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 .
This action is in response to the filing on 9/5/2025. Since the previous filing, clams 1-7 and 10-20 have been cancelled, claims 21-24 have been added and no claims have been amended. Thus, claims 21-24 are pending in the application.
In regards to the previous Claim Interpretation, Applicant has cancelled the relevant claims and the interpretation is rendered moot.
In regards to the previous 112 Rejections, Applicant has cancelled the relevant claims and the rejections are rendered moot. New 112 Rejections are entered below.
In regards to the previous 102 and 103 Rejections, Applicant has cancelled the relevant claims and the rejections are rendered moot. Now 103 Rejections are entered below.
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 21-24 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 21 recites the limitation "the lungs of the wearer" in line 7. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “the thoracic cavity of the wearer” to overcome this rejection.
Claim 21 recites the limitation "the body outside the thoracic cavity" in line 8-9. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “an outside of the thoracic cavity” to overcome this rejection.
Claim 24 recites the limitation "the elastomeric tubes" in line 1. There is insufficient antecedent basis for this limitation in the claim. Examiner suggests changing to “the one or more elastomeric tubes” to overcome this rejection.
Dependent claims inherit the rejection of the preceding claims.
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.
Claim(s) 21-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palmer (US 2021/0330549), hereafter referred to as Palmer-549, in view of Palmer (US 2017/0020768), hereafter referred to as Palmer-768.
In regards to claim 21, Palmer-549 teaches a conformal ventilator (distension device 10); one (tube 12, paragraph 31) or more elastomeric tubes (tubes 52, 54 and 56, paragraph 33), each tube having a continuous string bonded to, and wound helically about an outer surface of the tube (fibers 14, paragraph 31, Fig 2A and 2C), wherein elongation of each tube is controlled by a fluid pressure within the tube (paragraph 32 and 35), such that expansion and contraction of the tubes includes a breathing motion within the lungs of the wearer (paragraph 35); and an attachment system configured to secure the device to the body outside the thoracic cavity, the attachment system comprising a reversible adhesive (paragraph 38-39).
Palmer-549 does not teach wherein the conformal ventilator is a vest.
However, Palmer-768 discloses a conformal ventilator which is a vest (air splint 10, paragraph 31 and paragraph 52).
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 Palmer-549 wherein the conformal ventilator is a vest as taught by Palmer-768 as this would provide a form that is self contained and easy to move, attach to the patient and subsequently remove from the patient as needed.
In regards to claim 22, Palmer-549 in view of Palmer-768 teaches the device of claim 21 and Palmer-549 further teaches the helically wound fiber is bonded to a tube made of silicone elastomer (paragraph 32).
While Palmer-549 does not teach where the fiber is bound to the tube by a room-temperature curing silicone composition, even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (MPEP 2113).
In regards to claim 23, Palmer-549 in view of Palmer-768 teaches the device of claim 21.
While Palmer-549 does not explicitly teach wherein the elastomeric tube with helically wound fiber has a 10% secant modulus between about 1 MPa and 5 MPa and an elongation up to about 10%, Palmer-549 does teach the fiber wound tube is made of silicone (Palmer-549: paragraph 32; see instant Specification page 36-37) having an elongation of approximately 2% (Palmer-549: paragraph 32).
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 Palmer-549 wherein the elastomeric tube with helically wound fiber has a 10% secant modulus between about 1 MPa and 5 MPa and an elongation up to about 10% as taught by Palmer-549 as this would provide the appropriate ventilation support.
In regards to claim 24, Palmer-549 in view of Palmer-768 teaches the device of claim 21.
Palmer-549 does not disclose wherein the elastomeric tubes are covered with a low-friction fabric to reduce skin chafing during expansion and contraction of the tubes.
However, Palmer-768 teaches wherein the elastomeric tubes are covered with a low-friction fabric to reduce skin chafing during expansion and contraction of the tubes (paragraph 41 line 19-23).
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 Palmer-549 wherein the elastomeric tubes are covered with a low-friction fabric to reduce skin chafing during expansion and contraction of the tubes as taught by Palmer-768 as this would increase the comfort of the user.
Response to Arguments
Applicant’s arguments with respect to claim(s) 21-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 Arielle Wolff whose telephone number is (571)272-8727. The examiner can normally be reached Mon-Fri 8:00-4:00.
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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.
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/ARIELLE WOLFF/ Examiner, Art Unit 3785
/KENDRA D CARTER/ Supervisory Patent Examiner, Art Unit 3785