DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant's election with traverse of IMPLANT DEVICE – Species B (embodied in Figures 3A and 3B) in the reply filed on 21 August 2026 is acknowledged.
The traversal is on the ground(s) that “Applicant respectfully traverses the Restriction Requirement because it does not distinctly establish either (1) that the identified species are independent or patentably distinct as claimed” and “The Restriction Requirement nevertheless concludes that the species have "mutually exclusive characteristics" and "are not obvious variants of each other based on the current record." It does not identify the claim limitations considered in reaching those conclusions or explain why the limitations shared through claim 1 and the dependency of claims 2-20 require restriction”.
This is not found persuasive.
Independent claim 1 is broadly drawn to “An implant device”, which is generic. Since independent claim is NOT specific to a particular implant, therefore there is serious search and examination burden. Further, the only structural features of independent claim 1 are “an outer member” and “an inner member comprising one or more blades”. However, no specific structure has been recited for any of the “outer member”, “inner member”, and “blades”. Therefore, there is serious search and examination burden.
Pages 2-3 of Election of Species Requirement of 29 June 2026 clearly presents the mutually exclusive characteristics of the different embodiments. Notice the Election of Species Requirement clearly states (see page 5): “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”. Applicants’ traversal did not provide such evidence. The burden for submitting said evidence falls to the Applicant.
Applicant's traversal has been carefully considered, but fails to establish error in the propriety of the present requirement for restriction and election. Though Applicant asserts that examination of all pending claims would not pose an undue burden on the Examiner, such is not an accurate assertion in light of the disparate nature of the presently claimed subject matter as noted in the Election of Species Requirement of 29 June 2026.
Consideration of the plurality of inventions that Applicant has claimed would significantly compromise and preclude a quality examination on the merits. Furthermore, execution of a search encompassing the entirety of Applicant's groups/inventions and/or species would not only constitute an undue burden on the Examiner, but consideration of the findings of such a search in accordance with the requirements of the law under 35 U.S.C. §§101,102, 103 and 112 would be unduly onerous.
(a) The inventions have acquired a separate status in the art in view of their different classification;
(b) The inventions have acquired a separate status in the art due to their recognized divergent subject matter; and
(c) The inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries).
Moreover, it is further noted that a comprehensive search for the presently claimed subject matter is not solely limited to a search of the classes and subclasses in which they are classified. Therefore, it is obvious that a comprehensive search of the copious amounts of patent and non-patent literature for each of the patentably distinct inventions and their permutations presently claimed would necessarily place an undue burden on the Examiner.
The requirement is still deemed proper and is therefore made FINAL.
3. Applicant’s response indicates “Claims 1-3 are readable on elected Species B. Applicant therefore respectfully requests examination of claims 1-3 on the merits”. Claims 4-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected embodiments/species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 21 August 2026.
Claim Rejections - 35 USC § 102
4. 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.
5. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Pelssers et al. (EP 3 524 285 A1; cited in Applicant’s IDS).
The recitation “An implant device” has not been given patentable weight because it has been held that a preamble is denied the effect of a limitation where the claim is drawn to a structure and the portion of the claim following the preamble is a self-contained description of the structure not depending for completeness upon the introductory clause. Kropa v. Robei, 88 USPQ 478 (CCPA 1951).
Regarding independent claim 1, and referring to Figures 5A, 5B, 10A, and 10B, Pelssers et al. ‘285 teaches an implant device comprising:
an outer member (52) configured to position the implant device within one or more vessels (see vessel 35; further, the device can be used in any blood vessel); and
an inner member comprising one or more blades (Figures 5A and 5B – blades 50; Figures 10A and 10B – blades 50 and/or blade 100) configured to modify one or more of forward waves or backward waves ([0076]) within the one or more pulmonary vessels to reduce interference between the forward waves and the backward waves during systole, the one or more blades having a shape or surface that directs a portion (arrow 54) of the forward waves to a region of the one or more pulmonary vessels ([0076]-[0080], [0116], and [0117]).
While features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In re Schreiber, 128 F.3d 1473, 1477-78, 44 USPQ2d 1429, 1431-32 (Fed. Cir. 1997). A claim containing a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987).
With regards to statements of intended use and other functional statements (e.g., “configured to position the implant device within one or more pulmonary vessels”; “configured to modify one or more of forward waves or backward waves within the one or more pulmonary vessels to reduce interference between the forward waves and the backward waves during systole”; etc.), they do not impose any structural limitations on the claims distinguishable over the device of Pelssers et al. ‘285, which is capable of being used as claimed if one so desires to do so. In re Casey, 152 USPQ 235 (CCPA 1967) and In re Otto, 136 USPQ 458, 459 (CCPA 1963). Claims directed to apparatus must be distinguished from the prior art in terms of structure rather than function. In re Danly, 263 F.2d 844, 847, 120 USPQ 528, 531 (CCPA1959). “[A]pparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990). Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim. Ex parte Thibault, 164 USPQ 666, 667 (Bd. App. 1969).
Regarding claim 2, Pelssers et al. ‘285 teaches wherein the one or more blades are configured to divert the forward waves to a region of the one or more pulmonary vessels (the “a region” is not specified in the claim language, and the embodiment of Figure 5B is shown to divert the waves to at least a central region, and the embodiment of Figure 10B is shown to divert the waves to a central region and/or diverted to periphery of vessel). See [0076]-[0080], [0116], and [0117].
Regarding claim 3, the embodiment of Figure 4B shows blades (42) that flare outward to divert the forward waves. Further, the embodiment of Figures 10A and 10B comprises a “flow diverter” blade 100 that is clearly shown as flare outward to divert the forward waves ([0116], [0117]).
Conclusion
6. The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US PG Pub No. 2005/0125076 A1
US PG Pub No. 2013/0110221 A1
US PG Pub No. 2015/0051694 A1
US PG Pub No. 2017/0042551 A1
US PG Pub No. 2017/0239034 A1
US PG Pub No. 2018/0344994 A1
US PG Pub No. 2018/0036109 A1
US PG Pub No. 2020/0237495 A1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
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