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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
This office action is in response to the claims filed on 8/16/2023. Claims 1-7 were cancelled, therefore, claims 8-14 are presently pending in this application.
Claim Objections
Claims 8-14 are objected to because of the following informalities:
In claim 8, line 1, the term “an gas-treatment” is suggested to be changed to --a gas-treatment-- in order to clarify the claim.
In claim 9, line 2, the term “an HME” is suggested to be changed to --a heat and moisture exchange (HME)-- in order to clarify the claim.
In claims 9, 10, 11, 12, 13 and 14, line 1, the term “A gas-treatment device” suggested to be changed to --The gas-treatment device-- in order to clarify the claim.
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: the limitations “an gas-treatment element” (claim 8, line 1, the term “element” is a generic placeholder and the function is “gas-treatment”), “a manually-displaceable member that in a first position blocks the second gas-flow passage and reveals the first gas-flow passage so that all gas flow passes through the gas-treatment element and in a second position blocks the first gas-flow passage and opens the second gas-flow passage so that all gas flow by-passes the gas-treatment element and passes through the second gas-flow passage” (claim 8, lines 4-8, the term “element” is a generic placeholder and the function is “in a first position blocks the second gas-flow passage and reveals the first gas-flow passage so that all gas flow passes through the gas-treatment element and in a second position blocks the first gas-flow passage and opens the second gas-flow passage so that all gas flow by-passes the gas-treatment element and passes through the second gas-flow passage”), “an HME element” (claim 9, line 2, the term “element” is a generic placeholder and the function is HME in light of the specification and the meaning of “HME”, which represent “heat moisture exchange”), and “a planar member that is movable in the plane of the planar member” (claim 11, line 2, the term “member” is a generic placeholder and the function is “that is movable in the plane of the planar member”).
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“an gas-treatment element”: is preferably an HME element or a filter, see page 2, last two lines of the specification filed on 8/16/2023.
“a manually-displaceable member”: manually-displaceable member 30 takes the form of a shutter 30 having a curved plate 31 and knob 32, see page 6, first paragraph of the specification filed on 8/16/2023 or 201 in page 7, last paragraph of the specification filed on 8/16/2023.
“an HME element”: HME element 26, can be made from material such as foam or hollow fibers, see page 7 of the specification filed on 8/16/2023.
“a planar member”: curved plate in page 6, first paragraph of the specification filed on 8/16/2023 or 201 in page 7, last paragraph of the specification filed on 8/16/2023.
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 10-14 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 pre-AIA the applicant regards as the invention.
Regarding claim 10, the limitation “which in its first position blocks the second gas-flow passage and in its second position blocks the first gas-flow passage” (lines 2-3) is unclear as to what structure is being referred to by the term “which” (line 2 of claim 10) and “its” (lines 2 and 3 of claim 10). Furthermore, it is unclear if the first position and the second position are referring to “a first position” (claim 8, line 4) and “a second position” (claim 8, line 6) or different positions.
Regarding claim 11, the limitation “the plane” (line 2) lacks proper antecedent basis.
Regarding claim 12, the limitation “pivoted about an axis at right angles to the plane” (line 2) is unclear as to how to determine the metes and bounds of the limitation, specifically, it is unclear and confusing as to how there are multiple right angles between an axis and a plane.
Regarding claim 13, the limitation “the shutter can be moved” (line 3) is unclear as to how to determine the metes and bounds of the limitation because the term “can” can be defined as providing possibility, therefore, it is unclear if the shutter can or cannot be moved.
Regarding claim 14, the limitation “the manually-displaceable member is a first part of the housing of the device including a gas inlet” (lines 1-2) is unclear as to what structure is including the gas inlet, the manually-displaceable member/the first part or the housing of the device or the device.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 8-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Collazo (2013/0068219).
