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 because in fig. 8, the rectangular boxes “160” and “150” should be accompanied by descriptive text since the rectangular boxes is a generic graphic symbol. See 37 CFR 1.83(a) and examiner note to Formed Paragraph 6.22 in MPEP section 608.02(b).
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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
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.
Presently, no limitation(s) is/are being interpreted under 112(f).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 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 1, the limitations “an enhanced oxygen source” (lines 5-6 and 9-10), “a first enhanced oxygen source” (claim 9, line 2), and “a second enhanced oxygen source” (claim 12, line 2) are unclear as to how to determine the limitation “enhanced”, the term “enhanced” is too relative, furthermore it is unclear as to what the term “enhanced” is relative to.
Regarding claim 1, the limitation “an enhanced oxygen source” (lines 9-10) is unclear if the enhanced oxygen source is the same as or different from “an enhanced oxygen source” being claimed in claim 1, lines 5-6.
Regarding claim 1, the limitation “said second fluid path having a proximal end having a fitting” (line 9) is unclear as to how a fluid path can have a proximal end having a physical fitting. If the applicant meant to say that it is the second tube that comprises a the proximal end having the fitting then suggest to amend the limitation to --said second tube having a proximal end having a fitting--.
Regarding claim 2, the limitation “a first tube” (lines 1-2) is unclear if the first tube is the same as or different from “a first tube” being claimed in claim 1, line 4, if they are the same, suggest to amend to --the first tube--.
Regarding claim 2, the limitation “a second tube” (lines 2) is unclear if the second tube is the same as or different from “a second tube” being claimed in claim 1, line 7, if they are the same, suggest to amend to --the second tube--.
Regarding claim 3, the limitation “the path” (line 6) is unclear if the path is referring to the “airflow path”, “first fluid path” or “second fluid path” in claim 1.
Regarding claim 6, the limitation “and releasing gas therethrough” (line 2) is unclear as to what structure or reference point is being referred to by the term “therethrough.
Regarding claim 7, the limitation “a face mask” (line 2) is unclear if the face mask is the same as or different from “a face mask” being claimed in claim 1, line 3.
Regarding claim 9, the limitation “a first enhanced oxygen source” (line 2) is unclear if the first enhanced oxygen source is the same as or different from “an enhanced oxygen source” being claimed in claim 1, lines 5-6 and 9-10.
Regarding claim 9, the limitation “the proximal end of the first fluid path” (line 3) lacks proper antecedent basis. Furthermore, it is unclear how a fluid flow path which is a “path” can have a proximal end. It is noted that claim 1 claims “a first tube having a first fluid path and having a distal outlet within an airflow path near said outlet and a proximal end”, which is being interpreted as the first tube is what comprises the proximal end, not the fluid flow path, therefore, by claiming “the proximal end of the first fluid path” it is unclear and confusing if “the proximal end” in line 3 of claim 9 is referring to the proximal end of the first tube or not.
Regarding claim 12, the limitation “a second enhanced oxygen source” (line 2) is unclear if the second enhanced oxygen source is the same as or different from “an enhanced oxygen source” being claimed in claim 1, lines 5-6 and 9-10.
Regarding claim 15, the limitation “a resuscitation system” (line 1) is unclear if “a resuscitation system” is the same as or different from “a resuscitation system” being claimed in claim 1, line 1.
Regarding claim 15, the limitation “the device of claim 1” (line 1) lacks proper antecedent basis. It is unclear as to what the limitation “the device” of claim 1” is referring to.
Regarding claim 16, the limitation “a resuscitation system” (line 1) is unclear if “a resuscitation system” is the same as or different from “a resuscitation system” being claimed in claim 1, line 1.
Regarding claim 16, the limitation “the device of claim 6” (line 1) lacks proper antecedent basis. It is unclear as to what the limitation “the device” of claim 6” is referring to.
Regarding claim 17, the limitation “a mask” (line 1) is unclear if the mask is the same as or different from “a face mask” being claimed in claim 1, line 3.
Any remaining claims are rejected for their dependency on a rejected base claim.
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.
Claims 1-17 are rejected under 35 U.S.C. 103 as being unpatentable over Weingart (2022/0273897) in view of Kwok (2022/0370746).
