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 Objections
Claim(s) 4 is/are objected to because of the following informalities:
Claim 4 needs a comma at the end of its preamble
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 10, 13 and 15 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 10 recites the limitation “the at least one bacteria sensor is a condensate forming sensor, wherein the condensate forming sensor is configured to detect bacteria in condensation formed on the condensate forming sensor.” The specification only generically discusses a sensor 400 at various places within the apparatus 1000 (Pg. 6, Ln. 12-25). The specification’s discussion of condensate forming sensor 400a’’ is found at Pg. 11, Ln. 27 to Pg. 12, Ln. 26. The location discussion for condensate forming sensor 400a’’ in that section is clearly at humidification compartment 120. The location shown for condensate forming sensor 400a’’ in Fig. 2 is consistent with that particular location. Additionally, the condensate forming sensor 400a’’ is discussed as needing to include a first portion/part 410 exposed to ambient temperature, which is not a configuration reasonably expected to be applied to tube 200. One of ordinary skill in the art would not consider there to be any reasonable discussion in the originally filed application to indicate that condensate forming sensor 400a’’ would be specifically placed within tube 200 as opposed to instead in communication with humidification compartment 120. Additionally, there is no consideration in the originally filed claims of the parent application of this particularly claimed sensor location. There is thus lack of sufficient written description support in the application as originally filed for the particularly claimed sensor of the instant claim being located specifically within a breathing tube.
Claim 13 recites the limitation “the at least one bacteria sensor is a physical sensor configured to indicate bacteria on the at least one bacteria sensor.” The specification only generically discusses a sensor 400 at various places within the apparatus 1000 (Pg. 6, Ln. 12-25). The specification’s discussion of physical sensor 400b is found at Pg. 13, Ln. 13 to Pg. 15, Ln. 9. The physical sensor 400b is discussed as able to be located at any suitable location within the breathing treatment apparatus 1000 at any suitable location within the breathing treatment apparatus 1000 and specifically discusses the suitable locations of the underside of the lid 140, the lid of the humidification compartment 120 or a cartridge 450. There is nothing in the specification to indicate tube 200 would have been considered a “suitable location” for the particular structure discussed in the specification or physical sensor 400b. Further, when a sensor of tube 200 is specifically discussed only electronic sensor 400a is mentioned, because of the difficult to access location within tube 200, while other locations which are readily visible are discussed as instead able to receive either electronic sensor 400a or physical sensor 400b (Pg. 6, Ln. 26-30). One of ordinary skill in the art would not consider there to be any reasonable discussion in the originally filed application to indicate that physical sensor 400b would be specifically placed within tube 200 as opposed to other suitable locations within apparatus 1000. Additionally, there is no consideration in the originally filed claims of the parent application of this particularly claimed sensor location. There is thus lack of sufficient written description support in the application as originally filed for the particularly claimed sensor of the instant claim being located specifically within a breathing tube.
Claim 15 recites the limitation “the first bacteria sensor is an electronic bacteria sensor and the second bacteria sensor is a physical bacteria sensor.” The specification only generically discusses a sensor 400 at various places within the apparatus 1000 (Pg. 6, Ln. 12-25). The specification’s discussion of physical sensor 400b is found at Pg. 13, Ln. 13 to Pg. 15, Ln. 9. The physical sensor 400b is discussed as able to be located at any suitable location within the breathing treatment apparatus 1000 at any suitable location within the breathing treatment apparatus 1000 and specifically discusses the suitable locations of the underside of the lid 140, the lid of the humidification compartment 120 or a cartridge 450. There is nothing in the specification to indicate tube 200 would have been considered a “suitable location” for the particular structure discussed in the specification or physical sensor 400b. Further, when a sensor of tube 200 is specifically discussed only electronic sensor 400a is mentioned, because of the difficult to access location within tube 200, while other locations which are readily visible are discussed as instead able to receive either electronic sensor 400a or physical sensor 400b (Pg. 6, Ln. 26-30). One of ordinary skill in the art would not consider there to be any reasonable discussion in the originally filed application to indicate that physical sensor 400b would be specifically placed within tube 200 as opposed to other suitable locations within apparatus 1000. Additionally, there is no consideration in the originally filed claims of the parent application of a physical bacteria sensor at the claimed location. There is thus lack of sufficient written description support in the application as originally filed for the particularly claiming of a physical bacteria sensor being located specifically within a breathing tube.
