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 .
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.
Election/Restrictions
Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-3, 6-14, 18, 21, 22, 25, 27, and 28, drawn to methods for controlling the inflation of an intravascular balloon, classified in A61M5/1723.
II. Claims 46-48, drawn to balloon inflation systems, classified in A61B5/4836.
The inventions are independent or distinct, each from the other because inventions I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another materially different process such as, in response to determining that the proximal sensor data is at the proximal pressure threshold value, doing nothing.
Restriction for examination purposes as indicated is proper because all the inventions listed in this action are independent or distinct for the reasons given above and there would be a serious search and/or examination burden if restriction were not required because one or more of the following reasons apply:
There is a serious search burden because:
(1) the inventions have acquired a separate status in the art in view of their different classification;
(2) the inventions have acquired a separate status in the art due to their recognized divergent subject matter; and/or
(3) the inventions require a different field of search (e.g., searching different classes/subclasses or electronic resources, or employing different search strategies or search queries)..
Applicant is advised that the reply to this requirement to be complete must include (i) an election of an invention to be examined even though the requirement may be traversed (37 CFR 1.143) and (ii) identification of the claims encompassing the elected invention.
The election of an invention may be made with or without traverse. To reserve a right to petition, the election must be made with traverse. If the reply does not distinctly and specifically point out supposed errors in the restriction requirement, the election shall be treated as an election without traverse. Traversal must be presented at the time of election in order to be considered timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are added after the election, applicant must indicate which of these claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
During a telephone conversation with Lisa Amii on 23 January 2026, a provisional election was made without traverse to prosecute the invention of Group I, Claims 1-3, 6-14, 18, 21, 22, 25, 27, and 28. Affirmation of this election must be made by applicant in replying to this Office action. Claims 46-48 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Information Disclosure Statement
Applicant has submitted a long list of documents in the IDSs dated 1/4/24, 2/8/24, and 1/29/25. The Examiner refers Applicant to M.P.E.P. § 2004, and in particular to point 13, which states:
It is desirable to avoid the submission of long lists of documents if it can be avoided. Eliminate clearly irrelevant and marginally pertinent cumulative information. If a long list is submitted, highlight those documents which have been specifically brought to applicant’s attention and/or are known to be of most significance. See Penn Yan Boats, Inc. v. Sea Lark Boats, Inc., 359 F. Supp. 948, 175 USPQ 260 (S.D. Fla. 1972), aff’d, 479 F.2d 1338, 178 USPQ 577 (5th Cir. 1973), cert. denied, 414 U.S. 874 (1974). But cf. Molins PLC v. Textron Inc., 48 F.3d 1172, 33 USPQ2d 1823 (Fed. Cir. 1995).
Note that consideration by the Examiner of the information submitted in an IDS means nothing more than considering the documents in the same manner as other documents in Office search files are considered by the Examiner while conducting a search of the prior art in a proper field of search. See M.P.E.P. § 609. The Examiner has considered the garbage truck (2) and horse-drawn vehicle (1) documents cited.
The information disclosure statement filed 24 January 2024 fails in part to comply with 37 CFR 1.98(a)(1), which requires the following: (1) a list of all patents, publications, applications, or other information submitted for consideration by the Office; (2) U.S. patents and U.S. patent application publications listed in a section separately from citations of other documents; (3) the application number of the application in which the information disclosure statement is being submitted on each page of the list; (4) a column that provides a blank space next to each document to be considered, for the examiner’s initials; and (5) a heading that clearly indicates that the list is an information disclosure statement. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
More specifically, the following documents did not comply with one or more of the foregoing requirements:
(1) a 25-page document was located in the file which has no identifiers and appears to be missing one or more beginning pages; it was not considered, because it is not listed;
(2) Concerning “Screen capture from YouTube video clip entitled "Evolving Paradigms In Vascular Injury Management - Joseph DuBose - M.D.," 1 page, uploaded on September 12, 2017; Presented on March 22, 2016 by user "Surgery Grand Rounds 2016", only the page uploaded was considered, not the underlying video; see M.P.E.P. §§ 608.03 (”Where a video or DVD or similar item is submitted as a model or exhibit, applicant must submit photographs of what is depicted in the video or DVD (the content of the material such as a still image single frame of a movie) and not a photograph of a video cassette, DVD disc, or compact disc.”), 609.04(a) (“For example, published information, such as the visual output of a software program or a video, may be submitted only if reduced to writing, such as in the form of screen shots and/or a transcript”); and
(3) CA 2990479 A1, no copy provided.
