DETAILED ACTION
This is the initial Office action for non-provisional application 19/213,498 filed May 20, 2025, which claims priority from provisional application 63/649,748 filed March 20, 2024. Claims 1-20, as originally filed, are currently pending, wherein claims 5-7 and 14-18 have been withdrawn from further consideration.
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
Applicant’s election with traverse of Invention I and Species A in the reply filed on April 22, 2026 is acknowledged. The traversal is on the ground(s) that no search and/or examination burden exists. This is not found persuasive because although the claims are generally related to compression devices and providing compression to a part of a patient’s body, the structure of the system and garment of Invention I can be used to for providing therapy or treating other medical conditions or injuries. Since Invention II is specifically for treating a hypotension crisis event, the inventions have acquired a separate status in the art in view of their different classifications and would require a different filed of search which would result in a search burden. Further, since the distinct types of tension devices recited in Species A-C each have a significant structural difference from the other species, the species have acquired a separate status in the art in view of their recognized divergent subject matter and would require a different field of search which would result in a search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-18 have been withdrawn by Applicant from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 5-7, 14, and 15 have been withdrawn by Applicant from further consideration, pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim.
Since Applicant has elected claims directed to the product/apparatus, if all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims will 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.
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 3, 4, 13, and 20 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 3 recites the limitation “the pump unit activates upon receiving communication …”; however, this limitation appears to be directed to a process of using the system. While it appears Applicant is attempting to use functional language to define the invention by what it does rather than what it is, a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b). See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 1318, 97 USPQ2d 1737, 1748-49 (Fed. Cir. 2011). MPEP 2173.05(p). For examination purposes, the above limitation of claim 3 has been interpreted as “the pump unit is configured to activate upon receiving communication …”.
Claim 3 recites the limitation “causes the inflation of the inflatable cuff”; however, there is insufficient antecedent basis for the limitation “the inflation” in the claims. For examination purposes, the above limitation of claim 3 has been interpreted as “causes
Claim 4 is included in the rejection under 35 U.S.C. 112(b) based on its dependence from rejected claim 3.
Claim 13 recites the limitation “the response”; however, there is insufficient antecedent basis for this limitation in the claims. For examination purposes, the limitation “the response” has been interpreted as “a response”.
Claim 20 recites the limitations “the upper leg”, “the posterior”, and “the waist”; however, there is insufficient antecedent basis for these limitations in the claims. For examination purposes, the above limitations have been interpreted as “an upper leg”, “a posterior”, and “a waist”, respectively.
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.
Claims 1-4, 11-13, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Douglas et al. (US 2016/0166463).
Regarding claim 1, Douglas discloses a system (compression therapy system 105/200) capable of treating a hypotension crisis event, the system (105/200) comprising a sleeve (inflatable garment 110/205) shaped to be worn over a body part of a patient (user 100), a tension device (compression garment controller 210 + pneumatic chambers 220) disposed on the sleeve (110/205), and one or more sensors (sensors 225) in operable communication with the tension device (210+220) (Figs. 1-2; ¶ 0017, 0021-0024, & 0027).
Regarding claim 2, Douglas discloses that the tension device (210+220) comprises an inflatable cuff (pneumatic chambers 220) and a pump unit (pump 270) (Fig. 2; ¶ 0021-0024).
Regarding claim 3, Douglas discloses that the pump unit (270) is configured to activate upon receiving a communication from the one or more sensors (225) which causes inflation of the inflatable cuff (220) (¶ 0021-0024).
Regarding claim 4, Douglas discloses that the inflation of the inflatable cuff (220) causes increases compression of the body part of the patient (100) on which the sleeve (110/205) is worn (¶ 0022 & 0024).
Regarding claim 11, Douglas discloses that the one or more sensors (225) are temperature sensors (¶ 0027 & 0043).
Regarding claim 12, Douglas discloses that the one or more sensors (225) are blood-flow sensors (¶ 0052).
Regarding claim 13, Douglas discloses that a response of the tension device (210+220) is configurable with an application (APP 230) operating on a mobile device (mobile device 120/215) (figs. 1-2; ¶ 0017-0018, 0022-0023, & 0025).
Regarding claim 19, Douglas discloses a medical garment (compression therapy system 105/200) comprising one or more sleeves (inflatable garment 110/205) to be worn over one or more body parts of a patient (user 100), a tension device (compression garment controller 210 + pneumatic chambers 220) disposed on the garment (105/200), and one or more sensors (sensors 225) in operable communication with the tension device (210+220) (Figs. 1-2; ¶ 0017, 0021-0024, & 0027).
Regarding claim 20, Douglas discloses that the one or more body parts are chosen from a list consisting of an upper leg, a posterior, and a waist (¶ 0048).
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 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Douglas as applied to claim 1 above, in view of Arkans et al. (US 2020/0093383).
Douglas discloses the invention substantially as claimed, as described above, and further discloses that sleeve movement is collected for analysis to determine therapy system parameters (¶ 0019 & 0052).
However, Douglas fails to teach that the one or more sensors are motion sensors, gyroscopic sensors, or accelerometers.
Arkans discloses an analogous system (compression assembly) comprising a sleeve (compression wrap 202), a tension device (control unit 100 + fluid bladder 204) disposed on the sleeve (202), and one or more motion sensors including gyroscopic sensors (gyroscopes) or accelerometers (Figs. 1-2 & 6; ¶ 0009, 0040, 0043, 0046, 0049, & 0053-0054).
Therefore, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the invention, to modify the one or more sensors of the system taught by Douglas to include one or more motion sensors including gyroscopic sensors or accelerometers as taught by Arkans for the purpose of estimating the patient’s position or posture which can be used to provide values estimating an internal hydrostatic pressure for the body part of the patient to determine an appropriate therapeutic treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Keri J. Nelson whose telephone number is 571-270-3821. The examiner can normally be reached Monday - Friday, 9am - 4pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rachael E. Bredefeld, can be reached at 571-270-5237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KERI J NELSON/Primary Examiner, Art Unit 3786 5/27/2026
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