DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
This office action is responsive to the amendment filed on April 21, 2023. As directed by the amendment: claims 29, 31-34, 38, 40-42, 44-48, and 51 have been amended, claims 1-26 have been canceled, and no new claims have been added. Thus, claims 27-51 are presently pending in the application.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it contains the terms “comprising” in line 1 and “comprises” in line 3, which are terms considered claim terminology that should be avoided.
Correction is required. See MPEP § 608.01(b).
Claim Objections
Claim 31 is objected to because of the following informalities:
In claim 31, line 3 should read --…to provide electrical energy to the electrical energy storage device” to correct a typographical error.
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:
“a seal forming structure” in claims 27, 34, and 43
“a positioning and stabilizing structure” in claims 27, 34, 43, and 47
“an electrical energy storage device” in claims 29-31 and 33
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 38, 39, and 42-51 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.
Claim 38 recites the limitation "the sealed stator assembly" in line 2 and “the plurality of coils” in line 2. There is insufficient antecedent basis for these limitations in the claim.
Claim 42 recites the limitation "the at least one energy harvesting device" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 48 recites the limitation "the at least one energy harvesting system" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claims 39, 43-47, and 49-51 are rejected based solely on their dependency to rejected claims.
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 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 27-30, 32-35, 40-43, 45, and 46 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Connor (US 2012/0234323).
As to claim 27, Connor discloses a patient interface (Fig. 4, Fig. 5) comprising:
a plenum chamber 401 (the mask body interior, see Fig. 4, Fig. 5) pressurisable to a therapeutic pressure of at least 6 cmH2O above ambient air pressure (positive air way pressure mask 401, paragraph [0083], is capable of being pressurized to the claimed pressure level which is a well-known pressure level for CPAP masks), said plenum chamber 401 including a plenum chamber inlet port 402 (Fig. 5) sized and structured to receive a flow of air at the therapeutic pressure for breathing by a patient 101 (paragraph [0090]);
a seal-forming structure (edge of mask body 401 that touches and seals against the patient’s face, see Fig. 4, Fig. 5, paragraph [0083]) constructed and arranged to form a seal with a region of the patient's face surrounding an entrance to the patient's airways, said seal-forming structure having a hole therein such that the flow of air at said therapeutic pressure is delivered to at least an entrance to the patient's nares, the seal-forming structure constructed and arranged to maintain said therapeutic pressure in the plenum chamber 401 throughout the patient's respiratory cycle in use (Fig. 4, Fig. 5 paragraph [0083]);
a positioning and stabilising structure (straps) to provide a force to hold the seal-forming structure in a therapeutically effective position on the patient's head (paragraph [0084]: the mask may be held against the face by straps); and
a power system 601 (Fig. 6) for converting energy generated during use of the patient interface to converted electrical energy for powering at least one portion of the patient interface (paragraph [0126]), wherein the energy generated during use of the patient interface is one or more of: mechanical energy generated by or during breathing; mechanical energy generated by movement of the patient; mechanical energy from air flow within the patient interface; and thermal energy from the patient's skin and/or exhaled air (Fig. 6, paragraph [0129]-[0131]: kinetic/mechanical energy from exhaled gas is transduced into rotational energy via the impeller 603 and used to generate electricity via generator 605, which is stored in battery 609; paragraph [0132]: the stored energy can then be used by control mechanism 610 to drive impeller 603 in the opposite direction and increase gas flow during inhalation).
As to claim 28, Connor discloses a patient interface according to claim 27, wherein the power system 601 (Fig. 6) provides a DC voltage (from battery 609) to the at least one portion of the patient interface 401 (paragraph [0130]).
As to claim 29, Connor discloses a patient interface according to claim 27, wherein the at least one portion of the patient interface 401 is an electrical energy storage device (battery 609) electrically connected to the power system 601 and configured to provide electrical energy to the power system (see Fig. 6, paragraph [0130]).
As to claim 30, Connor discloses a patient interface according to claim 29, wherein the power system 601 is configured to provide the converted electrical energy to the electrical energy storage device 609 to recharge the electrical energy storage device 609 (Fig. 6, paragraph [0130]).
As to claim 32, Connor discloses a patient interface according to claim 29, wherein:
the at least one portion of the patient interface further includes one or more electronic components for monitoring, diagnosing and/or treating the patient (control mechanism 610, Fig. 6, paragraph [0132]), and
the one or more electronic components 610 receives electrical energy directly from the power system (paragraph [0132]: the control mechanism (610) is powered by the battery (609), the battery 609 being considered part of the claimed power system).
