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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17127300, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, there is no support in the parent application for the claim limitations regarding the wing extending transversely through the slit.
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.
Claims 1-10, 14, and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The independent claims variously recite said wing extending transversely through said slit. However, the claims, and the disclosure, recite and describe the wing as a defining side of the slit. There is no written description of how such a function of manipulating the wing could be accomplished given the nature of the slit.
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 1-15 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. The independent claims recite said wing extending transversely through said slit.
Regarding claims 1-10, 14, and 15, It is unclear how it would be possible for the wing to extend through the slit when the slit itself is defined on one side by the wing. It is further unclear how the wing would extend transversely through the slit, given the orientation of the slit itself relative to the usage of “transverse” in the claims.
Regarding claims 11 and 12, the phrase “transverse alignment” in the limitation “slipping the independently manipulatable wing of the laminate into transverse alignment” requires a point of reference to which alignment can be gauged, which appears to be lacking from the claim.
Regarding claim 13, “the second-revealed double backed adhesive” lacks antecedent basis.
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) 11 and 12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Graichen et al. (WO 2017105917).
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Regarding claim 11, as best understood, Graichen et al. discloses a method for installing a stabilizer (“dressing 1” of Fig. 1-3) to retain a catheter (“catheter 200” and “tubes 230” of Fig. 3) in an inserted condition at a point of penetration into the anatomy of a patient (see Fig. 3 illustrating the catheter retained in an inserted condition at a point of penetration into the anatomy of a patient), the stabilizer (1) having laminate front clear film (see Pg. 13, lines 1-6 indicating how, “The opening is provided with a transparent film” and see Pg. 8, lines 4-5 indicating how, “A layer of polymeric film as described above may be co-extensive with the dressing. It may be co-extensive with a layer of nonwoven material”) and rear double-backed adhesive layers (see Pg. 12, line 33-37 indicating how, “The underside of the dressing 1, not visible in Figure 1, is provided with a continuous layer of pressure-sensitive adhesive, by which the dressing 1 can be affixed to the skin of a patient. The layer of adhesive extends over the entire surface of the dressing 1” and note how the adhesive must, therefore, be double-back in order to adhere to the dressing on one side and the skin of a patient on the other side) and a slit (“lumen securement cut 151” of Fig. 1) dividing the laminate into a main body (see Examiner’s annotated Fig. 1 above) and an independently manipulable integral wing (see Examiner’s annotated Fig. 1 above), a method comprising the steps of: aligning the stabilizer (1) approximately on a vertical lengthwise plane through the catheter (200/230, see Fig. 2-3 illustrating the stabilizer aligned on a lengthwise plane through the catheter and note how, when the patient illustrated in Fig. 2-3 lays in a horizontal position, the stabilizer will be aligned approximately on a vertical lengthwise plane through the catheter) and an exposed portion of the catheter extending radially from the point of penetration along the vertical lengthwise plane toward a closed end of the slit (“end point 171” of Fig. 1, see Fig. 1-3 illustrating an exposed portion of the catheter extending radially from the point of penetration along the lengthwise plane which may be vertical toward the closed end of the slit); simultaneously smoothing and pressing the aligned stabilizer to adhere a portion of the main body of the laminate against an underlying portion of the anatomy (see Fig. 2-3 illustrating the stabilizer smoothed and pressed to adhere the main body portion of the laminate against underlying portion of the anatomy); slipping the independently manipulable wing of the laminate into transverse alignment under the catheter (200/230) with the catheter (200/230) seated in the closed end of the slit (151, see Fig. 3 illustrating the independently manipulable wing of the laminate slipped under the catheter transversely with the catheter seated in the closed end of the slit); and simultaneously smoothing and pressing the unadhered portions of the stabilizer (1) to adhere the unadhered portion of the main body (see Examiner’s annotated Fig. 1 above) of the laminate and the independently manipulable integral wing (see Examiner’s annotated Fig. 1 above) of the laminate against underlying portions of the anatomy and the exposed portion of the catheter (see Fig. 2-3 illustrating the unadhered portion of the stabilizer smoothed and pressed to adhere the unadhered portion of the main body and the independently manipulable integral wing against underlying portion of the anatomy and the exposed portion of the catheter).
