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
This Office action is responsive to the amendment filed 05/18/2026. Claims 21, 24, 27-28, 33, and 37 have been amended. Claims 22-23 and 26 have been cancelled. Claims 42-44 have been newly added. Claims 21, 24-25, and 27-44 are currently pending in the application with claim 39 being withdrawn from further consideration.
Response to Arguments
Arguments regarding the rejection of claim 21 as being anticipated by Miller
Applicant’s arguments with respect to the rejection of claim 21 as being anticipated by Miller, see pg. 7-9, filed 05/18/2026, have been fully considered. The amendments to claim 21 overcome the rejection. Therefore, the rejection has been withdrawn. However, Applicant’s arguments with respect to the functional limitations of claim 21 are addressed herein.
Applicant argues that the Examiner has not provided rationale or evidence to show that the system of Miller is inherently capable of receiving a cartridge of a skin grafting device.
The Examiner disagrees. The Examiner has presented the position that Miller teaches a clinical soil control system for use with a handheld tool which therefore would be inherently capable of being used with other handheld tools such as a skin grafting device. Miller has all the claimed structural features and it would therefore inherently be capable of “receiving a cartridge of a skin grafting device, the cartridge of the skin grafting device including a plurality of microneedles” as claimed. “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant” (see MPEP 2112). Applicant has not shown why Miller, having all the structural features of the claimed clinical soil control system, would not be capable of receiving a cartridge of a skin grafting device. Although the claim also recites “the cartridge of the skin grafting device including a plurality of microneedles,” this does not impose a structural limitation on the claimed system because there is no standard size or shape for a cartridge of a skin grafting device.
Arguments regarding the rejection of claim 28 as being anticipated by Miller
Applicant’s arguments with respect to the rejection of claim 28 as being anticipated by Miller, see pg. 9, filed 05/18/2026, have been fully considered but they are not persuasive. Applicant’s arguments regarding the rejection of claim 28 as being anticipated by Miller are similar to those regarding the rejection of claim 21. Therefore, the Examiner’s position regarding the rejection of claim 21 also applies to the rejection of claim 28.
The rejection is maintained.
Arguments regarding the rejection of claim 21 as being anticipated by David
Applicant’s arguments with respect to the rejection of claim 21 as being anticipated by David, see pg. 10, filed 05/18/2026, have been fully considered. The amendments to claim 21 overcome the rejection. Therefore, the rejection has been withdrawn. However, Applicant’ arguments with respect to the functional limitations of claim 21 are addressed herein.
Similarly, as discussed above with respect to the rejection of claim 21 as being anticipated by Miller, the Examiner’s position is that David teaches a clinical soil control system having all the claimed structural features and would therefore inherently be capable of “receiving a cartridge of a skin grafting device, the cartridge of the skin grafting device including a plurality of microneedles” as claimed. “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant” (see MPEP 2112). Applicant has not shown why David, having all the structural features of the claimed clinical soil control system, would not be capable of receiving a cartridge of a skin grafting device. Although the claim also recites “the cartridge of the skin grafting device including a plurality of microneedles,” this does not impose a structural limitation on the claimed system because there is no standard size or shape for a cartridge of a skin grafting device.
Arguments regarding the rejection of claim 28 as being anticipated by David
Applicant’s arguments with respect to the rejection of claim 28 as being anticipated by Miller, see pg. 11, filed 05/18/2026, have been fully considered but they are not persuasive. Applicant’s arguments regarding the rejection of claim 28 as being anticipated by David are similar to those regarding the rejection of claim 21. Therefore, the Examiner’s position regarding the rejection of claim 21 also applies to the rejection of claim 28.
The rejection is maintained.
Arguments regarding the rejection of claim 28 as being anticipated by Cancilla
Applicant’s arguments with respect to the rejection of claim 28 as being anticipated by Cancilla, see pg. 11-12, filed 05/18/2026, have been fully considered but they are not persuasive. Applicant argues that Cancilla fails to teach the gasket of Cancilla is capable of receiving a cartridge of a skin grafting device including a plurality of microneedles.