Regarding claim 8, Collazo discloses a gas-treatment device (entire device 100 shown in figs. 1-6B and paragraphs 0024-0029) including a gas-treatment element (170, fig. 2, paragraphs 0024 and 0029) in a housing (120 and 130 or 120, 130 and the manually displaceable member (150, 152, 180, 190, 160, 168, 161, 166), figs. 1-6B and paragraphs 0024-0025), characterised in that the device has a first gas-flow passage through the device via the gas-treatment element (the first gas-flow passage is the pathway 132 where 170 is positioned within and including the passage formed by 170, see fig. 2 with reference to figs. 5A and 5B and paragraph 0024), a second gas-flow passage through the device that by-passes the gas-treatment element (the second-gas flow passage is the pathway 134, see fig. 2 with reference to figs. 5A and 5B and paragraph 0024), and a manually-displaceable member (150, 152, 180, 190, 160, 168, 161, 166, fig. 2 with reference to fig. 5A and paragraphs 0025-0026) that in a first position blocks the second gas-flow passage and reveals the first gas-flow passage so that all gas flow passes through the gas-treatment element (fig. 5A and paragraphs 0025-0029) and in a second position blocks the first gas-flow passage and opens the second gas-flow passage so that all gas flow by-passes the gas-treatment element and passes through the second gas-flow passage (see fig. 5B, paragraphs 0025-0029).
Regarding claim 9, Collazo discloses that the gas-treatment element is an HME element (170, fig. 2-5A and paragraph 0024 and 0029).
Regarding claim 10, Collazo discloses that the manually-displaceable member (150, 152, 180, 190, 160, 168, 161, 166, fig. 2 with reference to fig. 5A and paragraphs 0025-0026) includes a movable shutter (160 and 150, figs. 2-6B), which in its first position blocks the second gas-flow passage (see fig. 5A) and in its second position blocks the first gas-flow passage (see fig. 5B, paragraphs 0025-0029).
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Regarding claim 11, Collazo discloses that the shutter (160 and 150) includes a planar member (160) that is movable in the plane of the planar member (see the annotated-Collazo fig. 6B above, as shown, the plane can be defined by a surface of 161, when 161 pivots, the planar member would be movable in the plane, see figs. 5A-5B and paragraphs 0025-0029).
Regarding claim 12, Collazo discloses that the shutter (160 and 150) is pivoted about an axis at right angles to the plane of the planar member (160, axis that the shutter pivots about can be defined as an axis at right angle to the plane, see the annotated-Collazo fig. 6B above and figs. 5A-5B and paragraphs 0025-0029).
Regarding claim 13, Collazo discloses that the shutter (160 and 150) includes a manually-rotatable knob (150, figs. 1-6B and paragraphs 0025-0029) mounted with the planar member (160) and aligned with the pivot axis so that the shutter can be moved between the first and second positions by rotating the knob (see figs. 1-6B and paragraphs 0025-0029).
Regarding claim 14, Collazo discloses that the manually-displaceable member (150, 152, 180, 190, 160, 168, 161, 166, figs. 1-6B) is a first part of the housing (120, 130 and the manually-displaceable member) of the device including a gas inlet (the housing includes an inlet 136 formed by 130, 136 is an inlet relative to a ventilator flow, alternatively 138 can be an inlet relative to a patient’s expiratory flow, fig. 2, paragraphs 0024-0025, the claim is being interpreted as the housing comprising the gas inlet), and that the first part is rotatable relative to a second part (130 or 120, figs. 1-6B and paragraphs 0025-0029) of the housing between a first position in which the gas inlet on the first part forms a gas connection with the gas-treatment element (170) and a second position in which the gas inlet on the first part forms a gas connection with the second gas-flow passage that by-passes the gas-treatment element (see figs. 1-6B and paragraphs 0024-0029, in either positions, relatively, the inlet (136 of 138) can be viewed as being mounted on the first part (manually-displaceable member), therefore, is “on the first part”, it is noted that the claim does not claim that the first part is what comprises the gas inlet).
Claims 8-11 and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shirley (2020/0405994).
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Regarding claim 8, Shirley discloses a gas-treatment device (entire device shown in figs. 10, 11A and 11B, paragraphs 0047-0053) including a gas-treatment element (1013/1105, fig. 10, paragraphs 0049-0050) in a housing (1001, 1003, 1021, 1012, 1015, 1017, 1009, 1023, 1025a, 1019, 1008, 1007, 1005, fig. 10, paragraphs 0049-0050), characterised in that the device has a first gas-flow passage through the device via the gas-treatment element (the first gas-flow passage is the passage where the HME foam 1013/1105 is positioned within and including the passage within the HME foam, see figs. 10-11B), a second gas-flow passage through the device that by-passes the gas-treatment element (second gas-flow passage is 1017, figs. 10-11B and paragraph 0050), and a manually-displaceable member (1009 comprising 1023, 1019, 1025a, 1104 and inlet, see the annotated-Shirley figs. 11A-11B) that in a first position blocks the second gas-flow passage and reveals the first gas-flow passage so that all gas flow passes through the gas-treatment element (see fig. 11A for first position) and in a second position blocks the first gas-flow passage and opens the second gas-flow passage so that all gas flow by-passes the gas-treatment element and passes through the second gas-flow passage (see fig. 11B for second position, paragraphs 0049-0053).
