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 .
Response to Amendment
Applicant’s amendments of claims 1, 5-6, and 8-9 are acknowledged by the Examiner.
Applicant’s cancelations of claims 2, 4, 10-11, and 17-20 are acknowledged by the Examiner.
Applicant’s addition of new claims 21 is acknowledged by the Examiner.
Applicant’s amendments of claims 1 and 8 has overcome the previous claim objections. Therefore, the claim objections are withdrawn.
Applicant’s amendment of claim 1 has rendered the previous claim interpretation under 35 U.S.C. 112(f) moot.
Applicant’s cancelation of claim 4 has rendered the previous claim rejection under 35 U.S.C. 112(b) moot. Therefore, the claim rejections under 35 U.S.C. 112(b) are withdrawn. Applicant’s amendment of claim 1 includes similar limitations to claim 4, but addresses the lack of clarity issues.
Applicant’s cancelation of claim 10 has rendered the previous claim rejections under 35 U.S.C. 112(b) and 35 U.S.C. 112(d) moot. Therefore, the claim rejections under 35 U.S.C. 112(b) and 35 U.S.C. 112(d) are withdrawn.
Currently claims 1, 5-9, 12-16, and 21 are pending in the application, and claims 12-16, and 21 are withdrawn as being drawn to a non-elected invention.
Response to Arguments
Applicant's arguments filed 03/20/2026 have been fully considered but they are not persuasive.
With respect to Applicant’s arguments that Newman does not disclose a region that is “prepared for connection to the covering element”, Examiner respectfully disagrees. Newman discloses in [col 3 ln 14-26] that “the first and second layers 31 and 32 are adhered to one another to provide an impervious seal around the coil”. Thus, Newman discloses the application of adhesive which “prepares a region for connection to the covering element as claimed.
With respect to Applicant’s argument that “Newman does not expressly disclose the manner in which the upper layer 32 and the lower layer 31 are connected to each other”, and that “it is not inherent that the cited layers of the sheet 16 of Newman are configured to be connected using a coil adhesive surface” and the suggestion that the layers may be stitched or folded, Examiner respectfully disagrees. Newman clearly discloses in the cited section above, that 31 and 32 are adhered to one another, Newman does not disclose any form of stitching or folding as Applicant suggests, and Applicant’s “coil adhesive surface” as claimed is an area of the cloth which comprises adhesive which surrounds the coil for connection of the cloth to the cover. It can clearly be seen in figure 3 of Newman that the location in which 31 and 32 are adhesively bound to one another surrounds the MRI coil, and thus, is structured, and positioned the same as Applicant’s coil adhesive surface.
Thus, Applicant’s arguments that the cloth (31) is not provided with a coil adhesive surface is non-persuasive for the reasons above.
With respect to Applicant’s arguments that “Newman fails to disclose the cited cover is a separate cover cloth corresponding to the cited cloth in terms of size, shape and material. The upper layer 32 and lower layer 31 of the drape 14 of Newman are adhered together (in an undisclosed way). However, Newman does not teach or imply that these two layers should be provided separately and then adhered to each other only later when needed to form a seal around a local coil”, Examiner respectfully disagrees. First in the cited section, Newman discloses that 31 and 32 are first and second layers, and thus, 32 is a separate cover cloth as claimed. Second in the cited section, Newman discloses that 32 is a second layer of 16. Thus, both layers 31 and 32 correspond in size, and shape to one another to form the shapes described in [col 2 ln 25-40], and are both made from the same sterile material described in [col 1 ln 52-55]. Lastly, in Newman discloses in [col 3 ln 1-27] a sequential method of forming the drape of providing 31, applying foam 34 with adhesive to the major surface of 31, the coil of 18 being located on said foam 34, applying a covering layer of resistant fabric 36 over the coil, and then applying the second layer onto 31 to seal the MRI coil, thereby disclosing the two layers should be provided separately and then adhered to each other only later when needed to form a seal around a local coil as argued by Applicant.
In regards to Applicant’s arguments regarding claim 8, Examiner respectfully disagrees. First, with respect to Applicant’s arguments regarding a flat element made of rigid plastic integrated into the cloth, Applicant’s claim 8 recites “and/or”, and thus, the limitation is optional, and the prior art does not need to disclose the limitation to meet the claim. Second, as can be seen in figure 3, the coil adhesive surface which binds 31 and 32 about the coil 18 is clearly seen to be an enlarged outline which corresponds in shape with respect to the coil 18.