Drawings
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: Fig. 5, #524a-f.
The drawings are objected to because the lead lines for the following reference numerals are required to include an arrowhead: Figs. 1A, 1B, #100 (cf. Fig. 1C); and, Fig. 4, #400.
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.
Specification
The Abstract of the Disclosure (“Abstract”) is objected to because it contains legal phraseology (“comprise” at line 2). A corrected Abstract is required. See MPEP § 608.01(b). Any replacement Abstract must commence on a separate sheet, apart from any other text, 37 C.F.R. §§ 1.52(b)(4), 1.72(b), and include markings to show added and deleted text, 37 C.F.R. § 1.121(b)(2).
The disclosure is objected to because of the following informalities: at [0126], line 4, 251a should probably be 251.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 22 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claim 22 requires, inter alia, “adjusting the volume of the expandable member such that . . . the expandable membrane sensor reaches a target expandable member pressure, wherein the target expandable member pressure is a negative pressure” (emphasis added).
Because the expandable member, i.e., inflatable balloon, is incapable of having an internal pressure below zero, because as the fluid is withdrawn from its interior it collapses, Claim 22 is directed to subject matter that is a physical impossibility, as claimed. Accordingly, there is no amount of experimentation that is required, much less a reasonable amount of experimentation, that will permit a person of ordinary skill in the art to make and/or use the claimed invention, because it is unattainable. With specific reference to the factors for determining compliance with the enablement requirement of 35 U.S.C. § 112(a) laid out in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988):
(A) The breadth of the claims - Claim 22 requires that the sensor “reach” a negative pressure, which is a physical impossibility;
(B) The nature of the invention - intravascular balloon inflation and deflation has been well explored over at least four decades;
(C) The state of the prior art - same, and the intraballoon pressure sensing and control is well-known;
(D) The level of one of ordinary skill - while high, there is no amount of skill that can permit a person of skill in the art to create a physical impossibility;
(E) The level of predictability in the art - the inflation/deflation characteristics of intravascular balloons is very well known and mostly predictable;
(F) The amount of direction provided by the inventor - the disclosure merely states that the value can be negative, without any guidance how to achieve that impossibility;
(G) The existence of working examples - none; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure - as discussed above, infinite.
In sum, because Claim 22 calls for performance of a manipulative step including reaching a physically unobtainable intraballoon pressure, the weight of each of the foregoing factors taken alone, and taken together, strongly weighs against Claim 22 being supported by an enabling Specification.
Claim Rejections - 35 USC § 102
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 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent App. Pub. No. 2020/046364, by Johnson et al. (“Johnson ‘364”).
Johnson ‘364 describes a method as claimed by Applicant, as follows.
Claim 1: A method for automatically controlling an expandable member in a blood vessel of a subject (Abstract), the method comprising:
obtaining, using a controller, proximal sensor data from a proximal pressure sensor (304) and distal sensor data from a distal pressure sensor (302) ([0050]);
comparing the obtained proximal sensor data to a proximal pressure threshold value ([0020], measuring flow is a measurement of pressure because of known relationships between them);
in response to determining that the proximal sensor data is above or at the proximal pressure threshold value, adjusting, using the controller, a volume of the expandable member based on the distal sensor data ([0020], [0054], processor changes balloon inflation state based on both sensors’ data, and therefore on the distal sensor’s data); and
in response to determining that the proximal sensor data is below the proximal pressure threshold value, adjusting, using the controller, the volume of the expandable member based on the proximal sensor data (id., for proximal sensor data).
Claims 1 and 10-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent App. Pub. No. 2021/0275783, by Johnson et al. (“Johnson ‘783”).
Johnson ‘783 describes a method as claimed by Applicant, as follows.
Claim 1: A method for automatically controlling an expandable member in a blood vessel of a subject (Abstract), the method comprising:
obtaining, using a controller, proximal sensor data from a proximal pressure sensor (Fig. 4, 120, 320) and distal sensor data from a distal pressure sensor (302) ([0032], [0064]-[0069]);
comparing the obtained proximal sensor data to a proximal pressure threshold value (Fig. 4, 340, [0064]-[0069]);
in response to determining that the proximal sensor data is above or at the proximal pressure threshold value, adjusting, using the controller, a volume of the expandable member based on the distal sensor data (Fig. 4, 350, processor changes balloon inflation state based on both sensors’ data, and therefore on the distal sensor’s data, [0064]-[0069]; 320, obtain pressure sensor data from “one or more” of the sensors, i.e., proximal and distal); and
in response to determining that the proximal sensor data is below the proximal pressure threshold value, adjusting, using the controller, the volume of the expandable member based on the proximal sensor data (id., for proximal sensor data).