Similarly, as discussed above with respect to the rejection of claim 21 as being anticipated by Miller and David, the Examiner’s position is that Cancilla teaches a clinical soil control system having all the claimed structural features and would therefore inherently be capable of “receiving a cartridge of a skin grafting device, the cartridge of the skin grafting device including a plurality of microneedles” as claimed. “Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the Examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant” (see MPEP 2112). Applicant has not shown why Cancilla, having all the structural features of the claimed clinical soil control system, would not be capable of receiving a cartridge of a skin grafting device. Although the claim also recites “the cartridge of the skin grafting device including a plurality of microneedles,” this does not impose a structural limitation on the claimed system because there is no standard size or shape for a cartridge of a skin grafting device.
The rejection is maintained.
Arguments regarding the rejections of Claims 40-41
Applicant’s arguments with respect to the rejection of claim 40, see pg. 12-12, filed 05/18/2026, have been fully considered but they are not persuasive. Applicant argues that the presence of the containment bag of Yoon in the device of Guiles would interfere with the insertion of disposable array 704 into base 708, thereby rendering the device of Guiles unsuitable for its intended purpose. Applicant’s argument relies on Yoon disclosure in paragraph [0087] that “In other embodiments, containment bags 530 can be coupled (e.g., attached via, for example, an adhesive, sonic welds, both, or the like) to coupler 514 so that an exterior (or distal) surface of the coupler is next to an interior surface of the containment bag.”
The Examiner disagrees. Yoon also describes within paragraph [0087] that “In some embodiments, containment bags 530 can be coupled (e.g., attached via, for example, an adhesive, sonic welds, both, or the like) to coupler 514 so that an interior (or proximal) surface of the coupler is next to an exterior surface of the containment bag.” In other words, Yoon discloses the containment bag can be positioned between the coupler 514 and the driver 526. This arrangement is also repeatedly shown in the Figures (see Fig. 8A-11A). Applying this teaching to Guiles, the containment bag would be positioned between device 732 and disposable array 704 rather than between the disposable array 704 and base 708. Accordingly, the containment bag of Yoon in the device of Guiles would not interfere with the engagement between array 704 and base 708.
Arguments regarding the rejection of Claim 36
Applicant’s arguments with respect to the rejection of claim 36, see pg. 13-14, filed 05/18/2026, have been fully considered but they are not persuasive. Applicant argues that Cancilla fails to teach that the gasket opening is rectangular. While the Examiner agrees that this limitation is not expressly taught by Cancilla, the Examiner maintains that modifying the gasket of Cancilla so that it has a rectangular shape would have been an obvious matter of design choice to one of ordinary skill in the art.
Cancilla teaches the gasket can have a non-circular shape and match the shape of an aperture (see [0095]). Therefore, Cancilla expressly contemplates the selection of the gasket shape based on the shape of the corresponding aperture that it forms a seal with. To select a rectangular shape would have been predictable solution for a correspondingly shaped aperture.
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 21, 24-25, 27, 37-38, 42-44 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 21 recites the limitation “wherein the cartridge of the skin grafting device is configured to…press against an exterior of the cartridge of the cartridge to form seal with the cartridge…” (see claim 21, lines 12-14). It is unclear how the cartridge can press against and form a seal with itself. For examination purposes, this limitation has been interpreted as the gasket is configured to press against an exterior of the cartridge to form a seal with the cartridge based on the specification and figures (see Fig. 14A-14E and [00163]).
Additionally, claim 21 recites the limitation “the projection surrounds the cartridge, extends along the cartridge, and contacts the exterior of the cartridge” in lines 16-17 which renders the scope of the claim indefinite because reciting the position of the projection relative to the cartridge creates ambiguity as to whether the cartridge is a structural limitation of the claimed clinical soil control system. During an interview on 07/20/2026, Applicant’s representative clarified that Applicant intends for the claimed clinical soil control system to include the device cover, gasket assembly and later recited absorptive material, but does not intend to positively recite the skin grafting device or cartridge as components of the claimed system (see attached interview summary). For examination purposes, the Examiner has interpreted the limitations of claim 21 consistent with Applicant’s stated intent. It is recommended that Applicant amends claim 21, lines 16-17 so that the claim reads “…the projection is configured to surround[[s]] the cartridge, extend[[s]] along the cartridge, and contact[[s]] the exterior of the cartridge” to fix the clarity issue.
