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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: relief valve 14. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim(s) 7-11 is/are objected to because of the following informalities:
Claim 7, Ln. 3 recites “open toward outside” which should read “open toward an outside”
Claim 8, Ln. 3 recites “open toward outside” which should read “open toward an outside”
Claim 9, Ln. 2 recites “recessed toward inside” which should read “recessed toward an inside”
Claim 11, Ln. 4 recites “recessed toward inside” which should read “recessed toward an inside”
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.
Claim(s) 1-18 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 1 recites the limitation “an exhaust port through which the gas inhaled or the gas exhaled is exhausted from the housing” in Ln. 7-8 which deems the claim indefinite. The claim recites “the gas inhaled” as being exhausted through the exhaust port. However, in plain language “the gas inhaled” should be inside of the patient and not at the exhaust port. And once gas has been inhaled it will only then return to the exhaust port as the already recited “gas exhaled.” It appears the limitation may instead intend the first portion of the “or” clause to read “the gas to be inhaled” to refer to gas still in the housing before it would actually pass to the patient. This interpretation will be applied to the below examination.
Claim Interpretation - 35 USC § 112(f)
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: “unlocking unit” in claim 14.
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.
The corresponding structure for the “unlocking unit” is best understood from the specification as at least: unlock button 6 (Figs. 2 & 8).
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 § 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) 1-4, 6-12 and 16-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Koledin (U.S. Pub. 2010/0199991).
Regarding claim 1, Koledin discloses a ventilator (parts of Fig. 1 #10; ¶0040) comprising: a housing (Fig. 1 exterior of #10), wherein the housing has an input port (Figs. 1 & 11 any of #75, pipe receiving #80 or pipe receiving #84; ¶¶0049-0053) through which a gas is introduced into the housing, a main port (Fig. 1 #78; ¶0048) through which the gas that is to be sent to and inhaled by a patient and a gas that is exhaled by the patient pass, an exhaust port (Figs. 1 & 3 #24; ¶¶0042-0043) through which the gas [to be] inhaled or the gas exhaled is exhausted from the housing, a ventilation path (Figs. 1 & 11 interior pathway) connecting the input port and the main port to each other, and a relief valve (Figs. 1-3 #20; ¶0044) that includes a valve body (Fig. 3 #34; ¶0044) configured to be opened by receiving a pressure from the ventilation path (Fig. 8 valve opened vs. Fig. 7 valve closed; ¶0045) and that allows communication between the ventilation path and the exhaust port in such a manner as to release the pressure (¶¶0043, 0045). In an alternate reading of the end of the claim Koldein discloses an exhaust port (Figs. 1 & 3 #88; ¶0052) through which the gas [to be] inhaled or the gas exhaled is exhausted from the housing (¶0052); and a relief valve (Figs. 1 & 11 #84; ¶0052) that includes a valve body (Fig. 11 #84; ¶0052) configured to be opened by receiving a pressure from the ventilation path (¶0052) and that allows communication between the ventilation path and the exhaust port in such a manner as to release the pressure (¶0052).
Regarding claim 2, Koledin discloses the housing further includes a heat and moisture exchanger filter (e.g. Fig. 17; ¶0055) disposed between the main port (Fig. 17 entry to #201; ¶0055) and the exhaust port (¶¶0054-0055, 0066). For this claim the “housing” of claim 1 is extended to include the body of the HME filter in Fig. 17. The claim has not required the housing to be a unitary structure.
Regarding claim 3, Koledin discloses the input port, the exhaust port, the ventilation path, and the relief valve are arranged inside the housing (Figs. 1 & 11).
Regarding claim 4, Koledin discloses the housing further includes a spontaneous-breathing valve (Fig. 11 #84; ¶0053) that is opened by an inspiratory pressure at which the patient spontaneously breathes in such a manner as to allow communication between the ventilation path and an area outside the housing (¶0053).
Regarding claim 6, Koledin discloses the housing is a resin-molded body (¶0072).
Regarding claim 7, Koledin discloses the input port is disposed inside the housing (Fig. 11 #96 is located within the housing) and is a first connection pipe (Fig. 11 #96) having an introduction port (Fig. 11 wherein numeral 80 is directed) that is open toward an outside of the housing.
Regarding claim 8, Koledin discloses the exhaust port (Figs. 2-3 #28, 42; ¶¶0042-0043) is disposed inside the housing (Figs. 2-3) and is a second connection pipe (Fig. 3 #42) having an outlet that is open toward an outside of the housing (¶0043 – orifice 50 extending through and between proximal and distal ends of #42). Alternately, Koledin discloses the exhaust port (Fig. 2 #38; ¶0042) is disposed inside the housing (Fig. 2) and is a second connection pipe (Fig. 2 #38) having an outlet that is open toward an outside of the housing (Fig. 3; ¶0042).