Regarding claim 12, as best understood, Graichen et al. discloses the method according to claim 11 and further dislcloses the adhesive layer having a window (“window 130” of Fig. 1, see Pg. 13, lines 1-5) through the main body (see Fig. 1 above illustrating the window being through said main body) and the step of aligning further comprising the window (130) displaying the point of penetration (220) of the catheter (200/230) into the anatomy of the patient (see Fig. 2-3 illustrating how the window displays the point of penetration of the catheter into the anatomy of the patient) and an exposed portion of the catheter (200/230) extending radially from the point of penetration along the vertical lengthwise plane toward the closed end of the slit (151, see Fig. 2-3 illustrating how the exposed portion of the catheter extends radially from the point of penetration along the lengthwise plane which may be vertical and toward the closed end of the slit).
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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Howell et al. (US 20150224285) in view of Graichen et al.
Howell et al.:
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Regarding claim 13, as best understood, Howell et al. discloses for installing a stabilizer (“dressing 400” of Fig. 8-10) to retain a catheter (“medical article 200” of Fig. 7) in an inserted condition at a point of penetration into the anatomy of a patient (see Fig. 26 illustrating the stabilizer retaining the catheter in an inserted condition at a point of penetration into the anatomy of a patient), the stabilizer (400) having laminate front clear film (“occlusive layer 418” of Fig. 10, see [0106] indicating how, “the occlusive layer 418 comprises a film which may or may not be transparent”), intermediate double-backed adhesive (“top surface 408” and “bottom surface 406” of Fig. 10, see [0115], lines 1-5 indicating how “bottom surface 406” corresponds to an adhesive surface and see Fig. 8-10 illustrating how the clear film is adhered to “top surface 406” such that the intermediate layer corresponds to a double-backed adhesive) and rear releasable paper layers (“release liners 435 and 436” of Fig. 8-10) and a slit (“channel 450” of Fig. 8-9) dividing the laminate into a main body (see Examiner’s annotated Fig. 9 above) and an independently manipulable integral wing (see Examiner’s annotated Fig. 9 above), the adhesive layer having a window (“insertion window 426” and “retainer window 425” of Fig. 8-10) through the main body (see Fig. 9 above illustrating how the window is disposed through said main body), a method comprising the steps of: aligning the stabilizer (400) approximately on a vertical lengthwise plane through the catheter (200) with the window (426/425) positioned to display the point of penetration of the catheter (200) into the anatomy of the patient (see Fig. 26 illustrating the stabilizer aligned on a vertical lengthwise plane through the catheter with the window positioned to display the point of penetration of the catheter) and an exposed portion of the catheter extending radially from the point of penetration toward a closed end of the slit (450, see Fig. 2 illustrating an exposed portion of the catheter extending radially from the point of penetration toward a closed end of the slit); peeling a first release paper (“release liner 436” of Fig. 8-10) of the releasable paper layer (436/435), revealing the double backed adhesive lying under the first release paper (see Fig. 22 illustrating the first release paper being peeled to reveal the double backed adhesive lying under the first release paper) and at least partly opening the window (426/425) so as to display at least the point of penetration of the catheter into the anatomy of the patient and a portion of the exposed portion of the catheter extending radially from the point of penetration (see Fig. 22 and Fig. 26 illustrating how peeling the first release paper partly opens the window to display the point of penetration and a portion of the exposed portion of the catheter extending radially from the point of penetration); simultaneously smoothing and pressing the aligned stabilizer (400) to adhere the first-revealed double backed adhesive against an underlying portion of the anatomy (see Fig. 26 illustrating how the first-revealed double backed adhesive has been smoothed and pressed against the underlying portion of the anatomy); peeling a second release paper (“release liner 435” of Fig. 8-10) of the releasable paper layer (436/435), revealing the double backed adhesive lying under the second release paper and fully opening the window to display more of the exposed portion of the catheter extending radially from the point of penetration (see Fig. 23-24 and Fig. 24 illustrating how the second release paper is peeled to reveal the double backed adhesive lying there under and fulling opening the window to display more of the exposed portion of the catheter extending radially from the point of penetration); and simultaneously smoothing and pressing the unadhered portions of the stabilizer to adhere the second-revealed double backed adhesive against an underlying portion of the anatomy and the exposed portion of the catheter (see Fig. 26 illustrating how the unadhered portions of the stabilizer are smoothed and pressed to adhere the second-revealed double backed adhesive against the underlying portion of the anatomy and the exposed portion of the catheter), except for dislosiong slipping the independently manipulable wing of the laminate under the catheter with the catheter seated in the closed end of the slit.
