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 in response to the amendment filed 8/20/2025. As directed by the amendment, claims 1, 3, 8-11 and 18-20 have been amended. Claims 1-20 are pending in the instant application.
In response to the objection to the specification, see the interview summary mailed 6/25/2025; the objection to the specification is withdrawn.
Applicant has amended Fig. 4A and the specification to include a label for the indentation of para [29]; the objection to the drawings is withdrawn.
Applicant has amended the claims to address most of the previous objections thereto; any claim objection not updated/maintained below has been withdrawn.
Applicant has amended the claims to remove the indefinite term “sufficient” and provided antecedent basis in claim 3; the previous rejections under 35 USC 112(b)/second paragraph are withdrawn.
Response to Arguments
Applicant's arguments filed 8/20/2025 (hereinafter “Remarks”) have been fully considered but they are not persuasive.
On page 12 of Remarks, regarding the rejection of claims 1-3, 10-13 and 20 as anticipated by Altemus, Applicant argues that “Altemus requires that the bellows thereof be attached to a support/harness such that the user must use the users [sic] arm, in cooperating [sic] with the user’s side, to compress the bellows,” whereas “the compressible bag hereof is generally freestanding…not attached to any positioning structure…provides for increased utility… over a broader variety of use situations than the system of Altemus.”
These arguments are unconvincing for several reasons. First, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., that the bag be “freestanding/not attached to any positioning structure”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). The Examiner respectfully notes that the instant claims do not exclude the presence/use of the harness of Altemus. Therefore, since the apparatus and methods of Altemus continue to meet the limitations of the instant claims, the rejections in view of Altemus are maintained/updated below. Second, the Examiner respectfully notes with regards to claim 1 (and its dependent claims), in response to applicant's argument that the harness of Altemus is intended to hold the bags under the arms rather than other locations, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. There is nothing in Altemus that would prevent the user from not donning the harness (e.g. if they do not have time or the harness is too small), and instead, placing the bag(s) e.g. under a knee or foot or behind the knee, as was commonly known before the filing date of the claimed invention, see e.g. previously-cited Clementz (US 3,342,177, col. 2, lines 31-35), previously-cited Gitschlag (US 2008/0257351 A1; Fig. 3), previously-cited Sitnik (maintained below), or previously-cited Louot (FR 1223630), such that, contrary to Applicant’s assertion, the device of Altemus is fully capable of being used “over a broader variety of use situations.” Third, even if the claims were amended to exclude the harness of Altemus, prior art is already on the record that anticipates (the use of) a resuscitation bag with no harness, see again previously-cited Clementz, Gitschlag, Sitnik and Louot, and also previously-cited Bergman (US 2012/0145151 A1, where the bagging system is fully capable of being used manually/without being placed in the automated housing system), previously-cited Pearce (US 2010/0263670 A1), and previously-cited Revankar (US 2022/0142859 A1). Compressing a resuscitation bag using body parts other than the hands was very well known before the effective filing date of the claimed invention and is not a point of novelty. As such, Applicant’s arguments are unconvincing, and the claims remain rejected in view of the prior art as discussed in the updated rejections below.
On page 13 of Remarks, regarding the rejection of claims 4-6 and 14-16 in further view of Sitnik, Applicant argues that “Sitnik, which is limited to a bellows-shaped resuscitation bag, does not overcome the limitations of Altemus set forth above.”
First, the Examiner fails to see how the shape of the bag of Sitnik is relevant to claims 1-6/10-16. Second, while not necessary for the art rejections since, as discussed above, Altemus does not have any “limitations” in light of the claims as currently written, the Examiner does note that Sitnik teaches pumping the bag with a hand or a knee (Sitnik abstract), which thus demonstrates the known practice of using various body parts, including a body part other than a hand OR an arm, to pump a resuscitation bag. The rejections in view of Sitnik are maintained.
On page 13 of Remarks, Applicant makes no further substantive arguments regarding the application of Pope to claims 7 and 17. The Examiner refers to the discussion of claims 1 and 10 above; the rejections in view of Pope are maintained.
On page 13 of Remarks, regarding the rejection of claims 8, 9, 18 and 19 in further view of Mayer, Applicant argues that “Mayer discloses a bag limited to use during surgery and, unlike the presently claimed bag, is shaped or formed for manipulation by a user’s hand.”
In response to applicant's argument that the bag of Mayer is shaped for hand use and “limited to use during surgery,” the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The base reference of Altemus already discloses a bag for non-surgical, non-hand use. Therefore, when applying the teachings of Mayer regarding a bag with an indented shape for easier squeezing/better gripability between the body parts being used to squeeze the bag to the bag of Altemus, an artisan would have obviously arrived at the claimed invention for the reasons maintained below, i.e. in order to provide the predictable results of a contoured bag that is more easily/securely gripped by/between the arm and side body (i.e. the location disclosed by Altemus) to avoid slippage/unintended displacement of the bag during use and thus allow for consistent and repeatable compressions therefrom (Mayer col. 1, lines 22-37). Therefore, the rejections in view of Mayer are maintained below.
