DETAILED ACTION
Election/Restrictions
Applicant's election with traverse of Group I claims 1-25 in the reply filed on 4/1/26 is acknowledged. The traversal is on the grounds that “the search of the non-elected invention would not be unduly burdensome because the non-elected invention has at least one related and inventive feature and would likely be involved in the same or very similar search strategy and class.” This is not found persuasive because a serious search and examination burden remains because the non-elected claims would require additional searching directed to disposable smoke evacuation tube assemblies, inlet filter nozzle arrangements, sheath covered tubes, filter usage communication systems, control systems and integrated assemblies separate from the search required for the elected claims. MPEP 803 indicates that restriction requires both distinctness and serious burden, where burden can be shown by different classifications, separate status in the art, or different fields of search strategy. In this case, a separate and expanded burdensome search would be required for the non-elected claims, and the groups are distinct with reasons set forth and maintained from the restriction dated 3/10/26
The requirement is still deemed proper and is therefore made FINAL.
Claim Objections
Claim 6 is objected to because of the following informalities: a “the” is needed before “filter housing” in line 3 of the claim.
Claim 9 is objected to as informal because the phrase “is at least one of a cylinder, polyhedron, or is pyramidal” is grammatically inconsistent. The Examiner suggests “has a shape that is cylindrical, polyhedral, or pyramidal”
Claim 14 is objected to because of wording clarity. The Examiner suggests “further comprises a sterile flexible tube drape or sheath disposed over/on the conformable tube member.”
Claim 16 is objected to because the phrase “is at least one of a cylinder, polyhedron, or is pyramidal” is grammatically inconsistent. The Examiner suggests “has a shape that is cylindrical, polyhedral, or pyramidal”
Claim 20 is objected to because of the following informalities: “replaced a single unit” should read “replaced as a single unit” in line 3 of the claim.,
Appropriate correction is required.
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 1-25 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 1 is indefinite for the phrase “at least one end or said second end being removably mounted…” but in line 6 of the claim the second end is already attached to the filter housing which creates ambiguity between the tube end and the filter housing.
Claim 2 is indefinite because the phrase “filter housing or support receiving area” conflicts with claim 1. Claim 1 only clearly introduces a filter housing, not a support. If the support is intended as an alternative to the filter housing, the claim should clarify what is being received. The specification seems refer to filter housing and support as the same entity, so having ‘support’ recited in the claims does not appear necessary or further limiting.
Claim 5 is indefinite for the phrase “a predetermined filter housing or support shape that generally complements a shape of said filter housing or support.” The filter housing shape cannot meaningfully complement itself. It is taken that the receiving area is complementary shaped to the filter housing’s shape. In further regards to claim 5, the overly long claim as a whole creates an unclear relationship between the receiving area, the filter housing, and fluid communication.
Claim 7 is unclear for the phrase “such that it is secure and stabilized” because “it” could refer to the predetermined shape, receiving area, or filter housing/support. The Examiner will consider “it” to mean the filter housing.
Claim 8 appears to be a duplicate of claim 2 and does not further limit the claim in a clear manner.
Claim 10 is unclear because the recitation “at least one of said first end or said second end can be situated in proximity to said surgical site” conflicts with claim 1’s basic arrangement where the first end is the inlet/nozzle and the second end has the filter housing. Thus, the phrase creates uncertainty whether the filter housing end is also intended to be placed near the surgical site.
Claim 11 is indefinite because the phrase “can be received therein” lacks antecedent basis for “therein” because claim 1 does not recite a vacuum generator receiving area.
Claim 12 is indefinite because the phrase “usage factors” is vague without bounds.
Claim 13 is indefinite because of the phrase “and/or other physical parameters.” The term “other” leaves the scope open-ended without identifying what parameters are included.
Claim 17 is indefinite because of potential inconsistency with claim 1. Claim 1 recites the first end has an opening/nozzle and the second end has the filter housing. Claim 17 says the filter housing is situated on the first end. If the filter housing can be at either end, claim 1’s recitation of “second end having a filter housing” makes this unclear.
Claim 18 is unclear because the phrase “resulting in self-supporting conformational change” is result-oriented and does not clearly define the structure. In further regards to claim 18, the phrase “mechanism or mechanisms integral to and/acting upon said tube is unclear because the mechanism can be integral, external, acting on the tube, or some combination.
Claim 19 is indefinite by virtue of its dependency from claim 17. The inlet end comprising a nozzle seems to be a duplicate of claim 1 requiring a nozzle or opening at the first end.
Claim 21 is indefinite for the phrase “or similar means to affect air contamination” is vague.
Claim 22 is indefinite because of the phrase “and/or other physical parameters.” The term “other” leaves the scope open-ended without identifying what parameters are included. The phrase “said air sensing means comprising modalities including carbon dioxide…said parameters feeding back into said air sensing means for display, memory, or transmission” is unclear. The Examiner assumes a typo and the claim should read “air sensing means detects modalities including…”
Claim 24 is indefinite because the phrase “such as” creates ambiguity as to whether the limitations following the phrase are part of the claimed invention.
