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 .
Election/Restrictions
Applicant’s election without traverse of Species II (Fig. 14A-14E) in the reply filed on 09/16/2025 is acknowledged.
Claim 39 is withdrawn from further consideration, there being no allowable generic or linking claim.
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 21-27 and 37 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 skin grafting system” in line 6. There is insufficient antecedent basis for this limitation in the claim. As best understood “the skin grafting system” should read “the skin grafting device” and has been interpreted as such for examination purposes.
Claims 22-27 are similarly rejected by virtue of dependency from claim 21.
Claims 27 and 37 each appear to positively recite an element (i.e., “an absorptive material”) positioned within an element that is not positively recited in the claim (i.e., “a peripheral housing of the cartridge”) which renders the scope of the claims indefinite. For examination purposes, the absorptive material has been interpreted as not being positively recited in the claims.
Claim 38 is similarly rejected by virtue of dependency from claim 37.
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 21-22, 27-29, 32-35, and 37-38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Miller et al. (US 2009/0194446).
Regarding claims 21 and 28, Miller discloses a clinical soil control system (see Fig. 2A-4A) comprising: a device cover (170) formed of a flexible polymer sheet (the containment bag may be made of flexible plastic, see [0138]) defining an interior volume (see Fig. 2B) configured to receive a handheld medical device (200); a gasket assembly affixed to the device cover to secure the device cover to the handheld 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).
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. 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”, it is understood that the clinical soil control system of Miller is capable of being used with a skin grafting device (i.e., another handheld medical device) having the claimed structural features. 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 configured to receive a cartridge of a skin grafting device depending on the size and shape of the cartridge.
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Regarding claim 22, Miller discloses the clinical soil control system of claim 21, wherein the gasket assembly includes a gasket positioned at the opening of the gasket assembly (see annotated Fig. 4B); and wherein when the cartridge extends through the opening of the gasket assembly, 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 (as discussed above with reference to claim 21, 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).
Regarding claims 27, 37 and 38, Miller discloses the clinical soil control system of claims 21 and 28. Claims 27, 37, and 38 each recite structural limitations of elements that are not positively recited by the claims (i.e., the cartridge and skin grafting device).
The clinical soil control system of Miller meets all the structural limitations of the claims and is capable of being used with a cartridge and skin grafting device having the claimed structural features including a plurality of microneedles, an absorptive material secured to an interior surface of a peripheral housing of the cartridge; the absorptive material including a hole that is aligned with a microneedle chamber of the cartridge; and the plurality of microneedles positioned within the microneedle chamber.
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; wherein the cartridge includes a plurality of microneedles; wherein the cartridge is configured to extend through the device cover.
It is noted that 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 of the structural limitations of the claim and is capable of being used with a skin grafting device having the features claimed.
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; wherein the cartridge includes a plurality of microneedles; wherein the cartridge is configured to extend through the device cover.
It is noted that 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 of 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”, it is noted that 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 of 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 and opening; the gasket of Miller is capable of pressing against an device component to prevent clinical soil from entering a handheld device, see [0011], [0218], and Fig. 4A-4B).
Claims 21-28 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by David et al. (US 6,716,215).
Regarding claims 21 and 28, David discloses a clinical soil control system (see Fig. 1) comprising: a device cover (40) formed of a flexible polymer sheet defining an interior volume, the device cover configured to receive a cartridge of a handheld medical device (bag 40 is made of polyethylene, which is a flexible polymer and 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 handheld medical device 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).
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. 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”, it is understood that the clinical soil control system of David is capable of being used with a skin grafting device (i.e., another handheld medical device) having the claimed structural features. 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 configured to receive a cartridge of a skin grafting device.
Regarding claim 22, David discloses the clinical soil control system of claim 21, wherein the gasket assembly includes a gasket (33, see Fig. 5) positioned at the opening of the gasket assembly; and wherein when the cartridge extends through the opening of the gasket assembly, 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 (as discussed above with reference to claim 21, the clinical soil control system of David can be used with a cartridge of a skin grafting device and includes an opening; the gasket of David is capable of pressing against an device component to prevent clinical soil from entering a handheld device, see col. 4, lines 18-20).
Regarding claim 23, David discloses the clinical soil control system of claim 22, wherein the gasket assembly includes a projection that is configured to contact the cartridge; and wherein the projection of the gasket assembly is configured to surround the cartridge (the seal 30 is formed of two projections extending on either side of the barrier 20 both of which surround the handheld device, see Fig. 5 and it is understood that the clinical soil control system of David can be used with a cartridge as claimed depending on the size and shape of the cartridge).
Regarding claim 24, David discloses the clinical soil control system of claim 23, wherein the projection is configured to face the skin grafting device when the cartridge extends through the opening of the gasket assembly (the projections formed by the projections formed by both halves of seal 30 are configured to face medical device 10, see Fig. 4-5, and it is understood that the clinical soil control system of David can be used with a cartridge and skin grafting device as claimed).
Regarding claim 25, David discloses the clinical soil control system of claim 23, wherein the projection includes a first notch and a second notch opposite the first notch (the internal edges of seal 30 form a first and second notch on either side of barrier 20, see Fig. 5).
Regarding claim 26, David discloses the clinical soil control system of claim 23, wherein the gasket assembly includes an exterior edge that extends away from the gasket (seal 30 has an exterior edge facing away from o-ring 33, see Fig. 5).
Regarding claim 27, David discloses the clinical soil control system of claim 21, further comprising an absorptive material positioned within a peripheral housing of the cartridge; wherein the absorptive material includes a hole that is aligned with a microneedle chamber of the cartridge; and wherein the plurality of microneedles are positioned within the microneedle chamber.
It is noted that claim 27 recites structural limitations of the cartridge which is not positively recited by the claim. The clinical soil control system of David meets all the structural limitations of the claim and is capable of being used with a cartridge having the claimed structural features including an absorptive material positioned within a peripheral housing of the cartridge; the absorptive material including a hole that is aligned with a microneedle chamber of the cartridge; and the plurality of microneedles positioned within the microneedle chamber.
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 portion of a skin grafting device”, it is understood that the clinical soil control system of Cancilla is capable of being used with a skin grafting device (i.e., another handheld medical device).
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.
It is noted that 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 of 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 if 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 of the structural limitations of the claim and is capable of being used with a cartridge having the features claimed.
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 19 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 is understood that a rubber band is an elastic band capable of contracting around an object.
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 include an elastic band as taught by Schwägli 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 “wherein 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 wherein 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 of 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
All of the documents cited in the attached PTO-892 teach related skin grafting devices, cartridges, and clinical soil control systems.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771