Claim Objections
Claims 1, 8-10, 12 and 20 are objected to because of the following informalities:
Claim 1, line 9 should read “which is/are selected”
Claim 8, line 3 should read “the body of the user
Claim 9, line 3 should read “bag” because it is clearly a typo
Claim 10, line 10 should read “which is/are selected”
Claim 12, there is an errant space after ‘self-’ that should be deleted
Claim 20, line 6 should include a comma after ‘the mask’
Claim 20, line 7 should read “which is/are selected”
Claim 20, line 10 should read “the hand
Appropriate correction is required.
Claim Interpretation
Regarding claims 9 and 19, the phrase “being formed to seat an arm…when compressing” (emphasis added) is considered to be intended use for the at least one indentation. The compressing is not understood to be a positively recited step in the method of claim 19 because the term “when” is read as conditional, see MPEP 2111.04.II, that is, claim 19 is not understood to require that an arm actually be seated in the indentation and the bag compressed between the arm and a side of the user, but simply that the bag thereof possess at least one indentation capable of this potential use. However, it is noted that Altemus discloses positioning and squeezing the bag between the arm and a side of the user, such that modified Altemus would teach seating an arm into the indentation and compressing the bag between the arm and the side of the user even if this step were positively recited, in order to provide the benefits taught by Mayer as discussed below.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 10-13 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Altemus, Jr. (US 2017/0128685 A1; hereinafter “Altemus”).
Regarding claim 1, Altemus discloses a device for manual respiratory resuscitation or ventilation assistance (respirator 100) (Figs. 1, 2 and 4C-E; paras [0050-59]), comprising:
a mask (mask 102) suitable to form a seal with a face of a patient (paras [0014], [0019], [0037], [0061-62]),
a compressible bag (e.g. bellows 104a) (paras [0041] and [0049]) and
an extending, flexible conduit (conduit 106a) (para [0046]) connected to a first opening in the compressible bag and to a first opening in the mask to place the mask in fluid connection with the compressible bag (Figs. 1, 4D-E; para [0046]), the extending, flexible conduit extending to allow a user to use one or more portions of a body of the user (arm and side), other than a hand of the user, and which are selected by the user, to compress the compressible bag, while each hand of the user is used in connection with at least one of the mask and the patient (Figs. 1 and 4C-E; paras [0015], [0018-19], [0050-59], [0062], where the user has selected to place bellows 104a between their right arm and right side).
Regarding claim 2, Altemus discloses the device of claim 1 wherein the compressible bag is self-inflating (paras [0019], [0027], [0046], [0049], [0053]).
Regarding claim 3, Altemus discloses the device of claim 2 wherein the extending, flexible conduit is of sufficient length to allow the user to compress the compressible bag between an arm of the user and a side of the user (Figs. 1, 4D-E; paras [0050-59]).
Regarding claim 10, Altemus discloses a method of manually applying respiratory resuscitation or ventilation assistance to a patient (Figs. 1, 2 and 4C-E; paras [0050-59]), comprising:
providing a device (respirator 100) including a mask (mask 102) suitable to form a seal with a face of the patient (Figs. 4C-E; paras [0014], [0019], [0061-62]), a compressible bag (e.g. bellows 104a) (Figs. 1, 4D-E; paras [0041] and [0049]), and an extending, flexible conduit (conduit 106a) connected to a first opening in the compressible bag and to a first opening in the mask to place the mask in fluid connection with the compressible bag (Figs. 1, 4D-E; para [0046]);
placing the mask in sealing connection with the patient's face (Figs. 4C-E; paras [0014], [0019], [0037], [0061-62]);
extending the extending flexible conduit to enable contact of one or more portions of a body of a user (arm and side), other than a hand of the user, and which are selected by the user, with the compressible bag (Figs. 1 and 4D-E; paras [0015], [0018-19], [0050-59], [0062], where the user has selected to place bellows 104a between their right arm and right side); and
compressing the compressible bag using the one or more portions of the body of the user while each hand of the user is used in connection with at least one of the mask and the patient (Figs. 1, 4D-E; paras [0050-59]).
Regarding claim 11, Altemus discloses the method of claim 10 wherein both hands of the user are used to maintain the mask in sealing connection with the patient's face (Figs. 4C-D; para [0057], [0059], [0062]).
Regarding claim 12, Altemus discloses the method of claim 11 wherein the compressible bag is self-inflating (paras [0019], [0027], [0046], [0049], [0053]).
Regarding claim 13, Altemus discloses the method of claim 12 wherein the compressible bag is repeatedly compressed by the user (Figs. 1, 4D-E; paras [0050-59], particularly para [0053]).
