluid within the tubular member comprises saline.
Grace teaches:
Claim 5: In the same field as endeavor, an ablation system (100, Fig. 1) comprises using excimer laser (130, para. 0224).
Claim 7: The fluid within the tubular member comprises saline (para. 0232).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ excimer laser as taught by Grace into Hebert in order to enhance ablating atherosclerotic material.
Allowable Subject Matter
Claims 8-9 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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: Regarding claim 8, the prior art fails to disclose the tubular member has a loop portion and one or more shock wave generators are positioned within the loop portion. Prior art Hebert discloses the tubular member with shock wave generators within the tubular member but fails to disclose the loop portion as claimed.
Conclusion
y inquiry concerning this communication or earlier communications from the examiner should be directed to PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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, Elizabeth Houston can be reached at 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771