Claims 24-25, 42 and 44 are similarly rejected by virtue of their dependency from claim 21.
Claim 27 recites the limitation “wherein the absorptive material includes a hole that is aligned with a microneedle chamber of the cartridge” which renders the scope of the claim indefinite since it is unclear whether the microneedle chamber of the cartridge is a positively recited component of the clinical soil control system. As noted above with respect to claim 21, the Examiner has interpreted the limitations of claim 27 consistent with Applicant’s stated intention that the skin grafting device, cartridge and microneedle chamber are not structural limitations of the claimed clinical soil control system.
The Examiner recommends amending claim 27 to make clear that the absorptive material includes a hole that is “configured to” align with a microneedle chamber of the cartridge.
Claim 37 appears to recite the absorptive material as both a part of the skin grafting device (see claim 37, lines 1-3) and the clinical soil control system (see claim 37, lines 3-4) which makes it unclear which features recited in claim 37 are structural requirements of the claimed clinical soil control system. Claim 37 further recites that “the absorptive material includes a hole that is aligned with a microneedle chamber of the cartridge” which renders the scope of the claim indefinite for similar reasons as stated above with respect to claim 27. For examination purposes, the Examiner has interpreted the limitations of claim 37 consistent with Applicant’s stated intention noted above; the clinical soil control system includes an absorptive material configured to be positioned within a peripheral housing of the cartridge, wherein the absorptive material includes a hole configured to be aligned with a microneedle chamber of the cartridge.
Claims 34 and 37 recites the cartridge “includes a plurality of microneedles,” which renders the scope of the claims indefinite since it is unclear if the recitation is referring back to the plurality of microneedles recited in claim 28 or if the recitation is introducing additional structure. For examination purposes, each recitation of the plurality of microneedles has been interpreted as referring to the same plurality of microneedles based on the specification and figures.
Claim 38 recites the limitation “wherein the absorptive material is secured to an interior surface of the peripheral housing of the cartridge” which renders the scope of the claim indefinite because it is unclear whether the interior surface of the peripheral housing of the cartridge is a positively recited component of the clinical soil control system. For examination purposes, the limitation has been interpreted consistent with Applicant’s stated intent as discussed above with respect to claims 21, 27 and 37.
The Examiner recommends amending claim 38 to make clear that the absorptive material is “configured to” be secured to an interior surface of the peripheral housing of the cartridge.
Claim 42 recites the limitation “wherein the periphery of the opening of the body of the gasket assembly, the gasket, the projection, and the cartridge each have the same shape,” which renders the scope of the claim indefinite because it is unclear if the cartridge is a positively recited component of the clinical soil control system. For examination purposes, the cartridge is not being treated as a positively recited component of system.
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 28-29 and 32-35 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 2009/0194446).
Regarding claim 28, Miller discloses a clinical soil control system (see Fig. 2A-4A) comprising: a device cover (170) defining an interior volume (see Fig. 2B) configured to receive a portion (250) of a handheld medical device (200); a gasket assembly affixed to the device cover to secure the device cover to the portion of the handheld medical device to inhibit fluid ingress into the interior volume of the device cover (a fluid seal is formed between the containment bag 170 and the coupler assembly 250 around the opening, see [0011], [0218], and Fig. 4A-4B).
The cartridge and skin grafting device are not positively recited in the claims and therefore are not structural requirements of the claimed clinical soil control system. Regarding the cover “configured to receive a cartridge of a skin grafting device, the cartridge of the skin grafting device including a plurality of microneedles”, since the clinical soil control system of Miller has all the claimed structural features, it is inherently capable of being used with a skin grafting device (i.e., another handheld medical device). Regarding “wherein the cartridge of the skin grafting device is configured to extend through an opening of the gasket assembly,” the device of Miller includes an opening (see annotated Fig. 4B below) which is inherently capable of receiving a cartridge of a skin grafting device, particularly since the claim does not provide any limit on the size and shape of the cartridge.
