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 .
Election/Restrictions
Claims 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group II, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 11/13/2025.
Applicant's election with traverse of group I in the reply filed on 11/13/2025 is acknowledged. The traversal is on the ground(s) that the method claims are not patentably distinct as they contain the same structure as the device claims. This is not found persuasive because: The method claims are patentably distinct from the device claims as they require the structural difference of a balloon and a triggered inflation device as well as the distinct steps of feeding a balloon through the stabilizing tube (this required the stabilizing tube to have a structure that can receive a balloon therein which is not required in the device claims), inserting the stabilizing tube into the body through a hole created by the penetrating injury (this requires the structure of be disclosed as inserted into a hole created by the penetrating injury which is not required by the device claims), and inflating the balloon. Furthermore, the device as claimed requires the structure of to separable housing portions not required by the method. Moreover, the device as claimed can be used in a materially different method, such as to plug a pipe.
The requirement is still deemed proper and is therefore made FINAL.
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in Canada on 06/21/2023. It is noted, however, that applicant has not filed a certified copy of the CA3202452 application as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed 08/12/2025 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
Drawings
The drawings are objected to because all of the dimensions are in the specification making the features of the invention hard to make out. 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.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 1, 2, 3, 4, 5, 6, 7, 8, 9. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) 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.
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: A, B, C, D, E, F, G, H, I, J, K. 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.
The Office recommends amending the drawings and specification such that the reference numbers are described in the specification and labeled (but not described) in the drawings and such that the dimensions are in the specification and not the drawings.
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.
Claims 1 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Croushorn et al. (US 20080281351 A1) in view of Chase (US 20230190295 A1).
Regarding claims 1 and 7 Croushorn discloses (fig. 3-5B) a device for minimizing blood loss from a penetrating injury to a body (see abstract) comprising:
a housing 18 comprising a balloon securing portion 22 (see [0040]);
a gas channel (channel through valve 52) running through the housing 18 and the balloon securing portion 22 (see fig. 4A-4B and [0045]), between a gas inlet (top portion of 52 that 54 is connected to) on a first face (upper side) of the housing 18 and a gas outlet (opening that connects with 20) on a second face (bottom side) of the housing 18 (see [0045]);
Croushorn is silent regarding a stabilizing tube in communication with the gas channel, extending from the balloon securing portion and gas outlet; the stabilizing tube is perforated along its length.
However Chase, in the same filed of endeavor, teaches (fig. 1-2 and 9) of a housing 12 comprising a balloon securing portion (end of 12 containing 16, see fig. 1 and [0045]); a gas channel (channel connecting 14 an 16, see fig. 1-2 and [0045]) running through the housing and the balloon securing portion (see fig. 1-2), a stabilizing tube 18 in communication with the gas channel (see fig. 1-2 and [0045]), extending from the balloon securing portion and gas outlet (see fig. 2, 9 and [0061]); the stabilizing tube 18 is perforated along its length (see fig. 9 and [0061]).
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 Croushorn to have a stabilizing tube in communication with the gas channel, extending from the balloon securing portion and gas outlet; the stabilizing tube is perforated along its length as taught by Chase, for the purpose of being able to quickly and efficiently inflate the balloon with even pressure throughout (see Chase [0061]).
Regarding claim 5, Croushorn as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Croushorn further discloses (fig. 3-5B) a pressure gauge in connection with the gas channel (see [0045]).
Regarding claim 6, Croushorn as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Croushorn further discloses (fig. 3-5B) gas inlet tubing 54 in connection with the gas inlet (see fig. 5A-5B and [0046]).
Regarding claim 8, Croushorn as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Croushorn as modified is silent regarding the stabilizing tube is 11 cm long.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Croushorn as modified to have the stabilizing tube be 11cm long since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Croushorn as modified would not operate differently with the claimed tube length as it would still inflate the balloon. Further, applicant places no criticality on the range claimed, as it is only in the drawings and original claims.
Regarding claim 9, Croushorn as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Croushorn as modified is silent regarding the stabilizing tube is 9 mm in diameter.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Croushorn as modified to have the stabilizing tube be 9 mm in diameter since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Croushorn as modified would not operate differently with the claimed tube dismeter as it would still inflate the balloon. Further, applicant places no criticality on the range claimed, as it is only in the drawings and original claims.
Regarding claim 10, Croushorn as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Croushorn further discloses (fig. 3-5B) a kit (portable package, see [0005] and [0014]) comprising the device of claim 1 (see above); and a balloon 20 (see [0040]).
Regarding claim 11, Croushorn as modified discloses the claimed invention substantially as claimed, as set forth above for claim 10. Croushorn further discloses (fig. 3-5B) a triggered inflation device 28 (see [0041]).
Claims 2-4 are rejected under 35 U.S.C. 103 as being unpatentable over Croushorn in view of Chase as applied to claim 1 above, and further in view of Morrison et al. (US 20170273693 A1).
Regarding claims 2-4, Croushorn as modified discloses the claimed invention substantially as claimed, as set forth above for claim 1. Croushorn as modified is silent regarding the balloon securing portion comprises: a hollow disc, having a circumferential external groove configured to receive a lip of a balloon; and a recess within the housing configured to receive the disc and the lip of the balloon; the recess comprises a channel in communication with each of the stabilizing tube and the gas channel; the housing comprises two separable portions: an upper portion comprising the recess; and a lower portion.
However Morrison, in the same filed of endeavor, teaches (1-11) a device comprising a housing 12 comprising a balloon securing portion 54 (see fig. 2A and [0043]); the balloon securing portion 54 comprises: a hollow disc 70 (see fig. 9 and [0043]), having a circumferential external groove 85 (Merriam-Webster online dictionary defines external as “of, relating to, or connected with the outside or an outer part” and 18 is on an outside, bottom, part of 70; see fig. 11) configured to receive a lip of a balloon (bubble 72+74+76+78; see fig. 11); and a recess within the housing (see annotated fig. 2B) configured to receive the disc 70 and the lip of the balloon (see fig. 8, 11 and [0056]); the recess comprises a channel 56 (see fig. 1); the housing comprises two separable portions: an upper 12 portion comprising the recess; and a lower portion 24 (see fig. 2B-3).
PNG
media_image1.png
384
598
media_image1.png
Greyscale
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 Croushorn as modified to have the balloon securing portion comprises: a hollow disc, having a circumferential external groove configured to receive a lip of a balloon; and a recess within the housing configured to receive the disc and the lip of the balloon; the recess comprises a channel; the housing comprises two separable portions: an upper portion comprising the recess; and a lower portion as taught by Morrison, for the purpose of having the balloon attached to the housing in a manner that enables movement of the balloon relative to the housing (see Morrison [0042]).
Croushorn as modified teaches the recess channel is in communication with each of the stabilizing tube and the gas channel. Croushorn as modified teaches the housing is in communication with each of the stabilizing tube and the gas channel (see Croushorn fig. 4A-4B) and the housing is modified to have the recess channel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ramsey (US 20140142504 A1) and Munoz (US 20210361291 A1) with both teach balloon hemorrhage control devices insertable into puncture wounds.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE H SCHWIKER whose telephone number is (571)272-9503. The examiner can normally be reached Monday - Friday 7:30 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, Darwin Erezo can be reached at (571) 272-4695. 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.
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771