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 .
Information Disclosure Statement
The references cited by applicants in the information disclosure statement filed 16 January 2025 and 1 September 2026 have been made of record. Examiner has considered the voluminous references to the best of her ability.
While the statements filed do not comply with the guidelines set forth in MPEP § 2004 regarding both the number of references cited and the elimination of clearly irrelevant art and marginally cumulative information, compliance with these guidelines is not mandatory. Furthermore, 37 CFR §§1.97 and 1.98 do not require that the information be material; rather, they allow for submission of information regardless of its pertinence to the claimed invention. Also, there is no requirement to explain the materiality of the submitted references. However, the cloaking of a clearly relevant reference by inclusion in a long list of citations may not comply with Applicant’s duty of disclosure. See Penn Yan Boats, Inc. v. Sea Lark boats Inc., 359 F. Supp. 948, aff’d 479 F. 2d. 1338.
Applicant is advised that the MPEP states the following with respect to large information disclosure statements:
Although a concise explanation of the relevance of information is not required for English language information, applicants are encouraged to provide a concise explanation of why the English-language information is being submitted. Concise explanations (especially those that point out the relevant pages and lines) are helpful to the Office, particularly where documents are lengthy and complex and applicant is aware of a section that is highly relevant to patentability or where a large number of documents are submitted and applicant is aware that one or more is highly relevant to patentability. MPEP § 609.04(a)(III).
This statement is in accord with dicta from Molins PLC v. Textron, Inc., 48 F.3d 1172 (Fed. Cir. 1995), states that forcing the Examiner to find “a needle in a haystack” is “probative of bad faith.” Id. at 1888. This case presented a situation where the disclosure was in excess of 700 pages and contained more than fifty references. Id. 1888.
The MPEP provides more support for this position. In a subsection entitled “Aids to Compliance With Duty of Disclosure,” item thirteen states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant information and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to Applicant’s attention and/or are known to be of the most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp 948 (S.D. Fla. 1972) aff’d 479 F.2d 1338 (5th Cir 1974). See also MPEP § 2004.
Therefore, it is recommended that if any information that has been cited by Applicants in the previous disclosure statement is known to be material for patentability as defined by 37 CFR § 1.56, Applicant should present a concise statement as to the relevance of that/those particular documents therein cited.
Election/Restrictions
This application contains claims directed to the following patentably distinct species:
Species A: FIGS 2A-F
Species B: FIGS 4A-E
Species C: FIGS 7A-B
The species are independent or distinct because Species A does not require the compression of a tube to regulate fluid flow, and uses a spherical valve, Species B uses a linear gate valve to regulate flow, Species C relies on tube compression to regulate fluid flow. 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, claims 1-21, 23-29, and 31-33 are generic to all three species.
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 discrete searches and rejections based on the different modes of operation.
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 Benjamin Cashdollar on 8 September 2026 a provisional election was made without traverse to prosecute the invention of Species B, claims 1-21, 23-29 and 31-33. (Counsel agreed to withdraw claim 30. Upon further review, Examiner determined that claim 22 was also ripe for withdrawal as being non-generic (that is, specific for Species A). Examiner attempted to call counsel, but call was declined.) Affirmation of this election must be made by applicant in replying to this Office action. Claims 22 and 30 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 1-6, 9-21, 23-29, 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,893,002 to Brice in view of US 2023/0248380 to Long et al.
In the specification and figures, Brice discloses the apparatus as claimed by Applicant. With regard to claims 1-6, 16-17, Brice discloses a fluid control device comprising a body with first and second opposite connector portions at 24, an inner surface defining a chamber with a lumen 22 therethrough, a gating assembly comprising handles 48 with flanges or tabs 42 connected to sliding valve member 40, wherein with the handle in a first position contacting the body (see FIG 2), the valve blocks fluid communication, with the handle in a second position away from the body (see FIG 9, the valve permits fluid communication (see FIGS 2, 9, and accompanying text). The handle 42 further comprises a guide or shaft 46 and the body comprises a bore or slot 34 for accommodating the handle slide (see col 3, ln 21 to col 4, ln 58).