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.
Claim(s) 12 is/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 12 recites the limitation “the at least one bacteria sensor comprises a filter to filter out particles over a predetermined size” which deems the claim indefinite. The only structure positively recited of the bacteria sensor is a filter. This creates confusion because a filter is not ordinarily considered to be a sensor. Because no sensor structure has been positively recited the claim is indefinite as it is unclear whether applicant is intending an overly broad meaning of the term “sensor” (e.g. as only a bacterial filter) or whether the claim has merely omitted reciting the specific structure of the bacteria filter. (Note that a bacteria sensor has no commonly recognizable structure, as opposed to such other sensor types as a pressure sensor or a flow sensor.) The disclosure of the instant application indicates the claimed filter as only present when the bacteria sensor is specifically an electronic sensor (Pg. 11, Ln. 8-9). It is thus suggested to make the instant claim depend on claim 3.
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 conflicting claims 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); 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 nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) 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 www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 2 and 16 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,395,859. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of instant claim 2 are found within the overall scope of patent claim 15, the instant claim merely being broader in scope.
Instant claim 16 as obvious in view of patent claim 15 – one of ordinary skill in the art would not have expected the only suitable location along the breathing tube for the at least one bacteria sensor to be at its end which connects to a patient interface. Any other suitable location on the breathing tube renders the instant claim as prima facie obvious in comparison to patent claim 15.
Claim(s) 2, 13 and 16 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 18 of U.S. Patent No. 11,975,119. Although the claims at issue are not identical, they are not patentably distinct from each other because all limitations of instant claim 2 are found within the overall scope of patent claim 18, the instant claim merely being broader in scope.
Instant claim 13 vs. limitations in patent claim 1
Instant claim 16 as obvious in view of patent claim 18 – one of ordinary skill in the art would not have expected the only suitable location along the breathing tube for the at least one bacteria sensor to be at its end which connects to a patient interface. Any other suitable location on the breathing tube renders the instant claim as prima facie obvious in comparison to patent claim 18.
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.
Claim(s) 2-5, 9 and 13-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goodall et al. (U.S. Pub. 2012/0209090).
Regarding claim 2, Goodall discloses a breathing tube (¶0109 – e.g. endotracheal tube) for use in a breathing treatment apparatus (endotracheal tubes are used with a ventilator), the breathing tube comprising: a gas flow path configured to convey breathing gases to a patient (function of an endotracheal tube), and at least one bacteria sensor (e.g. Fig. 2A #302 when used in an endotracheal tube; ¶¶0116-0117, 0120-0121, 0129-0130, 0212-0214) configured to detect bacterial growth in the gas flow path. It is noted that the breathing treatment apparatus is not read as positively recited.
Regarding claim 3, Goodall discloses the at least one bacteria sensor is an electronic sensor (e.g. ¶¶0116-0117, 0120-0121) configured to detect bacteria on or near the at least one bacteria sensor.
Regarding claim 4, Goodall discloses the at least one bacteria sensor is configured to transmit a signal to a control system of the breathing treatment apparatus (Fig. 3; ¶0366) when the at least one bacteria sensor detects bacteria in the gas flow path. It is noted that the breathing treatment apparatus is not read as positively recited.
Regarding claim 5, Goodall discloses the electronic sensor comprises an electronic sensor ID (¶¶0217, 0382, 0452) that is associated with a positioning code that indicates a location (¶¶0281, 0397, 0446, 0452) of the at least one bacteria sensor in the breathing tube, wherein the electronic sensor is configured to transmit the electronic sensor ID to the control system of the breathing treatment apparatus (¶¶0217, 0382, 0452).