Claim 25 is indefinite because the phrase “which can be sized or shaped to anatomical requirements of a specific surgical procedure” is a functional/result-orientated language and vague. “Anatomical requirements” is not clearly bounded. The Examiner suggests reciting nozzle structures, sizes, shapes, and/or surgical uses instead.
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.
Claim 6 recites “securing means…for securing or locking” the filter housing onto the vacuum generator. The claimed function is securing or locking the filter housing to the vacuum generator wherein securing means include at least one of a clip, fastener, magnet, compression, friction, nesting or similar means.
Claim 12 recites “communication means…for communicating data” to and/or from the vacuum generator controller regarding the state or condition of the filter. The claimed function is communicating filter state or condition data to and/or from the vacuum generator controller.
Claim 21 recites “air filtration…means to affect air decontamination.” The corresponding structure includes at least HEPA, ULPA, granular, chemical, catalytic, and electrostatic filtration media.
Claim 22 recites “air sensing means” for sensing parameters including carbon dioxide, volatile organic compounds, particulates, pressure, temperature, humidity, and/or other physical parameters. The claimed function is sensing one or more air/physical parameters.
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.
Claims 1-9, 11, 14-17, 19, 21, 23, and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Babini et al. U.S. Patent 9,943,355.
Regarding claim 1, Babini teaches a surgical smoke evacuation system 10 (Figures 1-3, columns 3-4) comprising:
a) A vacuum generator 28 for drawing smoke into the evacuation system 10 (column 3 lines 30-31);
b) A flexible tube 12 having a first opening end as intake ports 54 (column 4 lines 20-25), which includes nozzle 160 (Figure 3, column 4 line 43), and configured to receive smoke and vapor generated from a patient during surgery (column 3 lines 4-5);
c) The flexible tube 12 further comprises a second end 36 attached to front end cap 32 of a filter housing 18 and is adapted to convey the smoke entering through the first end 54 into the filter housing 18 for filtering and treatment (column 3 lines 54-60);
d) The second end of the flexible tube is removably connected to the vacuum pump 28 when the filter cartridge 18 is installed (Figure 1, column 3 line 35-46) while the other end of the tube is proximate to the patient (Figure 1, column 3 line 11).
Regarding claims 2 and 3, the filter cartridge 18 is releasably engaged within reception port 22 in the housing 26 that contains the vacuum pump 28 (column 3 lines 27-30). Figure 1 shows, that the filter cartridge 18 fits into the vacuum pump 28, thus the filter housing is adapted to fit into the vacuum pump. The second end of the flexible tube 12 securely fits into port 36 of the filter cartridge 18 while the other end of the flexible tube is near the patient and securely held with clamps 16b.
Regarding claims 4, 5, 6, and 7, the filter cartridge 18 is configured to releasably engage with the vacuum pump 28, further comprising complimentary cylindrical shapes that are configured to removably engage with another for secure fitting and allow fluid communication with the tube (Figure 1, column 3 lines 27-30). The front end cap 32 of the filter cartridge comprises a port 36 for the flexible tube 12, thus allows the tube to attach and release from the vacuum pump via the filter cartridge. The full assembly is depicted in Figure 1 where the tube inlets 12 are near the surgical site, the other end of the tube 12 fits into the filter cartridge 18 which further compliments with the vacuum pump 28.
Regarding claims 8, 9, and 11, the filter cartridge comprises cylindrical rear end cap that includes an outer port to communicate when fitted into the vacuum pump (column 3 lines 42-55). Figure 2a shows the rear end cap of the filter cartridge is shaped to fit into a receiving area of the vacuum pump 28 (Figure 1).
Regarding claims 14 and 15, the flexible tube 12 includes a removable surgical drape 14 to secure the tube 12 (Figure 1, column 3 line 16).
Regarding claim 16, the filter housing 18 is cylindrical shaped (column 3 line 37).
Regarding claim 17, the first end of the filter cartridge comprises port 36 which is the inlet for the evacuation device (column 3 line 38).
Regarding claim 19, the inlet further comprises nozzle (column 4 line 43).
Regarding claim 21, the filter cartridge includes HEPA and ULPA filters (column 3 lines 58-60).
Regarding claims 23, the flexible tube 12 includes a removable surgical drape 14 to secure the tube 12 (Figure 1, column 3 line 16).
Regarding claim 25, the tube 12 comprises nozzles 160 which comprise an elongated inlet slot adapted to increase smoke evacuation near the patient (column 4 lines 43-47).
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 10, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Babini et al. US Patent 9,943,355 in view of Hanson US Patent 5,769,702.
