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 .
Claim Status
Claims 1-39 are currently pending.
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 1-39 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.
The term “semi-rigid” present in claims 1 and 21, is a relative term which renders the claim indefinite. The term “semi-rigid” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. One of ordinary skill in the art would not be reasonably apprised of the scope of the invention as one cannot determine based on the applicant’s specification or the claim language at what point an object stops being considered semi-rigid and begins being fully rigid or non-rigid. For example, to illustrate a viscous liquid might be considered semi-rigid when compared to a non-viscous liquid with the opposite end of the spectrum being one metal might be less resistant to bending than another and therefore would be considered more rigid thus making the more bendable metal semi-rigid if the standard of rigid is applied to the less bendable metal. As such the limitation of “semi-rigid” has a scope that is indefinite as it is relative to the application or material to which the terminology is being applied and thus does not hold a definitive meaning within the scope of the claim. As the applicant’s specification does not provide any detail as to how the context in which the term “semi-rigid” is being defined, the term is considered indefinite and claims 1 and 21 are herein rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 and 28 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 8 and 28 simply restate the limitations of claims 5 and 25 from which claims 8 and 28 are dependent and therefore do not further limit the subject matter of the claim upon which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1 and 21 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101). The limitations of “the patient having body, the body including an outer surface having a contour, anatomical areas or spaces located in the body, a chest, a chest wall, a chest cavity or pleural space, a diaphragm, a torso, an outer surface skin, and lungs” is positively claiming the structure required of the human organism and is therefore rejected under 35 U.S.C. 101 as encompassing a human organism.
Claims 2-20 and 22-39 are rejected under 35 U.S.C. 101 as being dependent upon rejected claims 1 and 21 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.
Claim(s) 1 and 21 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Overstreet et al. (U.S. Publication 2019/0046771).
Regarding claim 1, Overstreet discloses a drainage system a drainage system (Fig. 4 and Fig. 9) for removing blood and other fluids from an anatomical area in a human (¶0003 removing from a patient, urine, blood, or other fluids) the patient having body (Fig. 6 shows representation of patient body), the body including an outer surface having a contour (outer surface of skin of person is generally naturally contoured), anatomical areas or spaces located in the body, a chest, a chest wall, a chest cavity or pleural space, a diaphragm, a torso, an outer surface skin, and lungs (these are inherent features to a human patient) the drainage system comprising: a tubular drainage device (Fig. 9 catheter equivalent to element 140) having a semi-rigid elongate body (¶0004 shows capability of catheter to both maintain the lumen or be “kinked” depending on how catheter is treated showing a semi-rigid structure), the semi-rigid elongate body including a patient end (Fig. 4 shows end of 140 placed in patient 135), a curvilinear portion (Fig. 4, curved portion exiting element 120) operatively connected to the patient end, the curvilinear portion being adapted to permit insertion of the patient end of the tubular drainage device through an external incision or aperture formed in a patient's skin and in the outer surface of the patient's body and into an anatomical area of interest (Fig. 4 shows catheter inserted into patient which would inherently occur through an aperture formed in a patient skin in the outer surface of the patient’s body), a machine end (end opposite to patient end), and a continuous sidewall (wall forming lumen 140) extending between the machine end and the curvilinear portion (extends length of catheter), the continuous sidewall forming a hollow drainage portion or conduit (lumen 140) adapted to conform and to be secured to the outer surface of the patient's body (secured through grommet 120); and a drainage system securing apparatus or assembly (Fig. 4 elements 105,115,120, 125, 145; Fig. 9 elements 1-8) the drainage system securing assembly including a removable incision seal adhesive pad (parts 1-3), an incision seal subassembly (part 7 and 8), and a tube clamp subassembly (part 4 and 5), the incision seal subassembly and the tube clamp subassembly being operatively connected to the removable incision seal adhesive pad (Fig. 9 shows connection to part 3 which is connected to adhesive pads 1 and 2).
Regarding claim 21, Overstreet discloses a chest (¶0005 chest tube) drainage system a drainage system (Fig. 4 and Fig. 9) for removing blood and other fluids from an anatomical area in a human (¶0003 removing from a patient, urine, blood, or other fluids) the patient having body (Fig. 6 shows representation of patient body), the body including an outer surface having a contour (outer surface of skin of person is generally naturally contoured), anatomical areas or spaces located in the body, a chest, a chest wall, a chest cavity or pleural space, a diaphragm, a torso, an outer surface skin, and lungs (these are inherent features to a human patient) the drainage system comprising: a chest tube (Fig. 9 catheter equivalent to element 140) having a semi-rigid elongate body (¶0004 shows capability of catheter to both maintain the lumen or be “kinked” depending on how catheter is treated showing a semi-rigid structure), the semi-rigid elongate body including a patient end (Fig. 4 shows end of 140 placed in patient 135), a curvilinear portion (Fig. 4, curved portion exiting element 120) operatively connected to the patient end, the curvilinear portion being adapted to permit insertion of the patient end of the chest tube through an external incision or aperture formed in a patient's skin and in the outer surface of the patient's body and into the patient’s chest cavity (¶0005 thoracic cavity; Fig. 4 shows catheter inserted into patient which would inherently occur through an aperture formed in a patient skin in the outer surface of the patient’s body), a machine end (end opposite to patient end), and a continuous sidewall (wall forming lumen 140) extending between the machine end and the curvilinear portion (extends length of catheter), the continuous sidewall forming a hollow drainage portion or conduit (lumen 140) adapted to conform and to be secured to the outer surface of the patient's body (secured through grommet 120); and a drainage system securing apparatus or assembly (Fig. 4 elements 105,115,120, 125, 145; Fig. 9 elements 1-8) the drainage system securing assembly including a removable incision seal adhesive pad (parts 1-3), an incision seal subassembly (parts 7 and 8), and a tube clamp subassembly (part 4 and 5), the incision seal subassembly and the tube clamp subassembly being operatively connected to the removable incision seal adhesive pad (Fig. 9 shows connection to part 3 which is connected to adhesive pads 1 and 2).
