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 OA is to replace the OA sent out on 12/12/25, as a wrong set of claims were examined.
DETAILED ACTION
Claims 31-50 pending. Claims 31-50 are examined on the merits.
Claim Objections
Claims 32-35, and 42-45 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.
Claim Rejections –35 USC § 112, 2nd
The following is a quotation of the second paragraph of 35 U.S.C. 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 36 and 46 recite the trademark/trade name “Xarelto, Arixtra, Lovenox, Coumadin, Eliquis, and Plavix” at line 2. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112, second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. Applicant is required to provide full generic chemical names of the reagents that are used in the claims since “Xarelto, Arixtra, Lovenox, Coumadin, Eliquis, and Plavix” do not tell one of ordinary skills in the art exactly what is in the compounds and such trademark can change the compositions at any time.
Therefore, the metes and bounds of claims are rendered vague and indefinite. The lack of clarity renders the claims very confusing and ambiguous since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
All other cited claims depend directly or indirectly from rejected claims and are, therefore, also, rejected under U.S.C. 112, second paragraph for the reasons set forth above.
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 31, 36-41, and 46-49 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Herz et al (US 20030069528 A1).
Herz et al teach prevention and treatment of deep venous thrombosis (see Title) (thus a method of treating or preventing thrombosis in a subject, thus claims 31 and 41 are met). Heparin (thus administering to the subject a pharmacologic agent to reduce clotting, thus claims 36 and 46 are met) or other inhibitors would be administered by continuous intravenous infusion or by subcutaneous injection (thus injectable, thus claims 37 and 47 are met) into sites in the foot while the superficial venous and lymphatic systems of the lower leg are collapsed. The simplest way to direct heparin or other inhibitory agent into the deep veins of the legs would be by pressure tourniquet (thus claim 38 is met, thus or by securing an appliance to a body portion of the subject; and transmitting energy into the body portion of the subject from at least one energy unit coupled to the appliance and positioned on the body portion of the subject, wherein the energy transmitted is configured to break up thrombosis in the body portion of the subject, thus claims 31 and 41 are met, thus a compressive force, thus claim 39 is met) pressure boots [0063].
Herz et al teach other anticoagulants have also been used in patients undergoing orthopedic surgery. Warfarin used as an anticoagulant resulted in a total incidence of DVT of 31% with an incidence of 3% proximal vein thrombosis in patients undergoing total hip replacement (Francis et al, 1992). No placebo group was used but these patients usually have an incidence of DVT of around 40% to 60%. Bailey et al (1991) found an incidence of DVT of 26.6% in hip replacement patients receiving low dose warfarin. Coumadin used as anticoagulant in a group of patient undergoing knee arthroplasty resulted in an overall incidence of DVT of 33% with an incidence of thigh vein thrombi of 6% [0029].
Herz et al teach because the energy levels of the ultrasonic transducer device is of a relatively low intensity level, the use of ultrasound (thus claim 40 is met) techniques may be an alternative embodiment facilitating absorption [0115].
Herz et al teach means have been sought to increase blood flow in the legs of immobilized patients. These have included elastic stockings, intermittent pneumatic leg (calf and thigh) compression, passive foot motion and electrical stimulation of the calf muscle [0036].
Herz et al teach compression of the superficial veins of the foot and calf will shift the blood that normally flows in these veins to the deep veins of the calf Since reduced blood flow in the deep veins of the calf is accepted as a contributing factor in the development of DVT, increasing the blood flow is an accepted means of reducing the risk (see background for description and documentation). Compressing the superficial veins and shifting blood flow to the deep veins of the calf is an essential element of the proposed new method for preventing or treating DVT [0065].
Herz et al teach in both versions pressure will be attained by inflation of her inner bladder with a hand compressible elastic bulb with a single one way valve for inflation. A separate valve will be provided for deflation [0073] (thus securing an appliance to a body portion of the subject; and transmitting a fluid from an inflation device into a plurality of bladders or chambers in the appliance to apply a compressive force to the body portion of the subject contacted by the appliance, wherein the appliance is at least one of a compression wrap or garment configured to couple to the inflation device, thus claim 41 is met; thus wherein the applied compressive force is configured to at least one of i) prevent thrombin formation, ii) prevent clot formation, iii) break-up thrombin formation, or iv) increase vascular flow, or vi) combinations thereof, in the body portion of the subject, thus claim 48 is met; thus further comprising controlling the plurality of bladders or chambers to inflate in succession to provide sequential compression against the body portion of the subject to at least one of increase blood flow, reduce swelling, or combinations thereof in the body portion of the subject, thus claim 49 is met).
Therefore, the reference is deemed to anticipate the instant claim above.
Claim Rejections –35 USC § 103
The following is a quotation of 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained through the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 31, 36-41, and 46-50 are rejected under 35 U.S.C. 103(a) as being unpatentable over Herz et al as applied to claims 31, 36-41, and 46-49 above, and further in view of Mcspadden et al (US 20130030331 A1).
The teachings of Herz et al are set forth above and applied as before.
The teachings of Herz et al do not specifically teach the heating or cooling step in claim 50.
Mcspadden et al teach method and system for application of thermal therapy (thus applying heating, thus claim 50 is met) relative to the treatment of deep-vein thrombosis and lymphedema (see Title). Mcspadden et al teach the system has a therapy cuff (1000) wrapped around an appendage e.g. ankle, of a patient, where the cuff comprises a resistive-heating element that is coupled to a control unit. A compression bladder (1002-1) is fluidly coupled to the control unit via a tube, and arranged outwardly of the resistive-heating element. A compression chamber is formed in the bladder. The resistive-heating element dilates a set of vessels in the appendage to facilitate removal of accumulated fluid from the appendage via inflation of the bladder. Another compression chamber is coupled to a third compression chamber (see Abstract).
It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to heat the body portion of the subject contacted by the appliance since Mcspadden et al teach application of thermal relative to the treatment of deep-vein thrombosis and the cuff comprises a resistive-heating element. Since both of the references teach treating thrombosis, one of the ordinary skill in the art would have been motivated to combine the teachings of the references together.
From the teachings of the references, it is apparent that one of the ordinary skills in the art would have had a reasonable expectation of success in producing the claimed invention.
Thus, the invention as a whole is prima facie obvious over the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/Qiuwen Mi/
Primary Examiner, Art Unit 1655