Regarding claim 1, Weingart discloses a resuscitation system (20 shown in figs. 1-2, paragraphs 0021-0022), comprising: a hand held collapsible resuscitation bag (entire assembly shown in fig. 2) having a bag body (22 and 50, fig. 2, paragraphs 0021-0026), an air inlet (air inlet is formed by 30 and 52, figs. 1-2, paragraphs 0022-0023) and an outlet (58, fig. 2, paragraph 0026) couplable with a face mask (see face mask 26, figs. 1-2, paragraph 0026); a first tube having a first fluid path and having a distal outlet within an airflow path (air flow path is wherever air is capable of flowing, this includes inside the resuscitation system and outside of the resuscitation system) near said outlet and a proximal end connectable to an enhanced oxygen source (see paragraphs 0028-0030, figs. 1-2, Weingart discloses that the air inlet 40 is connected to a supplemental oxygen source via tubing, therefore, there would be a distal end that is directly connected to the oxygen port 40, the distal end of the tube would be within an airflow path near said outlet, furthermore, the proximal end that is opposite from the distal end would be connectable to the oxygen source 34); and a second tube having a second fluid path and having a distal end within said airflow path located further upstream from said bag outlet than said first fluid path distal outlet, said second fluid path having a proximal end connectable to an enhanced oxygen source (see paragraph 0028 and fig. 1, as shown and disclosed by Weingart, a separate oxygen source 34 is connected to the air inlet 30 at 52, therefore, the distal end of the second tube would have a second fluid path that has a distal end within said airflow path located further upstream from said bag outlet than said first fluid path distal outlet), but fails to disclose that the proximal end of the first fluid path having fitting connectable to the first enhanced oxygen source and the proximal end of the second fluid path having a fitting connectable to the second enhanced oxygen source.
However, Kwok teaches a tube comprising a proximal end comprising a fitting connectable to an oxygen source (see proximal end of tube 506 comprising fitting 507, fig. 7, paragraph 0036).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the proximal end of each of the first and second tubes of Weingart to have the fitting as taught by Kwok for the purpose of providing a well-known means of connecting the tubes to the oxygen sources that would provide the predictable result of allowing oxygen to move from the oxygen sources to the respective first and second tubes (see paragraph 0036 of Kwok).
Regarding claim 2, the modified Weingart discloses that the first fluid path is defined within a first tube and wherein the second fluid path is defined within a second tube in parallel with said first tube (see figs. 1-2 and paragraph 0028 of Weingart, the first fluid path is being interpreted as within the first tube and the second fluid path is being interpreted as within the second tube, relatively, the first fluid flow path is parallel to the second fluid flow path since they are not connected in series at the point where they enter the resuscitation system, alternatively, the flow path can be interpreted as a portion of each first and second tubes that would be parallel to one another, since the path is defined as a space where the gas flows).
Regarding claim 3, the modified Weingart discloses a check valve (24, fig. 4 of Weingart) operably connected to the outlet of the resuscitation bag and substantially blocking gas flow upstream and allowing gas flow downstream thereof (see figs. 1-6, the check valve 24 is operably connected to the outlet, see paragraphs 0021-0027 of Weingart); and a first safety release valve operably located downstream of the resuscitation bag and operable to release gas from the airflow path at a first predetermined pressure differential between the path and the ambient, wherein the first safety release valve is located downstream of the check valve (see the first safety release valve 38, paragraphs 0022 and 0031 and figs. 4-6 of Weingart).
Regarding claim 4, the modified Weingart discloses a second safety release valve (36, fig. 4, paragraphs 0022 and 0031 of Weingart).
Regarding claim 5, the modified Weingart discloses that the second safety release valve (36 of Weingart) is located upstream of the check valve (see fig. 4 and paragraphs 0022 and 0031 of Weingart).
Regarding claim 6, the modified Weingart discloses that a PEEP valve downstream of the check valve and releasing gas therethrough to ambient at a pressure lower than a first predetermined pressure of a first safety release valve, wherein the PEEP valve includes a biological filter integrated within a housing of the PEEP valve (see PEEP valve 48 in figs. 1 and 5, paragraphs 0009, 0022, and 0052 and claims 8-9 of Weingart).
Regarding claim 7, the modified Weingart discloses a face mask operably connected downstream of the check valve (see mask 26 which is connected to 58, figs. 1-2 and paragraphs 0021 and 0025-0026 of Weingart).
Regarding claim 8, the modified Weingart discloses a pressure gauge for measuring the pressure downstream of the check valve (Weingart discloses that a pressure gauge 42 may be attached to the valve housing 32, fig. 1 and paragraph 0022 of Weingart).
Regarding claim 9, the modified Weingart discloses that a first enhanced oxygen source, wherein the first enhanced oxygen source is connected to the proximal end of the first fluid path (see paragraphs 0028-0030, figs. 1-2 of Weingart, Weingart discloses that the air inlet 40 is connected to a supplemental oxygen source via tubing, therefore, there would be a distal end that is directly connected to the oxygen port 40, the distal end of the tube would be within an airflow path near said outlet, furthermore, the proximal end that is opposite from the distal end would be connectable to the oxygen source 34, the oxygen source 34 connected to oxygen port 40 is the first enhanced oxygen source).