Regarding claim 9, Koledin discloses the outlet (Fig. 2 of #38) has a curved recess (Fig. 2 #38 is curved and recessed within #24; ¶0042) that is recessed toward an inside of the housing.
Regarding claim 10, Koledin discloses a ventilation groove (Fig. 3 between adjacent fins on exterior of #24) is formed in an outer surface of the housing, the outer surface having the exhaust port (Fig. 3 #24), in such a manner as to communicate with the outlet (Fig. 3 gas traveling through #24 can also pass along an exterior of #24) and to extend to an outer edge of the outer surface (Fig. 3 fins engage outer surface edge). It is noted that the claim has not specified how the groove serves as a “ventilation” groove.
Regarding claim 11, Koledin discloses the spontaneous-breathing valve has a spontaneous-breathing opening (Fig. 11 slits for air through #84) formed in the housing and a valve film (Fig. 11 #86; ¶0053) closing the spontaneous-breathing opening, the valve film being configured to be opened toward an inside of the housing by an inspiratory pressure at which a patient spontaneously breathes (Fig. 11; ¶0053).
Regarding claim 12, Koledin discloses the relief valve further includes a pressure setting dial (Fig. 3 #26; ¶0046) that has a disc-like shape (top of #26 may be considered “disc-like”) and that is configured to be rotated to enable setting of the pressure at which the valve body is opened (¶0046) and a dial cover (Fig. 3 #66; ¶0046) holding the pressure setting dial such that the pressure setting dial is rotatable (Fig. 3 threaded conduit holds the top of #26 from undesired movement).
Regarding claim 16, Koledin discloses a ventilator unit (Fig. 1 together with ¶0048) comprising: the ventilator according to Claim 1 (see above); and a patient-side breathing member (¶0048 – endotracheal tube or mask) one end of which is connected to the main port of the ventilator (¶0048) and another end of which is connected to a patient (¶0048).
Regarding claim 17, Koledin discloses a manual pulmonary resuscitator (¶0040 – manual manipulations are made to #10; e.g. ¶¶0042-0043) comprising: the ventilator according to Claim 1 (see above).
Claim(s) 1, 3-5, 7-8, 15-16 and 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lugtigheid (U.S. Patent 7207332).
Regarding claim 1, Lugtigheid discloses a ventilator (Fig. 1 #1; Col. 3) comprising: a housing (Fig. 1 exterior of #1), wherein the housing has an input port (Figs. 1-2 either of from #3 or from #4; Col. 3) through which a gas is introduced into the housing, a main port (Fig. 1 #5; Col. 3) through which the gas that is to be sent to and inhaled by a patient and a gas that is exhaled by the patient pass, an exhaust port (Fig. 1 #6; Col. 3) through which the gas [to be] inhaled
Regarding claim 3, Lugtigheid discloses the input port, the exhaust port, the ventilation path, and the relief valve are arranged inside the housing (Fig. 2).
Regarding claim 4, Lugtigheid discloses the housing further includes a spontaneous-breathing valve (Figs. 3-4 #12; Col. 4) that is opened by an inspiratory pressure at which the patient spontaneously breathes in such a manner as to allow communication between the ventilation path and an area outside the housing (Fig. 3 opened vs. Fig. 4 closed).
Regarding claim 5, Lugtigheid discloses the housing has a shape of a box-shaped polyhedron (Fig. 1).
Regarding claim 7, Lugtigheid discloses the input port is disposed inside the housing (Fig. 2 left pipe along #10 is threaded into the main housing) and is a first connection pipe (Fig. 2 left pipe along #10) having an introduction port (Fig. 2 farthest leftward opening) that is open toward an outside of the housing.
Regarding claim 8, Lugtigheid discloses the exhaust port is disposed inside the housing (Fig. 2 #6 is connected into the main housing) and is a second connection pipe (Fig. 2 #6) having an outlet that is open toward an outside of the housing.
Regarding claim 15, Lugtigheid discloses the relief valve further includes a valve shaft (Fig. 2 inside of #20; Col. 5, Ln. 7-22) that is integrally formed with the valve body (Fig. 2) and that supports movement of the valve body (Fig. 2; Col. 5, Ln. 7-22), and wherein the housing includes a bearing portion (Fig. 2 at top of #20 where lower shaft fits into bottom of #7) that guides movement of the valve shaft.
Regarding claim 16, Lugtigheid discloses a ventilator unit (Fig. 1) comprising: the ventilator according to Claim 1 (see above); and a patient-side breathing member (Fig. 1 #5; Col. 3) one end of which is connected to the main port of the ventilator (Figs. 1-2) and another end of which is connected to a patient (Col. 3, Ln. 27-43).