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) 2-6 and 22-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Overstreet et al. (U.S. Publication 2019/0046771) in view of Roman et al. (U.S. Publication 2006/0211994).
Regarding claims 2 and 22, Overstreet disclose the drainage system of claims 1 and 21. Overstreet further discloses the removable incision seal adhesive pad including a membrane body having an upper surface (shown in Fig. 9), a lower surface (shown in Fig. 8), a peripherally extending edge surface (outer edge of pad), the removable incision seal pad comprising first (Part 2) and second adhesive pad segments (Part 1).
Overstreet does not expressly disclose a perforated seam or joint extending intermediate first and second opposing portions of the peripherally extending edge surface.
However, Roman, in the same field of endeavor of catheter securement on a patient, discloses providing a perforated seam between 47 extending intermediate a first and second opposing portion of a peripherally extending edge (see below illustrative diagram of Fig. 2) between a portion (frame 15) of the device securing the catheter insertion site (¶0020 surround IV needle insertion site) and a second portion (15a and 16) intended to secure catheter tubing distally to the insertion site, for the purpose of allowing all components of the catheter securing device to be secured together until they are needed and be detachable from each other to allow for separate application or to reserve for later use (¶0023 releasably secured to backing until they are needed, perforation 47 permit base strip and its adhesive backing to be detached from frame 15, permits separation from each other for separate application or to reservation for later use).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the incision seal adhesive pad of Overstreet to have included a perforation intermediate to first and second opposing portions such that it was between the portion of the device securing the catheter to the incision point of the patient and the portion designated for securing the catheter past the incision point for the purpose of allowing all components of the catheter securing device to be secured together until they are needed and to be detachable from each other to allow for separate application or to reserve for later use (¶0023 releasably secured to backing until they are needed, perforation 47 permit base strip and its adhesive backing to be detached from frame 15, permits separation from each other for separate application or to reservation for later use).
Regarding claims 3 and 23, Overstreet in view of Roman suggest the drainage systems of claims 2 and 22. Overstreet further discloses the lower surface of the membrane body including a hydrogel (¶0068 hydrogel adhesive) adhesive layer 130 extending thereacross (adhesive layer extends across lower surface of pad 3), the hydrogel adhesive layer being adapted to provide adhesive engagement with and conformation to the patient’s outer body surface contour (¶0058 flexibility optimized to securely attach to patient’s chest and sustain substantial external forces that are diffuse over the wide surface area and multiple points of contact states conformation to surface contour).
Regarding claims 4 and 24, Overstreet in view of Roman suggest the drainage systems of claims 3 and 23. Overstreet further discloses including a removable release liner extending across the hydrogel adhesive layer (¶0069 bottom portion of device has a liner that can be pulled to expose the adhesive and stick the device onto a patient, Fig. 8 shows release liner over pad).
Regarding claims 5 and 25, Overstreet in view of Roman suggest the drainage systems of claims 4 and 24. Overstreet further discloses the incision seal subassembly (parts 7 and 8) being operatively connected (¶0073 part 2 adheres to catheter and filler grommet to the first adhesive pad segment (Part 2) and the tube clamp subassembly (Part 4 and 5) being operatively connected (part 5 connected to part 4 connected to portion of part 3 connected to part 1) to the second adhesive pad segment (Part 1).
Regarding claims 6 and 26, Overstreet in view of Roman suggest the drainage systems of claims 5 and 25. Overstreet further discloses the first adhesive pad segment including an aperture (Part 6) extending between the upper surface and the lower surface (¶0079 hole cut to allow catheter to be fed into micro suction adhesive pad which lies beneath this hole, Fig. 4 shows hole extending through pad so that catheter may enter patient 135) circumferentially about and coaxially along an axis (axis through the center of the aperture), the aperture being adapted to be removably placed over the external incision in the patient’s skin.
Claim(s) 7-8 and 27-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Overstreet et al. (U.S. Publication 2019/0046771) in view of Roman et al. (U.S. Publication 2006/0211994) and Murphy et al. (U.S. Publication 2012/0165715).