Claim 10: (The method of claim 1,) wherein the proximal pressure threshold value is a lower limit of a proximal pressure guard range (340, “falls outside of a range”), and wherein adjusting the volume of the expandable member based on the proximal sensor data further comprises adjusting the volume of the expandable member based on the proximal sensor data until the proximal sensor data is above a lower limit of the proximal guard range (350, adjust size of expandable element, loop back to 320, obtain pressure sensor data).
Claim 11: (The method of claim 1,) wherein adjusting the volume of the expandable member based on the distal sensor data further comprises adjusting the volume of the expandable member so that distal blood pressure obtained from distal sensor data reaches a target distal pressure (same).
Claim 12: (The method of claims claim 11,) further comprising indicating whether the distal sensor data is progressing towards the target distal pressure value (390, 395, when it’s not, indicating via alarm).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 25, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson ‘783 as applied to Claim 1 above, and further in view of U.S. Patent App. Pub. No. 2020/0038566, by Johnson et al. (“Johnson ‘566”), as evidenced by “Blood Product: Essential Transfusions and Uses”, healthencyclopedia.org/blood-product/ (accessed 1/30/26) (“Blood Products”)
Johnson ‘783 describes a device substantially as claimed by Applicant; see above. It does not, however, describe:
automatically delivering a blood product to the subject, wherein the blood product is one or more of red blood cells, plasma, platelets, and cryoprecipitate (Claim 25);
that the blood product is delivered in one or more predetermined volumes, at a predetermined rate, or both (Claim 27); or
that the blood product is delivered in one or more variably determined volumes, at a variably determined rate, or both (Claim 28).
Johnson ‘566 relates to REBOA systems and methods and is therefore from an art which is the same as, or very closely analogous to, those of Applicant’s claims. Johnson ‘566 teaches that, in the use of such systems, blood products can be delivered to the patient ([0030], “to modulate patient physiology based on” a comparison of the blood pressure and a target pressure, id.; [0084]), which Blood Products teaches includes red blood cells, among other things; that the blood product is delivered in one or more predetermined volumes, at a predetermined rate, or both (syringe has a predetermined volume); and that the blood product is delivered in one or more variably determined volumes, at a variably determined rate (the volume of blood products delivered by the pump changes over time, and is thus a variably determined volume); all in the service of maintaining the patient’s blood pressure within target ranges ([0046], passim).
It 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, to further include, in the method described by Johnson ‘783, the foregoing additional steps, because Johnson ‘566 teaches doing so in a closely-related process, in order to better maintain the patient’s blood pressure within target ranges.
Allowable Subject Matter
Claims 2, 3, 6-9, 13, 14, 18, and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including 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.
The prior art of record, taken both alone and in permissible combination, fails to identically disclose or fairly suggest the combinations of features recited in Claims 2, 9, and 13, taken with the features of the claims from which they depend. More specifically, there is not sufficient evidence in the record to support a conclusion that it would have been obvious to modify the processes described in the prior art of record device to further include steps of: adjusting the volume of the expandable member such that the distal sensor data approaches an interim set point, wherein the interim set point is lower than or at a target distal pressure value (Claim 2); holding, using the controller, an interim set point for the distal sensor data constant, wherein the interim set point is lower than or at a target distal pressure value; and adjusting the volume of the expandable member such that the distal sensor data approaches the interim set point. (Claim 9); and, providing a first indicator if an interim set point is progressing towards the target distal pressure value within a predetermined first time period, and providing a second, different indicator if an interim set point remains constant or moves away from the target distal pressure value within the predetermined first time period (Claim 13). None of the prior art of record utilizes an interim set point in the manner specified in each of Claims 2, 9, and 13.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent App. Pub. No. 2025/0249220 describes a system for reducing blood pressure variability in a patient.
The balance of the documents cited with this Office Action relate generally to REBOA systems.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Adam J. Cermak whose telephone number is 571.272.0135. The Examiner can normally be reached M-F 7:30-4:00 Eastern Time.
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, Bhisma Mehta, can be reached on 571.272.3383. 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.
/ADAM J. CERMAK/
Assistant Patent Examiner
Art Unit 3783
/BHISMA MEHTA/Supervisory Patent Examiner, Art Unit 3783