It is for at least these reasons that the arguments of claims 1 and 8 are non-persuasive, and the previous rejections of claims 1 and 8 are maintained.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Examiner has established that the reference of Newman discloses the sterile drape (14) is configured to be used on multiple aspects of the patient’s body (see [col 1 ln 48-62]), the drape (14) and attached local coil (18) are intended to conform to the contour of the part of the patient’s body (see [col 1 ln 57-62]), and has an opening (30; see [col 3 ln 35-40]; see figure 2) in the cover (32) and the cloth (31; 30 is made through the drape (i.e. both structures 31, and 32). Examiner also establishes the teaching reference of Puentes discloses the use of a circumferential opening in a drape intended to similarly conform to the contour of the part of the patient’s body (see [0037] and [0048]) is for the purpose of accommodating the natural geometry of the shoulder anatomy and create a circumferential seal that completely surrounds the patient's shoulder or other extremity (see [0048]), and to include such an aperture would further benefit the drape of Newman by providing premade openings through the drape which would remove any potential complications, or premature incisions in the patient which may arise from the surgeon being required to form the openings by cutting through the drape as disclosed by Newman in [col 2 ln 56-62]. Furthermore, one of ordinary skill in the art would not need to modify the reference of Newman to include the elastomeric sheet as suggested by Applicant.
Thus, the arguments of claim 7 are not persuasive and the previous grounds of rejection is maintained.
Election/Restrictions
Newly submitted claim 21 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claim 21 is drawn to non-elected species C (the embodiment of the cover element which comprises a rigid casing for receiving the MRI coil; see Requirement for Restriction/Election page 4)
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 21 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added 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.
Claim Objections
Claim 5 is objected to because of the following informalities:
Claim 5 recites the limitation “the rectangle side”. This limitation should be amended to recite “the single one of the rectangle sides” to maintain consistency in the claims.
Appropriate correction is required.
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, and 5-9 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 1 recites the limitation “the cover being made of a sterile and flexible material” in line 7. This limitation renders the claim indefinite because it is unclear if the cover is made from the same sterile and flexible material of the cloth presented earlier in the claim, or a new sterile and flexible material. For the purpose of examination, Examiner will interpret this limitation as being the same material.
Claim 5 recites the limitation “wherein the cover…has a rectangular outline”. This limitation renders the claim indefinite because it is unclear if the rectangular outline is the same outline of the cover recited in claim 1, or a new outline. For the purpose of examination, Examiner will interpret the outline of claim 5 as best understood.
Claim 5 recites the limitation “its rectangle sides”. This limitation renders the claim indefinite because it is unclear as to which structure “its” is referring to. For the purpose of examination, Examiner will interpret this limitation as “a single one of a rectangle side”.
Claim 5 recites the limitation "the coil adhesive area" in line 4. There is insufficient antecedent basis for this limitation in the claim. For the purpose of examination, Examiner will interpret this limitation as “the coil adhesive surface”.
Claims 6-9 are rejected under 35 U.S.C. 112(b) as being dependent on a rejected claim, and thus, contain the same offending limitations.
Claim Rejections - 35 USC § 102
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.
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, 5-6, and 8-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Newman et al. (US 5,396,905 A) (hereinafter Newman).
In regards to claim 1, Newman discloses a sterile drape (16; see [col 2 ln 13-20]; see figure 1) for use in magnetic resonance imaging examinations or operations by magnetic resonance imaging (see [col 1 ln 48-62]) using a magnetic resonance arrangement (18 and 28; see [col 2 ln 45-50]; see figure 2), the sterile drape (16) comprising:
a cloth (31; see [col 3 ln 5-10]; see figure 3) made of a sterile and flexible material (see [col 1 ln 50-55]); and
a covering element (32; see [col 3 ln 20-25]) comprising a cover (32; 32 forms a cover for 18 and therefore, comprises a cover) configured to cover a local coil (18) of the magnetic resonance arrangement (18 and 28; see [col 3 ln 20-25]) in a germ-proof manner (32 is sterile and thus covers 18 in a germ-proof manner; see [col 3 ln 25]), the cover being made of a sterile and flexible material (32 is a layer of 16, which is formed from a sterile material (see [col 1 ln 50-55]), and thus, 32 is made of the sterile and flexible material),
wherein the cloth (31) includes a region (upper surface of 31; see [col 3 ln 20-25]; see figure 3) that is prepared for connection to the covering element (32; the upper surface of 31 is prepared using adhesive for attachment to 32 see [col 3 ln 20-25]);
the region (upper surface of 31) includes a coil adhesive surface (adhesive on upper surface of 31 for attachment of 31 to 32; see [col 3 ln 20-25]) configured to attach the covering element (32) to the cloth (31; see figure 3 the adhesive of the upper surface of 31 is configured to attach 31 to 32); and
the cover (32):
is a separate cover cloth which corresponds to the cloth in terms of size, shape, and material (31 and 32 are two separate layers which together, form 16, and thus 31 and 32 correspond in size, shape, and material to form 16).
