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 .
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: “supply element” in claim 1, “discharge element” in claim 1, “connecting element” in claim 1.
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.
2. Claims 2, 4-6, 9, and 11 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.
Claim 2 recites the limitations "the delivery rate of the discharge element" and “the delivery rate of the supply element” in lines 1-2. There is insufficient antecedent basis for these limitations in the claim.
Claim 4 recites the limitations "the oscillating force" in line 2 and “the flow” in line 3. There is insufficient antecedent basis for these limitations in the claim. Is claim 4 meant to depend from claim 3 instead of claim 1?
Claim 5 recites the limitation "the flow" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 recites the limitation "the cleaning of undercuts" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 lines 2-3, it is unclear what is meant by “…preferably arranged arcuately…” Does claim 6 require that the bristles are arranged arcuately?
Claim 9 recites the limitation "the tip" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 line 1, it is unclear what is meant by “…preferably also the discharge element…” Does claim 11 require the discharge element to be guided through the connecting element?
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) 1-2, 6-12, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Enz et al., WO 2022/248455 A1 (see also English translation).
Regarding claim 1, Enz et al. disclose a device for surgical cleaning of infected implants containing: a brush head containing a bristle region having a plurality of bristles (010, Figure 3); a supply element configured to transport a cleaning liquid to the brush head (13 and 070, tube, Figure 1); a discharge element configured to remove liquid from the brush head (15 and 013, tube, Figure 1); and, a connecting element configured to releasably connect the supply element and the discharge element to an external lavage device (1 and 14, see English translation of claim 1). Regarding claim 2, the device is configured to achieve a ratio of delivery rate of the discharge element to a delivery rate of the supply element of at least 1 (in that it is configured to achieve a ratio of 1 in that the fluids are part of the same fluid circuit, see English translation). Regarding claim 6, the bristles have different lengths and are capable of cleaning of undercuts (Figure 3). Regarding claim 7, the supply element comprises an outlet opening arranged within the bristle region (08, Figure 3). Regarding claim 8, the discharge element comprises a suction opening arranged at a proximal end of the bristle region (09, Figure 3). Regarding claim 9, the device is configured to conduct cleaning liquid from the supply element through the bristles to release cleaning liquid at the tip of the bristles (see English translation paragraph [0070]). Regarding claim 10, the device does not comprise a pump (no pump mentioned in the English translation or shown in the Figures). Regarding claim 11, the supply element and discharge element are guided through the connecting element (connect at 14, see English translation and Figures 1-2). Regarding claim 12, there is a handle element arranged between the connecting element and the brush head, wherein the handle element is configured for a user to manually guide the device (see finger grips in Figure 2). Regarding claim 15, the supply element (13 and 070, part of shank/shaft 01) comprises a flexible tube (see paragraph [0082] and Reference Sign list on the last pages of the English translation, note that the English translation that is not done by WIPO states that shank 010 has a variable bending stiffness).
Claim(s) 1-4, 6-7, 9, 12-13, and 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carli et al., WO 2022/067014 A2.
Regarding claim 1, Carli et al. disclose a device for surgical cleaning of infected implants containing: a brush head containing a bristle region having a plurality of bristles (235, 240); a supply element configured to transport a cleaning liquid to the brush head (tubing 122, page 9 lines 21-28); a discharge element configured to remove liquid from the brush head (not shown, aspiration conduit, see page 9 lines 29-32); and, a connecting element configured to releasably connect the supply element and the discharge element to an external lavage device (110, page 5 lines 26-30, page 9 lines 21-26). Regarding claim 2, the device is configured to achieve a ratio of delivery rate of the discharge element to a delivery rate of the supply element of at least 1 (in that it is configured to achieve any specific ratio by having a control on the delivery rate of the discharge element, page 9 lines 29-34). Regarding claim 3, the brush head is configured to exert and oscillating force on the bristles (page 7 lines 2-5, page 10 line 21 to page 11 line 14). Regarding claim 4, the device comprises a drive element for generating the oscillating force on the bristles (215, page 6 lines 24-26). Regarding claim 6, the bristles have different lengths and are capable of cleaning of undercuts (page 7 lines 10-20). Regarding claim 7, the supply element comprises an outlet opening arranged within the bristle region (page 10 lines 5-15; Figures 1-3). Regarding claim 9, the device is configured to conduct cleaning liquid from the supply element through the bristles to release cleaning liquid at the tip of the bristles (page 10 lines 5-15; Figures 1-3). Regarding claim 12, there is a handle element arranged between the connecting element and the brush head, wherein the handle element is configured for a user to manually guide the device (210, Figures 1-3). Regarding claim 13, there is a stem element which connects the handle element to the brush head (224, Figures 1-3). Regarding claim 15, the supply element comprises a flexible tube (122, Figure 1).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Enz et al., WO 2022/248455 A1 (see also English translation) in view of Rontal, US 2006/0224103.