Where the claimed and prior art products are identical or substantially identical in structure, a prima facie case of either anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01 (I).
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Regarding claim 29, Miller discloses the clinical soil control system of claim 28, wherein the device cover includes an access opening (172, see Fig. 2B) that is sized, such that a user is able to hold the medical device (see Fig. 3A-3C).
Regarding claim 32, Miller discloses the clinical soil control system of claim 28, wherein the device cover is transparent; and wherein the device cover includes a flexible polymer sheet (the containment bag is made of a flexible clear plastic material, see [0011]).
Regarding claim 33, Miller discloses the clinical soil control system of claim 28, wherein the skin grafting device includes a handheld device and a cartridge; and wherein the cartridge is configured to extend through the device cover.
The skin grafting device is not positively recited and therefore is not a structural requirement of the clinical soil control system. The clinical soil control system of Miller meets all the structural limitations of the claim and is capable of being used with a skin grafting device having the features claimed.
Regarding claim 34, Miller discloses the clinical soil control system of claim 33, wherein the gasket is configured to secure the device cover to the handheld medical device (a fluid seal is formed between the containment bag 170 and the coupler assembly 250 around the opening, see [0011], [0218], and Fig. 4A-4B).
Regarding “wherein the cartridge includes a plurality of microneedles; and wherein the cartridge is configured to extend through the gasket opening”, the cartridge is not positively recited by the claim and is therefore not a structural requirement in clinical soil control system. The clinical soil control system of Miller meets all the structural limitations of the claim and is capable of being used with a skin grafting device and cartridge having the features claimed.
Regarding claim 35, Miller discloses the clinical soil control system of claim 34, wherein when the cartridge extends through the gasket opening of the gasket, the gasket is configured to press against an exterior of the cartridge to form a seal with the cartridge to prevent clinical soil from entering the handheld device (as discussed above, the clinical soil control system of Miller can be used with a cartridge of a skin grafting device and includes an opening; the gasket of Miller is capable of pressing against a device component to prevent clinical soil from entering a handheld device, see [0011], [0218], and Fig. 4A-4B).
Claim 28 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by David et al. (US 6,716,215).
Regarding claim 28, David discloses a clinical soil control system (see Fig. 1) comprising: a device cover (40) defining an interior volume, the device cover configured to receive a portion (12) of a handheld medical device (bag 40 defines an interior volume for receiving a medical device 10, see Fig. 1 and col. 4, lines 24-37); a gasket assembly (30) affixed to the device cover to secure the device cover to the portion to inhibit fluid ingress into the interior volume of the device cover (the sealed aperture forms a sterile seal about the device, see col. 4, lines 18-20).
The cartridge and skin grafting device are not positively recited in the claims and therefore are not structural requirements of the claimed clinical soil control system. Regarding the cover “configured to receive a cartridge of a skin grafting device, the cartridge of the skin grafting device including a plurality of microneedles”, since the clinical soil control system of David has all the claimed structural features, it is inherently capable of being used with a skin grafting device (i.e., another handheld medical device). Regarding “wherein the cartridge of the skin grafting device is configured to extend through an opening of the gasket assembly,” the device of David includes an opening (see Fig. 5) which is inherently capable of receiving a cartridge of a skin grafting device, particularly since the claim does not provide any limit on the size and shape of the cartridge.
Where the claimed and prior art products are identical or substantially identical in structure, a prima facie case of either anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01 (I).
Claims 28 and 33-34 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cancilla et al. (US 2022/0338947).
Regarding claim 28, Cancilla discloses a clinical soil control system (see Fig. 1A-2C) comprising: a device cover (14) defining an interior volume, the device cover configured to receive a portion of a handheld medical device (12); and a gasket (22) affixed to the device cover to secure the device cover to the handheld medical device to inhibit fluid ingress into the interior volume of the device cover (see [0073] and [0086]); and wherein the gasket includes a gasket opening (see Fig. 2C).