Regarding claim 10, the modified Weingart discloses that the first enhanced oxygen source is accessed by a flow path independent from the resuscitation system (see paragraphs 0028-0030, figs. 1-2 of Weingart, Weingart discloses that the air inlet 40 is connected to a supplemental oxygen source via tubing and after the modification is connected by a fitting and the first tubing, furthermore, Weingart discloses in paragraph 0029 that an air sampling tube may be connected to the capnography port to transport samples of air exhaled by the patient to be measured, therefore, the oxygen source would be accessed by a flow path (capnogram sensor/monitor 46) that is independent from the resuscitation system, since when oxygen is being provided into 40 and 58, as the user exhaled, some residual oxygen and exhalation would be sampled, therefore, some of the oxygen from the first enhanced oxygen source would be accessed by a flow path independent from the resuscitation system), alternatively, the flow path is interpreted as the flow path that exist within the ambient/surrounding atmosphere where the first enhanced oxygen source is being placed, such flow path would have access to the first enhanced oxygen source.
Regarding claim 11, the modified Weingart discloses that the first enhanced oxygen source is accessed by a flow path integrated and internally routed within the resuscitation system (see paragraphs 0028-0030, figs. 1-2 of Weingart, Weingart discloses that the air inlet 40 is connected to a supplemental oxygen source via tubing and after the modification is connected by a fitting and the first tubing, therefore, after the modification, the “flow path” is formed by the first fluid flow path, the fluid flow path within the fitting, which are internally routed within the resuscitation system and being used to accessed oxygen from the first enhanced oxygen source).
Regarding claim 12, the modified Weingart discloses a second enhanced oxygen source is connectable to the proximal end of the second fluid (see paragraph 0028 and fig. 1, as shown and disclosed by Weingart, a separate oxygen source 34 is connected to the air inlet 30 at 52).
Regarding claim 13, the modified Weingart discloses that the second enhanced oxygen source is access by a flow path independent from the resuscitation system (see paragraphs 0028-0030, figs. 1-2 of Weingart, Weingart discloses that the air inlet 30 is connected to a supplemental oxygen source via tubing and after the modification is connected by a fitting and the second tubing, furthermore, Weingart discloses in paragraph 0029 that an air sampling tube may be connected to the capnography port to transport samples of air exhaled by the patient to be measured, therefore, the oxygen source would be accessed by a flow path (capnogram sensor/monitor 46) that is independent from the resuscitation system, since when oxygen is being provided into 30 and 58, as the user exhaled, some residual oxygen and exhalation would be sampled, therefore, some of the oxygen from the second enhanced oxygen source would be accessed by a flow path independent from the resuscitation system), alternatively, the flow path is interpreted as the flow path that exist within the ambient/surrounding atmosphere where the second enhanced oxygen source is being placed, such flow path would have access to the second enhanced oxygen source.
Regarding claim 14, the modified Weingart discloses that the second enhanced oxygen source is accessed by a flow path integrated and internally routed within the resuscitation system (see paragraphs 0028-0030, figs. 1-2 of Weingart, Weingart discloses that the air inlet 30 is connected to a supplemental oxygen source via tubing and after the modification is connected by a fitting and the second tubing, therefore, after the modification, the “flow path” is formed by the second fluid flow path, the fluid flow path within the fitting, which are internally routed within the resuscitation system and being used to accessed oxygen from the second enhanced oxygen source).
Regarding claim 15, the modified Weingart discloses a kit for a resuscitation system comprising the device of claim 1 surgically sterilized and contained within a sterile package (paragraphs 0012 and 0032 of Weingart).
Regarding claim 16, the modified Weingart discloses a kit for a resuscitation system comprising the device of claim 1 surgically sterilized and contained within a sterile package (paragraphs 0012 and 0032 of Weingart).
Regarding claim 17, the modified Weingart discloses a mask surgically sterilized and contained within said sterile package (paragraphs 0012 and 0032 of Weingart).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Cook (GB 2 139 099) is cited to show a resuscitator bag comprising an oxygen tube.
Wang (CN 111956921) is cited to show a bag having a tube connectable to an oxygen source.
Lynn (2002/0117173) is cited to show a resuscitation system comprising an oxygen source.
Sinha (2008/0251082) is cited to show a bag connected to an oxygen source.
Boulanger (2020/0368470) is cited to show a resuscitation system comprising a mask, a bag and an oxygen source connected to both the upstream and the downstream points of the bag.
Phillips (5,427,091) is cited to show a bag connected to an oxygen source.
Lampotang (2006/0060199) is cited to show a bag and an oxygen tube positioned upstream of the bag.
Law (2014/0128676) is cited to show a tube and a fitting.
Boulanger (2021/0146074) is cited to show a resuscitation system comprising a mask, a bag and an oxygen source connected to both the upstream and the downstream points of the bag.
Bardwell (1,359,312) is cited to show a bag connected to an oxygen source.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TU A VO whose telephone number is (571)270-1045. The examiner can normally be reached Monday-Friday 9:00 AM - 6:00 PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy Stanis can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TU A VO/Primary Examiner, Art Unit 3785
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