With respect to the limitation of the cover has an outline that corresponds to an outline of the coil adhesive surface, and includes an edge that is connected to the cloth and coincides with an edge of the coil adhesive surface or extends parallel to the edge of the coil adhesive, this limitation is followed by the term “or”, and thus, is optional such that the prior art does not need to disclose this limitation to read on the claim.
In regards to claim 5, Newman discloses the invention as discussed above.
Newman further discloses wherein the covering element comprises the cover (32; see discussion above that 32 forms a cover for 18 and therefore, comprises a cover), wherein the cover (32) comprises the sterile and flexible material of the cloth (31; see [col 1 ln 50-55]; 31 and 32 are both structures of the surgical drape made from the sterile flexible material; thus, 32 comprises the same material of 31) and has a rectangular outline (see [col 2 ln 25-40] that 16 comprises a square shape, and can also be rectangular, and thus, because 32 forms an upper layer of 16, 32 has a rectangular outline) and is connected to the cloth (31) with a single one of its rectangle sides (the entirety of 32 is adhered to 31, and thus, a single rectangular side of the rectangular outline is adhered to 31), the rectangle side coinciding with a corresponding rectangle side of the coil adhesive area (adhesive on upper surface of 31; 32 is applied over 31; see [col 3 ln 20-25]; therefore 32 has a rectangle side which corresponds to a rectangle side of the adhesive on the upper surface of 31 as claimed)
In regards to claim 6, Newman discloses the invention as discussed above.
Newman further discloses wherein the cloth (31) has a cloth opening (30 in 31; see [col 3 ln 35-40]; see figure 2) arranged within the coil adhesive surface (adhesive on upper surface of 31) and the cover (32) has a similarly shaped cover opening (30 in 32; see [col 3 ln 35-40]; see figure 2) aligned with the cloth opening (30 in 31; 30 is made through the drape (i.e. 31, 32, and the adhesive for binding 31 to 32); thus, each 30 created in 31 and 32 through this process are similarly shaped and aligned with one another).
In regards to claim 8, Newman discloses the invention as discussed above.
Newman further discloses wherein the coil adhesive surface (adhesive on upper surface of 31):
corresponds to an enlarged outline of the local coil lying or projected on the cloth (31; the adhesive on the upper surface of 31 is intended to bond 31 to 32 to seal 18 within the a pocket of the drape defined by 32; thus the adhesive on the upper surface corresponds to an enlarged outline of 18 defined by the edges of said pocket; see [col 3 ln 20-27]; see figure 3),
is rectangular or square (the drape is square; see [col 2 ln 25-30]; thus, 31 and the adhesive on the upper surface of 31 are also square shaped).
With regards to the limitations of is a flat element made of rigid plastic integrated into the cloth,
has a coil area configured to have a reduced adhesion to the local coil relative to a remainder of the coil adhesive surface, an outline of the coil area corresponds to an outline of the local coil, wherein the coil area is formed from a protective film of the outline of the local coil and is glued to a continuous adhesive surface, these limitations are followed by the term “and/or”, and thus, are optional such that the prior art does not need to disclose these limitations to read on the claim.
In regards to claim 9, Newman discloses the invention as discussed above.
Newman further discloses further comprising a patient adhesive surface (33; see [col 2 ln 30-35]; see figure 3) on a side of the cloth (31) that is opposite the coil adhesive surface (adhesive on upper surface of 31; see figure 3), the patient adhesive surface (33) being arranged concentrically or congruent with the coil adhesive surface (both adhesives are applied onto 31 and thus are concentric or congruent with each other).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Newman in view of Puentes et al. (US 2017/0105807 A1) (hereinafter Puentes).
In regards to claim 7, Newman discloses the invention as discussed above.
Newman discloses the sterile drape (14) is configured to be used on multiple aspects of the patient’s body (see [col 1 ln 48-62]), the drape (14) and attached local coil (18) are intended to conform to the contour of the part of the patient’s body (see [col 1 ln 57-62]), and has an opening (30; see [col 3 ln 35-40]; see figure 2) in the cover (32) and the cloth (31; 30 is made through the drape (i.e. both structures 31, and 32), but does not disclose wherein the cover opening and the cloth opening are circular, and the cover opening has a diameter that is smaller than a diameter of the cloth opening by 0.5 cm to 2 cm or by 1% to 10%.