The cartridge and skin grafting device are not positively and therefore are not structural requirements of the claimed clinical soil control system. Regarding the cover “configured to receive a cartridge of a skin grafting device, the cartridge including a plurality of microneedles” and the gasket opening being “configured to receive the cartridge,” since the clinical soil control system of Cancilla has all the claimed structural features, it is inherently capable of being used with a skin grafting device (i.e., another handheld medical device), particularly since the claim does not provide any limit on the size and shape of the cartridge.
Where the claimed and prior art products are identical or substantially identical in structure, a prima facie case of either anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01 (I).
Regarding claim 33, Cancilla discloses the clinical soil control system of claim 28, wherein the skin grafting device includes a handheld device and a cartridge; wherein the cartridge includes a plurality of microneedles; wherein the cartridge is configured to extend through the device cover.
The skin grafting device is not positively recited and therefore is not a structural requirement of the clinical soil control system. The clinical soil control system of Cancilla meets all the structural limitations of the claim and is capable of being used with a skin grafting device having the features claimed.
Regarding claim 34, Cancilla discloses the clinical soil control system of claim 33, wherein the gasket is configured to secure the device cover to the cartridge of the handheld medical device (the gasket provides a seal about the device and device cover, see [0086]).
Regarding “wherein the cartridge includes a plurality of microneedles; and wherein the cartridge is configured to extend through the gasket opening,” the cartridge is not positively recited and therefore is not a structural requirement of the claimed clinical soil control system. The clinical soil control system of Cancilla meets all the structural limitations of the claim and is capable of being used with a cartridge having the features claimed.
Claims 21, 24-25, 28, 42 and 44 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Black et al. (US 20170027658).
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Regarding claims 21 and 28, Black discloses a clinical soil control system (see Fig. 1-4A) comprising: a device cover (10) formed of a flexible polymer sheet defining an interior volume (the cover is flexible and formed of a polymer material, see [0021] and [0033]), the device cover configured to receive a cartridge of a medical device (bearing carrier 27 can be considered a cartridge of a medical device since it carries shaft 26 and is removably attached to the medical device 12, see [0046]); a gasket assembly (29) affixed to the device cover to secure the device cover to the cartridge of the medical device to inhibit fluid ingress into the interior volume of the device cover (see [0047] and Fig. 4A), the gasket assembly including: a body including an opening, an exterior edge extending radially away from the opening, and a projection extending upwardly away from the opening, the projection being closer to the opening than the exterior edge (see opening, exterior edge and projection in annotated Fig. 4 above; the projection is the operation of the inner channel of the collar 29 that as a stepped increase in diameter – it can be considered projecting upwardly away from the opening, where “upwardly” depends on the orientation of the device); and a gasket (32) positioned at the opening and extending radially into the opening (seal 32 extends into the opening of collar 29, see annotated Fig. 4 and Fig. 4A); wherein the cartridge of the medical device is configured to extend through the opening of the body of the gasket assembly and the gasket is configured to press against an exterior of the cartridge to form a seal with the cartridge to prevent clinical soil from entering a handheld device of the skin grafting device (bearing carrier 27 extends through the opening in collar 26 and seal 32 presses against an exterior of carrier 27 to prevent fluids from entering the device, see [0047]); and wherein when the cartridge extends into the opening of the body, the projection is configured to surround the cartridge, extend along the cartridge, and contact the exterior of the cartridge (when bearing carrier 27 extends into the opening of the gasket assembly formed by collar 29, the projection surrounds, extends along and contacts an exterior of the cartridge, see annotated Fig. 4 and Fig. 4A).
