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 § 103
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 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) 1-2, 4, 6-7, 9, 12-13, and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carli et al., WO 2022/067014 A2 in view of Pasch et al., US 6,059,754.
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); a connecting element configured to releasably connect the supply element and the discharge element to an external lavage device (external lavage device 110, the connecting element includes connections made between the supply and discharge elements to 110, see page 5 lines 26-30, page 9 lines 21-26 and see the Figures), and 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 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 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), the bristles are arranged arcuately in the bristle region (Figures 4A and 7 show tufts of bristles arranged in arcs or so that the end plane of the bristles form an arc, Figure 12). 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).
With regards to claim 1, Carli et al. fail to explicitly disclose that the device for surgical cleaning does not comprise a pump and states that “The irrigation fluid can be delivered in any number of different ways; however, typically, the irrigation fluid is carried in a conduit that is open at a dispensing opening…” (page 9 lines 16-22). Carli et al. also discusses that the external lavage device (console 110), is connected to the irrigation conduit and can include controls (111) for controlling operation of the irrigation fluid (page 9 lines 22-26, 32-33). This fluid feature can include a first pump that operates to pump the irrigation fluid (column 9 lines 27-28).
Further regarding claim 1, Pasch et al. teach an external lavage device (20, column 3 lines 30-33) that is separate from a device used for surgical cleaning (wand 22, column 3 lines 33-36), the external lavage device comprises a pump so that a pump is not required within the wand device for surgical cleaning. The external device (20) connects to an outlet that is a device for surgical cleaning (irrigation suction wand 22, Figure 1; connects to outlet flow of irrigation from 20, see column 3 lines 33-40). The external device allows for a surgical irrigation device that is inexpensive and readily disposable (Abstract, column 2 lines 32-34).
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 for surgical cleaning of Carli et al. to not comprise a pump, and rather include the pump in the external lavage device, as taught by Pasch et al., so that the external device can be made inexpensively and disposably as separate from a cleaning device attached to its outlet.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carli et al., WO 2022/067014 A2 and Pasch et al., US 6,059,754 as applied to claim 1 in view of Rontal, US 2006/0224103.
Carli et al. and Pasch et al. disclose all elements previously discussed above, however fail 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. and Pasch 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) 8 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carli et al., WO 2022/067014 A2 and Pasch et al., US 6,059,754 as applied to claim 1 in view of McBride-Sakal, US 2003/0109837.
Carli et al. and Pasch et al. disclose all elements previously discussed above. Carli et al. fail to disclose that the discharge element comprises a suction opening arranged at the proximal end of the bristle region and also that the supply element and discharge element are guided through the connecting element. Note, Carli et al. disclose that the discharge element can comprise suction in the form of negative pressure to aspire fluid from a surgical site (page 6 lines 3-4) and that the external lavage device within system (100) includes a supply of the cleaning liquid as well as a source of negative pressure (page 6 lines 2-4).
McBride-Sakal discloses a device for surgical cleaning (Abstract, Figures), the device comprises a brush head containing a bristle region having a plurality of bristles (6, Figure 1), a supply element configured to transport a cleaning liquid to the brush head (via 14, paragraph [0035]), a discharge element configured to remove liquid from the brush head (through vacuum canula 7 or vacuum holes 19, Figures 1-3). Regarding claim 8, the discharge element comprises a suction opening arranged at the proximal end of the bristle region (suction via vacuum canula 7 or vacuum holes 19, Figures 1-3) in order to remove biological material that was loosened by the brush (paragraphs [0034]-[0035]). Regarding claim 11, the supply element and the discharge element are guided through a connecting element (the connecting element includes outer sheath 2, Figures 1-3 that guides the supply element and discharge element together).
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 discharge element of Carli et al. and Pasch et al. to further include a suction opening arranged at the proximal end of the bristle region, as taught by McBride-Sakal so that the suction opening is positioned nearby to any biological material that is loosened by the brush to remove the biological material from the site. Also, 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. and Pasch et al. so that the supply element and discharge element taught by McBride-Sakal are guided through the connecting element, as McBride-Sakal teaches a connecting element configuration that joins the supply and discharge elements within a single sheath for connection to a liquid and negative pressure source.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carli et al., WO 2022/067014 A2 and Pasch et al., US 6,059,754 as applied to claim 13 in view of Leis, US 2005/0155622.
Carli et al. and Pasch 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 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. and Pasch 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.
Response to Arguments
Applicant's arguments filed 17 June 2026 have been fully considered but they are not persuasive.
The applicant traverses the Examiner’s interpretation of the claim limitations under 35 USC 112(f). The applicant states that the Examiner must prove that the claim limitation fails to recite sufficient structure for performing the claimed function.
The applicant argues that neither Enz et al. or Carli et al. recite each and every claim limitation as recited by independent claim 1, as amended. The applicant further argues that Rontal (relating to the rejection of claim 5) and Leis (relating to the rejection of claim 14) fail to cure the deficiencies of Enz et al. or Carli et al.
The applicant argues that the rejections made under 35 USC 103 (relating to claims 5 and 14) to Carli in view of Rontal and Leis are deficient in that the examiner has not set forth adequate basis to conclude that one of ordinary skill in the art would have been motivated to modify Carli to arrive at the parameters recited in claims 5 or 14.
The examiner respectfully disagrees for the reasons set forth below.
The examiner maintains the interpretation of the claim limitations under 35 USC 112(f) as set forth previously in this office action and in the Non-final office action. As previously stated, prong C of the 3-prong analysis used to apply 35 USC 112(f) recites “the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function” (MPEP 2181). Claim 1 recites “supply element”, “discharge element”, and “connecting element”. In each of these phrases, the term “element” is the generic placeholder. In each of these phrases the term “element” does not provide any indication of structure and provides the same specified function as if the term ‘means’ had been used. The applicant alleges that claim 1 does include sufficient structure for performing the claim function, however the examiner is not persuaded. The “supply element configured to transport a cleaning liquid” does not indicate any structure of what the supply element includes. The “discharge element configured to remove liquid” does not indicate any structure of what the discharge element includes. The “connecting element configured to releasably connect…” does not set forth any structure of what the connecting element is required in claim 1. The applicant argues that one of POSA would understand these limitations to connote distinct physical pathways, boundaries, and mechanical couplings, however none of these are set forth structurally to perform the claimed functions recited in claim 1.
Relating to the applicants’ arguments in point (B) relating to the rejections under 35 USC 102, the examiner finds these arguments to be persuasive and therefore the rejections of 35 USC 102 to Enz et al. and Carli et al. have been withdrawn. However, upon further consideration, new grounds of rejection have been made in view of Carli et al. in view of Pasch et al. (WO 95/25188).
The examiner maintains that Carli et al. (as modified by Pasch et al.) provides sufficient motivation for modifying Carli et al. in view of the teachings of Rontal and Leis as applied to claims 5 and 14. Regarding claim 5, Carli et al. fails to disclose that the device further comprises a valve arranged between the connecting element and brush head and is configured to control a flow of a cleaning liquid through the supply element. As stated previously, Rontal teaches a device for cleaning biofilm covered surfaces (Abstract, 10) and 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]). In Rontal the device further comprises valves (not shown, paragraph [0011]) and is configured to use the valve 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]). Therefore, 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. and Pasch 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. Regarding claim 14, Carli et al. and Pasch fail 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 for a user to guide the device (12), and a stem element that connects the handle to the brush head (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. The examiner maintains that it would have been obvious to modify the adjustable stem element of Carli et al. and Pasch 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 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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, 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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