Regarding claim 9, Shirley discloses that the gas-treatment element is an HME element (1013/1105, fig. 10, paragraphs 0049-0050).
Regarding claim 10, Shirley discloses that the manually-displaceable member includes a movable shutter (see the annotated-Shirley figs. 11A-11B above and paragraph 0052), which in its first position blocks the second gas-flow passage (second gas-flow passage is 1017, figs. 10-11B and paragraph 0050) and in its second position blocks the first gas-flow passage (the first gas-flow passage is the passage where the HME foam 1013/1105 is positioned within and the passage within the HME foam, see figs. 11A-11B and paragraphs 0052-0053).
Regarding claim 11, Shirley discloses that the shutter includes a planar member (1104) that is movable in the plane of the planar member (the plane is formed by 1104, see the annotated-Shirley figs. 11A-11B above, the planar member can be moved in the plane when the entire device is moved, alternatively, when 1109 is being rotated relative to 1001, 1104 would move in the plane, see paragraphs 0050-0053).
Regarding claim 14, Shirley discloses that the manually-displaceable member (1009) is a first part of the housing (1001, 1003, 1021, 1012, 1015, 1017, 1009, 1023, 1025a, 1019, 1008, 1007, 1005, fig. 10, paragraphs 0049-0050) of the device including a gas inlet (see the annotated-Shirley figs. 11A-11B above, the gas inlet is interpreted as part of the first part 1009), and that the first part is rotatable relative to a second part (1001, figs. 10-11B and paragraphs 0049-0051) of the housing between a first position in which the gas inlet on the first part forms a gas connection with the gas-treatment element (1013/1105) and a second position in which the gas inlet on the first part forms a gas connection with the second gas-flow passage that by-passes the gas-treatment element (see the annotated-Shirley figs. 11A-11B and paragraphs 0049-0053).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 8-9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 6-10 of Co-pending US Patent Application No. 18/281,701.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the co-pending claims are minor and obvious from each other. For example, the instant claims 8-9 are a broader version of the co-pending claims 6-10 (i.e., the instant claims 8-9 do not include the at least two parts that can be manually connected or disconnected as in the co-pending claims 6-10). In the instant claims 8-9, the device included in the co-pending claims 6-10. Any infringement over the co-pending claims would also infringe over the instant claims. Therefore, the instant claims 8-9 do not differ in scope from the co-pending claims 6-10.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Claims 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10 of Co-pending US Patent Application No. 18/281,701.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the difference between the instant claims and the co-pending claim are minor and obvious from each other. For example, the instant claims 10-11 are a broader version of the co-pending claim 10 (i.e., the instant claims 10-11 do not include the at least two parts that can be manually connected or disconnected as in the co-pending claim 10). In the instant claims 10-11, the device included in the co-pending claim 10. Any infringement over the co-pending claims would also infringe over the instant claims. Therefore, the instant claims 10-11 do not differ in scope from the co-pending claim 10.
Following the rationale in In re Goodman, cited above, where applicant has once been granted a patent containing a claim for the specific or narrower invention, applicant may not then obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Korneff (2009/0301476) is cited to show an HME device comprising a knob.
Marler (7,347,203) (2004/0123974) is cited to show an HME device comprising a knob and a shutter.
Muhlbauer (11,351,327) (12,138,394) is cited to show an HME device.
Walstrom (7,624,731)(2006/0219243) is cited to show an HME device comprising a bypass mechanism.
Shirley (12,168,098) is cited to show an HME device having a bypass mechanism.
Burk (2006/0157056) is cited to show an HME device having a bypass mechanism.
Waldo (7,069,928) is cited to show an HME device comprising a bypass mechanism.
Waldo (6,792,946) is cited to show an HME device comprising a bypass mechanism.
Diehl (6,588,421) is cited to show an HME device bypass system.
Ryder (6,550,476) is cited to show an HME device.
Rosenkeotter (5,590,644) is cited to show an HME device.
Harwood (11,759,594) is cited to show an HME device.
Fenley (7,634,998) is cited to show an HME shuttle system.
Halperin (2004/0084046) is cited to show a bypass heat and moisture exchange unit.
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/TU A VO/Primary Examiner, Art Unit 3785