Enz et al. disclose all elements previously discussed above, however fails to disclose that the device further discloses a valve.
Rontal teaches a device for cleaning biofilm covered surfaces (Abstract, 10) and the device comprises a supply element of flexible tubing to transport cleaning liquid (14 and 20) and a discharge element configured to remove liquid (22, paragraph [0069]). Regarding claim 5, the device further comprises valves (not shown, paragraph [0011]) and is configured to control the flow of a cleaning liquid through the supply element so that a user can allow fluid flow that is continuous or intermittent (paragraph [0011]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Enz et al. by providing a valve arranged between its connecting element and brush head, as taught by Rontal, so that a user can control flow of a cleaning liquid through the supply element to allow the fluid to flow in a continuous or intermittent manner to achieve desired cleaning results.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carli et al., WO 2022/067014 A2 in view of Rontal, US 2006/0224103.
Carli et al. disclose all elements previously discussed above, however fails to disclose that the device further discloses a valve.
Rontal teaches a device for cleaning biofilm covered surfaces (Abstract, 10) and the device comprises a supply element of flexible tubing to transport cleaning liquid (14 and 20) and a discharge element configured to remove liquid (22, paragraph [0069]). Regarding claim 5, the device further comprises valves (not shown, paragraph [0011]) and is configured to control the flow of a cleaning liquid through the supply element so that a user can allow fluid flow that is continuous or intermittent (paragraph [0011]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Carli et al. by providing a valve arranged between its connecting element and brush head, as taught by Rontal, so that a user can control flow of a cleaning liquid through the supply element to allow the fluid to flow in a continuous or intermittent manner to achieve desired cleaning results.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carli et al., WO 2022/067014 A2 as applied to claim 13 in view of Leis, US 2005/0155622.
Carli et al. disclose all elements previously discussed above, however fails to disclose a specific length of the stem element (224). It is noted that Carli et al. teach that the stem element can vary in some embodiments where a stem element (314 or 332) can be adjustable or bent (page 16 lines 20-25, page 17 line 33 to page 18 line 18).
Leis teaches a cleaning system having a brush head (16), a supply element configured to transport a cleaning liquid (tubing 56), a handle element to for a user to guide the device (12), and a stem element that connects the handle to the brush head (14). Regarding claim 14, Leis discloses that the stem element (14) is telescoping can be adjusted based on a particular application (see arrow 137 in Figure 13 and paragraph [0061]) so that a user can adjust the length of the stem according to a particular application and can facilitate storage in a smaller space (paragraph [0061]). Leis does not describe a specific length, particularly a length of 5 to 10 cm.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adjustable stem element of Carli et al. so that it can be adjustable telescopically in length, as taught by Leis et al., so that the user can adjust the length of the stem element according to the particular application that the device is being used for and in addition it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to establish a length of the stem component of Carli et al. and Leis et al. to be in the range of 5 to 10 cm when a user finds this stem element length suitable for a particular cleaning application.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: US 2024/0269713 to McManus et al. that discloses a similar device, however the effective filing date is after the priority date of the present application.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Laura C Guidotti whose telephone number is (571)272-1272. The examiner can normally be reached typically M-F, 6am-9am, 10am-4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Posigian can be reached at 313-446-6546. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAURA C GUIDOTTI/Primary Examiner, Art Unit 3723
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