Regarding claim 9, Goodall discloses the at least one bacteria sensor is an electrochemical biosensor (¶¶0224-0227).
Regarding claim 13, Goodall discloses the at least one bacteria sensor is a physical sensor (¶¶0214-0232) configured to indicate bacteria on the at least one bacteria sensor. The claim has no concern for how the physical parameter is sensed. Some of the disclosed forms for sensor 302 determine such values as physical quantity, pH and targeted binding, each of which requires a physical interaction.
Regarding claim 14, Goodall discloses the at least one bacteria sensor comprises a first bacteria sensor and a second bacteria sensor (¶¶0217-0232).
Regarding claim 15, Goodall discloses the first bacteria sensor is an electronic bacteria sensor (¶¶0217-0232) and the second bacteria sensor is a physical bacteria sensor (¶¶0217-0232). The claim has no concern for how the physical parameter is sensed. Some of the disclosed forms for sensor 302 determine such values as physical quantity, pH and targeted binding, each of which requires a physical interaction.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (U.S. Pub. 2012/0209090).
Regarding claim 6, Goodall discloses the at least one bacteria sensor is configured to transmit a signal to a control system of the breathing treatment apparatus when the at least one bacteria sensor detects a quantity of bacteria (¶¶0214-0215).
Goodall is silent as to transmitting a signal when the at least one bacteria sensor detects a quantity of bacteria above a predetermined threshold.
However, several notes are made. Firstly, the claim does not limit the transmitting of a signal to only when the at least one bacteria sensor detects a quantity of bacteria above the predetermined threshold. Thus, as long a quantity of bacteria is detected its presence as a positively recognized quantity of bacteria can be considered to be above a predetermined threshold and the sensor’s regular communication can be considered as transmitting a signal. Further, Goodall discusses a particular interest in measuring either a physical quantity or a relative quantity (¶¶0214-0215). One of ordinary skill in the art would have considered it prima facie obvious that certain safety parameters would be put into place such that when sensor 302 detects a particular elevated level that elevated level would initiate some form of warning or alarm (e.g. ¶0368) which can be at least indirectly related to the presently recited signal transmission. The instant claim thus fails to patentably distinguish over Goodall.
Regarding claim 7, Goodall is silent as to whether the at least one bacteria sensor is configured to operate continuously.
However, Goodall teaches the sensor 302 as providing real-time data (¶0259). One of ordinary skill in the art would have considered it prima facie obvious that real-time data collection in one form would be provided in a continuous manner of sensing. Further, the instant claims indicate that the difference between sensing continuously (the instant claim) and sensing intermittently at fixed time intervals (claim 8) is merely a matter of design choice. The instant claim thus fails to patentably distinguish over Goodall.
Regarding claim 8, Goodall is silent as to whether the at least one bacteria sensor is configured to operate at fixed time intervals.
However, Goodall teaches the sensor 302 as providing real-time data (¶0259). One of ordinary skill in the art would have considered it prima facie obvious that real-time data collection in one form would be provided at fixed time intervals based upon the sampling rate of the sensor. Further, the instant claims indicate that the difference between sensing continuously (claim 7) and sensing intermittently at fixed time intervals (the instant claim) is merely a matter of design choice. The instant claim thus fails to patentably distinguish over Goodall.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Goodall et al. (U.S. Pub. 2012/0209090) in view of Ahmad et al. (U.S. Pub. 2008/0053194).
Regarding claim 12, Goodall fails to disclose the at least one bacteria sensor comprises a filter to filter out particles over a predetermined size.
Ahmad teaches a breath sensor (Fig. 1; ¶0091) including a filter (¶0125) to filter out particles over a predetermined size prior to interaction with the breath sensor. Ahmad teaches a filter as providing the benefit of removing moisture prior to interaction with a sensor (¶0125).