However, Graichen et al. discloses for installing a stabilizer (“dressing 1” of Fig. 1-3) to retain a catheter (“catheter 200” and “tubes 230” of Fig. 3) in an inserted condition at a point of penetration into the anatomy of a patient (see Fig. 3 illustrating the catheter retained in an inserted condition at a point of penetration into the anatomy of a patient), the stabilizer (1) having laminate front clear film (see Pg. 13, lines 1-6 indicating how, “The opening is provided with a transparent film” and see Pg. 8, lines 4-5 indicating how, “A layer of polymeric film as described above may be co-extensive with the dressing. It may be co-extensive with a layer of nonwoven material”) and rear double-backed adhesive layers (see Pg. 12, line 33-37 indicating how, “The underside of the dressing 1, not visible in Figure 1, is provided with a continuous layer of pressure-sensitive adhesive, by which the dressing 1 can be affixed to the skin of a patient. The layer of adhesive extends over the entire surface of the dressing 1” and note how the adhesive must, therefore, be double-back in order to adhere to the dressing on one side and the skin of a patient on the other side) and a slit (“lumen securement cut 151” of Fig. 1) dividing the laminate into a main body (see Examiner’s annotated Fig. 1 above) and an independently manipulable integral wing (see Examiner’s annotated Fig. 1 above), said slit (151) originating at approximately a quarter-point of a long edge (“second long edge 20” of Fig. 1) of the laminate and extending towards an opposing long edge (“first long edge 10” of Fig. 1), said slit (151) extending across a majority of the width of said laminate (see Fig. 1 illustrating how said slit extends across a majority of the width of said laminate), a method comprising the steps of: aligning the stabilizer (1) approximately on a vertical lengthwise plane through the catheter (200/230, see Fig. 2-3 illustrating the stabilizer aligned on a lengthwise plane through the catheter and note how, when the patient illustrated in Fig. 2-3 lays in a horizontal position, the stabilizer will be aligned approximately on a vertical lengthwise plane through the catheter) and an exposed portion of the catheter extending radially from the point of penetration along the vertical lengthwise plane toward a closed end of the slit (“end point 171” of Fig. 1, see Fig. 1-3 illustrating an exposed portion of the catheter extending radially from the point of penetration along the lengthwise plane which may be vertical toward the closed end of the slit); simultaneously smoothing and pressing the aligned stabilizer to adhere a main body portion of the laminate against an underlying portion of the anatomy (see Fig. 2-3 illustrating the stabilizer smoothed and pressed to adhere the main body portion of the laminate against underlying portion of the anatomy); slipping the independently manipulable wing of the laminate under the catheter (200/230) with the catheter (200/230) seated in the closed end of the slit (151, see Fig. 3 illustrating the independently manipulable wing of the laminate slipped under the catheter with the catheter seated in the closed end of the slit); and simultaneously smoothing and pressing the unadhered portions of the stabilizer (1) to adhere the unadhered portion of the main body (see Examiner’s annotated Fig. 1 above) of the laminate and the independently manipulable integral wing (see Examiner’s annotated Fig. 1 above) of the laminate against underlying portions of the anatomy and the exposed portion of the catheter (see Fig. 2-3 illustrating the unadhered portion of the stabilizer smoothed and pressed to adhere the unadhered portion of the main body and the independently manipulable integral wing against underlying portion of the anatomy and the exposed portion of the catheter).
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 stabilizer of Howell et al. such that the slit originates and extends from approximately a quarter-point of one of said long edges toward an opposite edge of said laminate across a majority of the width of said laminate as is taught by Graichen et al. Furthermore, 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 method of Howell et al. such that the method further comprises slipping the independently manipulable wing of the laminate under the catheter with the catheter seated in the closed end of the slit as is further taught by Graichen et al. Such a modification is advantageous because the slit taught by Graichen et al. facilitates attaching and guiding tubes of a catheter in a cost-effective manner so that the tubes are limited in their movement relative to the dressing which reduces mechanical stresses on the catheter and thereby reduces the risk of catheter dislodgement (see Pg. 10, lines 26-30 of Graichen et al.).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN R PRICE whose telephone number is (571)270-5421. The examiner can normally be reached Mon-Fri 8:00am-4:00pm Eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN R PRICE/Primary Examiner, Art Unit 3783