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
The amendments made to claims 1, 5, and 8 in the response filed on 5/7/2026 are acknowledged. Claims 1, 4-12, and 15-20 are still pending in the application and are examined below.
Response to Arguments
Applicant's arguments, see page 5, filed 5/7/2026, with respect to the objection of claim 8 have been fully considered and are persuasive. Therefore, the objections have been withdrawn.
Applicant's arguments, see page 5, filed 5/7/2026, with respect to the rejection of claims 5 and 13 under 35 U.S.C. 112(b) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn.
Applicant’s arguments, see pages 5-6, filed 5/7/2026, with respect to the rejection of claims 1, 6-10, 12-13, and 15 under 35 U.S.C 102 have been fully considered and are persuasive. However, upon further consideration, a new ground of rejection was made in view of Kim (KR 20160100011 A) to meet the newly added limitations of claim 1. Furthermore, the Office is maintaining the previous references used: Bennaars et al. (US 20240374335 A1), Kaska (US 20100275929 A1), Puentes et al. (US 20170105807 A1), and Rogers (US 20130167847 A1).
Applicant’s arguments, see page 7, filed 5/7/2026, with respect to the rejection of claims 4-5 and 16-20 under 35 U.S.C 103 have been fully considered but are moot due to a new rejection made for independent claim 1.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “attachment means (written specification: page 6, lines 18-20)” in claims 6-7, “support structure (written specification: page 7, lines 1-10)” in claim 10, and “attachment means (written specification: page 7, lines 27-34)” in claim 11.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
Claims 1, 4, 6-8, and 11-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim (KR 20160100011 A).
Regarding claim 1, Kim discloses a drape (1 – figure 5/6, surgical fabric: paragraph 0038-0039) for providing a sterile field around a portion of an imaging device (figure 5/6, the drape [1] is deployed to cover the patient and C-arm head: paragraph 0042-0044), the drape (1) comprising: an upper panel (210 – figure 5/6, a section that extends from the first cover [100 – figure 5/6]; it can have a folding structure: paragraph 0044) having an upper surface (N – see annotated figure 1, upper surface of the upper panel) and a lower surface (O – see annotated figure 1, lower surface of the upper panel); a front panel (100 – figure 3b/5/6, surgical cloth that covers the body of a patient: paragraph 0040) having an outer surface (P – see annotated figure 1, outer surface of the front panel) and an inner surface (Q – see annotated figure 1, inner surface of the front panel); and a rear panel (220 – figure 5/6, a section that extends from the upper panel [210]: paragraph 0052) having an outer surface (R – see annotated figure 1, outer surface of the rear panel) and an inner surface (S – see annotated figure 1, inner surface of the rear panel), wherein a side edge of the rear panel (T – see annotated figure 1, side edge of the rear panel) and a side edge of the front panel (U – see annotated figure 1, side edge of the front panel) define an opening therebetween such that the drape (1) is entirely free of side walls positioned between the rear panel (220) and the front panel (100) (see annotated figure 1/annotated figure 2, there is an opening between the side edge of the rear panel [T] and side edge of the front panel [U] that is free of side walls positioned between the rear panel [220] and front panel [100])
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Annotated figure 1: drape of Kim showing the different surfaces
Regarding claim 4, Kim discloses the invention as discussed in claim 1. Kim further discloses wherein the front panel (100) has a rectangular shape (figure 3b, the front panel [100] is rectangular).
Regarding claim 6, Kim discloses the invention as discussed in claim 1. Kim further discloses wherein attachment means (211 – figure 10, an attachment part such as Velcro: paragraph 0049) are positioned on the upper surface of the upper panel (N) adjacent an upper edge of the front panel (AA – see annotated figure 2, an upper edge of the front panel) (see annotated figure 1/annotated figure 2, the attachment means [211] is positioned on the upper surface of the upper panel [N] that is adjacent to the upper edge of the front panel [AA]: paragraph 0049), and wherein corresponding attachment means (211 – figure 10, another attachment part such as Velcro: paragraph 0049) are positioned on the upper surface of the upper panel (N) adjacent an upper edge of the rear panel (AB – see annotated figure 2, an upper edge of the rear panel) (see annotated figure 1/annotated figure 2, the attachment means [211] is positioned on the upper surface of the upper panel [N] that is adjacent to the upper edge of the rear panel [AB]; both attachment means [211] are configured to adhere to each other and are located on the upper surface [N] at both ends: paragraph 0049).
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Annotated figure 2: the lower/upper edge of the rear, upper edge front panel, and one or more pleats of Kim
Regarding claim 7, Kim discloses the invention as discussed in claim 6. Kim further discloses wherein the attachment means (211) on the upper surface of the upper panel (N) adjacent the upper edge of the front panel (AA) are aligned with the corresponding attachment means (211) on the upper surface of the upper panel (N) adjacent an upper edge of the rear panel (AB) when the drape (1) is folded inwardly along one or more fold lines to maintain the sterility of the upper panel (210) prior to use of the drape in a surgical procedure (see annotated figure 2, the attachment means [211] and corresponding attachment means [211] are configured to adhere to each other when the upper panel [210] is folded inwardly [there are one or more fold lines as seen in annotated figure 2], which is capable of maintaining sterility of the upper panel [210] prior to use [see examiner further notes below]: paragraph 0011/0049).