It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the invention to have incorporated in Goodall the at least one bacteria sensor comprises a filter to filter out particles over a predetermined size in order to provide the benefit of removing moisture prior to interaction with the bacteria sensor in view of Ahmad.
Allowable Subject Matter
Claim(s) 10 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 1st paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claim(s) 11 and 16 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims. Claim 16 is solely rejected based upon the above nonstatutory double patenting rejections.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 10, Goodall fails to teach or suggest the at least one bacteria sensor is a condensate forming sensor, wherein the condensate forming sensor is configured to detect bacteria in condensation formed on the condensate forming sensor. There is no consideration in the many possible sensor configurations of Goodall of a bacteria detecting sensor which operates to form condensation in order to perform its function of detecting bacterial growth.
Note is made of the narrowness of claim 2 where a bacteria sensor is used within a breathing tube of a breathing treatment apparatus to detect bacterial growth within the breathing tube. Based upon that claim language a prior art which detects oral bacteria in a patient’s exhaled breath (Pearce et al. – U.S. Pub. 2003/0105407; ¶0125 or Ahmad et al. – U.S. Pub. 2008/0053194; ¶0065 and included Table) would not be sufficient to read on the claimed detecting of bacterial growth within the breathing tube.
Note is further made of the 35 U.S.C. 112(a) of the instant claim and the apparent failure to provide sufficient written description support in the originally filed application for the particularly claimed sensor of the instant claim being located within a breathing tube.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 11, Goodall fails to teach or suggest the at least one bacteria sensor is a smell sensor configured to detect odors caused by bacterial colonies. There is no consideration in the many possible sensor configurations of Goodall of a bacteria detecting sensor which operates by detecting odors caused by bacterial colonies to perform its function of detecting bacterial growth.
Note is made of the narrowness of claim 2 where a bacteria sensor is used within a breathing tube of a breathing treatment apparatus to detect bacterial growth within the breathing tube. Based upon that claim language a prior art which detects oral bacteria in a patient’s exhaled breath (Pearce et al. – U.S. Pub. 2003/0105407; ¶0125 or Ahmad et al. – U.S. Pub. 2008/0053194; ¶0065 and included Table) would not be sufficient to read on the claimed detecting of bacterial growth within the breathing tube.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Regarding claim 16, Goodall fails to teach or suggest the at least one bacteria sensor is spaced away from an end of the breathing tube configured to connect to a patient interface. The sensor 302 of Goodall is always discussed as applied to a catheter device. In terms of “breathing” situations the examples provided by Goodall for the catheter device are endotracheal tubes and tracheostomy tubes (¶0109). While an endotracheal tube or a tracheostomy tube can be broadly read as a breathing tube in the context of the instant claim the endotracheal tube or tracheostomy tube would better be understood to correspond to the recited patient interface. An endotracheal tube or a tracheostomy tube would not be considered by one of ordinary skill in the art to be a breathing tube “configured to connect to a patient interface” since those types of tube are already themselves a patient interface. Goodall fails to consider use of sensor 302 in a further upstream location than the ventilation catheter types of either an endotracheal tube or a tracheostomy tube.
Note is made of the narrowness of claim 2 where a bacteria sensor is used within a breathing tube of a breathing treatment apparatus to detect bacterial growth within the breathing tube. Based upon that claim language a prior art which detects oral bacteria in a patient’s exhaled breath (Pearce et al. – U.S. Pub. 2003/0105407; ¶0125 or Ahmad et al. – U.S. Pub. 2008/0053194; ¶0065 and included Table) would not be sufficient to read on the claimed detecting of bacterial growth within the breathing tube.
It is thus found that one having ordinary skill in the art at the time of the effective filing of the invention would only have arrived at the instantly claimed invention by way of improper hindsight reasoning.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure, see PTO-892 for additional attached references.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH D BOECKER whose telephone number is (571)270-0376. The examiner can normally be reached M-F 9:00 AM - 4:00 PM.
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/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785
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