Regarding claim 20, Altemus discloses a method of operating a device for manual respiratory resuscitation or ventilation assistance (respirator 100) (Figs. 1, 2 and 4C-E; paras [0050-59]), comprising:
placing a mask (mask 102) of the device which includes a seal member (retaining edge 122) to form a seal with a face of a patient (Figs. 4C-D; paras [0014], [0019], [0037], [0061-62]),
extending a flexible conduit (e.g. conduit 106a) connected to a first opening in a compressible bag (bellows 104a), and to a first opening in the mask, to one or more portions of a body of a user (side and arm), other than a hand of the user, and which are selected by the user, to compress the compressible bag (Figs. 1, 4D-E; paras [0015], [0018-19], [0046], [0050-59], [0062], where the user has selected to place bellows 104a between their right arm and right side), and
using the one or more portions of the body of the user other than the hands of the user to compress the compressible bag, while each hand of the user is used in connection with at least one of the mask and the patient (Figs. 1, 4D-E; paras [0050-59]).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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) 4-6 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Altemus in view of Sitnik (US 4,870,962; hereinafter “Sitnik”).
Regarding claims 4-6 and 14-16, Altemus discloses the device of claim 2 and method of claim 10, where Altemus would have reasonably suggested to an artisan before the effective filing date of the claimed invention that the conduit 106a is longer than the typical length of an adult male human arm (Fig. 1), which is about 2 ft, but Altemus does not explicitly recite wherein the extending, flexible conduit is at least 18 inches in length, or at least 24 inches in length, or at least 30 inches in length. However, Sitnik demonstrates that it was known in the art of actuating manual resuscitation bags with parts of the body of than the hands (Sitnik abstract) before the effective filing date of the claimed invention for the conduit (tube 13) (Fig. 3) between a mask (face mask 16) and a compressible bag (bag 1) to be 18 inches in length (col. 3, lines 56-57), and optimization of ranges of parameters within prior art ranges or through routine experimentation is not sufficient to patentably distinguish the invention over the prior art, see MPEP § 2144.05. Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention for the conduit of Altemus to be at least 18 inches in length, or at least 24 inches in length, or at least 30 inches in length as suggested by Altemus and through routine experimentation around values known in the prior art as taught by Sitnik, in order to provide the predictable result of a sufficient length of conduit to enable to the bags of Altemus to be placed under the arms of a user (or under a knee as taught by Sitnik, if the user does not have time or interest in putting on the harness of Altemus) while the face mask is in place on the patient and without dislodging the face mask during use.
Claim(s) 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Altemus in view of Pope (US 5,803,074; hereinafter “Pope”).
Regarding claims 7 and 17, Altemus discloses the device of claim 1 and method of claim 10 wherein Altemus further discloses using the device/method to deliver oxygen (Fig. 2; paras [0016], [0026], [0035-38]), but Altemus is silent regarding a reservoir bag in fluid connection with the compressible bag and the mask. However, Pope demonstrates that it was well known in the compressible respiratory bag art before the effective filing date of the claimed invention to include a reservoir bag (reservoir bag 21) in fluid connection with the compressible bag (bag 10) and the mask (mask 12) (Fig. 1). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify the device/method of Altemus to include a reservoir bag in fluid connection with the compressible bag and the mask as taught by Pope, in order to provide the predictable result of a standard/well-known means by which avoid over or under pressurization within the system (Pope col. 1, lines 23-29) and/or oxygen waste.
Claim(s) 8, 9, 18 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Altemus in view of Mayer (US 5,285,775; hereinafter “Mayer”).
Regarding claims 8, 9, 18 and 19, Altemus discloses the device of claim 1 and method of claim 10 but Altemus is silent regarding wherein the compressible bag is contoured to facilitate compression thereof using the one or more portions of the body of the user [other than the hand of the user], particularly, wherein the compressible bag comprises at least one indentation in a side thereof being formed to seat an arm of the user when compressing the compressible bag between the arm of the user and a side of the user. However, Mayer demonstrates that it was known in the compressible respiratory bag art before the effective filing date of the claimed invention for a compressible bag (bladder 14) to be contoured (by virtue of having an hourglass shape/contour) to facilitate compression thereof (Fig. 1; col. 2, lines 18-20), particularly, wherein the compressible bag comprises at least one indentation (the indentation that forms waist 18) in a side thereof (Figs. 4-5). Therefore, it would have been obvious to an artisan before the effective filing date of the claimed invention to modify Altemus to include wherein the compressible bag is contoured to facilitate compression thereof using the one or more portions of the body of the user [other than the hand of the user], particularly, wherein the compressible bag comprises at least one indentation in a side thereof being formed to seat an arm of the user when compressing the compressible bag between the arm of the user and a side of the user in view of the teachings of Mayer as they apply to the under-arm usage disclosed by Altemus, in order to provide the predictable result of a contoured bag that is more easily/securely gripped by/between the arm and side body to avoid slippage/unintended displacement of the bag during use and thus allow for consistent and repeatable compressions therefrom (Mayer col. 1, lines 22-37).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHRYN E DITMER whose telephone number is (571)270-5178. The examiner can normally be reached M-Th 7:30a-4:30p, F 7:30a-11:30a ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brandy Lee can be reached at 571-270-7410. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHRYN E DITMER/Primary Examiner, Art Unit 3785