Regarding claim 18, Lugtigheid discloses an inhalation anesthesia apparatus (Fig. 1 and Col. 5, Ln. 35-37) comprising: the ventilator according to Claim 1 (see above).
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 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lugtigheid (U.S. Patent 7207332) in view of Koledin (U.S. Pub. 2010/0199991).
Regarding claim 6, Lugtigheid is silent as to whether the housing is a resin-molded body.
Koledin teaches an apparatus (Fig. 1 #10) for providing ventilatory support and resuscitation (¶0040) comprising a housing injection molded of polymeric materials (¶0072). Koledin teaches injection molding as a conventional manufacturing technique for polymeric materials (¶0072).
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 specified in Lugtigheid the housing is a resin-molded body based upon the conventional manufacturing technique of injection molding for polymeric materials in view of Koledin.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Koledin (U.S. Pub. 2010/0199991).
Regarding claim 15, Koledin discloses the relief valve further includes a valve shaft (Fig. 11 #100; ¶0052) that supports movement of the valve body (Fig. 11; ¶0052), and wherein the housing includes a bearing portion (Fig. 11 #102; ¶0052) that guides movement of the valve shaft.
Koledin fails to explicitly disclose the valve shaft is integrally formed with the valve body.
However, elongate post 100 and safety pop-off valve 84 are intended to move together in Koledin (Figs. 11 & 13; ¶0052). Thus, one of ordinary skill in the art would have considered it prima facie obvious to have integrally formed those two structures in order to ensure they only move in an intended manner.
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 specified in Koledin the valve shaft is integrally formed with the valve body in order to provide the benefit of ensuring the valve shaft and the valve body only move jointly, as intended by Koledin, in view of the overall teachings of Koledin.
Claim(s) 17 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Lugtigheid (U.S. Patent 7207332).
Regarding claim 17, Lugtigheid discloses the ventilator according to Claim 1 (see above). The ventilator of Lugtigheid is capable of being implemented into a manual pulmonary resuscitator at least since the manual pulmonary resuscitator as claimed requires no further structure than the ventilator of claim 1. For example, the claimed manual pulmonary resuscitator does not require any structure not already recited in claim 1.
In the alternative it is noted that one having ordinary skill in the art would have considered it prima facie obvious for the ventilator of Lugtigheid to be usable while performing manual pulmonary resuscitation as it only includes manually manipulated elements and is intended to be used to deliver gas to a user’s respiratory system which would complement any efforts at resuscitation.
Claim(s) 18 is/are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Koledin (U.S. Pub. 2010/0199991).
Regarding claim 18, Koledin discloses the ventilator according to Claim 1 (see above). The ventilator of Koledin is capable of being implemented into an inhalation anesthesia apparatus at least since the inhalation anesthesia apparatus as claimed requires no further structure than the ventilator of claim 1. For example, the claimed inhalation anesthesia apparatus does not require the use of any anesthetic gas.
In the alternative it is noted that one having ordinary skill in the art would have considered it prima facie obvious for the gas provided to the gas inlet port 75 to be able to include an anesthetic gas when desiring to perform ventilation or resuscitation, as taught by Koldein, but which required anesthetic delivery.
Allowable Subject Matter
Claim(s) 13-14 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 13, Koledin fails to teach or suggest discloses the dial cover includes a contact receiving portion that stops rotation of the pressure setting dial by coming into contact with the pressure setting dial, and wherein the pressure setting dial includes a stopper that comes into contact with the contact receiving portion at a position at which an intermediate set pressure between a minimum set pressure and a maximum set pressure is set. Koledin fails to teach or suggest at least the required stopper and its relation to an intermediate set pressure between a minimum set pressure and a maximum set pressure, as required by the claim. There is nothing in Koledin which would have led one of ordinary skill in the art to an expectation or desire of modifying Koledin to include that additional structure.
No other prior art which is alternately readable toward claim 1 would otherwise have rendered the instant claim as prima facie obvious.
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. Regarding claim 1 further attention is particularly drawn to: Greenberg (U.S. Patent 4437461; Figs. 1-5), Owczarczak (U.S. Pub. 2007/0204922; Figs. 1-2 & 34-36), Koledin (U.S. Pub. 2011/0197892; Figs. 1-5), Ishikita (U.S. Pub. 2013/0118484; Fig. 2), Battersby et al. (U.S. Pub. 2016/0256661; Figs. 1-7 & 9-10), and Ishikita (U.S. Pub. 2019/0022346; Figs. 2-4 & 8-9).
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.
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 at (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 published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785