Regarding claim 7 and 27, Overstreet in view of Roman suggest the drainage systems of claims 6 and 26. Overstreet in view of Roman do not expressly suggest the first adhesive pad segment including a plurality of internal one-way vents or venting channels embedded or formed in the membrane body, each of the one way vents being in fluid communication via a first end thereof with the aperture and via a second end thereof with the peripherally extending edge surface of the membrane body, whereby air, blood, fluids, and disease and/or infection produced matter and by-products are removed from the anatomical area of interest in the patient but are prevented from flowing back into the anatomical area of interest.
However, Murphy, in the same field of endeavor of coverings for chest cavity openings, discloses a covering (Figs. 1-3 element 10) wherein an adhesive pad segment 10 includes a plurality of internal one-way venting channels formed in the membrane body (¶0060 and ¶0061 valves integrally formed by the several layers, formed by top layer 80 and channel layer 70, open position, air and fluids are expelled from the wound into collection chamber 12, expelled fluids flow from collection chamber into drainage channel, negative pressure within the chest cavity can collapse the portion of the top layer against drainage channel in a fluid and airtight arrangement showing one-way function), each of the one way vents being in fluid communication via a first end (end connected to aperture) with the aperture and via a second end thereof with a peripherally extending edge surface of the membrane body (channel runs from inner aperture 12 to outside edge of membrane body), whereby fluids are removed from an anatomical area of interest in a patient but are prevented from flowing back into the anatomical area of interest (¶0060 and ¶0061 show one way nature of valve system with valve collapsing and closing upon negative back flowing pressure from the cavity) for the purpose of allowing fluids to escape from the patient chest cavity while blocking inflow of fluid into the patient cavity and preventing pneumothorax condition (¶0061 blocks inflow of fluid thus preventing a pneumothorax condition).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the first adhesive pad segment of Overstreet that includes the aperture leading to the patient incision, to have included a plurality of one-way venting channels leading from the aperture to the peripherally extending edge surface of the membrane body as disclosed by Murphy for the purpose of allowing any build up of fluid to escape from the patient chest cavity while blocking inflow of fluid into the patient cavity and preventing pneumothorax condition (¶0061 blocks inflow of fluid thus preventing a pneumothorax condition).
Regarding claims 8 and 28, Overstreet in view of Roman and Murphy suggest the drainage systems of claims 7 and 27 respectively. Overstreet further discloses the incision seal subassembly (parts 7 and 8) being operatively connected (¶0073 part 2 adheres to catheter and filler grommet to the first adhesive pad segment (Part 2) and the tube clamp subassembly (Part 4 and 5) being operatively connected (part 5 connected to part 4 connected to portion of part 3 connected to part 1) to the second adhesive pad segment (Part 1).
Allowable Subject Matter
Claims 9-20 and 29-39 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:
Regarding claims 9 and 29, Overstreet in view of Roman and Murphy suggest the drainage systems of claims 8 and 28 respectively. Overstreet further discloses the incision seal subassembly including a removable incision seal base frame 7 adapted to fit securely around and in sealing engagement with the apertured formed in the first adhesive pad segment, a sealing member (Part 8 as shown in figure 8 shows annular channel that would form seal between frame 7 and part 8) and an incision seal cap clamp (recess in part 8 that receives the catheter within it as seen in Fig. 9) removably positioned in an annular surface formed in the removable incision seal base frame (Part 7 forms annular ring and part 8 sits within that annular ring).
Overstreet in view of Roman and Murphy do not expressly disclose or suggest the seal base frame fitting securely into the aperture, as Overstreet discloses the frame being placed above the aperture, the annular surface being a stepped surface, or an incision seal elastic membrane removably positioned intermediate the incision seal cap clamp and a removable incision seal cap, and a securement mechanism adapted to releasably secure the incision seal cap clamp, the incision seal elastic membrane, and the incision seal cap to one another.
While some of these features of an incision seal assembly may be described separately in other prior art documents, one of ordinary skill in the art would not have been motivated at the time of the effective filing date of the current invention, to have modified the device of Overstreet in view of Roman and Murphy to have included that above features in conjunction with the features presented in relation to the adhesive pad structure as there is no teaching or motivation found in the art to perform such a modification.
As such the subject matter of claims 9 and 29, when taken into account with the limitations of the claims upon which they are dependent, is found to be considered allowable if rewritten to be presented in independent form.
As such claims 9 and 29, as well as claims dependent therefrom are allowable, but are herein objected to, as presented above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kantrowitz (U.S. Publication 2021/0268253) discloses an incision seal subassembly for maintaining positioning of catheters placed therein.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER DANIEL SMITH whose telephone number is (571)272-8564. The examiner can normally be reached Monday - Friday 7:30am-5:00pm.
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/PETER DANIEL SMITH/Examiner, Art Unit 3781
/GUY K TOWNSEND/Primary Examiner, Art Unit 3781