As to claim 33, Connor discloses a patient interface according to claim 29,
the at least one portion of the patient interface further includes one or more electronic components 610 for monitoring, diagnosing and/or treating the patient (control mechanism 610, Fig. 6, paragraph [0132]), and
the one or more electronic components 610 receives electrical energy directly from the electrical energy storage device 609 (paragraph [0132]: the control mechanism (610) is powered by the battery (609)).
As to claim 34, Connor discloses a patient interface according to claim 27,
As to claim 35, Connor discloses a patient interface according to claim 34, wherein the power system 601 (Fig. 6) comprises at least one energy-harvesting device (impellor 603, generator 605, battery 609), wherein the at least one energy-harvesting device comprises a turbine generator (paragraph [0089]).
As to claim 40, Connor discloses a patient interface according to claim 35, wherein the turbine generator is positioned in air inlet 402 of the patient interface, upstream from the patient in use (see Fig. 4 at gas channel 402, paragraph [0120]).
As to claim 41, Connor discloses a patient interface according to claim 35, wherein the turbine generator is positioned in air outlet of the patient interface, downstream from the patient in use (in Fig. 4 and Fig. 6, the inlet and outlet of the mask are through the same opening/channel 402, 602 (paragraph [0120],[0123]).
As to claim 42, Connor discloses a patient interface according to claim 34, wherein the at least one energy-harvesting device comprises at least one piezoelectric film (see paragraph [0110]).
As to claim 43, Connor discloses a patient interface according to claim 42, wherein at least one said piezoelectric film 605 is attached to or disposed within the plenum chamber and/or the seal-forming structure and/or the positioning and stabilising structure (see Fig. 4 at gas channel 402, paragraph [0120]).
As to claim 45, Connor discloses a patient interface according to claim 42, wherein the piezoelectric film 605 is positioned in air inlet of the patient interface 401, upstream from the patient in use (see Fig. 4 at gas channel 402, paragraph [0120]).
As to claim 46, Connor discloses a patient interface according to claim 42, wherein the piezoelectric film is positioned in air outlet of the patient interface, downstream from the patient in use (in Fig. 4 and Fig. 6, the inlet and outlet of the mask are through the same opening/channel 402, 602 (paragraph [0120],[0123]).
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 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.
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 2012/0234323), in view of Kassatly et al. (US 2014/0332010).
As to claim 31, Connor discloses a patient interface according to claim 29, but does not expressly disclose an external charging circuit electrically connected to the electrical energy storage device and configured to provide electrical energy to electrical energy storage device.
However, Kassatly teaches a discontinuous positive air way pressure device (DPAP 1500, Fig. 15A) powered by an electric energy storage device (self-rechargable battery 1616, Fig. 16) and an external charging circuit electrically connected to the electrical energy storage device 1616 and configured to provide electrical energy to electrical energy storage device 1616 (rechargable battery 1616 can be recharged by a solar charger 1630 or an external charger directly, see Fig. 16, paragraph [0148]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Connor to include an external charging circuit, as taught by Kassatly, in order to provide a direct means of recharging the battery, as a backup in the case that the energy harvesting system lacks enough energy to fully power the system.
Claims 36-39 are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 2012/0234323), in view of Vogel (US 4,204,810).
As to claim 36, Connor discloses a patient interface according to claim 35, wherein the turbine generator comprises a rotor (shaft 604) that comprises a plurality of turbine blades (see Fig. 6, paragraph [0124]), but does not disclose a plurality of magnets disposed around a periphery of the rotor.
However, Vogel teaches a rotor/stator arrangement 100/102 (for pump 20, see Fig. 5) comprising a rotor 102 that comprises a plurality of magnets 188, 190 (Fig. 8) disposed around a periphery of the rotor 102 (Fig. 5, Fig. 8, col. 8, ln. 41-50: plurality of magnetic sectors 188, 190 of alternating north and south polarity). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Connor so that the turbine generator has a rotor/stator arrangement with a plurality of magnets disposed around the rotor, as taught by Vogel, in order to provide a suitable known type of rotor/stator assembly that would perform equally well in the turbine generator of Connor for converting the mechanical energy into electrical energy.
As to claim 37, modified Connor discloses a patient interface according to claim 36, wherein the turbine generator comprises a sealed stator assembly (stator core assembly 100, see Vogel, Fig. 5, Fig. 8) housing a plurality of coils 133 (see Vogel, Fig. 5, col. 7, ln. 60-68), the sealed stator assembly 100 being disposed about the rotor 102 (see Vogel, Fig. 2, Fig. 8, col. 7, ln. 11-15).