Examiner further notes: A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Regarding claim 8, Kim discloses the invention as discussed in claim 1. Kim further discloses wherein the upper panel (210) includes one or more pleats (AC – see annotated figure 2, one or more pleats), wherein the one or more pleats (AC) are expandable outwardly when the drape (1) is in use to surround the portion of the imaging device (figure 5/6, the one or more pleats [AC] can be folded and unfolded [expand outwardly] when the drape [1] is in use: paragraph 0021/0029/0046/0049).
Regarding claim 11, Kim discloses the invention as discussed in claim 1. Kim further discloses wherein an attachment means (215 – figure 10, a fixing part that is an adhesive: paragraph 0074) is disposed on the lower surface of the upper panel (O) adjacent the front panel (100) (see annotated figure 3/figure 10, the attachment means [215] is an adhesive that is disposed on the lower surface of the upper panel [O] adjacent to the front panel [100]; the attachment means [215] is connected to the front panel [100]: paragraph 0073).
Regarding claim 12, Kim discloses the invention as discussed in claim 1. Kim further discloses wherein the front panel (100) is positioned a distance away from a front edge of the upper panel (AE – see annotated figure 2, a front edge of the upper panel) toward the rear panel (220) (see annotated figure 2, the front panel [100] is positioned a distance away from the front edge of the upper panel [AE] toward the rear panel [220]).
Claim Rejections - 35 USC § 103
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 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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20160100011 A) in view of Bennaars et al. (US 20240374335 A1).
Regarding claim 5, Kim discloses the invention as discussed in claim 1.
However, Kim fails to disclose wherein the rear panel and the upper panel each include a linear section extending from an end point of a curved section towards the front panel, wherein an angle formed between an edge defined by the linear section and an axis extending from the end point of the curved section and intersecting with a front edge of the upper panel to form a 90 degree angle therewith ranges from 5 degrees to 45 degrees as measured from the axis.
Bennaars et al. teaches wherein an analogous rear panel (112 – figure 1F, stockinette seal: paragraph 0040) and an analogous upper panel (110 – figure 1F, surgical incise seal: paragraph 0044) each include a linear section (I/J – see annotated figure 3, linear section of the rear panel [I] and upper panel [J]) extending from an end point of a curved section (see annotated figure 3, each linear section [I/J] extends from an end point of a curved section) towards an analogous front panel (108 – figure 1F, drape seal: paragraph 0044), wherein an angle (K – see annotated figure 3, angle) formed between an edge defined by the linear section (I/J) and an axis (L – see annotated figure 3, axis) extending from the end point of the curved section (see annotated figure 3, the axis [L] extends from the end point of the curved section) and intersecting with a front edge of an analogous upper panel (M – see annotated figure 3, a front edge of the upper panel) to form a 90 degree angle (the axis [L] intersects with the front edge of the upper panel [M] and forms a 90 degree angle) therewith ranges from about 5 degrees to about 45 degrees as measured from the axis (L).
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Annotated figure 3: drape of Bennaars et al.
It would have been an obvious matter of design choice to make the rear panel and upper panel of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47. Further, applicant places no criticality on the shape claimed, indicating simply that the rear panel and upper panel has “an angle α formed between an edge defined by the linear section and an axis extending from the end point of the curved section and intersecting with the front edge of the upper panel to form a 90 degree angle therewith can range from about 5 degrees to about 45 degrees as measured from the axis” (written specification: page 2, lines 12-15).
Claims 9-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20160100011 A) in view of Kaska (US 20100275929 A1).
Regarding claim 9, Kim discloses the invention as discussed in claim 1.
However, Kim fails to disclose wherein at least one handle is present on the rear panel.
Kaska teaches wherein at least one handle (72 – figure 5, a formable member that can act as a handle to grasp the drape while the C-arm is being moved from one location to another: paragraph 0036) is present on an analogous rear panel (42 – figure 2, the rear face/distal side: paragraph 0032) (figure 5, the one handle [72] is present on the rear panel)
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the rear panel of Kim with at least one handle as taught by Kaska in order to provide a drape that has an improved rear panel that allows practitioners to easily grasp the drape while the C-arm is being moved from one location to another (paragraph 0036, Kaska).
Regarding claim 10, Kim discloses the invention as discussed in claim 1. Kim further discloses an upper edge of the rear panel (AB – see annotated figure 2, an upper edge of the rear panel) and a lower edge of the rear panel (AD – see annotated figure 2, a lower edge of the rear panel).
However, Kim fails to disclose wherein a support structure is attached at an upper edge of the rear panel, a lower edge of the rear panel, or a combination thereof.