Brice fails to disclose a system for removing clot material. However, Long discloses a clot treatment system with catheters 120, 110, a suction source 108, and a valve 102 (see at least FIG 1). Where a claimed improvement on a device or apparatus is no more than "the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement," the
claim is unpatentable under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d 1509, 1518-19 (BPAI, 2007) (citing KSR v. Teleflex, 127 S.Ct. 1727, 1740, 82 USPQ2d 1385, 1396 (2007)). Applicant claims a combination that only unites old elements with no change in the respective functions of those old elements, and the combination of those elements yields predictable results; absent evidence that the modifications necessary to effect the combination of elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a). Ex Parte Smith, 83 USPQ.2d at 1518-19 (BPAI, 2007) (citing KSR, 127 S.Ct. at 1740, 82 USPQ2d at1396. Accordingly, since the applicant[s] have submitted no persuasive evidence that the combination of the above elements is uniquely challenging or difficult for one of ordinary skill in the art, the claim is unpatentable as obvious under 35 U.S.C. 103(a) because it is no more than the predictable use of prior art elements according to their established functions resulting in the simple substitution of one known element for another or the mere application of a known technique to a piece of prior art ready for improvement. In the instant case, it would have been within the skill of a worker in the art at the time of filing to place the valve disclosed by Brice in the clot removal system disclosed by Long.
With regard to claims 9, 14, Brice discloses sealing o-rings 30, 32 (which, as a circle, comprise an angle) disposed between the body and the gate mechanism to create a seal between the body and the valve portion (see col 3, ln 53-60).
With regard to claims 10-13, Brice fails to disclose the claimed angles. However, it has been held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See MPEP 2144.04(IV)(B). In the instant case, it would have been within the skill of a worker in the art to manipulate the diameter of the o-rings disclosed by Brice in order to provide appropriate sealing angles as claimed by Applicant.
With regard to claims 15, 18, 20, Brice does not disclose two discrete sealing elements between the housing chamber and the valve component. Rather, Brice discloses o-rings 30, 32 that surround the valve member between the valve and the housing, providing a sealing mechanism provided by two connected semicircular arcs. One having ordinary skill in the art at the time of filing would have looked at the bidirectional sealing provided by the o-rings in Brice and understood that a similar seal may be provided by two separate sealing members between the housing chamber and the valve, as claimed by Applicant. As such, Brice reasonably teaches first and second sealing elements as provided by circular o-rings.
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With regard to claims 19, 21, Brice illustrates that the apparatus comprises inner surfaces (see FIG 2, as annotated by the Examiner, herein) that lead to lumen 22 through the first connection portion 24, wherein the valve element 40 is spaced apart from the inner surfaces by o-rings.
With regard to claims 23-24, see rejections of claims 1 and 18 (from which claim 23 depends), above.
With regard to claims 25-29 and 31-32, Applicant claims that the flid control device comprises a body defining a chamber that may receive a tubing section within the chamber (with through the chamber listed as an alternative), which is taught by the combination of Brice and Long as set forth above.
With regard to claim 33, Brice in view of Long teach various tubing elements connected to a fluid control device 102 wherein a first tubing section 122 connects to a catheter 120 (second tubing section), and a third tubing section 110 connects the valve device 102 to a pressure source 108 (see Long FIG 1 and accompanying text), suggesting the limitations of the claim.
Claims 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over US 6,893,002 to Brice in view of US 2023/0248380 to Long et al, further in view of 2025/0090182 Slaughter et al.
In the specification and figures, the cited prior art suggests the limitations as set forth by Applicant (see rejections above). With regard to claims 7 and 8, the prior art fails to disclose an injection port. However, Slaughter discloses a multilumen clot aspiration assembly with a body with a first connector 102, second connector 104, and a valve portion 107, wherein the apparatus comprises an injection port 108 coupled to an injection lumen 114 to provide an injection fluid (see FIG 1, ¶0034). It would have been obvious to person having ordinary skill in the art at the time of filing to provide the clot treatment device suggested by the prior art with an injection port as disclosed by Slaughter in order to provide an injection fluid, as taught by Slaughter.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LESLIE R DEAK whose telephone number is (571)272-4943. The examiner can normally be reached Monday-Friday, 9am to 5:30pm.
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, Sarah Al-Hashimi can be reached at 571-272-7159. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LESLIE R DEAK/Primary Examiner, Art Unit 3799 10 September 2026