Regarding the language “the device cover configured to receive a cartridge of a skin grafting device, the cartridge of the skin grafting device including a plurality of microneedles,” it is noted that the cartridge and skin grafting device are not positively recited in the claims and therefore are not structural requirements of the claimed clinical soil control system. The clinical soil control system of Black meets all the structural limitation of the claim and is inherently capable of being used with a skin grafting device (i.e., another handled medical device) and a cartridge having the claimed structural features. The device of Black includes an opening (see annotated Fig. 4 and Fig. 4A) that is inherently capable of receiving a cartridge of a skin grafting device, particularly since the claim does not provide any limit on the size and shape of the cartridge.
Where the claimed and prior art products are identical or substantially identical in structure, a prima facie case of either anticipation has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). MPEP 2112.01 (I).
Regarding claim 24, Black discloses the clinical soil control system of claim 21, wherein the projection is configured to face the medical device when the cartridge extends through the opening of the gasket assembly (the projection face bearing carrier 27, see annotated Fig. 4 and Fig. 4A; the clinical soil control system of Black is capable of being used with a cartridge and skin grafting device as claimed).
Regarding claim 25, Black discloses the clinical soil control system of claim 21, wherein the projection includes a first notch and a second notch opposite the first notch (see annotated Fig. 4 above).
Regarding claim 42, Black discloses the clinical soil control system of claim 21, wherein the periphery of the opening of the body of the gasket assembly, the gasket, the projection, and the cartridge each have the same shape (the opening, gasket formed by seal 32, projection, and the cartridge formed by bearing carrier 27 all have a circular outer profile, see annotated Fig. 4 above).
Regarding claim 44, Black discloses the clinical soil control system of claim 21, wherein the gasket assembly includes a first end and a second end opposite the first end; and wherein the first end of the gasket assembly includes the gasket and exterior edge; wherein the second end of the gasket assembly includes the projection (see annotated Fig. 4 and Fig. 4A).
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.
Claims 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Miller, as applied to claim 29 above, and further in view of Schwägli et al. (US 2019/0290378).
Regarding claim 30, Miller discloses the clinical soil control system of claim 29, wherein the device cover includes a flexible stay (180, see Fig. 2B) at the access opening (172); the flexible stay may include an adhesive and restricts the size of the second opening when the cover is closed (see [0137]). Miller fails to teach an elastic band configured to contract to decrease the size of the access opening.
Schwägli, in the same field of art, teaches a device cover (10, see Fig. 7) having an opening (opening at the proximal end of the device, see Fig. 7) wherein the opening includes a means (62) for restricting a size of the second opening. The means (62) may be a rubber band, adhesive or tape, which are known as equivalent structures for securing a cover about a handheld medical device (see [0061]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the cover of Miller to substitute an elastic band as taught by Schwägli in place of an adhesive since an adhesive and an elastic band have been shown to be interchangeable and both would yield the predictable results of securing the device cover about the device.
Regarding claim 31, Miller and Schwägli teach the clinical soil control system of claim 30. Miller further teaches the gasket opening is positioned opposite the access opening (the position of the gasket is opposite the opening 172, see annotated Fig. 4B and Fig. 2B).
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Cancilla et al. (US 2022/0338947).
Regarding claim 36, Cancilla discloses the clinical soil control system of claim 34.
Regarding “the gasket opening is rectangular,” Cancilla discloses that the gasket while shown as circular may be non-circular (see [0095]). Cancilla fails to expressly teach the gasket opening is rectangular. However, it appears that the clinical soil control system of Cancilla would work equally well with a circular gasket, as disclosed, or a rectangular gasket, as claimed, depending on the shape of the aperture the gasket is sealing. Further, Applicant has not disclosed that the claimed shape solves any stated problem or is for any particular purpose.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the clinical soil control system of Cancilla such that the gasket opening is rectangular since it appears to be a matter of choice which fails to patentably distinguish over Cancilla. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding “wherein the cartridge opening is rectangular,” it is noted the cartridge is not positively recited by the claim and is therefore not a structural requirement of the claim. The clinical soil control system of Cancilla meets all the structural limitations of the claim and is capable of being used with a cartridge having a rectangular opening.
Claims 40-41 are rejected under 35 U.S.C. 103 as being unpatentable over Guiles et al. (US 2016/0310159) in view of Yoon (US 2014/0262880).