Kaska teaches wherein a support structure (72 – figure 5, a formable member that can be a strip of metal or foil: paragraph 0036) is attached at analogous upper edge of the rear panel (68 – figure 5 upper edge of the rear panel: paragraph 0035), an analogous lower edge of the rear panel (70 – figure 5, lower free edge: paragraph 0036), or a combination thereof (figure 5, the support structure [72] can be attached at the upper edge of the rear panel or at the lower edge of the rear panel [70]: paragraph 0036).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have attached the upper edge of the rear panel and lower edge of the rear panel of Kim with a support structure as taught by Kaska in order to provide a drape that has an improved upper edge of the rear panel and lower edge of the rear panel to facilitate forming the drape about the portion of the imaging device, which in turns keeps the drape properly disposed on the imaging device (paragraph 0036, Kaska).
Regarding claim 15, Kim discloses the invention as discussed in claim 1.
However, Kim fails to disclose wherein the upper panel, the front panel, the rear panel, or a combination thereof is translucent, transparent, or radiolucent.
Kaska teaches wherein an analogous upper panel (46 – figure 2, an upper wall: paragraph 0032), an analogous front panel (40 – figure 2, the front face/proximal side: paragraph 0032), an analogous rear panel (42 – figure 2, the rear face/distal side: paragraph 0032), or a combination thereof is translucent, transparent, or radiolucent (the upper panel [46], front panel [40], rear panel [42] are constructed of clear plastic material: paragraph 0027/0031).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the upper panel, front panel, and rear panel of Kim to be translucent, transparent, or radiolucent as taught by Kaska in order to provide a drape that has an improved upper panel, front panel, and rear panel to ensure a flexible, tear and puncture-resistant material that economical in construction and is disposable after use (paragraph 0027, Kaska).
Claims 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20160100011 A) in view of Puentes et al. (US 20170105807 A1).
Regarding claim 16, Kim discloses the invention as discussed in claim 1.
However, Kim fails to disclose wherein the upper panel, the front panel, the rear panel, or a combination thereof is formed from a nonwoven material.
Puente et al. teaches wherein an analogous upper panel (10 – figure 2, base panel: paragraph 0039-0040), an analogous front panel (43 – figure 2, base panel extensions: paragraph 0039-0040), an analogous rear panel (44 – figure 2, base panel extensions: paragraph 0039-0040), or a combination thereof is formed from a nonwoven material (the upper panel [10], front panel [43], and rear panel [44] are made of nonwoven material: paragraph 0039-0040).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the upper panel, front panel, and the rear panel of Kim to be formed from a nonwoven material as taught by Puente et al. in order to provide a drape that has an improved upper panel, front panel, and the rear panel that is fluid repellent to prevent the passage of fluids, as well as bacterial and viral contaminants, across a sterile barrier: paragraph 0003/0040).
Regarding claim 17, Kim in view of Puente et al. discloses the invention as discussed in claim 16. Puente et al. further teaches wherein the nonwoven material comprises a spunbond material, a meltblown material, or a combination thereof (the nonwoven material comprises a single web, or an assembly or laminate of multiple webs, formed of individual randomly laid fibers by using a spunlaid, thermobonded, spunbonded, meltblown or bonded carded web process: paragraph 0040).
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kim (KR 20160100011 A) in view of Rogers (US 20130167847 A1).
Regarding claim 18, Kim discloses the invention as discussed in claim 1.
However, Kim fails to disclose wherein the upper panel, the front panel, the rear panel, or a combination thereof is formed from a film.
Rogers teaches wherein an analogous upper panel (W – see annotated figure 4, upper panel), an analogous front panel (13 – see annotated figure 4, section of clear polyethylene: paragraph 0031), an analogous rear panel (V – see annotated figure 4, rear panel), or a combination thereof is formed from a film (the upper panel [W], front panel [13], and rear panel [V] are made from sheets of clear polyethylene: paragraph 0017/0024/0031/0051).
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Annotated figure 4: drape of Rogers
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the upper panel, front panel, and rear panel of Kim to be formed from a film as taught by Rogers in order to provide a drape that has an improved upper panel, front panel, and rear panel that allows technicians or surgeons to see clearly through the drape and prevent the equipment from exposure to surgical biohazard (paragraph abstract/0024/0051, Rogers).
Regarding claim 19, Kim in view of Rogers discloses the invention as discussed in claim 18. Rogers further teaches wherein the film comprises polyethylene (the film comprises polyethylene: paragraph 0017/0024/0031/0051).
Regarding claim 20, Kim discloses the invention as discussed in claim 1.
However, Kim fails to disclose wherein the drape is sterilizable.
Rogers teaches wherein an analogous drape (10 – figure 2A, an accordion styled drape material that covers equipment: paragraph 0031-0032) is sterilizable (the drape [10] is made of polyethylene-based fabric that is suitable for sterilization: paragraph 0024/0031/0051).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the drape of Kim to be sterilizable as taught by Rogers in order to provide an improved drape that prevents infections and keeps equipment sterilized in an operating room (paragraph abstract/0002/0008, Rogers).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ANDREW JUN-WAI MOK whose telephone number is (703)756-4605. The examiner can normally be reached 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/ANDREW JUN-WAI MOK/Examiner, Art Unit 3786
/KARI K RODRIQUEZ/Primary Patent Examiner, Art Unit 3786
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