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 .
Response to Amendment
This office action is responsive to the amendment filed on 1/29/26. As directed by the amendment: claims 1-40 have been amended, no claims have been cancelled, and no new claims have been added. Thus, claims 1-40 are presently pending in this application, claims 1-17 being withdrawn from consideration.
Election/Restrictions
Applicant’s election without traverse of Group II (claims 18-40) in the reply filed on 1/29/26 is acknowledged. Claims 1-17 are withdrawn from consideration.
Claim Objections
Claim 18 is objected to because of the following informalities: in the preamble, “supply and draining” is recited as performed “to a body cavity”, when the context of the claim indicates that supply is “to” a body cavity and draining is “from” the body cavity; in line 9, “between plurality of treatments” is missing an article between “between” and “plurality”, such as “a”. Appropriate correction is required.
Claim 30 is objected to because of the following informalities: “wherein a separating element.” forms a grammatically incomplete statement; either a different transitional term such as “comprises” with appropriate context is needed, or further context or language in the body of the claim is required. Appropriate correction is required.
Claim 39 is objected to because of the following informalities: “is has” should either be “is” or “has”. Appropriate correction is required.
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: “at least one through-flow element with a flow-direction dependent throttle function” in claim 18 and its dependent claims; “a separating element with a feces-separating function” in claim 30; “an element with a flow-reducing function” in claim 33; “an element with a flow-directing function” in claim 33.
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. Specifically, the claimed “through-flow element” covers the corresponding structure, as disclosed in fig. 2C and pg. 26-27 of the specification, of two branched lumina within the flow path, one of the branched lumina provided with a valve or equivalent which opens if pressure at the patient side is higher than at the bag side, and closes in the opposite situation. Specifically, the claimed “separating element” covers the corresponding structure of a perforated structure, as described at least on pages 24-25 of the specification, and in dependent claim 31, noting that claim 31 is modified by sufficient structure to perform the claimed function. Specifically, the claimed “an element with flow-reducing function” covers the corresponding structure of a plurality of small lumen openings as disclosed on pg. 12-13. Specifically, the claimed “an element with a flow-directing function” covers the corresponding structure of a thin-walled, spontaneously collapsible hose element” as disclosed on pg. 12-13
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 20-24 and 30-33, 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 claims 20-22, each claim recites steps using a letter followed by parenthesis designation, without setting forth any particulars of the step itself. Note that each of claims 20-22 depends directly from independent claim 18. They do not incorporate claim 19, which initially recites a step g), and claim 21 does not incorporate claim 20, which initially recites a step h). Additionally, if the claims were amended via changing the dependency, proper articles for antecedent basis reference would be needed.
Regarding claim 26, “the collecting bag” lacks antecedent basis. Note that claim 26 depends directly from independent claim 18, and does not incorporate intervening claim 20.
Regarding claims 27-29, it is unclear if the limitations recited are meant to be further limiting to the “at least one through-flow element with a flow-direction dependent throttle function” from independent claim 18, or additional limitations not a part of that “through-flowelement”, in particular since language in these claims reflect at least some of the corresponding structure disclosed in the specification for performing the claimed function of the “through-flow element”. It is further unclear if the structure recited in any of these claims is sufficient, or not, individually for performing the claimed function of the “through-flow element”.
Similarly, regarding claim 33, it is not clear if the elements recited are portions of the “through-flow element” of claim 18 or in addition to it, in particular since the elements recited appear to be performing some similar functions to the “through-flow element” of claim 18. It is further not clear how both types of elements can function together, and it is unclear whether inclusion of the limitations of claim 33 violates 35 U.S.C. 112(d) by not requiring the particulars of the parent claim and replacing them with an alternative element.
Regarding claim 38, it is unclear if “a connector element” is the same element as the “connector” recited in parent claim 37, or a different element.
The remaining claims rejected under this statute depend from one or more claims addressed above.
Allowable Subject Matter
Claims 18, 19, 25-29, and 34-40 are allowed over the prior art of record.
The following is an examiner’s statement of reasons for allowance: the prior art of record fails to disclose or teach either singly or in combination the claimed method for repetitive supply and draining of a substance to a body cavity of a patient.
The closest prior art of record is Gobel (US 20110160657) and Enhorning (US 5685843).
Regarding independent claim 18, Gobel fails to disclose/teach performing the draining step e) as claimed in addition to supply step d) and repeating the steps, utilizing at least one through-flow element with a flow-direction dependent throttle (see 112f interpretation above). Separately, Enhorning, while disclosing a mechanism for lavage which raises and lowers a compartment to achieve directional fluid flow, fails to disclose specifics of methodology claimed, including utilization of at least one through-flow element with flow-direction dependent throttle in achieving steps d) and e) and their repetition.
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.”
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: see attached notice of references cited.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783
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