Regarding claims 40 and 41, Guiles discloses a skin grafting system comprising: a cartridge (704) including a plurality of microneedles (disposable array 704 contains a plurality of hollow microneedles, see [0022] and [0081]).
Guiles fails to teach a device cover formed of a flexible polymer sheet defining an interior volume; wherein the device cover is secured directly to the cartridge; wherein the device cover and the cartridge form a singular component; and wherein the device cover is secured directly to the cartridge by welding the device cover and the cartridge together to form the singular component.
However, it is noted that the cartridge 704 of Guiles couples to a handheld device 732 and barriers for handheld medical devices are well known in the art.
Yoon, in the same field of art, teaches a device cover (530a, see Fig. 8A) formed of a flexible polymer sheet (the containment bag may be made of flexible plastic, see [0086]) defining an interior volume (546a); and wherein the device cover is secured directly to a device coupling (514) by welding the device cover and the coupling together to form a singular component (see [0087]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the skin grafting system of Guiles to include a device cover, as taught by Yoon, since doing so would prevent contamination of the device during a surgical procedure (see Yoon [0086]).
In the combined skin grafting system of Guiles and Yoon, the device cover would be secured directly to the cartridge by welding since Yoon teaches welding the device cover directly to the device coupling.
Claims 21, 27, 28, 37, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Guiles et al. (US 20160310159), in view of Black et al. (US 20170027658) and further in view of O’Brien et al. (US 20170354810).
Regarding claims 27, 37 and 38, Guiles discloses a system comprising a skin grafting device (732, see Fig. 7B) and a cartridge (704) including a plurality of microneedles (see [0022] and [0081]).
Guiles fails to teach a device cover and gasket assembly as claimed in claims 21 and 28.
Black teaches a device cover and gasket assembly as claimed in claims 21 and 28 (see rejections of claims 21 and 28 in view of Black above).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Guiles to include a device cover and gasket assembly, as taught by Black, since doing so would maintain sterility of the environment during a procedure (see Abstract of Black).
The combination of Guiles and Black fails to teach an absorptive material as claimed in claims 27, 37, and 38.
O'Brien (US 20170354810), in the same field of art, discloses a cartridge (200, see Fig. 2) containing a plurality of microneedles (215a) surrounded by a peripheral housing (210) and an absorptive material (250, see [0045]) secured to an interior surface of the peripheral housing (see Fig. 2) and including a hole (240, see Fig. 2A) configured to align with a microneedle chamber of the cartridge (see Fig. 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Guiles and Black to include an absorptive material as taught by O'Brien since doing so would prevent "liquid contaminants from flowing back through the cartridge and reaching the main body of the device" (see O'Brien [0007]).
Claim 21, 42, 43 is rejected under 35 U.S.C. 103 as being unpatentable over Guiles et al. (US 20160310159), in view of Black et al. (US 20170027658).
Regarding claim 43, Guiles discloses a system comprising a skin grafting device (732, see Fig. 7B) and a cartridge (704) including a plurality of microneedles (see [0022] and [0081]).
Guiles fails to teach a device cover and gasket assembly as claimed in claim 21 and 42.
Black teaches a device cover and gasket assembly as claimed in claims 21 and 42 (see rejections of claims 21 and 42 in view of Black above).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of Guiles to include a device cover and gasket assembly, as taught by Black, since doing so would maintain sterility of the environment during a procedure (see Abstract of Black).
It is the Examiner’s position that the combination of Guiles and Black teaches that the periphery of the opening of the body of the gasket assembly, the gasket, the projection, and the cartridge each have a rectangular shape since Black teaches these components all having the same shape (see rejection of claim 42 above) and the cartridge of Guiles is rectangular (see disposable array 704 in Fig. 7B of Guiles). Therefore, it follows that in modifying the system of Guiles to include a cover and gasket assembly, as taught by Black, that the peripheries of these components would also be modified to match the geometry of the cartridge of Guiles so that a seal can be formed as intended.
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.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