Regarding claims 10 and 18, Babini teaches that the hose and filter cartridge 18 form a continuous fluid channel way from the inlet port to the housing and can be removed and replaced together as a unit (pertinent to claim 20) but does not explicitly teach:
the conformable tube member having memory and being self-supporting so that it remains in position after the user has positioned said first end (claim 10);
can be reversibly re-shaped by the user and will substantially remain in said shape, allowing for placement proximate to a surgical site, without requiring direct patient contact (claim 18);
a self-supporting tube mechanism integral to and/or acting upon said tube resulting in self-supporting conformational change of said tube by the user, while maintaining a substantially contiguous internal lumen (claim 18);
However, Hanson teaches a malleable positioning tube that is used for evacuation devices for unwanted gases and configured to attach to a surgical smoke evacuator (column 4 line 8). The tube can be manipulated into various configurations such that the positioning tube maintains the last chosen configuration (column 2 lines 9-24, Figures 1 and 2), thus Hanson’s tube comprises positioning memory and a self-supporting feature and can be reversibly re-shaped by the user and will substantially remain in said shape without further contact or fasteners.
The self-supporting mechanical feature includes tubular bellows formed from a plurality of alternating large and small diameter rings joined by frusto-conical walls (30, 32 in Figures 1and 2. The malleable positioning tube may also include a malleable wire 50 associated with a semi-rigid tube. Interaction between the rings and the frusto-conical walls imparts malleable properties to the positioning tube. Thus, Hanson teaches a self-supporting tube mechanism integral (as the frusto-conical walls or wire) to and/or acting upon said tube resulting in self-supporting conformational change of said tube by the user, while maintaining a substantially contiguous internal lumen 42.
Thus, it would have been obvious to one having ordinary skill at the time of the invention to combine Babini’s evacuation device with Hansen’s self-supporting tube so that the smoke inlet can be positioned near the surgical site without being manually held or fastened to allow hands-free capture and quick repositioning during operation.
Regarding claim 20, Babini teaches that the hose and filter cartridge 18 form a continuous fluid channel way from the inlet port to the housing and can be removed and replaced together as a unit. However, Babini does not explicitly teach:
wherein said self-supporting tube mechanism and channel comprising a lumen being substantially air and water tight along its length from said first tube opening to said filter housing or support and through an airflow aperture.
However, Hanson teaches an internal liner 42, considered as the claimed lumen, that provides a smooth surface for air to travel along the length of the tube. Since the liner 42 is made of plastic, it is considered substantially air/water tight (column 4 lines 27-34). Thus, Hanson teaches said channel comprising a lumen 42 being substantially air and water tight along its length from said first tube opening to said filter housing or support and through an airflow aperture (column 4 lines 25-35 and Figure 2).
Thus, it would have been obvious to one having ordinary skill in the art to include a liner lumen 42 to allow an air/water tight fluid passageways and to prevent whistling during operation (column 4 lines 25-35). Babini provides a smoke evacuator with the removable filter cartridge 18 and vacuum housing. Hanson provides the self-supporting positioning tube that allows positioning memory. Thus, it would have been obvious to one having ordinary skill at the time of the invention to combine Babini and Hansen so that Babini’s smoke inlet can be positioned near the surgical site without being manually held or fastened to allow hands-free capture and quick repositioning during operation.
Claims 12, 13, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Babini et al. US Patent 9,943,355 in view of Ellman et al. US Patent 7,294,116.
Regarding claim 12, 13, and 22 Babini does not explicitly teach a vacuum generator controller, said filter housing or support comprises communication means or a filter housing or support control for communicating data to and/or from said vacuum generator controller regarding a state or condition data of said at least one filter, said state or condition data comprising data relating to at least one of usage time, filter expiration or usage factors.
However, Ellman teaches a similar smoke evacuation device comprising a removable filter cartridge 18 (Figures 6 and 11) that fits into housing 12 comprising the vacuum pump (column 2 lines 55-68). The device further comprises RFID control unit 94 added to the filter inside the housing and is used to determine the quality and lifetime of the filter (column 4 lines 50-65). Thus, it would have been obvious to one having ordinary skill in the art to modify Babini with a control and detection means such as the RFID control unit in Ellman in order to monitor the filter’s performance and lifespan. The system further comprises a microprocessor which controls the power of the vacuum motor, thereby controlling pressure.
While Ellman does not explicitly teach controlling or monitoring other parameters such as compound type, particulates, temperature, humidity and others, one having ordinary skill in the art would find it obvious that these can be monitored and detected with a microprocessor as in Ellman’s device, in order to optimize the environment conditions for surgery.
Regarding claim 24, Babini teaches the tube 12 is flexible and one having ordinary skill in the art would find it obvious to use materials known for flexibility and medical use such as plastics and silicones. Ellman further teaches that plastic hoses are typical in the art (column 1 line 24).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHARON PREGLER whose telephone number is (571)270-5051. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, In Suk Bullock can be reached at (571) 272-5954. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHARON PREGLER/Primary Examiner, Art Unit 1772
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