However, Puentes teaches an analogous sterile drape (100; see [0037]; see figure 1) which is similarly configured to be used on multiple aspects of the patient’s body (see [0037] and [0048]), is intended to conform to the contour of the part of the patient’s body (see [0037] and [0048]) comprising an analogous cloth (10; see [0037]; see figure 1) and an analogous cover (elastomeric panel; see [0048]); wherein the cover (elastomeric sheet) comprises a cover opening (aperture in the elastomeric sheet; see [0048]) and the cloth (10) comprises a cloth opening (40; see [0048]; see figure 2) for defining a surgical site (see [0037]) wherein the cover opening (aperture in the elastomeric sheet) and the cloth opening (40) are circular (see figure 2 that 40 is circular; see [0048] that the aperture in the elastomeric sheet is smaller in size than 40 and thus, is also considered circular), and the cover opening (aperture in the elastomeric sheet) has a diameter that is smaller than a diameter of the cloth opening (40; see [0048]) for the purpose of accommodating the natural geometry of the shoulder anatomy and create a circumferential seal that completely surrounds the patient's shoulder or other extremity (see [0048]).
Therefore 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 cloth opening and cover opening as disclosed by Newman and to have formed the cloth opening and cover opening as circular openings, and the cover opening with a smaller diameter than a diameter of the cloth opening as taught by Puentes in order to have provided an improved drape that would add the benefit of accommodating the natural geometry of the shoulder anatomy and create a circumferential seal that completely surrounds the patient's shoulder or other extremity (see [0048]) as well as the benefit of providing premade openings through the drape which would remove any potential complications, or premature incisions in the patient which may arise from the surgeon being required to form the openings by cutting through the drape as disclosed by Newman in [col 2 ln 56-62].
Newman as now modified by Puentes does not explicitly disclose the cover opening has a diameter that is smaller than a diameter of the cloth opening by 0.5 cm to 2 cm or by 1% to 10%.
However, Puentes teaches that the diameter of the cover opening (aperture in elastomeric sheet) is smaller in size than the diameter of the cloth opening (40) to accommodate the natural geometry of the shoulder anatomy and create a circumferential seal that completely surrounds the patient's shoulder or other extremity (see [0048]). Thus, the size of the diameter of the cover opening taught by Puentes is considered to be a result effective variable in that changing the diameter of the cover opening affects the ability of the cover opening to properly accommodate the natural geometry of the shoulder anatomy and create a circumferential seal that completely surrounds the patient's shoulder or other extremity as taught by Puentes (see [0048]). Further, it appears that one of ordinary skill in the art would have had a reasonable expectation of success in modifying the diameter of the cover opening of Newman as now modified by Puentes to be smaller than the cloth opening by either of the claimed ranges as it involves only adjusting the dimension of the cover opening disclosed to require a smaller diameter than the cloth opening.
Therefore 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 diameter of the cover opening as disclosed by Newman as now modified by Puentes by forming the cover opening with a diameter that is 0.5 cm to 2 cm or by 1% to 10% than the diameter of the cloth opening as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation” In re Aller, 220 F.2d 454, 456, 105 USPQ 223, 235 (CCPA 1955) (see MPEP 2144.05 II A). Such a modification would add the benefit of ensuring the cover opening would properly accommodate the natural geometry of the shoulder anatomy and create a circumferential seal that completely surrounds the patient's shoulder or other extremity as taught by Puentes (see [0048]).
Further such a modification would have been obvious to one of ordinary skill in the art since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” In re Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984) (see MPEP 2144.04 IV A). In the instant case, Applicant has not provided a criticality to the diameter of the cover opening being smaller than the diameter of the cloth opening, contrarily stating in the specification on page 17 that “The diameter D2 of the opening 18 of the drape 12c is preferably chosen to be slightly smaller than the diameter D1 of the opening 19 of the cloth 1” which evidences that a smaller diameter of the cover opening is a preferential design choice obvious to one of ordinary skill in the art. Additionally, a device having the claimed relative dimensions would not perform differently than the prior art device as the prior art device having the claimed dimensions would still provide an opening in the drape to perform surgery through, and sufficiently cover the local coil within the cloth and the cover.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIEL MILLER whose telephone number is (571)270-5445. The examiner can normally be reached Mon-Fri 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alireza Nia can be reached at 571-270-3076. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL A MILLER/ Primary Examiner, Art Unit 3786
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