As to claim 38, Connor discloses a patient interface according to claim 36, wherein the sealed stator assembly 100 further includes a plurality of bobbins 132, the plurality of coils 133 wrapped around the plurality of bobbins 132 (see Vogel, Fig. 5, col. 7, ln. 60-68).
As to claim 39, Connor discloses a patient interface according to claim 38, wherein a number of bobbins in the plurality of bobbins 132 is equal to a number of magnets 188, 190 in the plurality of magnets (see Vogel, Fig. 5 shows four bobbins 132 and Fig. 8 shows four sets of N-S magnet sectors 188, 190).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 2012/0234323), in view of Shen et al. (US 2015/0297849).
As to claim 44, Connor discloses a patient interface of claim 42, wherein said piezoelectric film is a sensor and is configured to measure patient snoring by sensing vibration and/or noise.
However, Connor does disclose detecting airway obstructions with sensors so that the increased airway pressure assistance can be limited to the respiratory cycles that indicate the presence of an obstruction or snoring (see paragraphs [0096]-[0097]).
Furthermore, Shen teaches a patient interface 10 (Fig. 1) having a piezoelectric sensor 130 for measuring patient snoring by sensing vibration of the patient’s airways (paragraph [0035]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Connor to include a piezoelectric film sensor, as taught by Shen, in order to provide the means for detecting snoring so that the positive pressure can be timed with the patient’s needs and energy can be conserved during the times the patient is breathing normally.
Claims 48 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 2012/0234323), in view of Kertser (US 2020/0009344).
As to claim 48, Connor discloses a patient interface according to claim 34, but does not disclose that the at least one energy-harvesting system comprises at least one thermoelectric generator (TEG) module. However, Kertser teaches a patient interface 400 (Figs. 4a-4b) including an energy harvesting system comprising at least one thermoelectric generator (TEG) module 450 (Fig. 4b, paragraphs [0087],[0055]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Connor to include at least one thermoelectric generator module as part of the energy harvesting system, as taught by Kertser, in order to provide an alternative or additional means for generating electrical energy without an external power source.
As to claim 49, modified Connor discloses a patient interface according to claim 48, wherein at least one TEG module 450 is at least partially exposed and is arranged to contact skin of the patient (see Kertser, Fig. 4b, paragraph [0087]).
Claim 50 is rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 2012/0234323), in view of Kertser (US 2020/0009344), as applied to claims 27, 34, 48, and 49 above, and further in view of Schneider et al. (US 2014/0299169).
As to claim 50, modified Connor discloses a patient interface according to claim 49, but does not disclose that the at least one TEG module is disposed within the positioning and stabilising structure. However, Schneider teaches a wearable energy harvesting system 111 having a thermoelectric generator module 10 positioned within a strap or headband (see Figs. 3-4, paragraphs [0042],[0006]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of modified Connor so that the thermoelectric generator is positioned within the positioning and stabilizing structure (straps), as taught by Schneider, in order to provide a suitable alternative or additional location for the generator where it can be in contact with the patient’s skin to utilize the patient’s body heat to generate electricity.
Claims 48 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Connor (US 2012/0234323), in view of Wisniewski (US 2022/0219026).
As to claim 48, Connor discloses a patient interface according to claim 34, but does not disclose that the at least one energy-harvesting system comprises at least one thermoelectric generator (TEG) module. However, Wisniewski teaches an energy harvesting system for a mask 1 comprising at least one thermoelectric generator (TEG) module 2 (Figs. 1-3, paragraph [0013]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the patient interface of Connor to include at least one thermoelectric generator module as part of the energy harvesting system, as taught by Wisniewski, in order to provide an alternative or additional means for generating electrical energy without an external power source.
As to claim 51, modified Connor discloses a patient interface according to claim 48, wherein at least one TEG module is arranged such that a first surface of said TEG module is exposed to an interior of the plenum chamber, and a second surface that is opposite the first surface is exposed to ambient (see Wisniewski, Figs 1-3, paragraph [0009],[0013], the thermoelectric generator 2 utilizes the temperature difference between the air inside the mask 1 and the surrounding ambient air).
Allowable Subject Matter
Claim 47 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Bowditch et al. (US 2010/0170513) discloses a patient interface having a turbine that serves to store energy from the air flow.
Barlow et al. (US 2014/0137870) discloses a patient interface having a PAP system powered by energy harvested from kinetic energy from the patient’s movements during sleep, or from heat or other chemical reaction from the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached on Monday - Friday 8:30 am - 4:30 pm.
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, KENDRA CARTER can be reached on 571-272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785