DETAILED ACTION
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 allowance or after an Office action under Ex Parte Quayle, 25 USPQ 74, 453 O.G. 213 (Comm'r Pat. 1935). 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, prosecution in this application has been reopened pursuant to 37 CFR 1.114.
Response to Arguments
Applicant’s arguments, see remarks, filed 3/2/2026, with respect to the rejection of claims 41-50, 52, 53, 56,57, and 63-67 have been fully considered and with the exception of claim 42, are persuasive.
The rejection of claims 41, 43-50, 52, 53, 56,57, and 63-67 has been withdrawn.
Applicant's arguments filed 3/2/2026 regarding the rejection of claim 35 under 35 U.S.C. 112(a) have been fully considered but they are not persuasive.
Applicant argues that the combination of the originally filed specification and the drawings provide sufficient support for the term. Although the specification discloses that the integral funnel may be made from a material “more flexible and/or elastic than the material that is used for all or a portion of the remainder of the sheath assembly”
Additionally, new grounds of rejection are presented. The new grounds were not necessitated by Applicant amendment, and this action is therefor made non-final.
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:
“separation features”, as in claim 46.
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 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 25-26, 29-32, 36-40, 42 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.
Regarding claim 25, the term, “free distal end”, lacks antecedent basis.
Regarding claim 31, in lines 10-11, the claim recites, “the distal end”. The claim recites three distal ends; the distal end of the catheter assembly, the distal end of the catheter body, and the distal end of the sheath assembly. It’s unclear which distal end is being referred to in lines 10-11 of the claim.
Additionally, the claim appears to use inconsistent language to refer to the distal ends. For example, the distal end of the catheter assembly and the distal end of the catheter body may refer to the same distal end, but it’s unclear; the term “catheter body” lacks express antecedent basis because the claim recites a “catheter assembly,” rather than a catheter body. Applicant should amend the claims to clearly identify which distal end is being referred to in each instance of each claim.
Regarding claim 34, the term “catheter body” lacks express antecedent basis because the claim recites a “catheter assembly,” rather than a catheter body.
Regarding claim 36, the claimed “heat pump” is inconsistent with the heart pump of claim 34.
Regarding claim 37, the claimed “heat pump” is inconsistent with the heart pump of claim 34. Additionally, the term, “deplays”, appears to be a typographical error which should read, “deploys”.
Regarding claim 42, the term, “non-tubular”, renders the claim indefinite as it is unclear exactly what is required of something to be tubular vs. non-tubular. For example, it’s not clear how long an opening or lumen have to be in order for the structure to be a tube. Similarly, it’s unclear how the term “tubular” limits the cross section of an elongated hollow element.
Regarding claim 77, the term “influsant” renders the claim indefinite, but will be interpreted to be a misspelling of “infusant” for the purpose of continued examination.
Regarding claim 79, the preamble of the claim refers to the heart pump of claim 78. Claim 78, however, is directed to a catheter system. Therefore, for the purpose of continued examination, the claim will be interpreted to read “The catheter system of claim 78”.
Claims 26, 29-30. 32, 35-40, and 42 are rejected for being indefinite as each depends from a claim(s) which is itself indefinite.
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 35 and 42 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. Applicant’s responses have not pointed to specific portions of the disclosure which are seen to support the following:
Regarding claim 35, the originally filed disclosure does not reasonably convey to a person of ordinary skill in the art that the inventors had possession of a funnel that is more flexible than the remainder of the catheter assembly. Although the specification discloses that the integral funnel may be made from a material “more flexible and/or elastic than the material that is used for all or a portion of the remainder of the sheath assembly” (see paragraph [0155]), the specification does not describe or establish the claimed relative-flexibility relationship between the funnel and the remainder of the broader catheter assembly, which includes structures beyond the sheath assembly, such as the catheter body, drive shaft, impeller assembly, and housing.
Accordingly, the disclosure of relative flexibility between the funnel and the sheath assembly does not provide adequate written-description support for the broader limitation that the funnel is more flexible than the remainder of the catheter assembly.
Regarding claim 42, the specification does not sufficiently describe non-tubular forms, and the figures only show generally tubular forms. Additionally, the originally filed claims and specification fail to provide any written description of whether the form was tubular or non-tubular.
Allowable Subject Matter
Claims 34, 41, 43-50, 52-53, 56-57, 63-67, 70-76, and 78 are allowed.
Claims 77 and 79 are 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.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN JACOB KLEIN whose telephone number is (571)270-5213. The examiner can normally be reached 8:00am - 5:00pm.
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, Jonathan Moffat can be reached at 571-272-4390. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
Prosecution Insights